IJPC 12 1 Compounding

J A NU A R Y / F E B R U A R Y 2 0 0 8
INTERNATIONAL JOURNAL
PHARMACEUTICAL
COMPOUNDING
C O M P O U N D I N G F O R H O S P I C E A N D C A N C E R P AT I E N T S
Page 8 Intravitreal Bevacizumab for Choroidal Page 38 Disposing of Expired Drugs and Chemicals
Neovascularization in Age-Related Macular
Degeneration Page 54 Considerations for Implementing USP Chapter
<797>: Verification of Accuracy, Sterility, and
Page 28 Hospice and Compounding Pharmacy Sterilization of Compounded Preparations
Volume 12 no.1
(january|february|08)
In This Issue...
Features
8 Intravitreal Bevacizumab for Choroidal Neovascularization in
Age-Related Macular Degeneration
Jean G. Dib, bspharm, PharmD, MS; saud abdulmohsin, bspharm, ms
16 Cancer-Related Terminology:
Glossaries for Compounding Pharmacists and Their Clients
Lavonn a. williams
28 Hospice and Compounding Pharmacy: Once
8
Inseparable
Lavonn a. williams
Applied Compounding
38 Disposing of Expired Drugs and Chemicals:
New Options for Compounders
Jane Vail
50 Quality-Control Analytical Methods:

Stability Versus Potency Testing: The Madness is in the Method
Thomas C. Kupiec, PhD; Rodney Skinner; Lance Lanier, RPh
54 Basics of Compounding:
Considerations for Implementing United States Pharmacopeia Chapter <797>
Pharmaceutical Compounding—Sterile Preparations, Part 5: Verification of
16
Accuracy, Sterility, and Sterilization of Compounded Preparations
Loyd V. Allen, Jr., PhD, RPh; Claudia C. Okeke, PhD, RPh
63 Standard Operating Procedure:

Compliance with the Health Insurance Portability and Accountability Act
(HIPAA) of 1996
Business of Compounding
48 Marketing
Websites: Keeping Current in 2008
Patricia L. Storey, RPh, FACA
38
www.ijpc.com International Journal of Pharmaceutical Compounding
Vol. 12 No. 1 | January/February 2008 1
IJPC TABLE OF CONTENTS
Peer Reviewed Departments INTERNATIONAL JOURNAL
74 Specialty 4 PreScription PHA RMACEUTICAL

Year Number 12…and Still Much Work COMPOUNDING™
Compounding for Improved to Do ADDRESS: 122 N. Bryant, Edmond, OK 73034-6301 USA
Patient Care: 2006 National Survey of TEL: 800-757-4572, 405-330-0094 FAX: 405-330-5622
From the editor
Compounding Pharmacists
D.C. Huffman, RPh, PhD;
( Edi tori al )
Erin R. Holmes, PharmD, MS 62 Calculations Editor-in-Chief
Loyd V. Allen, Jr, PhD, RPh
Compounding for Cancer Patients
Production Manager
83 Room Temperature Shelly J. Stockton, BSPharm,
PhD, RPh
LaVonn Williams
Stability of Injectable Designer

Kari Riley, BFA

Succinylcholine Dichloride
JULIE J. ROY, BPHARM, MSC, PHD
87 PostScription Contributing Authors
DANIEL BOISMENU, BSC, PHD

Consumer Options for the Disposal of Gigi Davidson, BSPh, RPh, FSVHP, DICVP
Unused Medications Shelly J. Stockton, BSPharm, PhD, RPh
orval a. mamer, phd
Bao T. Nguyen, BPharm, MSc; Jane vail Medical Editor
JEAN-MARc FOREST, BPHARM, MSC Kathryn Hale, MS, MLIS
88 Advertising
Patrice Hildgen, DPharm, PhD
( Ci rculati on )
Index of Advertisers
86 2007 Reviewers
IJPC Print/Electronic
CompoundingToday.com
Scientific and Professional Reviewers RxTriad
Deb Mehlhaff, BS
for 2007 Stephanie Eerebout
TEL: (toll free) 800-757-4572 or 405-330-0094
FAX: 877-757-4575 or 405-330-5622
EMAIL: [email protected]
( Interacti ve M edia )
Formulations Interactive Media Director
Chris Burr, BBA
64 Cyclosporine Topical Gel ( Adverti si ng )

Sales
Jeannie Couch
65 Diclofenac Sodium 1% Soft-Patch Gel TEL: (toll free) 800-757-4572 or 405-330-0094
FAX: 405-330-5622
66 Diclofenac Sodium 1% Soft-Patch Lipophilic Gel ( Board of Di recto rs )

Jake Beckel, PD, Chairman of the Board
67 Diltiazem 5% in Lipoderm, Veterinary Mike Collins, RPh, Treasurer
Pat Downing, RPh, Vice President
Bob Scarbrough, BSPharm, RPh, President
68 Emetine Hydrochloride 30-mg/mL Injection Loyd V. Allen, Jr, PhD, RPh
( Edi tori al Boa rd )

69 Flosulide 10-mg/mL Injection Harvey Ahl, RPh
Diane Boomsma, RPh, PharmD, FIACP
Marianna Foldvari, PhD, RPh
70 Pentoxifylline 20-mg/mL Oral Suspension Peter R. Ford, BSPharm, FACA, FIACP
Paul F. Grassby, PhD, MRPharmS
Hetty A. Lima, RPh, FASHP
71 Piroxicam 1% Soft-Patch Lipophilic Gel Dave Mason, DPh, fiacp
John Preckshot, RPh, FIACP
Lawrence A. Trissel, BS, RPh, FASHP
72 Piroxicam 1% Soft-Patch Topical Gel David J. Woods, MPharm, MRPharmS, FHPA
( w ebsi te )
73 Trimethoprim 10-mg/mL Oral Suspension www.ijpc.com
See our Website for subscription services, back issue
orders, products, and a searchable index.
Subscription and Advertising
Information See Page 88
International Journal of Pharmaceutical Compounding www.ijpc.com

2 Vol. 12 No. 1 | January/February 2008
quali I y-c n I l analy I ical me I d
p efromctheip Ii n
I
editor
calcula I i n
I
Year
ma ke Number
I ing I 12…and Still Much Work to Do
I never thought that the International pounded medications, potentially resulting
Journal of Pharmaceutical Compounding, in patient harm and even death.
Inc., after 11 years of publishing this jour- Many individuals thought they had a
nal, still would be involved so extensively vast knowledge of prescription compound-
and be spending so much time and money ing…they don’t! Many individuals did not
to ensure that prescribers have the right to think of an intravenous admixture prepara-
prescribe, patients have the right to receive, tion in hospitals as compounding…it is!
and pharmacists have the right to com- Many were being told that compounding is
pound individualized medications. unsafe and responsible for many deaths…it
The current situation would be better isn’t!
had the truth always been forthright, had Compounding is now recognized as a
pharmacists always abided by the letter and very safe practice enabling hundreds of
ub c ip I i n ad e I i emen I intent of the laws and regulations, had gov- thousands of patients to lead healthy lives
I
I
ernment agencies always been controlled free from pain and suffering. Many of the
in their efforts to expand their power and media stories were ultimately found to
influence in our society, and had pharma- be untrue and reported problems to not
ceutical manufacturers always been satisfied involve the pharmacists doing the com-
with over 90% of the prescription drug pounding.
market and been interested in the welfare We have come a long way in the last 11
of patients. years, but we still have much work to do.
When the journal started in 1996 (the If at all possible, we need to consider those
first issue appeared in January/February negative reminders as water under the
1997), I believed that most of our efforts bridge. As we enter our 12th year of publi-
would involve dissemination of information cation, I am reminded of the last stanza of
on technological, clinical, scientific, market- the poem, “Stopping by Woods on a Snowy
ing, business, and other related activities Evening,” written by Robert Frost.
supporting pharmacy compounding. We The woods are lovely, dark and deep,
received a wake-up call when the Food But I have promises to keep,
and Drug Administration Modernization And miles to go before I sleep,
Act of 1997 was enacted with compound- And miles to go before I sleep.
ing provisions, largely spurred on by the
pharmaceutical industry, attempting to rein We, as pharmacists, have miles to go be-
in a few pharmacies that were extending fore we sleep. We must continue to protect
beyond traditional compounding. The en- prescribers’ and patients’ access to individu-
acted legislation went too far, however—a alized compounded medications.
common problem when trying to correct a
situation. Compounding pharmacists were
immediately called to action to protect their
clients from the misdirected activities of the
U.S. Food and Drug Administration, which Loyd V. Allen, Jr., PhD, RPh
would have restricted availability of com- Editor-in-Chief

}
Book
The International Journal of Pharmaceutical Compounding proudly announces a new

book titled Suppositories, published by Pharmaceutical Press. This book is the first
complete book ever on this unique dosage form; a dosage form that has been around
since the history of man. The book contains clinical, biopharmaceutic, pharmacokinetic,
compounding, and other information.
Two years in the writing from over 2,500 references, this new book was written by
Dr. Loyd V. Allen, Jr., the editor-in-chief for the International Journal of Pharmaceutical
Compounding. The staff of the International Journal of Pharmaceutical Compounding
extends our congratulations to Dr. Allen on this latest addition to the many outstanding
books written by him. Those of you who would like to send notices of congratulations
to Dr. Allen may do so by sending an e-mail to [email protected].
Announcement
Copies of this book may be purchased through the CompoundingToday.com online
bookstore at www.compoundingtoday.com.

The
tri d relationship
{ ONE PATIENT. ONE PHYSICIAN. ONE PHARMACIST. }
A patient’s needs often require the combined efforts of several caring

individuals, including the patient’s pharmacist and physician.
The triad relationship between patient, pharmacist and physician —

a profoundly powerful approach to achieving a singular goal: a positive
therapeutic outcome through customized medications. From pediatric
preparations to pain management, compounding pharmacists have
provided personalized solutions for patients with medication challenges.
PCCA is committed to providing the highest-quality educational program- PCCA is a complete resource for high-quality
ming available in the profession. We’re pleased to offer an exciting line-up fine chemicals, equipment, accredited train-
ing and education, facility workflow and
of compounding topics and top-notch speakers in 2008! design, as well as pharmacy, management
and marketing consultation necessary for a
successful compounding practice.

© PCCA62008Vol. 12 No. 1 | January/February 2008
PCCA
PCCACECEPrograms
Programsand
andTraining
TrainingCourses
Courses 22000088 SSCCHHEEDDUULLEE
Aseptic Technique
Aseptic Compounding
Technique Course
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Jan. April 28-30,
April Aug.
28-30, 13-15,
Aug. Nov.
13-15, 17-19
Nov. 17-19 meceutical Symposium
meceutical Symposium ; May 2-3/2-3/
; May Quality
QualityAssurance
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Symposium
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; May 8-9/8-9/
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PCCA Canada
PCCA Seminars/Training
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Primary Compounding
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Feb. Technique
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Technicians /London,
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• Four-day course Ontario; Feb. 21-23/ BHRT Seminar /Toronto, Ontario; March 3-6/3-6/
Ontario; Feb. 21-23/ BHRT Seminar /Toronto, Ontario; March
Dates: Jan.
Dates: 14-17,
Jan. Feb.
14-17, 25-28,
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25-28, 7-10,
April June
7-10, 9-12,
June JulyJuly
9-12, 21-24,
21-24, Primary Training /London, Ontario; April 4-5/4-5/
Cosmeceutical Seminar / /
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Aug. 18-21,
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18-21, 22-25,
Sept. Nov.
22-25, 3-63-6
Nov. London, Ontario; June 2-5/2-5/
Primary Training /London, Ontario;
London, Ontario; June Primary Training /London, Ontario;
Primary Compounding Training June 6-7/6-7/
June Marketing Seminar
Marketing Seminar /London,
/London, Ontario;
Ontario;June 26-28/
June PCCA
26-28/ PCCA
Primary Compounding Training
London, Ontario • Four-day course Worldwide
Worldwide Networking
NetworkingInternational
International Seminar
Seminar/Honolulu, Oahu,
/Honolulu, Hawaii;
Oahu, Hawaii;
London, Ontario • Four-day course
Dates: March 3-6,3-6,
June 2-5,2-5,
Sept. 15-18, Dec. 1-41-4 Sept. 12-13/
Sept. Specialty
12-13/ Compounding
Specialty Compounding Regional
Regional Seminar /London,
Seminar /London,
Dates: March June Sept. 15-18, Dec.
Ontario; Sept.
Ontario; 15-18/
Sept. Primary
15-18/ PrimaryTraining /London,
Training /London, Ontario; Nov.
Ontario; 5-7/5-7/
Nov.
Technique forfor
Technique Technicians Training
Technicians Training Technique
Techniquefor for
Technicians
Technicians/London,
/London, Ontario;
Ontario;Nov. 21-22/
Nov. BHRT
21-22/ BHRT
Houston, Texas
Houston, • Two
Texas andand
1/2-day course Seminar /London,
Seminar /London,Ontario; Dec.
Ontario; Dec.1-4/1-4/
Primary
PrimaryTraining /London,
Training Ontario
/London, Ontario
Dates: March
Dates: 10-12,
March Aug.
10-12, 4-6,4-6,
Aug. Nov. 10-12
Nov. 10-12
Andropause/Men’s Health
Andropause/Men’s Symposiums
Health Symposiums
Technique forfor
Technique Technicians Training
Technicians Training Dates/Events/Locations: Feb.
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15-16/BHRTfor for
Male & Female
Male & FemalePatients
Patients
London, Ontario
London, • Two
Ontario andand
1/2-day course Symposium
Symposium/Savannah,
/Savannah,Ga.; June
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Men’sHealth Symposium
Health Symposium/ /
Dates: Feb.
Dates: 6-8,6-8,
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Health Symposium /Dallas, Texas
/Dallas, Texas
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Software Training
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Houston, Texas
Houston, • One-day
Texas course
• One-day course Dates/Events/Locations: April
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PCCA Canada Cosmeceutical
Canada Cosmeceutical
Dates: Jan.
Dates: 18,18,
Jan. Feb. 29,29,
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April (Advanced),
16-18 (Advanced), Seminar /London,
Seminar Ontario;
/London, April
Ontario; 24-26/
April Anti-Aging/Cosmeceutical
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Symposium/Houston,
/Houston,Texas; Nov.
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13-15/ Anti-Aging/Cosmeceutical/
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Pharmacy Student
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May Houston,
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Houston, ; June
Texas 16-17/
; June Houston,
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Texas; June
Texas; 30-July
June 1/Houston,
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1/Houston, JulyJuly
Texas; 10-11/ London,
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Feb. BHRT
15-16/ BHRTfor for
Male & Female
Male Patients
& Female Patients
JulyJuly
14-15/ London,
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London, Aug.
Ontario; 11-12/
Aug. Houston,
11-12/ Texas
Houston, Texas Symposium
Symposium /Savannah,
/Savannah, Ga.; Feb.
Ga.; 21-23/
Feb. PCCA
21-23/ PCCA Canada
Canada BHRT
BHRT
Seminar /Toronto,
Seminar Ontario;
/Toronto, Ontario;April 3-5/3-5/
April BHRT
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Symposium /Houston, Texas;
/Houston, Texas;
Pharmacy Student
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/Detroit, Aug.
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28-29, 31-Aug. 1 1
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21-22/ PCCA Canada
Canada BHRT Seminar
BHRT /London,
Seminar /London,Ontario
Ontario
London, Ontario
London, • Two-day
Ontario session
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Dates: Jan.
Dates: 21-22,
Jan. April
21-22, 14-15,
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14-15, 23-24,
June Sept.
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PCCA Compounding
International Seminars
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& Functional Symposium
Medicine / /
Symposium
Dates/Locations: Jan.
Jan. Houston,
24-26/ Texas
Houston, ; ;
Texas SanSan
Francisco, Calif.
Francisco, Calif.
June 26-28/
June Honolulu,
26-28/ Oahu,
Honolulu, Hawaii
Oahu, (PCCA
Hawaii (PCCAUSA, Australia,
USA, Canada)
Australia, ; ;
Canada)
Oct. 23-25/
Oct. Houston,
23-25/Houston,Texas
Texas Marketing Symposiums
Marketing Symposiums
Dates/Locations: May
Dates/Locations: 8-9/8-9/
May Marketing Symposium
Marketing /Houston,
Symposium Texas;
/Houston, Texas;
PCCA Specialty
PCCA Compounding
Specialty Regional
Compounding Seminars
Regional Seminars June 6-7/6-7/
June PCCA
PCCACanada
CanadaMarketing Seminar
Marketing /London,
Seminar Ontario
/London, Ontario
Dates/Locations: April
April Atlanta,
11-12/ Atlanta, ; Aug.
Ga.Ga. 15-16/
; Aug. St. St.
15-16/ Louis, Mo.Mo.
Louis, ; ;
Sept. 12-13/
Sept. London,
12-13/London,Ontario (PCCA
Ontario (PCCACanada)
Canada) Pain Management
Pain Symposium
Management Symposium
Houston, Texas
Texas session
• Two-day session
Triad Networking
Triad Dinner
Networking Dinner Date: Aug.
Date: 8-98-9
Aug.
Date/Location: Feb.
Date/Location: 22/22/
Feb. Nashville, Tenn.
Nashville, Tenn.
Quality Assurance
Quality forfor
Assurance Compounders Symposiums
Compounders Symposiums
CPM Services
CPM Client
Services Seminar
Client Seminar Houston, Texas
Texas session
• Two-day session
Houston, Texas
Houston, • One-day
Texas session
• One-day session Dates: May
Dates: 2-3,2-3,
May Nov. 14-15
Nov. 14-15
Date: Oct.
Date: 22 22
Oct.
Veterinary Symposium
Veterinary Symposium
IACP Compounders
IACP on on
Compounders Capitol HillHill
Capitol Columbus, Ohio
Columbus, • Three-day
Ohio session
• Three-day session
Washington, D.C.
Washington, • Four-day
D.C. session
• Four-day session Date: Sept.
Date: 18-20
Sept. 18-20
Date: May
Date: 31-June
May 31-June3 3
Wellness/Nutrition Symposium
Wellness/Nutrition Symposium
Detroit, Michigan
Detroit, • Two-day
Michigan session
• Two-day session
Date: May
Date: May16-17/BHRT
16-17/BHRT& Wellness Symposium
& Wellness Symposium
For more
For information
more call
information 800.331.2498
call 800.331.2498
oror
visit www.pccarx.com
visit www.pccarx.com

I
NT
R AV
IT REAL
Bevac i z um a b
fo r Chor oi d a l
N e o va s c u l a r i z at i o n
in Age-Related Ma cu la r D eg en erat i o n
w r i tt e n b y jean G. dib, bspharm, p h a rmD; s au d a b du lmoh s i n , B sp ha r m , m s
sau di aramco medical services or g an ization , dhahr an , s au di ar abi a

IJPC FEATURE
Abstract
Bevacizumab, a monoclonal antibody
against vascular endothelial growth fac-
tor, is used in the treatment of cancer.
It was the first clinically available angio-
genesis inhibitor in the U.S. Recently,
bevacizumab has been used by ophthal-
mologists in the intravitreal treatment
of choroidal neovascularization in age-
related macular degeneration. Since all
published trials were less than one year in
duration, including follow up, no conclu-
sion can be drawn about the long-term
safety and efficacy of intravitreal bevaci-
zumab. In open-label studies, however,
intravitreal bevacizumab has yielded
marked improvements in visual acuity and
central retinal thickness. Compounding
pharmacists who are validated in aseptic
compounding can prepare intravitreal
bevacizumab from the available preserva-
tive-free phosphate-buffered intravenous
solution using strict aseptic technique.
Introduction adjuvant/nonmetastatic colon cancer, meta- the primary cause of vision loss in ARMD.
Bevacizumab is a full-length recombi- static breast cancer, metastatic renal cell Photodynamic therapy using verteporfin
nant humanized monoclonal IgG1 antibody carcinoma, metastatic glioblastoma multi- and thermal laser photocoagulation are
that binds to and inhibits the biologic activ- forme, metastatic ovarian cancer, metastatic considered the standard treatment options
ity of human vascular endothelial growth hormone-refractory prostate cancer, or for CNV. VEGF has been implicated in
factors (VEGF), leading to inhibition of metastatic or unresectable locally advanced promoting endothelial cell growth and
VEGF-induced cell proliferation and new pancreatic cancer.3 increases vascular permeability in CNV.10,11
blood vessel formation.1,2 In February 2004, Bevacizumab has been used in clinical In December 2004, the FDA approved
the U.S. Food and Drug Administration trials to treat choroidal neovascularization intravitreal injection of pegaptanib, an
(FDA) approved bevacizumab for treat- (CNV) in age-related macular degeneration aptamer that targets only one of several
ment of metastatic cancer of the colon or (ARMD).4-8 ARMD, an incurable disease, is VEGF, for management of CNV second-
rectum. Bevacizumab also was approved in a chronic eye condition that typically affects ary to ARMD, but this treatment yielded
combination with carboplatin and paclitaxel people aged 50 and older, and is considered only modest to disappointing benefits.12,13
for first-line treatment of unresectable, the leading cause of legal blindness in the In June 2006, the FDA approved another
locally advanced, recurrent, or metastatic industrialized world;9 it affects more than monoclonal antibody, ranibizumab, for the
nonsquamous, non–small cell lung cancer. 10 million Americans. CNV is a process of treatment of neovascular ARMD. Ranibi-
Currently, several late-stage clinical studies new blood vessel growth in the choroid, zumab, which yielded results superior to
are underway to determine bevacizumab’s through the Bruch membrane; invasion of those of pegaptanib, is closely related to
safety and effectiveness for patients with these vessels into the subretinal space is bevacizumab.

FEATURE
IJPC
Macular Degeneration Risk Factors for Age-Related
As the name would indicate, ARMD is a disease that is associated Macular Degeneration16,21
with aging (see sidebar titled “Risk Factors for Age-Related Macular
n Age: Although ARMD may occur during middle age, stud-
Degeneration”). As we age, the tissue under the retina, known as
ies show that people aged 60 and older are clearly at greater
the retinal pigment epithelium, may degenerate. This degeneration
risk than other age groups.
is often the first step leading to macular degeneration. The specific
factors that cause macular degeneration are not known conclusively. n Family history: The lifetime risk of developing late-
The macula, the central area of the retina which provides detailed stage ARMD is 50% for people who have a relative with
central vision and is sometimes referred to as the “bulls eye” of macular degeneration and 12% for people who do not have a
the retina, is responsible for reading, driving, and color vision, and relative with ARMD.
the ability to see faces. Patients with ARMD may have normal n Sex: Women appear to be at greater risk than men.
peripheral vision from the nonmacular part of the retina, which n Macular degeneration gene: The genes
is undamaged by the disease, but their “straight ahead” vision is for the complement system proteins factor H and factor B
impaired.14,15 are strongly associated with a person’s risk for developing
Advanced ARMD has two forms, dry and wet. While no curative ARMD.
treatment is available for either form, certain supplements have n Obesity: Research studies suggest a link between obesity
been demonstrated to slow the progression of the dry form.16 New and the progression of early and intermediate stage ARMD
drugs that can be injected directly into the vitreous humor of the to advanced ARMD.
eye have been effective in inducing regression in wet macular de- n Race: Whites are much more likely to lose vision from
generation. Characteristics of wet and dry ARMD are as follows: ARMD than African Americans.
Dry macular degeneration15 n Smoking: The only environmental exposure clearly
associated with macular degeneration is tobacco smoking.
n Also referred to as geographic, nonexudative, or atrophic macu-
Exposure to cigarette smoke more than doubles the risk of
lar degeneration
ARMD.
n Most common form of ARMD
n Accounts for approximately 85% of clinically diagnosed ARMD
n Causes a gradual reduction (dimming) in central vision
n Usually affects both eyes symmetrically Common Signs and Symptoms of
n Must be monitored closely to prevent progression to wet ARMD Age-Related Macular
n Signs: Small, yellow-colored deposits between the retinal layers Degeneration16
(drusen)
Signs
Wet macular degeneration15 n Atrophy: Incipient and geographic
n Also referred to as neovascular or exudative macular degenera- n Drusen
tion n Exudative changes: Hemorrhages in the eye, hard
n Less common form of ARMD exudates, subretinal/subretinal pigment epithelial/intrareti-
n Accounts for approximately 15% of clinically diagnosed ARMD nal fluid
n Severe and rapid effect on the central area of vision, which even-
n Pigmentary alterations
tually diminishes the ability to see “straight ahead” and to read
and see small objects (peripheral vision retained) n Visual acuity: Drastic decreases (two levels or more)
n Affects one eye at first, but there is a risk of the same thing oc- (e.g., 20/20 to 20/80)
C
curring in the other eye over the following months17
n Signs: Abnormal growth of new blood vessels under the macula, Symptoms
where they leak and cause scar tissue n Blurred vision: No blurring or gradual loss of central
vision (nonexudative macular degeneration); rapid onset of
Additional signs and symptoms of ARMD are described in a vision loss (exudative macular degeneration)
sidebar to this article.
n Central scotomas: Shadows or areas of missing
vision
Intravitreal Bevacizumab
n Distorted vision (i.e., metamorphopsia): Wavy
The off-label use of intravitreal bevacizumab holds promise for
appearance of straight lines and areas of blankness in a grid
the treatment of ARMD associated with CNV. Following publica-
(Many patients have first noticed this when looking at mini-
tion of the first report of the use of intravitreal bevacizumab to treat
ARMD,18 many ophthalmologists worldwide began using it to treat blinds at home.)
patients who have CNV; the treatment was well tolerated in these n Trouble discerning colors: Specifically, dark
patients. More recently, intravitreal bevacizumab has been evaluated colors from dark colors and light colors from light colors
in the management of CNV in ARMD in open-label studies with n Slow recovery of visual function: Specifi-
cally, after exposure to bright light

IJPC FEATURE
duration of follow up ranging from 3 months to 1 year.4-8,19 No direct comparison quent administration.20 Furthermore, bevacizumab
between bevacizumab and ranibizumab for this indication has been published. It might penetrate the aged (diseased) human retina
has been hypostatized that bevacizumab is superior to ranibizumab in the manage- better than ranibizumab.5,18 Finally, it has been re-
ment of CNV in ARMD. The molecule is three times as large as ranibizumab and ported that bevacizumab is less immunogenic than
may remain in the eye longer, which might translate to a lower dosage and less fre- ranibizumab and causes less inflammation.4
The typical dose of intravitreal bevacizumab
used in trials was 1.25 to 2.5 mg (0.05 to 0.1 mL).
Intravitreal bevacizumab is compounded from the
available preservative-free phosphate-buffered
intravenous solution by using aseptic technique
and a laminar airflow hood (see the accompanying
sidebar for the intravitreal bevacizumab formula-
tion). Bevacizumab is then placed in 1-mL ready-
to-use polypropylene tuberculin syringes and
stored at 4oC for no more than 14 days;5 however,
no stability testing data are available to determine
if bevacizumab remains stable during the 14-day
period. For optimal drug utilization and to avoid
drug wastage, it is recommended that all patients
receiving intravitreal bevacizumab be scheduled
for treatment within the same 14-day period. A
100-mg (4-mL) vial of bevacizumab intravenous
solution costs around $550. The administered
intravitreal dose of bevacizumab is approximately
1/400th that of the intravenous dose (5 mg/kg);
accordingly, the cost of bevacizumab per dose in
the management of CNV is approximately US$10.
This provides both a safety and cost advantage
over intravenous bevacizumab and other available
treatments. On a molar basis, the typical dose of
bevacizumab (1.25 to 2.5 mg) is similar to the ap-
proved dose of ranibizumab, which costs approxi-
mately US$2,000.
Systemic administration of bevacizumab is
associated with several potential adverse effects,
such as increased risk of thromboembolic events,
hypertension, epistaxis, hemoptysis, proteinuria,
and impaired reproductive function. These adverse
effects usually are not seen with intravitreal beva-
cizumab; however, intravitreal injections may cause
endophthalmitis, vitreous hemorrhage, or retinal
detachment. Moreover, repeated injections of
intravitreal bevacizumab may cause inflammation.
Nevertheless, these side effects appear to be quite
infrequent and were not significant in published
trials.
Conclusion
Although not studied in a controlled environ-
ment and not currently approved in this form by
the FDA, injections of bevacizumab into the vitre-
ous cavity have been performed without significant
intraocular toxicity. Since all published trials were
less than one year in duration, including follow up,
no conclusion can be drawn about the long-term
safety and efficacy of intravitreal bevacizumab.
The results of open-labeled studies in patients

FEATURE
IJPC
with ARMD indicate, however, that intravitreal bevacizumab offers Opinions expressed in this article are those of the authors and not
marked improvements in visual acuity and central retinal thick- necessarily of SAMSO.
ness. Long-term controlled trials with longer follow-up intervals
are necessary to determine the long-term safety and efficacy of this References
treatment. The findings of the short-term trials suggest that intra- 1. Ferrara N, Hillan KJ, Gerber HP et al. Discovery and devel-
vitreal bevacizumab may be the most cost-effective therapy for the opment of bevacizumab, an anti-VEGF antibody for treating
management of CNV in ARMD. cancer. Nat Rev Drug Discov 2004; 3(5): 391–400.
2. Chen Y, Wiesmann C, Fuh G et al. Selection and analysis of an
Acknowledgment optimized anti-VEGF antibody: Crystal structure of an affinity-
The authors acknowledge the use of research data obtained from matured Fab in complex with antigen. J Mol Biol 1999; 293(4):
Saudi Aramco Medical Services Organization (SAMSO) facilities. 865–881.
Rx
3. [No author listed.] Bevacizumab. [Wikipedia, the free encyclope-
dia Website.] Available at: http://en.wikipedia.org/wiki/Bevaci-
Intravitreal Bevacizumab zumab. Accessed October 8, 2007.
Formulation for Neovascular 4. Rich RM, Rosenfeld PJ, Puliafito CA et al. Short-term safety
Age-Related Macular Degeneration and efficacy of intravitreal bevacizumab (Avastin) for neovascular
age-related macular degeneration. Retina 2006; 26(5): 495–511.
For 1.25 mg 5. Bashshur ZF, Bazarbachi A, Schakal A et al. Intravitreal beva-
cizumab for the management of choroidal neovascularization
Intravitreal injection of bevacizumab 1.25 mg in age-related macular degeneration. Am J Ophthalmol 2006;
Note: Each syringe contains 0.05 mL overfill. When a stan- 142(1): 1–9.
dard 30-gauge needle (5/8 inch) is placed prior to injection, 6. Spaide RF, Laud K, Fine HF et al. Intravitreal bevacizumab
the plunger should be advanced to 0.05 mL so that the final treatment of choroidal neovascularization secondary to age-re-
volume is 0.05 mL (1.25 mg of bevacizumab) and all the dead lated macular degeneration. Retina 2006; 26(4): 383–390.
space contains drug.
Note: This formulation should be prepared by using strict

aseptic technique in a laminar airflow hood in a cleanroom or
via isolation barrier technology by a compounding pharmacist
who is validated in aseptic compounding. This is a high-risk
preparation.
METHOD OF PREPARATION
1. Place a Mini-Spike Dispensing Pin with security clips into
the bevacizumab (25-mg/mL) vial.
2. Draw up 0.1 mL of bevacizumab into multiple 1-mL poly-
propylene tuberculin syringes (see note above).
3. Place a sterile cap on each syringe and label.
PACKAGING
Place final preparation in light-protective bags and store in
a refrigerator at 2°C to 8°C.15 Note: The syringe containing
the drug should be removed from the refrigerator just prior
to injection and should not sit at room temperature for longer
than 30 minutes.
LABELING
For intravitreal use only. For clinic use only. Contains 0.05 mL
overfill.
STABILITY
A beyond-use date of up to 14 days can be used for this prepa-
ration.5
USE
Intravitreal bevacizumab is used in the treatment of neovascu-
lar age-related macular degeneration.

IJPC FEATURE
*
7. Avery RL, Pieramici DJ, Rabena MD et al. Intravitreal bevaci-
zumab (Avastin) for neovascular age-related macular degenera-
tion. Ophthalmology 2006; 113(3): 363–372.
8. Chen CY, Wong TY, Heriot WJ. Intravitreal bevacizumab
IJPC
(Avastin) for neovascular age-related macular degeneration: A
short-term study. Am J Ophthalmol 2007; 143(3): 510–512.
9. Bressler NM, Bressler SB, Congdon NG et al. Potential public
health impact of Age-Related Eye Disease Study results: AREDS
Report No. 11. Arch Ophthalmol 2003; 121(11): 1621–1624.
10. Ng EW, Adamis AP. Targeting angiogenesis, the underlying
disorder in neovascular age-related macular degeneration. Can J
Ophthalmol 2005; 40(3): 352–368.
REPRINTS
11. Wang Y, Fei D, Vanderlaan M et al. Biological activity of bevaci-
zumab, a humanized anti-VEGF antibody in vitro. Angiogenesis
2004; 7(4): 335–345.
12. Spaide R. New treatments for AMD. Ophthalmology 2006;
113(1): 160–161.
Need a reprint of an article 13. Gragoudas ES, Adamis AP, Cunningham ET Jr et al. Pegaptanib
for neovascular age-related macular degeneration. N Engl J Med
previously published in IJPC 2004; 351(27): 2805–2816.
14. [No author listed.] BBC News. Age-Related Macular Degenera-
or the RxTriad... tion. [BBC News Website.] June 13, 2002. Available at: http://
news.bbc.co.uk. Accessed October 9, 2007.
15. [No author listed.] Laser Eye Surgery. Macular Degeneration.
*************** [Laser Eye Surgery Website.] Available at: www.seewithlasik.
com. Accessed October 9, 2007.
The International Journal of Pharmaceutical
16. [No author listed.] Macular Degeneration. [Wikipedia, the
Compounding, Inc. offers high-quality free encyclopedia Website.] Available at: http://en.wikipedia.
reprints, in black and white or color, of org/wiki/Macular_degeneration. Accessed October 9, 2007.
17. [No author listed.] netdoctor.co.uk. Age-Related Macular
specific articles and/or specific tables or Degeneration. [netdoctor.co.uk Website.] Available at: www.
figures within an article. netdoctor.co.uk. Accessed October 9, 2007.
18. Rosenfeld PJ, Fung AE, Puliafito CA. Optical coherence to-
mography findings after an intravitreal injection of bevacizumab
We provide you with a professional reprint (Avastin) for macular edema from central retinal vein occlusion.
quote. All that’s required is that you com- Ophthalmic Surg Lasers Imaging 2005; 36(4): 336–339.
19. Yoganathan P, Deramo VA, Lai JC et al. Visual improvement
plete the reprint quote request form at following intravitreal bevacizumab (Avastin) in exudative age-
www.ijpc.com/Editorial/Permissions.cfm related macular degeneration. Retina 2006; 26(9): 994–998.
20. Steinbrook R. The price of sight—ranibizumab, bevacizumab,
and follow the submittal instructions and the treatment of macular degeneration. N Engl J Med 2006;
outlined on the form. 355(14): 1409–1412.
21. [No author listed.] National Eye Institute. Age-Related Macular
Degeneration. [National Eye Institute Website.] Available at:
Once the form is completed, the request may www.nei.hih.gov. Accessed October 9, 2007.
be faxed or emailed to: [email protected].
Address correspondence to Jean G. Dib, BS Pharm, PharmD, c/o
For questions, please call 800.757.4572 or Saudi Aramco, P.O. Box 13349, Dhahran, 31311, Saudi Arabia.
405.330.0094 E-mail: [email protected]
***************
Material published in IJPC and the RxTriad is covered by copyright,
with all rights reserved. As provided by U.S. copyright law, no part of
such publications may be reproduced, displayed, or transmitted in any
form or by any means, electronic or mechanical, including photocopying
or by any information storage or retrieval system, without prior written
permission from IJPC.

Cancer-Related Terminology:
Glossaries for Compounding Pharmacists and Their Clients
LaVonn A. Williams
International Journal of Pharmaceutical Compounding, Inc.
Edmond, Oklahoma
Abstract
Webster’s dictionary defines cancer as “a pernicious, spreading evil…”, a defini-
tion that is hard to debate. Cancer is a life-changing disease for both the patient
with cancer and the family members. Compounding pharmacists have the re-
sources to assist patients in reducing their pain, nausea, and other symptoms of
cancer and the side effects of their cancer treatments. By providing a glossary of
terms for clients affected by cancer, compounding pharmacists also can reduce
at least a small part of their frustration. The International Journal of Pharma-
ceutical Compounding, Inc., has published many formulations and articles deal-
ing with cancer-related symptoms and treatment side effects, and is working
hard to get more formulations online so we can participate in the challenge and
victory of defeating the pain and suffering of patients with cancer.
“Cancer”…just hearing the word sends chills up your spine. If tion in which nobody wants to be involved. My husband and I lost
you have ever had a family member or friend develop cancer, you our 16-year-old son to a malignant brain tumor. He experienced the
are aware that the emotional and psychological effects are pro- disease and the physical pain associated with it, while we experi-
found. Losing a family member or friend to cancer…that’s a situa- enced the lasting results of the disease—the never-ending emo-

FEATURE
IJPC
tional pain of losing our precious son. We never thought this would (our son), and that the physician never looked directly at him. He
happen to us; cancer is something that happens to other people. was correct in his observation. On the day of the biopsy, when the
I now know that we are not alone, that many families are affected doctor came in before performing the procedure, I told the doctor
by this terrible disease. As a matter of fact, the National Cancer that I would like to introduce him to our son. At that time, I made
Institute estimated that approximately 1,444,920 new cancer cases formal introductions to both of them and they shook hands. Then I
would be diagnosed in the U.S. in 2007, with an estimated 560,000 told the doctor what a talented guitarist and artist our son was. The
cancer deaths expected. The NCI estimates that by 2050 close to physician asked our son what type of guitar he played and what type
three million people per year may develop some form of cancer.1 of music he played. The physician then informed our son that he,
After the loss of our son, a conversation I had with a medical too, was a guitarist; he pulled up a chair and he and our son had a
supply salesman turned to the way doctors distance themselves long conversation. Just before performing the procedure, the physi-
from patients who have a terminal illness. The salesman’s opinion cian took our son’s hand in his and reassured him that he would
was that doctors have no choice but to distance themselves from take good care of him. This had to have relieved some of the stress
patients they know will die because they would not be able to and concern our son was experiencing.
handle the emotional stress. My first thought was “well, boo-hoo!” At this point you may be asking yourself, how does this relate
Most patients and their family members would prefer to be treated to compounding pharmacy? Simply put, if you can’t stand the heat
as human beings and not just one of many “patients”; if that means then get out of the kitchen. You’ve seen the commercials where
the physician must react emotionally, then so be it. customer after customer goes to the cashier, slides a credit card
That said, I would like to share an experience our son had with through the processor, takes his or her purchase, and leaves. The
one of his many specialists while fighting his battle with cancer. The line moves like a well-oiled machine, the customers and the cashiers
specialist was about to do a stereotactic needle biopsy of our son’s are like robots. Then along comes a customer who tries to pay with
brain tumor, a dangerous procedure that had the potential to take cash, and everything simply falls apart. Compounding pharmacy
our son’s life. After the second meeting with this physician before should be that “kink” in the medical chain. True concern for a pa-
the procedure was performed, our son mentioned that the doctor tient dealing with the discomforts of a disease may be the vast dif-
always directed his comments to my husband and me, never to him ference between the drugstore chains and the compounding phar-
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IJPC FEATURE
macists. This is not to suggest that pharmacists at drugstore chains As a compounding pharmacist, you have the opportunity to
are unsympathetic, but as customers of many of these drugstores make such a glossary available to your clients. You will probably
can attest, the drugstores have such a large volume of business realize pretty quickly when a customer or relative of a customer has
that customers are more likely to encounter long waits, dispensing cancer by the prescriptions presented to you; sometimes the cus-
errors, and impersonal treatment than from an empathetic phar- tomer will disclose the information. The client may still be in shock
macist. So…be different, be sympathetic, and know your customers or denial and will definitely be sensitive at this stage, so the best way
“personally.” Just like the physician I had to “introduce” to our son to present the glossary may be to simply display it as a patient hand-
to create more concern and relieve some of our son’s stress, you out in an obvious location in your pharmacy. You may insert a brief
must connect with your customers. When they are experiencing notice with the dispensed medication that the glossary is available
the possible loss of a loved one or are enduring pain themselves, free of charge upon request as a handout or may be accessed free of
you must show them that you truly care and sincerely want to help charge on IJPC’s CompoundingToday.com website.
them. Will you experience emotional stress? I hope so!
Going through this tragic experience was more than difficult. The entire glossary is included with this article; it is presented as
One of the many frustrations of our journey through our son’s ill- several separate lists of terms, comprising the following:
ness was our lack of familiarity with some of the terminology used • Cancer-related terminology most commonly used by healthcare
by the medical professionals. We never thought it would be neces- team members
sary to learn the medical terms for specific types of tests, specialists, • Types of common cancers
treatments, cancer types, and other aspects of the disease which • Types of cancers most prevalent in children
were, for the most part, foreign to us. We were devastated and felt • Members of a healthcare team
as if we were moving in slow motion in a heavy fog, like a night- • Cancer-related surgeries
mare from which we couldn’t wake. Any reduction of stress would • Cancer-related procedures, therapy, and treatments
have been welcome. A glossary of these terms would have been
extremely helpful during this process.
Conclusion
Webster’s dictionary defines cancer as “a pernicious, spreading
evil…”,2 a definition that is hard to debate. Cancer is a life-chang-
ing disease for both the patient and the family members. Amidst the
emotional trauma and stress of receiving the diagnosis of cancer is
the added frustration of not understanding the terminology used by
the many specialists of the patient’s healthcare team. Compound-
ing pharmacists have the resources to assist patients in reducing
their pain, nausea, and other symptoms and the side effects of their
cancer treatments. By providing a glossary of terms for customers
affected by cancer, compounding pharmacists can reduce at least
a small part of the frustration of the patient and family members.
The International Journal of Pharmaceutical Compounding, Inc.,
has published many formulations and articles dealing with cancer-
related symptoms and treatment side effects, and is working hard
to get more formulations online (www.compoundingtoday.com) so
we can participate in the challenge and victory of defeating the pain
and suffering of patients with cancer.
References
1. [No author listed.] Estimated New Cancer Cases and Deaths
for 2007. [National Cancer Institute; US National Institutes of
Health Website.] Available at: www.cancer.gov. Accessed October
20, 2007.
2. [No author listed.] Cancer. Webster’s II New College Diction-
ary. Boston, NY: Houghton Mifflin Company; 1995: 161.
Address correspondence to LaVonn A. Williams, Production Man-

ager, International Journal of Pharmaceutical Compounding, Inc.,
122 North Bryant Avenue, Edmond, OK 73034. E-mail: lwilliams@
ijpc.com
The photos on the title page are of "Zack," son of Zack R. and LaVonn
Williams, shown in an effort to humanize the effects of cancer.

FEATURE
IJPC
Glossary of the Most Common Cancer-Related
Terminology Used by a Healthcare Team
Adrenal gland: Two glands, located near the kidneys, Cancer: A general term for more than 100 diseases in which ab-
which produce hormones that control metabolism, fluid balance, normal cells grow out of control. Also used to refer to a malignant
and blood pressure. They also produce small amounts of “male” (cancerous) tumor.
hormones (androgens) and “female” hormones (estrogens and
progesterone). Carcinogen: Any substance that causes cancer or helps cancer
grow (e.g., tobacco smoke contains many carcinogens that greatly
Advanced cancer: A general term describing later stages increase the risk of lung cancer)
of cancer (usually stage 3 or 4) in which the disease has spread
from the primary site (where it started) to other parts of the body. Catheter: A thin, flexible tube used to introduce fluids into the
When the cancer has spread only to nearby areas, it is called locally body or to remove fluids from the body
advanced. If it has spread to distant parts of the body, it is called
metastatic. Cell: The basic unit of which all living things are made. Cells re-
place themselves by dividing and forming new cells. The processes
Alopecia: Hair loss, usually temporary. This is a side effect of that control the formation of new cells and the death of old cells are
some chemotherapy drugs or radiation. disrupted in cancer.
Anemia: Having too few red blood cells (“low blood”). This may Central venous catheter (CVC): A special thin, flex-
be a complication of the cancer or a side effect of treatment. Symp- ible tube placed in a large vein, usually in the chest, neck, or upper
toms of anemia include feeling tired, weak, and short of breath. arm. It can remain there for as long as it is needed to deliver and
withdraw fluids.
Anesthesia: The loss of feeling or sensation caused by drugs
or gases. General anesthesia causes loss of consciousness (“puts you Cervix: The narrow, lower end of the womb (uterus) that opens
under”). Local or regional anesthesia numbs only a certain area. into the vagina
Antiemetic: A medicine that prevents or controls nausea and Chromosomes: Threadlike bodies that carry genetic infor-
vomiting mation. They are found in the nucleus, or center part, of a cell.
Clinical trials: Medical research studies conducted with

Asymptomatic: No symptoms present. Cancer is often
volunteers. Each study is designed to answer scientific questions
asymptomatic in its early stages. Screening tests help to find these
and to find better ways to detect, prevent, or treat cancer.
early cancers when the chance for cure is usually highest.
Combination chemotherapy: The use of more than
Atypical: Cancerous or precancerous cells that have an unusual
one drug to treat cancer
or abnormal appearance
Complementary and alternative medicine
Axillary: In the armpit (in cancer, usually refers to lymph (CAM): Nonconventional ways of dealing with disease. This covers
nodes) a broad range, such as herbs/vitamins/minerals, mind/body/spirit
therapy, diet and nutrition, physical touch, and biological methods.
Benign: Describes a tumor that is not cancerous. Benign tumors
typically grow, but they do not spread the way cancer does, and they Dysphagia: Having trouble swallowing or eating
are usually not a threat to life.
Dysplasia: Abnormal development of tissue
Benign prostatic hyperplasia (BPH): A noncan-
cerous enlargement of the prostate that may cause problems with Edema: Build up of fluid in the tissues, causing swelling or puffi-
urination such as trouble starting and stopping the flow ness
Blood cell counts: The number of red blood cells, white Emesis: Vomiting
blood cells, and platelets in a sample of blood. The test that mea-
sures this is called a CBC (complete blood count). Endocrine glands: Glands that release hormones into the
bloodstream. The ovaries are one type of endocrine gland.
Bone marrow: The inner, spongy tissue of bones where blood
cells are made Endometrium: The lining of the womb (uterus)
Bronchi: The two main air passages in the lungs that lead from Gastrointestinal tract: The digestive tract. It consists
the windpipe (trachea). The bronchi provide a passage for air to of organs and structures that process and prepare food to be used as
move in and out of the lungs. energy (e.g., stomach, small intestine, large intestine).

IJPC FEATURE
Growth factors: Substances that stimulate production of Necrosis: The death of living tissues. Necrotic refers to tissue
blood cells in the bone marrow. Also known as colony-stimulating that has died.
factors, they can help the blood-forming tissue recover from the
effects of chemotherapy or radiation therapy. Neoplasm: A collection of abnormal cells that multiply un-
checked by normal processes of cell death and destruction. The
Hematuria: Blood in the urine resulting tissue growth is a tumor. This term is usually used an a
synonym for cancer.
Hormones: Natural substances released by an organ that can
influence the function of other organs in the body and the growth Neuropathy: Nerve abnormality or damage which causes
of some types of cancer numbness, tingling, pain, muscle weakness, or even swelling. There
are various causes of neuropathy, including some cancers and some
Hospice: A special kind of care for people in the final phase of cancer therapies.
illness, their families, and caregivers. The care may take place in the
patient’s home or in a homelike facility. Neutrophils: The most common type of white blood cell.
These cells are essential for fighting infections. The neutrophil
Immune system: The complex system by which the body count (ANC) is an important measure of the body’s ability to resist
resists infection by germs such as bacteria or viruses and rejects infection. A low neutrophil count is called neutropenia.
transplanted tissues or organs. The immune system may also help
the body fight some cancers. Nodule: A small, solid lump that can be located by touch
Inguinal: In the groin (in cancer, usually refers to lymph Orally (PO): Taken by mouth
nodes)
Peripheral neuropathy: A condition of the nervous
Intra-arterial: Into an artery system that usually begins in the hands and/or feet with symptoms
of numbness, tingling, burning, and/or weakness. Can be caused by
Intracavitary: Into a cavity or space, especially the abdo- certain chemotherapy drugs.
men, pelvis, or chest
Platelets: Special blood cells that help blood clot, to plug up
Intralesional: Into a tumor damaged blood vessels and stop bleeding
Intramuscular (IM): Into a muscle Polyp: A mushroom-like growth in the mucous membrane that
lines many hollow organs such as the rectum, the uterus, and the
Intrathecal (IT): Into the spinal fluid (also called cerebro- nose. Some polyps are precancerous.
spinal fluid or CSF)
Predisposition: Susceptibility to a disease that can be trig-
Intravenous (IV): Into a vein gered under certain conditions. For example, some women have a
family history of breast cancer and are therefore more likely (but
Leukocytes: White blood cells not necessarily destined) to develop breast cancer.
Lump: Any kind of mass in the breast or elsewhere in the body Primary site: The place where cancer begins. Primary cancer
is usually named after the organ in which it starts. For example,
Lymph nodes: Small bean-shaped collections of immune cancer that starts in the breast is always breast cancer even if it
system tissue, found along lymphatic vessels that form a network spreads (metastasizes) to other organs such as bones or lungs.
through the body. The lymphatic system circulates a fluid called
lymph, which contains white blood cells called lymphocytes. The Primary treatment: The first, and usually the most im-
nodes remove cell waste, germs, and other harmful substances from portant, treatment
lymph. They help fight infections and also have a role in fighting
cancer, although cancers sometimes spread through them. Prosthesis: An artificial form to replace a part of the body that
is removed, such as a breast or a leg
Lymphocytes: A type of white blood cell found in the lym-
phatic system Radiation dose: The amount of radiation an object (such as
human tissue) receives. Radiation is delivered in various units, such
Malignant: Cancerous as gray, rad, rem, or sievert.
Metastasis/metastasized: The spread of cancer cells to Radioisotope: A type of atom that is unstable and prone to
distant areas of the body through the lymphatic system or blood- break apart (decay). Decay releases small fragments of atoms and
stream energy. Exposure to certain radioisotopes can cause cancer. But ra-

FEATURE
IJPC
dioisotopes are also used to find and treat cancer. In certain imaging Stomatitis: Sores on the inside of the mouth, usually a side
procedures, for example, radioisotopes are injected into the body effect of therapy
where they then collect in areas where the disease is active, showing
up as highlighted areas on the images. Supraclavicular: Just above the collarbone, or clavicle
(usually refers to lymph nodes)
Recurrence: The return of cancer after treatment. Local
recurrence means that the cancer has come back at the same place Systemic: Treatment that reaches and affects cells throughout
as the original cancer. Regional recurrence means that the cancer the body (e.g., chemotherapy)
has come back after treatment in the lymph nodes near the primary
site. Distant recurrence is when cancer metastasizes after treatment Systemic disease: In cancer, when a tumor that originated
to distant organs or tissues (e.g., lungs, liver, bone marrow, brain). in one place has spread to distant organs or structures
Red blood cells (RBCs): Cells that carry oxygen from the TNM stage: A system for denoting the stage of a cancer by its
lungs to tissues throughout the body size and the extent of regional spread (e.g., to lymph nodes) and
distant metastasis
Regimen: A strict, regulated plan designed to treat cancer
Topical: Applied directly to the skin
Relapse: Reappearance of cancer after a disease-free period
Toxicity: The harmful effects of a medication or treatment,
Remission: The partial or complete disappearance of signs and especially at higher doses
symptoms of disease
Tumor: An abnormal growth (lump or mass) of cells or tissues.
Risk factor: Anything that is related to a person’s chance of Tumors are either benign (noncancerous) or malignant (cancerous).
getting a disease such as cancer. Different cancers have different
risk factors. For example, unprotected exposure to strong sunlight Unilateral: Affecting one side of the body. For example,
is a risk factor for skin cancer; smoking is a risk factor for lung, unilateral breast cancer occurs in one breast only.
mouth, larynx, and other cancers. Some risk factors, such as smok-
ing, can be controlled. Others, such as age, can’t be changed. Vaccine: A modified version of a germ or other substance
related to a disease, usually given in injection. It stimulates the im-
Screening: The search for disease, such as cancer, in people mune system to bring about resistance to that disease for a period
without symptoms. For example, screening measures for prostate of time, or even permanently.
cancer include digital rectal examination and the PSA blood test;
for breast cancer, mammograms and clinical breast exams. Screen- Watchful waiting: Close monitoring as an alternative to
ing may refer to coordinated programs in large groups of people. active treatment. This treatment strategy is used often in prostate
cancer; it may be a reasonable choice for older men with small
Secondary tumor: A tumor that forms as a result of spread tumors that might grow very slowly. If the situation changes, active
(metastasis) of cancer from the place where it started treatment can be started.
Shunt: A hole or passage that allows movement of fluid from White blood cells (WBCs): The blood cells that fight
one part of the body to another. For example, a cerebral shunt is infection. There are several types of white blood cells. Certain
used in cases of hydrocephalus (excess fluid in the brain) as a one- cancer treatments such as chemotherapy can reduce the number of
way valve to drain excess cerebrospinal fluid from the brain and these cells and make a person more likely to get infections.
carry it to other parts of the body. The cerebral shunt is placed by a
surgeon, usually outside the skull but beneath the skin, somewhere
behind the ear.
Side effects: Unwanted effects of treatment. Examples

include hair loss caused by chemotherapy and fatigue caused by
radiation therapy.
Staging: The process of finding out whether cancer has spread

and, if so, how far; that is, to learn the stage of the cancer. Various
staging systems are in use for staging different types of cancer. The
most commonly used is the TNM system.
Stent: A device that is inserted to support and hold open a tube-

shaped organ, such as a blood vessel or intestine, after surgery

FEATURE
Glossary of Common Forms of Cancer
Adenocarcinoma: Cancer that starts in any glandular tis- the breast and does not penetrate through the wall of the lobules.
sue, such as the ducts or lobules of the breast Researchers think that most cases of lobular carcinoma in situ do
not progress to invasive lobular cancer. However, having this type
Basal cell carcinoma: The most common nonmelanoma of cancer places a woman at increased risk of developing an invasive
skin cancer. It begins in the lowest layer of the epidermis, called the breast cancer later in life. For this reason, it’s important for women
basal cell layer. It usually develops on sun-exposed areas, especially with lobular carcinoma in situ to have a physical examination three
the head and neck. Basal cell cancer is slow growing and is not times a year and an annual mammogram.
likely to spread to distant parts of the body.
Local or localized cancer: Cancer that is confined to
Breast cancer: Cancer that starts in the breast. The main the organ where it started; that is, it has not spread to distant parts
types of breast cancer are: of the body
• Ductal carcinoma in situ (in place; localized and confined to one
area; a very early stage of cancer) Lymphocytic leukemia: Any of several types of leukemia
• Invasive ductal carcinoma involving an abnormality of cells that are precursors to lympho-
• Invasive lobular carcinoma cytes, one of the two main types of white blood cells
• Lobular carcinoma in situ (opinions vary in whether this is a true
cancer) Lymphoma: Cancer of the lymphatic system, a network of thin
• Medullary carcinoma vessels and nodes throughout the body. Its function is to fight infec-
• Paget’s disease of the nipple tion. Lymphoma involves a type of white blood cells called lympho-
cytes. The two main types of lymphoma are Hodgkin’s disease and
Carcinoma: A malignant tumor that begins in the lining layer non-Hodgkin lymphoma. The treatments for these two types of
of the organs. At least 80% of all cancers are carcinomas. lymphomas are very different.
Carcinoma in situ: An early stage of cancer in which the Melanoma: A cancerous tumor that begins in the cells that
tumor is confined to the organ where it first developed. The disease determine skin color. Melanoma is almost always curable in its early
has not invaded other parts of the organ or spread to distant parts stages. It is likely to spread, however, and once it has spread to other
of the body. Most in situ carcinomas are highly curable. parts of the body, the chances for a cure are much lower.
Hodgkin’s disease: An often curable type of cancer that Mucinous carcinoma: A type of carcinoma that is formed
affects the lymphatic system by mucus-producing cells
Invasive ductal carcinoma: A cancer that starts in the
Myeloid leukemia: Any of several types of leukemia involv-
milk passages (ducts) of the breast and then breaks through the duct
ing myelocytes, precursors of one of the two main types of white
wall, where it invades the fatty tissue of the breast. When it reaches
blood cells. There are two main groups, acute myeloid leukemia
this point, it has the potential to spread elsewhere in the breast,
and chronic myelogenous leukemia; there are eight subtypes of
as well as to other parts of the body through the bloodstream and
acute myeloid leukemia.
lymphatic system. This the most common type of breast cancer,
accounting for about 80% of breast malignancies.
Nonmyeloid cancers: All cancers other than myeloid
Invasive cancer: Cancer that has spread beyond the layer of leukemias. These nonmyeloid cancers include all types of carci-
cells where it first developed to involve adjacent tissue noma, sarcoma, melanoma, lymphomas, lymphocytic leukemias, and
multiple myeloma.
Invasive lobular carcinoma: Cancer that starts in
the milk-producing glands (lobules) of the breast and then breaks Paget (PA-jet) disease of the nipple: A rare form of
through the lobule walls to involve the nearby fatty tissue. From breast cancer that begins in the milk passages (ducts) and spreads
there, it may spread elsewhere in the breast. About 15% of invasive to the skin of the nipple and areola. This affected skin may appear
breast cancers are invasive lobular carcinoma. This cancer is often crusted, scaly, red, or oozing. The prognosis is generally better if
hard to detect by physical examination or even by mammography. these nipple changes are the only sign of breast disease and no lump
can be felt.
Leukemia: Cancer of the blood or blood-forming tissues.
People with leukemia often have a noticeable increase in white Sarcoma: A malignant tumor growing from connective tissues,
blood cells. such as cartilage, fat, muscle, or bone
Lobular carcinoma in situ: An early type of breast Squamous cell carcinoma: Cancer that begins in
cancer that develops within the milk-producing glands (lobules) of nonglandular cells (e.g., skin)

FEATURE
IJPC
Glossary of Cancer Types Most Prevalent in
Children
Acute lymphoblastic leukemia (acute lym- Neuroblastoma: The most common extracranial (outside of
phocytic leukemia; ALL): A cancer of the lymphocytes, the brain) solid tumor in children and most often diagnosed during
white blood cells found in the blood and lymph. In this disease, the first year of life. This tumor can appear anywhere but usually
malignant, immature white blood cells continuously multiply and occurs in the abdomen (belly) as a swelling. It accounts for about
are overproduced in the bone marrow. This cancer causes damage 7% of childhood cancers.
and death by crowding out normal cells in the bone marrow and by
spreading (metastasizing) to other organs. Non-Hodgkin lymphoma and Hodgkin’s lym-
phoma: Cancers that start in the lymph nodes. These are
Acute myeloid leukemia (acute myelogenous sometimes called Hodgkin disease, Hodgkin’s disease, or Hodgkin’s
leukemia; AML): A cancer of the myeloid line of white lymphoma. They may spread to bone marrow and other organs.
blood cells. This disease is characterized by rapid proliferation of Hodgkin lymphoma can occur in both children and adults, and
abnormal cells which accumulate in the bone marrow and interfere accounts for about 4% of childhood cancers. Hodgkin lymphoma is
with production of normal blood cells. rare in children younger than 5 years. About 10% to 15% of cases
are diagnosed in children aged 16 years or younger.
Bone cancer: Usually refers to cancers that start in the bones.
Primary bone cancer (cancer that starts in the bones) is different Retinoblastoma: Cancer of the eye. Although relatively
than metastatic bone cancer (cancer that has spread to the bone). rare, it accounts for less than 3% of childhood cancers and about
Metastatic bone cancer is named for the place from which the 5% of cases of childhood blindness. It usually occurs in children
cancer originated. For instance, it might be described as prostate younger than 4 years.
cancer that has spread (metastasized) to the bone, or breast cancer
with bone metastasis. Metastatic bone cancer is more common than Rhabdomyosarcoma: Tumors that originate from the cells
primary bone cancer because many types of cancer can spread to in the embryo that develop into striated (voluntary) muscles. This
the bone. Two types of primary bone cancers occur in children: tumor can occur in the head and neck, groin, trunk, arms, or legs.
• Ewing sarcoma – An uncommon bone cancer that occurs mostly It is the most common soft-tissue sarcoma in children, making up
in children and adolescents. It accounts for a little more than 1% about 3% of childhood cancers.
of childhood cancers.
• Osteosarcoma – Another uncommon bone cancer, comprising Soft-tissue sarcoma: Cancer arising from nonbone con-
a little over 2% of all new childhood cancer cases in the U.S. It nective tissues, such as muscle, fat, nerve, or ligaments. These can-
often causes no pain or symptoms until swelling starts. cers account for about 7% of cancers diagnosed in persons younger
than 20 years.
Brain cancer: The second most common cancer in children,
making up about 22% of childhood cancers. Most brain cancers Thyroid carcinoma: A malignant tumor of the thyroid
in children involve the cerebellum or brain stem. Adults are more gland. This is one of the most common carcinomas in persons
likely to develop cancers in different parts of the brain, usually the younger than 20 years.
cerebral hemispheres. Because the spinal cord is part of the central
nervous system, tumors of the spinal cord are grouped with those of Wilms’ tumor: A cancer that may affect one or both kidneys.
the brain. Spinal cord tumors are less common than brain tumors in It is most often found in children aged between 2 and 3 years, and it
both children and adults. accounts for about 6% of childhood cancers.
Germ cell tumor: Tumors of the ovary or testis that are

uncommon but may be highly aggressive.
Hepatoblastoma: An uncommon malignant liver neoplasm

occurring in infants and children and composed of tissue resem-
bling fetal or mature liver cells or bile ducts
Leukemia: A cancer of the blood cells or the cells that become

blood cells. Leukemia is the most common childhood cancer,
accounting for about 30% of all childhood cancers. Acute lympho-
cytic leukemia (ALL) and acute myelogenous leukemia (AML) are
the most common types of leukemia in children.
Malignant melanoma: A cancerous tumor that begins

in the cells that produce skin coloring. Melanoma is almost always
curable in its early stages, but it is likely to spread, and once it has
spread to other parts of the body the chances for a cure are much
lower.

FEATURE
Glossary of Cancer-Related Physicians, Surgeons,

and Other Healthcare Team Members
Anesthesiologist: A doctor who specializes in giving Pathologist: A doctor who specializes in diagnosis and
medicines or other agents that prevent or relieve pain, especially classification of diseases by laboratory tests such as examining cells
during surgery under a microscope. The pathologist determines whether a tumor
is benign or cancerous, and, if cancerous, the exact cell type and
Endocrinologist: A doctor who specializes in diseases grade.
related to the endocrine system (e.g., thyroid, pancreas, adrenal)
Pediatric oncologist: A doctor who specializes in can-
Gastroenterologist: A doctor who specializes in dis- cers in children
eases of the digestive (gastrointestinal) tract
Physician assistant (PA): A licensed professional, usually
Gynecologic oncologist: A doctor who specializes in with a master’s degree, who is trained in diagnosis and treatment of
cancers of women’s reproductive organs diseases. The PA works on a team with one or more physicians.
Gynecologist: A doctor who specializes in women’s health Plastic and reconstructive surgeon: A surgeon
specializing in restoring appearance or in the reconstruction of
Hematologist: A doctor who specializes in diseases of the removed or injured body parts
blood and blood-forming tissues
Primary care physician: The doctor a person would nor-
Medical oncologist: A doctor who is specially trained to mally see first when a problem arises. A primary care doctor could
diagnose and treat cancer with chemotherapy and other drugs be a general practitioner, a family practice doctor, a gynecologist, a
pediatrician, or an internal medicine doctor (an internist).
Nephrologist: A doctor who specializes in diseases of the
kidneys Psychiatrist: A medical doctor specializing in mental health
and behavioral disorders. Psychiatrists provide counseling and can
Neurosurgeon: A doctor specializing in operations to treat prescribe medications.
nervous system disorders
Pulmonologist: A doctor who has specialized experience
Nurse practitioner: A registered nurse with a master’s or and knowledge in the diagnosis and treatment of pulmonary (lung)
doctoral degree. Licensed nurse practitioners diagnose and manage conditions and diseases
illness and disease, usually working closely with doctors.
Radiation therapist: A person with special training to
Oncologist: A doctor with special training in the diagnosis work the equipment that delivers radiation therapy
and treatment of cancer
Radiologic technologist: A health professional (not
Oncology clinical nurse specialist: A registered a doctor) trained to position patients for x-rays, take images (films),
nurse with a master’s degree in oncology nursing who specializes in and then develop and check the images for quality. The images
the care of cancer patients. Oncology nurse specialists may prepare taken by the technologist are sent to a radiologist to be read.
and administer treatments, monitor patients, prescribe and provide
supportive care, and teach and counsel patients and their families. Radiologist: A doctor with special training in diagnosis of
diseases by interpreting x-rays and other types of diagnostic imag-
Ophthalmologist: A medical doctor who specializes in ing studies (e.g., CT scan, MRI scan)
diseases of the eye
Surgical oncologist: A doctor who specializes in using
Oral and maxillofacial surgeon: A surgeon who surgery to treat cancer
specializes in surgery of the mouth, jaw, and face
Thoracic surgeon: A doctor who performs surgery to the
Orthopedic surgeon: A surgeon who specializes in dis- chest cavity
ease and injuries of the bones
Urologist: A doctor who specializes in treating problems of
Otolaryngologist (head and neck surgeon): the urinary tract in men and women, and of the genital area in men
A doctor who specializes in diseases of the ear, nose, and throat
Pain specialist: Oncologist, neurologists, anesthesiologists,

neurosurgeons, and other doctors, nurses, or pharmacists who are
experts in pain. A special team of health professionals may be avail-
able to address issues of pain control.

FEATURE
IJPC
Glossary of Cancer-Related Surgeries
Bone marrow transplant: A treatment that restores Radical prostatectomy: Surgery to remove the entire
blood-forming stem cells that have been destroyed by high doses prostate gland, the seminal vesicles (sac containing semen), and
of chemotherapy and/or radiation therapy. The bone marrow may nearby tissue
come from the patient or a donor.
Resection: Surgery to remove part or all of an organ or other
Colectomy: Surgical removal of all (total) or part (e.g., partial structure
colectomy or hemicolectomy) of the colon
Simple mastectomy or total mastectomy:
Colostomy: An opening in the abdomen for getting rid of A type of breast cancer surgery that removes only the breast and
body waste. A colostomy is sometimes needed after surgery for areola (area surrounding the nipple of the breast)
cancer of the rectum.
Stereotactic needle biopsy: A method of needle
Dissection: Surgery to divide, separate, or remove tissues biopsy that is useful in some cases in which calcifications or a mass
can be seen on mammogram but cannot be found by touch. A
Local excision: Surgery to remove small superficial (surface) computer maps the location of the mass to guide the placement of
cancers or polyps the needle.
Lumpectomy: Surgery to remove a breast tumor and a small Surgical biopsy: Removal of tissues via open surgery for
amount of surrounding normal tissue examination under the microscope to find out if they contain cancer
cells
Mastectomy: Surgery to remove all or part of the breast and
sometimes other tissue Tracheostomy: Surgery to create an opening of the trachea
through the neck
Modified radical mastectomy: A type of surgery
that removes the breast, skin, nipple, areola (area surrounding the Transverse rectus abdominis muscle flap
nipple of the breast), and most of the axillary (underarm) lymph procedure (TRAM or muscle flap procedure):
nodes on the same side, leaving the chest muscles intact A method of breast reconstruction in which tissue from the lower
adnominal wall is moved up to the chest to simulate a breast
Oophorectomy: Surgery to remove one or both ovaries mound. An implant is usually not needed.
Orchiectomy: Surgery to remove the testicles Urostomy: Surgery to divert urine through a new passage and
then through an opening in the abdomen (stoma). In a continent
Pancreatectomy: Surgery to remove the pancreas urostomy, the urine is stored inside the body and drained a few
times a day through a tube placed in the stoma.
Partial or segmental mastectomy: A type of sur-
gery that removes less than the whole breast, taking only the part of Wire localization: A method used during a surgical breast
the breast in which the cancer occurs and a margin of healthy breast biopsy when the lump is hard to find or when there is an area that
tissue surrounding the tumor looks suspect on the x-ray. A thin, hollow needle is placed into
the breast and x-rays are taken to guide the needle to the area in
Pelvic exenteration: Surgery to remove the organs question. A fine wire is inserted through the center of the needle.
found in the pelvis A small hook at the end of the wire keeps it in place. The hollow
needle is then removed, and the surgeon uses the path of the wire as
Pnuemonectomy: Surgery to remove a lung a guide to find the abnormal area to be removed.
Polypectomy: Surgery to remove a polyp
Prophylactic mastectomy: A mastectomy done before

any evidence of cancer can be found, for the purpose of preventing
cancer. This is usually done in only special cases, for example, for
women who have a very high risk of developing breast cancer.
Prostatectomy: Surgical removal of all or part of the pros-

tate gland
Quadrantectomy: A partial mastectomy in which the quar-

ter of the breast that contains a tumor is removed

FEATURE
Glossary of Cancer-Related Procedures, Therapy,

and Treatments
Adjuvant therapy: Treatment used in addition to the main Magnetic resonance imaging (MRI): A method of
treatment. It usually refers to hormone therapy, chemotherapy, ra- taking pictures of the inside of the body. Instead of using x-rays,
diation therapy, or immunotherapy added after surgery to increase MRI uses a powerful magnet to send radio waves through the body.
the chances of curing the disease or keeping it in check. The images appear on a computer screen as well as on film. Like
x-rays, the procedure is physically painless, but some people may
Angiography: A test in which a contrast dye is injected di- feel confined inside the MRI machine. For patients who experience
rectly into a blood vessel that goes to the area that is being studied. this feeling of confinement, open-sided MRI machines are available
A series of x-ray images are taken to show surgeons the location of as an alternative.
blood vessels around a tumor.
Mammogram, mammography: An x-ray of the breast;
Aspiration (fine-needle aspiration or biopsy):
the method of finding breast cancer that can’t be felt with the fin-
A procedure in which a thin needle is used to suction samples of
gers. Mammograms are done with a special type of x-ray machine
tissue for examination under a microscope
used only for this purpose. A mammogram can show a developing
breast tumor before it is large enough to be felt by a woman or even
Biopsy: The removal of a sample of tissue to see whether cancer
by a highly skilled healthcare professional. There are two types of
cells are present. There are several kinds of biopsies.
mammography: (1) screening mammography is used to help find
Brain scan: An imaging method used to find anything not nor- breast cancer early in women without any symptoms, while (2)
mal in the brain, including brain cancer and cancer that has spread diagnostic mammography helps the doctor learn more about breast
to the brain from other places in the body masses or the cause of other breast symptoms.
Chemotherapy: The use of drugs to treat disease. This term Neoadjuvant therapy: Systemic therapy, such as che-
most often refers to drugs used to treat cancer. motherapy or hormone therapy, or radiation therapy given before
surgery to shrink a tumor
Colonoscopy: Examination of the colon with a colonscope: a
long, slender, flexible tube with a light and tiny camera on the end. Nuclear medicine scan: A method for localizing diseases
The doctor passes the tube through the rectum and colon, and the of internal organs such as the brain, liver, or bone. Small amounts of
camera transmits the pictures to a monitor screen. The examiner a radioactive substance (isotope) are injected into the bloodstream.
can look for polyps during the exam and even remove them using a The isotope collects in certain organs and a special camera called a
wire loop passed through the colonoscope. scintillation camera is used to produce an image of the organ and
detect areas of disease.
CT scan or CAT scan (computed tomography):
An imaging test in which many x-rays are taken from different Palliative treatment: Treatment that relieves symp-
angles of a part of the body. These images are combined by a toms, such as pain, but is not expected to cure the disease. Its main
computer to produce cross-sectional pictures of internal organs. purpose is to improve the patient’s quality of life. Sometimes che-
Although in some cases a patient must receive an injection of a dye,
motherapy and radiation are used in this way.
this is a painless procedure that can be done in an outpatient clinic.
Photodynamic therapy (PDT): A treatment sometimes
Digital mammography: A method of storing an x-ray
used for cancers of the skin, esophagus, lung, or bladder. PDT
image of the breast as a computer image rather than on the usual
x-ray film begins with injection of a nontoxic chemical into the blood. This
chemical is allowed to collect in the tumor for a few days. A special
Immunotherapy: Treatments that promote or support the type of laser light is then focused on the cancer. This light causes
body’s immune system response to a disease such as cancer the chemical to change so that it can kill cancer cells. The advan-
tage of PDT is that it can kill cancer cells with very little harm to
Infusion: Slow and/or prolonged intravenous delivery of a drug normal cells.
or fluids
Positron emission tomography (PET): A PET scan
Injection: Using a syringe and needle to push fluids or drugs creates an image of the body (or of biochemical events) after injec-
into the body, often called a “shot” tion of a very low dose of a radioactive form of a substance such as
glucose (sugar). The scan computes the rate at which the tumor is
Internal radiation: Treatment involving implantation of using the sugar. In general, high-grade tumors use more sugar than
a radioactive substance normal, and low-grade tumors use less. PET scans are especially
useful in taking images of the brain, although they are becoming
Lymph node biopsy: A test in which all or part of a lymph more widely used to find the spread of cancer of the breast, colon,
node is removed and examined under the microscope to find out if rectum, ovary, or lung. PET scans also may be used to see how well
cancer has reached it the tumor is responding to treatment.

FEATURE
IJPC
Radiation therapy: The use of high-energy rays or sub- Scan: A study using either x-rays or radioactive isotopes to pro-
atomic particles to treat disease. Types of radiation include x-ray, duce images of internal body organs
electron beam, alpha and beta particles, and gamma ray.
Spinal tap (lumbar puncture or LP): A procedure
Radioactive implant: A source of high-dose radiation in which a thin needle is placed in the spinal canal to withdraw a
that is placed directly into or around a tumor to kill the cancer cells small amount of spinal fluid or to give medicine into the central
nervous system through the spinal fluid
Radiofrequency ablation (RFA): Treatment that uses
high-energy radio waves to heat and destroy abnormal tissues. A Stereotactic radiosurgery: A new treatment method
thin, needle-like probe is guided into the tumor by ultrasound or that focuses high doses of radiation on a tumor while limiting the
CT scan. The probe releases a high-frequency current that heats exposure that normal tissue receives. The treatment may be useful
and destroys cancer cells. RFA is sometimes used to treat tumors for tumors that are in places where regular surgery would harm
in the liver and is being studied for use in several other areas of the essential tissue, for example, in the brain or spinal cord, or when the
body. patient’s condition does not permit regular surgery.
Systemic therapy: Treatment that reaches and affects cells

Radionuclide bone scan: An imaging test that uses a throughout the body (e.g., chemotherapy)
small amount of radioactive contrast material given in the vein. The
radioactive material settles in “hot spots,” areas of bone to which Ultrasound: An imaging method in which high-frequency
the cancer may have spread, and shows up in the picture. sound waves are used to outline a part of the body. The sound wave
echoes are picked up and displayed on a television screen.
Rescue treatment: Procedures or treatments such as bone
marrow transplantation that “rescue” a patient’s immune system and Urine cytology: Examination of urine under a microscope
blood-forming organs from the effects of high-dose chemotherapy to look for cancerous and precancerous cells

&
Hospice
Compounding
Pharmacy:
Once Inseparable
LaVonn Williams
International Journal of Pharmaceutical Compounding
Edmond, Oklahoma
Abstract
Like hospice, compounding pharmacy offers a specialized service.
Hospice continues to offer the strong emotional, psychological,
and spiritual support to dying patients and their family members
that it has provided for many years, but the procedure for ordering
drugs for the patients of hospice care in the U.S. has changed.
Most hospice organizations work on a contract-only basis with
service providers, which include compounding pharmacists, and
in most cases a patient’s drugs are ordered from large, remote
pharmaceutical suppliers with whom hospice has contracts. At
times, hospice patients’ medication needs are not met by this
system, and compounding pharmacists may be called upon in such
situations, often to assist in the rapid relief of a patient’s pain and
discomfort. Since not every manufactured drug or dosage form is
suitable for every patient, especially those that have become frail
and weak, a compounding pharmacist should be one of the most
vital members of the hospice team. Unfortunately, from hospice
care’s humble beginnings at a time when “compounding” was
the sole source of medications, many hospice organizations now
consider compounding pharmacists and compounded preparations
as only one of many options for emergency treatments. A once
strong union is no longer so solid.

IJPC FEATURE
Hospice care originated in Biblical times, in the years following the dying became a main focus. Therefore, medications to ease the
the legalization of Christianity in 313 AD, when the eastern church pain and other symptoms associated with terminal diseases are an
began sponsoring nursing homes for the sick, travelers, and others integral part of hospice care. No large drug manufacturers existed
in need. The word hospice originally meant a place of shelter for
weary travelers. While care of the dying was part of early hospice
Rx
care, it did not become formalized as such until 1879, when Our
Lady’s Hospice for the Dying was founded in Dublin by the Irish
Sisters of Charity. In 1900, five of the Irish Sisters were invited to
London, where they established St. Joseph’s Convent and began Hemorrhoids
to visit the dying in their homes. In 1905, they opened a 30-bed
hospice for the dying poor. Fifty years later, St. Joseph’s became the For 6 5.865-g suppositories
training ground for Cicely Saunders, who was to become the leader
of the modern British hospice movement. In 1964, a building fund Analgesic Rectal Rocket
was established, and with money from the National Health Service,
St. Christopher’s Hospice was founded in London in 1967. Less Lidocaine 0.79 g
than 10 years later, the first U.S. hospice was opened, Hospice of Silica gel micronized 0.12 g
New Haven, Connecticut, which was incorporated in 1971. The Paraffin wax 12.8 g
offering of home-care service did not begin until 1974.1 MBK (fatty base) base, grated 24.8 g
Hospice and hospice care have changed over the years. It was Green food color 0.06 g
Saunders who recognized that the dying patient is a part of a family, Hydrocortisone, micronized 0.37 g
a community, and a culture. Simply put, the philosophy of hospice
is to combine the “…sophisticated science of our treatments with Note: This is a commonly used formula for rectal rockets.
the art of our caring, bringing competence alongside compassion.”2
Note: Be sure the molds are well lubricated or the suppositories
Hospice and Compounding will break when you try to remove them.
Pharmacy
METHOD OF PREPARATION FOR MOLDS
Although the hospice movement did not begin solely for the
treatment of medical conditions, eventually palliative treatment for 1. Coat the molds with light mineral oil.
2. Deliver from a syringe over the entire cavity.
3. Break mold apart, then lubricate.
Hospice-Related Formulations
Rx
4. Put mold back together.
5. Let the mold sit for awhile.
6. Turn the mold upside down and let it sit for awhile longer to
Catheter Care drain the excess.
METHOD OF PREPARATION FOR INGREDIENTS

For 1000 mL
1. Melt the base and paraffin using low heat. CAUTION: Do
Potassium Permanganate Irrigation 0.01% Solution not use a microwave oven for this procedure.
2. Mix hydrocortisone, lidocaine, and micronized silica gel in a
Potassium permanganate 0.1 g mortar until the mixture is uniform in size; add the mixture to
Sterile water for irrigation 1000 mL step 1.
3. Pour mixture into the molds using a syringe. Note: Fill each
CAUTION: Wear gloves when compounding this prepara- mold until a rounded top appears.
tion, as the preparation leaves a purple stain on whatever it 4. Allow the mixture in the molds to solidify at room
touches. Also, the preparation should be dispensed in a clean temperature for 10 minutes.
brown bottle. 5. Allow the molds to refrigerate for 15 minutes.
6. Remove the molds from the refrigerator, taking the molds
apart, and place the molds on paper towels.
7. Push the suppository away from the mold gently, using the
1. Place the potassium permanganate in 10 mL of sterile water
following suggested procedure:
for irrigation and dissolve.
a. Place your thumbs at the top of the mold’s flange until the
2. From this point, the preparation should be carried out
flange is a slight distance from the mold.
under a hood.
b. Don’t push too hard or the rocket may break.
3. Remove 10 mL from 1000 mL of water for irrigation.
c. Insert a small, thin spatula between the suppository and
4. Filter the 10 mL concentrate of potassium permanganate
the mold, and gently ease the rocket from the mold. Note:
through an appropriate 0.22-micron filter into the
Use this procedure only if the slight thumb pressure
remaining sterile water for irrigation.
doesn’t distance the suppository from the mold.

FEATURE
IJPC
Laxative Formulation
Rx
at the beginning of hospice care to supply these medications; rather,
those skilled in the compounding of natural ingredients filled this
need—those we now refer to as “compounding pharmacists.” This
Senna/Docusate Sodium created an almost inseparable union between hospice care and com-
Suspension 5 mL pounding pharmacists, a union that existed for many years.
Hospice care is “specialized.” Hospice provides a special kind of
For 100 mL (5 mL equal to 2 capsules) care for people who are terminally ill, backed by a philosophy that
involves the patient’s family. The care given by hospice is meant to
Senna 7.467 g
help make the most of the last months of life by providing comfort
Docusate sodium 85% 2.337 g
and relief from pain; the focus is on palliative rather than cura-
Sodium lauryl sulfate 1 g
tive treatment. In other words, hospice treats the person, not the
Alcohol 8.333 mL
disease. Hospice emphasizes quality rather than length of life and
Suspension vehicle 78.333 mL
neither hastens nor postpones death, but treats dying as a normal
Crème de menthe liquid flavor 0.167 mL
process while reaffirming life.
Orange concentrate natural liquid flavor 5 mL
Compounding pharmacists also offer “specialized” and “per-
Stevia concentrate solution 6.667 mL
sonalized” service, which puts them in a position of having to deal
Sodium saccharin concentrate solution 0.1 mL
more closely with their patients than other pharmacists. When
Sodium chloride 250 mg
one of these patients has a terminal illness, which may eventually
include hospice care, this makes the situation more emotional. Are
METHOD OF PREPARATION compounding pharmacists willing to accept that challenge? Yes,
1. Mix senna powder, docusate sodium, and sodium lauryl they are. The art and science of compounding has been around for
sulfate in a mortar. centuries and continues to be an integral part of not only special-
2. Add alcohol and mix until all the ingredients are wetted. ized medicine but everyday pharmacotherapy as well.
3. Add one-third volume of the suspension vehicle gradu-
ally, with strong mixing.
4. Add sweeteners and flavors.
5. Add the remainder of the suspension vehicle gradually
antibiotic
and qs to 120 mL.
6. Use a syringe-to-syringe transfer for 2 ounces or less.
powders
Note: Although this is not usually necessary, larger
amounts may be passed through an ointment mill to
reduce particle size.
Rx

Suspension Vehicle
For 2000 mL
USP for Prescription
Compounding
Xanthan gum 4 g Bacitracin USP
Sodium benzoate 2 g
Sodium saccharin 10 g Erythromycin USP
Citric acid anhydrous 2 g
Stevia powder extract 4 g Neomycin Sulfate USP
Paraben preserved water qs 2000 mL
Nystatin USP
Note: The paraben preserved water contains 0.5% methyl-
paraben and 0.25% propylparaben in purified water.
Polymyxin B Sulfate USP
1. Dissolve sodium benzoate, sodium saccharin, citric acid,
and stevia in 1000 mL preserved water.
2. Add xanthan gum gradually, sifting so it doesn’t clump.
3. Mix with spin bar until suspension is uniform. Note:
This mixture should be left mixing for 24 hours to insure TRUSTED CHOICES
complete hydration.
FOR TODAY’S
4. Bring to volume with preserved water.
5. Adjust the pH to 4.5 to 5.0, using 20% sodium hydroxide. PHARMACIST

IJPC FEATURE
Although the main focus of hospice is to provide comfort and • Coordinating necessary medical equipment
pain relief through medication, hospice care also provides other ser- • Joining in favorite pastimes
vices for the patient and family, including the following: • Talking to the patient about the illness
• Assisting with getting financial matters in order • Providing favorite foods or music
• Assisting with household chores Pharmacists who work with hospice must work closely with a
• Assisting with hygiene team of professionals, many of whom must be available on a
Rx
Rx
Oral/Facial/Skin Care Formulations
Stanford Mouth Rinse #5 Liquid
Acyclovir/Deoxy-D-Glucose/
Lidocaine Pluronic Lecithin
For 100 mL
Organogel 5%/2%/5%
For 100 mL Deoxy-D-glucose (2) 100 mg
Simethicone 2 mL
Acyclovir 5 g Cherry flavor concentrate 3 mL
Lecithin/isopropyl palmitate solution 22 mL Water (distilled) 5 mL
Pluronic F-127 20% gel 64 mL Nystatin 189 mg
Lidocaine 5 g Triamcinolone acetonide micronized 100 mg
Deoxy-D-glucose (2) 2 g Chlorpheniramine maleate 20 mg
Ethoxy diglycol 7 mL Tetracycline hydrochloride 1.2 g
Master suspension formula qs 100 mL
Note: This formula may be used to treat cold sores on lips
and in the nostrils. Note: This formula assumes that the assay of nystatin is 5000
U/mg; if not, the amount of nystatin must be adjusted.
1. Combine acyclovir and deoxy-D-glucose powders. METHOD OF PREPARATION
2. Add sufficient ethoxy diglycol to solubilize or make a 1. Weigh powders and mix in a mortar.
smooth creamy paste. 2. Add distilled water to step 1 in small amounts and mix until
3. Add step 2 to lecithin/isopropyl palmitate solution. a smooth suspension is formed.
4. Add Pluronic lecithin organogel 20% in small increments 3. Add simethicone and mix well.
to bring to volume or 100 mL (approximately 64 mL). 4. Transfer to suitable beaker, add flavor, and qs to 100 mL
5. Mix until uniform, using a shear-type mixer. with master suspension formula in a blender.
5. Package in amber bottles.
Rx
Milk of Bismuth Solution
For 100 mL
Rx Shake Skin Care (Triamcinolone/
Nystatin/Milk of Bismuth) Lotion
For 100 mL
Bismuth subcarbonate 6.126 g
Glycerin 4 mL Milk of bismuth 86 mL
Methylcellulose 1% solution 46 mL Nystatin 0.662 g
Methylcellulose 2% solution 46 mL Triamcinolone acetonide micronized 0.043 g
Emollient cream base 14.33 g
1. Wet the bismuth subcarbonate with sufficient glycerin to Note: This formula assumes a nystatin activity of 6499 U/mg.
make a stiff paste.
2. Triturate until smooth. METHOD OF PREPARATION
3. Begin adding methylcellulose 2% suspension until a pourable 1. Weigh triamcinolone acetonide and nystatin powders and
quantity is obtained. mix in a mortar.
4. Pour from mortar into dispensing bottles. 2. Add a small amount of milk of bismuth and make a paste.
5. Rinse mortar 2 or 3 times with the methylcellulose 3. Add the emollient cream.
1% solution. 4. Add more milk of bismuth and mix until uniform.
6. Add sufficient methylcellulose 1% solution to volume and
mix well.

FEATURE
IJPC
24-hour-a-day, 7-days-a-week basis. Compounding for Hospice:
Hospice care is offered as a ser- Depending on the individual patient and
An Informal Survey
vice not only for the patient but family needs, the team may include the
A brief and informal phone inquiry
also for the family. I have come following:
was conducted with seven compounding
to the conclusion, speaking from • Clergy and/or counselors
pharmacists from around the U.S. These
firsthand experience, that hospice • Dietician
pharmacists were asked if they worked with
care is a choice that, in many cases, • Family and/or caregiver (considered by
hospice organizations and/or patients and
hospice as part of the “unit of care”)
is easier for the patient than the to state what services they offer to patients
• Home health aides
family. Family members may have of hospice care. This was by no means a
• Nurse
mixed emotions about having their • Pharmacist scientific study. Five of the seven said they
loved one at home during the dying • Physician (e.g., specialist, general practi- have worked with hospice organizations
process. Hospice often trains family tioner) and/or patients, but only three still do so.
caregivers to administer medica- • Social worker The two compounding pharmacists who
tions, including intravenous medica- • Therapists (e.g., speech, physical) discontinued working with this group of pa-
tions, but the caregiver still may be • Volunteers tients cited as the reason for stopping that
plagued with doubts and questions: One of the primary contributions of the hospice work had become too challenging
Am I using appropriate technique? compounding pharmacist to this team is because of the changes hospices had made
What happens if the patient begins working with the physician to manage the in dealing with their prescription requests.
to choke on oral medications? Fam- patient’s pain. The pharmacist also may be It should be noted that most hospice orga-
called upon to prepare compounds to con- nizations require that any service provider
ily caregivers often wonder whether
trol other complications or symptoms, such (such as pharmacists) work only under a
they can handle watching their loved
as anxiety, nausea, and vomiting. written contract.
one die at home: Would his life have
been prolonged and his last few mo-
ments of life more comfortable had
he been in a hospital setting? Are
these actually her final moments or
is something going on that a medical
staff should be handling? These are
some of the concerns I had dur-
ing my experience with hospice.
Our hospice care provider was very
understanding and instructional, but
this wasn’t a patient…this was my
son. I state this personal experience =;8C`Z\ej\Ef%('*
LJ;8C`Z\ej\Ef%-)0
simply to make the point that the
very last thing that a family member
considers when faced with the loss
of a loved one is the “cost” of care.
The first consideration is always the
loved one. If I had been given the
choice of saving money and waiting
for a drug that might be the answer
to my son’s pain and suffering, or
giving him immediate relief with an
individualized compound for which
I may have had to pay a little more, I
would have chosen the latter. To the
family member who loves the patient
boundlessly, no living moment is
unimportant, no indication of pain is
bearable, and regrets are unaccept-
able.
LaVonn A. Williams

IJPC FEATURE
Has hospice care changed from its humble beginnings? Let’s situation (e.g., increased pain, breathing problems, seizures) may
hope not. Or has hospice been forced to change because of “big have to wait for the specialized medications they need. If these
business” at the expense of the patient? Again, let’s hope not. medications had been prepared and given sooner, they might have
For the most part, hospice organizations now sign contracts spared the patient unnecessary discomfort and the family members
with large pharmaceutical suppliers, many of which are located additional emotional distress. The personalized attention provided
out of state. This may be beneficial for the hospice organizations by compounding pharmacists can bring quicker comfort and peace
and the payers (typically medical insurance or Medicare), but it
Rx
can have a major negative impact on the patient and the patient’s
family. Although hospices maintain a large inventory of common
drugs so to not delay treatment, many times compounding pharma-
cists are called only when an emergency arises, such as overdoses, metronidazole polyox bandage
underdoses, side effects from manufactured drugs, or last-minute 2% Powder
new prescriptions. Therefore, patients who are suddenly in a dire
For 30 g
Wound Care Formulations Polyox WSR-301 3 g
Rx
Methocel E4M premium 26.4 g
Metronidazole benzoate 0.6 g
Chloramphenicol/
Metronidazole Polyox Bandage Note: This preparation is for the treatment of odor-producing
5%/2% Powder wounds.
For 30 g
Note: This preparation should be dispensed with regular
polyox bandage instructions.
Polyox WSR-301 powder 3 g
Methocel E4M premium powder 25.2 g
Note: This preparation should be dispensed with an 8-ounce
Metronidazole 0.6 g
spray bottle of sterile water for irrigation.
Chloramphenicol 1.5 g
Note: This preparation is a treatment for odor-producing METHOD OF PREPARATION

wounds as well as an antibiotic. 1. Reduce the particle size of the metronidazole benzoate in a
mortar.
Note: This preparation may be dispensed in a two by one 2. Mix the polyox and methocel together in another mortar.
ounce accordion insufflator. 3. Incorporate steps 1 and 2 geometrically until uniformly
mixed.
Rx
Note: Dispense sterile water for irrigation in a 30-mL bottle
with a long stem spray attachment to aid in application to the
wound. Monsel's Solution/Gel with
Lidocaine Hydrochloride 2%
1. Reduce the particle size of the chloramphenicol in a glass For 100 mL
mortar with gentle trituration.
2. Mix the powders thoroughly using geometric dilution. Ferric subsulfate–Monsel’s solution 100 mL
Hydroxyethycellulose–5000 2.22 g
Instructions for Use Lidocaine hydrochloride 2 g
1. Wet the affected area with sterile water (accordion applica-
tor containing the water). Note: This preparation is for the treatment of oozing and/or
2. Puff the powder lightly and cover the area with bandage bleeding breakthrough tumors.
material from the accordion puffer. Note: Use only one
puffer and when empty, use a second puffer. METHOD OF PREPARATION
3. Wet the area. 1. Place the solution in a large beaker on a magnetic stirrer.
4. Repeat step 2. 2. Add the lidocaine hydrochloride and stir until distributed.
5. Wet the area. 3. Add the hydroxyethycellulose gradually using a large 80-
6. Repeat step 2. mesh sifter.
7. Wet the area. 4. Mix thoroughly until evenly distributed.
8. Cover with a 4 × 4 sterile gauze and wrap with Kerlix ban- 5. Pour into a bottle.
dage. 6. Shake the mixture periodically over the next few hours to
9. Repeat this application once daily. ensure proper jelling.

FEATURE
IJPC
of mind for the patient and family. Compounding pharmacists Is hospice a bad idea? Absolutely not, and any comments here
should be consulted not just in “emergency” situations, but should should not be taken that way. Hospice provides a necessary and
be considered an important and active member of the hospice care extremely valuable service. Patients and the family members who
team. A list of state hospice agencies is provided with this article for are struggling to care for them (and often are struggling to pay
pharmacists who wish to inquire about the details of how to bid on for that care) need not be concerned about receiving hospice care,
contracts. because every patient is accepted into hospice regardless of ability
Two hospice organizations asked whether the payers “required” to pay. Hospice care is also an optional benefit under Medicaid and
that hospices purchase drugs from large pharmaceutical suppli- is covered by many private insurance companies.
ers did not respond to the question. That raises the question of
whether the decision to do so takes patient well-being into account
or is solely an economic decision. Conclusion
Hospice care is extremely important to the dying patient, as each
member of the multidisciplinary hospice care team is trained and
The Cost of Hospice Care available to provide strong emotional, psychological, and spiritual
One hospice organization’s handout on Medicare hospice ben- support. Compounding pharmacists are and should be considered
efits gave the following response to the question, “What will I have extremely important members of the hospice team. As patients be-
to pay for hospice care?” come more ill, weak, and frail, their failing bodies require medica-
Medicare pays the hospice for your hospice care. You will have tions specific to their medical conditions. Not every manufactured
to pay no more than $5 for each prescription drug and drug and dosage form is suitable for every patient, and this is when
other similar products: The hospice can charge up to $5 for compounded preparations become so vital. Patients in hospice care
each prescription for outpatient drugs or other similar prod- may have any number of physical problems that cause physical and
ucts for pain relief and symptom control.2 emotional distress, such as radiation burns; skin wounds, rashes,
lesions, and odors; salivary problems; seizures; and stomach distress,
At $5 per prescription drug, it is easy to see why hospice seeks to name just a few. Compounding pharmacists have the knowledge,
the cheapest source of drugs for their patients. However, if a family experience, and desire to assist the patient experiencing these and
member must watch a loved one experience physical distress for many other conditions while receiving hospice care, but they may
even one moment, distress that could have been relieved more be hindered in doing so because of mass drug ordering from out-
quickly by using a local pharmacist, the $5 cost would have been of-state manufacturers and the ridiculously low reimbursement for
the last thing on that family member’s mind. It seems that payers these services.
force hospice organizations to search out the cheapest drug sources The International Journal of Pharmaceutical Compounding,
without considering that patients are not the disease or a number, Inc., (IJPC) agrees completely with Dame Cicely Saunders’ state-
but a person who feels the terrible discomfort of illness. ment:
Rx
You matter because you are you. You matter to the last
moment of your life, and we will do all we can, not only to
help you die peacefully, but to help you live until you die.3
Thrombin Polyox Bandage
Powder – 5000 Units
The International Journal of Pharmaceutical Compounding
expresses its appreciation to George B. Muller, RPh, of the Com-
For 5 g
pounding Corner, located in Lacombe, Louisiana, for providing the
formulations contained within this article.
Polyox WSR-301 0.5 g
Methocel E4M premium 4.5 g
Thrombin topical 5000 Units 1 vial References
1. Carling MA. Role of the compounding pharmacist. IJPC 2000;
Note: This preparation is for the treatment of oozing and/or 4(4): 247.
bleeding breakthrough tumors. 2. Saunders C. The founding philosophy. In: Summers DH, Teller
N, eds. Hospice: The Living Idea. Philadelphia, PA: Saunders;
1981.
3. Staddard S. The Hospice Movement—A Better Way of Caring
1. Mix the thrombin vial contents with a portion of the metho-
for the Dying. New York: Vintage Books; 1992: 109.
cel and all of the Polyox in a mortar.
4. [No author listed.] U.S. Department of Health and Human Ser-
2. Mix in the remainder of the methocel geometrically.
vices. Medicare Hospice Benefits. Publication No. HCFA 02154.
3. Transfer the mixture to a puffer device using a funnel.
Baltimore, MD: Health Care Financing Administration: The
4. Place the top onto the device and shake well.
Federal Medicare Agency; 1999: 10–11.
Instructions for Use Address correspondence to LaVonn Williams, The International

Lightly puff onto the bleeding area when changing the ban- Journal of Pharmaceutical Compounding, Inc., 122 N. Bryant Av-
dage, or two to three times a day as needed. enue, Edmond, OK 73034. E-mail: [email protected]

IJPC FEATURE
State Hospice Agencies4 Louisiana Ohio

Louisiana Hospice Organization Ohio Hospice Organization
Alabama 504-945-2414 503-228-2104
Alabama Hospice Organization
334-213-7944 Maine Oklahoma
Maine Hospice Council Hospice Association of Oklahoma
Alaska 207-626-0651 918-835-0622
Hospice of Mat-Su 800-356-0622
907-352-4800 Maryland
Hospice and Home Health of Juneau Hospice Network of Maryland Oregon
907-463-3113 410-729-4571 Oregon Hospice Association
503-228-2104
Arizona Massachusetts
Arizona Hospice Organization Pennsylvania
Hospice Federation of Massachusetts
602-704-0210 Pennsylvania Hospice Network
781-255-7077
717-230-9993
Arkansas
Michigan Puerto Rico
Arkansas State Hospice Association
Michigan Hospice Organization Puerto Rico Home Health and Hospice
501-713-7385
517-886-6667 Association
c/o Washington Regional Hospice
787-897-0503
California Minnesota

California State Hospice Association Minnesota Hospice Organization Rhode Island
916-441-3770 651-659-0423 Rhode Island State Hospice Organization
401-444-9070
Colorado Mississippi Hospice Care of Rhode Island
Colorado Hospice Organization Mississippi Hospice Organization
303-449-1142 601-366-9881 South Carolina
Hospice for the Carolinas
Connecticut Missouri 919-878-1717
Hospice Council of Connecticut Missouri Hospice Organization
860-233-2222 662-232-7891 South Dakota
c/o Baptist Memorial Hospice South Dakota Hospice Organization
Delaware 605-668-8327
Delaware Hospice, Inc. Montana c/o Sacred Heart Hospice
302-478-5707 Montana Hospice Organization
406-247-3300 Tennessee
Florida c/o Baptist Memorial Hospice Tennessee Hospice Organization
Florida Hospice and Palliative Care, Inc. 615-228-1128
800-838-9800 Nebraska
850-878-2632 Nebraska Hospice Association Texas
308-687-6065 Texas and New Mexico Hospice Organization
Georgia 512-454-1247
Georgia Hospice Organization Nevada 800-580-9270
770-924-6073 Hospice Association of Nevada
Utah
Hawaii 702-796-5531 Utah Hospice Organization
Hawaii Islands Hospice Organization 801-321-5661
New Hampshire
808-924-9255
New Hampshire Hospice Organization Vermont
Idaho 603-228-9870 Hospice Council of Vermont
Idaho Hospice Organization, 802-229-0579
208-726-8464 New Jersey
c/o Hospice of the Wood Valley New Jersey Hospice and Palliative Care Virginia
Organization Virginia Association for Hospices
Illinois 908-233-0060 540-686-6448
Illinois State Hospice Organization
713-324-8844 New Mexico Washington
New Mexico and Texas Hospice Organization Washington State Hospice Organization
Indiana 512-454-1247 509-456-0438
Indiana Hospice Organization c/o Hospice of Spokane
317-338-4049 New York
New York State Hospice Association West Virginia
Iowa 518-446-1483 Hospice Council of West Virginia
Iowa Hospice Organization 304-529-4217
515-243-1040 North Carolina c/o Hospice of Huntington
Hospice for the Carolinas
Kansas Wisconsin
919-878-1717
Association of Kansas Hospices Hospice Organization of Wisconsin
316-263-6380 North Dakota 608-233-7166
Kentucky North Dakota Hospice Organization
Wyoming
Kentucky Association of Hospices 701-774-7430
Wyoming Hospice Organization
888-322-7317 c/o Mercy Hospice
307-632-1990

FEATURE
IJPC
Summary of Responses from Dave Mason
Innovative Pharmacy Solutions; Edmond, Oklahoma
Interviews with Compounding Responses:
Pharmacists Concerning 1. Yes, we do. We steadily compound preparations for approximate-
Hospice Care ly three hospice organizations.
2. Anxiety, bleeding skin cancers, nausea, pain, vomiting, wound
IJPC expresses its appreciation to the pharmacists who afforded the and lesion care for odorous tumors
author their valuable time for interviews. 3. I wouldn’t say that we do so regularly, but we do occasionally
and are available to do so at any time necessary.
4. Information not available.
List of Questions: 5. No, we don’t.
1. Do you compound preparations for hospice organizations?
2. For what types of ailments do you most frequently prepare
Jeff Robins
medications?
Preckshot Professional Pharmacy; Peoria, Illinois
3. Is it common for you to compound preparations after hours for
Responses:
patients receiving hospice care?
1. Yes, we do. We are located in a small town in Illinois where there
4. What is the most common age of patients receiving hospice care
are three main hospice organizations, and we compound prepa-
for which you prepare medications?
rations for all three. We average about one prescription per day.
5. Do you provide any type of cancer-care kits for patients receiv-
2. Anxiety, bowel motility (constipation or diarrhea), nausea, neu-
ing hospice care?
ropathy, pain, salivary problems (increase or decrease), seizures,
wound care for odorous tumors, vomiting. Note: Some of the
George B. Muller, RPh preparations that Jeff supplies for hospice patients are: morphine
Compounding Corner; Lacombe, Louisiana concentrate predosed in syringes (for pain), suppositories (for
Responses: various ailments; for patients taking a lot of oral medications or
1. Yes, we do. We’ve been compounding for hospice organizations for those who are unable to swallow medications), transdermal
since 1996. We have contracts with six different hospice organi- gels (for seizures).
zations, and we compound a substantial number of preparations 3. I wouldn’t say that we do so regularly, but we do occasionally
for three of them. I stay very active with these organizations as and are available to do so at any time necessary. The hospice
part of their Interdisciplinary Team. organizations in our area have learned through the years to plan
2. Anxiety, bowel motility (constipation or diarrhea), nausea, oral for emergencies (evenings and weekends), so they maintain an
care, pain, skin rashes, vomiting, wound care for odorous (break- ample supply of drugs and supplies for those occurrences. This
through) tumors, wound care for decubitus ulcers certainly makes the patients’ and their family members’ lives
3. It isn’t something we have to do a lot, but we are available to do much easier, as well as ours.
so at any time necessary. We also deliver those medications to 4. Over 60 years of age
either the caregiver or the patient. 5. Yes, we do. We provide a comfort care kit which includes
4. Over 60 years of age prochlorperazine, acetaminophen suppositories, ABHR supposi-
5. Yes, we do. We provide medication for treating their nausea, tories, lorazepam tablets, hyoscyamine, and morphine sulfate in
vomiting, fever, sleep problems, and excess saliva secretions. syringes.
Dianne Boomsma Joe Cabaleiro, RPh

Custom Prescriptions of Lancaster; Lancaster, Pennsylvania Triangle Compounding Pharmacy; Cary, North Carolina
Responses: Responses:
1. Not at my current pharmacy. However, at a previous pharmacy 1. Infrequently now, but we did more in the past. Most hospice
we worked vigorously with three hospice organizations with organizations in our area have contracts with large out-of-state
which we had a contract. Our pharmacy actually had one em- pharmaceutical suppliers. We only receive calls from hospice
ployee whose main role was integrated pharmacy care with the organizations when the out-of-state suppliers aren’t able to assist
hospice organizations’ nursing staffs. a patient with the medication he requires. The way hospice is set
2. Anxiety, nausea, pain, salivary problems (increase or decrease), up makes it too challenging for our pharmacy to work closely
seizures, sleeplessness (terminal restlessness), vomiting, wound with them.
care for malodorous tumors 2. Anxiety, nausea, nonfunctional gut or esophagus problems, pain,
3. We were available 24/7, which meant a lot of after hours vomiting, radiation burns. Note: Some of the preparations that
compounding and delivery of medications to the patient and/or Joe has supplied for hospice patients are: ABHR suppositories,
caregiver. ketamine 10% topical spray, oral methadone.
4. Since preparations were filled by specific prescriptions, we 3. It was in the past when we did more compounding for hospice
weren’t always aware of the patient’s age. patients.
5. Yes, we did. We provided an “emergency kit” which included 4. 50 years and older
morphine, antinausea medication, and other provisions. 5. No, we didn’t.

IJPC drug disposal
Disposing of Expired Drugs and Chemicals:

New Options for Compounders
Written by:
Jane Vail
St. Louis, Missouri
Abstract
Years ago, pharmacists disposed of expired drugs and chemicals by incinerating them, flushing them down the
toilet, washing them down the sink, or attempting to return them to the manufacturer. Some of those methods
of disposal have proven over time to exert a devastating effect on the environment (and often on the local com-
munity), and compliance with state and federal regulations for the management of expired drugs has become
essential to avoid incurring fines and to protect the public welfare. Now, pharmacists who must navigate the
complexities of that effort have professional allies. Over the last decade, the disposal of hazardous pharmaceuti-
cal waste has become a science, and companies with expertise in that specialty are increasing in number. In this
article, information about several pharmaceutical waste disposal or returns companies is compared, and criteria
for selecting a drug disposal service are presented.

drug disposal
FEATURE
IJPC
“I am starting to drown in my own expired medications because to ensure its rapid identification if a spill or accident should occur
I haven’t found an environmentally and financially feasible drug during transit to a disposal facility.5 U-list pharmaceuticals, which
disposal system. What are small compounders to do?” include chemotherapeutic agents such as mitomycin C, daunomy-
cin, chlorambucil, uracil mustard, cyclophosphamide, and diethyl-
“My state board inspector asked me for a record of the destruction stilbestrol, as well as commonly prescribed drugs such as resorcinol,
of expired drugs, including my compounds. He wanted more than reserpine, selenium sulfide, and saccharin, are considered by the
the double signature log that I keep for controlled drugs and the EPA to be toxic and must be identified by a U code at the time of
weight and lot numbers of the products. He wants me to use an disposal.5 D-list pharmaceutical waste is ignitable, toxic, reactive,
outside service....” and/or corrosive.5 Deactivation (pH adjustment) of corrosive waste
is required before its disposal; EPA regulations do not require the
“I want a drug disposal company that will provide a complete incineration of corrosive waste, although that is one permissible
turnkey package for me; one that will send someone here to the method of disposal (E. Koesterer, K. Olson, written communica-
site, let me ship all returns to the company in one box, supply good tion, November 2007).
accounting records and regulatory information that I can use, and
make the steps easy to follow so I can delegate the task to my tech
and quickly confirm that all loose ends are tied up.”
Drug Disposal Services
Compliance with state and federal regulations for the disposal
Daily, weekly, monthly, compounding pharmacists face the chal-
of expired drugs is essential to protect the public welfare and to
lenge of responsibly disposing of expired medications and chemi-
avoid incurring fines levied for violations, and now, pharmacists
cals. In years past, pharmacists avoided accumulating out-of-date
who must navigate the complexities of that effort have professional
drugs by incinerating them on the premises, washing them down
allies. Over the last decade, the disposal of hazardous pharmaceuti-
the sink, flushing them down the toilet, or attempting to return
cal waste has become a science, and companies with expertise in
them indirectly (via sales representatives) or directly to the manu-
that specialty are increasing in number. In this article, information
facturer. We now know that the onsite incineration of expired drugs
pollutes the air and that discarding medications in the dumpster
or trash bin can result in drug diversion or accidental poisoning.
Because many pharmaceutical agents are hydrophilic, biologically
active, and persistent and often resist wastewater treatment, expired
medications that are flushed away have been shown to upset the
ecosystem, contaminate drinking water, and increase the likelihood
Choose Wisely A
of antibiotic resistance.1,2 Drugs currently detected in environ-
mental samples include lipid regulators, hormones, antidepres-
sants, beta-blockers, antibiotics, oral contraceptives, antiepileptics,
antineoplastics, tranquilizers, nonopioid analgesics, and anti-in-
flammatory agents.3 Medications remain unused for many reasons:
noncompliance, the death of the patient,4 expiration, low utiliza-
tion, overstocking due to a one-time use for a patient’s special need,
a change in prescribing practices, the moving away of patients or
prescribers, unclaimed prescriptions, or (as with cisapride) the with-
drawal of the drug from the U.S. market. Regardless of the reason
for disposal, compounding pharmacists, like their institutional and
retail colleagues, are increasingly pressured to find environmentally
friendly and affordable methods of disposing of expired drugs.
Select in-stock cabinets, shelving and
When disposing of pharmaceutical waste, pharmacists must T
furniture accessories in six contemporary
comply with all pertinent state and federal regulations. Accord-
colors or design custom pieces and give your t
ing to the U.S. Environmental Protection Agency (EPA), specific H
space its own unique look. Either way, HCL’s affordable,
chemicals are listed as hazardous waste in the Resource Conserva-
ready-to-assemble solutions make it easy to find exactly what you s
tion and Recovery Act (RCRA). RCRA has classified hazardous
pharmaceutical waste into three categories: the P list, the U list,
need – quickly. We use state of-the-art equipment to design quality a
products and ship your order in five working days or less. n
and the D list.5 All RCRA hazardous waste must be managed and
disposed of according to specific guidelines and cannot be discarded Need inspiration? Let us get you started.
in sewers or landfills or destroyed via municipal incineration or at a Call Free 1.800.848.1633.
medical waste plant.5 P-list agents such as nicotine, arsenic trioxide,
physostigmine salicylate, nitroglycerin, epinephrine, and warfarin www.HealthCareLogistics.com/Cabinets C
in concentrations greater than 0.3% are considered by the EPA
to be acutely hazardous and most dangerous for acute exposure.5 w
Each such pharmaceutical must be identified by a unique P code © Health Care Logistics, Inc. 2008

IJPC drug disposal
about several pharmaceutical waste disposal or returns companies products such as partially used intravenous bags or already com-
is compared, and criteria for selecting a drug disposal service are pounded preparations should be stored in containers specifically
presented. designed to hold those types of hazardous waste and then disposed
of by an incineration company. However, if we receive a drug that is
found to be nonrefundable, we dispose of it (for a charge based on
Capital Returns, Inc weight) at an appropriate incineration facility.
Milwaukee, Wisconsin
Mary Hendrickson, RPh, MBA With which governmental regulations must a reverse
Director of Quality and Regulatory Affairs distributor comply?
Capital Returns, like similar companies, is subject to random
Reverse Distributor audits of all operations by regulatory organizations. We comply
with all required regulations for reverse distributors, which consist
How does working with a reverse distributor benefit
of those from the DEA (controlled substances), the EPA (waste
compounding pharmacists? management), the Department of Transportation (DOT; prod-
Capital Returns is a reverse distributor only; we accept no
uct shipping), the U.S. Food and Drug Administration (FDA; the
known hazardous waste. We offer clients the opportunity to return
processing of products), and various state pharmacy boards. We also
expired drugs and some chemicals for either a credit from the man-
comply with all regulations of the Occupational Safety and Health
ufacturer or (if agents are found to be nonrefundable) disposal as
Administration (OSHA), which ensure that Capital Returns staff
waste. Pharmacists can request assistance with completing required
paperwork, and we offer an onsite service in which a representative are safe in the workplace.
is sent to the pharmacy to inventory controls, box all nondispens- Some waste management firms accept biochemical
able products, and generate Drug Enforcement Administration
(DEA) 222 forms. Our clients return all items (after the separate
waste and also handle returns for their clients. What
bagging of schedule II-V controlled substances in tamper-evident are the advantages of working with a returns-only
bags provided) in a single, sturdy, well-packed cardboard box, and specialty firm?
we supply readily available detailed tracking and accounting infor- Speed and expertise in handling refunds for credit are major
mation for pharmacy records. advantages offered by a reverse distributor. Because we represent
more than 40 drug manufacturers, returns are processed very
How did the specialty of reverse distribution evolve? quickly. In addition, we provide detailed reports about creditable
Years ago, the return of expired drugs was handled on a case-by- versus noncreditable returns and the disposition of each returned
case basis by drug sales reps or wholesalers—or by the pharmacists product. We also assign a dedicated account representative to each
themselves, who depended on the goodwill of drug manufacturers to pharmacy to ease communications, and we provide regulatory
issue credit. In the early 1990s, the first reverse distributor com- consults for our clients.
panies were founded to provide that service for pharmacists and to In addition to preventing the loss of revenue that results from
dispose of expired drugs not eligible for return. Currently, there are discarding creditworthy drugs and chemicals, we can work closely
several dozen such companies nationwide that serve retail, hospital, with independent pharmacists to improve regulatory compliance
institutional, and compounding pharmacies. The return of virtually with federal waste disposal mandates. In certain regions of the
all out-of-date medications for credit is now handled by reverse dis- country, the EPA performs unannounced audits of waste manage-
tributors. When we at Capital Returns receive a shipment of expired ment disposal policies in healthcare facilities; primarily hospitals at
drugs and chemicals from a client, we process each of returned item this point, but compounding pharmacies are not exempt from those
according to the manufacturer’s policy and determine its creditwor- assessments. EPA inspections address details of waste management
thiness. We then submit a debit sheet to the manufacturer, which of which many pharmacists are unaware; for example, that the stor-
usually issues a credit to the pharmacy through its wholesaler. Many age containers for items on the RCRA list (such as warfarin) must
manufacturers provide credit for a drug for 1 year after its expiration
also be managed as hazardous waste. If violations are found during
date, but others have a shorter grace period. Large chain pharmacies
an EPA audit or after the investigation of a complaint, a fine for
usually have a good idea of the percentage of their credit returns
noncompliance with federal waste disposal regulations can be levied
because they have negotiated those arrangements, but independent
pharmacists, unless they maintain their own database of manufactur-
against the pharmacy.
ers' policies, usually don’t know in advance whether they’ll receive Which steps should a compounder follow to return
credit for an expired drug. Reverse distributors can be especially use-
ful for smaller pharmacies. If I were running my own independent
expired medications for credit via Capital Returns?
pharmacy now, I would recommend walking the shelves quarterly
Usually all arrangements are made by telephone. After provid-
and sending back products due to expire within the next few months ing necessary documentation of licensing (our clients must present
as well as those that have already expired. If a drug we receive can- proof of appropriate licensing, DEA registration, and a valid state
not be returned for credit, then we dispose of it in an EPA-approved pharmacy board license) and signing a contractual agreement, the
facility. pharmacist packs, in a lined sturdy box, all medications that are
deemed creditworthy and ships those drugs to us via a common
Which types of drugs does Capital Returns accept? carrier such as United Parcel Service or Federal Express. Returns
Many expired unused medications and some chemicals used in can be shipped either on a set schedule (which usually applies to
compounding can be returned to their manufacturer for credit, but large chains) or as needed any time. It’s important that drugs sent to

drug disposal
FEATURE
IJPC
a reverse distributor be considered to have some value and are not tals, blood banks, retail pharmacies, pharmaceutical manufacturers,
identifiable hazardous waste, which must be handled and disposed medical and dental offices, outpatient clinics, and laboratories.
of according to strict governmental guidelines. Products that are
confirmed to be waste are disposed of by incineration at either of With which governmental regulations does Stericycle
two facilities (one handles hazardous waste and the other, nonhaz- comply?
ardous waste); we never shred returned products for deposition in We are compliant with EPA and RCRA regulations for manag-
a landfill. The safe storage of drugs is ensured during processing, ing pharmaceutical waste in a facility and with DOT regulations
which is a seamless series of steps from our receipt of the expired for properly segregating, packaging, and manifesting pharmaceuti-
drugs to their return to the manufacturer for credit or their incin- cal waste for transportation over the road. We routinely undergo
eration. inspections by the DOT, the DEA, and state environmental regula-
tors.
How can a pharmacist determine which reverse
distributor to choose? Which of your services benefit pharmacies most directly?
The drug manufacturer (and not the reverse distributor) decides For most of our pharmacist clients, we provide a turnkey ser-
the amount of the refund credited, but fees among reverse distribu- vice that addresses all waste management needs, beginning with
tors and the type of reports they provide to pharmacists vary. A formulary characterization. Our proprietary database includes
good reverse distributor can provide the pharmacist with a detailed the national drug codes (NDCs) of 340,000 pharmaceuticals. We
report that describes how each returned product was handled and can accurately characterize each NDC, and by comparing the
includes a list of the drugs incinerated as waste and the reason for pharmacist’s formulary with our database, we can determine the
which each of those products was nonrefundable; for example, waste characteristics of each NDC and differentiate hazardous from
because the manufacturer does not provide credit for opened items nonhazardous pharmaceutical agents and chemicals. Then, we can
or partial quantities. provide implementation consulting, training and training materials,
transportation and disposal of medical and pharmaceutical waste,
What are the greatest benefits that Capital Returns and pharmaceutical returns for appropriate products. Onsite visits
offers compounding pharmacists?
• Timely and accurate processing
• Detailed reporting capabilities
Choose Wisely Assemble Quickly

• A dedicated account representative assigned to each account
Stericycle, Inc
Lake Forest, Illinois
Tony Martinez
Director of Service/Product Development
Returns and Waste Disposal

What are the consequences of improper pharmaceuti-
cal waste disposal?
Concern regarding the environment has increased since the
publication of the U.S. Geological Survey Study,6 which found
that 80% (111) of the streams sampled contained at least one waste
contaminant, 13% of the streams contained 20 or more waste
contaminants, and the water contaminants included drugs such as
antibiotics and over-the-counter medications. Toolless connect and
Many pharmacists don’t have the resources to dispose of their
colors or design custom pieces and give your toggle fittings on all
expired drugs and chemicals in accordance with federal (and often HCL’s cabinets and
state) requirements. Disregarding those mandates, though, dam-
ready-to-assemble solutions make it easy to find exactly what you shelving units make assembly
ages the environment and increases the risk of incurring fines for
need – quickly. We use state of-the-art equipment to design quality
noncompliance. Stericycle has a variety of programs useful to phar-
a snap. Enjoy your fresh
products and ship your order in five working days or less. new furnishings – fast!
macists who prefer to outsource their waste management: medical
Need
and inspiration? Letwaste
pharmaceutical us getdisposal
you started.
(including a mailback program
for sharps or mercury)
Call Free 1.800.848.1633.
and recall, retrieval, and returns manage- © Health Care Logistics, Inc. 2008
ment. Expired drugs and chemicals are handled through Stericycle’s

www.HealthCareLogistics.com/Cabinets
pharmaceutical waste compliance and expert returns service. All Call Free 1.800.848.1633 and find out how.
hazardous nonreturnable pharmaceuticals are incinerated at permit-
ted hazardous waste treatment facilities. We provide those services, www.HealthCareLogistics.com/Cabinets
among others, for a nationwide customer base that
© Health includes
Care hospi-
Logistics, Inc. 2008

IJPC drug disposal
can be scheduled to provide timely feedback to staff, which in- ensure compliance. Some pharmacists may combine hazardous
creases compliance with regulatory requirements. Protecting people waste with medical waste such as syringes or “sharps”; stockpile
and reducing risk are our key goals, and our mission is to promote their expired drugs, which (especially if they are flammable) could
safety, compliance, and risk management for our customers. pose a safety risk to staff and the facility; or pour out-of-date agents
down the drain or toilet, which contaminates the environment.
What are the greatest benefits that Stericycle offers Those methods of disposing of expired drugs are inappropriate.
compounding pharmacists? In addition to the environmental damage that can result, random
• Providing appropriate formulary classification inspections by a regulatory organization (the DOT, the EPA, or a
• Providing appropriate disposal of compounded medications after state agency) or the outcome of a complaint-based investigation can
extensive formulary analysis create bad publicity and result in substantial fines for noncompli-
• Enabling pharmacists to comply with essential regulations, in- ance.
cluding those of the EPA, RCRA, and DOT
How does Chemical Disposal Services manage
Chemical Disposal Services, Inc hazardous pharmaceutical waste for its clients?
Gary, Indiana First, we send an account representative to the pharmacy to
Russell A. Karlins review all current waste disposal practices; for example, how
President expired drugs and chemicals are stored or how drugs are handled
for reverse distribution or disposal. We then perform a formulary
Specialized Waste and Returns Company analysis, which enables us to understand all the various formularies
in the pharmacy and then classify them according to content, taking
Which types of services does Chemical Disposal Ser-
into account how many drugs are hazardous and which agents must
vices provide?
be stored in a specified manner. We then set up a system for ongo-
Chemical Disposal Services is a full-service waste disposal
ing analysis that addresses additions to the formulary, and we create
company with an excellent regulatory record. We serve many major
a system for the collection of expired drugs and chemicals. Most
pharmaceutical manufacturers and hospitals as well as smaller cli-
hazardous agents can be stored in either of two containers: one for
ents. We collect hazardous chemical waste (which, when generated
by a pharmacy, is usually flammable or toxic) that is then inciner- flammable and toxic drugs and the other for aerosols. We educate
ated or fuel blended, but we’ve found that most of our pharmacy the staff about which agents should be stored in which container
customers want to dispose of all expired drugs (not just those that until pickup, and finally, we develop a collection schedule that is
are toxic or flammable) responsibly. We assist a wide range of cli- convenient for the pharmacist.
ents (healthcare institutions, industry, dry cleaning, manufacturing) An EPA advisory cautions pharmacists that if there is not a high
with the disposal of their hazardous waste, and we also provide a probability of return for an expired agent, it should not be sent to
pharmaceutical returns service. Our recent affiliation with Steri- a reverse distributor. We can help pharmacists determine which
cycle enables us to offer our services nationwide. We can dispose expired drugs are hazardous waste and which have the potential for
of all hazardous materials (expired drugs and chemicals, medical return. Out-of-date compounded preparations are not creditwor-
waste) that a pharmacy generates. Pickups are made according to an thy; they are considered hazardous waste. If a compounded prepara-
arranged schedule or as needed, and periodic contact with appropri- tion has expired, the pharmacist can complete our profile form,
ate regulatory agencies ensures that the treatment facilities we use which lists the ingredients of that formulation, and we’ll accept his
comply with applicable regulations. or her word about the content of that preparation. It’s important to
remember, however, that the pharmacist is ultimately responsible
How would the services of a waste management com- for hazardous waste disposal. For that reason, he or she should
pany benefit a compounding pharmacist? carefully select a vendor that can provide excellent documentation
With respect to disposing of out-of-date drugs, pharmacists are and insurance and that has experience, good references, and a good
concerned with regulatory compliance, safety for staff and facili- regulatory compliance record.
ties, and long-term environmental impact. Substances are consid- We advise our independent pharmacy clients to perform a self-
ered hazardous for two reasons: Either they are characteristically assessment of their operations from a compliance standpoint. Com-
hazardous; that is, they are defined by the EPA as flammable, toxic, pounders are active and supportive members of their community;
reactive, or corrosive; or they are included in the EPA lists of less the service they provide is very different from that offered by the
hazardous substances (the U or P list). Current hazardous waste chain pharmacy on every street corner. An independent compound-
regulations in the U.S., which were originally designed for industri- ing pharmacy may never be inspected, but if it is and a violation is
al purposes rather than for pharmacies, are more than 30 years old identified, the fines levied and the bad publicity can be devastat-
and are badly out of date. However, those regulations are still being ing. Working with a returns or waste disposal company can help
applied to all generators of hazardous waste, including pharmacies. pharmacists to maintain regulatory compliance, reduce the negative
Many independent pharmacists are unaware of the stringent regula- environmental effects of dissposing of their hazardous pharmaceuti-
tions regarding the disposal of their expired drugs and chemicals, cal waste, and ensure workplace safety—without spending a million
and others do not have the resources to implement programs that dollars.

Choosedrug
Wisely
disposal
FEATURE A
IJPC
What are the greatest benefits that Chemical Disposal ous waste spills. All staff associated with our pharmaceutical waste
Services offers compounding pharmacists? program are certified healthcare environmental managers or certi-
• Maintaining ongoing regulatory compliance fied hazardous materials practitioners, or they have had extensive
• Reducing the negative environmental effects of hazardous phar- Hazardous Waste Operations and Emergency Response Standard
maceutical waste (HAZWOPER) and first responder training.
• Ensuring workplace safety
How would you develop a waste management plan for
an Select
independent pharmacy?
in-stock cabinets, shelving and
Healthcare Waste Solutions, Inc We haveaccessories
furniture no minimum volume
in six requirements. We would begin
contemporary
T
Cincinnati, Ohio t
withcolors
an onsite inventory
or design customanalysis
pieces andof all hazardous
give your drugs in the
Michael Schuster H
pharmacy.
space itsArmed with that
own unique look.list of agents,
Either we can
way, HCL’s evaluate the cur-
affordable,
Certified Healthcare Environmental Manager
rentready-to-assemble
collection, storage, and disposal
solutions practices
make it easy to findthat are in
exactly what place.youThe s
pharmacist may not
need – quickly. Webeuseaware
stateof drugs recently
of-the-art equipment added to the
to design RCRA
quality a
Waste Management, Disposal, and Consulting Services lists,products
and weand
canship
identify
your those
order inagents. We would
five working daysthen inform the
or less. n
Which types of companies does Healthcare Waste pharmacist about the proper disposal technique for each hazardous
Need inspiration? Let us get you started.
Solutions service? product, and we would recommend particular waste containers and
Healthcare Waste Solutions (HWS) is a waste management Call Free
container 1.800.848.1633.
types so that hazardous pharmaceuticals can be stored in
company focused on the environment with regard to employee a compliant manner. We can recommend appropriate and secure
www.HealthCareLogistics.com/Cabinets C
safety, environmental and regulatory compliance, and cost-effec- accumulation areas, and we also assist with the development of poli-
tive practices. We offer both professional waste removal services cies and protocols for training employees who must handle hazard-
w
and waste management services, and we can assist with or manage ous drugs or chemicals. We provide instructions for proper labeling
the proper disposal of unused or expired drugs. If the return of and compliant packaging for the shipping of hazardous drugs, and
© Health Care Logistics, Inc. 2008
expired drugs to the manufacturer for credit is preferred, then we we arrange pickup times according to the volume of drugs that
can recommend a pharmaceutical reverse distribution program. accumulate. HWS has incineration plants throughout the U.S. that
We suggest that a reverse distributor be a member of the Returns
Industry Association (RIA) and licensed as a DEA Schedule I reg-
istrant, because those criteria ensure the proper handling, contain-
ment, removal, transportation, and documentation of disposal that
are necessary for the handling of controlled substances.
Design Confidently
Our primary clients are healthcare systems in the U.S.: hospi-
tals and clinics, physicians’ and dentists’ offices, veterinary clinics,
outpatient pharmacies and laboratories, small urgent care centers,
surgery centers, nursing homes, and long-term care facilities. We
specialize in larger hospitals and healthcare systems. Our company
is only 5 years old, and we are interested in providing services to
small independent pharmacies, although we do not do so at this
time.
How do your services benefit pharmacists?

Most pharmacists aren’t familiar with RCRA regulations, and
noncompliance can result in serious consequences such as fines or
a substantial amount of negative exposure. A pharmacy should have
a plan in place for managing hazardous pharmaceuticals. We’ve had Maximize the potential for
situations in which a disgruntled employee has reported a pharma- your cabinet project with
cy’s violations or an unannounced inspection reveals them. Ulti- our FREE 3D Design Service.
mately, of course, public health is affected. Endocrine disruptors Our design specialists can
that pollute the water supply are among the worst offenders, and create a virtual layout of your
chemotherapeutic drugs tend not to deteriorate over time. Water space and help you choose
treatment facilities developed 30 years ago are not designed for or the combination of pieces to
capable of eliminating the types of chemicals that are dumped into best suit your pharmacy’s needs.
the water supply today. Make selections with confidence © Health Care Logistics, Inc. 2008
when you design with HCL.

With which types of regulations does Healthcare
Waste Solutions comply? Would you like a catalog? Call and we’ll send yours today.
We must obtain DOT permits to transport hazardous drugs and Call Free 1.800.848.1633.
a general permit to store them. Our truck drivers must be trained
in responses appropriate for managing and containing hazard-

IJPC drug disposal
IJPC
dispose of hazardous waste in compliance with all federal and state
requirements. We oversee the transport, tracking, and confirmation
of the waste in terms of delivery and incineration, and we provide a
detailed invoice to confirm that the waste was disposed of properly.
We work with our clients in a cradle-to-grave concept, and when a
client receives a certificate of destruction, he or she knows that the
disposal has been accomplished appropriately. In my opinion, the
proper disposal of hazardous pharmaceuticals is a big topic that will
just continue to get bigger.
What are the greatest benefits that Healthcare Waste

Solutions offers compounding pharmacists?
Each CD is a
Compounding Theme CDs
• Employee risk reduction

• Potential cost savings
compilation of • Assured environmental and regulatory compliance
previously published
Acknowledgment
IJPC articles and The author thanks George Muller, RPh, owner and principal of
formulations in PDF Muller’s Compounding Corner in Lacombe, Louisiana; and Kim
Olson, EPA public affairs specialist, US EPA, Region 7, Office of
format. Public Affairs, Kansas City, Kansas for contributing essential infor-
mation to this article.
For a complete list of

References
CD contents, see 1. Radjenovic J, Petrovic M, Barceló D. Analysis of pharmaceuti-
cals in wastewater and removal using a membrane bioreactor.
www.ijpc.com/products
[ ]
Anal Bioanal Chem 2007; 387(4): 1365–1377. Available at: www.
pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubme
did=17115140. Accessed November 5, 2007.
2. Pauwels B, Verstraete W. The treatment of hospital wastewater:
Order one CD for $95. An appraisal. J Water Health 2006; 4(4): 405–416.
3. Daughton CG, Ternes TA. Pharmaceuticals and personal care
Additional discount products in the environment: Agents of subtle change? Environ
with multiple cd orders. Health Perspect 1999; 107(Suppl 6): 907–938. Available at: www.
pubmedcentral.nih.gov/picrender.fcgi?artid=1566206&blobtype
(Plus shipping & handling) =pdf. Accessed November 5, 2007.
4. Ruhoy IS, Daughton CG. Types and quantities of leftover drugs
entering the environment via disposal to sewage – Revealed by
coroner records. Sci Total Environ 2007; 388(1–3): 137–148.
For more information 5. Saljoughian M. Pharmaceutical categories considered as hazard-
contact IJPC Circulation at ous waste. U.S. Pharm 2004; 6: HS-22–HS-24. Available at:
www.uspharmacist.com/index.asp?show=article&page=8_1296.
800.757.4572 or email: htm. Accessed October 24, 2007.
[email protected] 6. Barnes KK, Kolpin, DW, Meyer MT et al. Water-quality data for
pharmaceuticals, hormones, and other organic wastewater con-
taminants in U.S. streams, 1999–2000. [United States Geological
Survey Website.] Available at: http://toxics.usgs.gov/pubs/OFR-
02-94/. Accessed November 1, 2007.
PHARMACEUTICAL For additional information contact Jane Vail. E-mail: janevail@

sbcglobal.net
COMPOUNDING Profiles of selected pharmaceutical waste disposal firms and return distribu-
tors can be found on the International Journal of Pharmaceutical Com-
pounding Websites at www.ijpc.com and/or www.compoundingtoday.com.

Choose Wisely Assembledrug
Quickly
disposal
FEATURE
IJPC
Green Pharmacy: Helping Communities Dispose of
Expired Drugs
As awareness of the ecological effects of the casual disposal of ers to community members. The other three stores participate in
unused or expired drugs builds, many pharmacists have taken the a program run by the Teleosis Institute that picks up and disposes
lead in educating their community and offering an environmentally Toolless
of the connect
medications. Weandare delighted to offer this service in our
friendly solution to the problem of expired-drug disposal. In the stores! For fittings
toggle years, our
onpatients
all have told us that this is a service
colors or design custom pieces and give your
San Francisco Bay area, some pharmacists are partnering with the they desire. There is
HCL’s cabinets and an increasing awareness of the environmental
Teleosis Institute in Berkeley, California, to implement a popular impact of prescription medications that are improperly disposed of.
ready-to-assemble solutions make it easy to find exactly what you shelving units make assembly
program that helps communities divert unnecessary pharmaceutical In fact, detectable levels of prescription drugs have been found in
theaSan
snap. EnjoyBay,
your fresh because people have been flushing
need – quickly. We use state of-the-art equipment to design quality
waste from the environment. Teleosis provides educational pro- Francisco probably
products and ship your order in five working days or less. new furnishings – fast!
grams, resources, and tools to further Green Health Care, a concept their unused medications down the toilet. We promote healthful,
Needon
based inspiration? Let us
the theories gethuman
that you started.
health and the environment are earth-sustaining products in our stores, so it’s natural for us to offer
interdependent and that healthcare professionals who focus on this service. I believe that it does bring us© business, andInc.it2008
Health Care Logistics, shows our
Call Free 1.800.848.1633.
education, prevention, precaution, and wellness can improve the patients that we put our environmental beliefs into action.
health of their patients, preserve the environment, and benefit their Call Free 1.800.848.1633 and find out how.
community. Part of that effort involves the Green Pharmacy Pollu- For more information contact Peter Koshland, PharmD, Elephant
tion Prevention Campaign, which has a goal of zero pharmaceutical www.HealthCareLogistics.com/Cabinets
Pharmacy, 1607 Shattuck Avenue at Cedar, Berkeley, CA 94709.
waste in the environment. The Green Pharmacy © Health Program involves
Care Logistics, Inc. 2008
Telephone: Store 510-549-9200; Pharmacy 510-549-9201. E-mail:
partnership with local pharmacies, health professionals, and public [email protected]
and private organizations, and it supports the concept that every
sector involved with the production, prescription, consumption,
and disposal of pharmaceuticals is responsible for ensuring that
the disposal of unwanted drugs is safely managed. To improve
Design Confidently
drug-prescribing policies and reform that will close the loop on
cradle-to-grave product stewardship, Green Pharmacy also collects Work Efficiently
comprehensive data on all returned medications.
Pharmacists who participate in the Green Pharmacy Program
offer to members of their community the free safe disposal of un-
wanted medications of the following types: prescription drugs (ex-
cept for controlled medications), all over-the-counter medications,
vitamins, medication samples, empty inhalers, medicated ointments
and lotions, liquid medications in glass or leakproof containers,
pet medications, and homeopathic remedies. At present, the Green
Pharmacy Program operates within the San Francisco Bay area, but
Teleosis hopes to expand the program and offer Green Pharmacy
to other cities in the near future. Compounding pharmacist Peter
Koshland, PharmD, of Elephant Pharmacy in Berkeley, California,
who is participating in the Green Pharmacy Program, has found
that offering this service to his clients and neighbors has multiple
Maximize
benefits. He the potential
presents for below.
his views
your cabinet project with
our FREE 3D Design Service. Update appearance, utilize
Our design specialists can wasted space and improve
Notes from a Green Pharmacy Member
create a virtual layout of your productivity. Become more
space Koshland,
Peter and help youPharmD
choose efficient with organized storage and
the combination
Elephant Pharmacyof pieces to enjoy a clean, clutter-free
best suit California
Berkeley, your pharmacy’s needs. work environment.
Make selections with confidence © Health Care Logistics, Inc. 2008
when you design

At Elephant with HCL.
Pharmacy, we have four stores (each in a different
© Health Care Logistics, Inc. 2008
county) that offer the free disposal

Would you like a catalog? Call and of hazardous
we’ll send drugsyours to today.
members
of the community. Our store in Marin County offers a county-run Call Free 1.800.848.1633 and see for yourself.
Call Free
program that1.800.848.1633.
not only picks up and disposes of expired medications
but also picks up sharps and supplies free sharps disposal contain- www.HealthCareLogistics.com/Cabinets

IJPC drug disposal
What Pharmacists Can Do to Promote nonhazardous. Hazardous waste such as drugs, chemicals, and
compounds must be disposed of by a properly licensed treatment,
Green Pharmacy storage, and disposal facility (TSDF). Before you ship any hazard-
ous waste, check with the receiving disposal facility to confirm that
• Review and regularly reassess each client's total consumption of
medication. it is licensed as a TSDF.
• Educate consumers about the proper disposal of pharmaceutical
Jeff Hollar, COO
waste.
National Pharmaceutical Returns, Inc
• Host a Green Pharmacy Take-Back Site.
• Be informed and spread the word: Visit www.teleosis.org or call* For more information about National Pharmaceutical Returns, Inc.,
to learn about the environmental effects of expired drugs and please see the profiles of selected pharmaceutical waste disposal
ways of preventing drug-related pollution. The Website also firms and return distributors, which can be found on the Interna-
provides access to educational materials to share with colleagues, tional Journal of Pharmaceutical Compounding Websites at www.
friends, and family. ijpc.com and/or www.compoundingtoday.com.
For more information contact James Dong, Green Pharmacy Pro-

gram Coordinator, Teleosis Institute, 1521 B Fifth Street, Berkeley,
CA 94710. *Telephone: 510-558-7285. Website: [email protected]
Disposing of Picric Acid:
A Cautionary Tale
A Note to Compounders Excerpts from the IJPC
No compounding chemicals or the resulting compounds are
returnable to a manufacturer or wholesaler for credit. Therefore, Compounders’ Network List,
compounds must be handled and treated as waste. A determina-
tion must be made regarding whether that waste is hazardous or July 2007
A little warning for all collectors of old apothecary jars....
It is now 1:45 AM, and the bomb squad has just left my
SPEAKING PROFESSIONALLY pharmacy. I purchased an old apothecary jar from a phar-
macy that was sold about 5 years ago. That pharmacy had
had only 3 owners since the Civil War. One of the apoth-
with Store Planning, Store Fixtures & Decor ecary jars for sale said Ac. Pichrin in Latin on the old label,
and it had some yellow powder in it. I purchased the jar and
brought it into my pharmacy for decoration. Well, I found
out today that picric acid is a little less stable than TNT and
just as explosive, especially if it is in powder form. The jar
contained about 8 ounces of powdered picric acid, which
is equivalent to about a half stick of dynamite. This little jar
was about $75 to purchase and will cost "less than $10,000
Abrams Royal Pharmacy but more than $5000" to get rid of.You might want to check
Dallas, TX
your pharmacies for this chemical, and if you have it, hope it
is in a liquid form in a container that doesn't have a metal lid.
Potts & Associates is the firm with the experience
Mine didn't have a metal lid, but since it was potentially over
to assist you in planning your IV Clean Room, 100 years old and was in powder form, I got to see how a
Compounding Laboratory, and presenting a more hazmat team works. I wouldn't recommend it.
professional image to your customers. Call us today Concerned Compounder
or visit us online.
Hello, Concerned Compounder.
Serving Pharmacists Since 1954 Acidum picrinicum wetted with 50% aqua is stable and
nonexplosive.... Stability seems to be quite sufficient since
1865?
5050 BOYD BLVD | ROWLETT, TEXAS 75088 (DALLAS, TX Suburb)
main 9 7 2 . 4 7 5 . 4 3 7 1 | 9 7 2 . 4 7 5 . 4 6 2 0 | toll free 8 0 0 . 2 5 5 . 5 4 9 8
Gerhard Zueck
fax 9 7 2 . 4 7 5 . 4 8 3 9 | www.robtpotts.com Faust-Apotheke
Knittlingen, Germany

drug disposal
FEATURE
IJPC
Thanks, Gerhard. I know that you Twenty-five years ago, I had a At last:
just have to rehydrate the powder. pharmacist working for me who went The historical use of picric acid for
The trick is not having the equivalent through some expired chemicals. He pharmaceutical purposes: in aqueous
of a stick of dynamite in a glass bottle found an old bottle of picric acid, and solution as a disinfectant and for the
explode before it gets the chance to I called the local fire department and topical care of wounds caused by burns
become stable. The apothecary jar asked about the best way to dispose (wetted compresses) as an analgesic.
had a glass friction stopper that (as I of it. They very calmly told me not to Internal uses: as a remedy for febris in-
am sure we all know) can be a little worry about it, leave it on the counter, termittens, whooping cough, rheumatism,
"sticky" when it is removed. There was and someone would come by and take and neuralgia, as well as for repelling
a powder residue all over the inside of it off our hands. To make a long story intestinal worms. Single dose: 0.1 to
the stopper, so it wasn't like I could just short, within 30 minutes we had 5 or 0.2 g; maximum daily dose, 0.5 g.
take the top off and pour water in the 6 fire trucks, 5 police cars, and 3 local References: (1) The United States
bottle. The bomb squad had to use a news stations (both TV and radio). We Dispensatory. 15th ed. Part II. 1886:
robot to break the glass while the bot- were the second leading story on the 1727–1728; (2) Hagers Handbuch der
tle was submersed in a ferrous sulfate evening news in Los Angeles on that Pharmaceutischen Praxis. 2nd ed. Berlin:
solution. Not something I wanted to try evening. Verlag von Julius Springer. 1907; (3) Real-
on my own. I didn't want to kill myself Life can be fun. Enzyklopaedie der gesamten Pharmazie.
or hurt anyone else in the extremely 2nd ed. Berlin/Wien: Verlag Urban &
Irv Reitzenstein, PharmD Schwarzenberg. 1904.
busy hallway that is right outside of my Valley Drug and Compounding
lab while trying that little trick. Encino, California Gerhard
Concerned Compounder
Hi, Concerned Compounder. Ensuring�Consistency�and�Quality�

So we learn that you can happily in your compounded preparation one sample at a time . . .�
live with the bomb until you realize Potency Determination�•� Stability Studies�•�
Aseptic Technique Kits�
that it is a bomb! Three months ago, I Sterility Testing�•�
Endotoxin Testing�•�<�
795� >�and�<�
797�>�
Consulting�
wanted to get rid of my picric acid for
analytical purposes (about 20 g, just 40
years old). In our town, there is a large
waste reprocessing plant. After I called
them, 2 men with a truck and a proto-
col sheet drove to my pharmacy and
put the jar in a large plastic barrel filled
with sand. I signed the protocol, and the
cost of disposal was about $600. They
also disposed of about 35 kg of expired
compounding substances and chemical
substances, as well as insecticides and
aniline colors that had been slumbering
in the 3 attics of the pharmacy since
the last emperor’s time, all included in
the above price. This was a special offer
proposed to pharmacies by our Cham-
ber of Commerce. (European prices!)
Best regards,
Gerhard
Analytical�Research�Laboratories�
1-800-393-1595� www.arlok.com�

calcula I i n
ma ke I ing
ub c ip I i n ad e I i emen I
I
I
Websites: Keeping Current in 2008
Beginning with this issue of the Websites save time and money for smart to buy several domain names (“aliases”) that
healthcare providers and provide valuable can be directed to a primary URL.
International Journal of Pharma-
information 24/7 for both patients and It is essential that the owner of the
ceutical Compounding, Patricia practitioners. A website is today’s version business, or someone who is permanently
L. Storey, RPh, FACA, the owner/ of a “Yellow Page” listing for the 80% of associated with the owner, is registered as
president of Storey Marketing, will adults who search for healthcare informa- the owner of and administrative contact
contribute articles on marketing. tion and providers online. A well-designed for the domain name. Update your contact
website is a sign that a pharmacy keeps information with your current e-mail ad-
She has been providing marketing current; it can be a source of revenue, im- dress so you will receive important e-mails
materials and support for com- prove customer relationships, and build the about your domain name, such as renewal
pounding pharmacies since 1991, pharmacy’s professional image. This article notices. Know where your domain name
and we are sure that she will inspire describes the website development process is registered and securely record your user
and offers content and marketing tips for name and password for future use.
readers of our journal with new
existing websites.
marketing approaches.
Website Design
Domain Name When choosing a website designer
The first step in website development is (“webmaster”), consider the designer’s reli-
to select and purchase a domain name, i.e., ability, experience, and use of current tech-
your World Wide Web address, otherwise nology. Ask for examples of the designer’s
known as a URL (e.g., www.yournameph- work, references, and a detailed contract.
armacy.com). A domain name with a “.com” A website should be interactive and
extension is preferred not only because it dynamic, as well as user friendly, compre-
is more recognized and more standardized, hensive, and easy to navigate. While much
but because the .com extension is more of a website’s content should be unique, it
Patricia L. Storey, RPh, FACA commonly used for commercial activities. is possible to purchase “hosted content”
Storey Marketing Domain names can be purchased from which can be an economical source for cur-
Meadville, Pennsylvania registrars such as www.networksolutions. rent information specific to your pharma-
com or www.godaddy.com. You may choose cy’s specialty.

marketing
FEATURE
IJPC
In addition to standard information such tients/prescribers to announce your website
as a location map, hours, and staff biogra- and the benefits it offers. Capsules
KALCHEMINTERNATIONAL.COM
phies, a pharmacy’s website may include any
of the following:
Chemicals
Website Maintenance Flavors
• Consultation forms (Security Certificate It is important to keep your website
recommended) current by regularly updating content, Food Colors
• Online refill requests including copyrights, and adding features Supplies
• Nutritional supplements, durable medi- when new technology becomes available.
cation equipment, or gift shop (list of Stale websites with listings of past events
products/online store) are much less impressive. Websites can
• Schedule of seminars/screenings be modified with editing software such as
• Educational videos or audio files Frontpage or Dreamweaver, or from any
• E-mail newsletter sign-up and database computer using a Content Management
management System, or by hiring a designer to make
Pharmacies that send out newsletters to changes and updates.
patients or prescribers may wish to archive
these newsletters online in an indexed, Search Engine Optimization
searchable database for reference purposes. Search engine optimization is a custom
After the initial website design is com- marketing option that targets those who
plete, files are provided to the host, who are already searching for information about
is responsible for maintaining a website’s preparations or services that are avail-
presence on the Internet. A reliable host able through your pharmacy, and usually
that utilizes current technology is essential provides a high return on investment.
and helps to avoid unnecessary frustration Organic search engine marketing is de-
and problems secondary to “down time.” pendent on keywords and keyword phrases
When selecting a hosting company, the in a website’s content, while pay-per-click
best choice is usually not the megacompany results are linked to keywords or phrases
that advertises the lowest price. Beware of which are selected by the person who sets
hidden charges, which often result in a total up and maintains the campaign.
cost that is greater than a comprehensive
fee for service from a smaller company that Analyze Website Statistics
offers phone and e-mail support and faster Marketing analysis and tracking data
response should a problem occur. should provide more than a simple count of
Utilize an e-mail address that reflects a website’s visitors (“hits”). More meaning-
your domain name, e.g., yourfirstname@ ful statistics include the numbers of unique
yournamepharmacy.com. Ownership of a visitors, new visitors, return visitors, and
domain name precludes the need to change page views, as well as a description of the
your e-mail address in the future. Even if most common paths that visitors follow
you change your host, your e-mail address through a website. This information is very
can remain the same. useful in evaluating a website’s navigation
and the response to links provided in vari-
Marketing Your Website ous forms of advertising.
Setting up a website is like building
a store on a dead-end street. If you want Conclusion
visitors, you must find them and offer a Partnering with a reliable, experienced
compelling reason (vital health informa- company that can coordinate website de-
tion, features that will save them time and sign, hosting, and maintenance, and develop
money) to initially visit your website, and a marketing plan, is usually the most effi-
a reason to return. Include your website cient and the most effective way to take full
address in all ads, printed materials, and advantage of the marketing opportunities
your e-mail signature, and announce your provided by the World Wide Web.
website in discussion groups and when you
make a presentation: “See our website for Address correspondence to Patricia Storey,
details…” Clearly provide your URL (spell RPh, Storey Marketing, 19487 East Cole
if needed) on your Message-On-Hold and Road, Meadville, PA 16335-9673. Website:
answering service. Use in-store handouts www.storeymarketing.com. E-mail: info@
and send postcards or other mailings to pa- storeymarketing.com
888-298-9905

ba ic f c mp unding
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Stability VersusI iPotency
n Testing:
I
The Madness is in the Method
ma ke I ing I
Abstract
Potency tests, known as quantitative tests, are designed to determine how much of the active
I drug is in the sample. Stability tests are used to determine a beyond-use date for a preparation.
I
I
Employing the proper method to determine potency or stability is key to understanding the
difference between potency testing and stability testing. Methods of determining potency may
or may not be stability indicating, but stability can be determined only by a stability-indicat-
ing method. A stability-indicating method can determine both potency and stability. Quality
assurance programs are essential to establishing standards for compounded preparations. It
is important that compounding pharmacists understand the differences between potency and
stability tests and that these tests are made an integral part of the quality assurance program.
I
I
Thomas C. Kupiec, PhD Oftentimes the question is asked “What preparation, mixing, and assembling,
Analytical Research Laboratories, Inc. is the difference between potency and packaging, and labeling of a drug or device
Oklahoma City, Oklahoma stability?” This seems like a rather simple in accordance with a licensed practitioner’s
question and in some respects it is. To prescription of medication or under an
Rodney Skinner answer this question, however, the differ- initiative based on the practitioner/patient/
College of Pharmacy ences in the methods used to analyze the pharmacist/compounder relationship in the
University of Oklahoma potency and stability of a compound must course of professional practice.”2 The art of
Oklahoma City, Oklahoma be understood. The most common mistake pharmaceutical compounding has long been
in determining stability is failure to use an a fundamental element in the profession
Lance Lanier, RPh analytical method that has been demon- of pharmacy.3 In an effort to ensure that
Analytical Research Laboratories, Inc. strated to be stability indicating.1 It is not a each preparation is made appropriately and
Oklahoma City, Oklahoma surprise, therefore, that the most important safely, a set of standards has been devel-
aspect of determining potency and stabil- oped by the United States Pharmacopeial
ity is the methods employed in the process. Convention, Inc. (USP). One such standard,
Simply put, a stability-indicating method included in Chapter <1075>, is the require-
must be used to determine stability. A ment that a compounded preparation be
stability-indicating method also can deter- assigned a beyond-use date.2 The beyond-
mine potency, but not all potency tests can use date must be based on published data,
determine stability. appropriate testing (i.e., stability-indicating
The purpose of this article is to explain method), or USP–National Formulary stan-
the difference between potency and dards.2 It is the compounding pharmacist’s
stability, why they are important, and how responsibility to follow the USP guidelines
they are determined. The method used to when preparing compounded medications.
determine the concentration of the active Chapter <1163> Quality Assurance in Phar-
ingredient, or analyte, is the most critical maceutical Compounding defines a quality
step in the process. assurance program as “a system of steps and
actions taken to ensure the maintenance of
Quality Assurance in proper standards in compounded prepara-
Compounding tions.”4 A quality assurance program is
United States Pharmacopeia (USP) essential to ensuring that the USP guide-
Chapter <1075> Good Compounding lines are met and that each compounded
Practices defines compounding as “the preparation is safe.

quality-control
FEATURE
IJPC
When compounding a new preparation determined. As already mentioned, only a test performed indicates potency only, not
that has not been tested appropriately, it is stability-indicating method can be used to stability. In other words, at the predefined
important that potency and stability studies determine stability. time points of day 0, 30 days, and 60 days,
are performed to determine concentration This is where some compounding phar- the lab analyzes only how much of the com-
and a beyond-use date, respectively. A med- macists run into problems. For example, pound is present. The method used could
ication that is very potent (e.g., fentanyl) let’s say your pharmacy contracts an analyti- not differentiate the compound of inter-
or has a narrow therapeutic index (e.g., cal laboratory to run a potency test on your est from degradants or excipients in the
levothyroxine) may produce a magnified (or compound and you want results at day 0, preparation. The results reported indicate
greatly reduced) effect if its concentration is 30 days, and 60 days. The target concentra- that the concentration of the compounded
altered even slightly. Nitroglycerin, an anti- tion of your compound is 10 mg/mL. The preparation was 10 mg/mL at each time
anginal medication that patients rely on to
avoid chest pain, has a questionable stability
profile. In the event that the beyond-use
date is not accurate, and the patient does 450 - 2537
not experience relief because the medica-
tion is inactive, the consequences could be 400
450
-- 2537
severe, including hospitalization and even Analyte
death. Although these drugs may or may 350 -
400 -
not be compounded, they simply serve as
examples of the importance of determining 300
350
-- Analyte
potency and stability. In these situations, a

250 -
small error can cause significant harm to 300 -
the patient. It is imperative to understand
the difference between potency and stabil-
200
250
--
ity testing so that a concerted effort can be 150 -
made to meet quality standards. 200 -
100
150
--
Potency
50 -
Potency is defined as the concentration 100 -
of the drug in a compounded prepara-
tion.5 Potency tests are known as quantita-
0
50
--
-
-
0 0.5 1 1.5 2 2.5 3 3.5 4 min
tive tests and are designed to determine
how much of the drug is in the sample.3 0 -
Figure 1. Example chromatogram produced by a nonstability-indicating HPLC method that evaluates
-
-
High-performance liquid chromatog- 40 0 potency 0.5
- of a single analyte.
1 1.5 2 2.5 3 3.5 4 min
Analyte
raphy (HPLC) is the method typically
employed in determining potency.5 HPLC
is preferred because it is very specific and
40
30 -- Analyte
efficient. Although HPLC can be used in Degradant
stability-indicating methods, not all HPLC
procedures are stability indicating, and
30
20 --
Degradant
they must not be assumed to be so.6 Other
methods used to test potency include titra- 20 --
10
tion, which uses the principles of chemistry,
and microbial assays, which are sometimes
used to test antibiotics.5 Titration is based 10
0 --
upon a known chemical reaction with the
tested drug.5 A microbial assay uses bacteria
to examine what is known as “zones of inhi- 0
-10 --
bition” by the antibiotic in question.5 When
used alone (without chromatography),
ultraviolet (UV)/visible spectrophotometry
-10
-20 --
-
can be employed to determine potency of a 3.5 3.75 4 4.25 4.5 4.75 5 5.5 min
single analyte in solution. In this test, mul- -20 -
tiple compounds could interfere with ab-
-
3.5 3.75 4 4.25 4.5 4.75 5 5.5 min

sorption, yielding erroneous results. When 90 -
performing a potency test, the method used Figure 2. Example chromatogram produced by a nonstability-indicating HPLC method, exhibiting
determines whether stability also can be unresolved analyte and degradant peaks.
80
90 -
70
80 -
60
70 - Analyte
100
--
quality-control
-100 --
IJPC
-10
-20 --
-
-
3.5 3.75 4 4.25 4.5 4.75 5 5.5 min
-20 - Figure 1 represents a chromatogram
-
-
3.5 3.75 4 4.25 4.5 4.75 5 5.5 min produced by a nonstability-indicating
90 -
HPLC method that can be used to quan-
titate an analyte of interest. Figures 2 and
80
90 - 3 represent chromatograms produced by
a nonstability-indicating HPLC method,
70
80 - exhibiting analyte and degradant sample
peaks that are not resolved. All that can be
60 - concluded is that degradants were present
70
Analyte in the sample at the time of the analysis.
In Figures 2 and 3, no conclusions can be
50
60 - 7093
Analyte made about potency or stability. The peaks
are not resolved, and thus it is impossible
40
50 - Degradant
7093 to properly quantitate the analyte (i.e.,
determine potency). Stability cannot be de-
6813
30
40 - termined simply because stability-indicating
Degradant methods were not used.
6813
20
30 -
Stability
-
-
6 6.2 6.4 6.6 6.8 7 7.2 7.4 min
In USP Chapter <795>, stability is
20 - Figure 3. Example chromatogram produced by a nonstability-indicating HPLC method, exhibit- defined as “the extent to which a prepara-
-
-
6 ing unresolved
6.2 analyte and
6.4 degradant6.6
peaks. 6.8 7 7.2 7.4 min tion retains, within specified limits, and
3714
300 - throughout its period of storage and use,
the same properties and characteristics that
2631
3714 it possessed at the time of compounding.”2
300
250 - Analyte
This chapter defines beyond-use date as
Degradant
2631 “the date after which a compounded prepa-
250
200 - Analyte ration is not to be used and is determined
Degradant from the date the preparation is compound-
ed.”2 Stability testing is used to determine a
200
150 - beyond-use date, which is required by USP
guidelines to be on the label or package
of a compounded preparation.2 The terms
150
100 - stability, shelf life, and beyond-use date can
be used interchangeably when referring
100
50 - to compounded preparations. The term
expiration date is used when referring to
manufactured products.
500 - Chapter <797> Pharmaceutical Com-
-
0 0.5 1 1.5 2 2.5 3 3.5 4 min pounding—Sterile Preparations states, “It

0 - should be recognized that the truly valid
evidence of stability for predicting beyond-
-
0 0.5 1 1.5 2 2.5 3 3.5 4 min

use dating can be obtained only through
Figure 4. Example chromatogram produced by a stability-indicating HPLC method, exhibiting fully product-specific experimental studies.”7 It
resolved analyte and degradant peaks. is important to remember that the analyti-
cal method employed is key to determin-
ing stability versus potency. Once again, a
point. This result cannot be extrapolated as to recognize is that some tests determine stability-indicating method must be used to
representing stability at 60 days because the potency but not stability. Had stability-in- establish stability. Furthermore, a potency
preparation may have contained degradants dicating methods been used to determine test that used stability-indicating methods
or excipients that were present but not de- potency in this case, then the results could can be used to determine stability as well as
tected by this analysis. To put it into num- have been used to determine a beyond-use potency.
bers, for example, the reported concentra- date (i.e., stability). If a stability-indicat- Stability testing usually includes method
tion of 10 mg/mL may have comprised only ing method showed the concentration at development, method validation, and a sta-
6 mg/mL of the active ingredient, while time 60 days to be 10 mg/mL, you could be bility study. The method must separate the
3 mg/mL was degradants and 1 mg/mL sure that the entire 10 mg/mL was active active ingredient from its degradants and
was excipients. The most important thing ingredient. impurities, as well as any other excipients

quality-control
FEATURE
IJPC
in the preparation. This is done by force determine both potency and stability. It is
degrading the active ingredient and inactive easy to see that the madness truly lies in the
ingredients to ensure that no degradants methods.
interfere with the analysis. In the process of
force degradation, the compound is exposed References
to high heat and humidity, UV radiation, 1. Trissel LA. Avoiding common flaws in
an acid, a base, and peroxide.8 It is this stability and compatibility studies of in-
step that differentiates a stability-indicat- jectable drugs. Am J Hosp Pharm 1983;
ing test from a simple potency test. Figure 40(7): 1159–1160.
4 is an example chromatogram produced 2. United States Pharmacopeial Conven-
by a stability-indicating HPLC method, tion, Inc. United States Pharmacopeia
showing analyte and degradant peaks that 27–National Formulary 25. Rockville, "
are fully resolved from one another. When MD: US Pharmacopeial Convention,
looking at this chromatogram, it is impor- Inc.; 2007; 2 Supplement: 334, 511. #$
tant to notice that the active ingredient is 3. Kupiec T, Huerta PL Jr. Analytical test-
completely separated from its degradants.
Stability can be determined from this type
ing of extemporaneously compounded %"$
preparations. IJPC 2000; 4(2): 105–107.
of study, simply because stability-indicating 4. Kupiec TC. Quality-control analytical

methods were used in the analysis. methods: Chemical testing aspects of
Method validation ensures that the USP Chapter <797> for compounded
method meets certain criteria. The typical sterile preparations. IJPC 2005; 9(2):
analytical characteristics used in method
validation include accuracy, precision, speci-
136–138.
5. United States Pharmacopeial Conven-
ficity, detection limit, quantitation limit, tion, Inc. United States Pharmacopeia

linearity, range, and ruggedness, as outlined 31–National Formulary 26. Rockville,

in USP Chapter <1163>. The stability study MD: US Pharmacopeial Convention,
includes storing the preparation in stabil- Inc.; 2007. [In press.]
ity chambers, testing it at predetermined 6. Trissel LA. Stability studies: Five years
time points, and then determining stability. later. Am J Hosp Pharm 1988; 45(7):
These time points may be specified by the 1570.
compounder or dictated by the particular 7. [No author listed.] Chapter <797>
compound. Once again, it is crucial to Pharmaceutical Compounding—Sterile
understand that the methods used to deter- Preparations. PF 2007; 32(3): 952.
mine stability must be stability indicating. 8. Kupiec TC. Dr. Kupiec’s corner: What’s
Quality assurance programs are essential in a name? Beyond use dating–101, 201,
to establishing appropriate standards for 301. The Pharmacists Link. Oklahoma
compounded preparations. The specific City, OK: Analytical Research Laborato-
program implemented is up to the com- ries, Inc.; Spring, Summer, Fall 2003.
pounding pharmacy but should include a 9. [No author listed.] Pharmacy Com-
standard operating procedure, documenta- pounding Accreditation Board. PCAB
tion, verification, and testing as outlined in standards with compliance indicators:
USP Chapter <1163>.4 The standards of Standard 6.10 beyond-use date. 2006; +( ! "$
##
the Pharmacy Compounding Accreditation 7.2: 20. +'!"$)#
Board state that “a pharmacy must provide
documentation of the basis for its determi- +)

%"" %
Address correspondence to Thomas C.
nation of the beyond-use date assigned to Kupiec, PhD, Analytical Research Labo-

&)#
its compounded preparation.”9 ratories, Inc., 840 Research Parkway, Suite +!$*" (!('+# !()&$-*
546, Oklahoma City, OK 73104. E-mail: !$'$%"$#
Conclusion [email protected]
Employing the proper method to
determine potency or stability is the key to
understanding the difference between po- $(#,'%
tency testing and stability testing. Methods
of determining potency may or may not
be stability indicating, whereas methods
used to determine stability must be stability
indicating. Stability-indicating methods can

,ABRIX?6ERT!D?0HARM*RL?)ODINEINDD 0-
ba ic f c mp unding
I
I
I
I
I
Loyd V. Allen, Jr., PhD, RPh
International Journal of Pharmaceutical Compounding
Edmond, Oklahoma
p e c ip I i n Considerations
I
Claudia C. Okeke, PhD, RPh
United States Pharmacopeial Convention, Inc.
Rockville, Maryland
calcula I i n I for Implementing

United States
ma ke I ing Pharmacopeia Chapter
I
<797> Pharmaceutical
I Compounding—Sterile
I
I
Preparations, Part 5:
Verification of Accuracy,
Sterility, and Sterilization of
Compounded Preparations
I
I
This article is the fifth in a series of articles per-
taining to the implementation of United States
Pharmacopeia Chapter <797> Pharmaceuti-
cal Compounding—Sterile Preparations. Part
1 furnished an overview and discussed the In-
troduction to Chapter <797>; part 2 discussed
the responsibilities of compounding personnel
in implementing the standards described in this
chapter; part 3 discussed the risk levels involved
in compounding; part 4 discussed considerations
in the selection and use of disinfectants and an-
tiseptics; and this article (part 5) discusses veri-
fication of accuracy, sterility, and sterilization of
compounded preparations.

FEATURE
basics
IJPC
Abstract
United States Pharmacopeia Chapter <797> Pharmaceutical Compounding— Sections of United States
Sterile Preparations pertains to all preadministration manipulations and proce- Pharmacopeia Chapter <71>
dures involved in the preparation of sterile compounds for application, implanta- Sterility Tests1
tion, infusion, inhalation, injection, insertion, instillation, or irrigation, including Introduction
preparation, storage, and transportation. The chapter does not pertain to actual Media
clinical administration of compounded sterile preparations to patients. The intent • Fluid Thioglycollate Medium
of Chapter <797> is simply to prevent patient harm and fatalities that may result • Alternative Thioglycollate Medium
from nonsterility, excessive endotoxin load, large content errors in strength of • Media for Penicillins or
correct ingredients, or the presence of incorrect ingredients. Because the achieve- Cephalosporins
ment of sterility requires that facilities meet minimum cleanliness standards, that • Suitability Tests
personnel be trained adequately and undergo periodic testing and training in Diluting and Rinsing Fluids for
sterilization techniques, and that appropriate principles and practices be applied Membrane Filtration
• Fluid A
to sustain solution stability, compliance with Chapter <797> should be the goal of
• Fluid D
any facility where sterile preparations are compounded. Many pharmacies have • Fluid K
already achieved compliance with Chapter <797>, and those that have already met Validation Test
the new standards seem to support them strongly. This article discusses procedures • Membrane Filtration
for verification of the accuracy, sterility, and sterilization of compounded prepara- • Direct Inoculation
tions. The importance of United States Pharmacopeia Chapters <71>, <1035>, and Test for Sterility of the Product to
<1211>, all of which contain vital information, is also discussed. Be Examined
• Number of Articles to be Tested
• Membrane Filtration
- Aqueous Solutions
All procedures related to compounding, Chapter <71> titled “Test for Sterility of - Soluble Solids (Other than
including sterilization procedures, should the Product to Be Examined,” can be used Antibiotics)
be explained in detail in well-written and for verification. This section describes the - Oils and Oily Solutions
verified standard operating procedures number of samples needed and the quantity - Ointments and Creams
(SOPs), including each routine step in the of each sample (based on container size) - Prefilled Syringes
process. To ensure that the procedures are required. For high-risk compounding, a - Solids for Injection Other than
adequate and conducted correctly, a pro- nonpathogenic bacterial culture may be Antibiotics
gram of testing and verification is required. added to a sample that is not going to be - Antibiotic Solids for Injection
The pharmacy should verify the methods dispensed; this sample then undergoes ter- - Antibiotic Solids, Bulks, and
used on a regular basis. The pharmacy also minal sterilization, according to the SOPs Blends
should verify the performance of any device of the facility, to evaluate the sterilization - Sterile Aerosol Products
or kit routinely used to indicate sterility or process and establish its adequacy (see - Devices with Pathways Labeled
test for endotoxins. United States Phar- Chapter <1035> Biological Indicators). Sterile
macopeia (USP) Chapter <71> Sterility Another verification that is required is • Direct Inoculation of the Culture
Tests and Chapter <1211> Sterilization Medium
visual inspection for the expected ap-
and Sterility Assurance (see sidebars for - Oily Liquids
pearance, physical integrity, and final fill
the contents of these chapters) are used - Ointments and Creams
amount. The visual inspection can be
for verification of the sterilization process - Catgut and Other Surgical
performed against a black/white lighted
Sutures for Veterinarian Use
or of the aseptic processing procedures. background, by observing the sample while
- Solids
The following chapters should be read moving it; the movement should include
- Purified Cotton, Gauze,
and understood prior to implementing a inversion. A physical integrity test can
Surgical Dressings, and Related
program involving compounding of sterile involve observing for leaks while inverting
Articles
preparations. and moving the preparation around. Finally, - Sterile Devices
• USP Chapter <71> Sterility Tests the final fill amount can be observed by Observation and Interpretation of
• USP Chapter <1035> Biological Indica- looking at the volume in the container; the Results
tors for Sterilization observed volume is then compared with the
Application of the Test to
• USP Chapter <1211> Sterilization and expected volume. Depending upon the test-
Parenteral Preparations,
Sterility Assurance of Compendial Ar- ing program of the facility, a sample may be
Ophthalmic, and Other
ticles sent for potency analysis. The preparation
Noninjectable Preparations
should be confirmed to remain physically
Required to Comply with the
Generally speaking, for low-risk and and chemically stable when subjected to the
Test for Sterility
medium-risk compounding, the section of selected sterilization method.

IJPC basics
Verification of Sterility pable of operating within the prescribed

Sections of United States According to Chapter <1211>, a speci- parameters for the process equipment.
Pharmacopeia Chapter <1211> men would be deemed sterile, within the 3. Perform replicate cycles representing the
Sterilization and Sterility strictest definition of sterility, only when required operational range of the equip-
there is complete absence of viable micro- ment and employing actual or simulated
Assurance of Compendial
organisms. This absolute definition current- preparation. Demonstrate that the
Articles1 processes have been carried out within
ly cannot be applied, however, to an entire
Introduction batch of finished compounded preparations the prescribed protocol limits and finally
Methods of Sterilization because of limitations in testing: absolute that the probability of microbial survival
• Steam Sterilization sterility cannot be practically demonstrated in the replicate processes completed is
• Dry-Heat Sterilization without complete destruction of every not greater than the prescribed limits.
• Gas Sterilization finished article. The sterility of a batch 4. Monitor the validated processes dur-
• Sterilization by Ionizing Radiation purported to be sterile is therefore defined ing routine operation. Periodically,
• Sterilization by Filtration in statistical terms, where the likelihood of as needed, requalify and recertify the
Aseptic Processing a contaminated unit or article is acceptably equipment.
remote. 5. Complete the protocols and document
Sterility Testing of Lots the previous four steps.
Definition of a Lot and Selection The basic principles for verification of a
of Specimens for Sterility Test sterilizing process are as follows:1 Sterilization Methods
Purposes 1. Establish that the process equipment has The compounder must select an appro-
Performance, Observation, and the capability of operating within the priate sterilization method for the prepara-
Interpretation required parameters. tion that will maintain its strength, purity,
• Interpretation of Quality Control 2. Demonstrate that the critical control quality, and packaging integrity. The most
Tests equipment and instrumentation are ca- commonly used sterilization methods are
Table 1. Verification of Accuracy, Sterility, and Sterilization of

Compounded Preparations.
Item Requirements Yes No Comment/SOP
Sterilization Methods Appropriateness and effectiveness of all compounding
procedures tested
Sterility procedures evaluated and tested
Samples of CSPs assayed according to established procedure
Finished CSPs visually inspected for physical integrity and
expected appearance, including final volume
Sterilization method selected for specific CSP appropriate
and maintains:
*Strength
*Purity
*Quality
*Packaging integrity
Glass and metal devices properly depyrogenated
Sterile, depyrogenated items stored properly
Sterilization by Filtration Filters of appropriate material for each CSP
Filters compatible for each CSP
Filters of appropriate size for each CSP
Prefilters used for preparations with high particulate load
Filtration process completed rapidly and without filter
replacement
Bubble point test for integrity used as appropriate
Steam Sterilization Autoclave verified according to SOPs
Pressure and temperature recorded with each autoclave cycle
Items for autoclaving packaged appropriately
Autoclave conditions verified for specific CSPs
CSP = compounded sterile preparation
SOP = standard operating procedure

FEATURE
basics
IJPC
filtration, autoclaving, and dry heat. The and, in some cases, oils. Filtration can be a filter medium or substrate depends upon
efficiency of heat in destroying microorgan- verified by testing samples that have been the pore size of the porous material and
isms is dependent on temperature, time, “spiked” with nonpathogenic microorgan- may depend upon adsorption of bacteria on
moisture, and pressure. Heat sterilization isms and conducting sterility tests on the or in the filter matrix.
comprises both moist-heat and dry-heat sample after filtration. Filters should be
processes. Contract facilities can be used for certified by the manufacturer to retain at Filter Rating
gaseous and radiation processes of steriliza- least 107 microorganisms of a strain of Bre- The pore sizes of filter membranes are
tion. A checklist to assist in documenting vundimonas (Pseudomonas) diminuta on expressed as a nominal rating that reflects
the verification of accuracy, sterility, and each square centimeter of upstream filter the capability of the filter membrane to
sterilization of compounded preparations is surface under conditions similar to those retain microorganisms of size represented
provided in Table 1. used during the filter-sterilization process. by specified strains, not by determina-
It should be noted that sterile filtration tion of an average pore size and statement
Filtration does not remove endotoxins (pyrogens) or of distribution of sizes. Sterilizing filter
Filtration, one of the oldest methods of viruses. In the event that the prefiltered membranes (those used for removing a
sterilization, is a process whereby particu- solution contains excessive particulate mat- majority of contaminating microorgan-
late matter is removed from a flowing liquid ter, a “prefilter” may be used; this prefilter isms) are membranes capable of retaining
by passing it through a filter. Currently, is generally a larger pore size and is placed 100% of a culture of 107 microorganisms
perhaps 80% or more of all small-volume upstream from the actual sterilizing filter. of a strain of Pseudomonas diminuta per
parenteral preparations are sterilized by This removes the gross particulates and square centimeter of membrane surface
filtration followed by aseptic processing. increases the efficiency of the actual steril- under a pressure of not less than 30 psi (2.0
The filter retains the particulate because izing filter. bar). Such filter membranes are nominally
the particulate is unable to penetrate the A filter assembly generally consists of rated 0.22 mcm or 0.2 mcm, depending on
smaller pores in the filter matrix. Filtering a porous matrix sealed or clamped into an the manufacturer's practice. The user must
is recommended for most compounding impermeable housing. The effectiveness of determine whether filtration parameters
situations, as it removes microorganisms
(although it does not destroy them).
After filtration has been completed, the
sterile solution should be removed immedi-
ately, because microorganisms can eventu-
WHO’S DESIGNING YOUR CLEANROOM?
ally penetrate the pores of some filters if
left on the filter surface for a prolonged
period. Also, as bacteria grow on a filter,
their byproducts (pyrogenic substances)
may pass into the sterile solution. When
using filtration, the pharmacist should know
whether the drug, preservative, or any other
component in the solutions tends to sorb to
the filter material. If so, an alternative filter
material should be used. Filtration steriliza-
tion is used for drug preparations that are
chemically or physically unstable if steril-
ized by heat, gas, or radiation exposure. The
chemical and physical compatibility of the
compounded preparation with the steril-
izing filter must be determined prior to
performing the sterilization process.
Filtration is suitable for solutions
provided the proper membrane filtration
material is selected. The filters approved
for human use generally are obtained as
individually packaged, presterilized, pyro-
gen-free filters and are labeled with their » USP <797> Compliant
pore size and composition. Filters with a » Free standing (modular) or combination with existing structure
nominal pore size of 0.2 mcm (including
» Cleanroom fully customized to integrate with your work flow
0.22 mcm) are generally used. In some cir-
cumstances, a 0.45-mcm filter can be used.
Filtration is suitable for aqueous solutions
800.901.4109 www.spectrumrx.com

IJPC basics
employed in manufacturing significantly in- ent at a rate depending on the load or items crimped empty vials must contain a small
fluence microbial retention efficiency. Some in the autoclave. amount of moisture.
other important concerns in verification of The saturation of water, or steam, at
the filtration process include preparation high pressure is the foundation for moist- Dry-Heat Sterilization
compatibility; sorption of drug, preserva- heat sterilization effectiveness. When Dry-heat sterilization is widely used
tive or other additives; and initial effluent steam makes contact with a cooler object, and is suitable for oils, glassware, metal-
endotoxin content. it condenses and loses latent heat to the ware, and some equipment. The process
Since the effectiveness of the filtration object. Under autoclaving conditions, the of thermal sterilization of pharmacopeial
process is influenced by the microbial bur- amount of energy released is approxi- articles by dry heat is usually carried out
den of the solution to be filtered, determin- mately 524 cal/g, whereas 1 cal/g of energy by a batch process in an oven designed
ing the microbiological quality of solutions is released in dry-heat sterilization. The expressly for that purpose. A modern oven
prior to filtration is an important aspect difference explains why moist heat under
is supplied with heated, filtered air, distrib-
of verifying the filtration process. Another pressure is more effective than dry heat at
uted uniformly throughout the chamber
important aspect is establishing the other the same temperature in destroying micro-
by convection or radiation, and employs
parameters of the filtration procedure, bial organisms. It explains why objects or
a blower system with devices for sensing,
such as pressures, flow rates, and filter unit preparations to be sterilized in an autoclave
monitoring, and controlling the critical
characteristics. must contain water or permit saturated
parameters.
In some cases, pharmacies may use steam to penetrate and make contact with
Dry-heat sterilization requires heat in
filtration equipment that is “reusable.” The all surfaces to be sterilized, and why air
excess of that generated by autoclaving,
equipment must be suitably cleaned and pockets are of great concern. It also ex-
and thus the oven must be capable of high
rinsed with pyrogen-free water, dried, and plains why sealed containers must contain
temperatures. The following operating
assembled. The new filter is put in place water in order to be sterilized. Sealed, dry
conditions have been established as effec-
during assembly. The appropriate parts of containers reach only 121°C inside, and the
heat will not be moist; thus, sterilization tive in sterilizing: at 160°C, 120 to 180
the assembly are covered with autoclave minutes; at 170°C, 90 to 120 minutes; and
will likely not occur. Similarly, anhydrous
paper and taped. The device undergoes an at 180°C, 45 to 60 minutes. It should not
and oily solutions that contain no water
autoclave cycle and is then moved into the be assumed, however, that any of the three
will reach only 121°C and the heat will be
compounding area and treated as any other conditions will automatically suffice for all
dry. Moist-heat sterilization is the desired
autoclaved or sterile item. The autoclave formulations; rather trial runs should be
method of sterilization for any item that
paper is not removed from the filter device done to confirm the sterility and stability
can withstand high temperatures, including
until just prior to use. of the specific drug formulation. Besides
rubber closures, high-density plastic tub-
After completion of a filtration process, glass, stainless steel, and other hard surface
ing, filter assemblies, sealed-glass ampules
the integrity of the filter can be confirmed materials, the dry-heat method is used to
containing solutions that can withstand
by conducting the bubble-point test (see a sterilize dry powders not labile to high
high temperatures, stainless-steel vessels,
discussion of this test below). In appropriate temperatures. Injectable oily solutions
gowning materials, and various hard-sur-
circumstances, the operator can check for also can be dry-heat sterilized, if the active
face equipment items.
resistance on the plunger when filtering air With each “run” of the autoclave, its ingredient remains potent and stable, using
after the aqueous fluid has been filtered. All performance must be documented by a time/temperature cycle that produces a
this should be documented on the com- recording temperatures and times and, as verified finished sterile preparation.
pounding record. appropriate, incorporating “indicators” into Glass and metal devices may be covered
the run. These indicators may manifest tightly with aluminum foil, then exposed to
Autoclaving as a color change or as growth in a vial of dry heat in an oven at a mean temperature
Autoclaving is suitable for aqueous solu- bacteria that is subjected to the autoclaving of 230°C for 60 to 90 minutes or 250°C for
tions, and water must be present for the process and incubation. 30 to 60 minutes to achieve sterility and
autoclaving process to sterilize the prepara- Failure to expose items directly to depyrogenation. The glass or metal devices
tion. Autoclaving is an appropriate method pressurized steam may result in survival either should be used immediately or stored
of sterilization for heat-stable solutions and of microbial organisms and spores. Before in an environment suitable for compound-
suspensions. their sterilization, plastic, glass, and metal ing at the low- and medium-risk level.
Moist-heat sterilization (steam under devices are tightly wrapped in low-par- Note that the higher temperatures
pressure) uses an autoclave that provides ticle-shedding paper or fabrics, or sealed of 230°C or 250°C is required for de-
a saturated steam environment, typically in envelopes that prevent poststerilization pyrogenation, while 150°C is adequate
121°C at 15 psi. This environment can microbial penetration. Immediately before for sterilization. The effectiveness of the
be varied, depending on the equipment filling ampules and vials that will be steam depyrogenation process should be verified
being used. After the correct temperature sterilized, solutions are passed through a by using endotoxin challenge vials. The
and pressure are reached, the sterilization filter having a porosity not larger than 1.2 bacterial endotoxin test verifies whether
process continues for at least an additional mcm for removal of particulate matter. the sterilization conditions applied were
20 minutes, at which time the pressure and Sealed containers must be able to gener- adequate to achieve the required reduction
temperature are allowed to return to ambi- ate steam internally; thus, stoppered and in endotoxins (see Chapters <85> Bacterial

FEATURE
basics
IJPC
Endotoxins Test5 and <1211> Sterilization and Sterility Assurance of a verified sterilization process for a particular article. Biological
of Compendial Articles). indicators are used in processes that render a preparation sterile in
Verification of a dry-heat sterilization facility is carried out in its final package or container, as well as for sterilization of equip-
a manner similar to that for a steam sterilizer described earlier. ment, materials, and packaging components used in aseptic process-
Where the unit is employed for sterilizing components such as ing. Biological indicators also may be used to monitor established
containers intended for intravenous solutions, care should be taken sterilization cycles and in periodic reverification of sterilization
to avoid accumulation of particulate matter in the chamber. A typi- processes.1
cal acceptable range in temperature in the empty chamber is ±15°C
when the unit is operating at not less than 250°C. Types of Biological Indicators
There are at least three types of biological indicators. Each
Verification type incorporates a known species of a microorganism of known
Whatever sterilization method is used, the equipment and pro- sterilization resistance to the sterilization mode. Some biologi-
cesses must be verified. Use of biological indicators is appropriate, cal indicators contain two different species and concentrations of
including Bacillus subtilis var niger spores for dry-heat sterilization, microorganisms.1
Bacillus stearothermophilus for moist-heat sterilization, and Bacil- Type 1: A biological indicator that includes spores that are
lus pumilis spores for ionizing radiation. added to a carrier (a disk or strip of filter paper, glass, plastic, or
A typical verification program, as outlined below, is one designed other materials) and packaged to maintain the integrity and viability
for the steam autoclave, but the principles are applicable to the of the inoculated carrier.1
other sterilization procedures discussed in this informational chap- Type 2: A spore suspension that is inoculated on or into repre-
ter. The program comprises several stages, as follows:1 sentative units of the preparation to be sterilized. This represents an
inoculated preparation; however, a simulated inoculated preparation
1. The installation qualification stage is intended to establish that may be used if it is not practical to inoculate the actual preparation.
controls and other instrumentation are properly designed and A simulated preparation is a preparation that differs in one or more
calibrated. Documentation should be on file demonstrating the ways from the actual preparation, but performs as the actual prepa-
quality of the required utilities such as steam, water, and air.
2. The operational qualification stage is intended to confirm that
the empty chamber functions within the parameters of tem-
perature at all key chamber locations prescribed in the protocol.
It is usually appropriate to develop heat profile records, i.e.,
simultaneous temperatures in the chamber employing multiple
temperature-sensing devices. A typical acceptable range of
temperature in the empty chamber is ±1°C when the chamber
temperature is not less than 121°C.
3. The confirmatory stage of the verification program is the actual
sterilization of materials or articles. This determination re-
quires employment of temperature-sensing devices inserted into
samples of the articles, as well as either samples of the articles to
which appropriate concentrations of suitable test microorgan-
isms have been added, or separate biological indicators in opera-
tionally fully loaded autoclave configurations. The effectiveness
of heat delivery or penetration into the actual articles and the
time of the exposure are the two main factors that determine the
lethality of the sterilization process.
4. The final stage of the verification program requires documenta-
tion of the supporting data developed in executing the program.
Biological Indicators
A biological indicator is defined broadly as a characterized
preparation of a specific microorganism that provides a defined and
stable resistance to a specific sterilization process. These biological
indicators are discussed in Chapter <1035> Biological Indicators
for Sterilization. Microorganisms widely recognized as suitable for
biological indicators are spore-forming bacteria because, with the
exception of ionizing radiation processes, these microorganisms are
significantly more resistant than normal microflora. A biological
indicator can be used to assist in the performance qualification of
the sterilization equipment and in development and establishment

IJPC basics
ration using test conditions or during actual advantages of the bubble point test is that
production sterilization processing.1 it can be performed with any type of filter
Type 3: A self-contained indicator. A while the filter is in the conditions to be
Bubble Point
self-contained biological indicator is de- actually used. It does not contaminate the Procedure
signed so that the primary package, intend- filter and so can be used to determine the The procedure for the bubble point
ed for incubation following sterilization integrity of a filter at any time, as well as test is described in the American
processing, contains the growth medium for establishing the absolute rating. The liquid Society for Testing and Materials
recovery of the process-exposed microor- is held in the pores of the filter by surface Standard Method (ASTM) F316.4
ganisms. This form of biological indicator, tension and capillary forces. The minimum P = bubble point pressure
together with the self-contained growth pressure required to force liquid out of the d = pore diameter
medium, can be considered a system. In the pores is a measure of the pore diameter.2,3 k = shape correction factor
case of self-contained biological indicators, The bubble point test detects minor filter 0 = liquid-solid contact angle
the entire system provides resistance to the defects and out-of-size pores and correlates o = surface tension
sterilization process.1 with the bacteria passage test. The bubble P = 4k cos 0 o
Self-contained biological indicators point procedure is shown as a sidebar to d
may consist of a spore suspension in its this article.
own medium that may also contain a dye, Method
which indicates positive or negative growth Summary 1. Wet the filter with the appropriate
following incubation. Resistance of the USP Chapters <71>, <1035>, and fluid, typically water for hydro-
self-contained system is dependent upon <1211> contain vital information in a philic membranes or an alcohol/
penetration of the sterilant into the pack- compounding pharmacist’s efforts to water mixture for hydrophobic
age. Penetration may be controlled by the achieve compliance with Chapter <797>. membranes.
manufacturer through varying designs and All procedures, including each routine step, 2. Pressurize the system to about
compositions of the self-contained biologi- related to compounding, including steriliza- 80% of the expected bubble point
cal indicator package, ampule, or container. tion procedures, should be detailed using pressure, which is stated in the
Self-contained ampule biological indicators well-written and verified SOPs. In order manufacturer’s literature.
may be incubated directly following expo- to verify that the compounding procedures 3. Slowly increase the pressure until
sure to the sterilization process. The entire are adequate and being conducted correctly, rapid continuous bubbling is
system is then incubated under the specified a program of testing and verification is observed at the outlet.
conditions. Growth or lack of growth of the essential. 4. A bubble point value lower than
treated spores is determined visually (either the specification is an indication of
by observing a specified color change of an Resource one of the following:
indicator incorporated in the medium or by United States Pharmacopeial Convention, • Fluid with different surface
turbidity) or by microscopic examination of Inc. United States Pharmacopeia 30–Na- tension than the recommended
the inoculated medium.1 tional Formulary 25. Rockville, MD: US test fluid
Pharmacopeial Convention, Inc.; 2006. • Integral filter, but wrong pore
Commercial Products size
When verification devices are purchased References • High temperature
from a commercial source, their suitability 1. United States Pharmacopeial Convention, • Incompletely wetted membrane
for use in a specific sterilization process Inc. United States Pharmacopeia 30–Na- • Nonintegral membrane or seal
should be established through develop- tional Formulary 25. Rockville, MD: US
mental sterilization studies, unless existing Pharmacopeial Convention, Inc.; 2006:
data are available to support their use in the 97–102, 411, 669–674. Address correspondence to Loyd V. Allen,
process. The user should establish in-house 2. Dickenson TC, ed. Filters and Filtra- Jr, PhD, RPh, International Journal of
acceptance standards and consider rejection tion Handbook. 4th ed. Amsterdam, The Pharmaceutical Compounding, Inc., 122 N
in the event that the device does not meet Netherlands: Elsevier Science; 1997.
Bryant Avenue, Edmond, OK 73034.
the established performance standards. 3. [No author listed.] Millipore. Filtration
E-mail: [email protected]
Systems. [Millipore Website.] Available at:
A Certificate of Performance should be
www.millipore.com. Accessed October 30,
obtained for each lot of devices, and the
2007.
user should routinely perform audits of the
4. ASTM International Subcommittee
manufacturer's facilities and procedures.
D19.08. Active Standard: ASTM F316-
03 Standard Test Methods for Pore Size
Bubble Point Test Characteristics of Membrane Filters by
The bubble point test is the most widely Bubble Point and Mean Flow Pore Test.
used nondestructive integrity test for pore [ASTM International Website.] Available
size determination and is essential when at: www.astm.org. Accessed October 30,
sterilizing by filtration. One of the great 2007.

CNL ad

p e c ip I i n
I
calcula I i n
I
ma ke I ing
I
Compounding for Cancer Patients
Shelly J. Stockton, BSPharm, PhD, RPh
Southwestern Oklahoma State University, College of Pharmacy
Weatherford, Oklahoma
1
The “BIP” chemotherapy regimen to be given in a 21-day cycle
to treat cervical cancer consists of the following:1
Bleomycin 30 units/day continuous intravenous (IV) infusion,

E. If a 30-unit dose of bleomycin is usually diluted to 10 mL
with 0.9% sodium chloride, what is the percent strength range
of bleomycin in the final product?
15 mg/10 mL × 1 g/1000 mg × 100 = 0.15% w/v
day 1 20 mg/10 mL × 1 g/1000 mg × 100 = 0.2% w/v
Cisplatin 50 mg/m2 IV, day 2
Ifosfamide 5,000 mg/m2/day continuous IV infusion, day 2 Percent strength = 0.15% to 0.2% w/v
2
Mesna 6,000 mg/m2/cycle continuous IV infusion over 36 hours,
I
I
day 2 (start with ifosfamide) The Calvert formula for determining the initial carboplatin
dose based upon a patient's glomerular filtration rate (GFR in
A. How much cisplatin, ifosfamide, and mesna should be given mL/min) and carboplatin target area under the concentration vs
to a 62-year-old woman who is 5 ft. 8 in. tall and weighs 152 time curve (AUC in mg/mL·min) is as follows:1
pounds? Dose (mg) = (target AUC) × (GFR + 25)
The body surface area (BSA) for this patient can be calculated by
using the following equation: A. How much carboplatin should be administered to a patient
with a GFR of 46 mL/min to achieve an AUC of 5 mg/mL·min?
[Height (cm) × Weight (kg)]
BSA (m2) = Total dose = 5 mg/mL·min × (46 mL/min + 25) = 355 mg
3600
Height = 5 ft. 8 in. = 68 in × 2.54 cm/in = 172.72 cm B. Carboplatin is available as a 10-mg/mL aqueous injectable
Weight = 152 lb × 1 kg/2.2 lb = 69.09 kg solution that can be further diluted with 5% dextrose solution or
0.9% sodium chloride solution to a final concentration of not less
(172.72 cm × 69.09 kg)
BSA = = 3.31 = 1.82 m2 than 0.5 mg/mL.1 To what final volume should a 45-mL vial be
3600 diluted to achieve a concentration of 355 mg/100 mL?
Cisplatin: 50 mg/m2 × 1.82 m2 = 91.03 mg 45 mL × 10 mg/mL = 450 mg
Ifosfamide: 5,000 mg/m2/day × 1.82 m2 = 9,103.33 mg/day 450 mg × 100 mL/355 mg = 126.76 mL
Mesna: 6,000 mg/m2/cycle × 1.82 m2 = 10,924.002 mg/cycle
C. If a patient’s platelet count falls below 50 × 109/L (50,000 in
B. After reconstitution, the concentration of ifosfamide in solution conventional units) or the neutrophil count falls below 0.5 × 109/L
is 50 mg/mL. How many milliliters would be needed to supply (500 in conventional units), the dose should be decreased to 75%
the dose of ifosfamide for this patient? of the standard dose.1 What would be the dose for this patient if
her platelet count is measured as 38 × 109/L (38,000)?
9,103.33 mg × 1 mL/50 mg = 182.07 mL
355 mg × 75% = 266.25 mg
C. The dose of mesna is to be diluted to a final concentration of 20
mg/mL with a suitable diluent (i.e., 5% dextrose or 0.9% sodium References
chloride) and infused over 36 hours. What would be the final 1. Horenkamp JR, McCarron SM, Schweain SL eds. CliniSphere
volume for the dose of mesna for this patient and what would 2.0 [book on CD Rom]. St. Louis, MO: Facts and Comparisons;
be the infusion rate? 2007.
10,924.002 mg × 1 mL/20 mg = 546.2 mL final volume 2. United States Pharmacopeial Convention, Inc. Bleomycin Sul-
546.2 mL/36 hours = 15.17 mL/hour fate Monograph. In: United States Pharmacopeia 27–National
Formulary 22. Rockville, MD: US Pharmacopeial Convention,
D. The United States Pharmacopeia specifies that 1 mg of bleomy- Inc.; 2004: 257–258.
cin sulfate is equivalent to 1.5 to 2 bleomycin units.2 What is the
amount range (in milligrams) for the bleomycin dose? Address correspondence to Shelly J. Stockton, BSPharm, PhD,
30 units × 1 mg/1.5 units = 20 mg RPh, College of Pharmacy, Southwestern Oklahoma State Univer-
30 units × 1 mg/2 units = 15 mg sity, 100 Campus Drive, Weatherford, OK 73096.
Bleomycin sulfate range = 15 to 20 mg

I anda d pe a I ing p cedu e
I
ba Health
Compliance with the ic fInsurance
c mp unding
Portability
and Accountability Act (HIPAA) of 1996
quali I y-c n I l analy I ical me I
I
I
I
I
I
Purpose
The purpose of this standard operating procedure is to provide a consistent system for implementing the regula-
p e c ip I i n
tions required by HIPAA pertaining to pharmacies and educating and training pharmacy staff in their application.
I
Equipment/Materials H. Educate all employees about HIPAA requirements for
• Appropriate records and forms
calcula I i n computer systems and electronic transmission of informa-
I
• Employee file system tion. Examples:
1. Faxes
• Individual employee file folders
ma ke I ing
2. E-mail on the job
3. Passwords and computer equipment
I
Responsibility 4. Information about working with computers
The pharmacist-in-charge is responsible for this procedure. I. Educate all employees about patients’ rights:
1. Notice of privacy practice
2. Authorization
Procedure
I 3. Authorization exceptions
I
I
A. Read and understand the HIPAA Privacy Standards. 4. Right to access

B. Designate a security officer as a responsible person. 5. Nonreviewable grounds for denial of access
C. Develop and provide a complete job description for the 6. Reviewable grounds for denial of access
security officer. 7. Requests for amendment
D. Assess all areas of protected health information in the 8. Accounting of disclosures
pharmacy. 9. Right to complain
E. Develop and implement solutions to minimize unauthor- J. Document all training for all individuals and place in their
ized access of protected health information, including the personnel files.
following: K. Develop and implement privacy and security policies and
1. Computer screens procedures regarding HIPAA Privacy Standards.

2. Filled prescriptions
3. Prescription files ub c ip I i n ad e I i emen I
L. Incorporate state law.
I
I
M. Prepare Contingency and Disaster Recovery Plans.
4. Prescription orders N. Establish facility controls.
5. Trash O. Establish hardware and software controls.
F. Conduct HIPAA training of all personnel. P. Customize pharmacy’s Notice of Privacy Practices.
G. Educate all employees about basic HIPAA information, Q. Publish notice of pharmacy’s forms related to patients’
including the following topics: rights under HIPAA.
1. What is HIPAA? R. Print Notice of Privacy Practices for each customer or
2. What brought about this law? patient of record.
3. What are the consequences of not complying? S. Develop system for obtaining patient’s Written Acknowl-
4. What information is considered private and confidential? edgment of Receipt of Notice of Privacy Practices.
5. Who is authorized to see confidential information? T. Identify business associates with which the pharmacy ex-
6. Who oversees privacy policies? changes protected health information and execute business
7. How to report breaches in confidentiality? associate contract amendments as required.
Written By_______________________________________________ Date_____________________________________________________
Authorized By ____________________________________________ Date ____________________________________________________
Implementation Date ___________________________________________________________________________________________________

f mula I i n p I c ip I i n
I
I
Cyclosporine Topical Gel
I
I
consisting of 11 amino acids produced as a metabolite by the fungus
Rx species Beauveria nivea.4
For 100 g
ba ic f c mp unding
Carbopol 934 is a carbomer, a synthetic, high-molecular-weight
Cyclosporine A oral solution 20 mL polymer. The molecular weight of Carbopol 934 is approximately 3
Carbopol 934 1 g × 106. It is soluble in water and, after neutralization, in 95% ethanol
Propylene glycol 12 g or glycerin. When a carbomer is dispersed in water, an acidic col-
Diisopropanolamine 1.2 g loidal solution of low viscosity forms, which thickens on addition
quali I y-c n I
Polyoxyethylene glyceryl monostearate
Purified water qs l analy I ical me I
5
100
g
g d
of an alkaline material, such as triethanolamine. Maximum viscosity
I
I
I
I
I
can generally be obtained in a pH range of 6 to 11.5
Propylene glycol (C3H8O2, MW 76.09) occurs as a clear, color-

p e c ip I i n
less, viscous, practically odorless liquid with a sweet taste, somewhat
1. Calculate the required quantity of each ingredient for the total resembling glycerin. It has a specific gravity of 1.038 g/mL and
I
amount to be prepared. is miscible with acetone, chloroform, 95% ethanol, glycerin, and
2. Weigh and/or measure each ingredient accurately. water.6
calcula I i n
3. Combine the propylene glycol with about 50 mL of purified
water and heat to 50°C. Diisopropanolamine (C6H15NO2, MW 133.19, DIPA) occurs as
I
4. Incorporate the Carbopol 934 and mix well. a white crystalline solid with a mild, ammoniacal odor. It is very
5. Combine the cyclosporine A oral solution separately with the soluble in water, soluble in ethanol or acetone, and slightly soluble
ma ke I ing
polyoxyethylene glyceryl monostearate and heat to 50°C. in diethyl ether. It melts between 44.5°C and 45.5°C and is com-
6. Add the cyclosporine A mixture slowly to the Carbopol mixture bustible. It is hygroscopic and should be protected from light. It has
I
and homogenize at high speed for 10 minutes to obtain fine been used as an emulsifier for topical pharmaceuticals.7
droplets.
7. Add the diisopropanolamine, and then the purified water, to Polyoxyethylene glyceryl monostearate [CH3(CH2)16COOCH2
volume and mix well. COHHCH2(OCH2CH2)nOH, POE glyceryl monostearate] is used
I 8. Cool, package, and label. as a nonionic surfactant; solubilizer; dispersant; and emulsifier in
I
I
creams, lotions, flavors, perfumes, and vitamin oils. Different grades

PACKAGING available include PEG-5 glyceryl stearate, PEG-20 glyceryl stea-
Package in tight, light-resistant containers.1 rate, PEG-30 glyceryl stearate, and PEG-120 glyceryl stearate.7
LABELING Purified water is water that is obtained by distillation, ion ex-

Keep out of reach of children. Use only as directed. For external change, reverse osmosis, or some other suitable process. Water is
use only. miscible with most polar solvents and is chemically stable in all
physical states (ice, liquid, steam).8
STABILITY
A beyond-use date of 28 days at room temperature can be used for REFERENCES
this preparation.1,2 1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
I
macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005:

USE 408–413.
2. Tamura T, Takayama K, Satoh H et al. Evaluation of oil/water-type cy-
Cyclosporine topical gel has been used in the treatment of psoriasis
closporine gel ointment with commercially available oral solution. Drug
and other skin diseases.2 Cyclosporine A, generally used for preven-
Dev Ind Pharm 1997; 23(3): 285–291.
tion and treatment of organ transplant rejection, has also shown 3. Allen LV Jr. Standard operating procedure for performing physical qual-
efficacy in psoriasis and potential usefulness in other skin diseases.2 ity assessment of ointments/creams/gels. IJPC 1998; 2(4): 308–309.
4. [No author listed.] Physicians’ Desk Reference. 61st ed. Montvale, NJ:
QUALITY CONTROL Thomson PDR; 2007: 2275–2278.
Quality-control assessment can include theoretical weight com- 5. Koleng JJ, McGinity JW. Carbomer. In: Rowe RC, Sheskey PJ, Owen
pared to actual weight, pH, specific gravity, active drug assay, color, SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington,
clarity, texture-surface, texture-spatula spread, appearance, feel, DC: American Pharmaceutical Association; 2006: 111–115.
rheological properties, and physical observations.3 6. Owen SC, Weller PJ. Propylene glycol. In: Rowe RC, Sheskey PJ, Owen
SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington,
DC: American Pharmaceutical Association; 2006: 624–626.
DISCUSSION
7. Ash M, Ash I. Handbook of Pharmaceutical Additives. 3rd ed. Endicott,
Cyclosporine A oral solution (Sandimmune Oral Solution) NY: Synapse Information Resources, Inc.; 2007: 579, 804–805.
contains, in each milliliter, cyclosporine 100 mg and alcohol 12.5% 8. Galichet LY. Water. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook
dissolved in an olive oil/polyoxyethylated oleic glycerides vehicle. of Pharmaceutical Excipients. 5th ed. Washington, DC: American Phar-
Cyclosporine A is a cyclic polypeptide immunosuppressant agent maceutical Association; 2006: 802–806.

Formulations
FEATURE
IJPC
Diclofenac Sodium 1% Soft-Patch Gel

Rx less, viscous, practically odorless liquid with a sweet taste, somewhat
resembling glycerin. It has a specific gravity of 1.038 g/mL and
For 100 g
is miscible with acetone, chloroform, 95% ethanol, glycerin, and
Diclofenac sodium 1 g water. It is not miscible with fixed oils or light mineral oil. It will,
Propylene glycol 50 g however, dissolve some essential oils.5
Glycerin 33 g
Stearic acid 6 g Glycerin (C3H8O3, MW 92.10, glycerol, 1,2,3-propane triol) oc-
Sodium hydroxide 10.7% w/v solution 10 mL curs as a clear, colorless, odorless, viscous, hygroscopic liquid with
a sweet taste about two thirds as sweet as sucrose. It has a specific
gravity of about 1.25. It is miscible with water, methanol, and 95%
METHOD OF PREPARATION ethanol.6
1. Calculate the required quantity of each ingredient for the total
amount to be prepared. Stearic acid (C18H36O2, MW 284.47) occurs as a hard, white or
2. Weigh and/or measure each ingredient accurately. faintly yellow-colored, somewhat glossy, crystalline solid or a white
3. Combine the propylene glycol and glycerin and heat to 70°C. or yellowish white powder. It has a slight odor and taste suggest-
4. Add the stearic acid to the solution and mix well with continued ing tallow. It is a mixture of stearic acid (C18H36O2) and palmitic
heating until a clear solution is obtained. acid (C16H32O2). It is used as an emulsifying agent and solubilizing
5. Add the diclofenac sodium and sodium hydroxide solution while agent, and as a tablet and capsule lubricant. It melts at a tempera-
stirring continuously and mix well. ture of 54°C or higher. It is soluble in 95% ethanol or propylene
6. Pour into the desired mold. glycol and practically insoluble in water.7
7. Cool, package, and label.
Sodium hydroxide (NaOH, MW 40.00, caustic soda, soda lye) oc-
PACKAGING curs as dry, very deliquescent, white or almost white sticks, pellets,
Package in tight, light-resistant containers.1 or fused masses which are hard and brittle. It is soluble 1 g in 1 mL
of water and is freely soluble in alcohol. A 0.01% solution in water
LABELING has a pH of not less than 11.0.8,9
Keep out of reach of children. Use only as directed. For external
use only. REFERENCES
1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
STABILITY macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005:
A beyond-use date of 6 months at either room or refrigerated tem- 408–413, 681.
perature can be used for this preparation.1,2 2. Csoka G, Marton S, Zelko R et al. Stability of diclofenac sodium and
piroxicam in new transdermal “soft-patch” type gel systems. STP Pharma
Sciences 2000; 10(5): 415–418.
USE
3. Allen LV Jr. Standard operating procedure for performing physical qual-
Remove from mold, place on skin at indicated site, and cover with ity assessment of ointments/creams/gels. IJPC 1998; 2(4): 308–309.
an adhesive strip to affix to skin. Diclofenac sodium soft-patch gel is 4. McEvoy GK, ed. AHFS Drug Information–2007. Bethesda, MD: Ameri-
used for its anti-inflammatory effects. can Society of Health-System Pharmacists; 2007: 2042–2049.
5. Owen SC, Weller PJ. Propylene glycol. In: Rowe RC, Sheskey PJ, Owen
QUALITY CONTROL SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington,
Quality-control assessment can include theoretical weight com- DC: American Pharmaceutical Association; 2006: 624–626.
pared to actual weight, pH, specific gravity, active drug assay, color, 6. Price JC. Glycerin. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook
of Pharmaceutical Excipients. 5th ed. Washington, DC: American Phar-
clarity, texture-surface, texture-spatula spread, appearance, feel,
maceutical Association; 2006: 301–303.
rheological properties, and physical observations.3 7. Allen LV Jr. Stearic acid. In: Rowe RC, Sheskey PJ, Owen SC, eds.
Handbook of Pharmaceutical Excipients. 5th ed. London, UK: Pharma-
DISCUSSION ceutical Press; 2006: 737–739.
Diclofenac sodium (C14H10Cl2NNaO2, MW 318.13) is a phenyl- 8. Kibbe AH. Sodium hydroxide. In: Rowe RC, Sheskey PJ, Owen SC,
acetic acid derivative that is a nonsteroidal anti-inflammatory agent eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
with antipyretic activity. It is used in the treatment of inflammatory American Pharmaceutical Association; 2006: 683–684.
diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, 9. Reynolds JE, ed. MARTINDALE: The Extra Pharmacopeia. 30th ed.
London, UK: The Pharmaceutical Press; 1993: 1415.
juvenile arthritis) and dysmenorrhea, and for its antipyretic effect.
It is used topically in the treatment of actinic keratosis as a 3% gel.
It occurs as a white to off-white, hygroscopic, crystalline powder.
It is soluble in ethanol and sparingly soluble in water. It should be
preserved in tight, light-resistant containers.1,4

IJPC formulations
Diclofenac Sodium 1% Soft-Patch Lipophilic Gel
as a white or almost white, practically odorless, waxy, brittle mass.

Rx When heated to 50°C, they give a colorless or slightly yellowish
liquid. They are generally slightly soluble in warm ethanol and
For 100 g
practically insoluble in water.5 Fattibase is a preblended suppository
Diclofenac sodium 1 g base that is used when a fatty-acid base is preferred, occurring as
Fatty-acid base 60 g an opaque white solid. It contains triglycerides derived from palm,
Glycerol monostearate 39 g palm kernel, and coconut oils with self-emulsifying glyceryl mono-
stearate and polyoxyl stearate as emulsifying and suspending agents.
It is stable and has a bland taste and odor and a controlled melting
METHOD OF PREPARATION range. It is widely used as a cocoa butter replacement for supposi-
1. Calculate the required quantity of each ingredient for the total tories, lipsticks, and lip balms. It has a melting point between 35°C
amount to be prepared. and 37°C and a specific gravity of 0.890.6
2. Weigh and/or measure each ingredient accurately.
3. Combine and heat the fatty-acid base and the glycerol mono- Glycerol monostearate (C21H42O4, MW 358.6, glyceryl stea-
stearate until melted. rate) occurs as a white to cream-colored, waxlike solid in the form
4. Add the diclofenac sodium and mix well. of beads or flakes, or as a powder. It is waxy to the touch and has
5. Cool slightly, then pour into the desired mold. a slight fatty odor and taste. The commercial products occur as
6. Package and label. mixtures of glyceryl monostearate and glyceryl monopalmitate.
A number of different grades are available. It should be stored in
PACKAGING a tightly closed container in a cool, dry place and protected from
Package in tight, light-resistant containers.1 light. It is used as an emollient, an emulsifying and solubilizing
agent, a stabilizing agent, a sustained-release ingredient, and a tablet
LABELING and capsule lubricant.7
Keep out of reach of children. Use only as directed. For external
use only. REFERENCES
STABILITY macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005:
A beyond-use date of 6 months at either room or refrigerated tem- 408–413, 681.
perature can be used for this preparation.1,2 2. Csoka G, Marton S, Zelko R et al. Stability of diclofenac sodium and
Sciences 2000; 10(5): 415–418.
USE 3. Allen LV Jr. Standard operating procedure for performing physical qual-
Remove from mold, place on skin at indicated site, and cover with ity assessment of ointments/creams/gels. IJPC 1998; 2(4): 308–309.
an adhesive strip to affix to skin. Diclofenac sodium soft-patch lipo- 4. McEvoy GK, ed. AHFS Drug Information–2007. Bethesda, MD: Ameri-
philic gel has been used for its anti-inflammatory effects. can Society of Health-System Pharmacists; 2007: 2042–2049.
5. Moreton RC. Suppository bases, hard fat. In: Rowe RC, Sheskey PJ,
QUALITY CONTROL Owen SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Wash-
Quality-control assessment can include theoretical weight com- ington, DC: American Pharmaceutical Association; 2006: 762–766.
6. Fattibase [product information]. Minneapolis, MN: Paddock Laborato-
pared to actual weight, pH, specific gravity, active drug assay, color,
ries, Inc.
clarity, texture-surface, texture-spatula spread, appearance, feel, 7. Taylor AK. Glyceryl monostearate. In: Rowe RC, Sheskey PJ, Owen SC,
rheological properties, and physical observations.3 eds. Handbook of Pharmaceutical Excipients. 5th ed. London, UK: Phar-
maceutical Press; 2006: 308–310.
DISCUSSION
Diclofenac sodium (C14H10Cl2NNaO2, MW 318.13) is a phenyl-
acetic acid derivative that is a nonsteroidal anti-inflammatory agent
with antipyretic activity. It is used in the treatment of inflammatory
diseases (rheumatoid arthritis, osteoarthritis, ankylosing spondylitis,
juvenile arthritis) and dysmenorrhea, and for its antipyretic effect. It
is used topically in the treatment of actinic keratosis as a 3% gel. It
occurs as a white to off-white, hygroscopic, crystalline powder. It is
soluble in ethanol and sparingly soluble in water. It melts at about
284ºC. It should be preserved in tight, light-resistant containers.1,4
Fatty-acid base (hard fat suppository) consists mainly of mix-

tures of the triglyceride esters of the higher saturated fatty acids
(C8H17COOH to C18H37COOH) along with varying proportions
of monoglycerides and diglycerides. These mixtures generally occur

Formulations
FEATURE
IJPC
Diltiazem 5% in Lipoderm, Veterinary
Lipoderm is a liposome-containing base used to increase the

Rx permeation of various active ingredients. It is often used in place of
Pluronic lecithin organogels (PLO gels) for transdermal com-
For 100 g
pounded preparations. Its physical characteristics include smooth-
Diltiazem hydrochloride 5 g ness and creaminess. It is a stable system that does not separate
Ethoxydiglycol 1.5 mL upon refrigeration, and it tolerates ionic substances well.7
Lipoderm qs 100 g
REFERENCES
METHOD OF PREPARATION macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005;
1. Calculate the required quantity of each ingredient for the total 128, 408–413, 682.
amount to be prepared. 2. Buur JL, Baynes RE, Yeatts JL et al. Analysis of diltiazem in Lipoderm
trandermal gel using reversed-phase high-performance liquid chro-
matography applied to homogenization and stability studies. J Pharm
3. Dissolve the diltiazem hydrochloride in the ethoxydiglycol. Biomed Analysis 2005; 38: 60–65.
4. Incorporate the Lipoderm geometrically and mix until uniform. 3. Kerins DM, Robertson RM, Robertson D. Diltiazem. In: Harman JG,
5. Package and label. Limbird LE, eds. Goodman and Gilman’s The Pharmacological Basis of
Therapeutics. 10th ed. New York, NY: McGraw-Hill; 2001: 859–860.
PACKAGING 4. Bright JM, Golden AL, Gompf RE et al. Evaluation of the calcium
Package in tight, light-resistant containers.1 channel–blocking agents diltiazem and verapamil for treatment of feline
hypertrophic cardiomyopathy. J Vet Intern Med 1991; 5(5): 272–282.
LABELING
ity assessment of ointments/creams/gels. IJPC 1998; 2(4): 308–309.
Keep out of reach of children. Use only as directed. For external 6. Ash M, Ash I. Handbook of Pharmaceutical Additives. Brookfield, VT:
use only. Gower Publishing Company; 1995: 484.
7. Lipoderm [product information]. Sugarland, TX: Professional Com-
STABILITY pounding Center of America.
A beyond-use date of 60 days at either room or refrigerated tem-
perature can be used for this preparation.1,2
USE
Diltiazem in Lipoderm is used in the treatment of hypertrophic
cardiomyopathy in cats.3,4
QUALITY CONTROL
Quality-control assessment can include theoretical weight com-
rheological properties, and physical observations.5
DISCUSSION
Diltiazem hydrochloride (C22H26N2O4S.HCl, MW 450.98)
is a calcium channel antagonist used in the treatment of angina,
hypertension, and arrhythmias in humans. It also has a veterinary
application in treating hypertrophic cardiomyopathy in cats. It oc-
curs as a white, odorless, crystalline powder or small crystals. It is
freely soluble in water and sparingly soluble in dehydrated alcohol.
It melts at about 210°C with decomposition.1
Ethoxy diglycol (C6H14O3, CH2OHCH2OCH2CH2OC2H5, MW

134.20) is also called diethylene glycol monoethyl ether, diethylene
glycol ethyl ether, Carbitol, and Transcutol. It occurs as a colorless
liquid with a mild pleasant odor. It is hygroscopic and is miscible
with water and with common organic solvents. It has a density of
1.0272 and a boiling point of 195°C to 202°C and is combustible.
It is nonirritating and nonpenetrating when applied to human skin
and is used as a solvent, solubilizer, and cosurfactant.6

IJPC formulations
Emetine Hydrochloride 30-mg/mL Injection
white or very slightly yellowish, odorless, crystalline powder that is

Rx affected by light and is freely soluble in water and in alcohol.1,3
For 100 mL
Hydrochloric acid (HCl, MW 36.46) occurs as a clear, colorless,
Emetine hydrochloride 3 g fuming aqueous solution of hydrogen chloride that has a pungent
Sodium hydroxide or hydrochloric odor. Concentrated hydrochloric acid is 36.5% to 38.0% w/w
acid for pH adjustment qs concentration. It has a specific gravity of 1.18 g/cm3, is miscible
Sterile water for injection qs 100 mL with water, and is soluble in ethanol. The pH of a 10% v/v aqueous
solution is 0.1.6
Note: This formulation should be prepared according to strict aseptic
Sodium hydroxide (NaOH, MW 40.00, caustic soda, soda lye) oc-
compounding technique in a laminar airflow hood in a cleanroom or via
isolation barrier technology by a compounding pharmacist who is validated curs as dry, very deliquescent, white or almost white sticks, pellets,
in aseptic compounding. This is a high-risk preparation. or fused masses which are hard and brittle. It is strongly alkaline
and corrosive and rapidly absorbs moisture and carbon dioxide
METHOD OF PREPARATION when exposed to air. It is soluble 1 g in 1 mL of water and is freely
1. Calculate the required quantity of each ingredient for the total soluble in alcohol. A 0.01% solution in water has a pH of not less
amount to be prepared. than 11.0.7,8
3. Dissolve the emetine hydrochloride in about 90 mL of sterile Sterile water for injection is water for injection that has been ster-
water for injection. ilized and suitably packaged; it contains no added substances. Water
4. Add a 10% solution of sodium hydroxide or hydrochloric acid to for injection is water purified by distillation or by reverse osmosis.
adjust the pH to the range of 2.7 to 3.3. Note that water for injection is not prepared by an ion exchange
5. Add sufficient sterile water for injection to volume and mix well. process. Water has a specific gravity of 0.9971 at room temperature,
6. Filter through an appropriate sterile 0.22-mcm filter into sterile a melting point of 0ºC, and a boiling point of 100ºC. It is miscible
vials. with most polar solvents and is chemically stable in all physical
7. Package and label. states (ice, liquid, steam).9
PACKAGING REFERENCES
Package in tight, light-resistant containers.1
137, 408–413, 683.
LABELING 2. Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations.
Keep out of reach of children. Use only as directed. Volume 6–Sterile Products. Boca Raton, FL: CRC Press; 2004: 192.
3. Harvey SC. Antimicrobial drugs. In: Osol A, ed. Remington’s Pharma-
STABILITY ceutical Sciences. 16th ed. Easton, PA: Mack Publishing Co.; 1980: 1166.
If sterility tested, this preparation can take a beyond-use date of 6 4. Allen LV Jr. Standard operating procedure for particulate testing for
months at room temperature.1,2 sterile products. IJPC 1998; 2(1): 78.
5. Allen LV Jr. Standard operating procedure: Quality assessment for inject-
able solutions. IJPC 1999; 3(5): 406–407.
USE 6. Owen SC. Hydrochloric acid. In: Rowe RC, Sheskey PJ, Owen SC,
Emetine hydrochloride injection has been used in the treatment of eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
amebic infections.3 American Pharmaceutical Association; 2006: 328–329.
7. Kibbe AH. Sodium hydroxide. In: Rowe RC, Sheskey PJ, Owen SC,
QUALITY CONTROL eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
Quality-control assessment can include weight/volume, physical American Pharmaceutical Association; 2006: 683–684.
observation, pH, specific gravity, osmolality, assay, color, clarity, 8. Reynolds JE, ed. MARTINDALE: The Extra Pharmacopeia. 30th ed.
London, UK: The Pharmaceutical Press; 1993: 1415.
particulate matter, sterility, and pyrogenicity.4,5
9. Galichet LY. Water. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook
DISCUSSION maceutical Association; 2006: 802–806.
Emetine hydrochloride (C29H40N2O4.2HCl, MW 553.56) is used
to eradicate amebas from both intestinal and extraintestinal sites. It
has largely been replaced by newer, less toxic agents but is still used.
It concentrates in the liver and has been used especially for amebic
hepatitis and amebic abscesses in other locations. It has been used
in such cases as initial treatment, for rapid relief of symptoms, and
is then supplanted by other agents. A course of therapy should not
continue for more than 5 days. Emetine hydrochloride occurs as a

Formulations
FEATURE
IJPC
Flosulide 10-mg/mL Injection
and is miscible with castor oil. It is used as a solvent and a bioadhe-

Rx sive, and is used in spray bandages and veterinary pharmaceuticals.6
For 100 mL
Dimethylacetamide (C4H9NO, MW 87.12, DMA, DMAC) occurs
Flosulide 1 g as a clear, colorless, slightly hygroscopic liquid with a weak ammo-
N-methylpyrrolidone 5 g nia-like or fishlike odor. It is miscible with 95% ethanol, water, and
Dimethylacetamide 5 g most common solvents. It is used as a solvent in oral and injectable
Polyethylene glycol 400 30 g formulations and as a cosolvent.7
Benzyl alcohol 2 g
Alpha tocopheryl acetate 50 mg Polyethylene glycol 400 (carbowax, PEG, polyoxyethylene glycol)
Propylene glycol qs 100 mL is a clear, colorless or slightly yellow-colored, viscous liquid with
a slight but characteristic odor and a bitter, slightly burning taste.
It is soluble in water, miscible in all ratios with other polyethylene
Note: This formulation should be prepared according to strict aseptic glycols and is soluble in alcohols, glycerin, and glycols.8
compounding technique in a laminar airflow hood in a cleanroom or via
isolation barrier technology by a compounding pharmacist who is validated
in aseptic compounding. This is a high-risk preparation. Benzyl alcohol (C7H8O, MW 108.14) is an antimicrobial preserva-
tive, disinfectant, and solvent. It is soluble 1 g in 25 mL of water
and is miscible with ethanol.9
amount to be prepared. Alpha tocopheryl acetate (C31H52O3, MW 472.7, vitamin E)
2. Weigh and/or measure each ingredient accurately. occurs as a practically odorless, clear, yellow or greenish-yellow,
3. Mix the N-methylpyrrolidone, dimethylacetamide, polyethylene viscous oil that is practically insoluble in water and freely soluble in
glycol 400, and benzyl alcohol together. acetone, ethanol, or vegetable oils; it is soluble in 95% ethanol. The
4. Add the alpha tocopheryl acetate and flosulide and mix well. acetate form is much less susceptible to the effects of air, light, or
5. Add sufficient propylene glycol to volume and mix well until a ultraviolet radiation than the base form.10
clear solution is obtained.
6. Filter through an appropriate sterile 0.22-mcm filter into sterile Propylene glycol (C3H8O2, MW 76.09) occurs as a clear, colorless,
vials. viscous, practically odorless liquid with a sweet taste. It is miscible
7. Package and label. with 95% ethanol, glycerin, and water.11
PACKAGING REFERENCES
Package in tight, light-resistant containers.1 1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
LABELING 408–413.
Keep out of reach of children. Use only as directed. 2. Niazi SK. Handbook of Pharmaceutical Manufacturing Formulations.
Volume 6–Sterile Products. Boca Raton, FL: CRC Press; 2004: 202.
STABILITY 3. Allen LV Jr. Standard operating procedure for particulate testing for
If sterility tested, this preparation can take a beyond-use date of 6 sterile products. IJPC 1998; 2(1): 78.
4. Allen LV Jr. Standard operating procedure: Quality assessment for inject-
months.1,2
able solutions. IJPC 1999; 3(5): 406–407.
5. [No author listed.] USP Dictionary of USAN and International Drug
USE Names. Rockville, MD: US Pharmacopeial Convention, Inc.; 2006: 376.
Flosulide injection is used in the treatment of rheumatoid arthritis, 6. Ash M, Ash I. Handbook of Pharmaceutical Additives. Brookfield, VT:
osteoarthritis, and other inflammatory conditions. Gower Publishing Company; 1995: 754.
7. Guest RT. Dimethylacetamide. In: Rowe RC, Sheskey PJ, Owen SC,
QUALITY CONTROL eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
Quality-control assessment can include weight/volume, physical American Pharmaceutical Association; 2006: 253–254.
observation, pH, specific gravity, osmolality, assay, color, clarity, 8. Price JC. Polyethylene glycol. In: Rowe RC, Sheskey PJ, Owen SC,
particulate matter, sterility, and pyrogenicity.3,4 eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
American Pharmaceutical Association; 2006: 545–550.
9. Cahill E. Benzyl alcohol. In: Raymond CR, Sheskey PJ, Owen SC, eds.
DISCUSSION
Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
Flosulide (C16H13F2NO4S, MW 353.34) is a cyclooxygenase 2–in-
American Pharmaceutical Association; 2006: 69–71.
hibiting anti-inflammatory agent available in some countries.5 10. Owen SC. Alpha tocopherol. In: Raymond CR, Sheskey PJ, Owen SC,
eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
N-methylpyrrolidone (C5H9NO, MW 99.13) occurs as a color- American Pharmaceutical Association; 2006: 32–35.
less liquid with a mild amine odor. It is soluble in water, alcohols, 11. Owen SC, Weller PJ. Propylene glycol. In: Rowe RC, Sheskey PJ, Owen
ketones, ethers, ethyl acetate, aromatic hydrocarbons, and most SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington,
organic solvents. It is moderately soluble in aliphatic hydrocarbons DC: American Pharmaceutical Association; 2006: 624–626.

IJPC formulations
Pentoxifylline 20-mg/mL Oral Suspension
of 0°C, and a boiling point of 100ºC. It is miscible with most polar

Rx solvents and is chemically stable in all physical states (ice, liquid,
steam).6
For 100 mL
Pentoxifylline 2 g REFERENCES
Purified water qs 100 mL 1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
408–413.
METHOD OF PREPARATION 2. Abdel-Rahman SM, Nahata MC. Stability of pentoxifylline in an extem-
poraneously prepared oral suspension. Am J Health Syst Pharm 1997;
54: 1301–1303.
amount to be prepared. 3. Allen LV Jr. Standard operating procedure for performing physical qual-
2. Weigh and/or measure each ingredient accurately. ity assessment of oral and topical liquids. IJPC 1999; 3(2): 146–147.
3. Crush the required number of pentoxifylline tablets to a fine 4. Reynolds JE. MARTINDALE: The Extra Pharmacopoeia. London, UK:
powder. The Pharmaceutical Press; 1993: 1311–1312.
4. Add sufficient purified water to volume and mix well. 5. McEvoy GK, ed. AHFS Drug Information–2007. Bethesda, MD: Ameri-
5. Prepare a fine suspension of the pentoxifylline. can Society of Health-System Pharmacists; 2007: 1473–1477.
Note: A blender can be used to aid in this preparation. 6. Galichet LY. Water. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook
6. Package and label.
maceutical Association; 2006: 802–806.
PACKAGING
LABELING
Keep out of reach of children. Use only as directed. Shake well
before use.
STABILITY
A beyond-use date of 91 days at room or refrigerated temperature
can be used for this preparation.1,2
USE
An individual dose of this suspension can be mixed with a flavored
syrup at the time of administration. Pentoxifylline oral suspension
has been used to increase blood flow to various tissues.
QUALITY CONTROL
Quality-control assessment can include weight/volume, pH, specific
gravity, active drug assay, color, rheological properties/pourability,
physical observation, and physical stability (discoloration, foreign
materials, gas formation, mold growth).3
DISCUSSION
Pentoxifylline (C13H18N4O3, MW 278.31, Oxpentifylline) is a
synthetic trisubstituted xanthine derivative that is structurally
related to caffeine, theobromine, and theophylline. It occurs as a
white, odorless, crystalline powder with a bitter taste. It is soluble to
the extent of about 77 mg/mL in water and 63 mg/mL in alco-
hol. It and its metabolites reduce blood viscosity and are reported
to increase blood flow to ischemic tissues and to improve tissue
oxygenation in patients with peripheral vascular disease. It also is
reported to increase oxygen tension in the cerebral cortex and in
the cerebrospinal fluid.4,5
Purified water is water that is obtained by distillation, ion ex-

change, reverse osmosis, or some other suitable process. Water has
a specific gravity of 0.9971 at room temperature, a melting point

Formulations
FEATURE
IJPC
Piroxicam 1% Soft-Patch Lipophilic Gel
practically insoluble in water.4 Fattibase is a preblended suppository

Rx base that is used when a fatty-acid base is preferred, occurring as
an opaque white solid. It contains triglycerides derived from palm,
For 100 g
palm kernel, and coconut oils with self-emulsifying glyceryl mono-
Piroxicam 1 g stearate and polyoxyl stearate as emulsifying and suspending agents.
Fatty-acid base 60 g It is stable and has a bland taste and odor and a controlled melting
Glycerol monostearate 39 g range. It is widely used as a cocoa butter replacement for supposi-
tories, lipsticks, and lip balms. It has a melting point between 35°C
and 37°C and a specific gravity of 0.890.5
1. Calculate the required quantity of each ingredient for the total Glycerol monostearate (C21H42O4, MW 358.6, glyceryl stea-
amount to be prepared. rate) occurs as a white to cream-colored, waxlike solid in the form
2. Weigh and/or measure each ingredient accurately. of beads or flakes, or as a powder. It is waxy to the touch and has
3. Combine and heat the fatty-acid base and the glycerol mono- a slight fatty odor and taste. The commercial products occur as
stearate until melted. mixtures of glyceryl monostearate and glyceryl monopalmitate.
4. Add the piroxicam and mix well. A number of different grades are available. It should be stored in
5. Pour into the desired mold. a tightly closed container in a cool, dry place and protected from
6. Cool, package, and label. light. It is used as an emollient, emulsifying agent, solubilizing
agent, stabilizing agent, sustained-release ingredient, and tablet and
PACKAGING capsule lubricant.6
REFERENCES
LABELING 1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
Keep out of reach of children. Use only as directed. For external macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005:
use only. 260, 408–413, 703.
2. Csoka G, Marton S, Zelko R et al. Stability of diclofenac sodium and
STABILITY Sciences 2000; 10(5): 415–418.
A beyond-use date of 6 months at room or refrigerated temperature 3. Allen LV Jr. Standard operating procedure for performing physical qual-
can be used for this preparation.1,2 ity assessment of ointments/creams/gels. IJPC 1998; 2(4): 308–309.
4. Moreton RC. Suppository bases, hard fat. In: Rowe RC, Sheskey PJ,
USE Owen SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Wash-
Remove from mold, place on skin at indicated site, and cover with ington, DC: American Pharmaceutical Association; 2006: 762–766.
an adhesive strip to affix to skin. Piroxicam lipophilic gel has been 5. Fattibase [product information]. Minneapolis, MN: Paddock Laborato-
used in the treatment of rheumatoid arthritis, osteoarthritis, and ries, Inc.
6. Taylor AK. Glyceryl monostearate. In: Rowe RC, Sheskey PJ, Owen SC,
other inflammatory conditions. eds. Handbook of Pharmaceutical Excipients. 5th ed. London, UK: Phar-
maceutical Press; 2006: 308–310.
QUALITY CONTROL
Quality-control assessment can include theoretical weight com-
rheological properties, and physical observations.3
DISCUSSION
Piroxicam (C15H13N3O4S, MW 331.35) occurs as an off-white to
light tan or light yellow, odorless powder; it forms a monohydrate
that is yellow. It is very slightly soluble in water, in dilute acids,
and in most organic solvents. It is slightly soluble in alcohol and in
aqueous alkaline solutions.1
Fatty-acid base, or hard fat suppository base, consists mainly of

mixtures of the triglyceride esters of the higher saturated fatty acids
(C8H17COOH to C18H37COOH) along with varying proportions
of monoglycerides and diglycerides. These mixtures generally occur
as a white or almost white, practically odorless, waxy, brittle mass.
When heated to 50°C, they give a colorless or slightly yellowish
liquid. They are generally slightly soluble in warm ethanol and

IJPC formulations
Piroxicam 1% Soft-Patch Topical Gel

Rx less, viscous, practically odorless liquid with a sweet taste, somewhat
resembling glycerin. It has a specific gravity of 1.038 g/mL and
For 100 g
is miscible with acetone, chloroform, 95% ethanol, glycerin, and
Piroxicam 1 g water.4
Propylene glycol 50 g
Glycerin 33 g Glycerin (C3H8O3, MW 92.10, glycerol, 1,2,3-propane triol) oc-
Stearic acid 6 g curs as a clear, colorless, odorless, viscous, hygroscopic liquid with
Sodium hydroxide 10.7% w/v solution 10 mL a sweet taste about two thirds as sweet as sucrose. It has a specific
gravity of about 1.25 and a melting point of 17.8°C; if cooled to
crystallization, it must be heated to about 20°C to melt. It is mis-
METHOD OF PREPARATION cible with water, methanol, and 95% ethanol, practically insoluble
1. Calculate the required quantity of each ingredient for the total in oils or chloroform, and slightly soluble in acetone.5
amount to be prepared.
2. Weigh and/or measure each ingredient accurately. Stearic acid (C18H36O2, MW 284.47) occurs as a hard, white or
3. Combine the propylene glycol and glycerin and heat to 70°C. faintly yellow-colored, somewhat glossy, crystalline solid or a white
4. Add the stearic acid to the solution and mix well with continued or yellowish white powder. It has a slight odor and taste suggesting
heating until a clear solution is obtained. tallow. It is a mixture of stearic acid (C18H36O2) and palmitic acid
5. Add the piroxicam and sodium hydroxide solution while stirring (C16H32O2). It is soluble in 95% ethanol or propylene glycol and
continuously and mix well. practically insoluble in water.6
6. Pour into the desired mold.
7. Cool, package, and label. Sodium hydroxide (NaOH, MW 40.00, caustic soda, soda lye) oc-
curs as dry, very deliquescent, white or almost white sticks, pellets,
PACKAGING or fused masses which are hard and brittle. It is strongly alkaline
Package in tight, light-resistant containers.1 and corrosive and rapidly absorbs moisture and carbon dioxide
when exposed to air. It is soluble 1 g in 1 mL of water and is freely
LABELING soluble in alcohol. A 0.01% solution in water has a pH of not less
Keep out of reach of children. Use only as directed. For external than 11.0. It should be stored in airtight, nonmetallic containers.7,8
use only.
REFERENCES
STABILITY 1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
A beyond-use date of 6 months at room or refrigerated temperature macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005:
can be used for this preparation.1,2 260, 408–413, 703.
2. Csoka G, Marton S, Zelko R et al. Stability of diclofenac sodium and
USE piroxicam in new transdermal “soft-patch” type gel systems. STP Pharma
Sciences 2000; 10(5): 415–418.
Remove from mold, place on skin at indicated site, and cover with
an adhesive strip to affix to skin. Piroxicam topical gel is used in the ity assessment of ointments/creams/gels. IJPC 1998; 2(4): 308–309.
treatment of rheumatoid arthritis, osteoarthritis, and other inflam- 4. Owen SC, Weller PJ. Propylene glycol. In: Rowe RC, Sheskey PJ, Owen
matory conditions that are amenable to topical therapy. SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington,
DC: American Pharmaceutical Association; 2006: 624–626.
QUALITY CONTROL 5. Price JC. Glycerin. In: Rowe RC, Sheskey PJ, Owen SC, eds. Handbook
Quality-control assessment can include theoretical weight com- of Pharmaceutical Excipients. 5th ed. Washington, DC: American Phar-
pared to actual weight, pH, specific gravity, active drug assay, color, maceutical Association; 2006: 301–303.
6. Allen LV Jr. Stearic acid. In: Rowe RC, Sheskey PJ, Owen SC, eds.
Handbook of Pharmaceutical Excipients. 5th ed. London, UK: Pharma-
rheological properties, and physical observations.3 ceutical Press; 2006: 737–739.
7. Kibbe AH. Sodium hydroxide. In: Rowe RC, Sheskey PJ, Owen SC,
DISCUSSION eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington, DC:
Piroxicam (C15H13N3O4S, MW 331.35) is a nonsteroidal anti- American Pharmaceutical Association; 2006: 683–684.
inflammatory agent exhibiting analgesic and antipyretic activity. 8. Reynolds JE, ed. MARTINDALE: The Extra Pharmacopeia. 30th ed.
It is used in the symptomatic treatment of rheumatoid arthritis, London, UK: The Pharmaceutical Press; 1993: 1415.
osteoarthritis, and other inflammatory conditions. It occurs as an
off-white to light tan or light yellow, odorless powder; it forms a
monohydrate that is yellow. It is very slightly soluble in water, in
dilute acids, and in most organic solvents. It is slightly soluble in
alcohol and in aqueous alkaline solutions.1

Formulations
FEATURE
IJPC
Trimethoprim 10-mg/mL Oral Suspension
viscosity grades are used to thicken topically applied products

Rx such as creams and gels. It is hygroscopic; practically insoluble in
acetone, ethanol, saturated salt solutions, or hot water; and soluble
For 100 mL
in glacial acetic acid. In cold water, it swells and disperses to form a
Trimethoprim 1 g viscous, colloidal dispersion. The specific gravity of the powder is in
Methylcellulose 1%:syrup (1:1) qs 100 mL the range of 1.26 to 1.31. Its solutions are stable to alkalis and dilute
acids between pH values of 3 and 11. The viscosity is decreased out-
side this pH range. Methylcellulose solutions can be autoclaved, but
METHOD OF PREPARATION this may result in some loss of viscosity. Reported incompatibilities
1. Calculate the required quantity of each ingredient for the total include aminacrine hydrochloride, chlorocresol, mercuric chlo-
amount to be prepared. ride, phenol, resorcinol, tannic acid, silver nitrate, cetylpyridinium
2. Weigh and/or measure each ingredient accurately. chloride, p-hydrosybenzoic acid, p-aminobenzoic acid, methylpara-
3. Pulverize the required number of trimethoprim tablets to a fine ben, propylparaben, and butylparaben. Mineral acid salts, phenols,
powder or use trimethoprim powder. and tannins will coagulate solutions of the methylcellulose, but this
4. Add the methylcellulose-syrup mixture geometrically to volume can be prevented by the addition of 95% ethanol. Tetracaine and
and mix well after each addition. dibutoline sulfate may form complexes, and high concentrations of
5. Package and label. electrolytes may completely precipitate the dispersion.4
PACKAGING Syrup (simple syrup) is a clear, sweet vehicle used as a sweeten-

Package in tight, light-resistant containers.1 ing agent and the base for many flavored and medicated syrups.
It contains 85% w/v sucrose in water and has a specific gravity
LABELING of not less than 1.30. It is generally self-preserving as long as the
Keep out of reach of children. Use only as directed. Shake well sucrose concentration is maintained sufficiently high. The preferred
before use. preparation method uses no heat, but it can be prepared by the use
of boiling water. It should be stored in tight containers, preferably
STABILITY in a cool place.1
A beyond-use date of 91 days at refrigerated temperature or 6
weeks at room temperature can be used for this preparation.1,2 Purified water is water that is obtained by distillation, ion ex-
change, reverse osmosis, or some other suitable process. Water has
USE a specific gravity of 0.9971 at room temperature, a melting point
Trimethoprim oral suspension is commonly used in the treatment of 0°C, and a boiling point of 100ºC. It is miscible with most polar
of pediatric urinary tract infections or some types of pneumonia.2 solvents and is chemically stable in all physical states (ice, liquid,
steam).5
QUALITY CONTROL
Quality-control assessment can include weight/volume, pH, specific REFERENCES
gravity, active drug assay, color, rheological properties/pourability, 1. United States Pharmacopeial Convention, Inc. USP Pharmacists’ Phar-
physical observation, and physical stability (discoloration, foreign macopeia. Rockville, MD: US Pharmacopeial Convention, Inc.; 2005;
327, 388, 408–413, 715.
materials, gas formation, mold growth).3
2. Nahata MC. Stability of trimethoprim in an extemporaneous liquid
dosage form. J Ped Pharm Practice 1997; 2(2): 82–84.
DISCUSSION 3. Allen LV Jr. Standard operating procedure for performing physical
Trimethoprim (C14H18N4O3, MW 290.32) is a synthetic folate- quality assessment of oral and topical liquids. IJPC 1999; 3: 146–147.
antagonist anti-infective agent used in the treatment of urinary 4. Allen LV, Luner PE. Methylcellulose. In: Rowe RC, Sheskey PJ, Owen
tract infections, Pneumocystis jiroveci pneumonia, and travelers’ SC, eds. Handbook of Pharmaceutical Excipients. 5th ed. Washington,
diarrhea. It occurs as white to cream-colored, odorless crystals, or DC: American Pharmaceutical Association; 2006: 462–465.
as a crystalline powder. It is very slightly soluble in water, soluble in 5. Galichet LY. Water. In: Rowe RC, Sheskey PJ, Owen SC, eds. Hand-
benzyl alcohol, and slightly soluble in alcohol or acetone.1,2 book of Pharmaceutical Excipients. 5th ed. Washington, DC: American
Pharmaceutical Association; 2006: 802–806.
Methylcellulose (Methocel) is a practically odorless and tasteless,
white to yellowish-white colored granule or powder that is widely
used in both oral and topical formulations. It is used at concentra-
tions of 5% to 30% as a bulk laxative; 1% to 5% in creams, gels,
and ointments; 1% to 5% as an emulsifying agent; 0.5% to 1.0% in
ophthalmic preparations; 1% to 2% in suspensions; and in various
concentrations in tablet formulations. It is available in different vis-
cosity grades; the low-viscosity grades are used to emulsify oils and
as suspending and thickening agents for oral liquids, and the higher

pee e iewed
Specialty Compounding for Improved Patient Care:

f2006
mula I i nSurvey pof Compounding
National I c ip I i n Pharmacists
I
I
D.C. Huffman, RPh, PhD 94% of respondent pharmacies provided

Research & Education Foundation, American College of Apothecaries compounding services, and that 2.3% of
Bartlett, Tennessee their prescriptions required compounding.2
I
I This indicates the current state of the pro-

Erin R. Holmes, PharmD, MS fession of compounding. As the importance
School of Pharmacy, The University of Mississippi of compounding to pharmacy practice be-
University, Mississippi comes more salient, so does the regulatory
ba ic
Acknowledgment
f c mp unding debate regarding the best way to ensure the
safety and efficacy of compounded prepara-
tions.
This research was funded by an educational grant from Mallinckrodt
quali I y-c n I l analy I ical me Regulatory

d Debate
Pharmaceuticals, Hazelwood, Missouri.
I
In the U.S., commercial medications
I
I
I
I
Abstract are manufactured under federal law and
Pharmacy compounding is re-emerging as a critical area of pharmacy practice. are subject to U.S. Food and Drug Admin-
istration (FDA) regulations. In contrast,
p e c ip I i n
This re-emergence has generated considerable discussion among stakeholders
of the pharmacy profession about how pharmacy compounding is best regu-
compounding, as part of the practice of
I
pharmacy, is traditionally regulated at the

lated to ensure the safety and efficacy of compounded preparations. In light of state level and overseen by state boards of
calcula I i n
this discussion, the American College of Apothecaries conducted a survey in pharmacy.1 While the FDA recognizes that
August 2006 that was sent to compounding pharmacists, the list of which was state boards of pharmacy have the authority
I
provided by the International Journal of Pharmaceutical Compounding. The to regulate pharmacy compounding and di-
rect access to prescription records, it is con-
purpose of the survey was to (1) assess the safety and efficacy of compounded
ma ke I ing
cerned that limited resources and varying
preparations as reported by compounding pharmacists, (2) describe the types of standards and regulatory requirements may
I
compounding and other professional services that are offered by these pharma- prevent adequate regulation of compound-
cists, (3) describe selected business information for compounding pharmacies, ing practice.3 Thus, the FDA has become
and (4) monitor changes in the compounding pharmacy landscape since the increasingly involved in compounding
2005 National Survey of Compounding Pharmacists, the results of which were practice in recent years. In part, this has
I been motivated by the fear that large-scale
I
published in the November/December 2006 issue of the International Journal

I
drug manufacturing is being conducted

of Pharmaceutical Compounding. State boards of pharmacy were surveyed for under the pretext of pharmacy compound-
reports of problems related to instability of compounded preparations and ad- ing.3 It is the FDA’s concern that pharmacy
verse reactions caused by compounded preparations. Data trends in this study compounding that mimics this large-scale
are similar to those reported in the 2005 survey, also conducted by the American manufacturing undermines incentives for
College of Apothecaries. Respondents reported relatively few adverse events the pharmaceutical industry to develop and
submit new drug applications.3
caused by compounded preparations. These respondents, many of whom are
independent pharmacists, offer a variety of compounding, professional, and pa- Compounding: New Drugs?
tient care services. Of 18 responding state boards of pharmacy, four noted re-
The FDA contends that “all compound-
ports of compounding problems in their state. ed prescription drugs are ‘new drugs’ within
I
the meaning of the Federal Food, Drug and

Cosmetic Act (FD&C Act).” It goes on to
the importance of pharmacy compounding note that,
Introduction to patients who are intolerant of, or do not
With an estimated 30 to 40 million respond to, commercially manufactured When a pharmacist compounds a pre-
prescriptions compounded each year, drugs, or to those for whom an appropri- scription drug, by definition, he or she
compounding has again become a critical ate dosage or dosage form is not commer- creates a new drug under federal law
component of pharmacy practice.1 Indeed, cially available.1 In a study of independent because the compounded product is not
there is evidence to suggest that stakehold- pharmacists in Illinois, Missouri, Kansas, generally recognized among experts…as
ers of the pharmacy profession recognize and Iowa, McPherson et al reported that safe and effective.4

peer reviewed
FEATURE
IJPC
Finally, the FDA contends that, Recent Initiatives 5. Both the prescriber and the patient
In response to the regulatory debate should be aware that a compounded
Under the FD&C Act, a new drug— that surrounds pharmacy compounding, preparation is dispensed.
including a compounded new drug— several initiatives have been taken by vari- 6. The pharmacy may advertise or other-
may not be legally manufactured or ous stakeholders to address concerns over wise promote that it provides prescrip-
sold in the United States unless it has compounding practice. Perhaps the most tion drug compounding services.
been pre-approved by the FDA as safe significant of these initiatives is creation of
and effective for its intended uses. In the Pharmacy Compounding Accreditation To establish accreditation by PCAB,
virtually every instance, the drugs that Board (PCAB), a voluntary accreditation applicant pharmacies must meet ten general
pharmacists compound have not been body formed by eight pharmacy organiza- standards (as measured by compliance
so approved.4 tions (see accompanying sidebar). This indicators) for compounding practice (see
accreditating body was formed in 2004 to sidebar titled “Pharmacy Compounding
Despite the FDA’s increasingly aggres- strengthen standards for compounding Accreditation Board Accreditation Stan-
sive stance on regulating compounding, the pharmacies.1 dards”).8 As of June 2006, four compound-
agency recognizes that ing pharmacies had been accredited
by PCAB, and over 85 pharmacies
…traditional pharmacy com- were holding pending applications,
pounding serves an important
Pharmacy Compounding Accreditation
1 meaning that they had submitted
public health function by meeting Board Organizations most material and documentation
the specialized medical needs • American College of Apothecaries toward meeting PCAB standards.9
of individual patients for whom • American Pharmacists Association Other initiatives have been taken
commercially available approved by the profession’s stakeholders to
• International Academy of Compounding
drugs are inadequate or inappro- improve the safety of compounded
priate.3-5 Pharmacists
preparations. In early 2006, the In-
• National Association of Boards of ternational Academy of Compound-
That said, the FDA has historically Pharmacy ing Pharmacists (IACP) issued new
not taken action against traditional • National Community Pharmacists labeling guidelines to help patients
pharmacy compounding, but has Association better understand their compounded
enforced regulations against “manu- medications.10 The objective of this
facture under the guise of traditional
• National Council of State Pharmacy
initiative was to standardize labeling
compounding of large quantities of Association Executives
across the country and promote best
unapproved new drugs that are com- • National Home Infusion Association practices by compounding pharma-
mercial copies of approved drugs” or • United States Pharmacopeia cists.10 In addition to state require-
compounding practices that pose a ments for labeling of prescription
threat to public health or the integrity drugs, IACP recommends including
of the drug approval process outlined a label stating, “This medicine was
by the FD&C Act.4 The PCAB developed six prin-
ciples of compounding, as follows:7
The contention that compounded drugs 1. Compounding is the formulation Pharmacy Compounding
are “new” drugs under the FD&C Act has of components into a drug Accreditation Board Accreditation
been met with increasing opposition. In preparation as the result of a
practitioner’s prescription drug
Standards8
the 2006 case Medical Center Pharmacy v.
Gonzalez, U.S. District Court Judge Robert order based on a valid practi- 1.00 Regulatory Compliance
Junell issued a ruling that compounded tioner/patient/pharmacist 2.00 Personnel
drugs are not “new” drugs.6 In this case, it relationship. 3.00 Facilities and Equipment
was ruled that 2. Compounded medications may 4.00 Chemicals, Drug Products, and
be dispensed to prescribers for
office use as permitted by state
Components
...it is in the best interest of public
health to recognize an exemption for law, but the law does not allow 5.00 Compounding Process
compounded drugs that are created for prescribers’ reselling of com- 6.00 Beyond-Use Dating, Stability,
based on a prescription written for an pounded medications. Sterility
individual patient by a licensed practi- 3. Compounding may be conducted 7.00 Dispensing
tioner…6 in anticipation of receiving pre- 8.00 Practitioner and Patient Education
scription orders when based on
This ruling rejected FDA’s contention routine prescribing patterns.
9.00 Quality Assurance Plan and
that compounded drugs are “new drugs” 4. Compounding does not include Continuous Quality Improvement
under the FD&C Act and thus subject to preparation of copies of commer- 10.00 Self-Assessment
FDA regulation.6 cially available drug products.

IJPC peer reviewed
specially compounded in our pharmacy for you at the direction of

your prescriber.” IACP also recommends including an insert with
the compounded prescription to explain why the practitioner pre- Table 1. Therapeutic Categories of
scribed the compounded medication and what information should Compounded Prescriptions.
have been provided by the physician.11 For those compounded Therapeutic Number of
preparations that are for administration in a physician’s office, IACP Category Respondents
recommends the labeling, “This medicine was compounded in our
pharmacy for use by a licensed professional only.”12 Pain management 149
Dermatology 147
Hormone replacement therapy 143
2006 National Survey of
Veterinary 140
Compounding Pharmacists Neuropathy 116
Study Objectives
The objectives of the 2006 National Survey of Compounding
Dental 109
Pharmacists study were to (1) assess the safety and efficacy of com- Podiatry 108
pounded preparations as reported by compounding pharmacists, (2) Ophthalmic 88
describe the types of compounding and other professional services Steroid therapy 77
that are offered by these pharmacists, (3) describe select business Oncology 75
information for compounding pharmacies, and (4) monitor changes Rheumatology 73
in the compounding landscape since the 2005 National Survey of
Parenterals 71
Compounding Pharmacists, the results of which were published
in the International Journal of Pharmaceutical Compounding Inhalation/respiratory 70
(IJPC).13 The investigators surveyed state boards of pharmacy for Surgical 69
reports of compounding problems related to instability of com- Other 25
pounded preparations and adverse reactions caused by compounded
preparations.
being pain management, dermatology, and hormone replace-
Methods ment therapy. The therapeutic categories reported least frequently
On July 31, 2006, the American College of Apothecaries (ACA) were parenterals, inhalation/respiratory preparations, and surgi-
electronically sent a self-administered questionnaire to 5,376 phar- cal preparations. Table 1 shows the numbers of respondents who
maceutical compounders, the list of which was provided by IJPC. reported having provided compounded preparations for each of
No subsequent reminders were sent to recipients. Respondents had the therapeutic categories listed. Some respondents listed classes of
the option of providing their name and pharmacy contact informa- compounds other than those included in the questionnaire, such as
tion but were not required to do so. Respondents were assured that pediatric preparations, adrenal and thyroid preparations, impotency
their responses would remain confidential throughout the study treatments, vitamins, cholesterol-lowering agents, nutraceuticals,
and this was accomplished by having only the researchers review prolotherapy treatments, sports medicine treatments, and agents for
the information provided by the respondents. Respondents also had clinical trials.
the option to mail or fax their responses to the ACA. We received
162 completed surveys, two of which were considered unusable: Prescribers of Compounding Services
one completed by a respondent who was not in practice, and one The surveyed pharmacists were asked to indicate how many
received by mail that was a duplicate of a previously faxed survey. In physicians made use of their compounding services. The major-
all, we received 160 usable surveys, for an overall response rate of ity of respondents reported having compounded for between 1
approximately 3.0%. Descriptive statistical analyses were conducted and 30 physicians. Table 2 provides a breakdown of the number of
to determine the practice characteristics of compounding pharma- physicians who made use of the respondent’s compounding services.
cists. Data were entered into a computer database by using Micro- Variation in responses depended at least in part on the nature of the
soft Visual FoxPro v. 9.0 and analyzed by using SPSS v. 11.5 (SPSS, respondents’ practice sites.
Chicago, Illinois). Letters were sent to 50 state boards of pharmacy The subjects were asked to indicate how many veterinarians
requesting reports of compounding problems (e.g., instability, made use of their compounding services. The majority of respon-
adverse reactions, irritation/stinging) they may have received from dents reported having compounded for between 1 and 20 veterinar-
prescribers, patients, or pharmacists over the last 12 months. ians. Table 2 provides a breakdown of the number of veterinarians
who made use of the respondents’ compounding services. Again,
Results variation in responses depended at least in part on the nature of the
Therapeutic Categories respondents’ practice sites.
The questionnaire asked pharmacists to indicate the therapeutic
categories for which they formulated compounded preparations Reported Problems
in their practice during the survey period. A total of 15 categories The survey asked what types of problems prescribers or
were reported by the respondents, the most frequently reported patients reported with regard to medications compounded in the

peer reviewed
FEATURE
IJPC
Table 2. Prescribers Using Respondents’ Table 3. Frequency of Reported Problems
Compounding Services. with Compounded Preparations.
Number of Physicians Number of Reported Problems Number of Reportsa
Who Used Compounding Respondentsa with Compounded
Services Preparations
None 2 None reported 59
1-10 15 Product instability 46
11-20 26 Irritation/stinging 39
21-30 35 Other 38
31-40 8 Adverse reactions 27
41-50 13 Description of Number of Reportsb
51-60 12 Instability
61-70 1 Separation or 11
71-80 1 breakdown of cream
81-90 2 or gel
91-100 6 Short expiration 8
101-200 11 Patient-related storage 7
201-300 7 and expiration
301-400 4 Precipitation/settling 6
401-500 2 Color/viscosity 4
≥ 501 11 changes
Number of Veterinarians Number of Temperature 4
Who Used Compounding Respondentsb related/storage
Services Formulation/potency 3
None 13 Other 7
1-10 80 Description of Number of Reports
11-20 30 Irritation/Stinging
21-30 7 Base sensitivity 10
31-40 1 Allergic reaction/ 10
41-50 5 rash/burning
51-60 3 Skin irritation 6
61-70 1 Agent-specific 5
71-80 0 sensitivity
81-90 1 Inhalation/injection 5
91-100 3 irritation
101-200 4 Ophthalmic irritation 3
201-300 3
301-400 3
401-500 0
It should be noted that the accuracy of the information reported
≥501 4 on problems associated with compounded preparations was limited
aFour
bTwo
survey respondents did not reply to this question. by the self-reported nature of these data. Table 3 details the prob-
survey respondents did not reply to this question.
lems reported within each category, including preparation instabil-
ity, irritation/stinging, adverse reactions, and “other.”
Services and/or Training Lacking in the Marketplace

respondent’s pharmacy. The most commonly reported problem was The survey asked about services or training for compounding
preparation instability. Adverse reaction to medication was the least pharmacists that were unavailable or not readily available in the
reported problem; however, respondents appeared to have reported marketplace. Overall, the most commonly cited deficit was training
some adverse reactions under the category of “irritation/stinging.” in the areas of legal and regulatory compliance and quality control.

IJPC peer reviewed
Table 3 Continued. Table 4. Deficits in Services and/or Training

Description of Number of Reportsc for Pharmacists.
Adverse Reaction Description of Number of Reports
Side effects 5 Service or Training
Base/excipient allergy 5 Legal/regulatory/ 11
Rash 5 compliance training
Allergic/hypersensitive 4 Accreditation/ 5
response certification
Other 5 Quality-control training 5
Description of Number of Reportsd Sterile compounding 4
Other Problems training
Product consistency 9 Continuing education 4
Product taste 6 Affordable training 4
Product efficacy 5 Stability testing/data 4
Packaging/container 4 Pharmacy school 3
Third-party 3 education
payment/pricing Basic training 3
Product ease of use 3 Technology/equipment 3
Short expiration 3 training
Product labeling 2 Marketing training 2
Other 5 Pricing/reimbursement/ 2
aTwo survey respondents did not reply to this question.
purchasing
bTotal number of reports here is greater (50) than the total number of reports Specialty compounding 2
listed for preparation instabilities in this table, as some respondents provided
more than one incident for a reported problem.
Basic sciences training 2
cTotal number of reports here is less (24) than the total number of reports Local training locations 1
listed for adverse reactions in this table, as some respondents did not provide
an example of a reported incident for a reported problem.
Disease-specific training 1
dTotal number of reports here is greater (40) than the total number of reports Advanced training 1
listed for the “other” category in this table, as some respondents provided
more than one incident for a reported problem.
Pediatric training 1
Business management 1
Retraining 1
Product safety 1
Table 4 lists the services and/or training that respondents reported Formulas 1
to be lacking in the industry, and the frequencies with which they
Patient information 1
reported these deficits.
Compounding with Sterile Powders and Powders that Meet

United States Pharmacopeia Endotoxin Limits Forty-two of 146 respondents reported purchasing powders
Subjects were asked to indicate their preferred means for that meet United States Pharmacopeia (USP) endotoxin limits
receiving information from pharmaceutical suppliers about sterile for their practice. Respondents reported most frequently purchas-
powders for compounding. Most respondents preferred to receive ing powders that meet USP endotoxin limits for intrathecal/pain,
information by Internet (81), mail (75), or fax (68), or by review- steroid, ophthalmic, IV antibiotic, and inhalation/respiratory
ing the manufacturer’s website (58); some respondents preferred to preparations
receive information by telephone (35), from a salesperson (33), or in
various other ways (e.g., catalog) (6). Number of Prescriptions
Fifty-three of 152 survey respondents who answered this ques- The survey asked the total number of prescriptions (including
tion indicated that they purchased sterile powders for their practice. those for compounded preparations) filled for the most recent fiscal
These respondents reported that they most frequently purchased year. On average, respondents filled 60,563 prescriptions (Table 6).
sterile powders for intrathecal/pain, intravenous (IV) antibiotic, Variation in responses depended at least in part on the nature of
ophthalmic, steroid, and inhalation/respiratory preparations respondents’ practice sites. Respondents filled an average of 7,434
(Table 5). compounded prescriptions during the same period (Table 6).

peer reviewed
FEATURE
IJPC
Table 5. Compounded Preparations Table 6. Numbers of Prescriptions and
for Which Sterile Powders and Powders Compounded Prescriptions Filled for the Last
that Meet USP Endotoxin Limits Were Fiscal Year.
Purchased. Prescriptions Filled Number of
Sterile Powders Number of Reports Respondentsa
Intrathecal/ 14 1-999 4
pain preparations 1,000-9,999 20
IV antibiotics 10 10,000-49,999 66
Ophthalmic 8 50,000-99,999 30
preparations ≥ 100,000 17
Steroid preparations 7 Compounded Number of
Inhalation/ 4 Prescriptions Filled Respondentsb
respiratory preparations 1-499 5
Chemotherapy 2 500-999 11
preparations 1,000-4,999 62
Impotence treatment 2 5,000-9,999 30
Other 16 10,000-14,999 11
Endotoxin-Free Number of Reports 15,000-19,999 3
Powders ≥20,000 13
Intrathecal/ 20 aTwenty-three
bTwenty-five
pain preparations
Steroid preparations 5
Ophthalmic preparations 3
IV antibiotics 2 Table 7. Total Revenue Reported for Last
Inhalation/ 2 Fiscal Year.
respiratory preparations Revenue (US$) Number of
Other 25 Respondentsa
Less than 250,000 13
250,000-499,999 12
Revenue 500,000-999,999 12
The survey included a series of questions about pharmacy rev- 1,00,000-1,499,999 15
enue in the last fiscal year. Overall, the total revenue reported by re-
1,500,000-1,999,999 13
spondents was evenly distributed between $250,000 and 3,499,999.
A few respondents reported total revenue between $3,500,000 2,000,000-2,499,999 22
and $4,999,999, while 35 respondents reported total revenues of 2,500,000-3,499,999 15
$5,000,000 or greater (Table 7). On average, prescription medica- 3,500,000-4,999,999 6
tions represented 83.8% of total sales, and 69% of the respondents ≥5,000,000 35
reported that prescriptions represented a minimum of 90% of total aSeventeen survey respondents did not reply to this question.
sales (Table 8). Respondents were requested to report the percent-
age of total revenue in their practice that was represented by the
sale of compounded prescription medications. On average, 36.2%
of total sales fell into this category (Table 8). infusion company (Table 9). While respondents’ professional
practice settings were collected for the purpose of comparing data
Pharmacy Settings among these practice settings, the large differences in the numbers
Respondents were requested to indicate the types of professional of respondents in each practice setting prevented the investigators
settings in which they practice, and the vast majority reported from completing this analysis.
practicing in an independent pharmacy or an independent phar-
macy that provides only compounding services. Other respondents Pharmacy Services
reported practicing in chain pharmacies, hospital or acute care Respondents were requested to indicate what types of profes-
facilities, nursing homes or long-term care facilities, or for a home sional pharmacy services they offered to their patients, and the most

IJPC peer reviewed
Table 8. Percentage of Total Revenue Table 9. Types of Professional Pharmacy

Represented by Prescription Sales and Practice Settings.
Compounded Prescription Sales. Setting Number of
Revenue (Percentage) Number of from Respondentsa
Prescriptions Respondentsa Independent pharmacy 102
<1.0 3 Independent pharmacy 38
1.0-9.9 3 (exclusively compounding)
10.0-19.9 2 Chain pharmacy 5
20.0-29.9 2 Hospital/acute care 5
30.0-39.9 2 (inpatient)
40.0-49.9 1 Hospital/acute care 1
50.0-59.9 1 (outpatient)
60.0-69.9 5 Hospice 0
70.0-79.9 7 Nursing home/ 1
80.0-89.9 15 long term care
90.0-99.9 76 Home infusion 4
100.0 17 Other 3
aOne survey respondent did not reply to this question.
Revenue (Percentage) Number of
from Compounded Respondentsb
Prescriptions
<1.0 1 Table 10. Number of Respondents Who
1.0-9.9 50 Provided Professional Pharmacy Services.
10.0-19.9 24
20.0-29.9 4 Professional Service Number of Reportsa
30.0-39.9 5 Face-to-face counseling 149
40.0-49.9 4 Patient profiles 136
50.0-59.9 1 Patient information 136
60.0-69.9 2 leaflets
70.0-79.9 3 Deliveries 118
80.0-89.9 6 Speaking to local 116
90.0-99.9 12 organizations
100.0 18 Patient appointments 93
aTwenty-six survey respondents did not reply to this question.
bThirty survey respondents did not reply to this question.
Hospice services 79
24-hour emergency 78
services
Refill reminder services 43
common were counseling, patient profiles, and patient information
Other services 14
leaflets. The services offered least frequently included 24-hour aOne survey respondent did not reply to this question.
emergency services, refill reminders, and hospice services. Other
services that respondents indicated offering included 24-hour refill
lines, blister packaging for nursing homes, charge accounts, custom-
ized flavoring, monthly lectures on health-related topics, multilin-
gual services, participation in advocacy groups, pill reminder boxes, services least commonly offered by respondents included anticoagu-
third-party intervention, and bioterrorism response training. Table lation, smoking cessation, and weight loss services. Other services
10 provides a breakdown of the frequency with which professional that respondents indicated offering included bacterial diagnostics,
services were offered by respondents. wholeness and wellness services, fitting for durable medical equip-
The types of special services the respondents most commonly ment, integrative care, multiple sclerosis counseling, probiotic and
offered to their patients were hormone replacement therapy (120), symbiotic therapy services, skin care services, transplant services,
pain management services (84), and diabetes care services (62). The growth hormone, osteoporosis, rheumatology, and psoriasis ser-

peer reviewed
FEATURE
IJPC
reported advertising their compounding services, 78.5% of 158
Table 11. Patient Care Specialty Services indicated that they advertise to physicians and/or veterinarians, and
Provided by Respondents. 72.3% of 159 indicated that they advertise to the general public.
Of the respondents who advertise their compounding services,
Professional Service Number of Reportsa 97 indicated that they employ some type of print medium such as
Hormone replacement 120 mailings, brochures, flyers, letters, magazine ads, newsletters, and/or
therapy postcards. Respondents also reported using newspaper, radio, direct
marketing to practitioners, television, and seminars. A small number
Pain management 84 of practitioners reported using a website, convention or exposition,
Diabetes care service 62 telephone book or Yellow Pages, and/or word of mouth to advertise
Nutrition services 45 their compounding services. Respondents also reported using on-
Immunizations 44 screen movie ads, on-hold music, phone messages, billboards, busi-
Cardiovascular services 40 ness cards, e-mail, and referral programs to advertise their services.
Asthma care services 36 A summary of the numbers of respondents who use different types
of advertising media is provided in Table 12.
Weight loss services 25 Of the respondents who did not advertise their compounding
Infertility services 23 services, the most common reason, cited by 17 respondents, was
Dyslipidemia services 21 that advertising was not necessary for their practice. Respondents
Smoking cessation 20 also indicated that advertising was not effective (7), that they were
Anticoagulation services 6 unsure how to market their services (6), or that state law restric-
Other 24 tions prevented them from advertising (5). Other reasons cited for
aTwo
not advertising their services were lack of time, contentment with
current compounding volume, new practice, and discomfort with
liability associated with advertising; some indicated they would
consider advertising their compounding services in the future.
State Boards of Pharmacy

Table 12. Types of Advertising Used To
Of 18 state boards of pharmacy that responded to our letter, five
Market Pharmacy. boards indicated that they were unable to disclose data due to lack
Type of Advertising Number of Reportsa,b of a mechanism for tracking compounding-related problems or
Print media, other 97 confidentiality pursuant to their regulations. Nine boards of phar-
Newspaper 68 macy reported no problems after inspection of their records. Three
Radio 34 boards of pharmacy each reported two unspecified complaints
with regard to compounding. One board of pharmacy reported the
Direct marketing to 31 dispensing of an incorrect infusion pump by an infusion pharmacy,
practitioners resulting in death.
Television 19
Seminars 11
Discussion
Website 5 This study was designed to characterize the safety and efficacy of
Expo/conventions/ 4 compounded preparations as self-reported by the pharmacists who
health fairs prepare them. The 2006 survey results, along with those of the 2005
Phonebook/Yellow Pages 3 survey,13 provided the investigators two years of data from which to
Word of mouth 2 identify trends in compounding pharmacy practice.
The problems reported to compounding pharmacists about their
Other 7
aOne
preparations for 2006 were similar to those reported in 2005. The
survey respondent did not reply to this question.
bTotalnumber of reports in this table is greater than the number of respon- most common problems reported in 2006 were related to prepara-
dents who reported to advertise their services, as most respondents reported tion instability, irritation and stinging at application sites, or other
using more than one type of advertising. problems such as preparation consistency, taste, or efficacy, and
packaging/container issues. While 27 respondents reported adverse
reactions, we did note that such incidents were reported under the
category of “irritation/stinging.” Results of this particular question
vices. Table 11 provides a breakdown of the frequency with which
should be interpreted with caution, as these reports are subject to
patient care specialty services were offered.
respondents’ interpretation of reported problems and perception of
Advertisement of Compounding Services their severity.
Respondents were requested to indicate whether they advertise As in 2005, the top therapeutic categories for which our re-
their compounding services to practitioners (physicians and/or spondents formulated compounded preparations included pain
veterinarians) and the general public. Of those respondents who management, dermatology, and hormone replacement therapy.

IJPC peer reviewed
Respondents reported compounding for between 1 and 50 physi- pcab.html. Accessed December 5, 2006.
cians and between 1 and 15 veterinarians. In the 2006 survey, 120 2. McPherson TB, Fontane PE, Jackson KD et al. Prevalence of
respondents reported providing hormone replacement therapy as a compounding in independent community pharmacy practice. J
patient care specialty service. Pain management and diabetes care Am Pharm Assoc 2006; 465: 568–573.
followed as the second and third most frequently provided services 3. Galson SK. U.S. Food and Drug Administration. Statement by
in 2006, while they were the first and second most common services Steven K. Galson, M.D., M.P.H., Acting Director, Center for
offered in 2005. Counseling, patient profiles, and patient informa- Drug Evaluation and Research, U.S. Food and Drug Admin-
tion leaflets were the most frequently provided professional services istration, Department of Health and Human Services, Before
in 2006, the same as in 2005. the Senate Committee Hearing on Health, Education, Labor,
Legal, regulatory, and compliance training were the most com- and Pensions Hearing on “Federal and State Role in Pharmacy
monly cited deficits reported by the respondents. These increases Compounding and Reconstitution: Exploring the Right Mix to
in frequency relative to the 2005 survey may be due, in part, to the Protect Patients.” [U.S. Food and Drug Administration Web-
increasing attention paid by the FDA and the pharmacy profession site.] October 23, 2003. Available at: www.fda.gov/ola/2003/
to the regulatory debate surrounding pharmacy compounding. pharmacycompound1023.html. Accessed September 5, 2005.
Average numbers of total prescriptions and compounded pre- 4. Heppe CA. Warning Letter. [U.S. Food and Drug Administra-
scriptions filled were 60,563 and 7,434, respectively. These totals tion Website]. August 9, 2006. Available at: www.fda.gov/foi/
were up from 45,522 total prescriptions and 6,055 compounded warning_letters/g5964d.htm. Accessed December 6, 2006.
prescriptions reported in the 2005 survey. Not surprisingly, inde- 5. Allen LV Jr. Letter from the Editor: Four White Papers.
pendent pharmacists (including those who exclusively compound) Reasons the FDA Should Not Be Involved in Pharmacy
represented 87.5% of respondents, a number representative of the Compounding. [CompoundingToday.com Website.] April 14,
estimated 90% of IJPC subscribers who practice as independent 2005; 2: 13. Available at: http://compoundingtoday.com/White-
pharmacists.13 Papers/doc/Reasons_FDA_Not_Involved Compounding.pdf.
Respondents’ reports of revenue were evenly distributed among Accessed December 6, 2006.
the revenue categories, with the exception of six respondents 6. Paul R. Compounding caught in federal crosshairs. [Drug Top-
reporting total revenues between $3,500,000 and $4,999,000 and ics Website.] October 9, 2006. Available at: www.drugtopics.
35 respondents reporting total revenue exceeding $5,000,000. The com/drugtopics/article/articleDetail.jsp?id=376023. Accessed
distribution among the revenue categories also was even in 2005. December 5, 2006.
On average, 83.8% of respondents’ total revenue was represented 7. [No author listed.] PCAB principles of compounding. [Phar-
by sales of all prescription medications and 36.2% by sales of com- macy Compounding Accreditation Board Website.] Available at:
pounded prescription medications, up from the 78.1% and 34.6% www.pcab.info/. Accessed December 6, 2006.
reported in the 2005 survey. 8. [No author listed.] PCAB standards with compliance indicators.
[Pharmacy Compounding Accreditation Board Website.] Avail-
Limitations able at: www.pcab.info/. Accessed December 6, 2006.
Readers are cautioned when attempting to generalize the results 9. [No author listed.] Find a Pharmacy. [Pharmacy Compounding
of this study to all compounding pharmacists, as the generalizability Accreditation Board Website.] Available at: www.pcab.org/find-
of these results is affected by the low response rate of this survey a-pharmacy.html. Accessed December 7, 2006.
and the nonresponse bias inherent in survey research. That said, it 10. Ukens C. Compounding R.Ph.s get labeling guidelines.
is possible that similarities between 2005 and 2006 survey results February 20, 2006. [Drug Topics Website.] Available at: www.
are a function of similarities among respondents for both surveys. drugtopics.com/drugtopics/article/articleDetail.jsp?id=307593.
Comparisons between the two years’ survey results should be Accessed December 5, 2006.
interpreted with caution because of the small sample sizes. Finally, 11. [No author listed.] IACP recommended labeling for medica-
readers should interpret the results of this study knowing that the tions compounded for human use. [International Academy of
data were collected via self-report, making them vulnerable to social Compounding Pharmacists Website.] Available at: www.iacprx.
desirability bias. org/site/DocServer/IACP_Labeling_Guidelines-FINAL.
pdf?docID=902. Accessed December 7, 2006.
12. [No author listed.] IACP recommended labeling for medica-
Conclusion tions compounded for office use by human patients. Available
In general, respondents reported relatively few adverse events at: www.iacprx.org/site/DocServer/IACP_Labeling_Guidelines
associated with the more than 1 million compounded prescrip- Office_Use_FINAL.pdf?docID=901. Accessed December 7,
tions represented in this survey. Respondents, most of whom were 2006.
independent pharmacists, reported offering a variety of compound- 13. Huffman DC, Holmes ER. Specialty compounding for im-
ing, professional, and specialty care services. Trends identified in the proved patient care: A national survey of compounding pharma-
2006 survey of compounding pharmacy were very similar to those cists. IJPC 2006; 10(6): 462–468.
reported in the 2005 survey.
Address correspondence to D. C. Huffman, RPh, PhD, Executive
References Director, Research & Education Foundation, American College of
1. [No author listed.] About PCAB. [Pharmacy Compounding Ac- Apothecaries, 2830 Summer Oaks Drive, Bartlett, TN 38134-3811.
creditation Board Website.] Available at: www.pcab.org/about- E-mail: [email protected]

peer reviewed
FEATURE
IJPC
Room Temperature Stability of Injectable
Succinylcholine Dichloride
Julie J. Roy, BPharm, MSc, PhD Abstract

S.M.B.D. – Jewish General Hospital The purpose of this study was to determine the room temperature stability over
Montreal, Quebec, Canada a period of several months of commercially available intravenous succinylcho-
line dichloride (Quelicin, 20 mg/mL) in vials. A previously validated electro-
Daniel Boismenu, BSc, PhD spray tandem mass spectrometry method developed for the determination of
Orval A. Mamer, PhD succinylcholine dichloride in plasma was used. This method was based upon a
McGill University
stable isotope dilution assay using hexadeuterosuccinylcholine diiodide as the
Montreal, Quebec, Canada
internal standard and was shown to be specific, sensitive, and reproducible. Cal-
Bao T. Nguyen, BPharm, MSc ibration curves were plots of the ratios of intensities of the major product ions
Jean-Marc Forest, BPharm, MSc in the collision-induced dissociation spectrum for known concentration ratios
Sainte-Justine Hospital of succinylcholine dichloride and hexadeuterosuccinylcholine diiodide in solu-
Montreal, Quebec, Canada tions. The concentration of succinylchloline dichloride was shown to decline
linearly. After 1, 3, and 6 months at room temperature, the vial contents retained
Patrice Hildgen, DPharm, PhD approximately 98%, 95%, and 90% of their initial concentrations, respectively.
University of Montreal We suggest, therefore, that succinylcholine dichloride can be stored safely at
Montreal, Quebec, Canada room temperature under normal daylight for 6 months.
Introduction
Succinylcholine dichloride (SUX) is a neuromuscular depolariz- Equipment
ing blocking agent used in endotracheal intubation to produce skel- A Quattro II triple quadrupole (Micromass, Manchester, United
etal muscle relaxation. Its rapid onset of action (less than 1 minute) Kingdom) was configured for direct infusion, positive product ion
makes SUX a good choice in emergency situations when intubation analysis and used with the cone voltage set to 17V, source tempera-
must be performed promptly. It is currently part of many hospital ture 100oC, sample infusion rate 40 mcL/minute, nitrogen bath
emergency crash carts. The product monograph recommends that gas flow rate 150 L/h, and collision cell energy 14 eV with argon
SUX be refrigerated to prevent degradation, and states that the pressure 1 × 10-3 mbar. The spectrometer was programmed to scan
product is stable for up to 14 days at room temperature.1 Unfor- for the product ions of SUX and SUXd6 from m/z 110 to m/z 155
tunately, emergency carts are usually not equipped with refrigera- in multichannel acquisition mode.
tors. Therefore, the purpose of this study was to assess the stability
of SUX solutions at room temperature over time to determine
Preparation and Analysis of Calibration Solutions
whether the commercially available vials could be kept longer than
Tetramethylammonium chloride buffer (TMA, 10 mM) was
recommended at room temperature without significant deteriora-
prepared by dissolving 0.2756 g of TMA in water (1 mL), to which
tion of the drug. Figure 1 shows the chemical structure of SUX.
240 mL of methanol was added. The apparent pH was then ad-
justed to 3.0 with hydrochloride (0.1 M) and the volume was made
Materials and Methods up to 250 mL with methanol. This solution was filtered through an
Chemicals and Reagents appropriate 0.2-mcm membrane (Type HVLP, Millipore; Wa-
All the chemicals and reagents, which were purchased from Fish- ters Associates, Milford, Massachusetts). Stock solutions of SUX
er Scientific (Montreal, Canada), were United States Pharmacopeia standard (1 mg/mL) were prepared in the TMA buffer and kept
or analytical grade and were used without further purification. The in glass at 4oC. Working solutions were prepared fresh by diluting
SUX 20-mg/mL vials were manufactured by Abbott Laboratories the stock solution with a 50% acetonitrile solution in water. Stock
(Lot 74032NJ, Quelicin; Montreal, Canada). The hexadeuterosuc- and working solutions of SUXd6 were prepared similarly. The final
cinylcholine diiodide (SUXd6) internal standard was synthesized calibrating solutions were made with constant amounts of SUXd6
as described elsewhere.2 Figure 2 shows the chemical structure of internal standard and nine SUX concentrations ranging from 25
SUXd6. ng/mL (designated the lower limit of quantitation) to 4000 ng/mL

IJPC peer reviewed
in TMA buffer. Water used for each calibration curve was analyzed and the solution was infused into the mass spectrometer for analysis
and shown to be free of interference. Quality-control samples as already described.
were prepared by spiking TMA buffer with SUX stock solutions to
obtain final concentrations of 90, 150, or 750 ng/mL.
Acquisitions were made in multichannel analysis mode over Results
the range m/z 110 to 155 during 4 minutes of sample infusion. Table 1 presents the stability data for commercial SUX 20-mg/
Product ions m/z 115.5 and m/z 117.0 were monitored for SUX mL in vials left at room temperature for up to 14 months. Two vials
and SUXd6, respectively, which corresponds to the loss of one of were analyzed for each time point except day 114; one of the two
the amine functions as neutral trimethalymine.2 Calibration curves vials for this time point was broken during manipulation. The mean
were generated from the nine TMA calibration samples by plotting concentrations ± standard deviation are presented, as well as the
the intensity ratios of product ion m/z 115.5 (unlabeled) over prod- mean percentages of the initial mean concentration.
uct ion m/z 117.0 (labeled) against the concentration of unlabeled Figure 3 shows the mean percentage of SUX remaining at each
SUX. Linearity was assessed by weighted least-square regression time point relative to the initial mean concentration. Figure 3 also
of the ratios of the analyte to the internal standard peak intensities shows the results of the linear regression that was applied to the
against the corresponding analyte concentrations. data. The linear regression equation shows that at least 90% of the
initial concentration remained after 188 days or 6 months at room
Analysis of Study Samples temperature in accord with United States Pharmacopeia 28–Na-
Every month during the year preceding the day of analysis, two tional Formulary 23 recommendations.3
vials of 20-mg/mL SUX were taken out of the refrigerator and held
at room temperature until the analytical day. The vials were not Discussion
protected from normal ambient room light. All vials were analyzed Since drugs stored in emergency carts are left on wards for
on the same day. On the day of analysis, an aliquot was taken from immediate use, their stability under these conditions, especially
each vial and diluted 1 in 100,000, the internal standard was added, at room temperature, is of utmost importance. Knowledge of the
Figure 1. Chemical structure of succinylcholine dichloride.
CH 3 O
H 3C
H 3C N O
CH 3 , 2Cl-
O N
H 3C
CH 3
O
Figure 2. Chemical structure of hexadeuterosuccinylcholine diiodide.
CD 3 O
H 3C
H 3C N O
CH 3 , 2I-
O N
H 3C
CD 3
O

peer reviewed
FEATURE
IJPC
drugs’ room temperature stabilities permits optimal scheduling of wards for as long as possible while ensuring the safety and potency
when the carts have to be returned to the pharmacy for replace- of the drugs.
ment of the stocked drugs; the ideal, of course, is to leave carts on There is disagreement in the literature concerning the stability
of SUX at room temperature. In most cases, the reported stability is
very short. Trissel reports a 3-month room temperature stability for
SUX (Quelicin, Abbott Laboratories, Limited),4 while the product
Table 1. Stability of Succinylcholine Dichloride monograph reports a room temperature stability of up to 14 days.
(20 mg/mL) in Vials Left at Room Temperature. The method used here to determine SUX concentrations was
previously shown to be specific, sensitive, and reproducible.2 The
linear regression equation, obtained by using the results for all
Time at Room Mean Percentage
the individual vials analyzed, shows that SUX retains at least 90%
Temperature Concentration of Initial of its initial concentration for 6 months; this meets United States
(Days) ± SD (ng/mL) Concentration Pharmacopeial Convention, Inc., guidelines that a drug is stable
0 152.7 ± 0.3 100 as long as it retains at least 90% of its label concentration.3 The
18 152.6 ± 1.3 99.9 manufacturer’s recommendation for storage at room temperature is
46 156.0 ± 4.7 102.2 very conservative and could be extended, as this study demonstrates.
Our study does not consider the effect on stability of repeated and
81 149.6 ± 4.6 97.9
occasional sampling from the vials.
114 143.7 ± NA 94.1
139 144.7 ± 1.2 94.7
Conclusion
171 136.2 ± 3.2 89.2 The stability of SUX 20 mg/mL manufactured by Abbott Labo-
200 137.7 ± 9.1 90.2 ratories retained at least 90% retention of its initial concentration
231 131.6 ± 6.8 86.2 after 6 months storage unopened at room temperature.
259 137.0 ± 1.1 89.7
293 131.6 ± 7.3 86.1 Acknowledgment
322 124.9 ± 1.4 81.8 The authors acknowledge Abbott Laboratories Limited for its
354 117.7 ± 4.2 77.0 support of this study.
384 122.8 ± 0.5 80.4
NA = not available References
SD = standard deviation 1. Succinylcholine Chloride Injection USP (Quelicin) [product
monograph]. Saint-Laurent, Québec, Canada: Abbott Laborato-
ries, Limited. January 2000.
2. Roy JJ, Boismenu D, Gao H et al.
Measurement of succinylcholine con-
110 centration in human plasma by electro-
100
spray tandem mass spectrometry. Anal
Biochem 2001; 290: 238–244.
90
3. United States Pharmacopeial Conven-
Percent Remaining
80
tion, Inc. United States Pharmacopeia
g
in
70 28–National Formulary 23. Rockville,
n
i
a 60 MD: US Pharmacopeial Convention,
m
e 50 Inc.; 2004: 3187.
R y = -0.053 x + 100 4. Trissel LA. Handbook on Injectable
% 40 2
R = 0.9107 Drugs. 13th ed. Bethesda, MD: Ameri-
30
can Society of Health-System Pharma-
20 cists; 2005: 1360.
10
0 Address correspondence to Julie J. Roy,
0 50 100 150 200 250 300 350 400 450 PhD, Pharmacy Department, S.M.B.D.
Da y s
Jewish General Hospital, 3755 Côte-Ste-
Days at Room Temperature Catherine, Montreal, Quebec, H3T 1E2,
Canada. E-mail: [email protected]
Figure 3. Mean percentage of succinylcholine dichloride

concentration remaining in vials left at room temperature.

IJPC peer reviewed
Scientific and Professional Reviewers for 2007

The International Journal of Pharmaceutical Compounding (IJPC) expresses its sincere appreciation for the
efforts of its scientific and professional reviewers for the year 2007. Most of these reviewers also serve as review-
ers for other journals, so we are especially grateful for their efforts and interest in helping IJPC maintain a high
standard of excellence.
Kenneth S. Alexander, PhD Alekha K. Dash, RPh, PhD Maria P. Lambros, PhD
Professor Professor and Chair Associate Professor
College of Pharmacy Department of Pharmacy Sciences College of Pharmacy
The University of Toledo School of Pharmacy and Health Professions Western University of Health Sciences
Toledo, Ohio Omaha, Nebraska Pomona, California

Hassan Almoazen, PhD Kevin C. Farmer, PhD William Letendre, MS, RPh, MBA
Assistant Professor of Pharmaceutics Associate Professor Vice President
University of Tennessee College of Pharmacy Pharmacy Management Services
Department of Pharmaceutical Sciences University of Oklahoma Professional Compounding Centers of
Memphis, Tennessee Oklahoma City, Oklahoma America
Houston, Texas
Ajay K. Banga, PhD Vishnu D. Gupta, PhD Karen M. Nagel, PhD

Professor and Chairman Pharmaceutics Division Associate Professor
Department of Pharmaceutical Sciences University of Houston Chicago College of Pharmacy
Mercer University Houston, Texas Midwestern University
Atlanta, Georgia Dowers Grove, Illinois
Jamie G. Barnhill, PhD Jeffrey Hughes, PhD Dana Reed-Kane, PharmD, FIACP,
Associate Professor Professor, Graduate Coordinator FACA, FCP, NFPPhC
College of Pharmacy Department of Pharmaceutics Reed’s Compounding Pharmacy
University of New Mexico College of Pharmacy Tucson, Arizona
Albuquerque, New Mexico University of Florida
Gainesville, Florida
Rasma S. Chereson, PhD Ronald L. Koch, PhD Dennis F. Thompson, PharmD,

Professor Associate Professor FASHP, FCCP
St. Louis College of Pharmacy College of Pharmacy Associate Dean, Professor and Chair
St. Louis, Missouri University of Illinois at Chicago Southwestern Oklahoma State University
Chicago, Illinois Oklahoma City, Oklahoma
Adnan Dakkuri, PhD Chandra Sekhar Kolli, PhD Christy Wyandt, PhD
Professor Post Doctoral Scholar Professor/Associate Dean
College of Pharmacy Mercer University Graduate School
Ferris State University Atlanta, Georgia School of Pharmacy
Big Rapids, Michigan The University of Mississippi
University, Mississippi

f mula I i n p I c ip I i n
I
I
I andafordthe pe
Consumer Options a I ing
Disposal p cedu
of Unused e
Medications
I
Jane Vail sector involved with the production, prescription, consumption,
St. Louis, Missouri
ba ic f c mp unding
This issue of the International Journal of Pharmaceutical Com-
and disposal of pharmaceuticals is responsible for ensuring that the
disposal of unwanted drugs is managed safely.
Pharmacists who participate in the Green Pharmacy Program
pounding includes an article discussing options for the disposal of offer to members of their community the free, safe disposal of

expired drugs and chemicals by compounding pharmacists. Of equal unwanted medications of the following types: prescription drugs
importance, however, is the availability to consumers of environ- (except for controlled medications), all over-the-counter medica-
I
I
I
I
I
mentally safe methods for discarding unused medications. Com- tions, vitamins, medication samples, empty inhalers, medicated
pounders can play a key role in that effort. By following guidelines ointments and lotions, liquid medications in glass or leakproof
for the management of unused medications published by the federal containers, pet medications, and homeopathic remedies. Consumers
p e c ip I i n
government and by organizations such as the Teleosis Institute,
which promotes the concept of “green pharmacy,” pharmacists can
who are interested in the safe disposal of unwanted pharmaceuticals
are advised by Teleosis to do the following:
I
work effectively with prescribers and consumers to reduce the level • Check into whether a community pharmaceutical take-back pro-
of pharmaceutical waste in the environment. Those guidelines are
calcula I i n
gram is in place and drop off unused medications at the specified
summarized here for easy reference. site. To find a take-back program in a specific area, contact the
Office of National Drug Control Policy: Guidelines for

I nearest county water agency or local household hazardous waste
disposal center, both of which can be found online or by consult-
ma ke I ing
the Disposal of Prescription Drugs by Consumers ing a pharmacist.
In February 2007, the Office of National Drug Control Policy • If an unused medication cannot be accepted by a take-back pro-
I
in Washington, DC, published a press release1 presenting the fol- gram or household hazardous waste disposal center or if those
lowing guidelines for the proper disposal of prescription drugs by resources are unavailable, do not flush the medication down the
consumers. In that press release, Environmental Protection Agency toilet or wash it down the sink; landfill disposal options are bet-
(EPA) Administrator Stephen L. Johnson stated, “While EPA con- ter.
I
tinues to research the effects of pharmaceuticals in water sources, • If a medication must be discarded in the trash, then mix that
I
I
one thing is clear: improper drug disposal is a prescription for en- product with cat litter, coffee grounds, or something that is dis-
vironmental and societal concern. Following these new guidelines tasteful and will discourage people and animals from consuming
will protect our Nation’s waterways and keep pharmaceuticals out it; then add that mixture to the garbage.
of the hands of potential abusers.” • Become familiar with local legislation regarding disposal of
• Take unused, unneeded, or expired prescription drugs out of expired or unused medications.
their original containers. • Contact a pharmacist or physician about starting a pharmaceuti-
• Mix the prescription drugs with an undesirable substance, such cal take-back program. The Teleosis Institute is happy to supply
as used coffee grounds or kitty litter, and put them in imperme- information about initiating a Green Pharmacy Program.
able, nondescript containers, such as empty cans or sealable bags, • Remember the high cost of unused or expired medications. In
further ensuring that the drugs are not diverted or accidentally one month in just one location, Teleosis collected unusable
ingested by children or pets. medications that totaled about $4,000 in value. Better and more
I
I
• Throw these containers in the trash. judicious prescribing practices and emphasis on preventive
• Flush prescription drugs down the toilet only if the accompany- medicine will reduce that financial loss and promote personal
ing patient information specifically instructs that it is safe to do wellness.
so. Because compounders provide such a unique service to and work
• Return unused, unneeded, or expired prescription drugs to so closely with their clients, they can be instrumental in suggesting
pharmaceutical take-back locations that allow the public to bring practical and effective methods for disposing of expired or unused
unused drugs to a central location for safe disposal. medications. In so doing, they will protect their community and
safeguard the environment.
Teleosis Institute: Recommendations for Disposal of
Unused Medications by Consumers Reference
The Teleosis Institute of Berkeley, California, has implemented 1. de Vallance J. Federal government issues new guidelines for
in the San Francisco Bay area a popular program that helps com- proper disposal of prescription drugs: What every American
munities divert unnecessary pharmaceutical waste from the envi- can do to prevent misuse of prescription drugs [press release].
ronment. Part of that effort involves the Green Pharmacy Pollution Washington, DC; February 20, 2007. Available at: www.white-
Prevention Campaign, which has a goal of zero pharmaceutical housedrugpolicy.gov:80/news/press07/022007.html. Accessed
waste in the environment. The Green Pharmacy Program involves November 21, 2007.
partnership with local pharmacies, health professionals, and public For additional information contact Jane Vail. E-mail: janevail@
and private organizations, and it supports the concept that every sbcglobal.net

I
I J P C S u bscription and A dv ertisers :
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IFC
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No. 1092-4221, is published 6 times per year by International Journal of
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J A NU A R Y / F E B R U A R Y 2 0 0 8

28 Hospice and Compounding Pharmacy: Once

50 Quality-Control Analytical Methods:

63 Standard Operating Procedure:

Peer Reviewed Departments INTERNATIONAL JOURNAL

74 Specialty 4 PreScription PHA RMACEUTICAL

Stability of Injectable Designer

DANIEL BOISMENU, BSC, PHD

64 Cyclosporine Topical Gel ( Adverti si ng )

66 Diclofenac Sodium 1% Soft-Patch Lipophilic Gel ( Board of Di recto rs )

( Edi tori al Boa rd )

International Journal of Pharmaceutical Compounding www.ijpc.com

International Journal of Pharmaceutical Compounding www.ijpc.com

The International Journal of Pharmaceutical Compounding proudly announces a new

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{ ONE PATIENT. ONE PHYSICIAN. ONE PHARMACIST. }

A patient’s needs often require the combined efforts of several caring

The triad relationship between patient, pharmacist and physician —

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www.ijpc.com International Journal of Pharmaceutical Compounding

w r i tt e n b y jean G. dib, bspharm, p h a rmD; s au d a b du lmoh s i n , B sp ha r m , m s

sau di aramco medical services or g an ization , dhahr an , s au di ar abi a

www.ijpc.com International Journal of Pharmaceutical Compounding

International Journal of Pharmaceutical Compounding www.ijpc.com

www.ijpc.com International Journal of Pharmaceutical Compounding

International Journal of Pharmaceutical Compounding www.ijpc.com

Note: This formulation should be prepared by using strict

www.ijpc.com International Journal of Pharmaceutical Compounding

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Compounding Horizontal Laminar Vertical Laminar Biological

The Affordable Solution

11 Aviator Way, Ormond Beach, FL 32174 800.888.5357 www.GERMFREE.com

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Address correspondence to LaVonn A. Williams, Production Man-

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Clinical trials: Medical research studies conducted with

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International Journal of Pharmaceutical Compounding www.ijpc.com

Side effects: Unwanted effects of treatment. Examples

Staging: The process of finding out whether cancer has spread

Stent: A device that is inserted to support and hold open a tube-

www.ijpc.com International Journal of Pharmaceutical Compounding

Glossary of Common Forms of Cancer

International Journal of Pharmaceutical Compounding www.ijpc.com

Germ cell tumor: Tumors of the ovary or testis that are

Hepatoblastoma: An uncommon malignant liver neoplasm

Leukemia: A cancer of the blood cells or the cells that become

Malignant melanoma: A cancerous tumor that begins

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Glossary of Cancer-Related Physicians, Surgeons,

Pain specialist: Oncologist, neurologists, anesthesiologists,

International Journal of Pharmaceutical Compounding www.ijpc.com

Polypectomy: Surgery to remove a polyp

Prophylactic mastectomy: A mastectomy done before

Prostatectomy: Surgical removal of all or part of the pros-

Quadrantectomy: A partial mastectomy in which the quar-

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Glossary of Cancer-Related Procedures, Therapy,

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Written By_ Date_______

Authorized By Date ________