PRACTICE STANDARDS

SHPA Standards of Practice for the Provision

of Clinical Oncology Pharmacy Services
The Society of Hospital Pharmacists of Australia
Committee of Specialty Practice in Oncology

These are standards o f professional practice and not standards prepared or endorsed
by the Standards Association o f Australia. They are not legally binding.

INTRODUCTION well as community health professionals, patients and

These standards describe activities consistent with good their carers is the basis of successful clinical practice.
practice for the provision of clinical pharmacy services The oncology pharmacist should actively participate in
to an oncology unit. An oncology unit is defined as any all clinical activities such as ward rounds, ward meet­
unit caring for patients with malignancy. An oncology ings, case presentations, journal clubs and lectures.
unit includes oncology, haematology, bone marrow trans­ The oncology pharmacist should review all patients’
plant, palliative care and radiation therapy. The pharma­ medications as set out in SHPA guidelines.2 The oncolo­
cist responsible for the overall service to an oncology gy pharmacist should also liaise with the cytotoxic man­
unit is referred to as the oncology pharmacist. ufacturing service to coordinate the supply of cytotoxic
These standards supersede previously published chemotherapy.
Society of Hospital Pharmacists of Australia (SHPA) The oncology pharmacist must collaborate with oth­
‘Standards of Practice for the Oncology Pharmacist’.1 er health professionals in pursuing optimal drug therapy
They must be read in conjunction with developed stand­ for patients with cancer. This requires that the oncology
ards of practice relating to clinical pharmacy services, pharmacist collect and interpret pertinent clinical data,
and technical aspects involved in the safe handling of and assume professional responsibility for optimising
cytotoxic chemotherapy in pharmacy departments.2'3 drug therapy outcomes. Each patient of the service must
The director of pharmacy services is responsible for have a defined pharmaceutical care plan. The oncology
ensuring the implementation of these standards within pharmacist must be able to:
each institution. • collect and assess current and past patient and fam­
ily information necessary to design a pharmacother-
OBJECTIVES apeutic plan;
These standards describe the minimum requirements for • establish therapeutic goals in collaboration with the
a clinical service to an oncology unit. The standards patient and other professionals;
offer guidance for: • recommend, design and modify a therapeutic plan
1. optimal pharmaceutical care to patients; for identified patient-specific problem(s) through the
2. the minimum requirements for an oncology pharma­ integration of pathophysiological, pharmacothera-
cist; peutic, pharmacokinetic, pharmacodynamic, econom­
3. staff, training, education and quality aspects of the ic, and ethical considerations;
service. • recommend, design and implement a monitoring plan
These standards can be considered the minimum (e.g. follow-up assessment, adverse effect evalua­
accepted practice, which should be applied nationally. tion, physical assessment, laboratory assessment,
rating instruments, frequency and duration of fol­
EXTENT AND OPERATION OF THE SERVICE low-up);
Clinical Services • assess outcomes relative to therapeutic goals (e.g.
The pharmacy must offer the clinical service to all inpa­ effectiveness, drug-related problems, compliance);
tients and outpatients of the oncology unit. The phar­ • predict and recommend ways to prevent potential
macy department should make the service available seven drug-related problems, and identify and suggest
days a week. ways to resolve actual drug-related problems;
The pharmacist must work as a member of the health­ • effectively document and communicate findings and
care team. The establishment of a good working rela­ recommendations regarding pharmacotherapeutic
tionship with medical, allied health and nursing staff, as treatm ent with other professionals, patients and
family.
The information in the care plan must be detailed,
relevant and readily accessible. Pharmacists must have
The Society o f Hospital Pharmacists o f Australia Committee o f Specialty
Practice in Oncology: Jill Davis (Chair), Stuart Harsley, Robert easy and ready access to patient demographics, height,
McLauchlan, Li-ling Ng, Sheue-Ching Ooi, Jim Siderov, Angela weight, body surface area, treating physician, disease
Stefanou, Sue Kirsa (Convenor) and stage, chemotherapy protocol drugs and doses, goal
Address for correspondence: Jill Davis, Pharmacy Department, Austin &
Repatriation Medical Centre, 145-163 Studley Road, Heidelberg Vic. 3084
of treatment (i.e. adjuvant, neo-adjuvant, curative, palli­
E-mail: [email protected] ative), relevant laboratory m easurem ents, signs and

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symptoms of toxicity, preferred supportive care thera­ statistics, recommendations for the cost-effective use
pies (e.g. analgesics, antiemetics), allergies, adverse drug of drugs, and information on patient parameters,
reactions, cumulative drug doses where appropriate (e.g. pharmacy interventions, and medication errors.
anthracyclines, bleomycin, carmustine), past and cur­
rent medications. The information must be kept up to RESOURCES
date and referred to prior to every dispensing of chemo­ The oncology pharmacist should be provided with suf­
therapy in order to integrate all treatment. ficient staffing to run the service. Adequate support staff
The oncology pharm acist must contribute to the should also be made available to ensure that minimal
design of chemotherapy and supportive care protocols. non-clinical activities are performed by clinical pharma­
The use of well established chemotherapy protocols must cists.
be encouraged. Deviation from these standard proto­ Adequate office and storage space must be made
cols must only occur in consultation with the senior available for patient profiles, protocol books, and other
medical officer responsible for the patient. references required by the oncology pharmacist. A li­
The oncology pharmacist must be able to interpret, brary of reference and educational material should be
generate and/or disseminate knowledge in oncology as collated and maintained. This must include the referenc­
it applies to oncology pharmacy practice. In order to es listed in Appendix 2. The oncology pharmacist should
adequately fulfil this requirement the oncology pharma­ also have easy access to appropriate oncology and hae­
cist must be able to: matology journals (Appendix 3), and should have direct
• retrieve and evaluate the relevant oncology litera­ access to both e-mail and the Internet (Appendix 4).
ture; The oncology pharmacist should be provided with
• integrate new information with existing information sufficient resources to obtain formalised accreditation
to establish recommendations for clinical use; and/or training.
• provide education and medication-related counsel­
ling to patients, families, and caregivers and assess STAFFING STRUCTURE AND LEVELS
the effectiveness of these activities; There should be one individual responsible for the coor­
• provide formal and informal education and consul­ dination of all aspects of the service. Continuity of per­
tation to the professional community and assess the sonnel in the provision of the service is essential to
effectiveness of these activities. facilitate the achievement of this objective. Notwithstand­
The oncology pharmacist must be involved in the ing the above, aspects of the service may be delegated
preparation of any patient information leaflets which are to other pharmacists to ensure appropriate operation of
given to patients to aid in counselling. Counselling with the service.
the provision of patient information leaflets should be The primary consideration for staffing structure and
provided to patients with regard to cytotoxic chemo­ levels is the provision of patient-focused pharmaceuti­
therapy, supportive care and adverse effects. Advice cal care.2 To maintain a comprehensive service for effec­
on recognising and minimising potential delayed side tive full-tim e pharm acist input (38-hour w eek), a
effects is an essential component of this counselling suggested bed to pharmacist ratio is outlined in Table 1.
process.
Table 1. Suggested staffing ratios
Administrative Services
The administrative duties of the oncology pharmacist Ratio of beds
are those activities required for the management, organ­ per 1 EFT
isation and ongoing development of the clinical service. pharmacist Bed description
This includes: 75 Radiation Oncology
• preparation and annual review of a written policy
and procedure manual for the provision of a clinical 50 Palliative Care
service to oncology patients. Where possible this
20-25 Medical Oncology
should be done in conjunction with the pharmacist
responsible for the provision of clinical pharmacy 10-15 Haematology/Bone Marrow Transplant Service
services to the entire institute;
• development and maintenance of a quality assur­
ance program for the provision of clinical services These ratios must consider other factors such as
to the patients of the oncology unit. Quality indica­ patients attending outpatient clinics and day therapy.
tors are included in Appendix 1; Separate specialised oncology pharmacists for paediat­
• the supervision of unqualified staff as well as the ric oncology, and bone m arrow transplant services
provision of direction and education to pharmacy should be considered.
undergraduates, trainees, and pharmacists with less
experience in the provision of pharmacy services to TRAINING AND EDUCATION OF STAFF
oncology patients; The oncology pharmacist must have adequate educa­
• assessment of company-printed materials and pa­ tion and training in clinical oncology pharmacy practice.
tient aids to determine their applicability in oncolo­ The oncology pharm acist should have postgraduate
gy pharmacy practice; qualifications in clinical pharmacy. They must possess
• reporting to the director of pharmacy and the direc­ up-to-date clinical oncology knowledge and be capable
tor of each specialist unit on the functioning of the of exercising independent, responsible clinical judgment.
service when requested. The inform ation should The oncology pharmacist must maintain a minimum of
include preparation of workload and drug usage 20 hours of continuing education points per year (as

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defined by SHPA) within the field of oncology pharma­ • regulatory guidelines and information resources for
cy practice. The oncology pharmacist should be encour­ education and counselling;
aged to obtain formalised accreditation, which is available • regulatory and ethical issues related to research in
through the US Board of Pharmaceutical Specialties. patients with cancer (including confidentiality, in­
Pharmacists commencing practice in oncology should formed consent and patient rights), and
undertake a relevant orientation and training program. • the entire oncology drug development process.
Specialised training may be obtained through SHPA, the
American Society of Health-System Pharmacists, or the The oncology pharmacist must also understand estab­
American College of Pharmacy Practice. lished clinical practice guidelines for:
Regular attendance at specialist conferences and • the treatment of patients with cancer;
educational meetings must be undertaken to maintain • established methodology for developing clinical
and update specialist knowledge. The oncology phar­ practice guidelines;
macist should attend and participate in relevant contin­ • professional practice standards and guidelines that
uing education programs. This inform ation must be apply to oncology pharmacy practice;
disseminated to work colleagues. Liaison with special • quality improvement strategies to avoid medication
interest groups in oncology and the SHPA Committee of misadventures;
Specialty Practice in Oncology is recommended. • methods for handling cytotoxic drugs and related
The oncology pharmacist must act as a resource for materials;
the dissemination of oncology-related drug information. • investigational drug management; and
This includes collaboration with other professionals and • drug usage evaluation (DUE) processes.
the public in addressing public health issues as they Presentation of research at relevant conferences and
relate to oncology pharmacy practice. The dissemina­ seminars such as those organised by SHPA, Clinical
tion of oncology-related drug information should also Oncological Society of Australia (COSA), American So­
include the education of nursing, medical and allied health ciety of Clinical Oncology (ASCO), and the Internation­
staff, as well as colleagues, pharmacy trainees, and phar­ al Society of Oncology Pharmacy Practitioners (ISOPP)
macy students. is highly recommended.

Clinical Trials QUALITY

The oncology pharmacist must be familiar with all clini­ A quality assurance program for the provision of clinical
cal aspects of trials that involve patients with cancer. services to the patients of the oncology unit must be
They should liaise with the principal investigator, other developed and maintained. The program should be based
research personnel and the clinical trials pharmacist to on the accepted standards.2 The program should include
facilitate the smooth running of studies and to ensure a number of quality indicators. The suggested minimum
adherence to study protocols. Participation in clinical quality indicators are outlined in Appendix 1.
trial start-up meetings is encouraged.
Where clinical trials are conducted within the insti­
tution and a clinical trials pharmacist is not employed, Appendix 1. Quality indicators for provision of clinical
the oncology pharmacist is best placed to take on the oncology pharmacy services
responsibility for pharmacy aspects of the conduct of 1. Checking relevant laboratory measurements
oncology-related clinical trials. The oncology pharma­ The number of occasions (%) that the serum creatinine or
cist must be familiar with accepted codes of practice for creatinine clearance, or liver function tests (serum bilirubin and
clinical trials.4'6 Where a pharmacist is employed to over­ alkaline phosphatases) are checked and recorded prior to
see clinical trials, the oncology pharmacist should act as chemotherapy.
a valuable resource for advice and information on oncol­ 2. Referenced protocols
ogy-related studies. The number of occasions (%) that a cytotoxic chemotherapy
protocol is used and its validity has not been verified by the
Research clinical pharmacist. Validity refers to a referenced protocol
(published in peer-reviewed journals and based on well-designed
The oncology pharmacist should become involved in
clinical trials).
practice research. To facilitate this requirement the on­
cology pharmacist must possess knowledge in the areas 3. Dose recalculation
of epidemiology, statistical analysis, and research pro­ The number of occasions (%) that the clinical pharmacist
recalculates the dose of chemotherapy ordered. This may be
tocol development. The oncology pharmacist must poss­
through recalculation of body surface area, or glomerular
ess knowledge in the areas of: filtration rate where AUC is used to calculate carboplatin dosage.
• oncology literature and information retrieval sys­
4. Counselling
tems;
The number of occasions (%) where chemotherapy protocol
• study design and methodology;
progress sheets are given to patients to aid the counselling
• common study end points (e.g. response, adverse process.
events, economics, quality of life, pharmacokinet­
5. Clinical services
ics, pharmacodynamics);
The number of occasions (%) where pharmaceutical care plans
• selective strengths and limitations of different study are prepared and maintained.
designs;
• statistical methods used for data analysis;
• clinical versus statistical significance;
• educational and counselling methodology;

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Appendix 2. Reference texts R eferences
1. T he Society o f H ospital P harm acists o f A ustralia C om m ittee o f S pecialty
Reference library must include the following texts and their latest P ractice in O ncology. Standards o f practice for the oncology pharm acist. A ust
update. These texts may be available as either a hard copy or an J H osp Pharm 1995; 25: 455-8.
electronic copy. 2. The Society o f H ospital Pharm acists o f A ustralia C om m ittee o f S pecialty
Practice in Clinical Pharmacy. SHPA standards o f practice fo r clinical pharm acy.
• Dorr RT, von Hoff DD. Cancer chemotherapy handbook. 2nd In: Johnstone JM , V iénet M D , editors. Practice standards and definitions. The
edition. Connecticut: Appleton & Lange; 1994. Society o f H ospital Pharm acists o f A ustralia. M elbourne: SHPA; 1996.
3 . The Society o f H ospital Pharm acists o f A ustralia C om m ittee o f S pecialty
• De Vita VT, Heilman S, Rosenberg SA, editors. Cancer: P ractice in O ncology. Standards o f practice fo r the safe handling o f cytotoxic
principles and practice of oncology. 6th edition. Philadelphia: drugs in pharm acy departm ents. A ust J H osp Pharm 1999; 29: 108-16.
Lippincott-Raven; 2000. 4. International conference on harm onisation guideline for good clinical prac­
tice (IC H G C P). B russels: ICH Secretariat; M ay 1996.
• Finlay R, editor. Concepts in oncology therapeutics. 2nd 5 . T he Society o f H ospital P harm acists o f A ustralia C om m ittee o f S pecialty
edition. Bethesda: American Society of Health-System Practice in Investigational D rugs. SHPA standards o f p ractice fo r pharm acy
Pharmacists; 1998. investigational drugs services. A ust J H osp Pharm 1999; 29: 227-35.
6. Therapeutic Goods A dm inistration. C linical trials (chapter 4). In: A ccess to
• Doyle D, Hanks GWC, MacDonald N. Oxford textbook of u n approved th erapeutic goods in A u stralia. C o m m o n w ealth D ep artm en t o f
palliative medicine. Oxford: Oxford University Press; 1993. H ealth and A ged Care; M ay 2001. p. 54-127. A vailable from: w ww .health.gov.au/
tg a /d o cs/p d f/u n ap p ro v ed /u n a p p .p d f

Appendix 3. R eference journals A dopted by F ederal C ouncil: N ovem ber 2001

Journal Publisher
Annals of Oncology Kluwer Academic Publishers
Blood
British Journal of Cancer
American Society of Hematology
Harcourt International
ISOPP Secretariat
Cancer J Wiley and Sons for the American
Cancer Society
Journal of the National Oxford University Press
Cancer Institute
Journal of Pain and Elsevier Science
Symptom Management
Journal of Clinical Lippincott, Williams & Wilkins
Oncology
Seminars in Oncology WB Saunders Company

A ppendix 4. Web sites

The following web sites are considered appropriate at publication.

The oncology pharmacist must critically review all information
obtained from the Internet.

Web address Description

Jill Davis, Chair of the SHPA Committee of Specialty
cancer.org American Society of Cancer Practice in Oncology, was recently appointed to the Sec­
cancerbacup.org.uk UK-based cancer information service retariat of the International Society of Oncology Phar­
nci.nih.gov National Cancer Institute (NCI) m acy P ractitioners (ISOPP, w w w .isopp.org). The
Secretariat was installed at the Eighth International Sym­
oncolink.upenn.edu University of Pennsylvania Cancer Centre
posium on Oncology Pharmacy Practice (ISOPP VIII) in
cancemet.nci.nih.gov Cancer Information (provided by the NCI) Vancouver, Canada on 10 May 2002.
asco.org American Society of Clinical Oncology ISOPP officers include (from left to right): President,
Dr Barry Goldspiel, NIH Clinical Center, Maryland, USA;
nccn.org National Comprehensive Cancer Network
President-elect, Dr Graham Sewell, University of Bath,
United Kingdom; Treasurer, Thomas Garms, AK Har­
burg, Hamburg, Germany; Secretary, Dr Robert Ignoffo,
University of California, California, USA; and Secretari­
at Members: Jill Davis, Austin &Repatriation Medical
Centre (Austin Campus), Victoria, Australia; Franca Gof­
fredo, Istituto per la Ricerca e la Cura, Torino, Italy;
Camille Groos, Clinique Ste Elisabeth, Luxembourg, and
Saad Othman, School of Pharmaceutical Services, Uni-
versiti Sains, Malaysia.
The next ISOPP meeting will be held in April 2004 in
Turin Italy. C ontact Jill for further inform ation at
[email protected]

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