R.A. 6675
R.A. 6675
R.A. 6675
6675
September 13,1988
GENERICS
ACT OF
1988
R.A. 6675
Nelson T. Tubon,
“An act to promote, require,
and ensure the production
of an adequate supply,
distribution, use, and
acceptance of drugs and
medicines identified by
their generic names”
R.A. 6675
Nelson T. Tubon,
olicy of the S TATE
To promote, encourage and require
the use of generic terminology in
the importation, manufacture,
distribution, marketing, advertising
and promotion, prescription and
dispensing of drugs
R.A. 6675
Nelson T. Tubon,
olicy of the S TATE
To ensure the adequate supply of
drugs with generic names at the
lowest possible cost and endeavor to
make them available for free to
indigent patients
R.A. 6675
Nelson T. Tubon,
olicy of the STATE
To encourage the extensive use of
drugs with generic names through
a rational system of procurement
and distribution
R.A. 6675
Nelson T. Tubon,
olicy of the S TATE
To emphasize the scientific basis
for the use of drugs, in order that
health professionals may become
more aware and cognizant of their
therapeutic effectiveness
R.A. 6675
Nelson T. Tubon,
olicy of the STATE
To promote drug safety by
minimizing duplication in
medications and/or use of drugs
with potentially adverse drug
interactions
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
GENERIC NAME/TERMINOLOGY
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
ACTIVE INGREDIENT
is the chemical
component responsible
for the claimed
therapeutic effect of the
pharmaceutical product
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
CHEMICAL NAME
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
D
is the finished product R
form that contains the U
active ingredients, G
generally but not P
necessarily in association R
with inactive ingredients O
D
U
C
C
T
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
ESSENTIAL DRUG LIST/NDF
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
COMPLEMENTARY LIST
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
BRAND NAME
R.A. 6675
Nelson T. Tubon,
DEFINITION OF TERMS
GENERIC DRUGS
R.A. 6675
Nelson T. Tubon,
E.O. 49
January 21, 1993
Directed mandatory use of the PNDF
(Volume 1 or the Essential Drug List)
Basis for procurement of drug
products by government
A.O. 163 s. 2002
Implementing Guidelines and
Procedures in the Procurement and
Requisition of Drugs and Medicines
by the DOH pursuant to E.O. 49
A.O. 2012-0023
Replacement of the name PNDF
PNF
Revision of the of the National
Formulary Committee (NFC) to
Formulary Executive Council (FEC)
Detailing of the selection processes
for the inclusion an deletion of
medicines
Sec. 6: WHO WILL USE GENERIC
TERMINOLOGY
R.A. 6675
Nelson T. Tubon,
Sec. 6: WHO WILL USE GENERIC
TERMINOLOGY
R.A. 6675
Nelson T. Tubon,
Sec. 6: WHO WILL USE GENERIC
TERMINOLOGY
R.A. 6675
Nelson T. Tubon,
SEC 6. Who shall use Generic
Terminology
As amended:
“(e) There shall be appear prominently
on the label of a generic drug the
following statement: THIS
PRODUCT HAS THE SAME
THERAPEUTIC EFFICACY AS ANY
OTHER GENERIC PRODUCT OF
THE SAME NAME, SIGNED:
BFAD.”
R.A. 6675
Nelson T. Tubon,
Sec. 8 is hereby amended
“SEC 8. Required Production:
Subject to the rules and regulations
promulgated by the Secretary of Health,
every drug manufacturing company
operating in the Philippines shall be
required to produce, distribute and make
widely available to the general public an
unbranded generic counterpart of their
branded product”
R.A. 6675
Nelson T. Tubon,
1. GENERIC NAMES SHALL BE USED IN ALL
PRESCRIPTIONS
1.1. For drugs with a single active ingredient,
the generic name of that active ingredient
shall be used in prescribing
1.2. For drugs with two or more active
ingredients, the generic name as determined
by BFAD shall be used in prescribing
R.A. 6675
Nelson T. Tubon,
THINGS TO REMEMBER WHEN BUYING MEDICINES TO
CHECK IF IT IS REGISTERED WITH BFAD-DOH AND IF
IT COMPLIES WITH “GENERIC LABELING”
Bottle/Box (Syrup, Tablet, Capsule, Injectable, Ointment)
- Generic name / Brand name
- Dosage strength / form
- Pharmacologic category
- Company logo
- Name / Address of company
- Rx symbol if prescription drugs
- Net content
- Formulation
- Indication / Dosage
- Warning / contraindication / precaution
- DR number
- Expiry date
- Batch number / Lot number
- Manufacturing date
- Storage condition
R.A. 6675
Nelson T. Tubon,
Foil/blister (Tablet, capsule)
- Generic name
- Brand name
- Dosage from / strength
- Company logo or name of
company
- Rx symbol if prescription drugs
- Expiry date / Lot number
R.A. 6675
Nelson T. Tubon,
WHAT is the drug’s name (e.g. Paracetamol,
Amoxicillin)
WHEN does the patient take the medicine (e.g. in the
morning, twice a day)
HOW MUCH dosage does the patient take (e.g. 1
Tbsp, 1 capsule)
FOR HOW LONG does the patient take the
medicine (e.g. 4 days, 1 week)
HOW should the medicine be taken (e.g. with food,
empty stomach, with water)
R.A. 6675
Nelson T. Tubon,
A.O. NO. 62
“Rules and
regulations to
implement
prescribing
requirements”
R.A. 6675
Nelson T. Tubon,
I. ERRONEOUS Rx
R.A. 6675
Nelson T. Tubon,
II. VIOLATIVE Rx
Prescriptions are considered violative if:
The generic name is not written
The generic name is not legible and a brand
that is legible is written
The brand name is indicated and instructions
(such as the phrase “NO SUBSTITUTION”)
that tend to obstruct, hinder, or prevent generic
dispensing
R.A. 6675
Nelson T. Tubon,
III. IMPOSSIBLE Rx
Prescriptions are considered impossible if:
Only the generic name is written but is not
legible
The generic name does not correspond to
the brand name
Both generic name and the brand name are
not legible
The drug product is not registered in FDA
R.A. 6675
Nelson T. Tubon,
R.A. 6675
Nelson T. Tubon,
VIOLATIVE Rx
IMPOSSIBLE RX
Shall not be filled
Shall be kept & reported by the pharmacist to
the nearest DOH office
Pharmacist shall advise the prescriber about
the problem
Instruct the customer to get proper Rx
R.A. 6675
Nelson T. Tubon,
ERRONEOUS PRESCRIPTION
SHALL BE FILLED
Shall be kept & reported to the
nearest DOH office
R.A. 6675
Nelson T. Tubon,
RECORD
BOOKS
POISON BOOK 5 years
Prescription 2 years
DD BOOKS 1 year
Nelson T. Tubon,
CLASSIFICATION OF
DRUGS
Two broad legal classification of medications
Prescription or Ethical Drugs
R.A. 6675
Nelson T. Tubon,
Prescription or Ethical Drugs
Pharmaceutical products or drug
preparations dispensed upon written
order of a validly-registered licensed
physician, dentist or veterinarian
for the management or treatment of a
condition or disease.
R.A. 6675
Nelson T. Tubon,
Prescription or Ethical Drugs
All antibiotics except some ointments
All injectables (ampules or vials)
Cough syrups containing any amount of
narcotics (except dextromethorphan)
Vitamin products containing more than 10,000
units of Vitamin A
Highly potent drugs for special medication (ex.
steroids, digitoxin)
Paregoric Elixir (in emergency cases, 1 dose
may be dispensed without a prescription)
All drugs bearing the Rx symbol on their labels
R.A. 6675
Nelson T. Tubon,
All prescriptions dispensed in the
drugstore, botica or hospital pharmacy
Shall be kept in file for two years &
recorded in a Rx book duly registered by
FDA
Shall be open for inspection to Food & Drug
Inspectors at any time during business
hours of the outlet.
Rx book shall be kept for two years after
the last entry
R.A. 6675
Nelson T. Tubon,
Non-Prescription or OTC Drugs
Pharmaceutical products or drug preparations
that can be dispensed even without the
written order of a validly-registered licensed
physician, dentist or veterinarian
for the use of consumers for the prevention or
symptomatic relief of minor or self-limiting
ailments.
R.A. 6675
Nelson T. Tubon,
Non-Prescription or OTC
Drugs
Multivitamin products of low dosage
Anti-TB drugs except injectables
Cough syrups containing
dextromethorphan
Household remedies except paregoric
Simple analgesics (Aspirin,
Acetaminophen, etc.
R.A. 6675
Nelson T. Tubon,
DANGEROUS DRUGS
Refer to:
Prohibited Drugs
Regulated Drugs
R.A. 6675
Nelson T. Tubon,
DANGEROUS DRUGS
Prohibited Drugs
Include:
“opium & its active components & derivatives:
a narcotic drug
R.A. 6675
Nelson T. Tubon,
DANGEROUS DRUGS
Prohibited Drugs
Brown Mixture Tab. Morphine Sulfate H.T.
Brown Mixture Liq. Morphine with Atropine
Codeine Sulfate H.T. Morphine Sulfate Amp.
Codeine Sulfate T.T. Morphine Sulfate Tab.
Demerol Amp. Sublimaze Inj.
Demerol Tab. Repifen Inj.
Demerol Vial Codevite Syrup
Dolo-Adamon Supp. Deka Syrup
Dolo-Adamon Tab. Endotussin Syrup
Elixir Paregoric Raminon Syrup
Innovar Inj. Tussionex Susp.
R.A. 6675
Nelson T. Tubon,
DANGEROUS DRUGS
Include:
Regulated Drugs
Sleep-inducing sedatives
- secobarbital, phenobarbital, barbital,
amobarbital
Other drugs containing a salt or derivative of a salt of
barbituric acid
Any salt, isomer or salt of an isomer of amphetamine
- benzedrine or dexedrine
- any drug which produces a pharmacologic action
similar to amphetamine
Hypnotic drugs
- methaqualone or any other compound producing
similar pharmacologic effects
R.A. 6675
Nelson T. Tubon,
DANGEROUS DRUGS
Regulated Drugs
Nembutol Sod. Vial Plexonal
Noctec Robypnol
Noludar Tab. Seconal Sod. Cap.
Nuberene Tab. Sosegon Amp.
Paraldehyde Amp. Sosegon Tab.
Pentothal Sod. Vial Thiopental Sod. Vial
Placidyl Cap. Valamin Tab.
R.A. 6675
Nelson T. Tubon,
Requirements in the dispensing &
compounding of dangerous drugs
They should be prescribed in special Rx forms
issued by the DDB.
The pharmacist must record them in the
Dangerous Drugs Book in accordance with
the form prescribed by the DDB.
The pharmacist must check all the required
data as opium license number of the
physician, prof’l license number, and the
residence certificate of the buyer.
The pharmacist must keep these dangerous
drugs in a locked cabinet.
R.A. 6675
Nelson T. Tubon,
Requirements in the dispensing &
compounding of dangerous drugs
The pharmacist must keep and file the
original Rx.
Quarterly report covering 3 calendar
months of all transactions (copy of (2) to
be submitted to the Municipal Health
Officer within 15 days following the last
day of every quarter of the year.
R.A. 6675
Nelson T. Tubon,
List of Products Requiring Strict Precaution in
Prescribing, Dispensing & Use
Aminophylline: Suppository/Tablet
Amitriptyline Hydrochloride: Tablet
Betamethasone: Tablet
Busulfan: Tablet
Chlorambucin: Tablet
Chlorpropamide: Tablet
Chlorthalidone: Tablet
Cyclophosphamide: Tablet
Dexamethasone: Tablet
Dexamethasone Acetate: Injectable
R.A. 6675
Nelson T. Tubon,
List of Products Requiring Strict Precaution in
Prescribing, Dispensing & Use
Dicumarol: Capsule/Tablet
Epinephrine: Injectable
Estrogens, Conjugated: Injectable
Ethinyl Estradiol: Tablet
Ethosuximide: Capsule
Furazolidone: Suspension/Tablet
Hydrochlorothiazide: Tablet
Hydrocortisone: Injectable
Imipramine Hydrochloride: Tablet
Menadione: Tablet
R.A. 6675
Nelson T. Tubon,
List of Products Requiring Strict Precaution
in Prescribing, Dispensing & Use
R.A. 6675
Nelson T. Tubon,
List of Products Requiring Strict Precaution
in Prescribing, Dispensing & Use
Phenytoin Sodium, Prompt: Capsule
Probenecid: Tablet
Procainamide Hydrochloride: Capsule/Tablet/CR Tablet
Pyrazinamide: Tablet
Quinidine Sulfate: Capsule/Tablet/CR Tablet
Spironolactone: Tablet
Sulfadiazine, Sulfamerazine, Sulfamethazine: Tablet
Sulfamethizole: Suspension/Tablet
Sulfisoxazole: Suspension/Tablet
Theophylline: CR Capsule/CR Capsule (Sprinkles)/
Suspension/CR Tablet
R.A. 6675
Nelson T. Tubon,
List of Products Requiring Strict Precaution in
Prescribing, Dispensing & Use
Thyroglobulin: Tablet
Tolbutamide: Tablet
Triamcinolone: Tablet
R.A. 6675
Nelson T. Tubon,
R.A. 6675
Nelson T. Tubon,
DISPENSING
is the act by validly registered
Pharmacist of filling a
prescription or doctor’s order
on the patient’s chart.
R.A. 6675
Nelson T. Tubon,
GENERIC DISPENSING
means dispensing the patients’/ buyers’
choice among the generic equivalents, i.e.
finished pharmaceutical products having the
same active ingredient(s) same dosage form
and same strength as the prescribed drug
R.A. 6675
Nelson T. Tubon,
PARTIAL FILLING OF Rx
means dispensing less than the
total number of units prescribed
R.A. 6675
Nelson T. Tubon,
Generic Prescribing is prescribing
of drugs or medicines using their
generic names or generic
terminology
Generic name or Generic
Terminology is the identification of
drugs and medicines by their
scientifically and internationally
recognized active ingredients
Nelson T. Tubon,
I. All drug outlets are required
to practice generic dispensing.
R.A. 6675
Nelson T. Tubon,
II. Dispensing: products not in their original containers:
Small bottles; Tin cans; Boxes; Plastic or paper
envelopes
Information required on drug outlet’s labels:
1. Name of the patient
2. Generic name of the drug
3. Brand name, if any
4. Manufacturer
5. Dosage strength
6. Expiry Date
7. Directions for use
8. Name of the Pharmacist
R.A. 6675
Nelson T. Tubon,
III. In partial filling of the Rx.
Information required to be written on the Rx:
1. Date of partial filling
2. Quantity served & balance of the Rx
3. Name & address of the drugstore
Additional requirements:
1. The prescriber must have an S-2 license
2. The special DDB Rx form must be used
3. A recording system following pertinent DDB
regulation must be covered.
R.A. 6675
Nelson T. Tubon,
IV.In dispensing drugs in List A and List B:
1. Dispensing must be done by the pharmacist
2. Follow the order & instructions of the doctor on
the Rx
3. Partial filling of Rx for drugs in List A:
3.1 Rx must be retained by the pharmacist
3.2 The patient must asked the prescriber for
another Rx to complete the total dose of
the medication
R.A. 6675
Nelson T. Tubon,
IV. In dispensing drugs in List A and List B:
4. After the Rx is filled the original copy of the Rx
shall be retained & kept for a period of 1 year by the
pharmacist for inspection.
R.A. 6675
Nelson T. Tubon,
A.O. No. 90, s. 1990
SUBJECT: Amendment to A.O. 62 s. 1989 RE:
Rules and Regulations To Implement
Prescribing Requirements
“Permits the writing of the generic
names of more than one drug product
in one prescription form”
It is no longer regards a Rx form with more
than one drug product as erroneous
R.A. 6675
Nelson T. Tubon,
A.O. NO. 107 s 1991
May 16, 1991
“Dispensing Multiactive
Ingredients of Fixed -
dose Combination Drugs”
R.A. 6675
Nelson T. Tubon,
DRUGSTORES, BOTICAS, AND
OTHER DRUG OUTLETS
In order to ensure the informed choice and use of drugs by
the patient/ buyer, the outlets are required to:
Inform the patient/ buyer of all the available drug products
generically equivalent to the one prescribed with their
corresponding prices.
Shall not favor or suggest any particular product so that the
patient/ buyer may fully and adequately exercise his option
to choose
R.A. 6675
Nelson T. Tubon,
Post in a conspicuous place in their establishment a list
of drug products using generic names with their
corresponding brand names, if any, and their
corresponding current prices.
Provide a handbook or directory containing the
above-required information readily accessible to the
patient/ buyer.
R.A. 6675
Nelson T. Tubon,
1. Imposing a particular brand or product on the buyer
2. Inaccurate dispensing
3. Failure to post or make accessible the required up-to-date
information on drug product
4. Failure to adequately inform buyer on available product that
meet the Rx
5. Failure to indicate the generic name/ official name
designated by the BFAD & other required information on
the drug outlet’s label of the dispensing drug.
6. Failure to record and keep Rx filled
7. Failure to report to the nearest DOH office incorrect Rx
within 3 months after receipt of such Rx.
Suspension, or revocation of the LTO of the
drug outlet by the Secretary of Health
R.A. 6675
Nelson T. Tubon,
R.A. 6675
Nelson T. Tubon,
A prescription is an order
for medication issued by
a physician, dentist,
veterinarian, and other
properly licensed
practitioner
R.A. 6675
Nelson T. Tubon,
Parts of Prescription
1. Heading
2. Patient’s information
3. Date
4. Superscription – Rx symbol
5. Inscription – medication prescribed
6. Subscription – direction to the pharmacist
7. Transcription – direction to the patient
8. Special labeling and other instructions
9. Prescriber’s signature
R.A. 6675
Form used when prohibited and or regulated drugs
are prescribed.
No prescription once issued may be refilled. (Sec.
25, R.A.6425, as amended)
Original form shall be retained by the drugstore
pharmacist for a period of one (1) year from the
date of sale or delivery of the drug herein
prescribed
1 copy – retained by the buyer or by the person to
whom the drug is delivered until such drug is
consumed.
2nd copy – shall be retained by the person issuing
the prescription (Sec. 25, R.A. 6425, as amended)
R.A. 6675
Nelson T. Tubon,
PRA C TIC ES TO BE O BSERVED TO A VO ID
D ISPEN SIN G ERRO RS
1. One should have adequate knowledge about
drugs to avoid dispensing errors.
2. Careful examination of prescription. Read
accurately what is written on the prescription.
3. Read the label of the bottle/container twice or
thrice and should not rely on the familiarity of
its location.
4. Always label the products to be dispensed for
proper identification.
5. Allow other pharmacy assistants or pharmacist
to recheck your work.
6. Do not hesitate to ask the help of the
pharmacist-in-charge in case there is any doubt
about the prescription
VIOLATIONS
R.A. 6675
Nelson T. Tubon,
PENALTIES:
SEC 12 Penalty
as amended
First
conviction :
R.A. 6675
Nelson T. Tubon,
PENALTIES:
SEC 12 Penalty
as amended
Fourth
conviction :
Fine of NLT P10,000 (100,000)
and suspension of his license to
practice his profession for 1
year or longer at the discretion
of the court
R.A. 6675
Nelson T. Tubon,
Officers responsible for the violation
shall suffer a penalty of fine and
suspension or revocation of license to
practice & if applicable, imprisonment
of not less than 6 months but not to
exceed 1 year or both penalty and fine
R.A. 6675
Nelson T. Tubon,
New Law Sec 12 as amended
That its officers directly responsible for
the violation shall suffer the penalty of
fine of at least (Php 40,000) and
suspension or revocation of license to
practice profession, if applicable, and
by imprisonment of NLT 6 months nor
more than 1 year or both fine and
imprisonment at the discretion of the
court
R.A. 6675
Nelson T. Tubon,
Exercise 1
Prescription without specification on the
Generic name of the prescribed product is
a violation of:
A. R.A. 5921
B. R.A. 3720
C. R.A. 6675
D. R.A. 8203
Exercise 2
An act to promote, require, and ensure the
production of an adequate supply,
distribution, use and acceptance of drugs
and medicines identified by their generic
names
A. R.A. 3720
B. R.A. 5921
C. R.A. 6675
D. R.A. 9502
Exercise 3
Sudafed 200 mg Tablet prescription
is
A. Violative prescription
B. Erroneous prescription
C. Impossible prescription
D. Intentional prescription
Exercise 4
The objective of Generic Law is to
A. provide regulated drugs
B. use of habit forming drugs
C. provide prohibited drugs
D. provide the patient choice of the
drug at the lowest cost
Exercise 5
Considered as violative Rx
A. Mefenamic (Ponstan)
B. Ibuprofen (Brufen)
C. Nystatin (Mycostatin)
D. Rx Loviscol