Module 6: The Primer on the National Drug
Policy
National Drug Policy
➢ A policy and program of the national
government to ensure that safe and
effective drugs are made available to
all Filipinos at any time and place and
at a reasonable and affordable cost
➢ Enunciated by President Corazon C.
Aquino on April 30, 1987 during the
inauguration of the new BFAD building
*additional notes
RA 3720- Talks about the safety and
effectiveness of the drug.
Formulating the NDP
➢ Initiative of DOH – creation of a Task
Force on Pharmaceuticals, June 1986
Consultations
➢ Pharmaceutical industry, professional
organizations, academic and
consumer groups
Local Research
➢ Review of local researches and
publications dealing with drugs and
pharmaceuticals
International Research
➢ Face-to-face consultations from
Indonesia, Malaysia and Thailand
Pillars of the NDP
❖ Quality Assurance of Drug
● A task of BFAD, to ensure that
all pharmaceutical products
are safe and effective
● Strengthen capabilities of
BFAD to undertake quality
control, product registration
and licensing of sales
establishments
❖ Rational Use of Drugs by Health
Professionals and Consumers
● Rational use refers to the
practice of using only the
necessary and effective drugs
in treating an illness
● Passage of bills in Congress
requiring generic labeling,
prescribing and dispensing of
medicines
● Creation of the PNDF by the
National Drug Committee
● Regulation of advertising and
promotion of pharmaceutical
products
❖ Self- Sufficiency in Pharmaceuticals
● Reduce the country’s
dependence on multinational
drug companies
● In cooperation with UNIDO, a
private investment will be
given incentive to produce raw
materials and intermediaries
of pharmaceutical products
❖ Tailored Procurement of Drugs
● Design a procurement
program to achieve
economies of bulk purchasing
and enhance impact of DOH
resources
● Purchasing based on generic
nomenclature and based on
the PNDF
Generic Names
➢ A generic name is a simple term for
the scientifically recognized AI of a
drug
➢ Using generic names will reduce the
cost of treatment – reduced promotion
and advertising cost of the product
➢ Example:
1. Paracetamol 500 mg
- Biogesic- 2.80
- Tempra- 3.75
- Generic- 1.00
Philippine National Drug Formulary
➢ A list of medicines officially recognized
and approved by the DOH and
prepared by the National Drug
Committee
Essential Drug List
➢ A concept promoted by WHO and
refers to a list of drugs prepared and
periodically updated by the DOH on
the basis of health conditions obtained
in the Philippines, as well as on
internationally accepted criteria
Core List
➢ A list of drugs that meet the health
care needs of the majority of the
population
Complementary List
➢ A list of alternative drugs used when
there is no response/hypersensitivity
reaction to the core essential drug
Implementation of NDP
➢ NDP Management Committee headed
by the Assistant Secretary for
Standards and Regulations
➢ Units of the NDP Management
Committee
❖ Advisory Committee to BFAD
❖ National Drug Committee
❖ Other units involved in the
administration, legal affairs
and communications and
information.
Promotion of NDP
● Medical Practitioners
- Practice generic prescribing
- Maintain a healthy distance
from the drug companies
● Pharmacies and Sales
Establishments
- Practice generic dispensing
- Create and display a generics
menu card
● Ordinary Citizens
- Use drugs wisely
- Seek drug information from
doctors and pharmacists
Obstacles to NDP
➢ Companies that stand to lose money
when their products are judged unsafe
and ineffective are delisted and taken
off the market
➢ Fly-by-night companies which try to
take advantage of the new generics
law
➢ Individuals and groups who want to
maintain the status quo
★ REPUBLIC ACT NO. 6675
➢ Generic Act of 1988
➢ 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.
❖ TERMINOLOGIES
Generic Name
➢ Is the identification of drugs and
medicines by their scientifically and
internationally recognized active
ingredients or by their official generic
name as determined by the Bureau of
Food and Drugs of the Department of
Health.
➢ Non- proprietary name
Active Ingredient
➢ Is the chemical component
responsible for the claimed therapeutic
effect of the pharmaceutical product.
Chemical Name
➢ Is the description of the chemical
structure of the drug or medicine and
serves as the complete identification
of a compound.
Drug product
➢ Is the finished product form that
contains the active ingredients,
generally but not necessarily in
association with inactive ingredients.
Drug establishment
➢ Is any organization or company
involved in the manufacture,
importation, repacking and/or
distribution of drugs or medicines.
Drug Outlets
➢ Means drugstores, pharmacies, and
any other business establishments
which sell drugs or medicines.
Essential Drug List or National Drug Department of Interior and Local
Formulary Government
➢ Is a list of drugs prepared and ● Continuous information
periodically updated by the campaign for public
Department of Health on the basis of ● Continuing education and
health conditions obtained in the training for the medical and
Philippines, as well as; on allied medical professionals
internationally accepted criteria. It
shall consist of a core list and a Penalty for Violators of RA 6675
complementary list. ➢ 1st conviction- Reprimand
➢ 2nd conviction- Fine of 2,000 to
Core List 5,000
➢ Is a list of drugs that meet the health ➢ 3rd conviction- Fine of 5,000 to
care needs of the majority of the 10,000 and suspension of PRC
population. license for 30 days
➢ 4th and subsequent conviction-
Fine of NLT 10,000 and suspension of
Complementary List PRC license for 30 days
➢ Is a list of alternative drugs used when ➢ For juridical persons
there is no response to the core ● Fine of 5,000 to 10,000 and
essential drug or when there is a suspension of LTO for drug
hypersensitivity reaction to the core establishment/outlets
essential drug or when, for one reason ● Fine, suspension or
or another, the core essential drug revocation of PRC license and
cannot be given. imprisonment of 6 months and
1 year for personnel working
Brand name in the establishment/outlet
➢ Is the proprietary name given by the ➢ Deportation for alien violators
manufacturer to distinguish its ➢ The secretary of Health has the
production from those of competitors. authority to impose the sanctions for
➢ Proprietary name violators of this Act.

Generic drugs ★ PRESCRIBING REQUIREMENT

➢ Are drugs not covered by patent UNDER RA 6675
protection and which are labeled ➢ AO 62, s. 1989
solely by their international ➢ Concerned prescribing: Physician
nonproprietary or generic name.
❖ TERMINOLOGIES
Who shall use generic terminology?
➢ All government agencies and Prescription
personnel ➢ A written order and instruction a
➢ All medical, dental, and veterinary validity registered physician, dentist or
practitioners veterinarian for the use of a specific
➢ Any organization or company involved drug product
in the manufacture, importation,
repacking, marketing and distribution Generic Prescribing
of drugs ➢ The prescribing of drugs or medicines
➢ Drug outlets selling drugs using their generic names

Education Drive for RA 6675

➢ DOH with Department of Education,
Philippine Information Agency and
PRESCRIBING GUIDELINES
➢ Only validity registered medical, dental
and veterinary practioner
authorized to prescribe drugs
➢ All prescriptions must contain the
following information:
● Name of prescriber, office
address, professional
registration number
professional tax receipt
● Patient’s name, age and sex
● Date of prescription
➢ For List A drugs, the following are
required:
● 5-2 license number
● Special DDB prescription form
● Recording system following
pertinent DDB regulations
must be observed
MEDICINES IN PNDF WITH ABUSE
POTENTIAL (LIST A)
A. Dangerous Drug Preparation A1
➢ Drugs requiring S-2 license and DDB
Prescription Form
1. Alprazolam
2. Bromazepam
3. Butorphanol (as tartrate)
4. Clonazepam
5. Codeine (as phosphate)
6. Diazepam
7. Fentanyl (as citrate)
8. Flurazepam
9. Ketamine
10. Lorazepam
11. Methylphenidate
12. Midazolam
13. Morphine (as sulfate)
14. Nalbuphine
15. Oxycodone
16. Phenobarbital
17. Perthidine (meperidine)
18. Thiophental sodium
19. Zolpidem
B. Controlled Chemicals
➢ Drugs requiring S-2 License using
ordinary prescription form)
1. Ephedrine (as sulfate)
2. Ergotamine (as tartrate)
3. Methylergotamine (methylergonovine)
PRESCRIBING GUIDELINES
➢ Generic names shall be used in all
are prescription
➢ The generic name must be written in
full but the salt or chemical form may
be abbreviated
➢ The generic name of the drug ordered
must be clearly written on the
and prescription immediately after the Rx
symbol or on the order chart. A brand
name may be written below the
generic name and should be enclosed
in a parenthesis.
➢ Only one drug shall be prescribed on
one prescription form
➢ In prescribing drugs enumerated in the
List B which needs strict precaution in
their uses, the prescriber must comply
with the following:
● After the Rx symbol but before
the generic name, he must
write clearly “List B”
● The following information must
be written:
- Generic name (brand
name)
- Strength or dose level
- Manufacturer
- Delivery mode or
system
Violative Prescriptions
➢ Generic name is not written
➢ Generic name is not legible and a
brand anime is legibly written
➢ Brand name is indicated and
instructions added (such as the phrase
“no substitution”) which tend to
obstruct, hinder or prevent proper
generic dispensing
➢ Can be dispensed or allowed to
dispensed.
Erroneous Prescriptions
➢ Brand name precedes the generic
name
➢ Generic name is the one in
parentheses
➢ Brand name is not in parentheses
➢ More than one drug product is
prescribed on one prescription form
(amended AO 90, s. 1990)
 ➢ Can be dispensed or allowed to
dispensed.
Impossible Prescriptions
➢ Only the generic name is written but is
not legible
➢ Generic name does not correspond to
the brand name
➢ Both the generic name and brand
anime are not legible
➢ Drug product prescribed is not
registered with the BFAD
➢ Cannot be dispensed or not allowed.
★ DISPENSING REQUIREMENTS
UNDER RA 6675
➢ AO 63, 1989
❖ TERMINOLOGIES
Dispensing
➢ The act by a validity registered
pharmacist of filling a prescription or
doctor’s order on the patient’s chart
Generic Dispensing
➢ Dispensing the patient’s or buyer’s
choice from among generic
equivalents; a finished pharmaceutical
product having the same active
ingredients, same dosage form and
strength as the prescribed drug
Partial filling or Prescription
➢ Dispensing less than the total number
of units prescribed
DISPENSING GUIDELINES
➢ Prescription drugs can only be
dispensed upon written order of
validity registered physician, dentist or
veterinarian
➢ Over the counter drugs may be
dispensed even without a written order
of a validity registered physician,
dentist, or veterinarian; but the
pharmacists shall give the necessary
information and direction for use of the
drugs
➢ All prescription dispensed in the
drugstore shall be kept on the file for 2
years and recorded in a prescription
book duly registered by BFAD which
shall be open for inspection at any
time during business hours of the
outlet.
➢ All drug outlets are required to practice
generic dispensing.
Drugstore or boticas
● Inform the customers of
generic equivalents
● Post in a conspicuous place of
their establishment a generic
menu card
Hospital pharmacies
● Upon admission, the patient
shall indicate in writing
whether he shall submit to the
hospital drug policies or
reserve the option to buy
medicines outside the hospital
● Exempted from the following:
- Recording of
prescription filled
- Individually informing
the patient of generic
equivalents
➢ In dispensing to the buyer drug
products in unit dose or products
which are not in their original
containers but transferred to small
containers, the pharmacist shall affix a
drug outlet’s label
● Name of the patient
● Generic name (brand name)
● Manufacturer
● Dosage strength
● Expiry date
● Directions for use
● Name of pharmacist
➢ In partial filling, the following shall be
written on the face of the prescriptions:
● Date of partial filling
● Quantity served and balance
of the prescription unserved
● Name and address of the
drugstore
➢ The partially filled prescription shall be
returned to the buyer after recording
the partial filling in the prescription
book
➢ The drugstore which completes the
filling of the prescription shall be keep
the prescription on file.
 ➢ In dispensing drugs included in List A
and List B, the following shall be
observed:
● Dispensing must be done by a
pharmacist who shall affix his
signature on the prescription
filled
● The order and instructions of
the doctor as written on the
prescription must be precisely
followed
● Partial filling of prescription in
List A shall not be allowed
What to do with violative prescription?
● Violative prescription shall not be filled
● They are kept and recorded by the
pharmacist of the drug outlet to the
nearest DOH office for appropriate
action
● The pharmacist should instruct the
prescriber of the problem and instruct
the customer to get the proper
prescription.
● Failure to adequately inform the buyer
on available products that meet the
prescription
● Failure to indicate the generic name
and other required information on the
drug outlet’s label of the dispensed
drug
● Failure to record and keep prescription
filled
● Failure to report to the nearest DOH
office cases of violative, erroneous, or
impossible prescriptions within three
months after receipt of such
prescriptions.
ADMINISTRATIVE SANCTIONS
● Suspension or revocation of LTO
● Professionals directly involved shall be
penalized by reprimand, suspension or
revocation of license

What to do with erroneous prescriptions?

● Erroneous prescriptions shall be filled
● They shall be kept and reported by the
pharmacist of the drug outlet to the
nearest DOH office for appropriate
action.

What to do with impossible prescriptions?

● Impossible prescription shall not be
filled
● They are kept and recorded by the
pharmacist of the drug outlet to the
nearest DOH office for appropriate
action
● The pharmacist should instruct the
prescriber of the problem and instruct
the customer to get the proper
prescription.

VIOLATION OF DISPENSER AND OUTLETS

● Imposing a particular brand or product
to the buyer
● Inaccurate dispensing
● Failure to post or make accessible the
required up to date information on
drug products