LAWS & ETHICS AFFECTING PHARMACY
LEGAL CONTROL • Dispensing or allowing the dispensing or offering for sale
- The practice of pharmacy is regulated by the law
of the country. To practice pharmacy, a
pharmacist must be a registered pharmacist
(RPh) in that country.
- Administration of pharmacy laws and the
granting of registration to practice pharmacy are
authorities vested in the Board of Pharmacy.
R.A. No. The Pharmacy Act
10918
R.A. No. 3720 The Food, Drug and Cosmetics Act
R. A. No. 9165 The Dangerous Drug Act of 2002
R.A. No. 6675 The Generics Law of 1988
R.A. No. 8203 The Special Law on Counterfeit Drugs
R.A. No. 9994- The Senior Citizen Act
R.A. No. 7394 The Consumer Act of the Philippines
R.A. 10918
This act provides for and shall govern:
1) The standardization and regulation of pharmaceutical
education.
2) The examination for registration of graduate of schools of
pharmacy; and
3) The supervision, control, and regulation of the practice of
pharmacy in the Philippines.
Board of Pharmacy
The Board of Pharmacy shall be composed of 3 members
appointed by the President of the Republic.
Qualifications:
1) Natural born citizen of the Philippines
2) Duly registered pharmacist and has been in the practice of
pharmacy for at least 10 years
3) A member of good standing of bonafide national pharmaceutical
association in the Philippines
4) A foreigner residing in the Philippines for 5 years
5) Not a member of any college of Pharmacy
Provisions affecting Pharmacy Practice
Indication of Information
A pharmacist shall be required to indicate the serial numbers, the
date of expiry of the pharmacist’s PIC and APO Certificate of
Membership on all pertinent documents signed by him/her.
Display of Certificate of Registration
Display the COR in a prominent and conspicuous place. –
Category A (establishments that require direct supervision of
RPh)- original copy
Category B- (outlets where the supervision and oversight of a duly
registered and licensed pharmacist is required) duplicate copy
Dispensing/Sale and Compounding of Pharmaceutical
Products
It should be done by a registered Pharmacist in an establishment
with a valid.
License to Operate given by the FDA Phil. In emergency cases,
dispensing of Rx and Pharmacist only OTC can be done by non-
pharmacist.
NO LTO (Licensed to Operate)
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of prescription drugs or pharmaceutical products
(manufacturer and distributor) in a place not licensed by the
FDA as a pharmaceutical outlet is punishable by law.
- Partial filling of prescription less than
the total quantity indicated in the prescription shall be
allowed,
- Pharmacist dispensing the last quantity
completing the prescription to keep the prescription
according to proper prescription recording guidelines.
- Fully filled prescription- pharmacist will
keep the prescription
Dispensing & Recording of Prescription
All prescription drugs must be dispensed only by the
Pharmacist. All prescription must be recorded in a record
book. Logbooks:
1) Prescription record book—kept in the drug store for 2
years
2) Dangerous drug book- kept for 2 years
3) Poisonous substances record book—5 years 4)
Referral logbook- kept for 2 years
Administration of adult vaccines as approved by
the FDA, provided that the pharmacist shall undergo
trainings for safe administration. (RA10918)
GHOST PHARMACIST
• Allowing the display of one's COR in a pharmaceutical
establishment where the pharmacist is not employed and
practicing. • is an act punishable by the law.
Handling of Dangerous Drugs:
- Yellow prescription is needed
(Triplicate copy)
- Physician must have a s-license (issued
DDB)
PROTECTION OF PHARMACISTS
- Forcing, coercing, or intimidating a duly
registered and licensed pharmacist to compound
or dispense medical and pharmaceutical products
in violation of the provisions of RA 10918.
HISTORY OF FDA PHIL
Francisco Duque Sr.
- Created a subcommittee on Food and Drugs in year
1961-62
- June 22, 1963 Republic Act No. 3720 -was passed into
law --known as the “Food, Drug and Cosmetic Act”
Hon. Jesus M. Azurin
- December 2, 1982, Executive Order No. 851 by Section
4, under the Minister of Health, The FDA was
abolished and created the BFAD
Ms. Catalina C. Sanchez
- was appointed the first Director of the BFAD on Feb.
20, 1984 and took her oath on Feb. 28, 1984
1987, R.A. 3720- was amended by Executive Order 175 to the
new title “Foods, Drugs, and Devices and Cosmetics Act”
2009: BFAD renamed as FDA (FDA Act of 2009)
PURPOSES OF R. A 3720
 Establish standards and quality measures for food,
drugs and devices and cosmetics
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 Adopt measures to ensure pure and safe supply of TERMINOLOGY?

foods, drugs, devices and cosmetics, in the country - All government health agencies and their personnel as well as
 Adopt measures to ensure the rational use of drugs other government agencies
- All medical, dental and veterinary practitioners, including
and devices private practitioners, shall write prescriptions using the generic
 Strengthen the FDA name. The brand name may be included if so desired.
- Any organization or company involved in the manufacture,
The manufacture, importation, exportation, sale, offering for sale, importation, repacking, marketing and/or distribution of drugs
distribution or transfer of any food, drug, device or cosmetic that is and medicines shall indicate prominently the generic name of
adulterated or misbranded is prohibited. the product.
- drug outlets, including drugstores, hospital and non-hospital
pharmacies and non-traditional outlets such as supermarkets
Refusal to permit entry or inspection or to allow samples and
to be collected by the Food & Drug Administration or other stores, shall inform any buyer about any and all other drug
appropriate government agency. products having the same generic name, together with their
ADULTERATED DRUGS AND DEVICES corresponding prices so that the buyer may adequately exercise,
 If it consists any filthy and putrid, decomposed, his option
substance PRESRIPTION ERRORS
 Prepared, packed or held under unsanitary conditions Prescription- Is a medication order written by a
 A drug and its container is composed of any poisonous physician, dentist or other license medical practitioner
or deleterious substance and given to the patient for presentation to the
 Contains for purposes of coloring only, a coal-tar color pharmacist.
other than a permissible one - It contains specific medication and dosage to be
 Represented as a drug the name of which is recognized administered to a particular patient.
in an official compendium, and its strength differs Prescriber’s Information
from, or its quality or purity falls below the standard set - the name of the prescriber, his specialty, clinic address,
 If it is a drug and any substance has been contact number and office hours.
- Mixed or packed therewith so as to reduce its quality or Patient’s Information
strength or - full name of the patient, address, age, sex, weight, body
- Substituted wholly or in part therfor surface area (if pediatric)
- If the methods/ facilities used do not conform with Date
cGMP - prescription are dated at the time they are written.
MISBRANDED DRUGS & DEVICES Superscription or Rx Symbol
1) If its labeling is false or misleading - Consist of the heading where the Rx symbol is found
2) If in a package form unless it bears a label containing (1) the - the dispensing direction to the pharmacist
name Transcription or Signa
and place of business of the manufacturer, packer or - Must contain the following:
distributor; (2) an accurate statement of the quantity of the 1. Route of administration
contents in terms of weight/ measure 2. Number of dosage unit per dose.
3) If any work or statement required by or under authority appear 3. Frequency of dosing
on the label or labeling is not prominently placed with such 4. Duration of dosing
conspicuousness 5. Use of the drug (optional)
RA 6675 Inscription - medication prescribed
is known as the Generics Law of 1988. It was signed into law on Must contain the following:
September 13, 1988. By: Former Pres. Corazon Aquino 1. Non-proprietary name (Generic Name)
A.O. No. 55 (Labelling Requirement) 2. Proprietary name (Brand name)
A.O. No. 62 (Prescribing Requirement) 3. Dosage form
A.O. No. 63 (Dispensing Requirement) 4. Strength
5. Quantity
PURPOSES
1) To promote, encourage, and require the use of generic Refill information - if not indicated, it is generally assumed that
terminology in the importation, manufacture, distribution, no refills needed.
marketing, advertising and promotion, prescription and dispensing Prescriber’s Signature - contains complete name and signature of
of drugs; the prescriber who wrote the prescription order. (includes: PRC
2) To ensure the adequate supply of drugs with generic names at number, PTR and TIN)
the lowest possible cost of endeavor to make them available for
free to indigent patients;
3) To encourage the extensive use of drugs with generic names
through a rational system of procurement and distribution;
4) 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; and
5) To promote drug safety by minimizing duplication in
medications and / or of drugs with potentially adverse drug
interactions.

GENERIC NAME
- simpler term for scientifically recognized AI of the drug v
Using GN reduce the cost of treatment by reducing the promotions
and advertising cost associated with branded products
WHO SHALL USE GENERIC

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1. PUBLIC
2. PHYSICIAN
3. COLLEAGUES
4. INTERNS/ PHARMACY ASSISTANTS

S-1 physicians/ doctors

S-2 prescribers
S-3 retailers
S-4 co- saler
S-5 compounders
S-6 researcher

Depot
Importers
Compounders
VIOLATIVE PRESCRIPTION Exporters
- Generic name is not written
- Generic name is illegible but brand name is
legible
- Both are written but with word “NO
SUBSTITUTION”
ERRONOUS PRESCRIPTION
- Brand name precedes generic name
- Generic is in parenthesis
- Brand is not in parenthesis
IMPOSSIBLE PRESCRIPTION
Only generic is written but not legible
-
Generic name does not match with
brand name
- Both written – both illegible
- Drug is not registered with DOH
CODE OF ETHICS
Professional ethics are used only to denote the set of ethical
principles perceived only by the professionals themselves to be
appropriate for their professional behavior. IMPORTANCE
- A Code of Ethics makes the decision-making process
more efficient
- Individual professionals may occasionally need
guidelines for directing their professional behavior.
- Professional ethics establish a pattern of behavior
which clients come to expect of members of the
profession.
Declaration of Principles:
– Provide efficient service in compounding and
filling of prescriptions and the dispensing of
drugs, chemicals, and medicines
– Special knowledge, skill, and integrity are
demanded on the part of those engaged in
Pharmacy
- – Pharmacists should pursue a prescribed course
of study and should pass a professional
examination.
- – Qualified pharmacists have a full recognition of
their responsibility for the preservation of
public health.
- The pharmacist should therefore ever bear in mind that
he is more than a merchant. (We are not “glorified
merchant” we are an integral part of the health care
team giving drug information to the public.)
DUTIES OF PHARMACISTS
TOWARDS THE:

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