Control of the Practice of Pharmacy
Physical-chemical analyses for medical devices used in
R.A. 10918: Philippine Pharmacy Act
- “An act regulating and modernizing the practice of pharmacy in
the Philippines repealing for the purpose R.A. 5921 (Pharmacy
Law).”
Legal Control
Article 1, Section 3
1. Standardization and regulation of pharmacy education;
2. Administration of licensure examination, registration,
and licensing of pharmacists;
3. Supervision control, and regulation of the practice of
pharmacy in the Philippines;
4. Development and enhancement of professional
competence of pharmacists through continuing
professional development, research, and other related
activities;
5. Integration of the pharmacy profession
Board of Pharmacy
§ Chairman + 2 members
§ Supervised by the Professional Regulation Commission
(PRC)
§ Functions:
o Examine applicants for the practice of
Pharmacy
o Issue certificates of registration of pharmacists
o Reprimand any pharmacist or suspend or
revoke his certificate of registration
o Promulgate rules and regulation as necessary
o Regulate and monitor the practice of pharmacy
in the Philippines
Practice of Pharmacy (Article 1, Section 4)
1. Prepare, compound or manufacture, preserve, store,
distribute, procure, sell, or dispense, or both, any
pharmaceutical product or its raw material
2. Render services such as:
a. Clinical pharmacy
b. Drug information
c. Regulatory
d. Pharmaceutical marketing
e. Medication management
Whenever the expertise and technical knowledge of the
pharmacist is required
3. Engage in teaching scientific, technical, or professional
pharmacy courses in a school or college of pharmacy
4. Dispense pharmaceutical products in situations where
supervision of dispensing pharmaceutical products is
required
5. Chemical, biological or microbiological analyses and
assay of pharmaceutical products, food/dietary
supplements, health supplements, and cosmetics
6.
aid of administration of pharmaceutical products
7. Administration of vaccines as approved by the FDA
8. Conduct or undertake scientific research in all aspects
involving pharmaceutical products and health care
9. Provide other services where pharmaceutical knowledge
is required
Requirements for the Opening and Operation of
Pharmaceutical Outlet or Establishment (Article 4, Section
38)
§ In accordance with the rules and regulations prescribed
by Phil. FDA
§ Application is signed by a Filipino registered
pharmacist
Administration of Adult Vaccines (Article 4, Section 40)
§ Trained pharmacist shall administer adult vaccines
§ Doctor’s prescription (n.m.t 7 days) is required for the
vaccination
§ Submit a monthly vaccination report and Adverse Event
Following Immunization (AEFI) to DOH
Definition of Terms (Article 1, Section 5)
• Brand Name. Proprietary name given by the
manufacturer to distinguish its products from
competitors
• Generic Name. Scientifically and internationally
recognized name of the active ingredients
• Medicines. Drugs in their appropriate dosage forms,
with assured quality, safety and efficacy for humans and
animals
• Dispensing. Sum of processes performed by a
pharmacist, from reading, validating, validating &
compounding prescriptions, preparing, packaging,
labeling, record keeping, dose calculations, and
counseling or giving information in relation to sale or
transfer of pharmaceutical products, with or without
prescription.
• Cosmetics. Substance or preparation intended to be
placed in contact with external parts of the body or with
teeth and the mucous membrane of the oral cavity
• Household Remedies. Any preparation containing
pharmaceutical substances of common or ordinary use
to relieve common physical ailments; may be dispensed
without medical prescription in original packaging
• Biopharmaceuticals. Pharmaceutical products that are
used for therapeutic or for in vivo diagnostic purposes
(i.e. vaccines, sera, and drug derived from life forms
using biotechnology)
• Institutional Pharmacies. Pharmacies of institutions,
organizations and/or corporations that provide a range
of pharmaceutical services, given exclusively to the
employee or their qualified dependents
 • Medical Device. Instrument, apparatus, implement,
machine, etc. intended by the manufacturer to be used
alone, or in combination, for human beings
• Adulterated/Deteriorated Pharmaceuticals,
Proprietary Medicine or Pharmaceutical Specialties.
Any drug, preparation or mixture of drugs, mixed under
a trade name and intended for the cure, mitigation, or
prevention of disease
• Counterfeit Pharmaceutical Products.
Pharmaceutical products with do not contain the
amount as claimed; with wrong ingredients; without
active ingredients; or with insufficient quantity of active
ingredients
• Food/Dietary Supplements. Processed food products
intended to supplement the diet that contains one or
more of the dietary ingredients (i.e. vitamins, minerals,
herbs, amino acids, dietary substances)
• Health Supplements. Products that are used to
maintain, enhance, and improve health function of the
human body and contains herbal fatty acids, enzymes,
probiotics, and other bioactive substances.
R.A. 6675: Generics Act of 1988
- “An act to promote, require, and ensure that the production of
an adequate supply, distribution, use and acceptance of drugs and
medicines identified by their generic name.”
Statement of Policy (Sec. 2)
§ Promote, encourage, and require the use of generic
terminology
§ Ensure adequate supply of drugs with generic names at
the lowest possible cost and free to indigent patients
§ Encourage the extensive use of drugs with generic name
through a rational system of procurement and
distribution
§ Emphasize the scientific basis for the use of drugs
§ Promote drug safety by minimizing duplication in
medicine
Definition of Terms (Sec. 3)
• Brand Name. Proprietary name given by the
manufacturer to distinguish its products from
competitors
• Generic Name. Identification of drugs by their
scientifically and internationally recognized active
ingredients or their official generic name as
determined by the FDA and DOH.
• Generic Drug. Drugs not covered by patent
protection and are labeled solely by international
non-proprietary or generic name
• Active Ingredient. Chemical component
responsible for claimed therapeutic effect of the
product
• Chemical Name. Description of the chemical
structure of the drug and serves as the complete
identification of a compound
• Drug Products. Finished product form that
contains the active ingredients, generally but not
necessarily associated with inactive ingredients
• Drug Outlets. Drugstores, pharmacies, and other
business establishments that sell drugs
• Complimentary List. List of alternative drugs
used when there is no response to the core essential
drugs or when there is a hypersensitivity reaction to
the core drug or core drug cannot be given
• Core List. List of drugs that meet the health care
needs of the majority of the population
Generic terminologies are used by (Sec. 6):
1. All government agencies and their personnel during
the entire medication use process
2. All medical, dental, and veterinary practitioners in
prescribing
3. Any organization or company involved in
manufacture, importation, repacking, marketing
and/or distribution of drugs and medicine
4. Drug outlets, including drugstores, hospital, and
non-hospital pharmacies and non-traditional outlets
such as supermarkets and stores
Ethical Control
Ethics
§ Philosophical science dealing with the morality of
human act
§ Deals with right conduct directed towards the formation
of the individual
Special Ethics
§ Deals with application of the general principles or
morality to the particular actions of man as individuals
and as a member of society
Professional Ethics
§ The less the public know about the quality and
techniques of a human activity, the greater is the
opportunity of transgressing the standards of equity and
charity by those who have the know-how
§ For self-government of its members
Objectives of Professional Code of Ethics
1. To define professional privileges, behavior and
responsibilities towards the members of the same
profession and towards the members of the community
in general
2. To promote professional quality, professional conduct
and a moral method of procedure
3. To defend private professions from undue interference
by the government or other private agencies
4. To preserve the dignity of the profession and the
confidence of the public
5. To defend clients from unscrupulous professionals
6. To fix certain standards of compensation for services or
work

Ethics of Pharmacy
§ Primary consideration = SERVICE
§ Dedicated to preservation, promotion, and protection of
the nation’s health
§ Economic gain is important, legal compliance is
compulsory and social prestige is desirable
o Material gain is necessary but could remain a
secondary motive
o We cannot legislate morality
o Service and not material gain is the true
measure of success
§ Serves as guidelines for pharmacists in their relationship
with
1. The public
2. Other members of the health profession
3. Fellow pharmacists
The Public
§ Drugs of good quality
o Reputation and integrity of the
manufacturer should be considered
o Consult references like USP/NF
§ Conformity to laws
o Explain the pertinent legal
requirements, the purpose of those
requirements, and the proper
procedure to follow
§ Confidential information
o Only when patient’s welfare is at
stake may such a secrecy may be
disclosed
§ Physical facilities
o Appropriate environmental
condition for storage, quality of
professional service, professional
appearance of pharmacy staff,
displays, and general décor
o Should describe complete dedication
to advancing public health through
professional practice
§ Civic responsibilities
o Be an example of responsible
citizenship
- Informed and enlightened voter,
supporter of constructive efforts
for public welfare, firm upholder
of duty constituted authority,
participate in community
program on public health
§ Renumeration
o The value of life itself represents the
actual worth of their services
o Fees should commensurate with the
services rendered and with the
professional training
§ Pharmacist-Patient-Prescriber relationship
o Promote a close relationship with
patients
- Personal contact in receiving and
delivering Rx
- Attend and supervise sales of
OTC and other supplies
- Provide professional advice and
counsel
o Strengthen pharmacist-prescriber
professional relationship
- Invite him to pharmacy
- Keep him informed of unusual
patient problems, reactions, and
progress
- Provide updates on medications
- Participates in inter-professional
meetings
Other Members of the Health Profession (Inter-
professional Relations)
§ Drug consultant
o Drug experts = most knowledgeable
person regrading drugs
§ Diagnosing and Prescribing
o Pharmacist are not qualified to
diagnose and treat diseases
o Auto-therapy (self-medication)
Advantages disadvantages
Relieve the overloaded Treats only symptoms and not
medical profession the cause
Human instinct to self- Misuse and abuse of drug
medicate therapy
Home remedies are highly Misinterpretation of printed
effective and are now strictly directions & precautions
regulated
Self-medication can be Delays treatment
psychologically useful
§ Compounding and dispensing prescription
o Pharmacists are responsible for the
accuracy, quality, and safety of the
prescribed medication
§ Clandestine arrangements
o Exploitation of patients by certain
arrangements of the pharmacist with
other members of the healthcare
team should never be done
o Conflict of interest
§ Interpersonal Relationship
o Requires combined and cooperative
efforts of a team
 o Opportunities for a successful inter-
professional relationship
1. In-service visits between
practitioners
2. Co-sponsored seminars and
other professional meetings
3. Participation in inter-
professional and public health
activities
4. Formal and informal
correspondence related to
problems and plans of mutual
interest
5. Social and community
intercourse

Fellow Pharmacists (Intra-professional Relations)

§ Self-improvement
o Regular reading is the key to keeping
current with the practice
o Pharmaceutical research is valuable
tool of self-improvement
§ Recruitment
o Pharmacists should attract and
encourage promising, responsible
and superior student of good
character to pursue pharmacy
programs
§ Instruction
o Every pharmacist is a teacher by
precept and example
§ Professional Organization
o Pharmaceutical problems need group
effort
§ Unethical Practices
o Prevention and elimination of
unethical practices
o To function effectively, a profession
should police itself
§ Intra-professional relations
o Selfish interest should be
subordinated to public interest
o Service should always be the primary
objective of every pharmacist