QUALITY

CIRCLE for
GENERICS
ANGELICA MARIE GUEVARA – BOLOS
NATIONAL DRUG POLICY COMPLIANCE OFFICER
DEPARTMENT OF HEALTH REGION VIII
2018 Theme:

• “Tatlong Dekada: Generics, Abot

Kamay… Abot Kaya!”
 GENERICS ACT OF 1988
• aims to promote, require and ensure the
production supply, distribution, use and
acceptance of drugs and medicines using their
generic names
 What is a Generic medicine
Generic medicines are ‘copies’ of
originator branded products or “innovator”
drugs.
They contain the same active ingredients
and therefore should work as the more
expensive branded products provided that
they have passed the safety and quality
requirements of the Philippine Food and Drug
Administration (FDA).
 Why are Generic drugs actively
promoted by the Department of
Health?
Generics drugs offer substantial health and
economic benefits to patients, their families
and the national health system. The
affordability of these medicines will better
ensure that patients will complete their
treatment regimen and get well.
 The Philippine Generics Law (1988) contains
important provisions that champion the welfare
of the Filipino public through access to generics:

- Mandatory use of generic name in all

product labels, advertisement, doctor’s
prescriptions and drug outlets.

- Development and use of the Philippine

National Formulary in government procurement
and Phil-health reimbursement off medicines.
- Emphasis on the role of the pharmacists as
the source of information on available generically
products and their comparative prices.

- Empowerment of patients and consumers to

make informed choices through ethical drug
advertising and promotions.

- Incentives for manufactures to provide quality

generic products affordable to the Filipino public
and the government
Other Laws
a) Republic Act 9502, also known as
“Universally Accessible Cheaper and Quality
Medicines Act of 2008”
b) Republic Act 9711, also known as “Food and
Drug Administration (FDA) Act of 2009”
 Quality Circle for
• What is the

Generics?
 Quality Circle for Generics?
• a campaign to provide patients and
consumers with the best value in healthcare
by ensuring the safety, efficacy and
quality of a given medicinal products.
Quality Circle for Generics

• a practice and principle that should be

embodied by different stakeholders involved
in the regulation, manufacture, production,
prescription, dispensing, sale and use of
medicines.
 Quality does not depend solely on strong
regulations by the FDA but also adherence of all
players to the standards of quality which include:

Good Manufacturing Practices (GMP)

Good Laboratory Practices (GLP)
Good Clinical Practices (GCP)
Good Distribution Practices (GDP)
Good Storage Practices (GSP)
Good Pharmacy Practices (GPP)

Everyone has a stake in ensuring that generic

medicines fulfil their intended effects to provide cure
to patients as clinically tested and expected.
Why is Quality important?

Quality is important as this will ensure that

the product of the medicine will deliver the
clinically – tested effects of medicines when
used by the patients or consumers.
 Who are part of the Quality Circle for
Generics?
1. LEGISLATORS
• Provide the legal and policy
framework to assure the
quality of generic medicines
• Allocate adequate budget /
resources to ensure that
health regulators enforce
the provisions of health
laws.
2. REGULATORS
• Enforce the provisions of
the Generics Law (RA 6675)
and other pertinent laws
• Issue and update a sound
national medicines policy
anchored on the quality,
safety, efficacy and cost-
effectiveness of medicinal
products.
3.PHARMACEUTICAL INDUSTRY
• Produce and manufacture
quality generic drugs for the
Filipino public
• Adhere to the regulatory
standards on safety, efficacy
and quality as well as
ethical codes on the
promotions, marketing and
sale of medicinal products.
4. PRESCRIBERS
• Adhere to professional and
ethical standards on the
prescription and use of
medicines.
• Educate patients on the
benefits and rational use of
genetic medicines
5. DISPENSERS
• Source quality medicines
from reputable
manufactures, traders and
distributors.
• Ensure a safe , clean, and
secure dispensing
environment for generic
drugs
• Counsel individual patients
on generic drugs and give
informed choice to
consumers
6.CONSUMERS/PATIENTS
• Buy medicines only from FDA-
licensed outlets properly
authorized to dispense
medicines.
• Examine physically and visually
the medicines they purchase
to make sure that the right
product has a current expiry
date.
• Read product labels and follow
the advice of their physicians
and pharmacists to guarantee
that generic products work
 The DOH and FDA are committed in giving Filipino
patients only the highest standards of care through quality
generic medicines, we are aggressively pursuing the following
initiatives:

• Enforcement of cGMP • Formulation/ issuance of

requirement for all
manufacturers
• Expansion of the list of
medicines requiring proof of
Bioaviability and
Bioequivalence
• Regionalization of FDA
Laboratory Services
• Strengthening of the National
Pharmacovigilance Guidelines
the National Policy on the
Rational Use of Medicines
(RUM)
• Launching of the Philippines
Drug Price Reference Index
(PDPRI)
• Creation of a National
Procurement Strategy for
Medicines (NPSM)
 Generic Prescribing
• The Prescription
– a written order and instruction of a validly-
registered physician, dentist or veterinarian for
the use of a specific medicine (or medical device)
for a specific patient (A.O. 62 s. 1989 under R.A.
6675)
important requirement of Rx
• clear, legible and indicate precisely what should be given.
• The language used may be in English, Filipino, or the local
dialect

information required in Rx
• The patient’s name, age and sex;
• The prescriber’s name, office address, professional
registration number, and professional tax receipt number;
and
• Date of the prescription
Section 3 of the Generics Act

• Generic names shall be used in all prescriptions.

• The generic name must be written in full, but the
salt or chemical form may be abbreviated.
• The generic name must be clearly written
immediately after the Rx symbol or on the order
chart.(The symbol Rx means prescription which
originated in medieval manuscripts as an
abbreviation of the Latin verb recipe. The
imperative form is recipe which means “to take”
or “take thou”.)
• A brand name may also be included. If written
on a prescription pad, the brand name must
be enclosed in parentheses and written below
the generic name.
• Department Memorandum No. 2009-0009
(generics Only Prescribing) was issued on 07
January 2009 prohibiting government
physicians to prescribe branded medicines.
• The pharmaceutical form (e.g., “tablet”, “oral
solution”, “eye ointment”) should also be stated.
• The strength of the medicine should be stated in
standard units using abbreviations which are
consistent with the System International (SI).
• Avoid decimals whenever possible. If this is
unavoidable, a zero should be written before the
decimal point.
 : INCORRECT PRESCRIPTIONS :

A. Erroneous prescription:
– Where the brand name precedes the generic
name
– Where the generic name is the one in parentheses
– Where the brand name is not in parentheses
B. Violative prescription:
– Where the generic name is not written
– Where the generic name is not legible, and a
brand name which is legible is written
– Where the brand name is indicated and
instructions added (such as the phrase “no
substitution”) which tend to obstruct, hinder or
prevent proper dispensing
C. Impossible prescription:
– When only the generic name is written, but it is
not legible
– When the generic name does not correspond to
the brand name
– When both the generic and brand names are not
legible
– When the drug product prescribed is not
registered with the Philippine Food and Drug
Administration
What to do with incorrect Rx
• If erroneous prescription is received, the
prescription may be filled but it should be kept
and reported to the nearest Department of
Health (DOH) office for appropriate action.
• If a violative and impossible prescriptions are
not to be filled and should also be kept and
reported to the nearest DOH office.
 5 Tips to get the best value for your
money

1. Avail your medicines only from FDA-licensed

pharmacies. Check for the License to Operate
(LTO) issued by the FDA.
2. Discuss your treatment options with your
doctor. Doctors sometimes prescribe medicines
without regard to a patient's ability to pay.
3. Always ask for generics.
4. Follow the treatment regimen given by your
doctor. Take your medication as instructed by
the health provider.
5. Report any problems with your medicine to
the FDA. For any unusual reaction experienced
after taking your medicine, call the doctor
immediately and notify the FDA through its
hotline number: (02)8078275. Make sure to
keep a sample of the medicine for evaluation by
the FDA.
Thank you!