[SPECIAL DRUG CLASSIFICATIONS] RA 6675

Generics Act of 1988

[SECTION 1 - TITLE]

RA 6675 is also known as _______

● Mandatory Generic Use: Requiring generic terminology in importation, manufacture, distribution, advertising, prescription, and dispensing

● Accessibility: Ensuring adequate supply at the lowest possible cost, including free medicines for indigent patients

● Scientific Awareness: Emphasizing active ingredients to guide therapeutic effectiveness rather than brand names

● Safety: Reducing therapeutic duplication and preventing adverse drug interactions

[SECTION 2 - STATEMENT OF POLICY]

The state's mandates include:

Mandatory Generic Use:

[SECTION 2 - STATEMENT OF POLICY]

The state's mandates include:

Requiring generic terminology in importation, manufacture, distribution, advertising, prescription, and dispensing.

Accessibility

[SECTION 2 - STATEMENT OF POLICY]

The state's mandates include:

Ensuring adequate supply at the lowest possible cost, specifically targeting free medicine for indigent patients.

Scientific Awareness

[SECTION 2 - STATEMENT OF POLICY]

The state's mandates include:

Shifting focus to the active ingredients so health professionals understand therapeutic effectiveness rather than just brand names

Safety

[SECTION 2 - STATEMENT OF POLICY]

The state's mandates include:

Reducing "therapeutic duplication" (taking two brands of the same drug) and preventing adverse interactions.

Generic Name

[SECTION 3 - DEFINITION OF TERMS]

Scientifically recognized active ingredients or the official name determined by the Bureau of Food and Drugs (BFAD), now known as the FDA.

Active Ingredient

[SECTION 3 - DEFINITION OF TERMS]

The chemical component responsible for the therapeutic effect.

Chemical Name

[SECTION 3 - DEFINITION OF TERMS]

The complete identification of a compound via its chemical structure.

Drug Product

[SECTION 3 - DEFINITION OF TERMS]

The finished product containing active (and often inactive) ingredients.

Essential Drugs List (EDL)

[SECTION 3 - DEFINITION OF TERMS]

Also called the National Drug Formulary; updated quarterly by the DOH.

National Drug Formulary

[SECTION 3 - DEFINITION OF TERMS]

Essential Drugs List (EDL) is also called the _________; updated quarterly by the DOH.

quarterly

[SECTION 3 - DEFINITION OF TERMS]

Essential Drugs List (EDL) is updated ______ by the DOH.

DOH

[SECTION 3 - DEFINITION OF TERMS]

Essential Drugs List (EDL) is updated quarterly by the _____.

Core List

[SECTION 3 - DEFINITION OF TERMS]

Drugs meeting the health needs of the MAJORITY of the population

Complementary List

[SECTION 3 - DEFINITION OF TERMS]

ALTERNATIVE drugs used when core drugs fail, cause hypersensitivity, or are unavailable

Generic Drugs

[SECTION 3 - DEFINITION OF TERMS]

Drugs not covered by patent protection labeled solely by their generic name.

Board of Investments (BOI) and DOH

[SECTION 4 - INCENTIVES]

Under Sections 4, who provide incentives to companies that exclusively use generic terminology in manufacturing and marketing?

Annually and at least two newspapers

[SECTION 5 - PUBLICATION]

According to Section 5, how often must the DOH publish the list of generic and brand name drugs, and in how many newspapers must it be published?

● Government

● Private Practitioners

● Manufacturers

● Drug Outlets

[SECTION 6 - MANDATORY USAGE]

These establishments are subject to the mandatory use of generic names.

TRUE

[SECTION 6 - MANDATORY USAGE]

TRUE OR FALSE:

6(a) Government:

All government agencies (and personnel) must use generic names in purchasing, prescribing, dispensing, and administering.

Private Practitioners

[SECTION 6 - MANDATORY USAGE]

TRUE OR FALSE:

6(b) Private Practitioners:

All doctors, dentists, and veterinarians must write prescriptions using the generic name. The brand name is OPTIONAL and may be included in parentheses.

TRUE

[SECTION 6 - MANDATORY USAGE]

TRUE OR FALSE:

6(c) Manufacturers:

The generic name must appear prominently and, in branded products, immediately ABOVE the brand name on all labels and ads.

TRUE

[SECTION 6 - MANDATORY USAGE]

TRUE OR FALSE:

6(d) Drug Outlets:

Pharmacists must inform buyers of all available products with the same generic name and their prices. They must also post a "Generic Menu Card" or price list in a conspicuous place.

"Generic Menu Card" or price list

[SECTION 6 - MANDATORY USAGE]

6(d) Drug Outlets:

Pharmacists must inform buyers of all available products with the same generic name and their prices. They must also post a_______ in a conspicuous place.

● Name of manufacturer

● Country of manufacture

● Date of manufacture

● Expiration date

[SECTION 7 - LABELING]

Labels must contain the:

TRUE

[SECTION 8 - REQUIRED PRODUCTION]

TRUE OR FALSE:

Every drug manufacturer in the Philippines is required to produce and distribute their medicines in generic form.

TRUE

[SECTION 10 - AUTHORITY TO IMPORT]

TRUE OR FALSE:

During shortages, the DOH can import raw materials for Filipinoowned drug establishments to be sold exclusively under generic names.

● Department of Health (DOH)

● Department of Education (DepEd)

● Philippine Information Agency (PIA)

● Department of the Interior and Local Government (DILG)

[SECTION 11 - EDUCATION DRIVE]

A continuous campaign by the _______ to teach the public and professionals that generics are an alternative of equal efficacy to expensive brands.

Reprimand (Recorded by PRC)

[SECTION 12 - PENALTY MATRIX FOR PRACTITIONERS]

What is the penalty for a FIRST conviction of practitioners who violate Sections 6(a) or 6(b)?

Fine: ₱2,000 - ₱5,000

[SECTION 12 - PENALTY MATRIX FOR PRACTITIONERS]

What penalty is imposed for a SECOND conviction under Section 12?

● Fine: ₱5,000 - ₱10,000

● 30- day license suspension

[SECTION 12 - PENALTY MATRIX FOR PRACTITIONERS]

What are the penalties for a THIRD conviction for violating Sections 6(a) or 6(b)?

● Fine: at least ₱10,000

● License suspension for 1 year or longer

[SECTION 12 - PENALTY MATRIX FOR PRACTITIONERS]

What penalties apply starting from the FOURTH and subsequent convictions?

● Fine: ₱5,000 - ₱10,000

● Revocation of License to Operate (LTO).

[SECTION 12 - PENALTY FOR ESTABLISHMENTS]

What are the penalties for establishments that violate the generic usage law?

Subject to ipso facto deportation after serving their sentence

[SECTION 12 - PENALTY FOR ESTABLISHMENTS]

What is the consequence for ALIENS working in establishments who violate the law?

TRUE

[SECTION 13 - SEPARABILITY]

TRUE OR FALSE:

If one part is declared invalid, the rest remains in force.

TRUE

[SECTION 14 - REPEALING]

TRUE OR FALSE:

RA 6675 overrides any previous laws inconsistent with this Act.

15 days

[SECTION 15 - EFFECTIVITY]

How many days after publication did the law take effect?

September 13, 1988

[SECTION 15 - EFFECTIVITY]

When was the approval date of the law?

Erroneous Prescriptions

[PRESCRIPTION ERRORS]

These are prescriptions that contain the required information but in the wrong format.

Erroneous Prescriptions

[PRESCRIPTION ERRORS]

The brand name precedes the generic name (e.g., Ponstan (Mefenamic Acid)).

Erroneous Prescriptions

[PRESCRIPTION ERRORS]

The generic name is in parentheses (e.g., Biogesic (Paracetamol)).

Erroneous Prescriptions

[PRESCRIPTION ERRORS]

The brand name is NOT in parentheses (e.g., Paracetamol Biogesic).

Erroneous Prescriptions

[PRESCRIPTION ERRORS]

Pharmacist's Action: SHALL BE FILLED.

The prescription must be kept and reported to the DOH for the prescriber's guidance.

AO No. 90 s. 1990

[PRESCRIPTION ERRORS]

Previously, writing more than one drug product on a single prescription was "erroneous," but AO _______ now allows multiple generic drugs on one form.

Violative Prescriptions

[PRESCRIPTION ERRORS]

These are prescriptions where the generic name is missing or the prescriber is intentionally hindering generic dispensing.

Violative Prescriptions

[PRESCRIPTION ERRORS]

The generic name is not written (only the brand name is present).

Violative Prescriptions

[PRESCRIPTION ERRORS]

The generic name is illegible, while the brand name is legibly written.

Violative Prescriptions

[PRESCRIPTION ERRORS]

The prescriber adds instructions like "No Substitution" or "Dispense only this brand."

Violative Prescriptions

[PRESCRIPTION ERRORS]

Pharmacist's Action:

● SHALL NOT BE FILLED

● The pharmacist must keep the prescription and report it to the DOH

● Instruct the patient to go back to the doctor for a proper prescription

Impossible Prescriptions

[PRESCRIPTION ERRORS]

These occur when the information provided makes it impossible to identify the correct medication safely.

Impossible Prescriptions

[PRESCRIPTION ERRORS]

Only the generic name is written, but it is illegible.

Impossible Prescriptions

[PRESCRIPTION ERRORS]

The generic name does not match the brand name (e.g., Amoxicillin (Biogesic)).

Impossible Prescriptions

[PRESCRIPTION ERRORS]

Both the generic and brand names are illegible.

Impossible Prescriptions

[PRESCRIPTION ERRORS]

The drug product prescribed is not registered with the FDA

Impossible Prescriptions

[PRESCRIPTION ERRORS]

Pharmacist's Action:

● SHALL NOT BE FILLED

● Keep and report the prescription to the DOH

● Advise the prescriber and instruct the patient to get a new, correct prescription