The document discusses strengthening support for the Philippine Drug Enforcement Agency and promoting generic drug use in the Philippines. It notes that the Philippine Drug Enforcement Agency was created to efficiently enforce drug laws and the Dangerous Drugs Board is responsible for drug policy. It also explains that generic drugs contain the same active ingredients as branded drugs but are cheaper due to differences in patenting, production, and advertising costs. The document outlines how government agencies, medical practitioners, and drug outlets should use generic drug names and how pharmacists can apply the generic drug law.
Original Description:
Original Title
Topic 3.2_ Philippine Drug Regulations and Legislations
The document discusses strengthening support for the Philippine Drug Enforcement Agency and promoting generic drug use in the Philippines. It notes that the Philippine Drug Enforcement Agency was created to efficiently enforce drug laws and the Dangerous Drugs Board is responsible for drug policy. It also explains that generic drugs contain the same active ingredients as branded drugs but are cheaper due to differences in patenting, production, and advertising costs. The document outlines how government agencies, medical practitioners, and drug outlets should use generic drug names and how pharmacists can apply the generic drug law.
The document discusses strengthening support for the Philippine Drug Enforcement Agency and promoting generic drug use in the Philippines. It notes that the Philippine Drug Enforcement Agency was created to efficiently enforce drug laws and the Dangerous Drugs Board is responsible for drug policy. It also explains that generic drugs contain the same active ingredients as branded drugs but are cheaper due to differences in patenting, production, and advertising costs. The document outlines how government agencies, medical practitioners, and drug outlets should use generic drug names and how pharmacists can apply the generic drug law.
AGENCY WHEREAS, by virtue of the Comprehensive Dangerous Drugs Act of 2002 (Republic Act R.A. No. 9165), the Philippine Drug Enforcement Agency (PDEA) was created for the efficient and effective law enforcement of all the provisions on dangerous drugs and/or precursors and essential chemicals as provided in R.A. No. 9165;
WHEREAS, pursuant to R.A. No. 9165, the Dangerous Drugs
Board (DDB) is the policy-making and strategy-formulating body in the planning and formulation of policies and programs on drug prevention and control.
WHEREAS, R.A. No. 9165 provides for the abolition of the
drug enforcement units of the Philippines National Police (PNP), the National Bureau of Investigation and Bureau of Customs;
GENERICS ACT OF 1988 (REPUBLIC ACT NO. 6675)
This (RA 6675) Act, consisting of 15 sections, declares the policy to promote, require and ensure the production of adequate supply, use and acceptance of drugs (including for animal use) identified by their generic names. Its’ objectives are: to promote, encourage, and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising, and promotion, prescription, and dispensing of drugs; to ensure the adequate supply of drugs with generic names at the lowest possible.
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. A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics.
BOTH BRANDED AND GENERIC DRUGS ARE
IDENTICAL IN TERMS OF: ❖ Content ➢ Generic drugs have the same active ingredient to their branded counterparts. ❖ Quality ➢ Safety ➢ Efficacy ➢ Purity ➢ Potency
BRANDED DRUGS ARE MORE EXPENSIVE DUE TO:
❖ Patenting Cost ❖ Production Cost ❖ Advertising
WHO SHALL USE GENERIC TERMINOLOGY?
❖ All government health agencies and personnel ❖ All medical, dental, and veterinary practitioners & private practitioners
Every manufacturing company has a generic coounterpart of
their branded meds. HOW CAN PHARMACISTS APPLY THE LAW? 1. Provide generics menu card with updated prices. Let the client choose.
DRUG INFORMATION RESOURCES
❖ The nurse, as well as other health professionals who may prescribe, dispense, or administer medication, requires reliable and current drug information. Such a need is heightened when one considers the constant dynamic changes in pharmacology. Dozen of new drug products are released every year and recent years have seen several drug recalls. ❖ In an institution, the most readily available source of drug information may be the institution’s drug formulary. This is a continually revised (usually semi-annually) compilation of drugs and drug products available for use in an institution. ❖ Drug Information Handbook ➢ The drug information section of the handbook lists all drugs alphabetically by generic name with extensive cross-referencing provided by U.S. brand names, Canadian brand names, and index terms.
THE PRODUCT/PACKAGE INSERT
❖ A product insert is a detailed description of a drug product that is required to be included in the package of all legal drug products sold in the United States. The contents of the product insert must be approved by the FDA before the drug can be marketed. The insert must be periodically updated to represent the current information available about the drug.