RA 6675 Flashcards
Republic Act. 6675
Generics Act of 1988
Approved Date of RA 6675
September 13, 1988
RA 6675 Statement of Policy
- 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 cost and endeavor to make them available for free to indigent patients;
- To encourage the extensive use of drugs with generic names through a rational system or procurement and distribution;
- 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
- To promote drug safety by minimizing duplication medications and/or use of drugs with potentially adverse drug interactions.
List of drugs prepared and **periodically updated **by the DOH on the basis of health conditions in Phil.
Essential Drug List or National Drug Formulary
List of drugs that ** meet** the** health care needs** of the majority of the population
Core List
List of alternative drugs used when there is no response or hypersentivity reaction to core essential drugs.
Complementary List
Section 6. Who Shall Use Generic Terminology
(a) All government health agencies and their personnel as well as other government agencies
(b) All medical, dental and veterinary practitioners, private practitioners, shall write prescriptions using the generic name.
(c) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product.
(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores, shall inform any buyer about drug products having the same generic name, prices so that the buyer may adequately exercise, his option.
(e) “This product has the same therapeutic efficacy as any oter generic product of same name” shall appear prominently on the label (BFAD - Amended under 9502)
Section 4. The Use of Generic Terminology for Essential Drugs and Promotional Incentives
In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared within one hundred eighty (180) days
Updated quarterly by the Department of Health on the basis of health conditions obtaining in the Philippines and internationally accepted criteria.
Section 8. Required Production
Every drug manufacturing company operating in the Philippines shall be required to produce, distribute and make available to the general public the medicine it produces, in the form of generic drugs.
Section 10. Authority to Import
Within **3 years ** from the effectivity of this Act, extendible by the President for another **two years ** and during periods of critical shortage and absolute necessity , the DOH is hereby authorized to import raw materials of which there is a shortage for the use of Filipino-owned or controlled drug establishments to be marketed and sold exclusively under generic nomenclature.
The President may authorize the importation of raw materials **tax **and duty-free.
Section 11. Education Drive
The DOH, Dept. of Educ, Culture and Sports, Philippine Information Agency and the DILG.
* A continuous information campaign for the public
* A continuing education and training for the medical professions on drugs with generic names as an alternative to brand name drugs. Including information on the illnesses or symptoms and contraindications.
The DOH, Department of Local Government and the Philippine Information Agency
* Monitor the progress of the education drive
* Shall submit regular reports to Congress.
ADMINISTRATIVE ORDER NO. 62 Series of 1989
RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS UNDER THE GENERICS ACT OF 1988 (R.A. 6675)
ADMINISTRATIVE ORDER NO. 62 Series of 1989
Prescription
Generic Prescribing
Dispensing
Generic Dispensing
Generic Name
A written order and instruction of a validly registered physician, dentists or veterinarian for the use of a specific drug product for a specific patient.
Prescription
Prescribing of drugs or medicines using their generic name(s) or generic terminology.
Generic Prescribing
Act by a validly-registered pharmacist of filling a prescription or doctor’s order on the patient’s chart.
Dispensing
A.O. No. 62, S. 1989
Sec. 2 Guidelines On Dispensing Based on Prior Laws
Only validly registered practitioners are authorized to prescribed drugs.
Prescribing by unauthorized persons constitutes illegal practice of Medicine, Dentistry, or Veterinary
All Rx must contain necessary information
Reqs for drugs in List A (Annex I) Prohibited and Regulated Drugs
S2 License (Prescriber)
Special DDB precription Form
Recording system folling pertinent DDB regulation
Reqs for drugs in List B (Annex B) Prohibited and Regulated Drugs
After Rx symbol, write clearly (List B) before the generic name
Following information must accurately written:
* Generic Name of API, specific salt, or chemical Form
* Manufacturer
* brand Name
* Strength/Dose
* Delivery System
Sec. 3 Additional Guidelines on Prescribing
- Generic Names used in all prescription
- The generic name must be written in full but the salt/chemical form may be abbreviated
- The generic name must be written clearly on the prescription immediately after Rx symbol or on order chart
AO 62 Sec 4
Violative Prescription
GN is not written
GN is not elgible, BN is legibly written
“No substitution”
SHALL NOT BE FILLED.
Advice prescriber, instruct customer to get proper prescription.
Keep and report to DOH office
Impossible Prescription
GN is written but illegible
GN does not correspond to BN
Both GN and BN are not legible
Drug is not registered with BFAD
SHALL NOT BE FILLED.
Advice prescriber, instruct customer to get proper prescription.
Keep and report to DOH office
Erroneous Prescription
BN precededs GN
GN is in parenthesis
BN is not in parenthesis
SHALL BE FILLED.
Keep and report to DOH office
ADMINISTRATIVE ORDER NO. 90 Series of 1990
Amendment to A.O. 62 s. 1989
re: Rules and Regulations to Implement Prescribing Requirements
Approved date of ADMINISTRATIVE ORDER NO. 90 Series of 1990
April 23, 1990
Approved date of A.O. No. 62, S. 1989
March 15, 1989
A.O. No. 62, S. 1989
Sec 1 Amendment
Permits the writing of the GN of more than one drug product in one prescription form
When does a prescriber allowed not to use a Special Precription form for Dangerous Drugs (SPFDD)
All oral forms of FDA registered drug prep in the Phil Schedule 4 and 5
But should be prescribed in ordinary Rx-triplicate copies
Emergency Situation: Authorization for Emergency Dispensing
The drug prescribed and dispended must be limited to the quantity needed to treat the patient during the emergency period
AO No. 63 S. 1989
Rules and Regulation to Implement Dispensing Requirements under the Generics Act of 1988
Approval Date of AO No. 63 S. 1989
March 16, 1989
Dispensing the patient’s/buyer’s choice from among generic equivalents
i.e., finished pharmaceutical products having the same active ingredient(s), same dosage form and same strength as the prescribed drug.
Generic Dispensing
Dispensing less than the total number of unit required
Partial filling
Drugstore, pharmacy, and other business establishment which sells drugs or medicines
Drug Outlets
Can only be dispensed upon a written order of validly registered physician, dentist or veterinarian
Prescription/Ethical Drugs
Can be dispensed without a prescription
Non-prescription or OTC drugs
In Drug outlets
Inform patient of available drug proucts genericallly equivalent
Post in visible place a list of drug products using generic names with prices
In hospital pharmacies
Inform patient about drug policies or reserve option to buy drugs outside the hospital pharmacy
If operating in acceptable formulary system and pricing policy determined by the DOH, exempted from:
* Recording of prescriptions filed in the record book, kept for 2 years
* Generic dispensing
Reqs for Partial Filling of Prescription in List A and B
Date of partial filling
Quantity served and balance unserved
Generic dispensing
Name and address of drug store
Dispensing Drugs in List A/B
Must be done by Pharmacist with signature on Rx filled
Follow instruction of prescriber
Partial filling of drugs in List A is strictly not allowed
Violation of the part of Dispensers and Buyers
Imposing a particulr bran on the buyer
Inaccurate dispensing
Falure to:
Post accessible the required up to date info on drug products
Inform buyer on available products that meet the prescription
Indicate the GN designated by FDA
Record and keep prescription filled
Report to DOH office cases of prescription erros with 3 months
Where to report non-compliance
DOH Office
Who will impose the revocation and suspension of the LTO of the drug outlet
Secretary of Health
PRC for Professional
