Hay Republic of the Philippines Department of Health OFFICE OF THE SECRETARY Manila

March 9, 1989 ADMINISTRATIVE ORDER No. 62 s. 1989 SUBJECT: Rules and Regulations to Implement Prescribing Requirements under the Generics Act of 1988 (R.A. No. 6675)

Pursuant to Section 9 in relation to Section 6 (a) and 6 (d) of R.A. 6675 known as Generics Act of 1988, and the pertinent provisions of R.A. 3720 known as Food, Drugs and Devices and Cosmetics Act", as amended by Executive Order No. 175 s 1987, RA 5921 known as the Pharmacy Act and R.A. 4224 and R.A. 5946; R.A. 4419 known as the Dental Act, R.A. 382 known as the Veterinary Act, and R.A. 6425 known as the Dangerous Drug Act of 1972 as amended, the following rules and regulations are hereby promulgated: SECTION 1 1.1 Definition of Terms Prescription is the written order and instruction of a validly registered physician, dentists or veterinarian for the use of a specific drug product for a specific patient. For the purpose of these Rules and Regulations, the doctors order on the patients chart for the use of specific drug(s) shall be considered a prescription. Generic Prescribing is prescribing of drugs or medicines using their generic name(s) or generic terminology. Dispensing is the act by a validly-registered pharmacist of filling a prescription or doctor's order on the patient's chart. Generic Dispensing means 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 name or generic terminology is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official name as Drugs means (1) articles recognized in the current official United States Pharmacopoeia-National Drug Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Official Philippine National Drug Formulary, or any supplement to any of them, and (2) articles intended for use to diagnosis, cure, mitigation, treatment or prevention of disease in man or animals; and (3) articles (other than food) intended to affect the structure or function of the body of man or animals; and (4) articles intended for use as a component of any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories. Drug product or medicine is the finished form that contains the active ingredient(s), generally, but not necessarily in association with inactive ingredients.

1.2

1.3

1.4

1.5

1.6

1.7

1.7.1

Prescription or ethical drugs are pharmaceutical products or drug preparation that are to be dispensed only upon written order of a validly-registered licensed physician, dentist or veterinarian for the management or treatment of a condition or disease. Non-prescription or over-the-counter drugs are pharmaceutical products or drug preparations that can be dispensed even without the written order of a validly registered licensed physician, dentist or veterinarian, for the use of consumers for the prevention or symptomatic relief of minor or self-limiting ailments.

1.7.2

1.8

Dangerous drugs refer to either prohibited drugs or regulated drugs which require a special prescription form, the use of which is monitored by the Dangerous Drugs Board. 1.8.1 Prohibited drugs include opium and the active components and derivatives such as heroin and morphine; coca leaf and its derivatives, principally cocaine, alpha and beta Eucoine, hallucinogenic drugs, such as masculine, lysergic acid diethylamide (LSD) and other substances producing similar effects: Indian hemp and its derivatives; all preparations made derivatives; all preparation made from any of the foregoing; and other drugs, whether natural or synthetic, with the physiological effects of a narcotic drug. Regulated drugs includes sleep-inducing sedatives, such as secobarbital, Phenobarbital, barbital amobarbital and other drugs which contain a salt or derivative of a salt of barbituric acid; any salt, isomer or salt of an isomer, of amphetamine, such as Benzedrine or denadrine and hypnotic drugs such as , or ay other compound producing similar pharmacologic effects

1.8.2

1.9

Drug Outlets means drugstore, pharmacy and other business establishment which sells drugs or medicines. Guidelines On Dispensing Based on Prior Laws Prior to the Generic Act of 1988, the following general guidelines on dispensing have been operative. In order to have an integrated implementation of all relevant guidelines on dispensing, these guidelines based on prior laws are restated hereunder: 2.1. Prescription or Ethical Drugs These drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian. 2.2 Non-Prescription or Over-the-Counter (OTC) Drugs These drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing OTC drugs without a doctor's prescription, the pharmacist shall give the necessary information and direction for use of the drug. 2.3. All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a prescription book duly-registered by BFAD which shall be open for inspection to Food and Drug Inspectors at any time during business hours of the outlet. These prescription book shall be kept for two years after the last entry.

Section 2

Section 3.

Additional Guidelines on Dispensing to Implement the Generics Act of 1988 In addition to the guidelines contained in Section 2, the following shall specifically guide dispensing under the Generics Act of 1988: 3.1. All drug outlets are required to practice generic dispensing as defined in Section 1.2 of these Rules and Regulations, with some exceptions, modifications or qualifications in certain cases or circumstances, as described in Section 3.2 and 3.4. 3.1.1. Drug Stores, Boticas, and other Drug Outlets In order to ensure the informed choice and use of drugs by the patient/buyer, the drug outlet is required to: 3.1.1.1. Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose. 3.1.1.2. For this purpose, all drug outlets shall post in a conspicuous place in their establishment a list of drug products using generic names with their corresponding current prices. A hand-book or directory containing the above required information, readily accessible to the patient/buyer shall be considered substantial compliance. 3.1.2. Hospital Pharmacies Recognizing the special needs and circumstances of hospitals, the following modified rules and regulations shall govern generic dispensing in hospital pharmacies, in the case of in-patients only: 3.1.2.1. Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug policies or reserve the option to buy drugs and medicines outside of the hospital pharmacy. 3.1.2.2. Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health (DOH), and using generic terminology in procurement, prescribing, dispensing, and recording of drugs, shall be exempted from the following: 3.1.2.3. Recording of prescriptions filled in the prescription book, provided such prescription book, provided such prescriptions shall be kept in file for two years. 3.1.2.4. Individually informing the in-patient/buyer on the available generic equivalents and

their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the wards for patients, responsible relatives of patients, and professional staff. 3.2. In dispensing to the buyer, drug products in unit dose or products which are not in their original containers but transferred to small bottles, tin cans, boxes, plastic and/or paper envelopes and the like, the pharmacist shall place legibly on the required drug outlet's label the following information: 1. 2. 3. 4. 5. 6. 7. 8. Name of the patient; Generic name of the drug; Brand name, if any; Manufacture; Dosage strength; Expiry date; Directions for use; and Name of pharmacist

3.3. In partial filling of the prescription, the following shall be written on the face of the prescription: 1. the date of partial filling. 2. the quantity served and balance of the prescription unserved; and 3. name and address of the drugstore The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file. 3.4. Dispensing drugs in List A and List B In dispensing drugs included in List A (Prohibited and Regulated Drugs) and List B (Drugs Requiring Strict Precautions in their Use), attached as Annex and B respectively, the following shall be observed: 3.4.1. Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled. The order and instructions of the doctor as written on the prescription, must be precisely followed. Partial filling of prescription for drugs belonging to List A shall not be allowed.

3.4.2.

3.4.3.

Section 4

Guidelines on what to do with violative, erroneous, and impossible prescriptions 4.1. Violative and impossible prescriptions as defined in A.O. 62 (Generic Prescribing) shall not be filled. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. These violative and wrong prescriptions shall be kept and reported by the pharmacist or other interested parties to the nearest DOH office for appropriate action. 4.2. Erroneous prescriptions shall be filled, but they shall also be kept and reported to the nearest DOH office for appropriate action.

SECTION 5

Violations on the part of dispensers and outlets The following acts or omissions are considered violations of these rules and regulations: 5.1. Imposing a particular brand or product on the buyer. 5.2. Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as to any or all of the following: active ingredient, dosage form and strength. 5.3. failure to post or make accessible the required up-to-date information on drug products. 5.4. failure to adequately inform the buyer on available products that meet the prescription. 5.5. failure to indicate the generic name/official name designated by BFAD and other required information on the drug outlet's label of the dispensed drug. 5.6. failure to record and keep prescriptions filled. 5.7. failure to report to the nearest DOH office cases of violative, erroneous, and/or wrong prescriptions within three months after receipt of such prescriptions.

SECTION 6

Reporting and Monitoring of Non-Compliance Any interested party may report any verifiable violation of these Rules and Regulations to the nearest DOH office. the local DOH office is responsible for giving notice to erring pharmacists/outlets and for transmitting the report on violations to the Secretary of Health or the fiscal's office for appropriate action.

SECTION 7

Administrative Sanctions For violation of these Rules and Regulations, the following sanctions, after due notice and summary hearing, may be imposed: 7.1. Suspension, or revocation of the license to operate the drug outlet by the Secretary of Health. 7.2. Professionals directly involved in the violations shall be recommended by Secretary of Health for appropriate administrative sanctions by the PRC.

SECTION 8

Criminal Liability The imposition of the above sanctions does not preclude the institution of appropriate criminal proceedings pursuant to Section 12 of RA 6675 known as the Generics Act of 1988, RA 3720 known as "Foods, Drugs and Devices and Cosmetics Act" as amended and R.A. 5921 known as "Pharmacy Law" as amended, R.A. 6425 known as the Dangerous Drugs Act of 1972 as amended and other relevant laws, by the regional health office concerned, upon receipt of complaints or reports of violations.

SECTION 9

Timetable of Implementation In order to give all affected parties adequate time for learning and adjustment, the implementation of these Rules and Regulations shall be in three phases, as follows: Phase I Education Drive and Information Dissemination This phase shall be from the date of the effectivity of these Rules and Regulations to May 31, 1989. During this period, the DOH, in cooperation with the Department of Education, Culture and Sports, the Department of Local Government, and the Philippine Information Agency, shall undertake an education drive and information dissemination concerning the provisions of these Rules and Regulations as well as the Generics Act of 1988. Phase 2 Monitoring of Compliance without Sanctions or Penalties From June 1, 1989 to August 31, 1989, the DOH shall monitor voluntary compliance with the provisions of the Rules and Regulations on Prescribing and Dispensing. During this period, the associations of affected professionals are enjoined to promote compliance in order to achieve a smooth transition to the next phase of full implementation. Phase 3 Full Implementation Beginning September 1, 1989, the DOH and the other relevant agencies of government shall monitor compliance with these Rules and Regulations and all violations shall be subject to the appropriate sanctions and penalties provided for under these Rules and Regulations and the Generics Act of 1988.

SECTION 10

Separability Clause

In case any provision of this Administrative Order is declared contrary to law or unconstitutional, other provisions which are not affected thereby shall continue to be in force and in effect. SECTION 11 Repealing Clause

All administrative orders, rules and regulations and other administrative issuances or parts thereof inconsistent with the provisions of this A.O. are hereby repealed or modified accordingly. SECTION 12 Effectivity

This order shall take effect fifteen days after its publication in two newspapers of general circulation.

(Sgd) ALFREDO R.A. BENGZON Secretary