Republic of the Philippines
Department of Health
OFFICE OF THE SECRETARY
15 October 1991
DEPARTMENT OF AGRICULTURE
Administrative Order No. 39
DEPARTMENT OF HEALTH
Administrative Order No. 111-B
SUBJECT : RULES AND REGULATIONS TO IMPLEMENT PRESCRIBING REQUIREMENTS FOR
THE VETERINARY DRUGS AND PRODUCTS
Pursuant to R.A. No. 3720, as amended by Executive Order No. 175 otherwise known as the “Foods, Drugs and Devices and Cosmetics Act”. R.A. No. 6675, otherwise known as the “Generics Act of 1988”, R.A. 382 known as the “Veterinary Practice Act”. R.A. 5921 known as the “Pharmacy Act”, R.A. 6425 known as the “Dangerous Drugs Act of 1972” as amended, R.A. 1556, otherwise known as “Livestock and Poultry Feeds Act”, R.A. 1071, an Act to regulate the sale of veterinary biologics and medicinal preparation and R.A. 3101, an Act authorizing the Director of the Bureau of Animal Industry, subject to the approval of the Secretary of Agriculture and Natural Resources to promulgate regulations for the preparation, sale, traffic in, shipment and importation of viruses, sera, toxins or analogous products used for the treatment of domestic animals, the following are hereby promulgated for the information, guidance and compliance of all concerned:
Section 1. DEFINITION OF TERMS:
1.1 “Prescription” refers to the written order and instruction to the pharmacist by a duly-licensed veterinarian for the use of a specific veterinary drug and product for a specific species of animal. For the purpose of these Rules and Regulations, the Veterinary Drug Order (VDO) for the use of specific drug(s) shall be considered a prescription.
1.2 “Generic Prescribing” refers of the prescribing of veterinary drugs and products or medicines using their generic name(s) or generic terminology.
1.3 “Dispensing” refers to the act by a duly-licensed pharmacist and/or veterinarian of filling a prescription or veterinary drug order.
1.4 “Generic Dispensing” refers to dispensing the client’s/buyer’s choice from among generic equivalents.
1.5 “Generic Name or Generic Terminology” refers to the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official names as determined by the Bureau of Food and Drugs of the Department of Health and the Bureau of Animal Industry of the Department of Agriculture.
1.6 “Veterinary Drugs” refer to: (1) articles recognized in the current official United States Pharmacopeia (USP), National Formulary (NF), official homeophatic pharmacopeia of the United States, official Philippine National Veterinary Drug Formulary (PNVDF), or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in terrestial and aquatic animals; and (3) articles (other than food) intended to affect the structure or function of the animal body; and (4) articles intended for use as a component of any article specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories,.
1.6.1 “Prescription or Ethical Veterinary Drugs and Products” refers to any drug preparation that is to be dispensed only upon written order of a duly-licensed veterinarian for the treatment of a condition or a diagnosed disease of animals. Such preparation are labeled Rx. The general list of prescription or ethical veterinary drugs and product is found in List C (Annex C).
1.6.2 “Non-prescription Veterinary Drugs” or “Over-the-Counter Veterinary Drugs (OTC)” or “Self-Service Veterinary Drugs (SS)” refer to drug preparations that can be approved for animal use, even without the written order of a duly-licensed veterinarian.
1.7 “Veterinary Drug Products” refer to the finished forms that contain the active ingredient(s), generally, but not necessarily in association with inactive ingredients.
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” refer to opium and its derivatives such as heroin and morphine; cocoa leaf and its derivatives, principally cocaine, alpha and beta eucaine; hallucinogenic drugs, such as mescaline, lysergic acid diethylamide (LSD) and other substances producing similar effects; Indian hemp and its derivatives; all preparations made from any of the foregoing and other drugs, whether natural or synthetic, with the physiological effects of a narcotic drug.
1.8.2 “Regulated Drugs” refers to 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 Dexedrine, or any drug which produces a pharmacologic action similar to amphetamine; and hypnotic drugs such as methaqualone, or any other compound producing similar pharmacologic effects.
1.9 Definitions of different types of veterinary drug and product outlets.
1.9.1 Drugstore, pharmacy and botica are drug outlets where registered veterinary drugs and products, chemical products, active principles, proprietary medicines or pharmaceutical specialties are compounded and/or dispensed and sold excluding veterinary hospitals, clinic and farm storage areas where drugs and products are stored for their exclusive use.
1.9.2 Veterinary and Agricultural Supply Store, Livestock and Poultry Supply Store are outlets selling prescription veterinary drugs and products.
1.9.3 Retail-outlet for non-prescription drugs including non-traditional outlets such as supermarkets and stores, means a drug outlet where registered non-prescription or over-the-counter (OTC) or self-service (SS) veterinary drugs and products are sold in their original packages, bottle or containers or in smaller quantities not in their original containers.
Standards and requirements for License to Operate (LTO) a veterinary and product outlet are found in D.A. A.O. No. 138 and DOH A.O. No. 100 Regulations for the Licensing of Veterinary Drug and Product Establishments and Outlets.
1.10 “Veterinarian-Client-Patient Relationship (VCPR)”, (Annex F) the VCPR is a written agreement between the client and veterinarian wherein the following conditions have been met:
a. The veterinarian has assumed the responsibility for making clinical judgments regarding the health of animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian’s instructions.
b. The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept.
c. Veterinary Drug Order (Annex F) is a written instruction (prescription) to pharmacist or of veterinary drug establishment to fill a veterinary prescription of large quantities a specific veterinary drug and product provided that there is an accompanying VCPR letter (Annex F) from the prescribing veterinarian. VCPR is required when prescribing for ten (10) or more animal units.
Section 2. GUIDELINES ON PRESCRIBING BASED ON PRIOR LAWS
Prior to the Generics Act of 1988, the following general guidelines on prescribing have been operative. In order to have an integrated implementation of all relevant guidelines on prescribing, these guidelines based on prior laws are restated hereunder:
2. 1 Only duly-licensed veterinarians, whether in private practice or employed in a private institution/corporation or in the government, are authorized to prescribe drugs. Prescribing by unauthorized persons constitutes illegal practice of veterinary medicine punishable under R.A. 382 or the Veterinary Practice Act.
2.2 In accordance with R.A. 5921, or the Pharmacy Act as amended, all prescriptions (Annex G) must contain the following information: name of prescriber, office and address. In addition to the above requirements the following shall be included: professional registration number, professional tax receipt number, patient’s/client’s name, date of prescription, species and number of animal treated and: name(in generic), strength, unit size and quantity of the veterinary drug product to be delivered/dispensed.
2.3 For drugs in List A (Annex A) containing the list of Prohibited Drugs and Regulated Drugs as approved by the Dangerous Drugs Board (DDB), the following are required:
2.3.1 The prescriber must have an S-2 license.
2.3.2 The special DDB prescription form must be used.
2.3.3 A recording system following pertinent DDB regulations must be observed.
Section 3. ADDITIONAL GUIDELINES ON PRESCRIBING
In addition to the guidelines contained in section 2, the following shall specifically guide prescribing under the Generics Act of 1988;
3.1 Generic names shall be used in all prescriptions.
3.1.1 For veterinary drugs and products with a single active ingredient, the generic name of that active ingredient shall be used in prescribing.
3.1.2 For drugs with two or more active ingredients, the generic name as determined by BFAD/BAI shall be used in prescribing.
3.2 The generic name must be written in full but the salt or chemical form may be abbreviated.
3.3 The generic name of the veterinary drug and product ordered must be clearly written on the prescription immediately after the Rx symbol.
3.3.1 If written on a prescription pad, the brand name enclosed in parenthesis may be written after the generic name.
3.4 In prescribing veterinary drugs and products enumerated in List B (Annex B) which need strict precaution in their use, the prescriber must comply with the following:
3.4.1 After the Rx symbol but before the generic name, he must write clearly “(list B)”.
3.4.2 He must ensure that the following informations are accurately written on the prescription:
126.96.36.199 The generic name of the active ingredient(s) and the specific salt or chemical form.
188.8.131.52 The manufacturer
184.108.40.206 The brand name, if so desired
220.127.116.11 The strength or dose level using units of the metric system (see Annex D).
.18.104.22.168 The delivery mode or delivery system: quick-dissolve, sustained release, etc. and the corresponding appropriated dose frequency or dose interval.
Section 4. SPECIFIC GUIDELINES OF PRESCRIBING
In addition to the guidelines contained in section 2 and 3, the following shall guide prescribing to food and aquatic animals under the Generics Act of 1988.
In prescribing veterinary drugs and products the prescriber must comply with the following conditions:
4.1 The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian instructions.
4.2 The veterinarian has sufficient knowledge of animal(s) to initiate at least a general or preliminary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of examination of the animal(s) or by medically appropriated and timely visits to the premises where the animal(s) are kept.
4.3 The veterinarian is readily available for follow-up evaluation in the event of adverse reactions or failure of the treatment regimen.
4.4 In prescribing for non-food animals, the sample standard prescription (Annex G) is sufficient.
4.5 In prescribing for food animals the following guidelines should be followed.
4.5.1 When prescribing for individual animals a simple standard prescription is sufficient.
4.5.2 When prescribing for 10 or more animal units (Annex E) a VCPR letter accompanying a Veterinary Drug Order (VDO) is required.
The VCPR letter must contain the following:
a. Name and address of the client
b. Statement that the client has agreed to follow the veterinarian’s instructions and directions.
c. Statement that the veterinarian is readily available for follow-up and evaluation in the event of adverse reactions or failure of the treatment regimen.
d. Statement that the veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal and the need for medical treatment.
e. The veterinarian’s name, signature, PRC number and address.
f. Withdrawal period if there is any, of drug and product prescribed.
Section 5. VIOLATIVE, ERRONEOUS AND IMPOSSIBLE PRESCRIPTIONS
5.1 Violative Prescriptions:
5.1.1 Where generic name is not written;
5.1.2 Where the generic name is not legible and a brand name which is legible is written.
5.1.3 Where the brand name is indicated and instructions added (such as the phrase “no substitution”) which tend to obstruct, hinder or prevent proper generic dispensing.
5.2 What to do with violative prescriptions.
Violative prescription shall not be filled by the pharmacist/veterinarian. They shall be kept and reported by the pharmacist/veterinarian of the veterinary drug and product outlet or nay other interested party to the nearest DOH/DA Office for appropriate action. The pharmacist or veterinarian shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
5.3 Erroneous Prescriptions.
5.3.1 Where the brand name precedes the generic name.
5.3.2 Where the generic name is the one in parenthesis.
5.3.3 Where the brand name is not in parenthesis.
5.4 What to do with erroneous prescriptions
Erroneous prescriptions shall be filled. Such prescription shall also be kept and reported by the pharmacist/veterinarian of the veterinary drug and product outlet or any other interested party to the nearest DOH/DA Office for appropriate action.
5.5 Impossible Prescriptions
5.5.1 When only the generic name is written but it is not legible.
5.5.2 When the generic name does not correspond to the brand name.
5.5.3 When the veterinary drug and product prescribed is not registered with the BFAD/BAI.
5.6 What to do with impossible prescriptions.
Prescriptions mentioned in 5.5 shall not be filled. They shall be kept and reported by the pharmacist/veterinarian of the veterinary drug and product outlet or any other interested party to the nearest DOH/DA office for appropriate action. The pharmacist/veterinarian shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription.
5.7 In all cases enumerated in 5.1 and 5.5 the local DOH Office shall be responsible for giving written notice to the erring veterinarian concerned and for transmitting through channels the report of violation/error to the Professional Regulation Commission (PRC) or to the fiscal’s or to the Council of Ethics of the Philippine Veterinary Medical Association office for appropriate action.
Section 6. ADMINISTRATIVE SANCTIONS
For violations of Section 4 of these Rules and Regulations, the Secretary of Health shall recommend the imposition of appropriate administrative sanctions by the PRC.
Section 7. CRIMINAL LIABILITY
The imposition of the above sanctions does not preclude the institution of appropriate criminal proceedings pursuant to Section 12 of R.A. 6675 known as the “Generics Act of 1988”, R.A. 3720 known as “Food, Drug and Devices and Cosmetics Act” as amended, and R.A. 5921 known as “Pharmacy Law” as amended, R.A. 382 or the Veterinary Practice Act, R.A. 6425 known as the “Dangerous Drugs Act of 1972” as amended, R.A. 1556 known as the “Livestock and Poultry Feed Act”, R.A. 1071, R.A. 3101, and other relevant laws, upon receipt of complaints or reports of violations.
Section 8. 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 1 Education Drive and Information Dissemination
This phase shall be accomplished within six months from the date of the effectivity of these Rules and Regulations. During this period, the DOH/DA-BAI in cooperation with the Department of Education, Culture and Sports, the Department of Local Government, Philippine Information Agency, academic veterinary institutions, Philippine Veterinary Medical Association (PVMA) and its affiliates shall undertake information dissemination and education drive 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
Within twelve months the DOH/DA-BAI 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 January 1, 1993 the DOH/DA and the other relevant agencies of government shall monitor compliance with these Rules and Regulations and all violations shall be subject to the appropriate sanction and penalties provided for under these Rules and Regulations and the Generics Act of 1988 and prior laws.
The funding of the 3 phases will be provided by the DOH / DA.
Section 9. 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 10. REPEALING CLAUSE
All Administrative Orders, Rules and Regulations and other Administrative issuances or parts thereof, inconsistent with the provisions of the Administrative Order are hereby repealed and modified accordingly.
Section 11. EFFECTIVITY
This Order shall take effect fifteen (15) days after its publication in a newspaper of general circulation.
(Sgd.) SENEN C. BACANI (Sgd.) ALFREDO R.A. BENGZON, M.D.
Secretary of Agriculture Secretary of Health
LIST OF PHARMACEUTICAL PRODUCTS CLASSIFIED AS PROHIBITED DRUGS OR REGULATED DRUGS BY THE DANGEROUS DRUGS BOARD
I. Prohibited Drugs
II. Regulated Drugs
A. Available in the Market
Local suppliers no longer carry these drugs but are still available in some drugstores and hospital pharmacies.
B. Not Available in the Market
Local suppliers no longer carry these drugs but are still available in some drugstores and hospital pharmacies.
LIST OF VETERINARY DRUGS AND PRODUCTS REQUIRING STRICT PRECAUTION IN PRESCRIBING, DISPENSING AND USE
A. ALL ANTI-INFECTIVES EXCEPT TOPICAL FORMS
B. ALL ACARICIDES
C. ALL INSECTICIDES EXCEPT CARBAMATES, PYRETHIOIDS AND REPELLANTS
D. ALL BIOLOGICALS AND IMMUNOLOGICALS
E. ALL CARDIOVASCULAR DRUGS
F. ALL HORMONES
G. ALL ANTINEOPLASTICS
H. ALL PARENTERAL FLUIDS
I. ALL CORTICOSTEROIDS
J. ALL EUTHANIZING AGENTS
K. ALL ANABOLICS
STANDARD ABBREVIATIONS AND PRACTICE IN THE USE OF METRIC UNITS
1 grain = 60 mg
½ grain = 30 mg
Quantities of 1 gram or more should be written as 1 g, etc.
Quantities less than 1 gram should be written in milligrams, e.g. 500 mg. Not 0.5 g.
Quantities less than 1 milligram should be written in micrograms, e.g. 100 mcg, not 0.1 mg.
When decimals are unavoidable, a zero should be written in front of the decimal point when there is no other figure, e.g. 0.5 ml, not .5 ml.
The term millimeter (ml) should be used and not cubic centimeters or cm.3
No. of Animals No. of Animal Unit
1 Carabao 1 Animal Unit
1 Cattle 1 Animal Unit
1 Horse 1 Animal Unit
5 pigs 1 Animal Unit
100 Chickens 1 Animal Unit
VETERINARY DRUG ORDER (VDO)
NAME OF VETERINARY INSTITUTION
I, ________________________, the manager / owner of _____________________________________
(name of establishment)
Located at ______________________________________________ have contracted.
Dr. ______________________________ of ______________________________________
(name veterinarian) (address)
To diagnose and treat disease problems of the animals described as follows:
1. Species : _________________________
2. Breed : ____________________________
3. No. of Animals ______________________
I agree to follow the veterinarian’s instructions and directions including withdrawal period.
I, Dr. _____________________________ have agreed to assume the responsibility for making clinical judgments regarding the health of the animals described above and their need for medical treatment. I further agree to be readily available for follow-up and evaluation in the event of adverse reactions or failure of the treatment regimen.
TIN: ________________ PRC No. ____________
Copyright © 2007 Philippine Veterinary Medical Association.