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,,Repub,.lic of the Philippines Department of Health
OFFICE OF THE SECRETARY
~ Trunk Line 743-83-Q1 (d Fax Line 743-18-29 Direct Line 711-95-02 to 03
06 September 2004
ADMINISTRATIVE ORDER No. 109 s.2004
Subject
I. Rationale
·Implementing Guidelines for the Exclusive Use of Generic Names or Generic Terminology in all Prescriptions and Orders in all DOH Facilities ·
Republic Act (RA) No. 6675 also known as the Generics Act of 1988 provides that it is the policy of the State to encourage the extensive use of drugs with generic names through a rational system of procurement and distribution.
Generic Name or Generic Terminology is the identification of drugs and medicines by their scientifically and internationally recognized active ingredients or by their official generic name.as determined by the Bureau of Food and Drugs of the Department of Health.
RA No. 6675 further provides that all government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing, and administering of drugs and medicines.
Administrative Order No. 51 series of 1988 entitled, "Implementing Guidelines for Department of Health Compliance with Republic Act 6675 (Generics Act of 1988)," provides that all prescriptions and orders and medicines in Department of Health (DOH) facilities shall be specified in generic terminology and that all written orders the generic name of the active ingredient shall be stated. Also stated in the said issuance is that while brand names may also be added, eventually all orders shall use generic names exclusively.
With the premises cited and relative preference and acceptability to generic drugs, this Order is crafted to assure the exclusive use of generic names sans the brand name from hereon.
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II. Objectives
This Order is crafted to ensure that the following objectives are attained:
1) To provide guidelines in implementing the mandatory use of generic names in all DOH facilities and without the corresponding brand names.
2) To sustain the institutionalisation of promoting generic names and drugs by identifying the key personnel in the DOH and their corresponding roles and responsibilities.
3) To provide a system of monitoring compliance to generic prescription.
Ill. Applicability
This Order shall be applicable only to all DOH Facilities, which include Retained and Special Hospitals, Centers for Health Development, Service, Bureaus, Offices and Medical Centers, Sanitaria and all other units that are administratively and operationally under the control of the DOH.
IV. General Guidelines
1) All DOH facilities and their personnel shall only use generic names or terminology in all transactions related to procurement, prescribing, dispensing, and administering of drugs and medicines. This shall be inclusive of drugs, which are still covered with patent protection. The corresponding brand names of the drugs prescribed or ordered shall no longer be specified.
2) The Heads of the DOH facilities, i.e. Chiefs of Hospitals, Centers -for Health Development Directors, and others, shall act as the Head National Drug Policy Compliance Officer of their respective units and shall assign subordinate officers within their unit to assist or support them to ensure compliance with this Order and shall promulgate the corresponding issuance to implement and disseminate this Order.
3) Non-compliance to this Order shall be elevated by the concerned Heads of DOH Facilities to the Office of the Undersecretary, Project Executive Officer, Pharmaceutical Management Unit and the corresponding sanctions shall be imposed in accordance with RA 6675 and other applicable existing laws, rules and regulations.
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V. SPECIFIC GUIDELINES
A. Organizational Support Structure
1) The members and officers of the Therapeutics Committee of the Hospital or ttie Center for Health Development concerned as designated by their respective Heads of UniUOffice, in addition to their other roles and functions, shall serve as National Drug Policy Compliance Officers and shall provide staff work for routine and monitoring activities. They shall report directly to the Head of the National Drug Policy Compliance Officer at their office's level.
2) In the absence of a functional Therapeutics Committee, the Head of the DOH Facility concerned shall designate subordinate personnel to serve as National Drug Policy Compliance Officers.
3) All DOH Facilities shall establish a "Gamot Mabisa Abot-Kaya (GMA-50) Help Desk" to assist the public by providing access to low-cost essential drugs carried in its stock or by providing information on the relative availability of the demanded essential drugs through a referral system to other drug outlets of the Government and by providing other informational needs such as rational drug use. The GMA-50 Help Desk shall likewise be the central unit of the DOH Facility concerned with which public complaints shall be entertained and received. It shall be directly under the supervision of the Head of the DOH Facility.
4) All Nurses' Stations in DOH Hospitals must have an updated list of all available drugs carried in its stock or being sold by the hospital pharmacy. The physicians and nurses shall at all times exert diligence and prescribe the generically equivalent drugs that are carried in the hospital's stocks/pharmacy.
5} All DOH Facilities shall include in their work and financial plans, activities that will promote and strengthen the Generics Law and compliance with generic prescription. The minimum activities that can be undertaken, among others, shall include:
(a) Seminar/Training of new and old personnel to enhance awareness of the provisions of the Generics Law';
(b) Development and dissemination of Information, Education and Communication materials that will enhance public awareness on Generics Law and access to Generic Drugs by the public;
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(c) Establishment of the GMA-50 Help Desk; and (d) Yearly celebration of the Generics month.
B. Compliance Monitoring
1) The Head of the DOH Facility concerned shall submit a quarterly report (every three months, every second week of the month of April, July, October and January) to the Office of the Undersecretary, Project Executive Officer, Pharmaceutical Management Unit on all activities related to the Generics Law. Such shall include the list of personnel violating the Generics Law and non-compliance with Generic prescribing.
VI. Final Provisions
1) Separability Clause. If any provision of this Administrative Order is declared invalid or unconstitutional, the other provisions not affected thereby shall remain valid and subsisting.
2) Repealing Clause. Any provision of previous Orders and other related issuances inconsistent with those reflected in this are revised, accordingly modified and/or repealed.
3) Effectivity. This Order shall be effective immediately after publication in two (2) newspapers of general circulation.
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