Legal basis and prior issuances
- The policy basis is Republic Act No. 6675 (Generics Act of 1988), which encourages the extensive use of drugs with generic names through a rational procurement and distribution system.
- Republic Act No. 6675 requires all government health agencies and their personnel, and other government agencies, to use generic terminology or generic names in transactions related to purchasing, prescribing, dispensing, and administering of drugs and medicines.
- The Order is consistent with Administrative Order No. 51 series of 1988, which requires that prescriptions and orders in DOH facilities specify the generic name of the active ingredient, with brand names at most added initially but not as the exclusive practice.
- Provisions inconsistent with this Order are revised, modified, and/or repealed.
Policy, purpose, and institutional objectives
- The State’s policy is to promote exclusive use of generic names in government health transactions through rational systems of procurement and distribution.
- The Order is crafted to ensure exclusive use of generic names without brand names in DOH prescribing and ordering.
- The Order’s objectives are to:
- Provide guidelines implementing the mandatory use of generic names in all DOH facilities without corresponding brand names.
- Sustain institutionalization of promoting generic names and drugs by identifying key DOH personnel and their roles.
- Establish a system for monitoring compliance to generic prescription.
Coverage: where and to whom it applies
- The Order applies only to all DOH Facilities.
- DOH Facilities covered include Retained and Special Hospitals, Centers for Health Development, Service, Bureaus, Offices and Medical Centers, Sanitaria, and all other units under the DOH’s administrative and operational control.
- All DOH facilities’ personnel are covered in all transactions related to drugs and medicines.
- The Order’s compliance obligations apply across the DOH facilities’ processes for procurement, prescribing, dispensing, and administering of drugs and medicines.
Definitions and rule framework for generic use
- A 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.
- DOH facilities must use generic names or terminology in all transactions related to drugs and medicines.
- Prescribed or ordered drugs must be specified by generic names, not by corresponding brand names.
- The rule applies even to drugs still covered with patent protection.
Exclusive generic-naming requirements
- DOH facilities and their personnel must only use generic names or terminology in all transactions related to procurement, prescribing, dispensing, and administering of drugs and medicines.
- The prohibition covers prescribing and ordering of drugs even when the drugs are covered by patent protection.
- Corresponding brand names of prescribed or ordered drugs must no longer be specified.
- The facility leadership must implement and disseminate compliance through internal issuance to carry out the Order.
Facility compliance officers and governance roles
- Each DOH facility’s Head of Unit acts as the Head National Drug Policy Compliance Officer for the facility.
- Facility heads include Chiefs of Hospitals, Centers for Health Development Directors, and others designated as heads of DOH units.
- Facility heads must assign subordinate officers to assist and support compliance with the Order.
- Therapeutics Committee members and officers serve as National Drug Policy Compliance Officers for routine and monitoring work when designated by their unit’s Head.
- When a Therapeutics Committee is not functional, the DOH facility Head must designate subordinate personnel to serve as National Drug Policy Compliance Officers.
- Therapeutics Committee-designated compliance officers must report directly to the Head National Drug Policy Compliance Officer at the applicable office level.
- Non-compliance must be elevated to the Office of the Undersecretary, Project Executive Officer, Pharmaceutical Management Unit, and sanctions must be imposed under RA 6675 and other applicable existing laws, rules and regulations.
Public-access compliance support (GMA-50)
- Every DOH facility must establish a “Gamot Mabisa Abot-Kaya (GMA-50) Help Desk”.
- The GMA-50 Help Desk must assist the public by:
- Providing access to low-cost essential drugs carried in the facility’s stock; or
- Providing information on the relative availability of demanded essential drugs through a referral system to other government drug outlets.
- The GMA-50 Help Desk must provide other informational needs such as rational drug use.
- The GMA-50 Help Desk must serve as the central unit for receiving and entertaining public complaints, under the direct supervision of the Head of the DOH facility.
Nurse stations and prescribing practice
- All Nurses’ Stations in DOH Hospitals must have an updated list of all available drugs carried in stock or sold by the hospital pharmacy.
- Physicians and nurses must exert diligence and must prescribe generically equivalent drugs that are carried in the hospital’s stock/pharmacy.
Institutional planning and minimum activities
- DOH facilities must include in their work and financial plans activities that promote and strengthen the Generics Law and compliance with generic prescription.
- The minimum activities that can be undertaken include:
- Seminar/Training of new and old personnel to enhance awareness of the Generics Law.
- Development and dissemination of Information, Education and Communication materials to enhance public awareness on the Generics Law and access to generic drugs by the public.
- Establishment of the GMA-50 Help Desk.
- Yearly celebration of the Generics month.
Compliance monitoring and required quarterly reporting
- The Head of the DOH facility must submit a quarterly report (every three months) to the Office of the Undersecretary, Project Executive Officer, Pharmaceutical Management Unit.
- Quarterly reporting requires submission every second week of the month of April, July, October and January.
- The quarterly report must cover activities related to the Generics Law, including the list of personnel violating the Generics Law and non-compliance with generic prescribing.
Final provisions: separability, repeals, and effectivity
- The Order contains a separability clause: if any provision is declared invalid or unconstitutional, the remaining provisions remain valid and subsisting.
- The Order contains a repealing clause: previous orders and other related issuances inconsistent with it are revised, accordingly modified and/or repealed.
- The Order takes effect immediately after publication in two (2) newspapers of general circulation.