Legal basis and intent
- Section 40 of Republic Act No. 9165 (Comprehensive Dangerous Drugs Act of 2002) requires that all prescriptions containing dangerous drugs and/or controlled precursors and essential chemicals issued by physicians, dentists, veterinarians, or practitioners must be written on forms exclusively issued by and obtainable from the Department of Health (DOH).
- Republic Act No. 9165 requires those DOH forms to be made of a special kind of paper and to include such information and other data as DOH rules and regulations require.
- DOH Administrative Order No. 2012-0002 establishes revised operational rules to increase access to yellow prescription pads and improve their utilization and monitoring.
Coverage and application
- The revised guidelines cover all Department of Health Centers for Health Development (DOH-CHDs) and Hospitals nationwide.
- The revised guidelines cover partner agencies such as the Dangerous Drugs Board (DDB).
- The guidelines apply to the management, distribution, and sale of yellow prescription pads within the covered DOH-CHDs, hospitals, and partner agencies.
Purpose and rationale
- The guidelines are adopted to increase the access of authorized health personnel to yellow prescription pads.
- The guidelines are adopted to improve utilization and monitoring of yellow prescription pads.
- The guidelines are adopted because DOH had been distributing yellow prescription pads through DOH Centers and limited sites, and there is a need to increase distribution sites to improve access and respond to demand from government physicians and retained hospitals.
Central DOH responsibilities
- The Special Concerns Technical Cluster (SCTC) under DOH, through the Dangerous Drug Abuse Prevention and Treatment Program (DDAPTP), shall forecast the number of secured yellow prescription pads requested annually.
- The SCTC/DDAPTP shall estimate funding requirements for yellow prescription pads and include them in the Annual Procurement Plan.
- The SCTC/DDAPTP shall coordinate printing with the National Printing Office and shall prepare an allocation list based on need.
- The Materials Management Division shall store and deliver yellow prescription pads and distribute them based on the allocation list.
- The SCTC/DDAPTP shall inform distribution sites (CHDs, hospitals, and partner agencies) of initial shipment stocks and succeeding shipments.
- The Program shall safeguard the records submitted to it through the IT data-base system developed by the Information Management Service.
- The Program shall advocate and network with partner agencies to facilitate ease of distribution, utilization, and security of yellow prescription pads.
Site operations, sale price, and controls
- The FDA Regulatory Officers of the CHDs and designated personnel by the chief of hospital shall be the persons-in-charge of sale and distribution of yellow prescription pads.
- Yellow prescription pads shall be sold at PHP 250 per booklet.
- Payment for the pads shall be accepted in all DOH-CHD/Hospital Cashier’s Office and the Cashier’s Office of the DDB.
- Hospitals shall maintain separate recording of income derived from the sale of yellow prescription pads for accounting purposes.
- Proceeds of sale shall be retained and utilized by hospitals under existing accounting and auditing rules and regulations; proceeds from the CHDs and the DDB shall undergo the usual auditing and accounting rules and regulations.
IT database, purchase eligibility, and encoding
- Persons-in-charge shall use the web-based IT database system prescribed by the DOH Information Management Service to secure the following information:
- Name of Physician/dentist/Veterinarian.
- S2 License Number and Residential Address.
- Hospital/Clinic/Business Address.
- Residential and Business Telephone Numbers.
- Persons-in-charge shall maintain and manage records of purchases, security of available prescription pads, and confidentiality of the IT database.
- Persons-in-charge shall ensure that only physicians, dentists, and veterinarians with valid S2 Licenses shall be allowed to purchase controlled prescription pads, with S2 Licenses issued by the Philippine Drug Enforcement Agency (PDEA).
- Persons-in-charge shall encode all information required by the system to establish baseline information of professionals allowed by law through the issuance of the PDEA S2 license.
- Persons-in-charge shall ensure that only a maximum of ten (10) Prescription Pad Booklets at any given time shall be sold to an authorized S2 License holder.
- Persons-in-charge shall record the serial numbers of each sold booklet in the IT database system not later than two (2) weeks from the purchase date.
Limits, returns, and monitoring
- Persons-in-charge shall ensure that used pads shall be returned/surrendered to any distribution site.
- Returned pads shall be made available for monitoring by PDEA Regulatory officers for a minimum of two years and shall be properly kept in the facility storeroom, consistent with DDB Regulation No. 3, 2003.
- Persons-in-charge shall ensure that only professionals requiring new yellow prescription pad purchases may purchase only the same number of booklets returned and validated through the IT system.
- Persons-in-charge shall release pads only upon presentation of Payment Receipt.
- Persons-in-charge shall monitor the balance of existing stock and shall inform the Office for Special Concerns of the DOH if only ten percent (10%) of the total number of booklets allocated (threshold stock) is left.
Professional requirements and orientation obligations
- For specific cases, the CHD FDA Officer/Hospital/DDB authorized personnel shall require the professional securing the pads to present:
- a valid Philippine Regulatory Commission (PRC) License Identification Card, and
- the professional’s S2 License,
for recording purposes and post-validation with PDEA.
- Persons-in-charge shall orient first-time purchasers on the following:
- The carbonized feature of the yellow prescription pad will not necessitate carbon paper for the second and third copies required under Section 40 of RA 9165, and the professional should place a separator (usually a hard cardboard sheet) after each “three-copy-prescription” to prevent penetration/duplication on unfilled pads.
- The client must be advised on the consequences of unnecessary prescription of dangerous drugs under Section 18 of RA 9165, which warrants a penalty of imprisonment ranging from 12 to 20 years and a fine of PHP 100,000 to PHP 500,000.
- The client must be advised on the consequences of unlawful prescription of dangerous drugs under Section 19 of RA 9165, which warrants a penalty of life imprisonment to death and a fine of PHP 500,000 to PHP 10,000,000.
Authorized representatives and replacement rules
- A professional may authorize representatives to purchase yellow pad for him only for second time purchases and onwards, and only after validation of records from the IT system, upon presentation of:
- a duly signed authorization from the concerned professional,
- a duplicate (photocopied) copy of PRC and S2 License, and
- the number of surrendered booklets.
- Replacement purchases for lost booklets are allowed only if the following conditions are met:
- a written report is submitted to the distribution site (CHD or Hospital) within two weeks of the loss detailing the circumstances behind the incident,
- an affidavit of loss is submitted, and
- an original or duplicate copy of police report (blotter) is submitted.
Prohibitions, penalties, and sanctions
- No criminal or administrative penalties are created or specified by DOH Administrative Order No. 2012-0002.
- The guidelines require orientation on penalties under Section 18 and Section 19 of Republic Act No. 9165 for unnecessary prescription and unlawful prescription of dangerous drugs, including the imprisonment and fine ranges stated under those sections.
Repeal, separability, and ongoing validity
- A repealing clause provides that all existing issuances inconsistent or contrary to the provisions of DOH Administrative Order No. 2012-0002 are modified or repealed accordingly.
- A separability clause provides that if any part or provision is held invalid or unenforceable, the remaining parts, sections, or provisions continue to take effect.