Guidelines on Morphine Sulfate Distribution

Policy, objective, and rationale

The guideline establishes a policy that eligible indigent patients must receive morphine sulfate for palliative pain at no expense upon presentation of the DOH prescription requirement.
The guideline aims to decrease the under-treatment of patients with severe pain and to improve accessibility of opiate analgesics.
The guideline is anchored on the World Health Organization’s Three-Step Ladder of Cancer Pain Management and the dispensing of morphine to Filipino cancer patients through the Philippine Cancer Pain Control Program.
The guideline is intended to reverse gaps in morphine access and consumption for pain and palliative care.
The guideline directs nationwide distribution of morphine sulfate procured for indigent cancer patients with moderate to severe pain.

Coverage and eligible recipients

The guideline covers all DOH hospitals, selected government and private hospitals, selected hospice and morphine sulfate distribution centers nationwide.
The distribution system includes both out-patient and in-patient indigent patients requiring palliative medications for pain due to cancer, HIV, and other diseases.
The guideline covers indigent patients who are in the DSWD list under the National Household Targeting System.
The guideline covers indigent patients who have PhilHealth cards indicating Sponsored Program Members.
The guideline covers eligible patients outside the above categories when evaluated by the hospital and/or hospice care resident Social Worker.
Hospitals must allocate a maximum of 20% of existing morphine stocks to non-indigent patients, without prejudice to indigent client needs while supplies are available.
Hospice facilities must be able to refer patients for pain management to distributing hospitals for provision of the drug upon presentation of the DOH prescription form.
Only services that are medically necessary for palliative care qualify; cosmetic surgery and other non-palliative interventions are not eligible for free morphine sulfate.

Core definitions and licensing terms

“Dispense” means any act of giving away, selling, or distributing medicine or any dangerous drug with or without the use of prescription.
“DDB” means the Dangerous Drugs Board, the main policy-making body on Dangerous Drug Prevention and Control.
“DSWD” means the Department of Social Welfare and Development, the national agency mandated to identify the poor households.
“DOH-Prescribed Prescription Form” means the “yellow” prescription form for dangerous drugs made of a special kind of paper exclusively issued by and obtainable from DOH.
“Hospices” are facilities specializing in care for a terminally ill patient’s symptoms (physical, emotional, spiritual, or social) and are expected to seek accreditation by the National Hospice and Palliative Care Council of the Philippines (Hospice Philippines) and enter into an agreement with DOH regarding morphine utilization.
“License” means a written permission or authorization.
“MMD” means the Materials Management Division, an office under DOH that supervises/manages logistics and supplies.
“Morphine” is a highly potent opiate analgesic drug, the principal active agent in opium, and a prototypical opioid.
“NCDPC” means the National Center for Disease Prevention and Control Center, an office under DOH overseeing the Non-communicable Disease Program.
“OSC” means the Office for Special Concerns, an office under DOH handling the Dangerous Drug Abuse Prevention and Treatment Program.
“PDEA” is the Philippine Drug Enforcement Agency, which is the implementing arm of the DDB and responsible for efficient and effective law enforcement on dangerous drugs and controlled precursors and essential chemicals under Republic Act No. 9165.
“Prescription” means a written direction by a practitioner that a stated amount of a dangerous drug or Table I controlled chemical-containing drug be dispensed for the person named therein.
“Retail dispensing” is selling limited almost exclusively for personal use, in terms of number of sales, either to walk-in customers or by direct face-to-face transactions, where the buyer is the ultimate user/consumer and does not sell it again.
“S2 License” authorizes physicians, dentists, and veterinarians to prescribe (a) dangerous drugs preparations and/or (b) drug preparations in parenteral or tablet/capsule form containing Table I controlled chemical as the only active medicinal ingredient or containing Table I controlled chemical with therapeutically insignificant quantities of another active medicinal ingredient.
“S3 License” is required to sell, procure, acquire, deal in or with specified (a) dangerous drugs preparations and/or (b) drug preparations in parenteral or tablet/capsule form containing Table I controlled chemical as the only active medicinal ingredient or containing Table I controlled chemical with therapeutically insignificant quantities of another active medicinal ingredient.
“S4 License” is required to sell, procure, acquire, deal in or with specified (a) dangerous drugs and their preparations; (b) drug preparations containing Table I controlled chemicals for wholesale distribution to license holders; and (c) Table I controlled chemicals used in the manufacture of drugs.
“Table I Controlled Chemical” means chemicals enumerated in the list of substances in Table I of the 1988 UN Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, which is an integral part of Republic Act No. 9165.
“Wholesale distribution” means activities between the manufacturer and retail seller in purchases, consignments, or contracts for sale of dangerous drugs or controlled chemicals and their preparations.

General distribution controls and allocation

DOH’s distribution management sets roles for procurement specifications, technical allocation, monitoring, logistics, and permitting.
The DOH Central Bids and Awards Committee finalizes general specifications and packaging of the drug pursuant to the procurement plan.
The National Center for Disease Prevention and Control (NCDPC) provides technical specifications and quantities allocation and funds the procurement of morphine sulfate preparations starting 2011.
The Office for Special Concerns through the Dangerous Drugs Abuse Prevention and Treatment Program (DDAPTP) monitors distribution and allocation and related logistics.
The DOH Materials Management Division (MMD) coordinates with PDEA to secure necessary permits for purchase and distribution.
Stocks are secured by the MMD and are allocated depending on the need of a particular region or location as set/identified by the NCDPC.
Distribution and dispensing units must comply with PDEA’s regulation framework, specifically Dangerous Drugs Board (DDB) Regulation No. 3 s. 2003 on importation, distribution, manufacture, prescription, dispensing, sale, and other lawful acts connected to dangerous drugs and related substances.
Hospitals and hospices must secure from PDEA the applicable licenses for wholesale distribution (S-4) and retail dispensing (S-3).
Local stock transfer between license holders or between activities must be covered by an approved PDEA Form 1-04 (LOCAL TRANSFER PERMIT).
Dispensing by a current PDEA registered outlet requires a properly filled out DOH-prescribed prescription form issued by a current PDEA S-2 licensed doctor and dentist.
Dispensing sites must be informed during initial and succeeding shipments.
The initial shipment volume is determined at the DOH-Central Office level by the OSC using the allocation list provided by NCDPC.
Succeeding shipments are issued on a need basis while supplies are available.
When a hospital’s available stock reaches a critical volume of thirty percent (30%) of the initial allocation, the hospital must inform the OSC immediately for replenishment.
Hospitals must report to the OSC the average monthly consumption and available stock volume ten (10) months before the expiration date and as required by the DOH-Central Office.
Hospitals may request increased allocation from the OSC based on: anticipated increase in patients; increased prescribing due to training, residency, or addition of qualified doctors with pain management patients; and emergency needs requiring large dosage quantities to achieve adequate pain control.

Transport, security, and inspection duties

Only a DOH Accredited Freight Forwarder may transport the medications/supplies.
Transport shipments must include a duplicate copy of the approved PDEA permit and the respective hospital purchase request as part of the transport documents.
Transported medicines must be properly insured.
Inter-island transport must be done by airfreight.
Supplies must be received by the designated Supply Officer and/or Chief Pharmacist following recording and reporting procedures under DDB Regulation No. 3, 2003.
Each hospital must strictly comply with PDEA regulatory control measures, including security for storage, dispensing, distribution, and recording/reporting requirements.
DOH, PDEA, DDB, and other authorized agencies may conduct inspection and monitoring visits to ensure compliance.

Free dispensing requirements and hospice transition

Hospitals and hospices must dispense morphine medications free of charge to indigent patients with moderate to severe pain.
Hospices must seek accreditation by Hospice Philippines in consonance with Presidential Proclamation No. 1110 dated July 25, 2006.
Morphine dispensing must be covered by a duly accomplished DOH prescription issued by a current PDEA S-2 licensed doctor and dentist.
The prescription must be presented to the hospital pharmacy for dispensing.
Patients or their families must submit an accomplished “Statement of Commitment” to return any unused medications when the patient no longer needs morphine.
Returned unused morphine must be returned to the same dispensing-hospital pharmacy following existing prescribed reporting procedures.
The patient, family, guardian, or authorized person must ensure security of morphine against loss, theft, or misuse/abuse.
Recording and reporting of dispensed medication must follow DDB Regulation No. 3, 2003 using the required registers, forms, and attachments.
During the transition while hospices are seeking accreditation with Hospice Philippines, hospices may refer clients with morphine prescription to distributing hospitals using the same dispensing procedures.

Licensing and inter-institution distribution mechanics

The MMD-DOH distributes medications to non-DOH hospitals and hospice/palliative units upon presentation and receipt of a request letter from the concerned service provider, subject to NCDPC approval.
An MOA (Memorandum of Agreement) must be executed between DOH and a non-DOH government hospital or hospice facility.
The receiving non-DOH facility is responsible for securing approval of the PDEA transport permit.
Hospitals that distribute to authorized hospice/palliative care and other service units must secure PDEA-S4 License for wholesale distribution.
Hospice/palliative care and other service units must secure a PDEA-S3 License to dispense directly to patients and must follow all relevant procedures and DDB Regulation No. 3, 2003 compliance.
S4 and S3 application forms can be downloaded from pdea.gov.ph.
Applications by government hospitals/facilities are free of charge.

Roles and operational responsibilities

NCDPC must include funds for procurement of pain management medications in its operational plan, work and financial plan, and procurement plan; it must provide technical assistance for types and quantities using the step-ladder approach; it must determine quantity/allocation per hospital/region; it must participate in technical working group discussions; it must monitor movement and utilization of the logistics; and it must provide input on pain management messages developed.
COBAC must advertise/post bidding documents; facilitate procurement from eligibility screening through evaluation, awarding, and post-qualification; and monitor procurement activities for proper reporting when required.
MMD (Administrative Service) must coordinate with PDEA for issuance of permits for transfer, transportation, and distribution of morphine sulfate tablets, including preparation/approval flow of local purchase forms and procurement processing steps; it must manage security of inventory in DOH warehouse storage; it must ensure supervised access by authorized personnel; and it must submit monthly inventory reports prepared by the pharmacist and verified by the Officer-In-Charge to OSC-DDAPTP.
MMD must assist monitoring logistics distribution and drug utilization by coordinating with hospital pharmacists for PDEA compliance approval of local purchase forms, verifying proper distribution and documents, disseminating availability information, and monitoring utilization by DOH hospitals.
DDAPTP-OSC must assist in formulating related policies for DDB approval; convene a technical working group; determine volume of shipment based on allocations initially submitted to NCDPC and subsequent approved site requests; and assist monitoring logistic distribution and drug utilization.
NCHP must assist dissemination on pain management information; develop IEC materials on pain management and morphine sulfate use; and help mobilize support groups for easy access and utilization.
IMS must assist in development of an IT-based reporting system for pain medication utilization housed under the DOH website, and help capacitate hospitals/hospices/partners in using the IT system.
CHDs must assist in monitoring distribution and utilization; help identify and mobilize support groups/organizations that facilitate access and utilization; and provide feedback to NCDPC and DDAPTP to improve distribution and utilization systems.
Hospitals must ensure medication security following PDEA standards; secure permits for transportation, utilization, and dispensing; determine recipient eligibility; and submit regular utilization reports to NCDPC, DDAPTP, and CHDs.

Separability and encouragement provisions

A separability clause provides that if any provision is declared invalid, the remaining provisions remain in effect.
The guideline encourages all Filipinos to become members of Philippine Health Insurance (PhilHealth) or at least be a dependent of an active member, consistent with the National Insurance Act of 1995 and the Health Sector Reform Agenda.