(NAR) VOL. 22 NO. 3, JULY - SEPTEMBER 2011
a. The DOH Central Bids and Awards Committee shall be responsible for finalizing the general specifications and packaging of the drug pursuant to the procurement plan.
b. The National Center for Disease Prevention and Control of the DOH shall be responsible for technical specifications and the quantities allocation of the drug as well as funding of the procurement of Morphine sulfate preparations starting 2011.
c. The Office for Special Concerns through the Dangerous Drugs Abuse Prevention and Treatment Program (DDAPTP) shall monitor the distribution and allocation of drug and related logistics.
d. The DOH-Material Management Division (MMD) shall be responsible for coordinating with the Philippine Drug Enforcement Agency (PDEA) in securing the necessary permits for the purpose of purchase and distribution of the drug.
e. Stocks shall be secured by the MMD and shall be allocated depending on the need of a particular region or location as set/identified by the NCDPC.
f. Distribution and dispensing units shall comply with the regulatory requirements as provided for under Dangerous Drugs Board (DDB) Regulation No. 3 s. 2003 or the "Comprehensive Guidelines on importation, distribution, manufacture, prescription, dispensing and sale of, and other lawful acts in connection with dangerous drugs, controlled precursors and essential chemicals and other similar or analogous substances" (downloadable at www.pdea.gov.ph):
- Hospitals and hospices shall secure from the PDEA the appropriate licenses for wholesale distribution (S-4 license) and retail dispensing (S-3) whichever is applicable;
- Local stock transfer from one license holder to another or from one activity to another shall be covered by an approved PDEA Form 1-04 (LOCAL TRANSFER PERMIT);
- Dispensing by a current PDEA registered outlet shall require a properly filled out DOH prescribed prescription form issued by a current PDEA S-2 License holder.
g. Dispensing sites are/shall be informed on the initial shipment of stocks and succeeding shipments thereafter.
1) Initial shipment volume shall be determined at the level of the DOH-Central Office by the OSC as indicated by the allocation list provided by NCDPC.
2) Succeeding shipments shall be on a need basis while supplies are available.a) Hospitals shall be required to inform the OSC, DOH when the available stock reaches the critical volume of thirty percent (30%) of the initial allocation for immediate replenishment;
b) Likewise, hospitals shall also 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;
c) Hospitals may also submit requests to the OSC for increased allocation using the following basis:i. anticipated increase in the number of patients;
ii. increased prescribing due to training, residency, or the addition of qualified doctors with pain management patients;
iii. emergency needs such as the large amount dosages needed for the cancer patient to achieve adequate pain control.
h. Only a DOH Accredited Freight Forwarder shall be authorized to transport the medications/supplies. The following are the transport and receiving procedures:
- Duplicate copy of the approved PDEA permit and respective hospital purchase request shall accompany the shipment and shall form part of the transport documents;
- The transported medication should be properly insured,
- Inter-island transport shall be by airfreight,
- Supplies shall be received by the designated Supply Officer and/with the Chief Pharmacist following recording and reporting procedures as provided for by DDB Regulation No 3, 2003.
i. Each hospital shall strictly comply with the regulatory control measures set forth by PDEA to include among others the prescribed security for storage, dispensing, distribution, recording and reporting requirements.
j. The hospitals/hospices shall dispense the medications free of charge to indigent patients with moderate to severe pain. Participating hospices, in consonance with Presidential Proclamation No. 1110 of the President of the Republic of the Philippines dated July 25,2006, shall seek accreditation by the National Hospice and Palliative Care Council of the Philippines (Hospici Philippines). Morphine distribution shall comply with the following:
- Morphine dispensing shall be covered by a duly) accomplished DOH prescription issued by a current PDEA S2 licensed doctor and dentist. The prescription shall be presented to the Hospital pharmacy;
- Patients or their families shall submit an accomplished "Statement of Commitment" to return any "unused" medications when instances arise that the patient would no longer need the Morphine. The Morphine shall be returned to the same dispensing-hospital pharmacy following existing prescribed reporting system;
- The patient, family, guardian or person duly authorized in behalf of the patient should ensure the security of Morphine against loss, theft or misuse/abuse;
- Reporting and recording of dispensed medication shall follow DDB Regulation No 3,2003 using the same required register, forms and attachments and;
- During the transition when hospices are seeking accreditation of Hospice Philippines, hospices can refer clients with morphine prescription to distributing hospitals following the above-mentioned procedures (refer to 8a), pending their accreditation. This is to ensure smooth delivery of services to clients in need of pain management.
k. The MMD-DOH, upon approval by NCDPC shall distribute medications to non-DOH hospitals and hospice/palliative units upon presentation and receipt of a request letter from the concerned service provider. A Memorandum Of Agreement (MOA) between the Department of Health and a non-DOH government hospital or a hospice facility shall be undertaken. The said facility shall be responsible in securing approval of the PDEA Transport permit
- Hospitals who wish to distribute to authorized hospice/palliative care and other service units shall be required to secure a PDEA-S4 License (for the wholesale distribution).
m. Hospice/ palliative care and other service units shall be required to secure a PDEA-S3 License to authorize them to dispense directly to patients and shall follow all of the above-mentioned procedures in compliance to DDB Regulation No 3 20031) S4 and S3 application forms can be downloaded at the PDEA website: www.pdea.gov.ph
2) Applications by government hospitals/facilities are free of charge.
n. The DOH, PDEA. DDB and other authorized agencies may conduct inspection and monitoring visits to ensure compliance to this Order.
VII. ROLES AND RESPONSIBILITIESa. National Center for Disease Prevention and Control (NCDPC):1) Shall include funds for the procurement of pain management medications in its operational plan, work and financial plan and procurement plan from hereon;
2) Shall provide technical assistance in determining types and quantity of medications to be procured, taking into consideration the dosage requirements and the "step - ladder" approach;
3) Shall determine the quantity / allocation of the medications per hospital / region;
4) Shall participate in technical working group discussion;
5) Shall monitor movement of said logistic and its utilization and;
6) Shall provide input on the messages to be developed on pain management.
b. Central Office Bids and Awards Committee (COBAC):1) Shall be responsible in advertising and/or posting of bidding documents to interested bidders;
2) Shall facilitate the procurement process from eligibility screening, evaluation of bids, awarding of contract and post qualifications and;
3) Shall monitor the procurement activities for proper reporting to relevant agencies when required.
c. Materials Management Division (MMD) -Administrative Service:1) Shall coordinate with PDEA for the issuance of necessary permits for the transfer, transportation and distribution of Morphine Sulfate tablets;
a) The PDEA Local Purchase Form will be prepared by the Pharmacist with valid S4 license before procurement for approval at the Compliance Service of the PDEA.
b) The approved Local Purchase Form will be submitted to the Procurement Division for processing of the procurement.
c) The supplier will notify schedule of delivery to the MMD - DOH Quirino Warehouse and the items will be received together with other documents in accordance to the quantity and specification stated in the Purchase Order.
d) DOH Hospitals with valid PDEA S3 License can request for the Morphine Sulfate by sending their PDEA Local Purchase Form and a copy of their valid S3 License to the MMD - DOH Quirino Warehouse. The Pharmacist will coordinate with the Compliance Service of PDEA for approval of the transaction.
e) The copy of the approved Local Purchase Form, Invoice Receipt and Bill of Lading will be prepared together with the stocks of Morphine Sulfate requested bytheDOH Hospital.
f) For the transportation of Morphine Sulfate tablets, the DOH contracted forwarder will be assigned for the distribution to the DOH Hospitals.
g) The original copy of the Local Purchase Form will be filed by the Pharmacist and the transaction recorded in the Dangerous Drug Book needed for the semi-annual reporting to the PDEA.
2) Shall take charge of the security of the inventory;
a) Morphine Sulfate tablets are placed in a secure storage room at the MMD - DOH Quirino Warehouse upon receipt from the supplier and inspection by the DOH inspection team and FDA inspectors for FDA test analysis sampling.
b) Storage place and premises are in fit condition, appropriate temperature and has sufficient space.
c) Adequate supervision should be properly carried out at all times by the Pharmacist and Supply Officer who have access in handling Morphine Sulfate tablets.
d) Report of monthly inventory of stocks will be submitted to the OSC - DDAPTP prepared by the Pharmacist and verified by the Officer-In-Charge of MMD.
3) Shall assist in the monitoring of logistics distribution and drug utilization;
a) Coordination with the DOH Hospital Pharmacist regarding the' sending of their Local Purchase Form for approval at the Compliance Service of PDEA.
b) Verification of the proper distribution of Morphine Sulfate tablets and documents to the DOH Hospitals.
c) Assists in the information dissemination regarding the availability of Morphine Sulfate tablets at the DOH Central Office Warehouse.
d) Assists in the monitoring of the utilization of Morphine Sulfate tablets by the DOH Hospitals.
d. Dangerous Drug Abuse Prevention and Treatment Program - Office for Special Concerns (DDAPTP-OSC):1) Shall assist in the formulation of related policies for approval of the Dangerous Drugs Board;
2) Shall convene the technical working group to discuss among others the availability and accessibility of opioid analgesic for pain and palliative care;
3) Shall determine the volume of shipment for distribution to sites based on the allocation as initially submitted to NCDPC and the subsequent requests of the respective sites as approved by NCDPC and;
4) Shall assist in the monitoring of logistic distribution and drug utilization.
e. National Center for Health Promotions (NCHP):1) Shall assist in the dissemination on information pertaining to pain management;
2) Shall develop necessary Information Education and Communication materials on pain management and morphine sulfate use and;
3) Shall help mobilize support groups for easy access and utilization of the pain management medications.
f Information Management Service (IMS):1) Shall assist in the development of an IT-based reporting system of pain medication utilization which shall be housed under the Department of Health website and;
2) Shall help capacitate hospitals, hospices and other partners in the use of the IT reporting system.
g. Centers for Health Development (CHDs):1) Shall assist in the monitoring of pain management medication distribution and utilization;
2) Shall help identify and mobilize support groups and organizations that can facilitate easy access and utilization of the pain management medications and;
3) Shall provide feedback to the NCDPC and the DDAPTP of the necessary arrangement that will help improve distribution and utilization systems.
h. Hospitals:1) Shall ensure the security of the pain medications which should follow the PDEA set standards;
2) Shall be responsible in securing all the necessary permits for the transportation, utilization and dispensing of the pain medications;
3) Shall determine eligibility of recipient to receive pain medications and;
4) Shall submit regular utilization reports to the NCDPC.DDAPTP and CHDs.