Pursuant to Section 36(a) of R A. 6425 as amended the Dangerous Drugs Board hereby amends Board Regulation No. 4-A Series of 1989 which prescribes the procedural requirements covering the purchase and dispensing of Morphine and Pethidine for medical purposes as follows:

SECTION 1. The Title thereof shall read thus:

"Subject: Procedures on the Purchase and Dispensing of Morphine or Pethidine that can be prescribed exclusively for cancer patients."

SECTION 2.Requirements. - For a practitioner to be able to purchase DDB Form No. 8-72 for dispensing of Morphine or Pethidine to cancer patients the following requirements must be complied with:

a. He must file with the DDB or Regional Health Office an application for the purchase of DDB Form No. 8-72 (for local purchase)

b. His application must be accompanied by:

1. A 2 x 2 photo taken not earlier than a month from the time of intended purchase (for initial purchase only).

2. Current Privilege Tax Receipt (PTR); a government physician or practitioner must present in lieu of the PTR a certification from a responsible official of his Office to the effect that he is a government employee.

3. Current S-2 license.

4. Current registration card issued by the Professional Regulation Commission (PRC) or the official receipt indicating up-to-date payment of the registration fee.

5. Three (3) specimen signatures (for initial purchase only).

6. The amount covering the cost of one (1) booklet of DDB Form No. 8-72 (Local Purchase).

c. His application must be approved by the Executive Director or his duly authorized representative or by the Regional Health Director with appropriate jurisdiction in regional offices. In the absence of the Regional Health Director, the Assistant Regional Health Director deputized by the Board shall approve the application.

SECTION 3. Procedure for the purchase of Morphine or Pethidine by the patient himself or through his duly authorized representative. - The following requirements must be complied with:

a. Submission to the Office of the Executive Director, if it is in Manila , or to the Regional Health Office, if it is in the region, for processing:

1.1 An updated certification signed by the attending physician that the patient is in need of Morphine or Pethidine indicating therein the diagnosis of cancer.

1.2. DDB Form No. 8-72 (Local Purchase) duly accomplished by the physician.

b. Approval of the DDB Form No. 8-72 by the Executive Director or his duly authorized representative or by the Regional Health Director, or the Assistant Regional Health Director, as the case may be.

c. Presentation of the approved DDB Form No. 8-72 to the hospital pharmacist for the purchase of Morphine or Pethidine.

SECTION 4. Dispensing . - Dispensing of Morphine or Pethidine exclusively for cancer patients shall be through a duly licensed hospital pharmacy upon presentation of DDB Form No. 1-72 or DDB Form No. 8-72.

SECTION 5. Validity . - DDB Form No. 8-72 and DDB Form No. 1-72 shall be valid only for a period of thirty (30) days after approval or issuance thereof, as the case may be. They shall not be honored thereafter.

SECTION 6. Prohibition Against Alteration . - In no instance shall alterations be made on the approved DDB Form No. 8-72 or on the issued DDB Form No. 1-72.

SECTION 7. Additional Purchase . - Should additional purchase of Morphine or Pethidine be necessary, a new form shall be issued (DDB Form No. 1-72) or duly accomplished (DDB Form No. 8-72) by the prescribing physician. The latter form shall be submitted for approval of the proper officials. Such form shall be accompanied by a copy of the clinical chart of the patient duly signed by the attending physician indicating therein how the drugs were consumed.

SECTION 8. In cases where the patient dies, the remaining dangerous drugs which were issued to the patient shall be:

a. Surrendered directly to the Dangerous Drugs Board by the attending physician or by the family of the patient without any refund; or

b. With prior approval of the Board, donated to deserving institutions.

SECTION 9. Violation of this Regulation shall be a ground for administrative action without prejudice to criminal prosecution if warranted.

SECTION 10. All Board regulations and other issuances inconsistent with these provisions are hereby repealed or amended accordingly.

SECTION 11. This Regulation shall take effect fifteen (15) days after its publication in the Official Gazette and once a week for two (2) consecutive weeks in a newspaper of general circulation whichever is earlier.

Adopted: 19 Oct. 1989

(SGD.) TOMAS P. MARAMBA JR. M.D., M.H.A.
Vice-Chairman
(Undersecretary of Health for Standards and Regulation)

Effective: 28 November 1989