Module 7 Dangerous Drugs and their Control

Question 1

refer to drugs included in the list of Schedules annexed to the 1961 Single Convention on Narcotic Drugs, as amended by the 1972 protocol, and in the Schedules annexed to the 1971 Single Convention on Psychotropic Substances as enumerated in the annexes which are an integral part of the Comprehensive Dangerous Drugs Act of 2002.

Answer 1

Dangerous drugs

Question 2

R.A. 9165

Answer 2

Comprehensive Dangerous Drugs Act of 2002

Question 3

Dangerous Drug Board (DDB) Regulation No. 1 Series of 2014 or the “_____”, which entails comprehensive amendments to Board Regulation No. 3 Series of 2003, pursuant to existing Republic Act (RA) 9165, otherwise known as the “Comprehensive Dangerous Drugs Act of 2002”,

Answer 3

“Comprehensive Guidelines on Importation, Distribution, Manufacture, Prescription, Dispensing, and Sale of, and Other Lawful Acts in Connection with Any Dangerous Drugs, Controlled Precursors and Essential Chemicals and Other Similar or Analogous Substances”

Question 4

policy-making and strategy-formulating body for the entire country with regard to dangerous drugs, controlled precursor and essential chemical matters

Answer 4

Dangerous Drugs Board

Question 5

implementing arm that is responsible for the efficient law enforcement of all provisions pertaining to Dangerous Drugs, and Controlled Precursor and Essential Chemicals

Answer 5

Philippine Drug Enforcement Agency (PDEA)

Question 6

Role of Pharmacists:

Answer 6

•Involved in the Licensing, Procurement, Requisition, Dispensing, Recording, Safekeeping and Storage, Disposal and Reporting of Dangerous Drugs
• Distribution, recording, and reporting of Special Prescription Forms for Dangerous Drugs

Question 7

Processes:

Answer 7

1. Licensing
2. Procurement

Question 8

Licensing:

Answer 8

Hospital Pharmacies must secure and S-3 Retail Distributor/ Dispenser License

*Dangerous drugs preparations in any form
*Drug preparations containing a controlled chemical for retail, except those containing Norephedrine/Phenylpropanolamine at doses 25mg or below

Question 9

Procurement:

Answer 9

Hospital Pharmacist must apply for a Local Order permit prescribed by the PDEA.

Question 10

Requisition of DDs for Floor-Stocking:

Answer 10

1. The Nurse-in-charge/Pharmacist-in-charge must legibly fill up a duplicate copy of Requisition Sheets. The complete name of the person issuing it must be specified. Specific name, quantity, form and strength of the drug must be indicated and to the specific ward or dispensary where the drug is required. It must be originally signed and dated by the Nurse-in-charge and PDEA-licensed medical practitioner in-charge of the ward/unit.
2. The Requisition Sheets must be countersigned by the issuing pharmacist who will supply the dangerous drug given that all requirements for filling up the requisition sheet have been met. Stock levels shall be periodically assessed by the nurse and the pharmacist prior to ordering/issuance to prevent overstocking of dangerous drugs.
3. The receiving nurse must indicate his/her name, signature, date and time upon the receipt of the issued stocks of Dangerous Drugs by the pharmacist.
4. One copy of Requisition Sheet shall be kept and filed by the pharmacist and the other one shall be the receiving copy of the Nurse-in-charge/Pharmacist-in-charge. 5. Dangerous Drug issuance from the pharmacy shall be recorded by the issuing pharmacist within 120 hours after the transaction has been made. (Under Art 3, Sec. 38, No. 2)

Question 11

Dispensing and Administration:

Answer 11

1. Orders of Dangerous Drugs upon administration shall be recorded with the required information
2. Recording of DD orders shall be accomplished by the NIC/PIC (Narcotics Interdiction Committee/Pharmaceutical Inspection Convention) in chronological order using the Controlled Drug Administration Sheet (CDAS) within 24 hours after the drug has been administered.
3. NIC/PIC and Prescribing Practitioner shall certify the correctness of the information entered and affix their signatures in the CDAS, prior to submission to the hospital pharmacy for replenishment.

Question 12

Semi-Annual Reporting:

Answer 12

1. Semi-annual report to be submitted to the PDEA Regional Office within 15 days following the last day of June and December of each year.
2. DD Registers, Requisitions, and commercial documents shall be retained by the RPh for two years after the date of the last year. DD Rxs shall be retained for 1 year.

Question 13

Safekeeping and Storage

Answer 13

The security of the cabinet/ vault should conform to the regulatory standards of the Comprehensive Dangerous Drugs Act of 2002:

•Double Lock
•In isolated area
•Immovable/ Fixed Area Cabinet
•Exclusive storage for DD/DDP/PP containing Table 1 Substances/PECS

Question 14

Storage

Answer 14

One senior pharmacist should be designated and shall be responsible for the keys of the controlled drugs cabinet/s or rooms. Only the authorized staff is allowed at the restricted area.

An updated record of dangerous drugs in the DDB book in required.

Question 15

Disposal

Answer 15

Special Prescription Form for Dangerous Drugs