Question & AnswerQ&A (DDB BOARD REGULATION NO. 1, S. 2010)
Section 93, Article XI of Republic Act No. 9165, also known as the Comprehensive Dangerous Drugs Act of 2002, grants the Board the power to reclassify, add to, or remove any drug or substance from the list of dangerous drugs.
Nalbuphine Hydrochloride was included due to its capacity to produce dependence when used indiscriminately, its serious side effects requiring administration by a licensed medical practitioner, and reports of abuse and related public health problems such as needle sharing and the spread of diseases like HIV/AIDS.
The Philippine Drug Enforcement Agency (PDEA) and the Department of Health (DOH) initiated the inclusion of Nalbuphine Hydrochloride in the list of dangerous drugs.
The regulation covers Nalbuphine Hydrochloride and the salts, isomers, and complexes of Nalbuphine and their preparations.
Only medical practitioners with a valid S-2 license are authorized to prescribe Nalbuphine Hydrochloride.
Prescriptions of Nalbuphine Hydrochloride must be made through a special prescription form issued by the Department of Health and must not exceed 40 mg per prescription.
Nalbuphine Hydrochloride is subject to the provisions of Republic Act No. 9165 and Dangerous Drugs Board Regulation No. 3, Series of 2003, along with other applicable issuances by the Board.
The regulation took effect fifteen (15) days after its publication in two newspapers of general circulation and after registration with the Office of the National Administrative Register (ONAR).
Abuse of Nalbuphine Hydrochloride, an injectable drug, can lead to needle sharing, which poses serious public health risks including the spread of HIV/AIDS, malaria, and hepatitis.
The Dangerous Drugs Board conducted a series of public hearings on February 10, 2006, March 28, 2007, and May 6, 2009, before promulgating this regulation.