Law Summary
Rationale for Including Nalbuphine Hydrochloride
- Nalbuphine Hydrochloride is widely used for treatment of moderate to severe pain.
- Administration is limited to trained medical practitioners with a valid S-2 license due to serious side effects.
- Studies show potential for dependence when used indiscriminately.
- It was identified as the 5th most commonly abused drug among treatment-seeking individuals in DDB 2009 reports.
Public Health Concerns Associated with Abuse
- Abuse has been reported in many major Philippine cities.
- Injectable nature raises risks of needle sharing.
- Needle sharing contributes to spread of HIV-AIDS, malaria, and hepatitis.
- The abuse constitutes a serious public health and social problem.
Legislative and Regulatory Actions Taken
- Initiated by the Philippine Drug Enforcement Agency (PDEA) and Department of Health (DOH).
- After public hearings held on 10 February 2006, 28 March 2007, and 6 May 2009, the DDB found merit in including Nalbuphine Hydrochloride as a dangerous drug.
Section 1: Inclusion in the List of Dangerous Drugs
- Nalbuphine Hydrochloride, including its salts, isomers, complexes, and related preparations, is officially included in the list of dangerous drugs.
Section 2: Prescription Requirements
- Only medical practitioners with a valid S-2 license may prescribe Nalbuphine Hydrochloride.
- Prescription must use a special form issued and obtainable from the Department of Health.
- Each prescription is limited to a maximum of 40 mg of Nalbuphine Hydrochloride.
Section 3: Application of Relevant Laws and Regulations
- Nalbuphine Hydrochloride is subject to the provisions of RA 9165.
- It is also subject to Dangerous Drugs Board Regulation No. 3, Series of 2003, and other applicable issuances of the Board.
Section 4: Effectivity of the Regulation
- The regulation takes effect 15 days after its publication in two newspapers of general circulation.
- It also requires registration with the Office of the National Administrative Register (ONAR), U.P. Law Center, Diliman, Quezon City.
Summary of Legal Significance
- The regulation enhances control over Nalbuphine Hydrochloride due to its abuse potential and adverse health effects.
- It imposes stricter prescription controls to ensure responsible medical use.
- It aligns with the goals of RA 9165 to prevent drug abuse and protect public health.