Title
Supreme Court
Nalbuphine Hydrochloride as Dangerous Drug
Law
Ddb Board Regulation No. 1, S. 2010
Decision Date
Dec 16, 2010
The Dangerous Drugs Board adds Nalbuphine Hydrochloride to the list of dangerous drugs due to its serious side effects and potential for abuse, requiring special prescriptions and limited quantities for medical use to address public health and social problems caused by its abuse.

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.

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