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Temple University of the Commonwealth System of Higher Education
Beasley School of Law

PROJECT ON HARM REDUCTION IN THE HEALTH CARE SYSTEM
Scott Burris

About the Project

              Naloxone, the standard treatment for heroin overdose, is a safe and effective prescription drug typically administered by emergency room personnel or first responders acting under standing orders of physicians. High numbers of overdose deaths and evidence that witnesses to heroin overdose are often unwilling or unable to call for help has motivated some public health professionals to institute programs that distribute naloxone directly to opiate drug users (ODUs). In such programs, drug users, their partners, or others are instructed in resuscitation techniques and provided a “take-home” dose of naloxone for administration in cases when medical help is not immediately available.

              Evidence from US and abroad indicates that naloxone distribution helps reduce opiate overdose deaths and results in cost-savings to society. Despite the high and rising incidence of overdose events in many US locales, however, both the number and the scope of overdose programs remain inadequate. Legal concerns about provider and program liability act as one of the most important limiting factors, often complicating or derailing authorization, expansion, funding and implementation of these programs.

              We were funded by the Drug Policy Alliance to analyze the legal issues for naloxone distribution programs in the fifty United States. Detailed state-by-state findings and tables are available via the links on the left side of this page. Our analysis finds, generally, that:

  1. Naloxone is not a controlled substance as defined by the federal or state law, but is a prescription drug subject to the general laws and regulations that govern all prescriptions in regular medical practice.
  2. Prescribing naloxone to ODUs is fully consistent with state and federal laws regulating drug prescribing.
  3. Teaching overdose response techniques, including the administration of naloxone, to naloxone recipients and others who might be in a position to administer it to an ODU to whom it has been prescribed is legal and appropriate.
  4. Naloxone may not be given to patients or participants in an overdose prevention program with the explicit purpose of encouraging them to distribute or administer the drug to other ODUs who are not patients.
  5. Any legal risks in distributing naloxone are not substantial and can be mitigated by informed program design; the risks of malpractice liability are consistent with those generally associated with providing healthcare, and can be further minimized by following the guidelines we describe.
Each state memorandum addresses the following specific questions:
  1. May a physician legally prescribe naloxone to an IDU patient?
  2. May an allied health professional other than physician prescribe naloxone to an IDU patient?
  3. What instructions should accompany naloxone prescription/dispensation?
  4. How may naloxone be dispensed?
  5. Is it legal to prescribe or dispense naloxone for recipients to give or administer to third parties who have not been prescribed the drug by a licensed professional?
  6. What is the risk of disciplinary action by a professional board arising from naloxone prescription or distribution, and how can the risk be minimized?
  7. What kind of malpractice liability may arise from naloxone prescription or distribution, and how can the risk of liability be minimized?

1 See, e.g. Seal KH, Thawley R, Gee L, et al. Naloxone distribution and cardiopulmonary resuscitation training for injection drug users to prevent heroin overdose death: a pilot intervention study. J Urban Health. 2005;82(2):303–311.

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