Leanne Hewlett1, Daniel P Wermeling2. 1. Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, Kentucky. 2. Professor, Department of Pharmacy Practice and Science, University of Kentucky College of Pharmacy, Lexington, Kentucky.
Abstract
OBJECTIVE: To survey the federal and state-by-state legal status for prescribing, dispensing, and administering naloxone injection. DESIGN: The survey was a review of legislation, which encompassed analyzing current and proposed laws regarding naloxone's role in opioid overdose prevention and treatment. MAIN OUTCOME MEASURE(S): The primary study outcome was to evaluate the legal aspects of current naloxone overdose prevention and treatment. Aspects of the legislation studied included Food and Drug Administration (FDA) regulatory status, prescriber authorization, prescription requirements, defining the patient, authority to administer naloxone, status of lay person administration, and provisions for Good Samaritan protections from criminal and civil liability. RESULTS: To date, 10 states have legislation implementing opioid overdose prevention programs including naloxone. Several states with high opioid overdose burdens are in the legislative process. Reasons for hesitation to initiate such programs include fear of liability, a proxy endorsement for drug abuse, and apprehension of increasing drug usage. CONCLUSIONS: A number of state legislatures have passed legislation permitting lay administration of naloxone to individuals in an attempt to revive a person with an apparent opioid overdose. These emerging state policy initiatives parallel similar laws and regulations governing lay person epinephrine administration for anaphylaxis and applying automated electric defibrillators for sudden cardiac arrest. Public health initiatives increasing access to naloxone will likely continue in states with high opioid overdose burdens. FDA approval of a new needle-free naloxone delivery system would facilitate greater public access.
OBJECTIVE: To survey the federal and state-by-state legal status for prescribing, dispensing, and administering naloxone injection. DESIGN: The survey was a review of legislation, which encompassed analyzing current and proposed laws regarding naloxone's role in opioid overdose prevention and treatment. MAIN OUTCOME MEASURE(S): The primary study outcome was to evaluate the legal aspects of current naloxoneoverdose prevention and treatment. Aspects of the legislation studied included Food and Drug Administration (FDA) regulatory status, prescriber authorization, prescription requirements, defining the patient, authority to administer naloxone, status of lay person administration, and provisions for Good Samaritan protections from criminal and civil liability. RESULTS: To date, 10 states have legislation implementing opioid overdose prevention programs including naloxone. Several states with high opioid overdose burdens are in the legislative process. Reasons for hesitation to initiate such programs include fear of liability, a proxy endorsement for drug abuse, and apprehension of increasing drug usage. CONCLUSIONS: A number of state legislatures have passed legislation permitting lay administration of naloxone to individuals in an attempt to revive a person with an apparent opioid overdose. These emerging state policy initiatives parallel similar laws and regulations governing lay personepinephrine administration for anaphylaxis and applying automated electric defibrillators for sudden cardiac arrest. Public health initiatives increasing access to naloxone will likely continue in states with high opioid overdose burdens. FDA approval of a new needle-free naloxone delivery system would facilitate greater public access.
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