naloxonebottle

By Jennifer J. Thomas

Recognizing the global problem of abuse and addiction to opioids, the Louisiana Legislature and the Louisiana Board of Pharmacy have enacted legislation and regulations to provide for the prescribing, dispensing and administration of Naloxone, an opioid antagonist.

In 2014, the Louisiana Legislature passed legislation authorizing “first responders” (peace officers, firefighters, EMS practitioners) to receive a prescription for Naloxone and maintain the Naloxone in the first responder’s possession for administration to any individual who is undergoing or who is believed to be undergoing an opioid-related drug overdose. The first responder is required to complete training necessary to safely and properly administer Naloxone including: techniques on how to recognize symptoms of an opioid-related overdose; standards and procedures for the storage and administration of Naloxone; and emergency follow-up procedures. First responders are immune from civil liability, criminal prosecution or disciplinary action under any professional licensing statute as a result of the administration of the Naloxone unless personal injury results from the gross negligence or willful or wanton misconduct of the first responder administering the drug.

During the 2016 legislative session, the Louisiana Legislature expanded the use of Naloxone and other opioid antagonists by authorizing a licensed medical practitioner, either directly or by standing order, to prescribe or dispense Naloxone without having examined the individual to whom it may be administered if: (1) the practitioner provides the individual receiving and administering the Naloxone or other opioid antagonist all the training required by the Louisiana Department of Health (“LDH”) for safe and proper administration of Naloxone; and (2) the Naloxone or other opioid antagonist is prescribed or dispensed in such a manner that it shall be administered through a device approved for this purpose by the United States Food and Drug Administration. Like first responders, licensed medical practitioners are granted immunity from civil liability, criminal prosecution, or disciplinary or other adverse action under any professional licensing statute. The 2016 legislation also authorized licensed pharmacists to dispense Naloxone or other opioid antagonists that is prescribed, directly or by standing order, as provided for in the rules promulgated by the Louisiana Board of Pharmacy. A licensed pharmacist who, in good faith, dispenses Naloxone or other opioid antagonists shall not be subject to civil liability, criminal prosecution or disciplinary or other adverse under any professional licensing statute.

The Louisiana Board of Pharmacy (“LBP”) has published in the Louisiana Register Declarations of Emergency providing for standing orders for the distribution of Naloxone. The first Emergency Rule was effective August 10, 2016, but because the LBP needed additional time, it directed the reissuance of the original Emergency Rule effective December 7, 2016. The Emergency Rule provides for the issuance by a Louisiana-licensed medical practitioner of a nonpatient-specific standing order for the facilitated distribution of Naloxone or other opioid antagonists. The standing order shall expire one year after the date of issuance. A Louisiana-licensed pharmacist may distribute Naloxone or other opioid antagonist according to the terms of the standing order until the one-year expiration of the standing order. Before Naloxone or other opioid antagonist drug product can be released to the recipient, the pharmacist shall verify the recipient’s knowledge and understanding of the proper use of the drug product including: (1) techniques on how to recognize signs of opioid-related drug overdose; (2) standards and procedures for the storage and administration of the drug product; and (3) emergency follow-up procedure including the requirement to summon emergency services either immediately before or immediately after administrating the drug product to the individual experiencing the overdose. The pharmacist is required to attach a copy of the standing order to the invoice or other record of sale or distribution of Naloxone or other opioid antagonist and shall store the transaction documents with the other distribution records in the pharmacy.

LDH has promulgated the Final Rule setting forth the best practice training requirements by licensed medical practitioners. Training includes: signs of overdose; signs of overmedication; instructions for storage and administration; and referral to the Substance Abuse and Mental Health Services Administration’s (“SAMHSA”) opioid overdose toolkit. Licensed medical practitioners shall instruct persons administering the opioid antagonist to immediately call 9-1-1 for medical assistance. Once the person is stable by emergency medical services, the treating practitioner is required to refer the patient to substance use treatment services. In the Final Rule, LDH strongly encourages prescribers to co-prescribe Naloxone or another opioid antagonists once in a given year to persons receiving opioid therapy for greater than 14 days.

The promulgation of the legislation and regulations increasing access to potentially life-saving medication will hopefully reduce the number of deaths resulting from opioid overdose in Louisiana.