September 9, 2015
Pharmacies Establishing Protocols to Provide Naloxone Rescue Kits Without Prescription

Boston—While many states that have not yet granted pharmacists the authority to provide naloxone rescue kits without prescription to patients at risk for opioid overdose, they are likely to do so soon. About half of the states have either active legislation or a bill to that effect.

Meanwhile, several other states have granted pharmacists that authority through a variety of mechanisms, including collaborative practice agreements, pharmacists-as-provider laws or standing order legislation, which is used in 12 states including California and New York.

A report published recently in Harm Reduction Journal discusses how the model of pharmacy-based naloxone (PBN) education and distribution is one of the public health strategies currently being evaluated at hundreds of pharmacies in two of the states that allow pharmacists to provide naloxone without a doctor’s prescription, Massachusetts and Rhode Island, to determine the effect on opioid overdose death rates.

Researchers at Boston Medical Center (BMC), Rhode Island Hospital, and the University of Rhode Island College of Pharmacy, suggest protocols being used by those two states could serve as models for implementation at pharmacies across the country, or even internationally.

“We are encountering an unprecedented public health crisis related to opioid abuse and overdose,” said first author Traci Green, PhD, MSc, deputy director of BMC’s Injury Prevention Center and associate professor of emergency medicine at The Warren Alpert Medical School of Brown University. “Given that nearly every community has a pharmacy, there is a tremendous opportunity to help save lives by allowing pharmacists to provide naloxone rescue kits to those at risk for overdose.”

Through Pharmacy Standing Orders and Collaborative Pharmacy Practice Agreements, programs in Massachusetts and Rhode Island, respectively, allow naloxone, an opioid agonist that reverses the fatal side-effects of an opioid overdose, to be provided by pharmacists to at-risk populations, including patients who use illicit drugs as well as those who may be at risk of overdosing from a prescribed medication, without explicit instruction from physicians.

“Pharmacists, highly trained professionals expert at detecting and managing medication errors and drug-drug interactions, safe dispensing, and patient counseling, are an under-utilized asset in addressing overdose in the US and globally,” the authors write.

“Pharmacies provide a high-yield setting where patient and caregiver customers can access naloxone—an opioid antagonist that reverses opioid overdoses—and overdose prevention counseling. This case study briefly describes and provides two US state-specific examples of innovative policy models of pharmacy-based naloxone, implemented to reduce overdose events and improve opioid safety: Collaborative Pharmacy Practice Agreements and Pharmacy Standing Orders.”

In the report, the authors briefly outline two models of pharmacy-based naloxone (PBN) and provide state-specific examples that are immediately implementable within existing regulatory frameworks of many U.S. states.

A necessary element is a clear path for prescription drug reimbursement on public and private payer formularies, in addition to a consultation fee, similar to that paid to pharmacists for immunization administration, the study notes. While most major public and private insurers cover naloxone formulations, the reimbursement does not include a pharmacist’s consultation with the patient, according to the report.

Other barriers to implementation, study authors point out, include access to formulation and products; legal misconceptions about naloxone prescription, dispensing and use, as well as ethical considerations such as pharmacists who refuse naloxone to certain patients. The authors also emphasize the need for more education of pharmacists and physicians.

“Pharmacy-based naloxone is one public health intervention that better leverages pharmacies’ capacity and pharmacists’ skills,” the authors write. “By utilizing well-established health systems, where appointments are not required, services are provided at low or no-cost and trusted health professionals are accessible, PBN expands the reach of naloxone to individuals beyond those currently being served by community-based and harm reduction organizations. While implementation is early and more comprehensive evaluations are in order, PBN is being dispensed to patients and caregivers.

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