INTRODUCTION/BACKGROUND

In the face of rising opioid overdose fatalities, the importance of naloxone as a life-saving measure cannot be understated. In a meta-analysis examining individuals who had witnessed overdoses, it was shown that naloxone administration by bystanders was safe, feasible, and associated with at least eight times the odds of recovery than when not administered.1 This editorial discusses a randomized control trial that involved formalized implementation of naloxone dispensation and education by intervention pharmacies, and provides dialogue on the important role of pharmacies in delivering evidence-based public health interventions including Opioid Overdose Education and Naloxone Distribution (OEND).2

The U.S. Food and Drug Administration (FDA) advises healthcare professionals to discuss naloxone availability with all patients who are prescribed opioid pain relievers, and the Centers for Disease Control and Prevention (CDC) recommends providing naloxone to patients prescribed opioids at 50 morphine milligram equivalents or more per day. Within the U.S.A., federal guidance and state laws have ensured that pharmacies are legally permitted to dispense naloxone without the need for a patient to first see a physician prescriber.3 However, a recent CDC report showed that in the year 2018, only one naloxone prescription was dispensed for every sixty-nine high-dose opioid prescriptions.4

BARRIERS TO NALOXONE ACCESS

What barriers are prevalent that may potentially limit pharmacies’ provision of OEND to appropriate patients? Historically, one central issue has been concern that the provision of naloxone may increase the likelihood that individuals will take their opioid in higher amounts than prescribed. Additionally, insurance coverage for naloxone may be insufficient, requiring patients to pay out-of-pocket for remaining costs.5, 6

Other cited barriers to providing naloxone within a survey of California community pharmacists included lack of patient awareness about available services, lack of payment for services, and difficulty incorporating services within pharmacy workflow.7

The provision of OEND and other services by pharmacists highlights their critical role in scaling evidence-based public health interventions with sufficient legislative and financial support. Reyes et al. note that on a federal level, pharmacists are not deemed healthcare providers; however, in a state such as California where recent bills have expanded pharmacists’ roles as healthcare providers, eligible pharmacists within the state (when enrolled and having undergone specified clinical training) are able to bill for certain services though California Medicaid (Medi-Cal).

STUDY FINDINGS

This cluster randomized control trial by Binswanger and colleagues analyzed patients receiving overdose education and co-dispensed naloxone with opioid prescriptions from intervention pharmacies, compared to patients receiving opioid prescriptions from control pharmacies with usual services. The researchers measured patient opioid risk behavior with the Opioid-Related Behaviours in Treatment (ORBIT) instrument, which captures the need for escalating opioid doses, use of another person’s opioid medication, or saving up an opioid prescription for possible later use.8 The trial found that among patients receiving naloxone from intervention pharmacies, as compared to patients within control pharmacies, there was no increase in opioid risk behavior. Notably, intervention pharmacies focused on dispensing naloxone to patients receiving a long-acting/extended-release opioid, or if they received greater than or equal to eighty-four opioid pills.

One key secondary outcome of the study revealed that patients within intervention pharmacies demonstrated increased knowledge about overdose prevention and naloxone, which suggests benefit from the education that was provided when naloxone was dispensed to them by participant pharmacists. Implementation challenges suggested by the authors included identifying the appropriate patients for naloxone dispensation and securing insurance coverage. Despite these challenges, after 10 months, intervention pharmacies had a threefold greater number of naloxone receipts than control pharmacies. There was no difference in levels of hazardous drinking, tobacco use, non-medical sedative use, and other drug use between participants enrolled in intervention and control pharmacies.

DISCUSSION: IMPACT OF RESULTS AND THE GENERAL IMPORTANCE OF COMMUNITY PHARMACIES

The results of the study certainly contest existing trepidation about associations between naloxone and patient opioid risk behaviors. Additionally, it illustrates that pharmacies can feasibly distribute naloxone with increased patient knowledge about overdose prevention and naloxone administration.

Findings from this study are particularly relevant for geographic areas with limited access to harm reduction services and community naloxone distribution programs.9 More broadly, it is important to highlight the key role of pharmacies in scaling evidence-based interventions for patients. Internationally, the significance of community pharmacies serving as health hubs is exhibited for a variety of medical conditions. For instance, a cluster randomized trial in Scotland examined pharmacist-administered treatment for the hepatitis C virus and demonstrated a greater completion of treatment as compared to treatment at a more conventional care center.10 In Australia, government support has enhanced community pharmacies’ role in chronic disease management (e.g., comprehensive medication reviews, smoking cessation, and management of prevalent conditions such as diabetes mellitus and hypertension).11 These examples are indicative of the notion that community pharmacies are readily accessible sources of care for a variety of healthcare needs.

FUTURE CONSIDERATIONS/CONCLUSIONS

Going forward, how can naloxone dispensation be scaled to ensure ubiquitous access among patients receiving opioid prescriptions? Considerations, as discussed below, may be held at the systems level, at the level of healthcare providers, and within the pertinent patient population that is being served.

Notably, in 2017, the states of Virginia and Vermont were first to initiate mandates for prescribing naloxone to patients with higher risk factors; since that time, other states have followed suit with similar laws.5 Presently, there are no federal mandates that scale access to naloxone or other pharmacy interventions, including vaccines, over-the-counter birth control, HIV postexposure prophylaxis (PEP), and expedited partner therapy (EPT). Similar to California, there should be greater recognition of pharmacists as healthcare providers and providing them with reimbursement for services targeting people who use opioids and other vulnerable patient sub-groups. Additional systems approaches to consider include increasing professional associations’ support for these services and involving retail pharmacy leadership to support effective naloxone dispensation.

At the clinician level, further training is needed for physicians and pharmacists related to OEND and overcoming stigma when caring for people who use opioids. Optimization of physician-pharmacist communication will also be essential. In states where reimbursement for naloxone dispensing and education is possible, increasing pharmacists’ understanding of how and when to bill for these services may be crucial.

For appropriate patients with opioid prescriptions, general strategies for increasing naloxone receipt include focusing on underserved populations with reduced access to care and expanding insurance coverage. It will also be imperative to address patients’ concerns about being labeled as someone who has an opioid use disorder. When providing naloxone education, the inclusion of patients’ family or other social supports would appear to be a critical component when feasible.

This study centers on OEND at the level of pharmacies. Further studies are needed to address barriers to scaling opioid overdose education and naloxone distribution. To improve naloxone accessibility, it will require not only expert stages of change within pharmacies but also a committed partnership between governmental entities, other forms of leadership, pharmacists, and practicing physicians.