Increasing Access to Naloxone

Access to naloxone has been increasing in recent years. Between 2017 and 2018, naloxone prescriptions doubled from 270,000 prescriptions written in 2017 to 556,000 prescriptions written in 2018.¹³ During this same time, prescriptions for high-dose opioids decreased from 48 million in 2017 to 38 million in 2018. Prescriptions for naloxone, while increasing, are still low compared to the number of patients who are prescribed high-dose opioids. To put these numbers into perspective, if each person prescribed a high-dose opioid in 2018 also received a prescription for naloxone, 9 million prescriptions for naloxone would have been written.¹³ The CDC guidelines for prescribing opioids for chronic pain recommend that healthcare providers co-prescribe naloxone along with a high-dose opioid prescription in patients at risk for overdose including:¹⁴

• • Patients with a history of overdose
• • Patients with a history of substance use disorder
• • Patients taking benzodiazepines with opioids
• • Patients returning to a high dose to which they are no longer tolerant
• • Patients taking opioids at a dose of >50 MME/day (Table 24.2)

Many states allow pharmacists to dispense naloxone without a prescription, otherwise known as “standing orders.” In addition to providing greater access to naloxone, it is also necessary for

TABLE 24.2

Calculating Morphine Milligram Equivalents (MME)^a for Commonly Prescribed Opioids

^a MME=dose of opioid multiplied by the conversion factor.

^b All doses in mg/day, except fentanyl, which should be in mcg/hr before multiplying by conversion factor. ^c Dose conversions are estimated and cannot account for all individual differences in genetics and pharmacokinetics. ^d Tapentadol is a mu-receptor agonist and norepinephrine reuptake inhibitor. MMEs are based on degree of mu- receptor agonist activity, but it is unknown if this drug is associated with overdose in the same dose-dependent manner as observed with medications that are solely mu- receptor agonists.

Source: Reference 15.

healthcare providers to become actively involved in providing education on both opioid overdose and the proper use of naloxone during an emergency situation. Education is important not only for the patient, but also any household members and for the greater community.

The FDA has addressed better targeting of naloxone in the community through supporting the development of over-the-counter (OTC) forms of naloxone. In an effort to speed development of OTC versions, the FDA created labeling that can be used by sponsors to obtain approval of naloxone for OTC status.¹⁶

Cost can also be a barrier to naloxone access and use. In September of 2019, the FDA announced its commitment to prioritize and expedite the review of generic medications indicated for the emergency treatment of opioid overdoses.¹⁷

Conclusion

The opioid crisis was created by multiple factors, and it will take a concerted effort from multiple disciplines, including healthcare professionals, legislators, and the general public, to address it effectively. Wider access to naloxone is an important component to help fight opioid deaths and ensure that this crisis does not continue in the future.

References

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• 13. Center for Disease Control and Prevention, National Center for Injury Prevention and Control. Lifesaving naloxone from pharmacies. More dispensing needed despite progress, https://www.cdc.gov/vital signs/naloxone/index.html. Accessed December 16, 2019.
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• 16. Statement from FDA Commissioner Scott Gottlieb, M.D., on unprecedented new efforts to support development of over-the-counter naloxone to help reduce opioid overdose deaths [Press Announcement], U.S. Food and Drug Administration January 17, 2019. https://www.fda.gov/news-events/press-announc ements/statement-fda-commissioner-scott-gottlieb-md-unprecedented-new-efforts-support-developme nt-over. Accessed December 16, 2019.
• 17. Statement on continued efforts to increase availability of all forms of naloxone to help reduce opioid overdose deaths [Press Announcement], U.S. Food and Drug Administration. September 20, 2019. https:// www.fda.gov/news-events/press-announcements/statement-continued-efforts-increase-availability-all- forms-naloxone-help-reduce-opioid-overdose. Accessed December 16, 2019.