NALOXONE AVAILABILITY

To recognize the public health benefits of naloxone for opioid reversal; further,

To support efforts to safely expand patient and public access to naloxone through independent pharmacist prescribing authority, encouraging pharmacies to stock naloxone, supporting availability of affordable formulations of naloxone (including zero-cost options), and other appropriate means; further,

To advocate for statewide naloxone standing orders to serve as a prescription for individuals who may require opioid reversal or those in a position to aid a person requiring opioid reversal; further,

To support and foster standardized education and training on the role of naloxone in opioid reversal and its proper administration, safe use, and appropriate follow-up care, and dispelling common misconceptions to the pharmacy workforce and other healthcare professionals; further,

To support the use of objective clinical data, including leveraging state prescription drug monitoring programs and clinical decision-making tools, to facilitate pharmacist-initiated screenings to identify patients who may most benefit from naloxone prescribing; further,

To encourage the co-prescribing of naloxone with all opioid prescriptions; further,

To support legislation that provides protections for those seeking or providing medical help for overdose victims.

Rationale

According to the Centers for Disease Control and Prevention (CDC), prescription drug abuse is a national epidemic. Deaths from prescription opioid overdose number 10,000 per year; in contrast, deaths from heroin overdose number 2000. People at risk for opioid overdose include not only substance abusers, but also opioid-naive patients, such as those being admitted for or discharged from ambulatory surgery.

Naloxone is a competitive opioid antagonist that rapidly rescues patients from opioid overdose by displacing mu2 opioid receptors in the central nervous system. Naloxone has an excellent safety profile. The World Health Organization includes naloxone on its model list of essential medicines.

Evidence has demonstrated a clear public health benefit from expanding access to naloxone. Naloxone is currently distributed without a prescription via standing orders, collaborative practice agreements, or pharmacist prescribing authority in all 50 states to ensure liberal access to this lifesaving drug. Several states have also started to permit pharmacy technicians to dispense naloxone under these provisions as well.

Currently there are several formulations of naloxone on the market, which vary in strength and route of administration, including subcutaneous injection (which caregivers or peers may have difficulty administering properly) and intranasal formulations. Studies have shown that intranasal naloxone is as effective as injectable routes in rapid opioid reversal. However, its cost ($130-300 per kit) presents a barrier to widespread use. ASHP encourages the Food and Drug Administration to explore ways to get more user-friendly and less-costly formulations to the market for patients and caregivers. Recognizing that naloxone should not be cost-prohibitive, efforts should be made to fully subsidize the cost of this lifesaving medication.

Despite expanded access to naloxone, there are still significant barriers to its widespread use, including hesitancy among pharmacists to dispense naloxone. Uniform education for those administering the drug, training on safe administration, and recommendations on follow-up care with abuse treatment programs for treated individuals is needed.

Furthermore, although great strides have been made in many areas to improve naloxone access, it is necessary to recognize areas of practice where such efforts are inadequate as a one-size-fits-all model. While pharmacists in all 50 U.S. states now have the ability to participate in naloxone prescribing in some form, barriers to access may still exist, such as in rural communities with no physician willing to participate in a collaborative practice agreement, or indeed, perhaps no physician whatsoever. To that end, pharmacists’ naloxone prescribing authority should be independent  (i.e., not requiring a protocol or collaborative practice agreement to be in place). Where there are barriers to such independent authority, ASHP should advocate for legislation that promotes standing orders for naloxone as a part of patient care, much as ASHP advocates for pharmacists’ independent prescribing authority for medication-assisted treatment (ASHP policy 1909).

Pharmacists should make every effort to intervene on behalf of their patients’ safety;therefore, pharmacist education regarding use of naloxone should begin in the didactic curriculum in schools of pharmacy and be part of an ongoing effort for pharmacists as lifelong learners. Current literature suggests that one key barrier to expanded pharmacist involvement in naloxone prescribing is a lack of confidence — which may be addressed by increased education — and also by persistent misconceptions, such as the notion that increased naloxone availability will promote opioid misuse. Because the pernicious nature of this idea is so harmful, it should be highlighted for targeted educational efforts.

Significant access and racial prescribing disparities have been noted in clinical literature regarding naloxone (Dayton L et al. Racial Disparities in Overdose Prevention among People Who Inject Drugs. J Urban Health 2020; 97:823–30). Encouraging pharmacists to be proactive in making clinical interventions is important, but safeguarding patients to protect them from the harms of bias is essential in ensuring equitable access to this medication. Whenever possible, pharmacists should use objective measures (e.g., history of overdose, polypharmacy including multiple CNS-depressing agents, high morphine milligram equivalents per day) to identify high-risk patients and make proactive interventions to provide naloxone to them.

Finally, encouraging co-prescribing of naloxone with every opioid prescription aligns ASHP with the American Medical Association, CDC guidelines, and other organizations that  recommend prescribing or co-prescribing naloxone to reduce the risk of overdose deaths. Laws, including medical amnesty and those that provide protection against legal liability for persons administering naloxone (i.e., Good Samaritan laws), are needed as well as laws protecting individuals who call for help for someone who has overdosed from prosecution from minor drug possession or drug paraphernalia.