By: Michael Lim, PharmD Candidate c/o 2020
In 2017, 70,237 overdose deaths occurred in the United States. Of those deaths, 47,600 (sixty-seven point eight percent of all drug overdose deaths in 2017) involved opioids.1 As the current main driver of drug overdose deaths, opioids and their misuse and abuse represent an ongoing health epidemic that has been targeted by the Trump administration, the Food and Drug Administration (FDA), and other organizations.1 Among the various strategies enacted to address the epidemic, perhaps one of the most important has been the effort to increase education and awareness about the availability of naloxone (Narcan®). Naloxone is an opioid receptor antagonist that temporarily reverses the effects of an opioid overdose. In a suspected overdose, naloxone is a safe antidote, and when given in time, it can save a life.2 As the United States continues to grapple with the opioid crisis, the Department of Health and Human Services (HHS) released a guidance in December 2018 detailing new recommendations for naloxone’s use in combatting the opioid epidemic.
According to the guidance, while prior Centers for Disease Control and Prevention (CDC) guidelines and the April 2018 Surgeon General’s Advisory on naloxone and opioid overdose have heightened awareness, increased dispensing, and increased the availability of naloxone in reversing opioid overdose, additional measures can be implemented to improve this response and save more lives.3,4 The most notable gap in the current response was found in the infrequent co-prescribing of naloxone to patients who are prescribed opioids or to individuals with a high risk of experiencing an opioid overdose.4 In fact, based on national data from patients to whom clinicians should consider co-prescribing naloxone, less than one percent of the patients who need naloxone actually receive a prescription for it.4 Consequently, in the spirit of reducing the risk of overdose related deaths, the guidance recommends that clinicians strongly consider prescribing or co-prescribing naloxone as well as counseling about its use to a variety of patients who are prescribed opioids.4 This includes patients who are prescribed opioids at a dosage of 50 morphine milligram equivalents (MME) per day or greater, have respiratory conditions such as COPD or obstructive sleep apnea regardless of opioid dose, have been prescribed benzodiazepines regardless of opioid dose, have a non-opioid substance use disorder, report excessive alcohol use, or have a mental health disorder regardless of opioid dose.4 Furthermore, it is recommended that clinicians consider prescribing or co-prescribing naloxone to patients who are at a high risk of experiencing or responding to an opioid overdose.4 This population includes individuals using heroin, illicit synthetic opioids, illicit stimulants such as methamphetamine or cocaine which may be contaminated with illicit synthetic opioids, individuals misusing prescription opioids, patients receiving treatment for opioid use disorder, and individuals with a history of opioid misuse that were recently released from incarceration or other controlled settings where tolerance to opioids has been lost.4
The guidance was narrowly approved in a 12-11 vote by an advisory panel to the FDA.5 While approved in response to the growing number of opioid overdose cases, concerns were also raised based on FDA studies which found that co-prescribing naloxone could increase annual healthcare costs by sixty three point nine billion dollars to five hundred and eighty point eight billion dollars.5 Mary Ellen McCann, MD., MPH, Associate Professor of Anesthesia at Harvard Medical School as well as a panelist who voted against the guidance stated, “I think co-prescribing is an expensive way to saturate the population with naloxone. The at-risk populations are not necessarily the ones that are being prescribed new narcotics. I’m concerned about a person going in with a broken arm and ending up with thirty dollars of a codeine product and a (naloxone) autoinjector at four thousand dollars plus.”5 However, it is unclear whether these prices reflect actual out-of-pocket costs.5 On the other hand, one FDA advisor who voted in favor of the guidance stated that the co-prescribing of naloxone may prompt more discussion between clinicians and patients.6 Ultimately, at this early stage the guidance presents a difficult dilemma in regard to weighing costs against benefits.
Naloxone is a highly effective antidote to overdose.4 However, it can only save lives from opioid overdose if it is in the right hands at the right time.4 Given the nationwide spread of the opioid epidemic, all healthcare providers have a responsibility to ensure that naloxone is available to high risk populations and that these individuals are trained to use naloxone in the event of an overdose. From the pharmacy perspective, pharmacists may be useful in counseling about naloxone and its proper use in the aforementioned high-risk populations as well as in educating prescribers about the new HHS guidance to ensure that naloxone is made available to the applicable groups. Overall, while divisive, the December 2018 HHS naloxone recommendations could offer another promising approach to curbing the opioid epidemic. The effect this guidance has will be interesting to follow throughout 2019.
- Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Morbidity and Mortality Weekly Report (MMWR). Centers for Disease Control and Prevention. https://www.cdc.gov/mmwr/volumes/67/wr/mm675152e1.htm?s_cid=mm675152e1_w. Published 12/21/18. Accessed 01/02/19.
- General S. Surgeon General’s Advisory on Naloxone and Opioid Overdose. SurgeonGeneral.gov. https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html. Published 04/18. Accessed 01/02/19.
- U.S. Department of Health and Human Services. HHS recommends prescribing or co-prescribing naloxone to patients at high risk for an opioid overdose. HHS.gov. https://www.hhs.gov/about/news/2018/12/19/hhs-recommends-prescribing-or-co-prescribing-naloxone-to-patients-at-high-risk-for-an-opioid-overdose.html. Published 12/19/18. Accessed 01/02/19.
- U.S. Department of Health and Human Services. Naloxone: The Opioid Reversal Drug that Saves Lives. HHS.gov. https://www.hhs.gov/opioids/sites/default/files/2018-12/naloxone-coprescribing-guidance.pdf. Published 12/19/18. Accessed 01/02/19.
- Joseph S. FDA panel backs prescribing overdose reversal drug with opioids. Reuters. https://www.reuters.com/article/us-usa-opioids-naloxone/fda-panel-backs-prescribing-overdose-reversal-drug-with-opioids-idUSKBN1OH2CA. Published 12/19/18. Accessed 01/02/19.
- NEJM Journal Watch. HHS Recommends Coprescribing Naloxone with Opioids in High-Risk Patients. NEJM Journal Watch: Summaries of and commentary on original medical and scientific articles from key medical journals. https://www.jwatch.org/fw114907/2018/12/20/hhs-recommends-coprescribing-naloxone-with-opioids-high. Published 12/20/18. Accessed 01/02/19.