An Update on National Naloxone Distribution Efforts

Oct 2, 2018 9:30:00 AM by Mario Ramirez, MD

At AffirmHealth, we’ve directed much of our blog content towards safe and responsible opioid prescribing practices with an emphasis on the application of state and federal guidelines to daily clinician activities. 

But, we’ve also acknowledged that responsible prescribing will only be one part of a multifactorial solution to the opioid epidemic.  When we analyzed the epidemic management guidelines from various expert groups, most had the following approaches in common:

  • Responsible prescribing to stem inappropriate prescription drug use
  • Limiting the inflow and supply of illegal opiates from overseas
  • Improving access to addiction treatment and detoxification resources; and
  • Expanding access to naloxone and potential reversal agents

Naloxone Distribution Changes 

With that last point in mind, there are some important changes around naloxone access practices that stakeholders should be aware of from a public policy standpoint.

In August 2018, the U.S. Centers for Disease Control and Prevention published a seminal Morbidity and Mortality Weekly Report aptly named “Opportunities to Prevent Overdose Deaths Involving Prescription and Illicit Opioids,” covering 11 states from 2016-2017.[1]  In the paper, they made the critical point that our understanding of the demographics around the opioid epidemic are still quite limited.  Across 11 states and 42,249 opioid related fatal overdoses, 17.4% tested positive for prescription opioids alone, 58.7% for illicit opioids alone, and 18.5% included both.  10% had recently been released from an institutional setting and nearly 40% had bystanders present at the time of overdose.  Yet, naloxone was rarely administered in any of these cases.1 That leads us to the important conclusion that distribution efforts should focus on both opioid users and their family members and friends, but that there is also a critical need for improved education.

In response, many states and communities have used state and federal grants through recent funding bills to expand community-based opioid overdose prevention programs (OOPPs) to expand naloxone distribution.  A systematic review by Clark, et al. in the Journal of Addiction Medicine showed “the current evidence from nonrandomized studies [suggests] that bystanders (mostly opioid users) can and will use naloxone to reverse opioid overdoses when properly trained, and that this training can be done successfully through OOPPs.[2]”  Within those OOPPs, the components may vary slightly, but typically include instruction around recognizing an overdose, prevention, risk factors, appropriate response, and the actual administration of naloxone.

As of 2016, 47 states had authorized expanded access to naloxone to include paramedics, police, and firefighters.[3]  Through a series of laws passed over the last seven years, “further expansion to OOPPs, drug treatment facilities, prisons, syringe exchanges, the Veterans Administration healthcare systems, primary care clinics, and schools has also occurred,” and include a variety of education and support mechanisms.[4] 

Nalxone access by state-1

Reprinted from Network for Public Health Law. Legal interventions to reduce overdose mortality: naloxone access and overdose Good Samaritan laws. June 2016.

 

How Naloxone Distribution Increases 

It’s estimated that between 2010 to 2014, naloxone distribution from these various organizations increased by 187% with a concomitant rise in the number of successful overdose reversals.[5]  Interestingly, one of the most heavily targeted areas has been schools with Adapt Pharma (a leading naloxone producer), in partnership with the Clinton Foundation, distributing free Narcan kits to over 2,300 high schools in 42 states, and 8,200 doses to more than 250 colleges and universities in 36 states. 

From a legal standpoint, recent state legislation has focused around the mitigation of criminal, civil, and professional liability concerns for healthcare professionals and lay persons.  As of 2016, 47 states had codified specific changes around naloxone access so that “39 states provide immunity to prescribers, 41 remove criminal liability for possession of naloxone, 42 shield a lay administrator from civil liability, 37 authorize naloxone prescriptions to third parties, and 33 authorize standing orders for naloxone prescriptions.[6]”  These standing orders and the ability to obtain naloxone without a prescription, in combination with Good Samaritan laws that shield naloxone users from legal prosecution (drug distributors or sellers are excluded from these laws), have driven a significant increase in the number of overdose rescues in the United States.

Legislation Package Limiting Opioid Supply 

Finally, examining recent federal legislation this week, the House and Senate agreed upon an $8.4 billion package that takes some important steps including efforts to limit the supply of opioids through the mail and spurs the development of non-opioid pain management therapies.  Critically, however, the package does not include a provision to allow the federal government to negotiate with drug companies on the price of naloxone which was a key recommendation of the President’s Commission on Combating Drug Addiction and the Opioid Crisis chaired by Gov. Chris Christie.  Critics argue that by leaving this provision out, the door remains open for price gouging and abdicates the leverage that bulk purchasing by the federal government would afford.  Conversely, others argue that the states themselves still have the ability to negotiate bulk purchasing agreements and that the issue can still be revisited in future bills.

It’s clear that significant effort is being made to improve naloxone access for a variety of groups.  Unfortunately, however, the ever-rising number of deaths attributed to illicit opioid use suggests that further expanding access to this life saving drug remains a critical approach.  AffirmHealth continues to support these expanded access efforts and we’ll continue to keep you updated on their progress.

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References:

[1] MMWR Morb Mortal Wkly Rep. 2018 Aug 31; 67(34): 945–951.  Published online 2018 Aug 31.

[2] J Addict Med. 2014 May-Jun;8(3):153-63

[3] Network for Public Health Law. Legal interventions to reduce overdose mortality: naloxone access and overdose Good Samaritan laws. June 2016. www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf.

[4] https://journalce.powerpak.com/ce/expanding-access-to-naloxone-role

[5] Wheeler E, Jones TS, Gilbert MK, Davidson PJ. Opioid overdose prevention programs providing naloxone to laypersons—United States, 2014. MMWR Morb Mortal Wkly Rep. 2015;64(23):631-635. www.cdc.gov/mmwr/preview/mmwrhtml/mm6423a2.htm

[6] The Policy Surveillance Program. Naloxone overdose prevention laws map. LawAtlas. http://lawatlas.org/query?dataset=laws-regulating-administration-of-naloxone#.U3YljijzDEU.

 

The information presented on or through this website is made available solely for general information purposes and is not intended to substitute for professional, medical or legal advice. We do not warrant the accuracy, completeness, or usefulness of this information. Any reliance you place on such information is strictly at your own risk. We disclaim all liability and responsibility arising from any reliance placed on such materials.

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