A Thousand Ways to Say “No” to Naloxone

Every 5 minutes someone in America dies of an overdose. The single greatest barrier to increasing naloxone access is FDA’s designation of naloxone as prescription-only. For the first time, we highlight how prescription-only status cascades into myriad legal and practical barriers in ways that are unexpected. We ask FDA to remove generic naloxone’s prescription requirement for Harm Reduction programs, so that we may prevent overdose deaths more effectively. Remedy Alliance (For The People) operates the Opioid Safety and Naloxone Network (OSNN) Buyers Club, established in 2012. The Buyers Club is a collective of over 100 harm reduction programs who distribute naloxone directly to people who use drugs, their loved ones and community

Naloxone access is too complicated. A simplified future will save lives.

The current system is complicated and inefficient. Only harm reduction programs with physicians can obtain naloxone from manufacturers and distributors, or from health departments with standing orders. However, a simplified future will save lives. Non-profit supplies should be exempt from wholesale distributor regulations during a Public Health Emergency on overdose deaths. We can effectively remove the prescription requirement for programs and reduce reliance on imperfect standing orders. In face, FDA proposed doing exactly this last month, more broadly. Pending Drug Supply Chain Security Act regulations exempt distribution of emergency medications during a declared Public Health Emergency. If FDA enacted this proposed general rule for naloxone immediately, harm reduction programs could obtain naloxone without having to beg doctors to buy naloxone for them

Overdose rescues by trained and untrained participants and change in opioid use among substance-using participants in overdose education and naloxone distribution programs: a retrospective cohort study

Background: One approach to preventing opioid overdose, a leading cause of premature, preventable mortality, is to provide overdose education and naloxone distribution (OEND). Two outstanding issues for OEND implementation include 1) the dissemination of OEND training from trained to untrained community members; and 2) the concern that OEND provides active substance users with a false sense of security resulting in increased opioid use. Methods: To compare overdose rescue behaviors between trained and untrained rescuers among people reporting naloxone rescue kit use; and determine whether heroin use changed after OEND, we conducted a retrospective cohort study among substance users in the Massachusetts OEND program from 2006 to 2010. We used chi square and t-test statistics to compare the differences in overdose management characteristics among overdoses managed by trained versus untrained participants. We employed Wilcoxon signed rank test to compare median difference among two repeated measures of substance use among participants with drug use information collected more than once. Results: Among 4,926 substance-using participants, 295 trained and 78 untrained participants reported one or more rescues, resulting in 599 rescue reports. We found no statistically significant differences in help-seeking (p = 0.41), rescue breathing (p = 0.54), staying with the victim (p = 0.84) or in the success of naloxone administration (p = 0.69) by trained versus untrained rescuers. We identified 325 OEND participants who had drug use information collected more than once. We found no significant overall change in the number of days using heroin in past 30 days (decreased 38%, increased 35%, did not change 27%, p = 0.52). Conclusion: Among 4926 substance users who participated in OEND, 373(7.6%) reported administering naloxone during an overdose rescue. We found few differences in behavior between trained and untrained overdose rescuers. Prospective studies will be needed to determine the optimal level of training and whether naloxone rescue kits can meet an over-the-counter standard. With no clear evidence of increased heroin use, this concern should not impede expansion of OEND programs or policies that support them

Remedy Alliance For The People Annual Report 2023

This report covers August 2021 to July 2023, Year Zero and Year One of Remedy Alliance For The People. In our first year of operations as Remedy Alliance we sent 1,639,542 doses of generic injectable naloxone to 196 harm reduction projects in 44 US states, DC, and Puerto Rico, of which 206,371 doses were provided at no-cost to 138 under-resourced harm reduction projects; and we redistributed $180,000 in unrestricted funds to 20 under-funded harm reduction programs and mutual aid projects through our Community Support Initiative.“WE ENSURE HARM REDUCTION PROGRAMS HAVE SUSTAINABLE AND EQUITABLE ACCESS TO NALOXONE FOR DISTRIBUTION IN THEIR COMMUNITIES.

What is known about community pharmacy supply of naloxone? A scoping review

There is growing evidence that expanded supply of take-home naloxone to prevent opioid overdose deaths is needed. Potential routes for expansion of naloxone provision include through community pharmacies. The aim of this scoping review is to establish what is known about community pharmacy supply of naloxone, in light of unique challenges and opportunities present in pharmacy settings. A scoping review methodology was employed using the six stage iterative process advocated by Arksey and O’Malley (2005) and Levac et al. (2010). Searches used key words and terms such as ‘naloxone’; ‘overdose prevention/drug overdose/opiate overdose’; ‘community/retail pharmacy’; ‘pharmacist/pharmacy/community pharmacy/pharmaceutical services’; ‘professional practice/role’; ‘community care’; attitude of health personnel’; ‘training/supply/cost’. Appropriate search terms were selected for each database. After initial exploratory searches, comprehensive searches were conducted with Cochrane Database of Systematic Reviews, Medline, Medline in Process, Embase, PsycINFO and CINAHL. Eligibility criteria centered on whether studies broadly described supply of naloxone in community pharmacy or had content relating to community pharmacy supply. The search identified 95 articles, of which 16 were related to pharmacy supply of naloxone. Five themes were presented after initial review of the data and consultation with the project Expert Group, and are; ‘Pharmacists Perceptions of Naloxone: Facilitators and Barriers’, ‘Patient Populations: Identification and Recruitment’, ‘Supply Systems and Cost’, ‘Legal Issues’, and ‘Training of Pharmacists and Community Pharmacy Naloxone Recipients’. Findings from this scoping review suggest that community pharmacy based supply of take-home naloxone warrants the community pharmacy based route for distribution of take home naloxone provision warrants further consideration and development. Existing strengths include a range of established supply models, and training curricula, few direct concerns regarding legal liability of pharmacists in the supply of naloxone (once legal supply systems have been established) and the wide range of potential identifiable patient populations, which include pain patients that may not be in contact with existing naloxone supply programmes

Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists

InMarch of 2015, the United States Department of Health and Human Services identified 3 priority areas to reduce opioid use disorders and overdose,which are as follows: opioid-prescribing practices; expanded use and distribution of naloxone; and expansion ofmedication-assisted treatment. In this narrative review of overdose prevention and the role of prescribers and pharmacists in distributing naloxone, we address these priority areas and present a clinical scenario within the review involving a pharmacist, a patient with chronic pain and anxiety, and a primary care physician. We also discuss current laws related to naloxone prescribing and dispensing. This review was adapted from the Prescribe to Prevent online continuing medical education module created for prescribers and pharmacists

Overdose Prevention and Naloxone Prescription for Opioid Users in San Francisco

Opiate overdose is a significant cause of mortality among injection drug users (IDUs) in the United States (US). Opiate overdose can be reversed by administering naloxone, an opiate antagonist. Among IDUs, prevalence of witnessing overdose events is high, and the provision of take-home naloxone to IDUs can be an important intervention to reduce the number of overdose fatalities. The Drug Overdose Prevention and Education (DOPE) Project was the first naloxone prescription program (NPP) established in partnership with a county health department (San Francisco Department of Public Health), and is one of the longest running NPPs in the USA. From September 2003 to December 2009, 1,942 individuals were trained and prescribed naloxone through the DOPE Project, of whom 24% returned to receive a naloxone refill, and 11% reported using naloxone during an overdose event. Of 399 overdose events where naloxone was used, participants reported that 89% were reversed. In addition, 83% of participants who reported overdose reversal attributed the reversal to their administration of naloxone, and fewer than 1% reported serious adverse effects. Findings from the DOPE Project add to a growing body of research that suggests that IDUs at high risk of witnessing overdose events are willing to be trained on overdose response strategies and use take-home naloxone during overdose events to prevent deaths

Remedy Alliance - August 2022 distribution infographic

In our first month, Remedy Alliance shipped 1.5 tons of naloxone. That comes to 7,380 doses per day, to 28 states, including 18,605 free because 28% of programs don't have ANY funding