WHAT IS HARM REDUCTION?
Harm reduction is an approach to help minimize the negative consequences of both drug use and harmful drug policy, with an emphasis on practicing radical compassion to help reduce the harms that people who use drugs experience.
One key focus of harm reduction is to keep people alive and reduce suffering. This approach meets the needs of people who use drugs “where they’re at” in their journey and recognizes that some people may not be willing or able to change their behavior.
Harm reduction focuses on providing judgment-free healthcare solutions that empower people and help them to lower the health risks associated with substance use. These include safe access to drug accessories, allowing drug intake in a controlled environment, use of naloxone for those experiencing an overdose, and health education at the individual and community level.
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HISTORY OF NALOXONE
Naloxone has been used around the world to reverse opioid-related overdoses since the early 1960s, initially restricted as a prescription drug and more recently FDA-approved as an over-the-counter (OTC) drug available to everyone as a nasal spray.
Naloxone has proven effective at intranasal dosage levels as low as 2 mg, which is the most commonplace level in Europe. While 4 mg dosage levels are most common in the United States, RiVive’s 3 mg level is a new and equally effective treatment to 4 mg nasal sprays with less chance of causing a problematic, precipitated withdrawal that can potentially cause harm to the person who has overdosed as they are recovering from a near death experience.
| 1961 | First patent is filed for naloxone. |
| 1971 | United States: FDA approves 0.4 mg/ml injectable naloxone as prescription-only medication. Naloxone enters clinical practice in Europe in subsequent years. |
| 1983 | World Health Organization (WHO) adds naloxone to its model list of essential medicines. |
| 1985 | Original naloxone patent expires.1 |
| 1990 | Italy: Naloxone is removed from a list of prescription-only emergency medications. |
| 1991 | Italy: Experimental distribution of naloxone by doctors at public drug services in Piemont and Lazio regions. |
| 1992 | Notion of making naloxone more broadly available is mooted at International Harm Reduction Conference. Italy: Naloxone provision reported in Rome and Naples. |
| 1994 | First reported use of intranasal naloxone for overdose reversal (Loimer et al.). Italy: Naloxone provision continues to extend to further cities. |
| 1996 | United States: Naloxone pilot programs begin in 15 U.S. states and Washington, D.C. Italy: Ministry of Health officially reclassifies naloxone as an OTC medicine. |
| 1998 | United States: Chicago Recovery Alliance distributes the first Take Home Naloxone (THN) kits. United Kingdom: Channel Island of Jersey starts THN distribution. Germany: Start of overdose response training and naloxone distribution in Berlin. |
| 2001 | United Kingdom: Introduction of first mainland THN scheme in South London. First published report on THN distribution in peer-reviewed journal (Dettmer et al.). |
| 2005 | United Kingdom: Legal status of naloxone is changed to permit emergency administration of naloxone by any member of the general public (Schedule 7 of the Medicines Act). |
| 2007 | United Kingdom: Scotland and Wales establish THN pilot studies. |
| 2008 | UK: Medical Research Council funds N-ALIVE trial on prison-release naloxone. Spain: Formal THN program launched in Barcelona. |
| 2010 | Denmark: Naloxone pilot project launched in Copenhagen. |
| 2011 | United Kingdom: Scottish Lord Advocate issues guidelines enabling drug services to stock and supply naloxone. United Kingdom: Scotland and Wales launch national THN programs. Australia: First THN program is introduced in Canberra. |
| 2012 | Commission on Narcotic Drugs Resolution 55/7 encourages Member States to include effective overdose prevention measures in national drug policies and share best practices and information, including on the use of naloxone (CND, 2012). |
| 2014 | WHO Guidelines for the community management of opioid overdose published. EU: European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) holds expert meeting on ‘Take home naloxone’ Norway: THN program using purpose-built atomizer for intranasal administration begins. Germany: THN pilot in Frankfurt starts. |
| 2015 | Ireland: THN demonstration projects start in Dublin, Waterford/South-East, Limerick and Cork. EU: EMCDDA systematic review on the effectiveness of THN programs (Minozzi et al., 2015) published. United Kingdom: Amendment to Human Medicines Regulation allows drug treatment services to provide naloxone without prescription as a life-saving precautionary measure. France: National Commission on narcotics and psychotropic substances allows piloting of nasal naloxone spray (0.9 mg/0.1 ml) under cohort temporary authorization for use. United States: FDA approves nasal naloxone spray developed for community use (4 mg/0.1 ml) developed for community use. |
| 2016 | United States: Commercial launch of nasal naloxone in February 2016. EU: EMCDDA Insights published on preventing opioid overdose deaths with THN. France: National study of nasal naloxone for newly released inmates and drug users after withdrawal. Germany: Further city-based THN programs start in Cologne, Munich and cities in North Rhine-Westphalia. Canada: Health Canada approves 4 mg/0.1ml nasal naloxone spray for non-prescription community use. |
| 2017 | France: National regulatory authority approves naloxone nasal spray for emergency treatment of opioid overdoses; low-threshold harm reduction centers now also allowed to dispense nasal naloxone. EU: EU Action Plan on Drugs 2017-2020 includes an action (8b) to provide ‘access to authorized pharmaceutical dosage forms of medicinal products containing naloxone specifically certified to treat opioid overdose symptoms by trained laypersons in the absence of medical professionals’. EU: European Commission authorizes the first intranasal naloxone spray (1.8 mg/0.1 ml) for EU-wide marketing. United States:
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| 2018 | United States: Surgeon General issues an Advisory that calls for more people to get access to naloxone. EU: Nasal naloxone spray commercially launched in individual European countries. Sweden: National Board of Health and Welfare publishes national guidelines for naloxone programs. Implementation of naloxone programs by health care services strongly recommended. National overdose response plan includes naloxone. |
| 2019 | United Nations Office on Drugs and Crime (UNODC): Stop Overdose Safely (S-O-S) initiative on THN in Ukraine, Kazakhstan, Kyrgyzstan, and Tajikistan begins. France: Since June 2019, naloxone for IM injection in a pre-filled syringe can be obtained from pharmacies without a prescription. |
| 2020 | FDA publishes its own label comprehension study encouraging pharma to submit an OTC switch application for naloxone. (https://www.nejm.org/doi/full/10.1056/NEJMsa1912403) |
| 2022 | FDA accepts RiVive New Drug Application (NDA) from HRT for priority review. |
| 2023 | RiVive (naloxone HCl nasal spray 3 mg) approved by FDA, first shipment of RiVive December 2023. |
| 2024 | Call for compassionate opioid overdose response white paper published. |
1 https://www.nejm.org/doi/full/10.1056/NEJMp1609578
Note: Timeline adapted and amended from Strang and McDonald, EMCDDA (2016), p. 51.