Legal Interventions to Reduce Overdose Mortality: Naloxone Access and Overdose Good Samaritan Laws

“Opioid overdose is typically reversible through the timely administration of the drug naloxone and the provision of emergency care. However, access to naloxone and other emergency treatment is often limited by laws and that pre-date the overdose epidemic. In an attempt to reverse this unprecedented increase in preventable overdose deaths, a number of states have recently amended those laws to increase access to emergency care and treatment for opiate overdose.”

The Network for Public Health Law has published an update on access to naloxone by state and Good Samaritan laws.

http://www.networkforphl.org/_asset/qz5pvn/network-naloxone-10-4.pdf

Source: Network for Public Health Law – May, 2013

Study: Distributing Naloxone Injection Kits Could Help Addicts Reverse Heroin Overdoses

Distributing a drug that reverses drug overdoses in heroin users would save lives and be cost-effective, according to a new analysis.

U.S. researchers, who published their findings in the Annals of Internal Medicine on Monday, calculated that one death may be prevented for every 164 naloxone injection kits they distribute to heroin users. That, the researchers say, works out to be a few hundred dollars for every year of healthy life gained.

“The great news here is these overdose deaths can be prevented, it’s cost effective to do so, and may even be cost saving,” said Dr. Phillip Coffin, the study’s lead author from the San Francisco Department of Public Health.

http://medcitynews.com/2012/12/study-distributing-naloxone-injection-kits-could-help-addicts-reverse-heroin-overdoses/

Source: MedCityNews.com – December 31, 2012

Preventing Overdose: Obama Administration Drug Czar Calls for Wider Access to Overdose Antidote

governmentSpeaking at a North Carolina overdose-prevention program, the Obama administration’s drug czar Gil Kerlikowske called for increased action to prevent drug overdose deaths. Notably, for the first time Kerlikowske urged wider distribution of a medication called naloxone, an antidote to overdoses of opioid drugs, including prescription pain relievers and heroin, saying that “naloxone can be expanded beyond public health officials.”

http://healthland.time.com/2012/08/22/preventing-overdose-obama-administration-drug-czar-calls-for-wider-access-to-overdose-antidote/

Source: Healthland.Time.com – August 22, 2012

OTC Naloxone? It’s Possible

FDA officials are considering whether naloxone should be more widely available beyond medical settings, including through over-the-counter (OTC) sales and/or an intranasal version of the drug.

 ”Certainly, considering naloxone as an over-the-counter drug is forging new territory,” said Andrea Leonard-Segal, MD, director, FDA Division of Nonprescription Clinical Evaluation, Office of Nonprescription Products. Classifying the drug OTC would probably be accomplished through the new drug application (NDA) process, she said. To accomplish it by FDA rulemaking would take years. The NDA process for switching to OTC classification, she said, would require a fresh look at the drug’s chemistry, pharmacology/toxicology, microbiology, and clinical pharmacology. There might not be a need for efficacy data if a current formulation were used, she said.

http://drugtopics.modernmedicine.com/drugtopics/Modern%2BMedicine%2BNow/OTC-naloxone-Its-possible/ArticleStandard/Article/detail/772754?contextCategoryId=40159

Source:  DrugTopics.com – May 15, 2012

Government Considers Overdose Antidote, Naloxone, to Fight Prescription Drug Misuse

The U.S. Food and Drug Administration (FDA) has for the first time advocated considering the distribution of the naloxone, an overdose antidote, as a way to curb the rising toll of overdose deaths in America.

The director of the National Institute on Drug Abuse, Dr. Nora Volkow, has said that the drug should be available without a prescription.

http://healthland.time.com/2012/04/27/government-considers-overdose-antidote-naloxone-to-fight-prescription-drug-misuse/

Source: Healthland.Time.com – April 27, 2012

Naloxone (Narcan) in the News

Naloxone Debate: FDA Hears Testimony About Making an Overdose Antidote Nonprescription

Parents testified at an open meeting called by the FDA to consider whether the lifesaving antidote to opioid overdose — a non-addictive, non-toxic drug called
naloxone (Narcan) — should be made available over-the-counter, so that everyone can keep it in their first aid kit, just in case.

The meeting was sponsored by the FDA, the Centers for Disease Control and Prevention (CDC) and the National Institute on Drug Abuse, whose director, Dr. Nora Volkow, has said that she supports making the drug available without a prescription.

http://healthland.time.com/2012/04/13/naloxone-debate-fda-hears-testimony-about-making-an-overdose-antidote-nonprescription/

Source: Time Healthland.com – April 13, 2012

Antidote (Naloxone) Hard To Find As Heroin Death Toll Rises

In the face of the rising death toll, the state of Washington in 2010 made the lifesaving opiate antidote Naloxone available by prescription. The drug, also known by several brand names, has long been used by paramedics and emergency-room doctors to pull overdose victims back from the brink of death.

It’s legal, but it’s not widely available, said Caleb Banta-Green, a research scientist at the University of Washington’s Alcohol and Drug Abuse Institute. “It’s an issue of needing enough demand. People don’t know to ask for it,” he said.

http://www.yakima-herald.com/stories/2012/04/06/antidote-hard-to-find-as-heroin-death-toll-rises

Source: Yakima-Herald.com – April 6, 2012

CDC Report: Community-Based Opioid Overdose Prevention Programs Providing Naloxone – U.S., 2010

Since the mid-1990s, community-based programs have offered opioid overdose prevention services to persons who use drugs, their families and friends, and service providers. Since 1996, an increasing number of these programs have provided the opioid antagonist naloxone hydrochloride, the treatment of choice to reverse the potentially fatal respiratory depression caused by overdose of heroin and other opioids.

In October 2010, the Harm Reduction Coalition, a national advocacy and capacity-building organization, surveyed 50 programs known to distribute naloxone in the United States, to collect data on local program locations, naloxone distribution, and overdose reversals. This report summarizes the findings for the 48 programs that completed the survey and the 188 local programs represented by the responses. Since the first opioid overdose prevention program began distributing naloxone in 1996, the respondent programs reported training and distributing naloxone to 53,032 persons and receiving reports of 10,171 overdose reversals.

Nineteen (76.0%) of the 25 states with 2008 drug overdose death rates higher than the median and nine (69.2%) of the 13 states in the highest quartile did not have a community-based opioid overdose prevention program that distributed naloxone.

Twenty-one (43.7%) responding programs reported problems obtaining naloxone in the “past few months” before the survey. The most frequently reported reasons for difficulties obtaining naloxone were the cost of naloxone relative to available funding and the inability of suppliers to fill orders.

http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6106a1.htm?s_cid=mm6106a1_w

Source: Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report (MMWR) – February 17, 2012

FDA Calls for Public Comments on Wider Distribution of Naloxone for Opioid Overdose Fatality Prevention

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), in collaboration with the Office of the Assistant Secretary for Health, National Institutes of Drug

Abuse, and the Centers for Disease Control and Prevention, is announcing a scientific workshop to initiate a public discussion about the potential value of making naloxone more widely available outside of conventional medical settings to reduce the incidence of opioid overdose fatalities.

http://www.gpo.gov/fdsys/pkg/FR-2011-11-17/pdf/2011-29703.pdf

Source: Federal Register / Vol. 76, No. 222 / Thursday, November 17, 2011 / Notices

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