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1 1 (September 27, 2017)

handle is hein.crs/govcgvt0001 and id is 1 raw text is: 01;0i E.$~ & September 27, 2017 Naloxone for Opioid Overdose: Regulation and Policy Options In the United States, the annual number of drug overdose deaths involving opioids has more than quadrupled since 1999, according to the Centers for Disease Control and Prevention (CDC). Recent estimates (through the third quarter of 2016) show that the age-adjusted rate of drug overdose deaths has continued to rise. Research published in the American Journal of Preventive Medicine finds that the proportion of drug overdose deaths involving opioids has been underestimated (Ruhm 2017). The prescription drug naloxone is currently the only safe and appropriate treatment for opioid overdose, according to the Substance Abuse and Mental Health Services Administration (SAMHSA) Opioid Overdose Prevention Toolkit. How Nalon* WoOrkS The drugs commonly called opioids-whether prescription drugs (e.g., oxycodone) or street drugs (e.g., heroin)-are opioid agonists, meaning they bind to and activate opioid receptors in the brain. Opioids relieve pain, may induce euphoria, and have other effects such as depressing both the central nervous system and the respiratory system. In the event of an overdose, these latter effects may manifest in a range of physical problems, including severe drowsiness, dangerously slow breathing, coma, and even death. Naloxone is an opioid antagonist, meaning it binds to opioid receptors but does not activate them. When administered during an opioid overdose, naloxone temporarily displaces opioid agonists from the opioid receptors and blocks additional opioid agonists from binding to the opioid receptors. By temporarily displacing and blocking opioid agonists, naloxone temporarily stops their effects, thus reversing the overdose. SAMHSA's Opioid Overdose Prevention Toolkit includes five steps for first responders to take in the event of an opioid overdose: (1) call for help (dial 911), (2) check for signs of opioid overdose, (3) support the individual's breathing, (4) administer naloxone, and (5) monitor the individual's response. Mi,<-yNro~be , , >, .- - Concern about opioid overdose deaths has led many people, including the members of the President's Commission on Combating Drug Addiction and the Opioid Crisis, to call for increased access to naloxone. Comparatively few people oppose expanded access to naloxone, arguing that such efforts implicitly condone opioid abuse. Naloxone must often be administered by lay people outside a medical setting (as described above); however, until recently naloxone was available only in an injectable form, which may be difficult for a lay person to administer (see Dosage Form in the next column). Also, naloxone is currently available by prescription only, which limits access (see Prescription Requirement in the next column). Naloxone is regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), which gives the Food and Drug Administration (FDA) in the Department of Health and Human Services (HHS) primary responsibility for ensuring the safety and effectiveness of drugs, regardless of whether they are controlled substances. See CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness. Naloxone is not known to carry risk of addiction and is not regulated under the federal Controlled Substances Act. Representatives of the FDA and other HHS agencies have publicly discussed two major options for increasing access to naloxone: (1) making naloxone available in easier-to- administer forms and (2) making naloxone available without a prescription. For more than 40 years, naloxone was available only in an injectable form, which is difficult for nonprofessionals such as friends or family members to administer. Further, both medical professionals and nonprofessionals are at risk of accidental needle sticks when giving injections. In recent years, the FDA has approved naloxone in forms that are easier to administer. Table I. Naloxone: Dosage Form Dosage Form Sold As Year Approved Injectable naloxone (generic) 1971 Auto-injector Evzio®D 2014 Nasal spray NARCAN® 2015 Source: Data publicly available from the FDA's Orange Book. Notes: Injectable naloxone is available as a generic drug marketed by multiple manufacturers: Evzio® is a registered trademark of Kal~o, Inc., and NARCAN® is a registered trademark of Adapt Pharma Operations Limited. Naloxone is currently available only by prescription. The FFDCA offers two mechanisms by which naloxone could become a nonprescription (over-the-counter) drug. One mechanism is the submission of a new drug application (NDA) or a supplemental NDA, which would have to be submitted by the manufacturer. The other mechanism is via rulemaking pursuant to 21 C.F.R. §310.200(b), which allows a prescription exemption when the Commissioner of Food and Drugs finds that prescription-dispensing requirements are unnecessary for safe and effective use of a drug in self-medication (as directed by proposed labeling). This process may be initiated by the commissioner or any interested person (i.e., a citizen petition). .O 'T gogn, q \popmm- , goo g , q aS ' X 11LULANJILiN,

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