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handle is hein.crs/govemul0001 and id is 1 raw text is: Con gressios Informing the legi nal Research Service sIative debatesinco 1914 0 September 11, 2023 Naloxone for Opioid Overdose: Considerations for Congress Opioids, such as heroin, fentanyl, and some prescription pain medications (including morphine and oxycodone), are substances that act on receptors in the body important in regulating pain and emotion. As opioid agonists, these substances attach to and activate opioid receptors that can relieve pain, induce euphoria, or depress the central nervous and respiratory systems. In an overdose, opioids cause dangerously slow breathing, coma, and even death. In 2021, opioids were involved in over 80,000 overdose deaths in the United States. Opioid Overdose Reversal Medications: Naloxone Naloxone is a medication that can reverse an opioid overdose. As an opioid antagonist, it attaches 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 attaching, thus temporarily stopping their effects and reversing the overdose. (Naloxone is the most commonly used, though not the only, opioid overdose reversal medication. Nalmefene, another opioid antagonist, works in a similar manner.) Naloxone can cause withdrawal symptoms to an opioid user, though it is mostly harmless when administered to someone not using opioids. Naloxone only works to counteract the effects of opioid drugs; it has no effect in reversing overdoses from other substances. Comparable overdose reversal medications for non-opioid drugs, such as methamphetamine and cocaine, do not yet exist. Federal Regulation of Naloxone Naloxone is regulated under the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §§301 et seq.), which gives the U.S. Food and Drug Administration (FDA) primary responsibility for ensuring the safety and effectiveness of drugs. (See CRS Report R41983, How FDA Approves Drugs and Regulates Their Safety and Effectiveness.) Naloxone is not a controlled substance and does not carry risk of misuse. Until 2023, naloxone was available only by prescription. To increase accessibility of naloxone, many states issued standing orders or third-party prescriptions, which allow pharmacists to dispense naloxone without a prescription. These state laws also permit broad distribution and use of naloxone via community organizations and schools. Naoxone Formulations From its approval in 1971 through 2014, naloxone was available only in an injectable form. This formulation can be difficult for nonprofessionals to administer and poses risks of needle sticks when giving injections. An atomization attachment can transform liquid naloxone from a syringe into a mist for intranasal use, though this process requires multiple steps for use during an overdose. In 2015, the FDA approved naloxone in a more user-friendly nasal spray form (Narcan®), and a generic nasal spray in 2019 (Table 1). In March 2023, FDA approved Narcan as an over-the-counter drug (OTC), and a second nasal spray, RiVive, in July 2023. Naloxone is currently available in several prescription and nonprescription (i.e., OTC) forms. Depending on the strength of the formulation and the overdose circumstances, multiple doses of naloxone may be needed for effectiveness. Table I. Naloxone Nasal Spray Product Examples Product and FDA Manufacturer Formulation Status Narcan® by Emergent 4 mg naloxone OTC BioSolutions HCI nasal spray RiVive by Harm Reduction 3 mg naloxone OTC Therapeutics HCI nasal spray Naloxone HCI (generic) by 4 mg naloxone OTC Padagis Israel Pharmaceuticals HCI nasal spray Naloxone HCI (generic) by 4 mg naloxone Rx Teva Pharmaceuticals HCI nasal spray Kloxxado by Hikma 8 mg naloxone Rx Pharmaceuticals HCI nasal spray Source: FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (List is not exhaustive.) Notes: FDA=U.S. Food and Drug Administration; HCl=hydrochloride (a salt included for drug administration); OTC=available over-the-counter (i.e., without a prescription), mg=milligram, Rx=available by prescription only. Considerations for Congress Naloxone is effective only if it is available and administered during an overdose. As such, Congress may have an interest in increasing accessibility of the drug. Most determinations on distribution and use of naloxone are made at the state and local levels, though Congress has some relevant authorities. A common strategy at the federal level, for instance, is to provide support for state and local initiatives through grants or technical assistance. Distribution of Naloxone Naloxone is currently distributed by pharmacies, health care facilities, and entities outside the traditional health care system, such as harm reduction organizations, first responders, prisons, and schools. According to a March 2023 report by the Reagan-Udall Foundation, nearly half (45%) of the 17 million doses of naloxone distributed in the United States in 2021 were distributed outside retail pharmacies and health care facilities. In these instances, local health departments, harm reduction organizations, first responder groups, schools, and other community

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