PLEASE NOTE: THIS RESOLUTION WILL BE DEBATED AT THE 2013 COUNCIL MEETING. RESOLUTIONS ARE NOT OFFICIAL UNTIL ADOPTED BY THE COUNCIL AND THE BOARD OF DIRECTORS (AS APPLICABLE). RESOLUTION: 39(13) SUBMITTED BY: Larry Bedard, MD, FACEP Richard Bukata, MD, FACEP Jerome Hoffman, MD, FACEP James Mitchiner, MD, FACEP SUBJECT: Naloxone Prescriptions in the ED PURPOSE: Support and advise emergency physicians to dispense and/or prescribe Naloxone for victims of opioid overdose treated in the ED and promote the ability of emergency physicians to lawfully prescribe Naloxone explicitly for potential future opiate overdose through legislative or regulatory advocacy. FISCAL IMPACT: Committee and staff time to provide information to members regarding Naloxone and to provide legislative or regulatory advocacy at the local, state, and national levels. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 WHEREAS, Accidental drug overdose accounted for more than 22,400 deaths in 2005; and WHEREAS, Since 2005 accidental drug overdose from both legal and illegal drugs is the second leading cause of accidental deaths; and WHEREAS, Between 1995 and 2002 heroin related ED visits increased from 69,556 to 93,519; and WHEREAS, Naloxone is a highly effective treatment for narcotic overdose if administered in a timely fashion; and WHEREAS, Support is growing among some physicians for regularly pairing Naloxone with all opioid prescriptions; and WHEREAS, New York State passed legislation in 2005 establishing that physicians may lawfully prescribe Naloxone explicitly for potential future opiate overdose; therefore be it RESOLVED, That ACEP supports and advises emergency physicians to dispense and/or prescribe Naloxone for victims of opioid overdose treated in the ED; and be it further RESOLVED, That ACEP promote the ability of emergency physicians to lawfully prescribe Naloxone explicitly for potential future opiate overdose through legislative or regulatory advocacy at the local, state, and national levels. Background This resolution calls for ACEP to support and advise emergency physicians to dispense and/or prescribe Naloxone for victims of opioid overdose treated in the ED, and to promote the ability of emergency physicians to lawfully prescribe Naloxone explicitly for potential future opiate overdose through legislative or regulatory advocacy. Drug overdose death rates have increased in the United States with prescription opioid analgesics, cocaine, and heroin the drugs most commonly involved. In the United States, mortality rates closely correlate with opioid sales. Death from an overdose typically occurs one to three hours after taking the drug, frequently occurs in the presence Resolution 39(13) Naloxone Prescriptions in the ED Page 2 of other people, and medical help is often not sought or is sought too late. Fear of police involvement has been a barrier to calling 911 during an overdose event. Naloxone (commonly referred to as Narcan) is an opioid receptor antagonist currently approved for use by injection only for the reversal of opioid overdose and for adjunct use in the treatment of septic shock. It is used mainly in emergency departments and in ambulances by trained medical professionals. Prescribing Naloxone is considered an off-label use of the drug. Naloxone has no effect on nonopioid overdoses. Since the mid-1990s, a number of community-based programs have offered opioid overdose prevention services to persons who use drugs, their families and friends, and service providers. Yet, barriers to intervention and overdose reversal still existed. Other approaches began to be considered. In the late-1990s, a number of these programs started providing Naloxone hydrochloride to reverse the potentially fatal respiratory depression caused by overdose of heroin and other opioids. In 1995, some European countries began to provide prescription Naloxone for injection drug users. Underground programs first distributed Naloxone in 1999 in the United States, first in Chicago, then in San Francisco. A pilot study that included opiate education and Naloxone prescription was sponsored in 2001 by the San Francisco Department of Public Health. New Mexico was the first state to encourage prescribing take-home Naloxone to heroin-injecting patients, and implemented legislation to provide medical liability protection for those prescribing Naloxone. As of July 2012, eight states have Naloxone prescribing laws; seven states provide criminal prosecution immunity for licensed health care professionals for prescribing, dispensing, or distributing Naloxone to a layperson; three states provide physicians with civil liability immunity; seven states provide criminal prosecution immunity for laypersons administering Naloxone; and two states provide civil liability for laypersons. In 2013, Colorado enacted a law providing civil and criminal immunity for licensed health care providers and for laypersons (with education of the layperson strongly encouraged), and Maryland passed a bill that allowed laypersons receiving a certificate (after educational training) to administer Naloxone, and protected physicians from discipline when prescribing to those individuals. On April 12, 2012, the Food and Drug Administration (FDA), Center for Drug Evaluation and Research, in collaboration with the Office of the Assistant Secretary for Health, National Institutes of Drug Abuse, and the Centers for Disease Control and Prevention (CDC), held 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. At this meeting, the FDA discussed ways to expand access to Naloxone through the development of new formulations (would require a bioequivalence study), or making Naloxone approved for use over the counter (additional clinical data would be needed). Other issues discussed at the April 12 meeting, included: (1) the need for easier access to Naloxone; (2) that there needs to be better data on whether Naloxone is effective in saving lives; (3) the relatively short half-life of Naloxone compared to some longer-acting opioid formulations; (4) that after Naloxone is administered, it is important to seek immediate medical attention; and (5) the concern that increasing the overall availability of Naloxone might lead to increased drug use by giving a false sense of security. One speaker stated that such interventions do not necessarily lead to more risky behaviors; instead, the results are dependent on the prevention strategy, the target of the strategy, individual characteristics, and the larger social context. The meeting ended with each of the federal partners expressing willingness to work with interested manufacturers and developers to further explore the best uses of Naloxone to prevent opioid overdose deaths. Other papers have stressed the importance of layperson education about Naloxone use, including recognizing symptoms of overdose, the importance of calling 911, rescue breathing, and administration of the opiate antagonist. The February 17, 2012 issue of “Morbidity and Mortality Weekly Report” (MMWR), reported on communitybased opioid overdose prevention programs providing Naloxone. The report was based on an online survey conducted by the Harm Reduction Coalition, a national advocacy and capacity-building organization, of 50 programs known to distribute Naloxone in the United States. A total of 48 programs completed the survey. The report states that the findings suggest that distribution of Naloxone and training in its administration might have prevented numerous deaths from opioid overdoses. The report states that the report findings are subject to limitations because the data are based on unconfirmed self-reports from the responding programs, and due to incomplete data collection on numbers of persons trained in Naloxone administration , the number of overdose reversals involving Naloxone, and the number of untreated opioid overdoses that survived without Naloxone Resolution 39(13) Naloxone Prescriptions in the ED Page 3 administration. The report also states that 43.7% of the responding programs had problems obtaining Naloxone related to cost and drug shortages. Price increases of some formulations of Naloxone appear to restrict current program activities and the possibility of new programs. The report states that economic pressures on state and local budgets could decrease funding of opioid overdose prevention activities. The report recognizes that during the same time, various other prevention measures have been adopted, such as opioid prescribing guidelines, prescription drug monitoring programs, and prescription drug take-back programs. In October 2012, the Network for Public Health Law provided a webinar on issues related to take-home Naloxone for opioid overdose including legal/regulatory barriers to Naloxone access. Some possible solutions listed included removal of civil and criminal penalties for prescribers and administrators of Naloxone with Naloxone access laws and Good Samaritan laws. In June 2013, the CDC issued a health advisory regarding overdose with a synthetic opioid, acetyl fentanyl. Acetyl fentanyl is not available as a prescription drug in the United States. It is up to five times more potent than heroin. It is believed that Naloxone will have the same reversal effect as it does for fentanyl and other synthetic opioids, however, larger doses of Naloxone may be required to reverse the opioid induced respiratory depression because of the higher potency of fentanyl and acetyl fentanyl compared to heroin. The CDC advised that emergency departments and emergency medical services ensure they have adequate Naloxone available as some services have run out of Naloxone in the face of increased numbers of overdoses and administering higher doses of Naloxone in a short period of time. ACEP Strategic Plan Reference Goal 1 – Reform and Improve the Delivery System for Emergency Care Objective B – Promote quality and patient safety, including the development and validation of quality measures. Tactic 5 – Promote legislative proposals that seek to reduce/eliminate prescription drug abuse. Tactic 6 – Advocate for legislation to reduce/eliminate drug shortages. Goal 2 – Enhance Membership Value and Member Engagement Objective B – Provide robust educational offerings including novel delivery methods. Tactic 8 – Begin development of the following new education/CME activities:…opioid educational package. Fiscal Impact Staff and committee time to provide information to members regarding Naloxone, and to provide legislative or regulatory advocacy at the local, state, and national levels supporting lawful prescribing of Naloxone for potential future opiate overdose. Prior Council Action None Prior Board Action June 14, 2012, approved “Clinical Policy: Critical Issues in the Prescribing of Opioids for Adult Patients in the Emergency Department.” Background Information Prepared By: Rhonda Whitson, RHIA Clinical Practice Manager Reviewed By: Marco Coppola, DO, FACEP, Speaker Kevin Klauer, DO, EJD, FACEP, Vice Speaker Dean Wilkerson, JD, MBA, CAE, Council Secretary and Executive Director