HD20 - Report on the Pilot Program for Opioid Overdose Reversal (REVIVE!)


Executive Summary:
Overview

House Bill 1672 enacted by the 2013 Session of the Virginia General Assembly amended §§ 8.01-225 and 54.1-3408 of the Code of Virginia (COV) to authorize the Virginia Department of Behavioral Health and Developmental Services (DBHDS) to implement pilot programs on the administration of naloxone to counteract the effects of opiate overdose. The legislation allowed prescribers to issue non-patient specific prescriptions to a friend or family member (a “lay rescuer”) so that they could administer naloxone to an individual experiencing an opioid overdose. The legislation also provided civil immunity to these lay rescuers. individuals. The legislation called for DBHDS to work in cooperation with the Department of Health, the Department of Health Professions, substance abuse recovery support organizations and other stakeholders. The project, named REVIVE!, was funded with $10,000 in General Funds. This report provides information about how this pilot was implemented, its outcomes and recommendations for going forward.

Epidemiology of Opioid Overdose in the Commonwealth

The Commonwealth of Virginia has been severely impacted by opioid abuse, including heroin, as well as prescription analgesics such as codeine, desomorphone, fentanyl, hydrocodone, methadone, oxycodone, oxymorphone, and tramadol. In 1999, the first year for which such data is available, approximately 23 Virginians died from abuse (due to limitations in available data, this figure is approximate) of fentanyl, hydrocodone, methadone and oxycodone (FHMO). By 2012, the numbers of deaths from these drugs increased to 354, an increase of 1,439%. From 1999 to 2006, the number of fatal heroin overdoses never surpassed 19 per year, but by 2012 that figure was 135, an increase of more than 611%. Treatment data from DBHDS shows more Virginians identifying opioids as their primary drug of abuse as well.

Opioid Overdose Emergencies and Naloxone

An opioid overdose emergency occurs when an individual administers too much opioid into their system, resulting in the inhibition of the central nervous system, limiting the body’s ability to control heart rate and respiration. Opioid overdose emergencies are rarely instantaneous as the central nervous system slowly loses its ability to control heart rate and respiration, which can take anywhere from one to three hours to occur. When naloxone is administered, it binds to opioid receptors in the brain, removing the opioid, allowing the central nervous system to regain control of heart rate and respiration. Naloxone is a proven public health response to the opioid overdose epidemic, and has saved the lives of more than 10,000 individuals in the United Sates.

Initial Implementation

DBHDS worked in cooperation with the Department of Health and the Department of Health Professions to make initial decisions about how to implement a naloxone program that would utilize family and friends by allowing prescribers to issue non-patient specific prescriptions for naloxone to these individuals to have available for use should an individual overdose as a result of opioid use. This state agency workgroup selected the metropolitan Richmond area (city of Richmond and counties of Chesterfield, Henrico, and Charles City) and the far Southwest Virginia area (the cities of Bristol and Norton and the counties of Buchanan, Dickenson, Lee, Russell, Scott, Tazewell, Washington and Wise) to implement pilot programs. These areas were chosen based on opioid treatment and mortality data. DBHDS worked with its state agency partners as well as stakeholder groups in both communities to determine the most effective strategies to implement the pilot program for each area. While the metropolitan Richmond area is primarily urban with heroin as the primary opioid of abuse, the far Southwest Virginia area is rural and prescription opioids are the primary opioids of abuse. When the project began, the formulations of naloxone available were for intramuscular injection, intravenous injection, or intranasal injection. Most naloxone programs that utilize Lay Rescuers use the intranasal method to avoid having to train individuals how to inject medication using a hypodermic needle. Initial implementation included determining that intranasal administration of naloxone was the most effective for use by the friends and family members. In addition, considerable attention was given to preparing materials to train Lay Rescuers, and producing the kit bags that contain the equipment, minus the naloxone, necessary to administer naloxone.

Public Implementation

Public implementation of REVIVE! began with the first series of Training of Trainer events in June 2014. Six events were held across the two pilot areas, and an initial cadre of 61 trainers participated. Those 61 trainers were provided with all the information, knowledge, and materials needed to perform Lay Rescuer training events in the pilot areas. In addition to leading Training of Trainer events, DBHDS also made presentations and participated in other activities to provide public education about naloxone and why it was being distributed in selected communities. This included meeting with first responder and law enforcement groups about the purpose and scope of the pilot so that they would understand the implications for their own rescue protocols.

Successes and Challenges

REVIVE! has trained 187 trainers who have gone on to train 339 Lay Rescuers in the two pilot areas. To date, DBHDS is not aware of any successful opioid overdose emergency reversals as a result of REVIVE! Lay rescuers report having difficulty obtaining prescriptions for naloxone, finding pharmacies to fill those prescriptions, and being able to afford naloxone. A recent price increase from approximately $30 per dose to as high as $60 per (two doses are required for each Lay Rescuer because the effects of naloxone only last 30-45 minutes, and in some cases a single administration may not be sufficient to reverse an overdose before medical help arrives.) has made the cost barrier an even more difficult hurdle. REVIVE! has provided an opportunity for state agencies to work collaboratively in the implementation of the pilot, which has increased inter-agency discussion about the overall problem of opioid abuse. The primary challenges facing REVIVE! in the future are funding of the infrastructure (training and REVIVE! kits bags), stigma about addiction (particularly opioid addiction), engaging the level of community involvement necessary for success, the diversity of the pilot locations, poor access to prescriptions due to lack of physician understanding, pharmacy stocking practices, and manufacturer pricing and availability of naloxone.

The Future of Naloxone in Virginia and in the United States

Since the project began another formulation of naloxone, Evzio®, an auto-injector formulation, has been approved by the U.S. Food and Drug Administration (FDA), but it is very expensive, at about $500 per dose. Produced by Kaléo, Evzio® is a small, handheld device that contains the medication (administered through a retractable needle to help prevent accidental exposure) and provides automated voice instructions for administration. Reckitt-Benckiser Pharmaceuticals has recently begun development of an intranasal formulation that provides a pre-dosed, pre-filled, disposable delivery system that is already assembled with the mucosal atomizer device.

The U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) has recently announced that states may use their allocations from the Substance Abuse Prevention and Treatment Block Grant to support naloxone distribution. However, the block grant allocation has been stable for more than 10 years and is not likely to increase; funds spent for this purpose would not be available to support community-based prevention and treatment activities. Meanwhile, agencies as diverse as the Office of the U.S. Attorney General, the World Health Organization and the Office of National Drug Control Policy are promoting naloxone as an opioid overdose emergency strategy.

Recommendations

Interest in REVIVE! has been widespread and DBHDS has received several requests to be included in an expanded pilot. In addition, DBHDS has received interest from several law enforcement agencies about officers carrying naloxone as part of their official duties. DBHDS therefore recommends that the pilot format be discontinued and that REVIVE! be available statewide, including non-patient specific prescribing and civil immunity to lay rescuers.

We also recommend that, in addition to civil immunity, some form of criminal immunity be extended to naloxone rescue situations. This would remove barriers to Lay Rescuers calling 911 who fear that either they or the overdose victim will be criminally charged if illegal drugs are present at the rescue site.

Finally, we recommend that additional funding be made available to continue this project, which has been largely funded by other sources beyond the initial appropriation of $10,000.