Prescribing Naloxone and Overdose Prevention Within an Addiction Treatment Program Neil A. Capretto, D.O., F.A.S.A.M. Medical Director Conflict of Interest Statement: Dr. Capretto has no fiduciary or other conflicts of interest to disclose

YearNumber of Overdose Fatalities Average of 58 per year Number of Overdoses by Year Allegheny County

Drug Overdose Deaths Increasing in Allegheny County …. Roberta Lojak holds a high school graduation picture of her daughter Ashley Elder, who died of a heroin overdose in October Lojak is standing in a garden she planted in her daughter's memory. September 27, 2004, Pittsburgh Post-Gazette

Time, June 2015

33-year Study Finds Lifelong, Lethal Consequences of Heroin Addiction Heroin addiction exacts a terrible toll. For many addicts the condition lasts a lifetime – a lifetime shortened by health and social consequences of addiction. NIDA-supported researchers at the University of California, Los Angeles (UCLA), examined the patterns and consequences of heroin addiction over 33 years in nearly 600 heroin-addicted criminal offenders and found that their lives were characterized by repeated cycles of drug abuse and abstinence, along with increased risk of crime or incarceration, health problems, and death.

33-year Study … continued The death rate among the members of the group is 50 to 100 times the rate among the general population of men in the same age range. “The high mortality rate is evidence of the severe consequences of heroin use,” Dr. Hser says “Even among surviving members of the group, severe consequences such as high levels of health problems, criminal behavior, incarceration, and public assistance were associated with long term heroin use.”

Naloxone Opioid Overdose Reversal ACT 139 In recent years, there has been a significant increase in deaths resulting from heroin and prescription opioids. This epidemic has spread across Pennsylvania as currently one in four families struggle with a substance abuse problem. Coroners’ reports since 2009 have shown there have been more than 3,000 deaths due to overdose. The enactment of ACT 139 provides first responders, friends and families access to an opioid overdose reversal medicine that will save lives and hopefully lead an individual toward the substance abuse treatment they need. Allows first responders (law enforcement, fire fighters, EMS) or other organizations acting at the direction of a health care professional authorized to prescribe naloxone, to administer the drug to individuals experiencing an opioid overdose.

Colorado Clinicians Hesitate to Prescribe Naloxone as OD Antidote, Study Says Doctors expressed concerns that patients might be offended or engage in riskier opioid use m/news/ci_ /col orado-clinicians-hesitate- to-prescribe-naloxone-as- od-antidote-study-says

Clinicians Fear Offending Patients When Discussing Opioid Overdose Risk, Study Finds es/cjarlotta/2015/06/10/cli nicians-fear-offending- patients-when-discussing- opioid-overdose-risk- study-finds/

Gateway Rehab and the Kenneth S. Ramsey, PhD. Research & Training Institute Naloxone Research Project

Gateway Rehab is a private, not-for-profit organization that is a positive force and leader in the prevention, treatment, education and research of substance misuse and addiction. Our Mission: To help all affected by addictive diseases to be healthy in mind, body and spirit. Our Vision: To be a preeminent national resource for effective addiction treatment, prevention, education and research.

Naloxone: Increasing Access, Saving Lives Research Project Original funding provided by the Pennsylvania Commission on Crime and Delinquency: $114K Additional funding provided by Staunton Farms Foundation $50K –To include outpatient locations

As much as we want our patients to “get it” the first time, to leave rehab and abstain from drug use for the rest of their lives, we know, for a significant number of our patients, that isn’t realistic. And that is especially so for those with opiate dependence. One of the most dangerous periods for overdose risk is immediately following discharge from a treatment program. Because the person’s physical tolerance for heroin or other opiate medications has decreased significantly during treatment, going back and using the same amount of the drug as their last dose can be deadly. Of course we want them NOT to use, but we know that some will. We need to educate our patients and their families about the risks of relapse, including overdose, AND give them the tools to protect themselves and/or reverse overdose. Naloxone: Increasing Access, Saving Lives Research Project

The 5 Ws

WHY - Primary Goals 1)To provide overdose prevention education to all inpatients and their family members/concerned other person 2)To enroll patients and family members in a research study where intranasal (IN) naloxone will be distributed at no cost 3)To conduct in-person follow-up data collection on naloxone use and other clinical variables

WHY - Secondary Goals 1)To increase family involvement in a patient’s post- discharge care by strengthening the family’s connection to Gateway 2)To “fast track” – when appropriate – patients back into treatment if a treatment need is identified at follow-up 3)To train staff in overdose prevention education and build a sustainable naloxone initiative by this project’s conclusion 4)To promote Gateway Rehab as a leader in overdose prevention via innovative research

WHO OD prevention education – all inpatient adults and visitors during family program 150 patient + family member dyads = 300 total subjects Prevention Point Pittsburgh will provide initial educational sessions An expanded program was offered to outpatients starting July 2015

WHO Research staff will be responsible for all duties related to study participation Research staff will eventually provide OD prevention education throughout study enrollment period until n=150 dyads inpatients plus an expanded arm for outpatients

WHEN Initial OD prevention education session and research enrollment occurred April 15 Subsequent education and enrollment sessions were scheduled throughout April, May and June Follow-up began mid-May Follow-up visits will happen monthly for six months

WHERE Research enrollment will occur at Center Township Main Campus in Aliquippa Follow-up visits will occur at any Gateway Rehab location of the patient’s choice

WHAT minute educational videos –How to recognize an overdose –How to assemble IN naloxone 10 minute “live” IN naloxone assembly demo with Q&A

WHAT Research staff will ask for interested patients/family members –Study specifics will be discussed –Consent forms will be reviewed and signed –Baseline data will be collected ALL family program participants will be given a naloxone resource list of locations where the medication can be obtained

WHAT At discharge, nursing will give naloxone kit to family member or patient (if family is not available) –Kits include naloxone, nasal adapter, personal protective equipment, instructional brochure, Gateway Rehab contact info

WHAT Research staff will schedule first follow-up appointment; goal = schedule prior to inpatient discharge Follow-up appointment will take approximately one hour; includes patient and family member –Data collection –UDS (pt. only) –$10 gift card payment

WHAT If the patient experienced a lapse/relapse and is open to re-connecting with treatment, procedures have been developed to connect him or her with an evaluator or clinical specialist during the follow-up session If naloxone was used, a replacement dose will be provided at no cost

Take-home Naloxone Opioid 1. This standing order authorizes Registered Pharmacist(s) at HOMETOWN APOTHECARY DRUGS INC. NEW BRIGHTON, PA to maintain supplies of naloxone rescue kits for the purpose of dispensing to a person at risk of experiencing an opiate related overdose or a family member, friend or other person in a position to assist a person at risk of experiencing an opiate-related overdose. 2. This standing order authorizes Registered Pharmacist(s) at HOMETOWN APOTHECARY DRUGS INC. NEW BRIGHTON, PA to dispense naloxone rescue kits to a person at risk of experiencing an opiate-related overdose of a family member, friend or other person in a position to assist a person at risk of experiencing an opiate related overdose. 3. The Pharmacist Manager of Record must file a copy of the signed standing order with the Pennsylvania Board of Registration in Pharmacy and must maintain a copy of this signed standing order and the “Naloxone Pamphlet” on file and readily retrievable at the pharmacy location. 4. The pharmacy that assembles naloxone rescue kits will label kits as “Naloxone Rescue Kit” and note the expiration date based on the expiration date of the included Naloxone Hydrochloride Unit. 5. The Registerd Pharmacist dispensing naloxone rescue kits must be familiar with the “Naloxone Pamphlet” 6. The Registered Pharmacist dispensing naloxone rescue kits should be familiar with the use of naloxone rescue kits. NOTE: INDIVIDUALS SHOULD BECOME FAMILIEAR WITH ASSEMBLY AND ADMINISTRATION OF NALOXONE PRIOR TO THE NEED TO USE IT.

Learning Curve Stages of Change for… 1. Patients 2. Family and Friends 3. Addiction Treatment Professionals 4. Addiction Treatment Programs 5. Other Mental Health/Medical Professionals and Organizations Step Community

Obstacles Getting Naloxone to Patients, Family and Friends 1. Provide overdose kit on site 2. Provide a prescription of naloxone 3. Direct to a pharmacy with a standing order for naloxone

Potential Benefits of Increasing Availability of Naloxone 1. Saves lives 2. Confront and reduce stigma 3. Improve community relations for police and first responders 4. Improve availability and effectiveness of treatment

Addiction Batters Thriving Families …

Addiction is a BIO-PSYCHO-SOCIAL- SPIRITUAL DISEASE Good treatment addresses all four aspects

Contact Information NEIL A. CAPRETTO, D.O., F.A.S.A.M. MEDICAL DIRECTOR GATEWAY REHABILITATION CENTER 100 MOFFETT RUN ROAD ALIQUIPPA, PA , x1119