1. Naloxone for Opioid Safety Phillip O Coffin MD MIA San Francisco Department of Public Health University of California San Francisco

2. Disclosures No financial disclosures Discussion of intranasal use of naloxone, a route of administration not yet FDA-approved All results are preliminary

3. Oxycontin Dilaudid/ Duragesic Kadian Norco Atiq HMO enrollment >80 million FDA lifts rules on Direct-to- Consumer advertising Welfare reform State law/boards liberalize opioids for chronic pain JCAHO 5th Vital Sign Fentora Subsys Abstral Roxicodone Embeda Exalgo Acurox generic morphines Palladone Avinza generic hydrocodone generic fentanyl lozenge generic oxycodones Opana Opana ER Dilaudid (lower dose) Onsolis Lazanda Oxecta Zohydro Hysingla generic oxymorphone Targiniq CDC reports rising Rx deaths Policy and practice changes to reduce OA prescribing begin 1995 1990

4. Naloxone Timeline

5. Fatal Opioid Overdose / Naloxone in MA Cumulative enrollments per 100,000 population ARR*95% CI No enrollment Ref- 1-100 0.730.57-0.91 >100 0.540.39-0.76 * Adjusted Rate Ratios (ARR) adjusted for city/town population rates of age<18, male, race/ ethnicity (Hispanic, white, black, other), below poverty level, medically supervised inpatient withdrawal treatment, methadone treatment, BSAS-funded buprenorphine treatment, prescriptions to doctor shoppers, year Walley, BMJ 2013 Emerging evidence in California (Davidson Unpublished) 14 of 58 counties initiated naloxone between 1998 and 2010 Naloxone programming was associated with reduced drug overdose death compared to sites without naloxone.

6. Naloxone Distribution and Opioid Deaths

7. Opioid Overdose Deaths in San Francisco, 2010-2012 <10% involved heroin Primary care data available for 50% of decedents, 80% of whom were prescribed opioids

8. 6 safety net clinics Staff trained Atomizer/brochure in ziplock bag IM or IN naloxone prescribed (covered by all public insurance) Pharmacists trained as needed Clinical Program

9. Indications for Naloxone Prescription All Patients Using Opioids ChronicallyRisk-Stratification Simple to rememberLess costly Clinicians are poor at predicting riskPotentially less work for clinician / clinic Risks are based on retrospective data analyses Patients do not perceive a risk of “overdose” from prescribed medications 1 ~40% of deaths result from diverted medications 2 ; co-prescribed naloxone may go with the opioids 1) Coffin PO, unpublished data; 2) Hirsch A, Proescholdbell SK, Bronson W, Dasgupta N. Prescription histori es and dose strengths associated with overdose deaths. Pain Med. 2014;15(7):1187-95.

11. How to Prescribe Naloxone Offer naloxone / discuss opioid safety Select formulation / prescribe Educate patient Assist pharmacy in dispensing / billing

12. Setting up a “Program” If planning intranasal and/or want to involve clinic staff in educating patients … Determine who’s in charge Obtain supply of atomizers, brochures, baggies Find a box to put supplies in and a place for box Determine who’s going to educate patients

13. Offer naloxone and discuss opioid safety

14. Select formulation and prescribe

15. Educate patient When should they use naloxone How do they use the device? Ensure someone else knows when and how to use it

16. Pharmacy dispensing/billing

17. prescribetoprevent.org

19. Acknowledgments Funded by NIDA R21DA036776; California Healthcare Foundation Project team including: Emily Behar, Diana Coffa, Michele Geier, Matthew Bald, Taylor Cuffaro, Chris Rowe, Glenn-Milo Santos, Eric Vittinghoff Site leaders Diana Coffa, Soraya Azari, Karen Deutsch, Barb Wismer, Jan Gurley, Keith Seidel The many people who have been lost to overdose and who have helped save a life