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Overdose Solutions 2013. Addressing Opioid Overdose with Community-based Education and Naloxone Rescue Kits Alexander Walley, MD MS c Medical Director, Massachusetts Dept. of Public Health Opioid Overdose Prevention Pilot.
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Overdose Solutions 2013 Addressing Opioid Overdose with Community-based Education and Naloxone Rescue Kits Alexander Walley, MD MSc Medical Director, Massachusetts Dept. of Public Health Opioid Overdose Prevention Pilot
Addressing opioid overdose with community-based education and naloxone rescue kits Alexander Y. Walley, MD, MSc Boston University School of Medicine Boston Medical Center Allegheny County Overdose Prevention Coalition Wednesday, July 24th, 2013 9:15am-10:45am
Disclosures –Alexander Y. Walley, MD, MSc • The following personal financial relationships with commercial interests relevant to this presentation existed during the past 12 months: • Consultant for Social Sciences Research Inc. which is developing a training module for first responders • My presentation will include discussion of “off-label” use of the following: • Naloxone is FDA approved as an opioid antagonist • Naloxone delivered as an intranasal spray with a mucosal atomizer device has not been FDA approved and is off label use • Funding: CDC National Center for Injury Prevention and Control 1R21CE001602-01
Learning objectives At the end of this session, you will know: • Epidemiology of overdose, the rationale and history of the MA OEND program • The scope of the MA OEND program • Effectiveness of OEND: INPEDE OD Study • Venues and models • How to incorporate OEND into medical settings • To acknowledge and address overdose stigma
More Opioid Overdose Deaths than MVA Deaths in Massachusetts Poisoning Deaths vs. Motor Vehicle-Related Injury Deaths, MA Residents (1997-2008) The source of the data is: Registry of Vital Records and Statistics, MA Department of Public Health
More Opioid Overdose Deaths than MVA Deaths in Massachusetts Poisoning Deaths vs. Motor Vehicle-Related Injury Deaths, MA Residents (1997-2008) Rate of opioid-related fatal overdoses in MA in 2006 was 9.9 per 100K The source of the data is: Registry of Vital Records and Statistics, MA Department of Public Health
Motor vehicle traffic, poisoning, drug poisoning, and unintentional drug poisoning death rates: United States, 1999--2010 NOTES: Drug poisoning deaths are a subset of poisoning deaths. Unintentional drug poisoning deaths are a subset of drug poisoning deaths. SOURCE: CDC/NCHS, National Vital Statistics System; and Warner M, Chen LH, Makuc DM, Anderson RN, Miniño AM. Drug poisoning deaths in the United States, 1980–2008. NCHS data brief, no 81. Hyattsville, MD: National Center for Health Statistics. 2011. http://www.cdc.gov/nchs/data/databriefs/db81.htm. Intercensalpopulations http://www.cdc.gov/nchs/nvss/bridged_race/data_documentation.htm
Allegheny County Trends in Accidental Drug Overdose Deaths 2000-2012* *Data is from Allegheny County Medical Examiners Annual Reports and includes all overdose deaths where these drugs were present at time of death, not necessarily cause of death.
Opioid overdose costs • $20.4 billion per year in 2009 • $2.2 billion direct costs • inpatient, ED, MDs, ambulance • $18.2 billion indirect costs • lost productivity from absenteeism and mortality • $37,274 cost per opioid overdose event Inocencio TJ et al. Pain Medicine 2013
What is Driving the Increase in Overdose? • New Drug Use Patterns • New Initiates to prescription drugs • Vicodin/Percocet/oxycodone >>> heroin • Heroin Availability/Purity/Lethal Mixture • Heroin is the leading drug threat in New England • From ‘93-’10 Heroin reported as primary drug increased from 20% - 40% of treatment admissions in MA • Prescribing Patterns • Schedule II Opioid prescriptions more than doubled since the 1990s
Strategies to address overdose • Prescription monitoring programs • Paulozzi et al. Pain Medicine 2011 • Prescription drug take back events • Safe disposal • Safe opioid prescribing education • Albert et al. Pain Medicine 2011; 12: S77-S85 • Expansion of opioid agonist treatment • Clausen et al. Addiction 2009:104;1356-62 • Safe injection facilities • Marshall et al. Lancet 2011:377;1429-37
Rationale for overdose education and naloxone distribution • Most opioid users do not use alone • Known risk factors: • Mixing substances, abstinence, using alone, unknown source • Opportunity window: • opioid OD takes minutes to hours and is reversible with naloxone • Bystanders are trainable to recognize OD • Fear of public safety
Overdose Education and Naloxone Rescue Kits Wheeler E et al. Morb Mortal Wkly Rep 2012;61:101-5.
About Naloxone • Naloxone reverses opioid-related sedation and respiratory depression = pure opioid antagonist • Not psychoactive, no abuse potential • May cause withdrawal symptoms • May be administered IM, IV, SC, IN • Acts within 2 to 8 minutes • Lasts 30 to 90 minutes, overdose may return • May be repeated • Narcan® = naloxone • naloxone ≠ Suboxone ≠ naltrexone
Evaluations of OEND programs • Feasibility • Piper et al. Subst Use Misuse 2008: 43; 858-70 • Doe-Simkins et al. Am J Public Health 2009: 99: 788-791 • Enteen et al. J Urban Health 2010:87: 931-41 • Bennett et al. J Urban Health. 2011: 88; 1020-30 • Walley et al. JSAT 2013; 44:241-7 (Methadone and detox programs) • Increased knowledge and skills • Green et al. Addiction 2008: 103;979-89 • Tobin et al. Int J Drug Policy 2009: 20; 131-6 • Wagner et al. Int J Drug Policy 2010: 21: 186-93 • No increase in use, increase in drug treatment • Seal et al. J Urban Health 2005:82:303-11 • Reduction in overdose in communities • Maxwell et al. J Addict Dis 2006:25; 89-96 • Evans et al. Am J Epidemiol 2012; 174: 302-8 • Walley et al. BMJ 2013; 346: f174
MA Timeline: Key events & players • 2000-2004: 1 CBO underground • 2005: 2 CBO underground • Boston EMTs equipped with IN via special project waiver
MA Timeline: Key events & players • 2000-2004: 1 CBO underground • 2005: 2 CBO Boston underground • Boston EMTs equipped with IN via special project waiver • 2006: underground suspended>> incorporated, 2 city governments • 2007: city, state government, CBOs • 2009: expansion to more CBOs and outreach • 2010: first responders – police and fire • 2011: parents organizations • 2012: legislature passed good samand limited liability protection
Implementing the Massachusetts public health pilot: December 2007 Pilot program conducted under DPH/Drug Control Program regulations (M.G.L. c.94C & 105 CMR 700.000) Medical Director issues standing order for distribution Naloxone may be distributed by public health workers
Massachusetts DPH standing order • Authorizes Registered Programs to maintain supplies of nasal naloxone kits • Authorizes Approved Opioid Overdose Trainers to possess and distribute nasal naloxone to approved responders • Authorizes Approved Opioid Overdose Responders who are trained by Approved Opioid Overdose Trainers to possess and administer naloxone to a person experiencing an overdose
Program Components Approved staff enroll people in the program and distribute naloxone Curriculum delivers education on OD prevention, recognition, and response Referral to treatment available Reports on overdose reversals are collected as enrollees return for refills Enrollment and refill forms submitted to MDPH Kits include instructions and 2 doses
Staff Training and Support Staff complete: • 4 hour didactic training • At least 2 supervised bystander training sessions Sites participate in: • Quarterly all-site meetings • Monthly adverse event phone conferences
Intranasal Administration Pro 1st line for some local EMS RCTs: slower onset of action but milder withdrawal Acceptable to non-users No needle stick risk No disposal concerns Con Not FDA approved No large RCT Assembly required, subject to breakage High cost: $40-50+ per kit Prefilled naloxone ampule Mucosal Atomization Device (MAD) Luer-lock syringe
Enrollments and Rescues: 2006-2012 • Rescues • 1,741 reported • >1 per day • Enrollments • 16,379 individuals • >10 per day • AIDS Action Committee • AIDS Project Worcester • AIDS Support Group of Cape Cod • Brockton Area Multi-Services Inc. (BAMSI) • Bay State Community Services • Boston Public Health Commission • Greater Lawrence Family Health Center • Holyoke Health Center • Learn to Cope • Lowell House/ Lowell Community Health Center • Manet Community Health Center • Northeast Behavioral Health • Seven Hills Behavioral Health • Tapestry Health • SPHERE
Enrollee characteristics: 2006-2012 Program data
Enrollee past 30 day use: 2006-2012 Data only from people with current use or in treatment n = 10,589
OEND program rescues: 2006-2012 Program data
Adverse Events: Sept 2006-Dec 2012 Program data
Withdrawal symptoms after naloxone Program data
Do trained rescuers perform differently than untrained rescuers? Doe-Simkins et al. Under review
Objective: Determine the impact of opioid overdose education with intranasal naloxone distribution (OEND) programs on fatal and non-fatal opioid overdose rates in Massachusetts INPEDE OD (Intranasal Naloxone and Prevention EDucation’s Effect on OverDose)Study Co-authors: ZimingXuan H Holly Hackman Emily Quinn Maya Doe-Simkins Amy Sorensen-Alawad Sarah Ruiz Al Ozonoff
Opioid Overdose Related Deaths: Massachusetts 2004 - 2006 OEND programs 2006-07 2007-08 2009 Towns without Number of Deaths No Deaths 1 - 5 6 - 15 16 - 30 30+
Design, population and setting • Design: • Quasi-experimental interrupted time series • Population: • 19 Massachusetts cities and towns with 5 or more opioid-related unintentional or undetermined poison deaths in each year from 2004-2006 • Setting: • MA OEND programs were implemented by 8 community-based programs starting in 2006
OEND program data collection • Enrollment form: • program staff collect potential bystander demographics and OD risk factors • Refill form: • Upon return to program for more naloxone, staff collect data on use of naloxone, including overdose rescues
Analyses Poisson regression to compare opioid-related overdose rates among cities/towns with no vs. low and high implementation between 2002 and 2009 • Natural interpretations as rate ratios (RRs) calculated by exponentiating the beta coefficents
Fatal opioid OD rates by OEND implementation Walley et al. BMJ 2013; 346: f174.
Fatal opioid OD rates by OEND implementation Naloxone coverage per 100K Opioid overdose death rate 27% reduction 46% reduction Walley et al. BMJ 2013; 346: f174.
Opioid-related ED visits and hospitalization rates by OEND implementation Walley et al. BMJ 2013; 346: f174.
INPEDE OD Study Summary • Fatal OD rates were decreased in MA cities-towns where OEND was implemented and the more enrollment the lower the reduction • No clear impact on acute care utilization
Cost-effectiveness of distributing naloxone to heroin users for overdose reversal In a simulation model: • One heroin overdose death prevented for every 164 kits distributed • Cost for naloxone distribution would range between: • $438-$14,000 (best-worst case scenario) for every quality-adjusted life year gained • Generally accepted threshold is $50,000/year • For dialysis: recently calculated as $129,000 • Lee et al. Value Health 2009;12(1): 80-7. • For primary care-based SBIRT: recently calculated as $6960 • Tariq et al. PLoS One 2009;4(5) Coffin and Sullivan. Ann Intern Med. 2013; 158: 1-9.
Enrollment locations: 2008-2012 Program data Data from people with location reported: Users: 9,824 Non-Users: 4,818
Implementing OEND in MMT and detox Among 1553 OEND participants who reported taking methadone, 47% were trained in detox, 25% at HIV prevention programs, and 17% in MMT. Previous overdose, recent inpatient detox or incarceration, and polysubstance use were OD risks common among all groups. Among 29 MMT and 93 detox staff who received OEND, 38% and 45% respectively reported witnessing and overdose in their lifetime. Walley et al. JSAT 2013; 44:241-7.
Other venues and models • First responder OEND • Quincy, Revere, Gloucester • Emergency Department (ED) SBIRT • Post-incarceration • Prescription naloxone • Prescribetoprevent.org
Quincy P.D. Statistics • May 2009 – October 2010 (17 months) • 47 Fatal Overdoses • October 2010 – December 2012 (26 months) • 206 Non-Fatal Overdoses • 19 Fatal Overdoses • 134 Naloxone Administrations • 131 Successful Reversals (98%) • 2 Deceased (1.5%) • 1 No Effect (probably not an opioid O.D.)
Incorporating overdose education and naloxone rescue kits into medical and addiction practice Prescribe naloxone rescue kits PrescribeToPrevent.org Work with your OEND program
Challenges for community programs Opportunities for prescription naloxone • Prescription and prescriber typically required • Naloxone cost is increasing, funding is minimal • Missing people who don’t identify as drug users, but have high risk • CBOs target IDU, people w/ substance use disorders, HIV prevention • Co-prescribe naloxone with opioids for pain • Co-prescribe with methadone/ buprenorphine for addiction • Insurance should fund this • Increase patient, provider & pharmacist awareness • Universalize overdose risk
Practical Barriers to Prescribing Naloxone Prescriber knowledge and comfort How to write the prescription? Does the pharmacy stock rescue kits? Rescue IN kit with MAD? Rescue IM kit with needle? Who pays for it? Insurance in Massachusetts covers naloxone, but not the atomizer yet The MAD costs $3 each>> $6-7 per kit Work with your pharmacy to see if they will cover it
Legal Barriers to Prescription Model “Prescribing naloxone in the USA is fully consistent with state and federal laws regulating drug prescribing. The risks of malpractice liability are consistent with those generally associated with providing healthcare, and can be further minimized by following simple guidelines presented.” Only prescribe to a person who is at risk for overdose Ensure that the patient is properly instructed in the administration and risks of naloxone Burris S at al. “Legal aspects of providing naloxone to heroin users in the United States. Int J of Drug Policy 2001: 12; 237-248.