Overdose Prevention with Community Based Naloxone: An …

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Overdose Prevention with Community Based Naloxone

Sharon Stancliff, MD Harm Reduction Coalition

Motor vehicle traffic, poisoning, drug poisoning, and unintentional drug poisoning death rates: United States, 1999--2010

18 16 14 12 10 8 6 4 2 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010

Motor vehicle traffic Poisoning Drug poisoning Unintentional drug poisoning

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

. Intercensal populations http://www.cdc.gov/nchs/nvss/bridged_race/data_documentation.htm

Number of drug poisoning deaths involving opioid analgesics by opioid analgesic category, heroin and cocaine: United States, 1999--2010

12 000 10 000 Natural and semi synthetic opioid analgesic Methadone 8 000 6 000 Cocaine 4 000 Heroin 2 000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Synthetic opioid analgesic, excluding methadone NOTES: Opioid analgesic categories are not mutually exclusive. Deaths involving more than one opioid analgesic category shown in this figure are counted multiple times. Natural and semi-synthetic opioid analgesics include morphine, oxycodone and hydrocodone; and synthetic opioid analgesics include fentanyl. 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

Inpatient admissions for heroin use

6 5 4 3 2 1 0 1993 1997 2001 2005 2009 Unick, GJ et al, 2013, PLOSONE, in press 16-19 20-23 24-27 28-31 32-35 36-39 40-43 44-47 48-51 52-55

Opioid overdoses • • • •

Overdoses evolve over 1-3 hours There are often bystanders Naloxone is a safe and effective antidote Many overdoses deaths are preventable with prompt recognition and treatment Source: Sporer, K. 2006

Naloxone (Narcan)

• • • • • Prescribed opioid antagonist which rapidly reverses opioid related sedation and respiratory depression and may cause withdrawal Overdose victims wake up minutes after administration Displaces opioids from the receptors for 30-90 minutes No pleasant psychoactive effects Routinely used by EMS

Naloxone preparations

• •

Injectable – Less expensive: $6.50 per dose – Well-documented efficacy – Requires injection, drawing from a medical vial into a syringe Intranasal – More expensive: $21.00 per dose – Less well-documented efficacy – Requires assembly of spay device with nasal adaptor and naloxone capsule 7

Models of increasing access to naloxone • • • •

Community prescribing/distribution to drug user and/or social networks Prescribing in outpatient care Increasing access among first responders Pharmacy collaborative agreements

Legal issues

• • • Most states allow for prescription of naloxone to those at risk of overdose Some states have passed legislation to allow for prescribing to anyone potentially at risk of witnessing an overdose (NY, NM, Il, WA, CA, RI, MA, CT) Other jurisdictions have passed local laws or initiated pilot programs

• • •

Appropriate Settings for Naloxone Assess

Syringe access programs HIV programs Drug treatment – Methadone or Suboxone programs – Detoxification – Residential or outpatient treatment

• • • •

Homeless shelters Post-incarceration Primary care and other health care settings Parent support groups

Overdose prevention knowledge

• Prevention understanding the role of: – mixing drugs – reduced tolerance – using alone • • Overdose recognition Actions – Call 911 – Rescue breathing – Naloxone administration – After-care

Reversing an overdose:

Program Support

• • • New York, New Mexico and Massachusetts operate state-wide programs supported by State Departments of Public Health City Health Departments support programs in Baltimore, San Francisco, Seattle, New York City Connecticut, Washington, New Mexico, New York, have passed Good Samaritan laws to encourage calling 911 (NM, WA, NY, CT IL

Overdose prevention programs: US •

 MMWR report based on survey of programs known to the Harm Reduction Coalition As of 2010, there were 48 known programs, representing 188 community-based sites in 15 states and DC.

CDC MMWR February 17, 2012 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6106a1.htm

Survey completed by Eliza Wheeler [email protected]

Overdose fatality prevention programs that distribute naloxone: USA, 2010 •

2010 survey of programs known to the Harm Reduction Coalition 189 local programs in 16 states ranging from state-funded to underground

• •

1996 - 2010: 53,339 individuals have received kits 10,194 overdose reversals reported CDC MMWR February 17, 2012 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6106a1.htm

naloxone: USA, 2010

Implementation in NYS

Agencies register and use their own resources • • • • • • 0ver 80 so far Syringe exchange/syringe access sites Hospitals Drug Treatment: Methadone, detox, 28 day and Therapeutic Community HIV programs Homeless shelters Primary care

Prescribing to those at risk

• •

Project Lazarus, North Carolina: A multifaceted OD prevention program including provision of naloxone to chronic pain patients Operation OpioidSafe, Ft Bragg: replicated aspects of Project Lazarus including naloxone Brason, Replication of Project Lazarus comprehensive community based model to reduce opioid medication overdoses among active duty soldiers determined to be at risk within select US military bases by implementing the naloxone rescue component as Standard Operating Procedure APHA 2011

Potential Indications/Populations

1. Patient release after emergency medical care involving opioid poisoning/intoxication 2. Suspected history of illicit or nonmedical opioid use 3. High-dose opioid prescription (> 50 mg of morphine equivalence/day) 4. Any methadone prescription to opioid naïve patient Any opioid prescription and … 5. smoking/COPD/emphysema/asthma or other respiratory illness or obstruction 6. renal dysfunction, hepatic disease 7. known or suspected concurrent alcohol use 8. concurrent benzodiazepine prescription 9. concurrent SSRI or TCA anti-depressant prescription 10. Prisoner released from custody 11. Release from opioid detoxification or mandatory abstinence program 12. Voluntary request from patient 13. Patients in methadone or buprenorphine detox/maintenance (for addiction or pain) 14. Patient may have difficulty accessing emergency medical services (distance, remoteness)

Pharmacy Collaboration

NEW NEWS!

Collaborative Drug Therapy Agreement for Naloxone Medication in Opioid Overdose Reversal

I, __________________, MD, a licensed health care provider authorized to prescribe medication in the State of Washington, delegate prescriptive authority to _______________________ Pharmacy and the pharmacists listed below to initiate drug therapy for the treatment or prophylaxis of opioid overdose according to the protocol that follows. The protocol provides written guidelines for the pharmacists to dispense medication in accordance with the laws (RCW 18.64.011) and regulations (WAC 246 ‐ 863 ‐ 100) of the State of Washington.   The pharmacists shall document all drug therapy initiated under this protocol. As the authorizing prescriber, I or authorized staff under my supervision will be available to review the drug therapy initiated by the pharmacists. This protocol will be in effect for two years unless rescinded earlier in writing to the Washington State Board of Pharmacy by either party. Any modification of the protocol shall be treated as a new protocol and filed with the Washington State Board of Pharmacy.

Creative strategies for preventing overdose: Massachusetts

Source:

Four Tales of Overdose Survival

, Massachusetts Bureau of Substance Abuse Services, SA1069, 2009

Source:

Four Tales of Overdose Survival

, Massachusetts Bureau of Substance Abuse Services, SA1069, 2009

Source:

Four Tales of Overdose Survival

http://www.maclearinghouse.com/PDFs/SubstanceAbuse/SA1069.pdf

Source:

Four Tales of Overdose Survival

, Massachusetts Bureau of Substance Abuse Services, SA1069, 2009

Source:

Four Tales of Overdose Survival

, Massachusetts Bureau of Substance Abuse Services, SA1069, 2009

Source:

Four Tales of Overdose Survival

, Massachusetts Bureau of Substance Abuse Services, SA1069, 2009

Role of EMS

• • • Patients receiving naloxone, not being transported to ER: deaths known to medical examiner 998 patients refused transport: none within 12 hours 552 patients refused transport: none within 48 hours 2241 patients discharged by EMS over 10 yrs: 3 died (0.13%) of potential rebound overdose Limitations: some medical evaluation, varying doses of naloxone; all SKOOP responders instructed to call EMS • San Diego: Vilke Acad Emerg Med 2003; San Antonio: Wampler Prehosp Emerg Care 2011; Copenhagen: Rudolph Rescusitation 2011

Incremental Cost Effectiveness Ratio • • • •

ICER = Added cost of intervention divided by increase in Quality adjusted life year Generally accepted threshold is $50,000/year Chlamydia screening, Problem drinking screening both < $14,000 Naloxone provision $438- $14,000 depending on variables used • Coffin 2013,

Outcomes per 1 million heroin users

Change if naloxone given to 20% of heroin users

Baseline OD OD death Kits to prevent 1 death Cost / QALY gained Increase by 60,000 Decrease by 10,000 164 $400 If naloxone reduces OD risk behaviors OD OD death Kits to prevent 1 death Cost / QALY gained Decrease by 1,000,000 Decrease by 43,000 36 Cost-saving

Opioid Overdose Prevention: Who Gets there first?

Richard Cotroneo, Director HIV Education and Training Programs OMD, AIDS Institute NYSDOH

• • • •

1,250 EMT staff trained More than 50 overdose events reversed Excellent news coverage No serious adverse events reported

Is naloxone distribution decreasing mortality?

Observational studies in places with overdose prevention programs find an association with reductions in overdose deaths: Massachusetts, New York City, San Francisco, Baltimore, Pittsburgh, Chicago More studies are in progress 39

Heroin-related Deaths, San Francisco, 1993-2011

160 140 120 Naloxone distribution begins, 2003 100 80 60 40 Heroin-related deaths 20 0 1993 1994 1994 1995 1995 1996 1996 1997 1997 1998 1998 1999 1999 2000 2002 2003 *Data compiled from San Francisco Medical Examiner

s Reports, www.sfgsa.org

**no data available for FY 2000-2001 2003 2004 2004 2005 2005 2006 2006 2007 2007 2008 2008 2009 2009 2010 2010 2011

700

The DOPE Project 2003-2012

600 500 400 300 200 100 0 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 New Enrollments Refills Reversals

Unintentional drug poisoning deaths decreased by 37% in NYC from 2005 to 2010

Number of unintentional drug poisoning deaths Age-adjusted Rate 900 800 700 600 500 400 300 200 100 0 12,3 801 12,9 838 10,5 695 9,4 631 2005 2006 2007 2008

Year of death Source: NYC OCME & NYC DOHMH- BADUPCT, 2005-2009

9,3 624 2009 7,9 516 2010 2 0 6 4 14 12 10 8

500 Cocaine and heroin rates decreased while opioid analgesic rate increased 400 300 200 100 0 2005

* P-Value less than .05; (2005 vs. 2009)

2006 2007 Year 2008 Drugs are not mutually exclusive 2009 Heroin Cocaine* Benzodiazepines * Sedatives Opioid Analgesics* Anti-Depressants Methadone Anti-Psychotics 2010

43

Massachusetts

• Massachusetts compared towns by enrollment in Opioid Education and Naloxone Distribution programs determining Adjusted Rate Ratios • Controlled for: city/town population rates of age under 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, and year A. Walley et al Is implementation of bystander overdose education and naloxone distribution associated with lower opioid-related overdose rates in Massachusetts? AMERSA 2011

Results Fatal opioid OD rates were lower in cities towns:

• Where program enrollment reached a density of 150 per 100k population (ARR: 0.74) • Where drug user enrollment was high (ARR:0.78) • Where there were high annual rates of reversals reported (ARR: 0.74) No differences were found in nonfatal opioid OD rates.

Federal Support

SAMHSA is finalizing an overdose prevention tool kit to be sent to all Outpatient Treatment Programs ONDCP participated in a webinar on the topic with Safe States and CDC 12/12 FDA which held a workshop in collaboration with HHS, NIDA and CDC on increasing access to naloxone 4/12

Italy

Rescheduled naloxone as an over the counter medication in 1987 Medication not subject to medical prescription.

International Support

UN Resolution: Promoting measures to prevent drug, in particular opioid overdose

Encourages Member States to include effective drug overdose prevention and treatment elements in national drug policies ... including the use of opioid receptor antagonists such as naloxone; Requests the UNODC & WHO, circulate best practices on drug overdose treatment and emergency response and to provide advice, guidance and capacity-building on preventing mortality from drug overdose

Programs without Naloxone

• • Lack of naloxone should not deter overdose prevention education and training Screening for risk of overdose and giving information: risks, prevention, recognition, calling 911 and rescue breathing CAN HELP SAVE LIVES!

Make OD screening and training a standard of care 49

Conclusions

• • • • Many overdoses can be prevented • Ask about risk factors and educate patients Overdose training consists of a few basic components • Integrate into intake, medical visits and patient care Drug users, friends, and family can learn to prevent and safely treat overdose Goals: • Overdose training as standard of care • Naloxone available over the counter 50