Responding to the Opioid Morbidity and Mortality Crisis

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Session ID: 17 16 Disclosures of Interests: Wilson M.

Company (under $1,) General Electric Corporation (under $1,) Pfizer, Inc.

Relationships: None Responding to the Opioid Morbidity and Mortality Crisis Wilson

1 Session ID: Disclosures of Interests: Wilson M. Compton, MD, MPE Long-Term Stock Equity (unrelated to the presentation): 3M Company (under $1,) General Electric Corporation (under $1,) Pfizer, Inc. (under $1,) Speaker s Bureau(s): None Sources of Research Support: NIH Consulting Relationships: None Responding to the Opioid Morbidity and Mortality Crisis Wilson M. Compton, M.D., M.P.E. Deputy Director National Institute on Drug Abuse Science = Solutions Wilson M. Compton, M.D., MPE 1

High Levels of Opioid Prescriptions have Facilitated Diversion & Contributed to Overdose Deaths Near Tripling of Opioid Prescriptions from U.S.

2 High Levels of Opioid Prescriptions have Facilitated Diversion & Contributed to Overdose Deaths Near Tripling of Opioid Prescriptions from U.S. Retail Pharmacies, Total Rx Opioid Tablets Dispensed in Retail Pharmacies in the USA: ,972,34, ,66,882,755 Source: Jones CM, et al. JAMA Internal Medicine 216: doi: 1.11/jamainternmed IMS Health, Vector One : National, IMS Health, National Prescription Audit, Opioid Analgesic Prescriptions Dispensed from US Retail Pharmacies by Provider Specialty, Number of Prescriptions Dispensed 12,, 1,, 8,, 6,, 4,, 2,, Source: CM Jones. NIDA Webinar 9/1/215. Based on IMS Health National Prescription Audit (extracted 8/24/215) Retrieved from events/215/9/latest prescription trends controlled prescription drugs. Wilson M. Compton, M.D., MPE 2

3 Marked Increases in Prescription Opioid and Heroin Overdose Deaths in the USA 2 to 214 Number of Deaths 3, 25, 2, 15, 1, 5, USA 214 Overdose Deaths: 47,55 Any Drug 27,119 Any Opioid 18,893 Rx opioid 1,574 Heroin Any opioid Prescription Opioids Heroin Source: CDC, NVSS Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 1999 Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System; Tom Frieden Presentation at the Opioid Summit, Atlanta, April 216 Wilson M. Compton, M.D., MPE 3

4 Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 22 Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System; Tom Frieden Presentation at the Opioid Summit, Atlanta, April 216 Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 25 Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System; Tom Frieden Presentation at the Opioid Summit, Atlanta, April 216 Wilson M. Compton, M.D., MPE 4

Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 28 Designed by L. Rossen, B. Bastian & Y. Chong.

5 Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 28 Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System; Tom Frieden Presentation at the Opioid Summit, Atlanta, April 216 Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 211 Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System; Tom Frieden Presentation at the Opioid Summit, Atlanta, April 216 Wilson M. Compton, M.D., MPE 5

6 Marked Geographic Variation in Mortality: Estimated Ageadjusted Death Rates for Drug Poisoning by County 214 Designed by L. Rossen, B. Bastian & Y. Chong. SOURCE: CDC/NCHS, National Vital Statistics System; Tom Frieden Presentation at the Opioid Summit, Atlanta, April 216 High Rates of Rx Opioid Abuse: 12 Month Prevalence of Rx Opioid Misuse, USA Ages 18 64, % 4 3 Trend, p <.1 2 Rx Opioid Use 1 Data sources: Han, Compton et al. JAMA October 13, 215; SAMHSA s National Survey on Drug Use and Health (NSDUH) data, , adults aged in the United States. Wilson M. Compton, M.D., MPE 6

7 Increasing Frequent Rx Opioid Misuse: 12 Month Prevalence of 1+ days Rx Opioid, USA Ages 18 64, % Trend, p <.1 1+ Days.2 Data sources: Han, Compton et al. JAMA October 13, 215; SAMHSA s National Survey on Drug Use and Health (NSDUH) data, , adults aged in the United States. Increasing Rx Opioid Abuse/Depedence: 12 Month Prevalence of Rx Opioid Ab/Dep, USA Ages 18 64, % Trend, p <.1 Opioid Ab/Dep.2 Data sources: Han, Compton et al. JAMA October 13, 215; SAMHSA s National Survey on Drug Use and Health (NSDUH) data, , adults aged in the United States. Wilson M. Compton, M.D., MPE 7

8 Increasing Intensity of Opioid Misuse: 12 Month Prevalence of Rx Opioid Misuse without Frequent Use or Ab/Dep, Rx Opioid Ab/Dep, 1+ days Rx Opioid in USA Ages 18 64, % Trends, p <.1 Rx Opioid Use Without 1+ or Ab/Dep Opioid Ab/Dep 1+ Days Data sources: Han, Compton et al. JAMA October 13, 215; SAMHSA s National Survey on Drug Use and Health (NSDUH) data, , adults aged in the United States. Doubling of Treatment for Analgesic Use : Most Recent Treatment in the Past Year for the Use of Pain Relievers among USA Persons Aged 12 or Older Numbers in Thousands 1, Difference from the 213 estimate is statistically significant at the.5 level. Source: SAMHSA, 213 National Survey on Drug Use and Health, released September 214 Wilson M. Compton, M.D., MPE 8

9 Outbreak of HIV Linked to IDU of Oxymorphone in Indiana, 215 8% 162 HIV Infections in a Community of % 17% (23) All reported injecting tablets of oxymorphone As drug of choice 84.4% 114 co infected with Hepatitis C Injection Drug Use No Injection Drug Use Status Not Determined Reported average of 9 syringe sharing partners, sex partners, or other social contacts at risk for HIV infection 61.7% 4.6% 247 located 373 HIV 23 tested HIV % 47% syringe sharing or sex partners 128 not located contacts % 42.2% social contacts regarded as at high risk for HIV Increasing Neonatal Abstinence Syndrome NICU Admissions for NAS (Number per 1 Admissions) Source: Tolia VN, Patrick SW, et al. NEJM 215;372: Wilson M. Compton, M.D., MPE 9

Increasing Neonatal Abstinence Syndrome: Incidence & Geography, U.S. 29 212 Patrick SW, Davis MM, Lehman CU, Cooper WO.

10 Increasing Neonatal Abstinence Syndrome: Incidence & Geography, U.S Patrick SW, Davis MM, Lehman CU, Cooper WO. Increasing incidence and geographic distribution of neonatal abstinence syndrome: United States 29 to 212. J Perinatol. 215 Aug;35(8):667. doi: 1.138/jp PubMed PMID: Overlap of Benzodiazepines and Opioids Opioid Analgesic ED Visits and OD Deaths Involving Benzodiazepines & Benzodiazepine ED Visits and OD Deaths Involving Opioids AAPC = 1.5% (95% CI.8% 2.2%) 7 6 Percent AAPC = 8.4% (95% CI 7.1% 9.7%) AAPC = 3.% (95% CI 1.3% 4.8%) AAPC = 4.5% (95% CI2.4% 6.6%) 2 1 Deaths Involving Benzodiazepines ED Visits Involving Benzodiazepines Deaths Involving Opioid Analgesics ED Visits Opioid Analgesics Opioid Analgesics Benzodiazepines Source: CM Jones, JK McAninch. American Journal of Preventive Medicine 215;49: Wilson M. Compton, M.D., MPE 1

Abuse of Opioid Medications has led to a Rise in Heroin Abuse and Associated Deaths from Overdoses Numbers in Thousands Past Month &Past Year Heroin Use Persons Aged 12 or Older 1 9 8 Past Year 669 7

11 Abuse of Opioid Medications has led to a Rise in Heroin Abuse and Associated Deaths from Overdoses Numbers in Thousands Past Month &Past Year Heroin Use Persons Aged 12 or Older Past Year Past Month , 1, 8, 6, 4, 2, Heroin Overdose Deaths 3,41 3,278 3,36 1,96 1,779 2,8 2,9 2,339 1,842 2,89 2,88 1,878 4,397 5,925 8,257 1, SAMHSA, 213 National Survey on Drug Use and Health, 214. CDC/NCHS, National Vital Statistics System, Mortality File Similarities of Illicit & Prescription Opioids Wilson M. Compton, M.D., MPE 11

Increases in All Regions, Especially Northeast and Midwest: Age Adjusted Rates for Heroin Drug Poisoning Deaths Increases for All, Especially

7 6 5 4 3 2 1 2 213 Northeast Midwest South West 18 44 45 64 18 44 45 64 18 44 45 64 Non Hispanic White Non Hispanic Black Hispanic CDC, NCHS

Changing Pattern of Newer Cohorts of IDU: Trends Observed on East Coast & Midwest These young IDUs tend to be: young (under 3) white more

12 Increases in All Regions, Especially Northeast and Midwest: Age Adjusted Rates for Heroin Drug Poisoning Deaths Increases for All, Especially Non Hispanic Whites: Heroin Drug Poisoning Deaths by Subgroups Deaths per 1, population Northeast Deaths per 1, population Northeast Midwest South West Non Hispanic White Non Hispanic Black Hispanic CDC, NCHS Data Brief, No 19, March 215. CDC, NCHS Data Brief, No 19, March 215. Changing Pattern of Newer Cohorts of IDU: Trends Observed on East Coast & Midwest These young IDUs tend to be: young (under 3) white more equally male/female more non urban (suburban, rural) Increase in injection drug use driven by increase in prescription opioids use Valdiserri R., et al. Am J Public Health. 214; 14(5): Wilson M. Compton, M.D., MPE 12

13 Which Drug is First Opioid in Treatment Seekers? Shifting Pattern of Heroin vs. Rx Opioid First Total Sample, % Percentage of Opioid Treatment Admissions that Used Heroin or Prescription Opioid as First Opioid ` ` ` ` Prescription Opioid Heroin 196s 197s 198s 199s 2s 21s (n=88) (n=114) (n=214) (n=482) (n=1613) (n=286) Decade of First Opioid Use (n=no. of Patients in Study) Source: Cicero et al. JAMA Psychiatry. 214;71(7): ` ` ` 196s: more than 8% started with heroin 2s: 75% started with prescription opioids : Increasing initiation with heroin Most Heroin Users Report Previous Non Medical Use of Prescription Opioids, BUT Only a Small Proportion of Non Medical Users Progress to Heroin National General Population: Within 5 years, 3.6% of non medical users of opioids progressed to heroin within 5 years (i.e. less than 1% per year) (Muhuri, Gfroerer, Davies. 213) Local Longitudinal Study of Non medical users: Within 3 years, 7.5% progressed to heroin (i.e. 2.8% per year) (Carlson, Nahhas, martins, Daniulaityte. 215) Wilson M. Compton, M.D., MPE 13

Heroin Market Has Changed: Heroin Price Has Been Lower in Recent Years $3,5 $3, $2,5 $2, $1,5 $1, $5 $ "Retail" Price Per Pure Gram Source: National Drug Control Strategy Data Supplement 214.

pdf Fentanyl: A Particularly Potent Opioid Schedule II synthetic and short acting opioid ~ 8 to 1 times stronger than morphine and 25 to 4 times more potent than heroin Introduced into medical

14 Heroin Market Has Changed: Heroin Price Has Been Lower in Recent Years $3,5 $3, $2,5 $2, $1,5 $1, $5 $ "Retail" Price Per Pure Gram Source: National Drug Control Strategy Data Supplement and research/ndcs_data_supplement_214.pdf Fentanyl: A Particularly Potent Opioid Schedule II synthetic and short acting opioid ~ 8 to 1 times stronger than morphine and 25 to 4 times more potent than heroin Introduced into medical practice as an intravenous anesthetic under the trade name of Sublimaze in the 196s and approved for managing acute or chronic pain associated with advanced cancer It is a µ opioid receptor agonist with a rapid onset and short duration of effects. Similar to other µ opioid receptor agonists (like morphine or oxycodone) in its pharmacological effects Most overdoses are from non pharmaceutical fentanyl manufactured in illicit laboratories Wilson M. Compton, M.D., MPE 14

Increases in Fentanyl Reports in Northeast, Midwest and South Jan. June 29 Jan.

fentanyl during the first half of 29. No States had more than 49 fentanyl reports.

In the first half of 214, 46 States reported fentanyl, including 6 with 1 or more reports and

Overall Increases in Deaths in 45 54 Year Old, White, Non Hispanics in USA (Compared to Other

15 Increases in Fentanyl Reports in Northeast, Midwest and South Jan. June 29 Jan. June 214 Reports per State 1or More No Data 35 States reported analyzing fentanyl during the first half of 29. No States had more than 49 fentanyl reports.two States hadbetween2and49 reports. In the first half of 214, 46 States reported fentanyl, including 6 with 1 or more reports and 5 States between 5 and 99. Highest numbers mainly in Midwest and Northeast. Overall Increases in Deaths in Year Old, White, Non Hispanics in USA (Compared to Other Countries) U.S. Whites France Germany U.S. Overdose Hispanics United Kingdom Canada Austria Sweden Major Causes: Drug Alcohol Suicide Case and Deaton, PNAS, 2 November 215 Wilson M. Compton, M.D., MPE 15

5 1 1 2 3 4 5hr Time After Morphine % of Basal Release 2 15 1 5 Empty Box Feeding FOOD 6 12 18 Time (min) Di Chiara et

16 Why Do People Abuse Prescription Drugs? Opioid prescription drugs, like other drugs of abuse (cocaine, heroin, marijuana) raise brain dopamine levels Dopamine Neurotransmission % of Basal Release MORPHINE Dose (mg/kg) hr Time After Morphine % of Basal Release Empty Box Feeding FOOD Time (min) Di Chiara et al. What is the Difference Between Therapeutic Use and Abuse? Dose and Frequency of Dosing Lower, fixed regimes vs higher, escalating use Route of Administration Oral vs injection, smoking, snorting Expectation of Drug Effects Expectation of clinical benefits vs euphoria high Context of Administration School, clinic, home vs bar, party Wilson M. Compton, M.D., MPE 16

Secretary Burwell s/hhs Opioid Priority Areas Opioid prescribing practices to

to treat opioid overdoses Expanded use of medication assisted treatment (MAT)

gov/sp/reports/215/opioidinitiative/es_opioidinitiative.

Patients In a 2 year follow up of 2848 commercially insured patients (from 2

14% 13% 1% 63% of high dose opioid patients were still on a high dose 31 9

years high dose moderate dose low dose none 33 39% of those with active opioid

17 Secretary Burwell s/hhs Opioid Priority Areas Opioid prescribing practices to prevent opioid use disorders and overdose The expanded use of naloxone, used to treat opioid overdoses Expanded use of medication assisted treatment (MAT) for opioid use disorders Doctors Continue to Prescribe Opioids for Ninety one Percent of Overdose Patients In a 2 year follow up of 2848 commercially insured patients (from 2 to 212) who had a nonfatal opioid overdose during long term opioid therapy : 14% 13% 1% 63% of high dose opioid patients were still on a high dose 31 9 days after overdosing 17% of high dose patients overdosed again within two years high dose moderate dose low dose none 33 39% of those with active opioid prescriptions during follow up also were prescribed benzodiazepines. Larochelle et al. Ann Intern Med. 216;164(1):1 9. Wilson M. Compton, M.D., MPE 17

Doctors (and other clinicians) Should Know What Prescriptions Have Been Given to

included in the patients electronic health care records 2.

immediate information Variation in PDMP State Laws and Regulations (as of

Permitted to Share Data with other PDMPs 34 states permit sharing of PDMP data

18 Doctors (and other clinicians) Should Know What Prescriptions Have Been Given to Their Patients By Other Practitioners This information should be: 1. included in the patients electronic health care records 2. accessible through a Prescription Drug Monitoring Program (PDMP) that provides immediate information Variation in PDMP State Laws and Regulations (as of February 1,216) PDMP Authorized 49 states and DC have authorized PDMPs PDMP Permitted to Share Data with other PDMPs 34 states permit sharing of PDMP data with other states PDMPs Prescribers Required to Check PDMP 13 states require prescribers to check the PDMP Wilson M. Compton, M.D., MPE 18

Three Pillars of CDC s Prescription Drug Overdose Prevention

providers with resources to improve patient safety Strengthen

interventions http://www.cdc.gov/washington/testimony/215/t21551.

providers Applies to patients >18 years old in chronic pain

SAMHSA summary on Common Elements in Guidelines for Prescribing

19 Three Pillars of CDC s Prescription Drug Overdose Prevention Work Improve data quality and track trends Supply healthcare providers with resources to improve patient safety Strengthen state efforts by scaling up effective public health interventions Recent Landscape for Guidelines: Small Number Outdated Not Conflict Free Solution. Opioid Prescribing Guidelines Intended for primary care providers Applies to patients >18 years old in chronic pain outside of end of life care Builds on joint CDC, NIDA, ONC, SAMHSA summary on Common Elements in Guidelines for Prescribing Opioids for Chronic Pain and the NIH Pathways to Prevention for Opioids in Treating Chronic Pain PUBLISHED MARCH 15, 216 Wilson M. Compton, M.D., MPE 19

Doctors (and other clinicians) Need to Know What Prescriptions Have Been Given to Their Patients By Other Practitioners This information should be: 1.

20 Doctors (and other clinicians) Need to Know What Prescriptions Have Been Given to Their Patients By Other Practitioners This information should be: 1. included in the patients electronic health care records 2. accessible through a Prescription Drug Monitoring Program (PDMP) that provides immediate information People Abusing Analgesics DIRECTLY & INDIRECTLY Obtain Them by Prescription: Most Recent Pill Source Source Where Respondent Age 12+ Obtained Analgesics: More than One Doctor One Doctor (2.6%) (21.2%) Other 1 Free from (4.3%) Friend/ Bought on Relative Internet (53.%) (.1%) Drug Dealer/ Stranger (4.3%) Bought/Took from Friend/Relative (14.6%) One Doctor (83.8%) 1 Other category includes Wrote Fake Prescription," "Stole from Doctor s Office/Clinic/Hospital/Pharmacy," and "Some Other Way." Source Where Friend/Relative Obtained More than One Doctor (3.3%) Free from Friend/Relative (5.1%) Bought/Took from Friend/Relative (4.9%) Drug Dealer/ Stranger (1.4%) Bought on Internet (.3%) Other 1 (1.2%) Source: SAMHSA, 212 and 213 National Survey on Drug Use and Health Wilson M. Compton, M.D., MPE 2

Direct Overdose Intervention Naloxone Distribution for opioid overdose victims.

Note the April 3, 214 FDA approval of the naloxone auto injector (called Evzio )

antidote. Adapt Pharma NARCAN nasal spray APPROVED BY FDA, November 18, 215.

By Standing Order Authorized 33 states have standing orders to authorize non medical

states protect naloxone prescribers from both criminal and civil liability Good

21 Direct Overdose Intervention Naloxone Distribution for opioid overdose victims. The potential for direct intervention to save lives. Note the April 3, 214 FDA approval of the naloxone auto injector (called Evzio ) Naloxone Nasal Spray Development Needle free, unit dose, ready to use opioid overdose antidote. Adapt Pharma NARCAN nasal spray APPROVED BY FDA, November 18, 215. Variation in State Naloxone and Good Samaritan Laws As of February 1,216 Prescription By Standing Order Authorized 33 states have standing orders to authorize non medical Personnel to issue naloxone Prescribers Immune from Criminal And Civil Liability 27 states protect naloxone prescribers from both criminal and civil liability Good Samaritan Overdose Prevention Law 36 states offer legal protections to those who call 911 to report an overdose Wilson M. Compton, M.D., MPE 21

Layperson Distribution of Naloxone Kits Increases Markedly A survey of 136 organizations in mid 214 shows an increase in Naloxone distribution From 1996 to 214, ~26,5 overdoses were reversed using

22 Layperson Distribution of Naloxone Kits Increases Markedly A survey of 136 organizations in mid 214 shows an increase in Naloxone distribution From 1996 to 214, ~26,5 overdoses were reversed using naloxone by laypersons MMWR. Opioid Overdose Prevention Programs Providing Naloxone to Laypersons June 19,215/64(23); United States, Retail Pharmacy Prescriptions for Naloxone Increase Markedly Retail prescriptions show an increase of 117% from the 4 th quarter of 213 to 2 nd quarter 215. Outpatient prescribing of naloxone may complement communitybased distribution and first responder access. Evzio Naloxone 2mg/2ml Other Jones CM, Lurie PG, Compton WM. American Journal of Public Health 216;16(4): Science = Solutions Wilson M. Compton, M.D., MPE 22

23 Medications for Opioid Addiction Full Agonist: Methadone (daily dosing) Partial Agonist: Buprenorphine (3 4X week) Antagonists: Naltrexone (ER 1 month) agonist antagonist Full Agonist (Methadone) effect no effect Binds to the receptor and activates it; Full agonists have maximal effect Partial agonist have intermediate effect Prevent Heroin from binding Binds to receptor but has no effect. Prevents heroin from binding Opioid Effect Log Dose Partial Agonist (Buprenorphine) Antagonist (Naltrexone) Accessing Medications Can Save Lives Opioid Agonist Treatments Decreased Heroin OD Deaths Baltimore, Maryland, Heroin overdoses Buprenorphine patients Methadone patients Schwartz RP et al., Am J Public Health 213. Wilson M. Compton, M.D., MPE 23

24 How Can Research Help? PREVENTION:Develop Less Abusable Analgesics and Alternative Therapeutics; Overdose treatment; Universal prevention ADDICTION: New Medications and Immunotherapies PHARMACOGENOMICS: Precision Medicine IMPLEMENTATION SCIENCE: Greater Use of Evidence Prevention: Risk for Young Adult Non Medical Use of Prescription Opioids Predicted by Early Behavior In MTF (Monitoring the Future) Follow up Study, 12 th Grade Predictors of Young Adult Non medical Use of Prescription Opioids (all p <.5): FACTOR RELATIVE RISK Lifetime MJ (at least 6 times use): Lifetime Cigarettes (any): Lifetime Rx Opioid Misuse (any): Lifetime Sedative (1 5, 1 39 times): Racial/ethnic Minority:.62 College Educated Parents: 1.23 Medical Use of Rx Opioid: 1.33 Source: Miech R, Johnston L, O Malley PM, Keyes KM, Heard K. Pediatrics 213;136:e1169 Wilson M. Compton, M.D., MPE 24

Overall, three studies now suggest the impact of universal prevention on prescription drug abuse. Notes: General=Misuse of narcotics or CNS depressants or stimulants. Source: R Spoth et al.

25 Prevention: Universal Drug Abuse Prevention Reduces Prescription Drug Misuse 16% 12% 8% 4% % ** p<.1; 15.5% 5.4% ** Age 25 General 13.5% 4.7% ** Age 25 Opioids Control Family Program In this study, for 1 young adults in general population starting Rx abuse, only 35 young adults from an intervention community started. Overall, three studies now suggest the impact of universal prevention on prescription drug abuse. Notes: General=Misuse of narcotics or CNS depressants or stimulants. Source: R Spoth et al. American Journal of Public Health 213 Prevention: Less Abusable Medications Uptake in Striatum (nci/cc) Slow!! Time (minutes) Develop medications with lower abuse potential including drugs that don t cross the Blood Brain Barrier (i.e., CbR2 agonist) Develop slow release formulations (low dose and long duration) and prodrug formulations (only activated with digestion) Develop novel formulations to reduce abuse liability including mixture formulations (e.g., naloxone and buprenorphine) Wilson M. Compton, M.D., MPE 25

PAIN: Non Medication Treatments for Pain and Addiction Transcranial Magnetic Stimulation (TMS) Left periventricular gray Left sensory thalamus Deep Brain Stimulation (DBS) Stereotaxtic implantation

al., J Pain 214; 15(3): 283 292. Morena Duarte I et al., Neuroimage 214; 85(3): 13 113.

26 PAIN: Non Medication Treatments for Pain and Addiction Transcranial Magnetic Stimulation (TMS) Left periventricular gray Left sensory thalamus Deep Brain Stimulation (DBS) Stereotaxtic implantation of electrodes that emit electrical stimulation to a targeted neuronal region High Definition transcranial Direct Current Stimulation (HD tdcs) Transcranial Direct Current Simulation (tdcs) Gray AM et al., J Pain 214; 15(3): Morena Duarte I et al., Neuroimage 214; 85(3): ADDICTION: New Medications Challenge: Compliance with daily intake Solution: Develop long acting medications % of Patients Failing to Exceed Each Possible Criterion of Success Placebo Sublingual Buprenorphine Buprenorphine Implants % of Urines Negative (out of 72) for Opioids Across Weeks 1 to 24` Rosenthal RN et al., Addiction 213;15: Wilson M. Compton, M.D., MPE 26

27 ADDICTION: Immunotherapies (Vaccines) Antibodies (i.e. Vaccines) reduce amount of drug in the brain Vaccin Antibodies e Targets drugs, not receptors Capillary Blood Flow Brain Binding sites Capillary Blood Flow Brain Rosenthal RN et al., Addiction 213;15: Additional Challenge: Lack of medication assisted treatment capacity Rate of Opioid Abuse/Dependence (rate per 1, persons aged 12 years and older) Source: Jones CM, et al. AJPH. 215 Rate of OA-MAT Capacity Wilson M. Compton, M.D., MPE 27

Treatment: Access to Buprenorphine in Emergency Department Increased Engagement In Addiction Treatment & Reduced Self reported Illicit Opioid Use % engaged in treatment on the 3 th day after

4 Implementation: Methadone Discontinuation During Incarceration Associated with Less Treatment Continuity After Prison/Jail Release Continued During Incarceration Discontinued During Incarceration

28 Treatment: Access to Buprenorphine in Emergency Department Increased Engagement In Addiction Treatment & Reduced Self reported Illicit Opioid Use % engaged in treatment on the 3 th day after randomization D Onofrio, et al. JAMA % % 45% Buprenorphine Referral Brief Intervention Number of days of illicit opiate use per week Implementation: Methadone Discontinuation During Incarceration Associated with Less Treatment Continuity After Prison/Jail Release Continued During Incarceration Discontinued During Incarceration Continuation of methadone maintenance during incarceration as compared to forced withdrawal increased the likelihood of re engaging in methadone treatment (combined US prison and jail, randomized, open label trial) Rich et al., The Lancet Published online May 29, 215. Science = Solutions Wilson M. Compton, M.D., MPE 28

Improving Treatments for Addiction: Extended Release Naltrexone in Criminal Justice Involved Populations Participants:

Community treatment, including methadone or Suboxone (encouraged) Relapse Frequency Probability of No Relapse Naltrexone Treatment as

, Poster presentation Weeksat the Annual Meeting of the College on Problems of Drug Dependence, June Science 215.

physicians by 375% (from 24 to 114) within 3 years New Mexico Project ECHO Initiation of SUD focused clinic associated with much more

29 Improving Treatments for Addiction: Extended Release Naltrexone in Criminal Justice Involved Populations Participants: parolees/probationers with opioid addiction all volunteers received either Monthly injections of extended release naltrexone for 6 months Community treatment, including methadone or Suboxone (encouraged) Relapse Frequency Probability of No Relapse Naltrexone Treatment as usual Overdoses in 78 weeks: Control: 7 Naltrexone: Lee et al. NEJM March 31, 216. O Brien et al., Poster presentation Weeksat the Annual Meeting of the College on Problems of Drug Dependence, June Science 215. = Solutions State Successes in Improving Treatment Capacity Massachusetts Collaborative Care Model Expanded the number of DATA waived physicians by 375% (from 24 to 114) within 3 years New Mexico Project ECHO Initiation of SUD focused clinic associated with much more rapid growth in waivered physicians practicing in traditionallyunderserved areas compared with the rest of the US Sources: LaBelle CT, et al. J Subs Abuse Treat 215., and Komaromy, M. et al. Substance Abuse 216 Wilson M. Compton, M.D., MPE 29

30 Increasing Buprenorphine* prescriptions dispensed from US retail pharmacies, Q429 Q2215 3,, All Buprenorphine Subutex & generics Suboxone & generics Zubsolv Number of dispensed prescriptions 2,5, 2,, 1,5, 1,, 5, Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q *Does not include Butrans or Buprenex (or generics) Source: CM Jones. NIDA Webinar 9/1/215. Based on IMS Health National Prescription Audit (extracted 8/24/215) Retrieved from events/meetings events/215/9/latest prescription trends controlled prescription drugs. Decreasing Hydrocodone Prescriptions dispensed from US retail pharmacies after DEA Upscheduled Hydrocodone to Schedule 2 7,, 6,, 5,, Total Opioids Prescriptions 4,, 3,, 2,, 1,, Hydrocodone Prescriptions Rescheduling to Schedule 2 on October 6, 214 Source: CM Jones, PG Lurie, DC Throckmorton. JAMA Internal Medicine Jan 25, 216, and CM Jones. NIDA Webinar 9/1/215. Based on IMS Health National Prescription Audit (extracted 8/24/215) Retrieved from events/meetings events/215/9/latest prescription trends controlled prescription drugs. Wilson M. Compton, M.D., MPE 3

Decline in Drug Overdose Deaths After State Policy Changes in Florida, 21 212 Semi-Annual Drug Overdose Death Rates * for Selected Drugs, & Selected Prescription Drug Diversion & Misuse Actions

2/23/211 Operation Pill Nation raids E. 7/1/211 Physician dispensing prohibited & statewide regional strike forces F. 9/1/211 Mandatory PDMP reporting G.

31 Decline in Drug Overdose Deaths After State Policy Changes in Florida, Semi-Annual Drug Overdose Death Rates * for Selected Drugs, & Selected Prescription Drug Diversion & Misuse Actions Taken, Florida, Deaths per 1, population A. 1/4/21 Pain clinics must register B. 2/21 Operation Pill Nation C. 1/1/21 Pain clinic regulation D. 2/23/211 Operation Pill Nation raids E. 7/1/211 Physician dispensing prohibited & statewide regional strike forces F. 9/1/211 Mandatory PDMP reporting G. 7/1/212 Wholesale regulations AB C D E F G Alprazolam Oxycodone Methadone Morphine Hydrocodone Heroin Jan-JunJul-DecJan-JunJul-DecJan-JunJul-DecJan-JunJul-DecJan-JunJul-DecJan-JunJul-DecJan-JunJul-Dec PERIOD *Per 1, population. Based on Florida Department of Health resident population estimates. + The source of overdose death data is the Florida Medical Examiners Commission. Source: CDC, MMWR Vol 63, July 1, 214. Multi-pronged approaches to save lives: Staten Island Case Study data brief 2. opioid Rx guidelines 3. PSAs 4. PDMP law 5. ED opioid Rx guidelines 6. town halls and detailing campaign to promote guidelines 7. PDMP mandated use 8. PSAs Source: MMWR, May 15, (18): Wilson M. Compton, M.D., MPE 31

The President s Opioid Initiative Actions across federal, state, local governments and the private sector Improve Prescriber Training Train >54, health care providers Double PDMP registration Reach

abuse messaging Multiple Partners with Commitments from: Over 4 provider groups, including physicians, dentists, advanced practice registered nurses, physician assistants, physical therapists and

32 The President s Opioid Initiative Actions across federal, state, local governments and the private sector Improve Prescriber Training Train >54, health care providers Double PDMP registration Reach >4M providers with appropriate prescribing practices messaging Improve Treatment Access Double number of buprenorphine prescribers Double number of naloxone providers Reach >4M providers with opioid abuse messaging Multiple Partners with Commitments from: Over 4 provider groups, including physicians, dentists, advanced practice registered nurses, physician assistants, physical therapists and educators CVS Health, Rite Aid and several pharmacy and pharmacist organizations (naloxone, PDMPs) CBS, ABC, The New York Times, Google, the National Basketball Association, and Major League Baseball will donate media space for PSAs Summary Opioid misuse can be prevented and addiction treated. Complex biological, developmental and social aspects of substance abuse and addiction suggest multipronged responses. Science provides clues and is essential in planning responses. Wilson M. Compton, M.D., MPE 32

33 Science = Solutions Wilson M. Compton, M.D., MPE 33

Policy Implications of the Neurobiology of Addiction

Policy Implications of the Neurobiology of Addiction Facilitator: Jay Butler, MD, President of ASTHO, Chief Medical Officer Alaska Department of Health and Social Services Director, Alaska Division of