Part of the "Fourth Annual Health Law Year in P/Review" held at Harvard Law School on January 29, 2016. This symposium featured leading experts discussing major developments during 2015 and what to watch out for in 2016. The discussion covered hot topics in such areas as health insurance, health care systems, public health, innovation, and other issues facing clinicians and patients. This year's Health Law Year in P/Review was sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, the New England Journal of Medicine, Health Affairs, the Hastings Center, Harvard Health Publications at Harvard Medical School, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University. Visit our website for more information: http://petrieflom.law.harvard.edu/events/details/fourth-annual-health-law-year-in-p-review.

1. OPIOID ADDICTION:
LEGAL AND PUBLIC HEALTH RESPONSES
REBECCA L. HAFFAJEE, JD MPH
THOMAS O. PYLE FELLOW IN PHARMACEUTICAL POLICY RESEARCH
HARVARD MEDICAL SCHOOL / HARVARD PILGRIM HEALTH CARE INSTITUTE
HEALTH LAW YEAR IN P/REVIEW
JANUARY 29, 2016

2. OVERVIEW
 Opioid-related public health challenges
 Policy responses to address opioid addiction
1. Primary prevention: abuse-deterrent drug formulations
2. Secondary prevention: prescription drug monitoring programs
3. Tertiary prevention: access to naloxone
 Using evidence to address opioid addiction
2

3. PRESCRIPTION DRUG DUAL PUBLIC HEALTH CHALLENGES
DUAL PUBLIC HEALTH OPIOID CHALLENGES
3
Opioid Abuse and
Misuse
Under-Treatment
of Pain

4. OPIOID ABUSE & ADDICTION
4
Medical Use Abuse
Addiction &
Dependence

5. MOTORVEHICLE, POISONING,AND DRUG OVERDOSE DEATH RATES,
UNITED STATES, 1980-2010
5
0
5
10
15
20
25
1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010
Deathsper100,000population
Year
Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose)
Source: NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.

6. AGE-ADJUSTED RATES OF DEATH IN THE U.S., 2000-2014
6
Source: Compton WM et al. N Engl J Med 2016;374:154-163

7. WHO IS AT RISK FOR OPIOID OVERDOSES?
 Whites
 Middle-aged
 Increasingly women
 People taking high daily doses of opioids
 “Doctor shoppers” (variably defined)
 People using multiple abusable substances
 Low-income people in rural areas
 People with substance abuse or other mental health conditions 7

8. OPIOID SALES, DEATHS, ANDTREATMENT ADMISSIONS BY MAJOR DRUG TYPE,
UNITED STATES, 1999–2010
8
0
1
2
3
4
5
6
7
8
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Rate
Year
Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000
Source: CDC.Vital Signs – Overdoses of Prescription Opioid Pain Relievers – United States, 1999-2008. Morbidity and MortalityWeekly Report 2011; 60(43):1487-1492. Updated with 2009
mortality and 2010 treatment admission data.

9. SOURCES OF PRESCRIPTION DRUGS
9
Source: NSDUH 2013. http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.htm

10. OVERVIEW
 Opioid-related public health challenges
 Policy responses to address opioid abuse
1. Primary prevention: abuse-deterrent drug formulations
2. Secondary prevention: prescription drug monitoring programs
3. Tertiary prevention: access to naloxone
 Using evidence to address opioid addiction
10

11. POLICY RESPONSES TO ADDRESS OPIOID ABUSE
11
• prescriber education & guidelines
• drug approval and abuse-deterrent formulations
• medication take-back or disposal programs
• “pill mill” regulation
Primary Prevention:
reduce incidence of a disease or condition
•prescription drug monitoring programs
•urine testing
•insurer/pharmacy benefit manager mechanisms
•doctor shopping laws
Secondary Prevention:
identify health condition after onset but before it
causes serious complications
• opioid addiction treatment (incl. pharmacotherapies)
• access to naloxone & good samaritan laws
• access to syringe exchange programs
Tertiary Prevention:
therapeutic and rehabilitative measures once a
disease is firmly established.
Source: Kolodny A et al.The Prescription Opioid and Heroin Crisis:A Public Health Approach to an Epidemic of Addiction, Ann. Rev. Public Health 2015;36:559-74.

12. 12
POLICY OPTIONS TO ADDRESS RX DRUG ABUSE
Opioid
Abuse
Prevention
Federal Government:
FDA (drug approval, REMs), DEA
(surveillance, take-back programs,
pill mill crackdowns)
State/Local Government &
Communities:
PDMPs, Rx drug laws,
prescriber guidelines, needle
exchange programs
Insurer/PBMs:
claims analysis, formularies,
monitoring, reimbursement
incentives
Providers:
urine testing, addiction treatment,
prescriber education/guidelines
Drug Manufacturers:
formulations, prescriber
education

13. OVERVIEW
 Opioid-related public health challenges
 Policy responses to address opioid abuse
1. Primary prevention: abuse-deterrent drug formulations
2. Secondary prevention: prescription drug monitoring programs
3. Tertiary prevention: access to naloxone
 Using evidence to address opioid addiction
13

14. OXYCONTIN REFORMULATION,AUGUST 2010
14
Source: Cicero TJ & Ellis ME. Abuse-Deterrent Formulations and the Prescription Opioid Abuse Epidemic in the United
States: Lessons Learned From OxyContin. JAMA Psychiatry. 2015;72(5):424-430. doi:10.1001/jamapsychiatry.2014.3043

15. OVERVIEW
 Opioid-related public health challenges
 Policy responses to address opioid addiction
 Primary prevention: abuse-deterrent drug formulations
 Secondary prevention: prescription drug monitoring programs
 Tertiary prevention: access to naloxone
 Using evidence to address opioid addiction
15

16. Prescription Drug Monitoring
Programs (PDMPs)
What is a PDMP?
Electronic systems
that digitally store,
monitor, & analyze
controlled
substance
dispensing
information
Who implements
PDMPs?
49 States
Missouri is only
state without one
What data do
PDMPs collect?
Patient info
Prescriber info
Dispenser info
Schedule II-IV drugs
Who can access
PDMP data?
Prescribers
Pharmacies
Law enforcement
State medical
boards 16

17. PDMP GOALS
Patient CareTool
• identify Dr.
shoppers
• avoid drug
interactions
• adequately
prescribe
painkillers
Surveillance &
Evaluation Tool
• drug epidemic
early warning
system
• track prescribing
trends
• evaluate
interventions
Law Enforcement
Tool
• identify outlier
prescribers
• identify outlier
patients
17

18. PDMP EFFECTIVENESS
 Mixed evidence of PDMP impact on drug prescribing & health
 Little/no impact on opioid overdoses, except in Florida
 Associations b/w PDMPs with lower rates of abuse, changed prescribing
 Little evidence comparing PDMP features (e.g., mandates)
 Little known about potential unintended consequences of PDMPs
 Low/variable prescriber use of PDMPs, but seems to be increasing
18

19. OVERVIEW
 Opioid-related public health challenges
 Policy responses to address opioid addiction
 Primary prevention: abuse-deterrent drug formulations
 Secondary prevention: prescription drug monitoring programs
 Tertiary prevention: access to naloxone
 Using evidence to address opioid addiction
19

20. ACCESS TO NALOXONE
20
 Naloxone: opioid antagonist … reverses overdoses
 Community-based overdose education and naloxone distribution: provide naloxone to at-
risk individuals, family members, friends
 Over 200 across country
 (also related Good Samaritan laws)
 Promising community programs strategy:
 Effectiveness: reversal of heroin overdoses, but not much in Rx opioid area
 But small studies, self-reported outcomes, not rigorous designs generally
 Need further evidence

21. OVERVIEW
 Opioid-related public health challenges
 Policy responses to address opioid addiction
 Primary prevention: abuse-deterrent drug formulations
 Secondary prevention: prescription drug monitoring programs
 Tertiary prevention: access to naloxone
 Using evidence to address opioid addiction
21

22. USING EVIDENCE TO ADDRESS OPIOID ADDICTION
 State “Success” Stories – Comprehensive Approaches:
 Florida: cracked down on pill mills, PDMP
 Washington: prescribing guidelines, increased pain specialists, good samaritan law
 NewYork: comprehensive PDMP mandate
 Don’t yet understand what works to curb opioid abuse and addiction
 Urgent public health problem
 Need to target high-prescribing but also provide treatment
 No single intervention is a panacea; need a combo & carefully tailored prevention efforts
 Need to continue to generate evidence!
 Careful about unintended consequences…pain epidemic resurgence 22