Post on 12-Apr-2017
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
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
PRESCRIPTION DRUG DUAL PUBLIC HEALTH CHALLENGES
DUAL PUBLIC HEALTH OPIOID CHALLENGES
3
Opioid Abuse and Misuse
Under-Treatment of Pain
MOTOR VEHICLE, 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
Dea
ths
per
10
0,0
00
po
pu
lati
on
Year
Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose)
Source: NCHS Data Brief, December, 2011. Updated with 2009 and 2010 mortality data.
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
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
OPIOID SALES, DEATHS, AND TREATMENT 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 Mortality Weekly Report 2011; 60(43):1487-1492. Updated with 2009
mortality and 2010 treatment admission data.
SOURCES OF PRESCRIPTION DRUGS
9
Source: NSDUH 2013. http://www.samhsa.gov/data/sites/default/files/NSDUHresultsPDFWHTML2013/Web/NSDUHresults2013.htm
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
POLICY RESPONSES TO ADDRESS OPIOID ABUSE
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• 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.
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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
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
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
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
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
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PDMP GOALS
Patient Care Tool
• 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
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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
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
ACCESS TO NALOXONE
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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
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
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
New York: 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
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