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

OPIOID ABUSE & ADDICTION

4

Medical Use Abuse Addiction & Dependence

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

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

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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