Drug Diversion, Sources, and Extent:United States Case Study

Drug Diversion, Sources, and Extent:United States Case Study

Aaron M. Gilson, MS, MSSW, PhDResearch Program Manager/Senior Scientist

Pain & Policy Studies Group

International Pain Policy Fellowship

Pain & Policy Studies Group

WHO Collaborating Center for Pain Policy & Palliative Care

University of Wisconsin Carbone Cancer Center

August 7, 2012

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Fentanyl ME

Hydromorphone ME

Methadone ME

Morphine ME

Oxycodone ME

Pethidine ME

Morphine Equivalence (Mg/person)

U.S. National Retail Sales ofOpioid Analgesics

1980-2010

U.S. National Retail Sales ofOpioid Analgesics

1980-2010

Data sources:Consumption data - International Narcotics Control BoardPopulation – United Nations World Population Prospects, 2010 RevisionME conversion factors – WHOCC Centre for Drug Statistics Methodology

Past-Month Use ofPain Relievers and Illicit Drugs

1990-2010

Past-Month Use ofPain Relievers and Illicit Drugs

1990-2010

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10

1990

1991

1992

1993

1994

1995

1996

1997

1998

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2004

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2007

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2009

2010

Pain RelieversIllicit DrugsIllicit Drugs (Without Pain Relievers)

0

2

4

6

8

10

1990

1991

1992

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1997

1998

1999

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2001

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2005

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2009

2010

Pain RelieversIllicit DrugsIllicit Drugs (Without Pain Relievers)

PercentagePercentagePercentagePercentage

– “ ” “ ” “ ”

Prescription Pain Medication DiversionPrescription Pain Medication Diversion

Event:A. Increased prescribing of opioids for pain

Event:A. Increasing reports of non-medical use

Causal Attribution:A. Diversion is due primarily to increased availability

to patients for pain managementB. Prescribers and patients are to blame

– Increased stigmatization

C. Safety of prescription opioids is questionedFallacyFallacy

Prescription Pain Medication DiversionPrescription Pain Medication Diversion

Increased monitoring of prescribersTightening prescription requirements

Imposing undue limits on legitimate prescribing

Increased scrutiny of patientsPublicize risks of pain medicines

But...

What if there are non-medical diversion sources?

If attribution is correct,Then the main solutions are:

ManufacturersDistributors

1. DISTRIBUTION SYSTEM (lawful distribution)

•Pharmacies•Hospitals/Clinics•Internet w/Rx•PractitionersPrescribersDispensers

•Nursing homes•Hospices

Patients(Lawful medical use)

(Pre

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atio

n)(C

omm

on

Car

rier

s)

International smuggling

Abusers, addicts, impaired health care professionals use what they steal

2. PRIMARY DIVERSION (unlawful; supplies some

abusers and re-distribution)

Theft from manufacturers and distributors*

Theft in transit *

•Theft from hospitals*Pharmacies/robbery*Employee/customer Pilferage *

•Script docs/pill mills•Inappropriate prescribing•Doctor shopping

Internet sales without Rx

Theft of Rx/forgery

•Patient sells or gives•Theft from home•Theft from patient•Improper disposal

Dealers

PeersRelatives

3. REDISTRIBUTION(Layers of re- distribution;

illicit industry)

All Nonmedical users:

Used for reward, high, recreation;compulsive use due to addiction;treatment of withdrawal;Self medication for mood, sleep, pain

4. NON MEDICAL USES

5. MEASUREMENT OF IMPACTS

•SurveysPostmarketingNonmedical useAbuseAddictionAddiction treatmentKey informantsPain patients

•Reporting systemsAdverse eventsAccident/PoisoningEmergency DeptInternet surveillanceMedical ExaminerTreatment episodesArrests

LiteratureMisuse, abuse, addictionSelf medication

Un

pre

scri

bed

dru

gs

Diversion Schematic: Lawful distribution; primary diversion; layers of redistribution, non medical uses; measurement of impacts

PPSG, 2007

Pre

scri

bed

m

edic

atio

ns

* = Amounts reported by law on DEA Form 106

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Recent Federal and State Responses toMedication Abuse and Diversion

Recent Federal and State Responses toMedication Abuse and Diversion

FDA Risk Evaluation and Mitigation Strategies (REMS)

Reducing Volume of Unused Medications DEA Take Back DEA Disposal Regulations

Electronic Prescribing of Controlled Substances Prescription Series for Controlled Substances Prescription Monitoring Programs (PMP) Office of National Drug Control Policy Prescription

Drug Abuse Prevention Plan

Office of National Drug Control Policy (ONDCP)

Office of National Drug Control Policy (ONDCP)

White House Report:

Prescription Drug Abuse Prevention Plan(April, 2011, pp. 1-10)

Domain #1: Education Healthcare practitioners

CECurricula in health professional schoolsMethods to facilitate and assess adequateness and

effectiveness of pain treatment

Parent, youth, and patient Research and development

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Domain #2: Tracking and Monitoring PMPs Electronic prescribing Epidemiology

Domain #3: Proper Medication Disposal

Domain #4: Enforcement Reduce “doctor shopping” and “pill mills”

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

ONDCP

Bureau of Justice Assistance Centers for Disease Control and Prevention Centers for Medicare and Medicaid Services Department of Justice Environmental Protection Agency Health Resources and Services Administration High Intensity Drug Trafficking Area Program Indian Health Service National Institute of Justice National Institute on Drug Abuse

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Federal Agencies Involved

Office of the National Coordinator for Health Information Technology

State Medical Boards Substance Abuse & Mental Health Services Administration U.S. Bureau of Prisons U.S. Department of Defense U.S. Department of Education U.S. Department of Health and Human Services U.S. Drug Enforcement Administration U.S. Food and Drug Administration Veterans Administration

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Office of National Drug Control PolicyPrescription Drug Abuse Prevention Plan

Federal Agencies Involved

Prescription Drug Abuse Prevention PlanAddressing UNODC Recommendations

Prescription Drug Abuse Prevention PlanAddressing UNODC Recommendations

Interagency cooperationPractitioner trainingModel lawsMedication monitoring

systemsEngaging the public

ONDCP StrategyNational policiesTrandisciplinary

committees to share information

Illegal internet sales

Other U.S. Activities

ConclusionsConclusions

Medical use of pain medications has increased contemporaneously with non-medical use, with little understanding of the relationship

Efforts to reduce pain medication abuse and diversion historically has focused on the prescriber/patient relationship

A comprehensive approach has been slow to come

The U.S. government has recently issued a comprehensive strategy to reduce abuse/diversion

More evidence is needed to guide interventions

Action Steps:A Critical Need for More Information

Action Steps:A Critical Need for More Information

Target multiple sources of diversion Are there non-medical diversion sources? Is diversion only/mostly the result of increased prescribing

for pain?

Quantify amounts diverted and motivations for use

Evaluate effectiveness of interventions attempted Improving prescribing and dispensing practices Improving monitoring and coordination Improving treatment of people who use non-medically Limit adverse impact on medical availability

Epidemiological understanding