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Curbing Diversion of

Prescription Opioids
Nathaniel Katz, MD, MS
Tufts University School of Medicine
Analgesic Research
Opioid Prescribing to Adolescents in Dental Settings
National Institute of Drug Abuse
February 23, 2009

Outline
1. Define and characterize diversion
2. Present what is known about sources
of diverted prescription opioids
3. Speculate about role of dentists
4. Describe potential solutions

1
Define and Characterize
Diversion

Definition of Diversion
The transfer of a controlled substance from a lawful
to an unlawful channel of distribution or use.
Section 309, Diversion Prevention and Control
Uniform Controlled Substances Act
National Conference of Commissioners on
Uniform State Laws, 1994

means manufacture, possession,delivery or use of a


controlled substance by a person or in a manner not
specifically authorized by law.
Section 3302.(12) of the New York State Public Health Law

Diversion Examples
Diversion
Sharing
Selling, buying
Stealing
Prescription forgery
Doctor shopping
Illegal internet Rx
Criminal prescribing

Not Diversion
Using your own
legitimately
prescribed
medication to get
high
(~20% of NMU)

2
What is Known About Sources of
Diverted Prescription Opioids

Source of Pain Relievers by Past Year


Users Aged 12: 2006
Totals may not =100% because of rounding or
because suppressed estimates not shown
Other includes: Wrote fake prescription,
Stole from doctors office/clinic/hospital/pharmacy,
& Some other way.

68% from docs

Percentage

5 Most Common Sources of Misused


Prescription Opioids: By Population

*For free & bought;

Own prescription, 1 doctor, & >1 doctor

Stolen, stole from friend/family, theft, & forged prescription

Sources of Diverted Dosage Units


Distribution System

Primary Diversion

Manufacturers

Theft from Manufacturers

Distributors

Theft from Distributors

706,558

Pharmacies

Theft from Pharmacies

2,633,098

Hospitals/Clinics

Theft from Hospitals/Clinics

Internet

Illegal Internet

Practitioners

Internatl Smuggling

Nursing Homes

Forgery

Hospices

Script Doc/Pill Mill

Patients

Doctor Shopping
Patient Sells/Gives

TOTAL

2007 Total Doses


3,251,539

Tens of millions?

Tens of millions?
175,000,000?
?

1,000,000,000?

Criminal Prescribing: 1 case


The board investigator
presented evidence that Brown
was the single leading
prescriber of OxyContin in the
entire state, with his
prescriptions accounting for
288,859 of the 922,985
OxyContin tablets sold through
pharmacies in 2004.
For a 30-month period, Brown
was the state's second largest
prescriber of OxyContin

Estimated percentage

Schedule II Opioid Rx Dispensed to


Individuals Showing Questionable Activity*
6
5
4

63,000
scripts

3
2
1
0

96

97

98

99

00

01

02

03

3.5 million
doses
04

05

Fiscal yr
*Questionable activity = obtained Schedule II opioid prescriptions from
4 pharmacies & 4 physicians during the specified yr

Quantifying Diversion:
Research Agenda
Clean up NSDUH data:

Break down non-medical use data


How many dosage units ingested
How many dosage units acquired through different sources*
Update drug picture cards

Clean up DEA Form 106 Database


Compile Internet diversion data
Compile criminal prescribing data; validate algorithms
for identifying criminal prescribing
Compile doctor shopping data; validate algorithms for
identifying inappropriate doctor shopping

3
Speculate About the Role of
Dentists in Prescription Opioid
Diversion

Top Specialties Prescribing


Immediate-Release Opioids, 1998 vs. 2002
(WITH Hydrocodone & Oxycodone Combination Products)

199
8
MD Specialty

%
Prescriptions

200
2
MD Specialty

%
Prescription
s

DENTISTRY

15.5%

FAMILY PRACTICE

13.0%

FAMILY PRACTICE

14.6%

ORTHOPEDIC SURGERY

11.5%

DENTISTRY

12.2%

INTERNAL MEDICINE

11.1%

INTERNAL MEDICINE

12.2%
10.2%

OSTEOPATHIC MEDICINE

6.7%

ORTHOPEDIC SURGERY

EMERGENCY MEDICINE

5.5%

OSTEOPATHIC MEDICINE

7.8%

GENERAL SURGERY

4.2%

EMERGENCY MEDICINE

6.1%

OBSTETRICS/GYNECOLOGY

3.5%

GENERAL SURGERY

3.6%

OBSTETRICS/GYNECOLO
GY

3.2%

ALL OTHERS

28.9%

ALL OTHERS

30.2%

Dentists likely prescribe about a billion doses per year of opioids, mostly
immediate-release combination products
14
Source: IMS Health, National Prescription Audit PlusTM, Year 1998 to 2002, Excluding Long-Term Care & Mail Order

Speculations About Role of Dentists


in Prescription Opioid Diversion
Dentists prescribe large volumes of drugs most commonly
abused by adolescents and others
The extent to which opioids are prescribed in greater
quantities than necessary is unknown but probably
considerable
Anecdotal evidence suggests that adolescents use opioids
non-medically that they or family members obtain from
dentists
Dentists rarely screen for opioid abuse risk factors or doctor
shopping, monitor pts, educate them on risks of controlled
substances or med storage/disposal, etc.
It is not clear how well dentists understand the basic
pharmacotherapy of pain and the appropriate role of opioids

4
Potential Solutions

FDA, Opioids, and REMS


FDAAA September 2007
RISK EVALUATION AND MITIGATION STRATEGIES
(REMS) REQUIREMENTS
Title IX, Subtitle A, Section 901 of the Food and Drug
Administration Amendments Act of 2007 (FDAAA)
amends the Federal Food, Drug, and Cosmetic Act
(FDCA) to authorize FDA to require the submission of a
REMS for an approved drug if FDA becomes aware of
new safety information and determines that such a
strategy is necessary to ensure that the benefits of the
drug outweigh the risks (section 505-1(a)). This
provision took effect on March 25, 2008.

Switch-Based Retail Solution


FDA
Prescriber

Web-based
training

REMS
registry

Explains
Med Guide

Patient

Patient
trainingenrollment

Data

Client

Switch
company(ies)
Enrollment
verified

Prescription filled

Prescription brought

Retail
Pharmacy

Closed
Distribution

Solutions
Problem

General Approach

Dentists

Poor pt selection,
monitoring,
treatment

REMS-based mandatory
training
(Not education)

Guidelines
Mandatory training
Research

Poor monitoring

Urine drug monitoring

Urine drug monitoring

Sharing/selling

Universal pt
education/training
Natl awareness campaign
Lockboxes

Training dental pts


Lockboxes
Natl awareness
campaign

Forgery

Tamper-proof scripts

Tamper-proof scripts

Doctor shopping

Prescription monitoring

Prescription monitoring

Theft

Rational disposal

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