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Transcript Project Kickoff Meeting Template

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 doctor’s office/clinic/hospital/pharmacy,”
& “Some other way.
68% from docs
5 Most Common Sources of Misused
Prescription Opioids: By Population
NSDUH: gen. population
18-25
NSDUH dependent 1825
Methadone maint.
AATOD
Subst. abuse treatment
NAVIPPRO
Subst. abuse treatment
RADARS 21-30
90
Percentage
80
70
60
50
40
30
20
10
0
Friend/
relative*
Rx from MD†
Dealer
Stolen/forged
Rx‡
*For free & bought;
†Own prescription, 1 doctor, & >1 doctor
‡Stolen, stole from friend/family, theft, & forged prescription
Internet
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
Internat’l 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)
2002
1998
MD Specialty
% Prescriptions
MD Specialty
% Prescriptions
DENTISTRY
15.5%
FAMILY PRACTICE
14.6%
FAMILY PRACTICE
13.0%
DENTISTRY
12.2%
ORTHOPEDIC SURGERY
11.5%
INTERNAL MEDICINE
12.2%
INTERNAL MEDICINE
11.1%
ORTHOPEDIC SURGERY
10.2%
OSTEOPATHIC MEDICINE
6.7%
OSTEOPATHIC MEDICINE
7.8%
EMERGENCY MEDICINE
5.5%
EMERGENCY MEDICINE
6.1%
GENERAL SURGERY
4.2%
GENERAL SURGERY
3.6%
OBSTETRICS/GYNECOLOGY
3.5%
OBSTETRICS/GYNECOLOGY
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 Channels, Data Extracted August 2003.
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
Nat’l awareness campaign
Lockboxes
Training dental pts
Lockboxes
Nat’l awareness
campaign
Forgery
Tamper-proof scripts
Tamper-proof scripts
Doctor shopping
Prescription monitoring
Prescription monitoring
Theft
Rational disposal