1. Preventing Pharmaceutical Abuse:
Prescription Monitoring Programs
Robert Twillman, PhD
American Academy of Pain Management
The University of Kansas Medical Center

2. Pain is a major public health issue
 80% of patients present for health care
because of pain
 Chronic pain affects an estimated 116
mission American adults
 Chronic pain costs up to $635 billion per year
in medical treatment and lost productivity

3. How big is this issue?
Problem Number Affected Annual Cost
Chronic Pain 116 million $635 billion
Diabetes 17.5 million $174 billion
Cancer 11.7 million $264 billion
Heart disease,
27.1 million $197 billion
stroke, CHF
TOTAL 56.3 million $635 billion

4. Prescription Opioid Abuse is a
Public Health Issue
 2010 National Survey on Drug Use and
Health (NSDUH):
 34.8 million Americans (12.8%) had used a
pain reliever non-medically at least once in
their lifetimes (18% increase from 2002)
 12.2 million Americans (4.1%) had used a
pain reliever non-medically at least once in
the past year (number stable since 2002)

5. Prescription Opioid Abuse is a
Public Health Issue
 Among those initiating substance use in the past
year, pain relievers ranked behind only alcohol,
cigars, cigarettes, and marijuana as the drug of
choice
 1.9 million (0.6% of US population) had DSM-IV
diagnosable dependence or abuse of pain
relievers in the past year
 Based on a Montana study, estimated cost of
prescription drug abuse is $6.1 billion per year

6. NSDUH Data Are Unclear
 Definition of “nonmedical use” is problematic
 12.2 million in the past year admit nonmedical
use
 1.9 million qualify for a diagnosis
 This means 10.3 million are doing other things
 Recreational use
 Abuse without consequences
 Misuse to treat pain
 Does not mean we don’t have a problem

7. Prescription Opioid Abuse is
a Public Health Issue
 2009 Drug Abuse Warning Network data
(DAWN; ED visits) :
 342,628 for opioid analgesics (137% increase from
2004)
 2007 Treatment Episode Data Set (TEDS):
 Non-heroin opioids were primary drug of abuse for
90,516 patients entering substance abuse treatment
nationwide (456% increase from 1997)

8. Drug Treatment Admissions, Non-
Heroin Opioids as Primary Drug

9. Most-Abused Prescription Opioids:
2009 DAWN Data

10. Prescription Drug Misuse is
Dangerous
 More people now die from prescription
drug misuse than from use of heroin and
cocaine combined
 In 17 states, more people now die from
prescription drug misuse than from
automobile crashes

11. Recent Survey
 Teen-agers now say it is easier to get
prescription drugs than it is to get beer
National Center on Addiction and Substance Abuse, August 2008

12. Prescription Monitoring Programs
 Designed to track prescriptions for controlled
substances as an means of identifying patterns
indicative of abuse and diversion
 Initially set up in 1939 in California
 Prescription details are transmitted electronically
 Information can be obtained for patients by their
treating prescribers and dispensers
 Law enforcement, licensing boards also can
access information in most states

13. Prescription Monitoring Programs
 Many programs have been funded through
start-up and into implementation phases
by federal grants from the Bureau of
Justice Assistance, Department of Justice
 Some have found sustainable sources of
funding
 Others still need to address this issue

14. State PMP Status, 2003
Operating
No PMP Programs

15. State PMP Status
November 5, 2011
No Statute PMP Pending PMP Operating

16. States with Recent Bills
 Missouri: Bill passed House in 2011; will
need to be reintroduced in 2012
 New Hampshire: Bill sent to House floor
with recommendation for interim study
 Pennsylvania: Bill in House committee to
expand coverage to all CS schedules and
to allow access by providers

17. States Mandating Use of Advisory
Committees
Advisory
Committees

18. Housing Entities for PMPs
2 1 1 Board of Pharmacy/Health
1 Dept./Single State
Authority
Law Enforcement
6
Dept. of Public Safety
Professional Licensing
Dept. of Consumer
Protection
Office of Controlled
37 Substances

19. Assessing Outcomes of PMPs
 What are the expected outcomes from a
PMP?
 What do we need to know?
 What do we already know?
 How can we go about verifying the
outcomes?

20. PMP Outcome Domains
 The initial reason for PMPs was based in law
enforcement; they may have other uses
 Outcomes can fall into three general domains
 Improved pain management
 Misuse/abuse/addiction detection
 Diversion deterrence, detection, and prosecution
 We need to evaluate outcomes in each of
these three domains

21. PMP Outcome Domains:
Improved Pain Management
 Clinician review of PMP data may promote
improved pain management
 Increased prescriber comfort that patient is
not abusing/diverting
 Exposure of patterns of inadequate
prescribing
 More accurate review of data than relying on
patient self-report

22. PMP Outcome Domains:
Detection and Treatment of Addiction
 Clinician review of PMP data may lead to
detection of drug abuse/addiction
 Aberrant patterns of medication use may spur
in-depth assessment
 Such assessment may result in diagnosis of
substance abuse/addiction
 If so, referral to substance abuse treatment is
indicated

23. PMP Outcome Domains:
Preventing and Detecting Diversion
 Clinician review of PMP data may prevent
or uncover diversion activities
 Knowledge of data review may prevent
diversion activities (and/or shift source?)
 Aberrant patterns may spur in-depth
assessment, leading to detection of diversion
 Legal and ethical obligations of clinician?

24. So, What Do You Know?
Not much. You?

25. Normative Data: Katz et al. (2010)
 Analysis of 11 years’ data from Massachusetts
PMP
 This PMP covered only Schedule II medications
 Did not allow access to data by healthcare
providers
 Goal: Describe normative patterns of
prescription use by Massachusetts residents
during this time frame; define “questionable
activity”

26. Normative Data: Katz et al. (2010)
Trends in C-II Prescribing
 Number of prescriptions increased by 142% during
this time frame
 Doses dispensed increased by 292%
 Greatest increase was for short-acting oxycodone
 Number of estimated individual recipients increased
by 71%
 Approximately 11% of Massachusetts residents
received C-II prescriptions in 2006

27. Normative Data:
Prescribers & Dispensers (2006)
Prescribers Dispensers
Mean Number 1.36 + 0.93 1.13 + 0.52
Median Number 1 1
% Using 1 or 2 92.3% 97.5%
% Using 10 or More 0.1% 0.02%

28. Normative Data: Katz et al. (2010)
Early Refills
 Defined as two consecutive prescriptions for the
same individual/same drug, with the number of
days between prescriptions being > 10% lower
than number of days’ supply in first prescription
 Mean was 0.12 (+ 0.67); median was 0
 93.1% had NO early refills
 Fewer than 1% had more than three

29. Normative Data: Katz et al. (2010)
“Questionable Activity”
 Defined as use of > 3 prescribers AND > 3 pharmacies in 2006:
 1.6% of individuals (n = 8797)
 7.7% of prescriptions (n = 112,381)
 8.5% of dosage units (n = 7,622,840)
 Defined as use of > 4 prescribers AND > 4 pharmacies in 2006:
 0.5% of individuals (n = 2748)
 3.1% of prescriptions (n = 45,102)
 3.1% of dosage units (n = 2,805,613)
 Defined as use of > 5 prescribers AND > 5 pharmacies in 2006:
 0.2% of individuals (n = 1149)
 1.5% of prescriptions (n = 22,075)
 1.4% of dosage units (n = 1,247,666)
 For all criteria, numbers increased 1996 to 2002, then decreased to
2006

30. Examples from Early Queries
(KS)
 Top 5 utilizers of pharmacies (9 months):
 Wichita: 28 pharmacies/31 prescribers
 Stilwell: 21 pharmacies/23 prescribers
 Olathe: 20 pharmacies/26 prescribers
 Paola: 20 pharmacies/28 prescribers
 Olathe: 18 pharmacies/24 prescribers
 These 5 utilizers received 1842 days’ supply of
controlled substances, totaling 5833 dosage units

31. Examples from Early Queries
(KS)
 Top 5 utilizers of prescribers (9 months):
 Topeka: 45 prescribers/11 pharmacies
 After 12 months, 80 prescribers/61
pharmacies, 1788 days’ supply
 Overland Park: 37 prescribers/13 pharmacies
 Wichita: 31 prescribers/28 pharmacies
 Wichita: 30 prescribers/15 pharmacies
 Mission: 30 prescribers/16 pharmacies
 These 5 utilizers received 3197 days’ supply of
controlled substances, totaling 14,282 dosage units

32. PMPs and Overdose Death Rates
 Study in Pain Medicine (Paulozzi, Kilbourne, &
Desai, 2011)
 Examined opioid consumption in states from
1999-2005
 Studied effects of PMPs on rates of drug
overdose mortality, opioid overdose
mortality, and opioid consumption
 Also examined effects of some PMP
characteristics

33. PMPs and Overdose Death Rates:
Key Findings (PMP vs. no PMP)
 No significant differences in rates of drug or
opioid overdose mortality or opioid use
 No effect for proactive reporting
 More hydrocodone, less C-IIs consumed in PMP
states
 Rates of increase in OD mortality and opioid
consumption were lower in states requiring use
of special prescription forms

34. PMPs and Overdose Death Rates:
Explanations, Potential Confounds
 Increased C-III use may reflect substitution
effect due to some states not monitoring C-IIs
 No control for availability of data to clinicians
 No control for utilization of PMP in each state
 Decreases in consumption due to elimination of
“doctor shoppers” may be offset by increased
prescribing due to reassurance provided by
PMP report data
 Conclusion: “TBU”

35. What Should We Expect to Find
in Reviewing Reports?
 For each 100 PMP reports reviewed, how
many “cases” of SUD and “doctor
shopping” should we expect to find?
 Relatively no data on this, but it will
probably look like this:
 85% of reports will be completely “clean”
 14.5% of reports will cause concerns
 0.5% of reports will show “doctor shopping”

36. Research Needs
 Normative data
 Effects of PMPs on the three outcome
domains
 Specific qualities of PMPs that are most
conducive to achieving desired effects
 Cost/benefit analysis

37. What’s Next for PMPs?
 Interstate data sharing
 Hub run by National Association of Boards of
Pharmacy, called PMP InterConnect
 In first 60 days, processed 13,600 requests
 Average response time: 15.07 seconds

38. PMP Interconnect Status
November 5, 2011
PMPI PMPI Pending PMPI Operating
Considered

39. What’s Next for PMPs?
 Efforts to make checking the PMP
mandatory before controlled substances
are prescribed
 Increased recognition of need for
meaningful outcome data
 Shorter timelines for dispensers to report
 Inclusion of dispensing physicians

40. Future Efforts
 Increase evaluation of PMPs’ impacts
 Enhance awareness and utilization
 Improve resources for pain and substance
abuse assessment and treatment
 Enhance real-time capability
 Assess utility of Advisory Committees
 Evaluate cost effectiveness

41. Thank You!