Preventing Pharmaceutical Abuse: Prescription Monitoring Programs
Robert Twillman, PhDAmerican Academy of Pain Management
The University of Kansas Medical Center
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
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, stroke, CHF 27.1 million $197 billion
TOTAL 56.3 million $635 billion
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)
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
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
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)
Drug Treatment Admissions, Non-Heroin Opioids as Primary Drug
Most-Abused Prescription Opioids: 2009 DAWN Data
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
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
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
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
State PMP Status, 2003
Operating ProgramsNo PMP
State PMP StatusNovember 5, 2011
PMP Pending PMP OperatingNo Statute
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
States Mandating Use of Advisory Committees
Advisory Committees
Housing Entities for PMPs
37
6
12 1 1
Board of Pharmacy/Health Dept./Single State Author-ity
Law Enforcement
Dept. of Public Safety
Professional Licensing
Dept. of Consumer Protec-tion
Office of Controlled Substances
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?
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
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
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
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?
So, What Do You Know?
Not much. You?
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”
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
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%
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
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
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
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
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
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
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”
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”
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
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
PMP Interconnect StatusNovember 5, 2011
PMPI Pending PMPI OperatingPMPI Considered
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
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
Thank You!