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!