Prescription Drug Monitoring Programs

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Prescription Drug Monitoring Programs

Montana State Fund

13th_{Annual Medical Conference}

November 1, 2013 Peter Kreiner, Ph.D.

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Primary non-heroin opiates/synthetics admission rates, by State (per 100,000 population aged 12 and over)

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Overview

• What are prescription drug monitoring programs

(PDMPs) and how can they help?

• A quick aside: Why is the evidence base for PDMPs so

limited?

• Selected best and promising practices of PDMPs

• Using identified PDMP data • Using de-identified PDMP data

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What Data Fields Does PDMP Data Contain?

• Patient first and last name, street address, town/city,

Zip Code, birth date, gender

• Prescriber and pharmacy DEA license #, street

address, town/city, Zip Code

• Prescription information: date prescribed, date filled,

drug name, drug NDC code, dosage, days supply, source of payment

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System

Overview

State PDMP Dispensers Prescribers Law Enforcement & Professional Licensing Agencies Pharmacists Data Submitted Reports Sent Reports Sent Reports Sent

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50 PDMPs 0 10 20 30 40 50 60 N um be r of P D M P s Years

Number of Prescription Drug Monitoring Programs (PDMPs): Authorizing Legislation Passed Between 1939 and 2012

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Why Is the Evidence Base So Limited?

• Nearly half of currently operational state PDMPs

become so since 2008 (21 out of 46 = 46%)

• 13 PDMPs (28%) became operational since 2011 Limited years for studying effects

• Great variation in characteristics across PDMPs Difficulty in separating out PDMP effects

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PDMP Characteristics

Location of PDMP in state government

No. of states

Health dept., board of pharmacy, single state authority 38 Law enforcement agency 6 Professional licensing board 2

Drugs that can be monitored

Only Schedule II drugs 1 Only Schedule II and III

drugs

2 Schedule II, III, and IV

drugs

45 Schedule II – V drugs 29

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PDMP Characteristics II

Access to law enforcement

For probable cause, search warrant, subpoena, other judicial process 17 Pursuant to active investigation 29 On request from law

enforcement 1

Access other than to law enforcement No. of states To prescribers and dispensers 45 To patient, parent, or guardian 35 To licensing or regulatory boards 44 To Medicare, Medicaid, or state insurance programs 29

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PDMP Characteristics III

Frequency of pharmacy submission

of data to PDMPs No. of states

Real-time data submission 1

Weekly data submission 22

Monthly data submission 6

No provision for electronic

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PDMP Characteristics IV

Interstate data

sharing No. of states

Share data with other

PDMPs 19

Share with users in

other states 8

Share with both other PDMPs and authorized users 15 Provide unsolicited reports No. of states No reports 7 To prescribers only 2 To law enforcement only 2 To prescribers and pharmacists only 5 To prescribers, pharmacists, law enforcement, and licensing entities 20

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Multiple provider episode rates* for CS II drugs, Quarter 4 of 2011 vs. Quarter 4 of 2012, Florida

0.0 4.7 6.9 1.9 0.0 1.8 2.6 0.8 0 1 2 3 4 5 6 7 8 <18 18-34 35-54 55+ R at e p er 100,000 re si d en ts Age Group Q4 2011 Q4 2012

*Having CSII rx from 5+ prescribers dispensed at 5+ pharmacies during one quarter.

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Florida’s PDMP Continued

• The PDMP became operational in September, 2011 • The law authorizing the PDMP was accompanied by

several other provisions:

• A requirement for pain clinics to register with the state • Increased penalties for operating a “pill mill”

• Drug overdose deaths associated with Schedule II

opioids declined in 2012 from 2011 • Oxycodone: 33%; Oxymorphone: 35%

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Selected PDMP Best Practices

• Unsolicited reporting to providers

• Interstate data sharing with other PDMPs • Weekly or more frequent data submission

• Use of PDMP data for surveillance and to support

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Notes from the Field : Wyoming PDMP

66 39 27 32 28 31 40 33 26 18 26 15 0 10 20 30 40 50 60 70 N umbe rs of hi s tor ie s Source: Wyoming PDMP

Unsolicited Prescription Histories per Month, 10/2008 – 9/2009 524 459 541 681 682 750 726 685 730 651 773 949 300 400 500 600 700 800 900 1000 N umbe rs of hi s tor ie s Source: Wyoming PDMP

Solicited Prescription Histories per Month, 10/2008 – 9/2009

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Why Unsolicited Reports Are Important

• MA PDMP survey – physicians receiving unsolicited reports:

• Only 8% of respondents were “aware of all or most of other

prescribers”

• Only 9% said “based on current knowledge, including PDMP

report, patient appears to have legitimate medical reason for prescriptions from multiple prescribers”

• Alert prescribers of persons receiving more than 100 mg morphine equivalents of opioids per day

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Massachusetts: Evaluation of Unsolicited Reporting

• MA initiated unsolicited reporting in 2010

• Schedule II only

• Unsolicited reports sent on a small fraction of patients who met

questionable activity threshold

• We constructed profiles of patients on whom reports were

sent and developed a comparison group (on whom reports not sent) based on propensity score matching

• Intervention and comparison groups matched on age, gender,

and # prescriptions, # prescribers, # pharmacies in the 12 months prior to sending of reports

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Massachusetts: Evaluation of unsolicited reporting

Preliminary results

Case Group (N = 84) Comparison Group (N = 84) Pre Post %

Change Pre Post

% Change Probability Total # of Schedule II Rx 48.3 24.0 50.3 49.1 30.0 38.9 .08 Average # of Prescribers 18.5 8.2 55.7 18.0 9.7 46.1 .19 Average # of Pharmacies 11.0 5.3 51.8 11.7 7.0 40.2 .02 Average Dosage Units 2,309 1,404 39.2 2,428 1,700 30.0 .32 Average days Supply 473 272 42.6 475 359 24.4 .02

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Interstate Data Sharing

• All PDMPs receive data on prescriptions written in

every other state and filled in their state

• 3 “hubs” currently enable provider access to patient

prescription history data from multiple state PDMPs

• Interstate sharing varies: Provider requests for data

from other states mostly focus on neighboring states

• More comprehensive data should lead to better

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Weekly or More Frequent Data Submission:

Physician Use of PDMP Data

• OH study of Emergency Department

• 41% of prescribers who received PMP report altered

prescribing for patients receiving multiple simultaneous narcotics prescriptions

• Of these providers, 63% prescribed no narcotics or fewer • 39% prescribed more

• For non-ED physicians, need for data frequency not as

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Use of PDMP Data for Surveillance

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2005 Opioid-related Health Problems Rate per 100,000 by Town

Rate per 100,000 Quintiles 0 0.01 - 19.82 19.82 - 37.5 37.5 - 56.92 56.92 - 225.51 Overdose

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2005 Prescriptions Associated with Questionable Activity (Rates per 100,000 Prescriptions) by Pharmacy Town

Questionable activity rates 0

1 - 1095 1096 - 1897 1898 - 2882 2883 - 14184

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Massachusetts Geospatial Analysis

• Do rates of questionable activity predict subsequent

changes in rates of opioid overdoses at the community level?

• Controlling for community socio-demographic variables

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Spatial regression: questionable activity rate as a predictor of subsequent change in opioid overdose rate

(Data from Massachusetts PDMP in partnership with Brandeis University)

Variable Coefficient Probability

Constant -.543 .185

Opioid OD rate 2001-03 average .519 <.001

Population density 2000 .143 <.001

Poverty rate 2000 .096 .025

Ethnic heterogeneity 2000 -.066 .145

Population mobility 2000 .034 .334

Percent > 65 .078 .019

Questionable activity rate 2001-03 average .226 <.001

Nonprofit intensity -.030 <.001

Spatial lag (Opioid OD rate 2004-06 average) .191 .025

Lambda (spatial association error term) .034 .833

Dependent variable: Opioid OD rate 2004-06 average Pseudo R-squared: .699

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Implications

• Highlights importance of PDMP-based measures for

surveillance

• Questionable activity measure predicts subsequent

increases in rates of overdoses

• Timeliness of PDMP data compared to health outcome

data

• Importance of PDMP-based measures for prevention

• Identify areas at high risk for increase in opioid overdoses • Identify clusters of communities at high risk: targeting

cluster for intervention may be more effective

• Identify low-risk “islands” amidst high-risk communities:

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Other Surveillance Applications

• Examine prescribing rates in different states/regions

and over time

• Broken out by age groups and gender

• Examine (trends in) measures of risky patient and

provider behavior

• Examine geographic variation and factors associated

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Opioid prescription rates by age group,

Florida and Maine, 2012

0 200 400 600 800 1,000 1,200 1,400 <18 18-24 25-34 35-44 45-54 55-64 65+ R at e p er 1 ,0 0 0 r esiden ts Age Group Florida Maine

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Daily opioid dosage in MME and high dosage by quarter, Florida, 2011-2012 0 20 40 60 80 100 120 Q1 11 Q2 11 Q3 11 Q4 11 Q1 12 Q2 12 Q3 12 Q4 12 P er cen t a nd M M E/ da y Quarter/Year MME/day % > 100 MME/day

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Percent of prescriptions accounted for by prescriber decile by CS type, Florida, 2012

0 10 20 30 40 50 60 70 80 1-4 5 6 7 8 9 10 P er cen t Prescriber Deciles Opioid Benzodiazepine Stimulant

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Mean daily opioid dosage by prescriber decile by quarter, Florida, Q4 2011 to Q4 2012 0 20 40 60 80 100 120 Q4 2011 Q1 2012 Q2 2012 Q3 2012 Q4 2012 M ea n da ily dosa g e ( M M E) Calendar Quarter Top Fifth Tenth TOTAL -13.4%

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Percent of a prescriber’s patients seeing multiple providers by distance deciles,

Florida, 2012 0 20 40 60 80 100 120 140 160 180 0.0 0.2 0.4 0.6 0.8 1.0 1 2 3 4 5 6 7 8 9 10 M ea n m iles t o p resc rib er P er cen t

Prescriber Distance Deciles

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Prescribers are divided into deciles according to the mean distance between them and their patients for all CS prescriptions. Multiple providers means 5+ prescribers and 5+ pharmacies in 3 months. Includes out of state residents.

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New and Promising Practices

• Collect ID of person picking up prescription

• Mandatory provider registration with and use of

PDMP

• Batch data sharing with 3rd party payers (Medicare,

Medicaid, public Workers Comp)

• Interoperability of PDMP data with health

information exchanges, electronic health record systems, pharmacy dispensing software

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Collect ID of Person Picking Up Prescription

• Require pharmacies:

• To do photo ID check before dispensing a controlled substance Rx

to verify who has the drug

• To submit ID information on who picks-up each prescription -- so

PDMP knows who actually has the drug

• MA PDMP has mandated such reporting and positive

ID for Schedule II prescriptions since 1/2/2009

• MA found 38% of the persons who dropped off or picked up the

prescriptions are not the patient

• As of 1/1/2011, MA requires reporting and positive ID for all

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Mandatory Provider Registration and Use

• Recently begun in Kentucky (July, 2012)

• Provider must check PDMP at:

• First C-II or C-III hydrocodone prescription or change in drug • Continued prescribing of these Rx at three months

• Average weekday requests to KASPER:

Before mandate -- 2,900 After mandate -- 19,000

• Legislation passed in three other states (MA, NY, TN),

in process of being implemented

• No evidence as yet of effects on patient care and

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Batch Data Sharing with 3

rd

_{Party Payers}

• Most PDMPs allow Medicare, Medicaid, and/or state

insurance programs to access PDMP data on individual patients

• WA PDMP – first example of batch data sharing, with

Medicaid agency and state Workers’ Comp agency • > 2,000 Medicaid patients were found to have obtained

prescriptions using both Medicaid and cash on the same day in 2012

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Interoperability of PDMPs with HIEs, EHRs, Pharmacy

Dispensing Software

• The Substance Abuse and Mental Health Services

Administration (SAMHSA) has recently awarded

grants to 9 state PDMPs to improve interoperability: • Integrate PDMP data into EHRs (e.g., for hospital ED) and

in pharmacy dispensing software

• Many of these projects build on earlier pilot studies

conducted by MITRE

• Cross-site evaluation by the Centers for Disease

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Evaluate Prescriber Education Initiatives

• Many efforts underway nationwide to influence

prescriber behavior

• The FDA has engaged PDMP Center of Excellence to

inventory these efforts and summarize the evidence base

• PDMP data can be used to evaluate whether desired

changes in prescriber behavior have occurred

• Population-based evaluation only is possible, since PDMP

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PDMP Center of Excellence White Paper on PDMP Best and Promising Practices

Available at:

http://www.pewhealth.org/uploadedFiles/PHG/Content_Level_Pages/R eports/PDMP_Full%20and%20Final.pdf

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Prescription Drug Monitoring Programs