What you need to know about
Prescription Drug Monitoring
Programs
Jennifer Fan, PharmD, JD
Jinhee Lee, PharmD
Division of Workplace Programs
Division of Pharmacologic Therapies
Center for Substance Abuse Prevention Center for Substance Abuse Treatment
2012 USPHS Scientific and Training
Symposium
Disclosure Statement
• The presenters for this session, Jennifer Fan
and Jinhee Lee, have disclosed no relevant,
real or apparent personal or professional
financial relationships.
Outline
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PDMPs: The Context
PDMPs: Description and Update
Current System: Advantages and Limitations
PDMPs and Patient Confidentiality: 42 CFR
Part2
• Integrating PDMPs into practice
1. PDMPS: THE CONTEXT
The Problem
• The CDC* has declared that the U.S. is in the midst of an epidemic
of prescription painkiller overdose deaths. Deaths from these drugs
now outnumber deaths from heroin and cocaine combined.
*Centers for Disease Control and Prevention
Past Month Illicit Drug Use among Persons
Aged 12 or Older: 2010
Source: 2010 NSDUH
1 Illicit Drugs include marijuana/hashish, cocaine (including crack), heroin, hallucinogens,
inhalants, or prescription-type psychotherapeutics used nonmedically.
Challenges
• In 2010, an estimated 22.1 million persons– 8.7% of the U.S.
population aged 12 or older -- were classified with substance abuse
or dependence.
– 2.2 million reported past year dependence or abuse of
psychotherapeutics (non-medical use) – 1.9 million of them for
pain relievers
• 20.4% persons reported non-medical use of psychotherapeutics at
sometime during their lifetime – 13.7% reporting non-medical use
of pain relievers, and
• 2 million people (12 or older) initiated illicit use of pain relievers
during 2010, second only to those who initiated marijuana use (2.4
million)
Source: 2010 NSDUH
Low Perception of Risk
• Prescription drugs obtained from a medicine
cabinet or pharmacy are perceived to be less
addictive and not as dangerous as illegal drugs
obtained from a drug dealer.
• Teens’ perception of the risks associated with
abusing prescription drugs is relatively low.
• Low perception of risk, coupled with easy
availability, is a recipe for an ongoing problem.
Source Where Pain Relievers Were Obtained for Most
Recent Nonmedical Use among Past Year Users
Aged 12 or Older: 2010
Source Where Respondent Obtained
More than One Doctor
(2.1%)
One Doctor
(17.3%)
Other1 (4.6%)
Bought on
Internet
(0.4%)
Drug Dealer/
Stranger (4.4%)
Bought/Took from
Friend/Relative
(16.2%)
Source: NSDUH 2010
1The
Source Where Friend/Relative Obtained
Free from
Friend/
Relative
(55.0%)
More than
One Doctor
(3.6%)
One Doctor
(79.4%)
Free from
Friend/Relative
(6.3%)
Bought/Took from
Friend/Relative
(6.5%)
Drug Dealer/
Stranger (2.3%)
Bought on Internet
(0.2%)
Other1 (1.7%)
Other category includes the sources "Wrote Fake Prescription," "Stole from Doctor’s Office/Clinic/Hospital/Pharmacy," and "Some Other Way."
10
Federal Strategy to Address the Problem of
Prescription Drug Abuse
• Prescription Drug Abuse Prevention Plan
released by the White House in April 2011
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Educate patients and healthcare providers
Increase use of PDMPs
Implement and promote use of Rx drug disposal programs
Support law enforcement efforts against illegal prescribing
• 2011,2012 National Drug Control Strategy
SAMHSA’s Strategic Initiatives
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•
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•
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Prevention of Substance Abuse & Mental Illness
Trauma and Justice
Military Families
Recovery Support
Health Reform
Health Information Technology
Data, Outcomes, and Quality
Public Awareness and Support
2. PDMPS: DESCRIPTION AND
UPDATE
What is a PDMP?
• Description
– Collect, manage, analyze, and provide prescription
data under the auspices of a state, territory,
district, or commonwealth
• Purpose
– Tool for curtailing drug abuse and diversion while
ensuring controlled substance access to patients
with legitimate medical need
Courtesy of Dave Hopkins , Alliance of States of Prescription Monitoring Programs
PDMP Goals
• Ensure access to controlled substances for legitimate
medical purposes
• Provide education and information regarding drug
abuse and diversion issues
• Support public health initiatives
• Identify potential misuse and abuse to support early
intervention and treatment
• Enable more efficient investigation and enforcement
Courtesy of Dave Hopkins , Alliance of States of Prescription Monitoring Programs
PDMP History
• First PDMPs
– 1939 – 1943 – California, Hawaii
– 1972 – 1990 – New York, Washington, Texas,
Illinois, Michigan, Rhode Island, Indiana
• Duplicate/Triplicate Prescription Forms
• 1991 – Oklahoma first electronic program
Federal Programs
• Harold Rogers Prescription Drug Monitoring
Program (Department of Justice)
• National All Schedules Prescription
Electronic Reporting Program (NASPER)
(Substance Abuse and Mental Health
Administration)
• The Enhancing Access to PDMP project
sponsored by ONC and funded by SAMHSA
The Story So Far
Federal & State Partners
Action Plan
State Participants
Stakeholders
White House
Roundtable on
Health IT
& Prescription
Drug Abuse
June 3, 2011
Organizations
Enhancing Access to Prescription Drug
Monitoring Programs
• Use health IT to increase timely access to
PDMP data in an effort to reduce prescription
drug misuses and overdoses.
– Develop the standards and policies necessary to
connect existing health information technologies
to increase timely use of PDMP data by providers,
emergency department providers, and
pharmacists.
Research is current as of May 30, 2012. http://www.namsdl.org/documents/PMPProgramStatus05302012.pdf
What Agency Administers the PDMP in
each State?
• Type of state agencies that administer the
PDMP:
– Consumer Protection – 1
– Substance Abuse – 2
– Law Enforcement – 7
– Professional Licensing – 5
– Departments of Health – 16
– Boards of Pharmacy – 18
Source: Dave Hopkins, Alliance of States of Prescription Monitoring Programs
Drug Schedules Monitored
Schedules Collected
States
Number
Schedule II
PA
1
Schedules II-III
RI, WI
2
Schedules II-IV
AZ, CA, FL, IA, KS, ME, MN, NV, NJ, NM, OR, SC, SD, VT, VA,
WV, WY
17
Schedules II-V
AK, AL, AR, CO, CT, DE, GA, Guam, HI, ID, IL, IN, KY, LA, MA,
MI, MS, NY, NC, ND, MD, MT, OH, OK, TN, TX, UT, WA
28
To be determined
NE
1
Source: Alliance of States of Prescription Monitoring Programs, www.pmpalliance.org
PDMP Data Collection Frequency
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Daily – 3 States
Weekly – 20 States
Bi-Weekly – 11 States
Monthly – 5 States
Source: Alliance of States of Prescription Monitoring Programs, www.pmpalliance.org
Prescription Information Collected
•
•
•
•
Patient Information
– Name, address, date of birth, gender, method of payment
Prescriber Information
– DEA registration number
– Date Rx issued
Dispenser Information
– DEA registration number
– Date Rx dispensed
Drug Information
– National Drug Code (drug name, type, strength, manufacturer)
– Quantity
– Days supply
– New or refill
Source: Dave Hopkins, Alliance of States of Prescription Monitoring Programs
Types of PDMP Reports
• Typical PDMP reports include:
– Patient
– Prescriber
– Pharmacy
• Solicited – all PDMPs (except PA)
• Unsolicited – not all states
• States may also run specialized reports (e.g., by drug
or region)
Source: Dave Hopkins, Alliance of States of Prescription Monitoring Programs
Who is authorized to Request Patient
Rx Data?
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•
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•
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Prescribers
Pharmacists
Pharmacies
Law Enforcement
Licensing Boards
Patients
Others
Source: Dave Hopkins, Alliance of States of Prescription Monitoring Programs, www.pmpalliance.org
3. CURRENT SYSTEM:
ADVANTAGES & LIMITATIONS
Advantages
• Inappropriate use of Rx drugs can lead to:
o Treatment failure
o Drug-drug interactions
o OD and death
• PDMP = invaluable tool:
o Patient monitoring
o Treatment planning
o Risk management
Issue
• PDMPs collect a considerable amount of
useful information but utilization of these
programs in unacceptably low
Limitations
• Some states do not have PDMPs yet, though
most do (49 states with legislation, 42
operational)
• Lack of interoperable PDMPs to enable crossState checks
• PDMPs are only one part of the effort to
reduce prescription drug abuse
Limitations (cont)
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•
•
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Time lag between Rx and reporting
“Extra” burden on provider
Potential errors (FP/FN)
Providers are only able to view some of their patient’s
Rx data
• Policy and technical standards – vary from state to state
• Some states do not allow for unsolicited reporting (e.g.
real-time push to prescribers via Direct messaging)
4. PDMPS AND
PATIENT CONFIDENTIALITY:
42 CFR PART2
Confidentiality: 42 CFR Part 2
• 42 CFR Part 2 enacted by Congress
• To protect confidentiality of patients receiving
treatment for alcohol/substance use disorders
by federally-assisted programs*
• Because stigma associated with substance
abuse and fear of prosecution deter people to
enter treatment
Confidentiality (cont)
• Disclosure of patient-identifying information is
permitted with written patient consent
• BUT redisclosure of such information is
prohibited
PDMPs and 42 CFR Part 2
• Accessing patient information from PDMP
disclosure of patient information
• Patient consent is NOT required to access
PDMP
• Notifying patient that PDMP will be checked
is, however, encouraged
PDMPs and 42 CFR Part 2 (cont)
• PDMPs disclose patient information to
authorized providers
• PDMPs do not fall under 42 CFR, part 2
• THUS, if information is entered in PDMPs, it
could be redisclosed
• If under 42 CFR, Part 2: Do NOT disclose
patient information to PDMPs
PDMPs and 42 CFR, Part 2 (cont)
• Once Rx is issued and either sent through
electronic means or given to patient, no
longer protected by 42 CFR, part 2
• Rx information (buprenorphine) will be
entered in PDMP by pharmacists
• Consider clarifying this with patient
5. INTEGRATING PDMPS INTO
PRACTICE
Integrating PDMPs into practice
• Illicit use of prescription drugs (i.e., opioids,
stimulants, and sedatives) has reached
epidemic level
• Drug-drug interactions and increased risk of
overdose in patients abusing rx drugs
• Self-report and U. Toxicology might not tell the
whole story, in particular with Rx drugs
Case study (March 2011)
• Setting: Large outpatient OTP
• Data: PDMP report on all patients
• Results: ~ 23% of patients, unknown to clinical
staff, were Rx significant quantities of opioids,
benzodiazepines, and other controlled
substances by providers outside the clinic
Case study-March 2011 (cont)
• Patients were advised that successful treatment
and their own treatment required they d/c
seeking unauthorized or duplicate Rx
• Most patients complied and were retained in
treatment , subject to ongoing monitoring of
State’s PDMP
• “I consider the database as one of the best tools I
have to help identify and treat opioid addiction”
Barriers
• Time lag: “I have called these pharmacies to
explain why it is important to me they participate
in the PDMP “
• Technology: “I ‘m not particularly computer savvy,
but it didn’t take long to become proficient in
checking the database “
• Time: “ I can check a patient in about 20 seconds,
though much more time is required if I find any
prescriptions”
Rx drug abuse: Epidemic & Risks
overlooked
“Since most patients (…) in our State are
addicted to Rx opioids (…) goldmine of
information. Many (…) got at least part of
their opioids by RX from doctors and were
often Rx other (…) often did not seem to
realize how addictive and dangerous Rx drugs
can be (…)”
Rx drug abuse: Epidemic & Risks
overlooked (cont)
“Methadone, oxcycontin, fentanyl, or relatively
large amount of benzodiazepines (…) mostly
alprazolam, diazepam, or clonazepam . Some
patients … taking these Rx, and found
methods to avoid detection on observed urine
screens (…) some (…) giving (…) selling them.
None of their community-based doctors knew
(…) No one at our treatment center knew (…)
prior to … PMP.”
Intervention
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•
•
•
Sign up for your State PDMP
Get familiar with system and limitations
Check PDMP on all new and current patients
Tailor PDMP monitoring based on patient’s
risk profile (as you do with U. Tox)
• Inform patients through general notice,
individual notice, patient agreement
Intervention (cont)
• Confront patient if get unexpected report
• Explore if for own use and/or diversion
• Question if patient gets Rx drugs from other
sources (out-of-state, friends or family, dealer)
• Discuss risks associated with use/diversion
• Obtain consent to talk with prescribing
doctors
Intervention (cont)
• Establish clear practice guidelines in case of
unexpected report:
 Patient agrees to sign consent and subsequent checks are negative
 Patient denies to sign consent but subsequent checks are negative
 Patient misuses drugs and continues to have positive checks
 Patient diverts Rx and continues to have positive checks
 Patient states report is inaccurate
Intervention (cont)
“As long as the patient agreed to stop getting
other opioids, they could stay in treatment
with us, and the patient was better off. Many
such patients later said they were glad this
had happened. They said it burned the bridge
of access to drugs they often misused.”
Intervention (cont)
• Safety should always be #1 driver in treatment
• Keep countertransferance in balance and
treatment goal in perspective
“Thirty or forty patients on take home level
five or six were found to be furtively obtaining
methadone or Oxycontin or fentanyl, and I felt
their deception was greater.” (Case study OTP
Medical Director)
Individual and PH outcomes
• Improved treatment outcomes
• Reduced risk of overdose and death
• Reduced diversion and risk of Rx drug abuse
(over 70% of Rx drugs abused are obtained
from family/friends)
Supporting evidence
• National comparison b/w states with vs. without PDMPs
between 1993-2003 showed :
 Slower growth in per capita availability of scheduled II
pain relievers and stimulants in states with PDMPs
PDMPs reduces probability of abuse of those drugs
(lower rates of treatment admissions than
anticipated)
Difference more pronounced for proactive
(unsolicited reports) vs. reactive PDMP systems
Simeone & Holland, 2006 (http://www.simeoneassociates.com/simeone3.pdf)
Supporting evidence (cont)
• National analysis of poison center data of states with
vs. without PDMPs, 2003-2009, found
 12% vs. 4.5% decrease in calls related to
intentional exposure to long acting opioids
4.1% decrease vs. 4.1% increase in calls related to
intentional exposures to immediate release
opioids
Reifler, 2010 (http://rmpdc.org/Portals/23/Poster%20PC%20rates%20for%20PMP-LAOs%2015SEP10.pdf )
• PDMPs impact prescribers practices:
Study conducted in ED in OH in summer of 2008:
- 18 providers, 179 patients with painful conditions (not
acute injuries)
- Median Rx for pain relievers in last 12 mos was 7 (0-128)
- Providers altered Rx based on PDMPs report for 41% (74)
of cases
- 61% (45) were Rx no or fewer narcotics and 39% (29)
more than originally planned
Baehren et al., Ann Emerg Med, 2010
Supporting evidence (cont)
• 2010 KASPER (KT PDMP) Satisfaction Survey:
Question: “To what extent do you feel KASPER is an
effective tool to keep track of an individual’s scheduled
prescription drug history?”
Response: 96.4% responded “very effective” or
“somewhat effective”, 1% “neutral”, and 0.7%
“somewhat ineffective”; none “very ineffective”
http://chfs.ky.gov/NR/rdonlyres/BDC0DFC9-924B-4F11-A10A5EB17933FDDB/0/2010KASPERSatisfactionSurveyExecutiveSummary.pdf
For more…
• PDMPs:




Alliance of States with PMPs: http://www.pmpalliance.org/
PMP Center of Excellence: http://pmpexcellence.org/
National Alliance for Model State Drug Laws: http://www.namsdl.org/home.htm
Dear Colleague letter:
http://www.dpt.samhsa.gov/pdf/pmp_otp_2011_letter.pdf
• 42 CFR Part 2:
 FAQs 2010 - HIT: http://www.samhsa.gov/healthPrivacy/docs/EHR-FAQs.pdf
 FAQs 2011 – FAQs revised:
http://www.samhsa.gov/about/laws/SAMHSA_42CFRPART2FAQII_Revised.pdf
Contact Information
• Jennifer Fan –
jennifer.fan@samhsa.hhs.gov
• Jinhee Lee –
jinhee.lee@samhsa.hhs.gov
Questions?