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3/31/2017
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Maryland Prescription Drug MonitoringProgram (PDMP)
Kate Jackson, MPHPDMP Manager
Department of Health and Mental Hygiene
MD-ASCP Spring SpectacularApril 8, 2017
• National and Maryland Landscape
• PDMP Data Collection, Access, Legal Provisions
• Clinical PDMP Registration and Use
• Program Activities and Enhancements
Agenda
National and MarylandLandscape
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National Opioid Addiction and Overdose Epidemic
Number of opioid-analgesic poisoning deaths,by involvement of benzodiazepines: United States, 1999-2011
In 2011,benzodiazepineswere involved in31% of opioid-analgesicpoisoning deaths,up from 13% ofsuch deaths in1999.
Chen LH, Hedegaard H, Warner M. Drug-poisoning deaths involving opioid analgesics: United States, 1999–2011. NCHS data brief, no166. Hyattsville, MD: National Center for Health Statistics. 2014.
Unintentional Intoxication Deaths Occurring in Maryland fromJanuary-June of Each Year.*
*2016 counts are preliminary.
Source: Maryland Vital Statistics Administration
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Prescription Drug Use in Maryland
Source: Maryland PDMP, January 20, 2017
Note: See 2016 Annual Report for additional prescription statistics
Prescription Drug MonitoringProgram (PDMP)
• National overdose epidemic driven largely by Rxopioid misuse and availability of opioids
• Recent increases in heroin use & overdoseaccompanying elevated prevalence of Rx opioidmisuse in Maryland
• PDMPs are important tool for preventing, identifyingand intervening with opioid addiction and diversion
PDMP’s Role in Addressing Opioid Misuse and Diversion
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Source: National Association for Model State Drug Laws (NAMSDL), May 2016
• Secure, state-wide, electronic database
• Contains dispensing of Schedule II-V pharmaceuticalcontrolled dangerous substances (CDS)
• Rx data can be disclosed for clinical, investigative andresearch/public education purposes as allowed by law
• Administered by Department of Health and MentalHygiene, Behavioral Health Administration, Office ofOverdose Prevention
What is the Maryland PDMP?
• Assist medical, pharmacy and public health professionals inthe identification and prevention of prescription drug abuse
• Assist law enforcement and regulatory agencies in theidentification and investigation of illegal prescription drugdiversion
• Promote a balanced use of prescription data that preservesthe professional practice of healthcare providers andlegitimate patient access to optimal pharmaceutical-assistedcare.
PDMP Goals
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• Give healthcare providers real-time access at thepoint-of-care to patient CDS Rx history to:
PDMP as a Clinical Tool
• Improve patient-provider communication tooptimize patient care
• Initiate referral to appropriate assessment,treatment & recovery services
• Initiate referral to specialty care, like painmanagement
• Increase confidence in prescribing/dispensingdecisions
• Identify aberrant drug use (i.e. “doctor/pharmacyshopping”) indicating possible misuse ordiversion
• Ohio ED Study1:
– 41% who reviewed PDMP data altered prescribing for patientsreceiving multiple simultaneous narcotics prescriptions.
– Of these, 61% prescribed no narcotics or fewer narcotics thanoriginally planned, while 39% prescribed more.
• Prescriber survey in RI / CT2:
– PDMP users more likely than non-users to take clinicallyappropriate action in response to suspected cases ofprescription drug abuse or diversion
– Actions included, but not limited to, conducting drug screens orreferring patients for substance use disorder treatment /recovery services
PDMP in Clinical Practice
1 Baehren, D. et al., A statewide prescriptionmonitoring program affects emergency department prescribingbehaviors. Annals of Emergency Medicine, 2010 Jul; 56(1):19-23. http://www.ncbi.nlm.nih.gov/pubmed/200455782 Green, T. et al. How does use of prescriptionmonitoring program change medical practice? Pain Medicine, 2012.Oct;13(10):1314-23. http://www.ncbi.nlm.nih.gov/pubmed/22845339
• Investigators only submit one subpoena for all PDMPrecords instead of subpoenas for multiple pharmacies’records
• Patient, prescriber or dispenser specific reports
• Data reports for all CDS prescriptions dispensed inMaryland over period of time
PDMP as an Investigative Tool
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• Clinical Use: **REGISTRATION MANDATE IN EFFECT**
– Prescribers (in connection with care of patient)
– Pharmacists (in connection with dispensing prescription)
– Delegates (as authorized by registered Prescriber orPharmacist)
• Investigative Use:
– Law Enforcement (existing investigation & subpoena)
– Licensing Boards (existing investigation & subpoena)
– DHMH Agencies (existing investigation required)
• OCME, OIG, OHCQ, Medicaid, DDC
Who Can Request PDMP Data
• Other uses:
– Fatality Review Teams (existing case review required)
– Other states’ PDMPs (if authorized and employingconfidentiality, security and access standards consistentwith Maryland’s PDMP)
– Researchers (de-identified data only)
– Patient (may include parent/guardian for minors)
– Provider (self-request)
Who Can Request PDMP Data
● Records of all Schedule II-V CDS dispensed to patient inMaryland, including identifying information for:
○ Patient for whom the drug is prescribed, ○ Prescriber ○ Dispenser○ Drug
● Dispensers required to report:○ hospital outpatient pharmacies○ community / retail pharmacies○ mail-order pharmacies dispensing to Maryland address○ Dispensing practitioners
● Dispensers must report to the PDMP within 3 business days ofdispensing a prescription
○ Daily Reporting will be required upon promulgation of regulations, asrequired by 2016 legislative change
What Data Can Be Found in the PDMP
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● Direct administration of CDS to a patient
● Drug samples provided to a patient
● Records from pharmacies that serve only hospital inpatients
● Records from speciality pharmacies that are waivered by the
Maryland Board of Pharmacy to serve exclusively assistedliving, comprehensive care, and developmental disabilities
facilities
● Dispensing by a pharmacy to hospice inpatients (if approvedby DHMH for a waiver)
● Opioid treatment programs (OTPs) / methadone clinics
● Dispensing from a veterinary clinic or hospital
What Data Are Not Reported to the PDMP
Drug & Rx data
• Rx #
• Rx date issued
• Rx date filled
• Rx new or refill
• # refills ordered
• Payment sources
• Drug metric quantity
• Days supply
• NDC populate drug info
Patient data
• Name (first, last)
• DOB
• Gender
• Address / Telephone Number
• ID #
Prescriber data
• DEA # populate info
• Last name
Dispenser data
• DEA # populate info
Main Data Elements
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Chesapeake Regional Information System for ourPatients (CRISP)
• Statewide health information
exchange (HIE)
• State’s PDMP IT contractor
Health Information Designs (HID)
• CRISP’s PDMP contractor
• RxSentry®: Data collection & other services
IT Partners
Clinical Users
– Register with CRISP
– Access data through CRISP HIE web portal, SSO (singlesign-on) or direct integration with EMRs
– Single source for PDMP (& HIE clinical info)
Investigative Users (LE, licensing boards, DHMHagencies)
– Register with HID
– Submit requests & retrieve reports through RxSentry®
PDMP Data Access
• Data are confidential, privileged, not subject to discovery orsubpoena in civil litigation, not public records
• Program does not create new clinical practice standards
• Civil penalty for dispenser failure to report ($500/incident)
• Criminal penalty for unlawful data access/use
• Re-disclosure of PDMP data allowed only:
– For treatment purposes by clinicians
– For cross-agency collaboration on investigations
Legal Provisions
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Caution in Interpreting PDMP Data
● Prescription information is reported to the PDMP by a dispensing pharmacy or
practitioner; it does not serve as the official record of a dispensing
● PDMP staff and vendors make all efforts to ensure data are complete and accurate,
reports may contain omissions or errors
● If you or your patient has concerns about possible data inaccuracies:
● Contact the dispenser to verify whether the prescription information was reported
to the PDMP accurately (The original prescription retained by the dispenser
serves as the official record)
● If an error is confirmed by the dispenser, please contact the PDMP administrator
at DHMH by email at [email protected] or call 410-402-8686
When You Find Something in the PDMP
Talk to your patient about appropriate medical care and management
Talk to other providers treating and/or prescribing/dispensing to patient
Screen for substance use disorders (SBIRT)
Consult existing guidelines on safe prescribing for acute or chronic pain
Consider referring patient to pain management specialist
Consider referring patient to substance use disorder treatment facility orspecialist
Consider prescribing naloxone to patients known to be taking opioids
Visit the DHMH PDMP website (www.MarylandPDMP.org)and click on Clinical Resources
Clinical PDMP Registrationand Use
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Clinical User Roles
• Prescriber:
– Healthcare practitioners authorized to prescribe CDS
– May access PDMP data in connection with the medical care of apatient
• Pharmacist:
– Pharmacists that are licensed to dispense CDS in/into Maryland
– May access PDMP data in connection with the dispensing of aCDS medication
– Clinical access to PDMP data is for treatment purposes,independent of the requirement for dispensers to report datato the PDMP
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Delegate Clinical Users
• PDMP-registered CDS prescribers and pharmacists may authorize staff toobtain CRISP user accounts and query PDMP data on their behalf.
• Prescriber Delegate
• Pharmacist Delegate
• Delegates may access PDMP data on behalf of a delegating Prescriber orPharmacist
• Primary goal is to integrate PDMP data review into existing clinicalworkflow
Delegates may include (Pharmacist / Presriber authorized):
• licensed practitioners without prescriptive authority
• non-licensed clinical staff that are employed by, or undercontract with, the same professional practice or facilitywhere the prescriber or pharmacist practices **NEW**
PDMP Registration and Use
- 2016 PDMP Law Changes Impacting Providers- Step-wise registration and use mandates- Time to acquaint users to PDMP before use mandate
- PDMP Registration Homepage on CRISP Website- Registration Mandate Quick Reference- Step-by-step Registration Guides- Link to Registration Page
- Pharmacists – Standard Registration Process :- 30 minutes to complete the registration- Computer with internet connection and audio- An individual e-mail address that only you access- An electronic copy of your Driver's License, Employee ID, or Passport- Your healthcare professional license** MUST REGISTER SELF – CANNOT BE DONE BY OFFICE STAFF**
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• Pharmacists and Prescribers Deadline: 7/1/2017
• Required Training including use of PDMP: video incorporated intoregistration
• Streamline Registration and Guides
• Only register once: any clinician already ever registered meetsrequirement
• Non-Compliance Implications for providers:• In future, PDMP registration required for new/renewal CDS
Prescribing Permit• After deadline, Health Profession Licensing Boards can take
action for failure to be PDMP Registered
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PDMP Registration Mandate
Registration through CRISP
Fact Sheetsand UserGuides
RegistrationLink!
www.MarylandPDMP.org andclick on PDMP logo toget to Registration page:
• Goes into effect: 7/1/2018
• Pharmacists: when suspect prescription being filled forsomething other than treatment of an existing medicaldiagnosis – corresponding responsibility under federalregulations
• Prescribers:
• New treatment episode prescribing opioid orbenzodiazepine
• At least every 90 days thereafter for duration of treatment
• Exceptions in statute for clinical and technical situations
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PDMP Use Mandate
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CRISP Query PortalEasily search for patients using Name and DOB or known MRN
Navigate to Patient Summary
Downloador printdata!
Click on Number to getMedication Detail Screen
CRISP Query Portal: Patient Summary
Tab between info screens
CRISP Query Portal: Medication Detail
Click between prescriptions of same medication type
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• Allows MD practitioners to query other states’ PDMPs andvice versa
• Connect through a central hub (PMPi), facilitated by NationalAssociation of Boards of Pharmacy (NABP)
Interstate Interoperability
Currently connected to 4states:
VA, WV, CT, AR
Addressing challenges toconnecting with additionalstates
Terp, Oriole B.
Raven, Mary L.
Calvert, Henry 21201
21228
1788
PrintingMaryland andother stateresults
SelectingOtherStates
New Clinical User Interface in CRISP:in-state and out-of-state requests
Progress toward Registration Mandate Compliance by Prescribersand Pharmacists
Clinical User Stats
Source: CRISP/PDMP, March 15, 2017
* Number of prescribers obtained from roster of licensees who have an active CDS registration with Office ofControlled Substance Administration (OCSA, formerly Division of Drug Control), the State CDS permit authority.** Number of pharmacists obtained from communication with Board of Pharmacy staff October 26, 2016 abouttotal licensees in possession of an active Maryland pharmacy license.
Type of User # of Registered
Users
# of
Active Users
(% of
Registered)
# Licensees subject
to Registration
Mandate
% of Licensees
who are PDMP
Registered
Prescriber 25,835 20,854 (80.72%) 33,807* 76.42%
Pharmacist 4,214 3,219 (76.39%) 11,296** 37.31%
Delegates 3,894 2,417 (62.07%) N/A N/A
Total 33,943 26,490 (78.04%) 45,103 75.26%
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Clinical User Registration
Source: CRISP/PDMP, March 15, 2017
HB437 Passed Auto-Registration
Weekly Clinical PDMP Query Volume
Source: CRISP/PDMP, March 15, 2017
PDMP Activitiesand Enhancements
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• Unsolicited Reporting: proactive dissemination of PDMP dataor notification of PDMP users about aberrant drugprescribing, dispensing or use patterns
• Authorized to review PDMP Data for…
– Indications of possible misuse or abuse
• If found, may proactively report to prescriber orpharmacists only
– Possible violations of law or possible breaches ofprofessional standards **NEW**
• If found, may proactively report to prescriber orpharmacist for educational purposes only
Provider Education: Unsolicited Reporting
• Provider Education Tool
– Currently sent as paper notifications
– Engage new PDMP users, provide clinical resources
– Longterm goal is electronic, in-context, comparisons torelevant peers, etc
– Integration into other DHMH edu activities
• Clinical Expertise leveraged through TAC: **NEW**
– May review reports for indicators of misuse or abuse
– Must review reports for possible violations of law /breaches of professional standards
Unsolicited Reporting
Technical Advisory Committee
• Purpose:
• Provide clinical guidance & interpretation of PDMP data
• Membership:
• Pharmacist
• 4 physicians with expertise in pain management,behavioral health, anesthesiology, oncology
• 2 health professionals with experience or expertise insubstance –related or mental health disorders **NEW**
• Dentist **NEW**
• Internist or family medicine practitioner **NEW**
• Can expand membership
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• Massachusetts PDMP1: survey of unsolicited reportingrecipients
– 8% were “aware of all or most of other prescribers”
– 9% said “based on current knowledge, including thereport, the patient appears to have a legitimate medicalreason for prescriptions from multiple providers.”
Clinical Impact of Unsolicited Reporting
1 Prescription Drug Monitoring Program Center of Excellence at Brandeis, Briefing on PDMP Effectiveness, Updated September 2014.http://www.pdmpexcellence.org/sites/all/pdfs/Briefing%20on%20PDMP%20Effectiveness%203rd%20revision.pdf
Enhancing Clinical Utility of PDMP
Clinical WorkflowIntegration and Patient /
Data Searches
Data Alerts,Visualization, Analytics
Enhancement Priorities
Auto-registration workflow
Data Integrations in EMRs
Improved PDMP Search Fx
Prescriber DEA Self Look-up
Delegation Dashboard
Electronic Unsolicited Reports
Provider Report Cards
In-system Alerts and Graphs
Clinical User Feedback / Pilots
PDMP / CRISP Closer to the Clinical Workflow
“One-Click”access =Single Sign-On (SSO)
25 facilities inMarylandutilizing thisfunctionality
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PDMP / CRISP Closer to the Clinical Workflow
“Zero-Click” access = In-context Notifications
10 facilities in Maryland utilizing this functionality
PDMP Advisory Board Clinical User Experience Subcommittee
Being Implemented:• Fuzzy logic’ patient search and data display – ‘PDMP Search’• Out of state patient query updates• Prescriber self look-up
In the works:• Delegation dashboard• CRISP Integrations
On the horizon:• Electronic data alerts, visualization, unsolicited reporting
notifications
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Clinical User Experience Enhancements
PDMP Search – NEW User Interface
In Pilot User Testing starting March 2017Roll-out to all PDMP users during calendar year 2017
Filter by each column Sort by each column Maryland and Inter-state data Select in and out possible patient matches Located in the new CRISP Unified Landing Page
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Kate Jackson, MPHPDMP Manager
Department of Health and Mental HygieneBehavioral Health Administration
DHMH/BHA PDMP website:www.marylandpdmp.org
CRISP website:www.crisphealth.org
Questions?
