Pdmp 1 giglio hopkins

Introduction to Prescription Drug Monitoring Programs

James Giglio Director, PDMP Training and Technical Assistance Center Brandeis University

David Hopkins KASPER Program Manager Office of Inspector General Kentucky Cabinet for Health and Family Services

Disclosures

•  James Giglio has disclosed no relevant, real or apparent personal or professional financial relationships.

•  David Hopkins has disclosed no relevant, real or apparent personal or professional financial relationships.

Learning Objectives

1.  Outline the history and operation of PDMPs.

2.  Outline strategies used by PDMPs to analyze and use collected data to identify drug abuse trends.

3.  Identify strategies for best practices that participants can implement in their state.

Agenda

•  History of Prescription Drug Monitoring Programs (PDMPs)

•  How PDMPs Operate •  PDMP Best Practices •  What is Your State Doing? •  Where to Learn More

Prescription Drug Abuse and Diversion

History of Prescription Drug Monitoring Programs (PDMPs)

What is a Prescription Drug Monitoring Program?

•  A prescription drug monitoring program (PDMP) is a state program that collects controlled substance prescription records from dispensers (e.g., pharmacies) state-wide and then provides prescription histories and other compiled and/or analyzed data to authorized end-users for use in clinical care, law enforcement, regulation of professional practice, research and evaluation.

Status of Prescription Drug Monitoring Programs (PDMPs)

Research is current as of December 23, 2013

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Opera9onal PDMPs

Enacted PDMP legisla9on, but program not yet opera9onal

Legisla9on Pending

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Enactments of PDMPs

Enactments of PDMPs

First Prescription Drug Monitoring Program

• New York State 1918 • Drugs ▫ Cocaine ▫ Morphine ▫ Heroin • State’s Role • Doctor’s Role • Pharmacist’s Role ▫ Copy to State within 24hrs of

Dispensing

Early Prescription Drug Monitoring Programs

•  1939-43 ▫ California-1939 (Oldest Continuous

Program) ▫ Hawaii – 1943 •  1960-1989 ▫  Illinois (1961) ▫  Idaho (1967) ▫  Pennsylvania (1972) ▫ New York (1972)* ▫ Rhode Island (1978) ▫  Texas (1981) ▫ Michigan (1988)

Early PDMP Characteristics

• Purpose of PDMPs ▫ Law Enforcement ▫ Curtail Diversion • Collected ONLY Schedule II Drugs • Use of State Issued Prescriptions • Frequency of Collecting Data ▫ 30 days from time of dispensing

Early PDMP Characteristics Paper Era (1939 - 1990)

• Paper Prescriptions ▫ Triplicates ▫ Duplicates ▫ Individually Serialized ▫ Issued by the State ▫ Cost to Prescribers • Copies sent to States ▫ Data entry process

Early PDMP Information Gathering

State PDMP Issues Rx

Doctor Prescribes on triplicate Rx

Keeps One Copy

Pa9ent Brings 2 copies of

Rx to Pharmacy

Pharmacy Dispenses

Keeps Original and forwards 3rd copy to state

State PDMP enters

informa9on into database

Electronic Era – Breaking New Ground

•  Oklahoma (1990) ▫  First to Require Electronic Transmission of Data ▫  No serialized prescriptions ▫  Reduced Operational Costs ▫  Increased accuracy and timely submissions ▫  Enabled other States to Consider PDMPs •  Nevada (1995) ▫  First to Require the Reporting of More than

Schedule II drugs (Schedules II-IV) ▫  First to provide Unsolicited Reports to Practitioners

Present PDMPs – Federal Era

•  Harold Rogers Prescription Drug Monitoring Programs Grant (2003)

 Funds to Plan, Implement, Enhance PDMPs  Program Administered by Bureau of Justice

Assistance (BJA)  2003-2012: Thirty Three (33) States Enacted

PDMP legislation •  SAMHSA (NASPER) •  CDC •  DEA •  ONDCP •  ONC

History of PDMPs

Year Legislation Enacted

Harold Rogers Program Implemented

How PDMPs Operate

PDMP System Overview

Data Submitted

Reports Sent

Reports Sent

Reports Sent

Prescription Information Collected by PDMPs

• Patient identification: ▫ Name & Address ▫ DOB & Gender • Prescriber Information • Dispensing Pharmacy Information • Drug Information, e.g. ▫ NDC # = name, type, strength,

manufacturer ▫ Quantity & date dispensed ▫  Source of payment (some states)

Controlled Substance Schedules

•  Schedule I – Illegal Drugs •  heroin, marijuana, LSD

•  Schedule II – Most addictive legal drugs; high abuse potential •  oxycodone, methylphenidate, oxymorphone

•  Schedule III – Less abuse potential than I or II •  hydrocodone combinations

•  Schedule IV – Less abuse potential than III •  benzodiazepines

•  Schedule V – least abuse potential •  codeine containing cough mixtures

Data Collected from Pharmacies

•  PDMPs Collect Dispensed Controlled Substances Rx: •  30 collect Schedules II – V •  18 collect Schedules II – IV •  1 collects Schedule II & III •  1 collects Schedules II only •  Some Collect Non-Controlled Medications •  8 collect tramadol (Ultram®) •  1 each – Butorphanol, butalbitol w/acetamenophen

•  Electronic Data Collection - Batch Reporting •  Reporting Frequency varies – POS, 24 hours, 7-30 days

PDMP Data •  Data is Provided to:

•  Doctors and other prescribers •  Pharmacists •  Health Professional Licensing

Boards •  Law Enforcement •  Medical Examiners •  Medicaid State Agencies •  Drug Courts

PDMP Report Types

•  Standard Reports - Prescriber, Dispenser, Patient

•  Specialty Reports – Statistical, Geographical, Trend Analysis

•  Solicited vs. Unsolicited Reports

Uses by Prescribers/Pharmacists •  Prescription history of a current or a new patient

–  Misuse or Addiction

–  Multiple Prescribers/Dispensers

–  Drug Interactions

– Compliance with Pain Contracts

•  Practitioner prescribing history

– Fraudulent Scripts

– Monitor Patient’s Compliance with Rx Directions

Uses by Law Enforcement Agencies

•  Unlawful Sale of Controlled Substances/Prescriptions

•  Unlawful Prescribing/Dispensing

•  Organized Forgery Rings

•  Organized Doctor Shopper Rings

Uses by Boards/Licensing Agencies

•  Meeting Standard of Care

•  Improving the Prescribing & Dispensing of Drugs

•  Monitoring compliance of prescribers/dispensers currently on probation

•  Monitoring compliance of dispensers reporting information to PDMPs

OTHER USE OF PDMP REPORTS •  Public Health

•  Research, Treatment, Prevention & Education

•  Drug Courts •  Assist in monitoring compliance of participants

•  Medical Examiners •  Assist in identifying cause of death in drug overdose cases

•  Impaired Professional Programs •  Assist in monitoring compliance of health care professionals

•  Medicaid •  Drug Utilization Review Boards •  Identify Other Sources of Drugs (forms of payment) •  Monitor clients restricted to single practitioner/pharmacy

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PDMP Best Practices

PDMP Best Practices

Why Is a New Generation of PDMPs Needed?

The Prescription Drug Abuse Epidemic is Increasing

The New Generation of PDMPs

THE PARADIGM SHIFT: In addition to simply responding to

others’ requests, PMPs need to proactively confront the epidemic.

White Paper on PDMP Best Practices

Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices

September 20, 2012

at www.pdmpexcellence.org

Developed by PMP Center of Excellence at Brandeis University with support from BJA and Pew Charitable Trusts

Improve Data Collection Being Done: •  Collect all schedules II to V •  Use most recent data submission standard,

e.g., ASAP version 4.2. •  For each Rx, collect data on method of

payment To Be Done: •  Collect prescription data in real time or within

24 hours of dispensing

ID Person Picking Up the Prescription

To Be Done: •  Require pharmacies to submit ID information on who

picks-up each prescription -- so PDMP knows who actually has the drug.

•  Require pharmacies to check photo ID check before dispensing a controlled substance to verify who has the drug.

•  Massachusetts PDMP mandated reporting and positive ID for Schedule II prescriptions since 2009. •  Found 38% of the persons who dropped off or

picked up the Rx are not the patient. •  Now MA requires reporting and positive ID for all

Schedule II to V prescriptions.

Remain Current with Technology To Be Done: •  Integrate electronic prescribing with PDMP data.

•  Could e-Prescribing become the source for PDMP data?

To Explore: •  Utilize state-issued prescription forms.

•  serialized •  single copy

Maintain Data Quality Being Done: •  Verify data quality

•  Require pharmacies correct data reported in error •  Identify gaps in data and enforce reporting

requirements

To Be Done: •  PDMPs should check for obvious anomalies, e.g.;

•  Prescribers who have died •  Prescribers whose licenses/registrations are

suspended or revoked

User Access and Report Dissemination

Being Done: •  Provide online access and automated reports - 24/7 •  Allow prescribers to review their own records •  Allow law enforcement, including prosecutors to have access To Be Done: •  Develop batch requesting for prescribers to request an entire

day’s calendar of appointments •  Integrate PDMP reports with health information exchanges

(HIE) and electronic health records (EHR)

Increase PDMP Utilization Being Done: •  Mandate prescriber enrollment in PDMP

To Explore: •  Enabling access for appropriate users:

•  State Medicaid Agencies •  Federal Medicare •  Medical examiners and coroners •  Drug courts, probation and parole officers •  Drug treatment professionals and agencies

Unsolicited Reports and Alerts To Explore: •  Proactively analyze PDMP data to identify

potential misuse and diversion, e.g.; •  Potential doctor shopping •  Organized drug rings •  Prescription forgery •  Pill Mills

•  Provide analyzed data to those who can intervene

•  Prescribers and Pharmacists •  Law Enforcement •  Health Professional Licensing Agencies

Collaboration with Other Agencies To Be Done: •  Indian Health Service •  Department of Veterans Affairs •  Department of Defense

•  DOD Facilities •  Tricare

•  Medicaid and Medicare •  Private third party payers

•  Health insurers •  Workers Compensation

What is Your State Doing?

COMPILATION OF STATE PRESCRIPTION MONITORING PROGRAM MAPS

© 2014 Research is current as of March 2014. In order to ensure that the information contained herein is as current as possible, research is conducted using nationwide legal database software, individual state legislative websites., and direct communications with state PDMP representatives. Please contact Heather Gray at 703-836-6100, ext. 114 or [email protected] with any additional updates or information that may be relevant to this document. Headquarters Office: THE NATIONAL ALLIANCE FOR MODEL STATE DRUG LAWS (NAMSDL). 215 Lincoln Ave. Suite 201, Santa Fe, NM 87501.

This project was supported by Grant No. G1299ONDCP03A, awarded by the Office of National Drug Control Policy. Points of view or opinions in this document are those of the author and do not necessarily represent the official position or policies of the Office of National Drug Control Policy or the United States of Government.

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Prescription Drug Monitoring Programs States With Authority to Monitor Schedule II Substances

© 2014 The National Alliance for Model State Drug Laws (NAMSDL). Headquarters Office: 215 Lincoln Ave. Suite 201, Santa Fe, NM. 87501. This information was compiled using legal databases, state agency websites and direct communications with state PDMP representatives.

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Prescription Drug Monitoring Programs States With Authority to Monitor Schedule II & III Substances

© 2014 The National Alliance for Model State Drug Laws (NAMSDL). Headquarters Office: 215 Lincoln Ave. Suite 201, Santa Fe, NM 87501.

This information was compiled using legal databases, state agency websites and direct communications with state PDMP representatives

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*Iowa’s PDMP monitors Schedule III and IV substances that the advisory council and the Board of Pharmacy determine can be addictive or fatal if not taken under the proper care or direction of a prescribing practitioner.

Prescription Drug Monitoring Programs States With Authority to Monitor Schedule II, III and IV Substances



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1Tennessee’s law authorizes the monitoring of Schedule V substances which have been identified by the controlled substances database advisory committee as demonstrating a potential for abuse.

Prescription Drug Monitoring Programs States With Authority to Monitor Schedule V Substances



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Prescription Drug Monitoring Programs States With Authority to Monitor Non-controlled/Non-Scheduled Substances

Please note that although a state may have statutory authority to monitor Non-controlled/Non-Scheduled substances, that state may not currently be monitoring prescriptions for such substances and may in fact require implementation of additional regulations before that monitoring can commence.


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Data Collec@on Interval

Weekly/7 Days

Twice Monthly

Monthly

Real Time

Daily/24 Hours

3 Days

1 New York requires the submission of data in real time by statute, but that has been interpreted by regulation to mean no later than 24 hours after the substance is delivered. 2 Ohio requires submission of data from pharmacies weekly and from wholesalers monthly. 3 Utah requires submission weekly, but for those participating in the statewide pilot program, submission is required daily. 4 Michigan is going to daily reporting in July 2014.

D.C.


Breakdown of Housing En@@es*

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Health Departments, Single State Authority or Boards of Pharmacy

Law Enforcement Agencies

Board of Pharmacy and Inves9ga9on Division of the Department of Public Safety

Professional Licensing

Department of Consumer Protec9on

Narco9c and Drug Agency at the direc9on and oversight of the Board of Pharmacy

* This information is based on the agency the PMP statute or regulation indicates is required to establish the PMP.


This information was compiled using legal databases, state agency websites, and direct communications with state PDMP representatives.

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Types of Authorized Recipients -‐ Prescribers and Dispensers


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States that Require All Licensed Prescribers and/or Dispensers to Register with PMP Database*



* Many states require that persons requesting access to the state PMP database first register as an authorized user. This map and the memorandum located on the NAMSDL website are concerned with only those states that require all practitioners licensed in the state to also register to use the PMP database. 1 Alabama only requires physicians with or seeking a pain management registration to be registered with the PMP. 2 The Virginia provision goes into effect on July 1, 2015.

Maine’s statute requires all prescribers in six classes to register by March 1, 2014 if less than 90% of prescribers in each class have not registered to use the PMP by January 1, 2014.

Mandatory enrollment

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States that Require Prescribers and/or Dispensers to Access PMP Informa@on in Certain Circumstances*

* Please see the accompanying memorandum for specifics as to the circumstances under which a prescriber and/or dispenser is obligated to access the PMP database in each state. 1 The Virginia provision goes into effect on July 1, 2015.



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Types of Authorized Recipients -‐ Licensing/Regulatory Boards


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Types of Authorized Recipients – Law Enforcement Officials

Probable cause, search warrant, subpoena, or other judicial process

Pursuant to an active investigation

Upon request from law enforcement officials

May only receive information from professional licensing boards

1 Law enforcement requests must be approved by the Office of the Attorney General. Law enforcement officials do not have direct access. 2 Law enforcement officers must make a declaration that probable cause exists, but there is no judicial process involved.


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Types of Authorized Recipients – Judicial and Prosecutorial Officials

Probable cause, search warrant, subpoena, or other judicial process in criminal cases

Pursuant to an active investigation or prosecution

Upon request of the grand jury

Both judicial process or pursuant to an active investigation

Upon request from judicial or prosecutorial officials

1 The Pennsylvania provision pertains only to cases involving criminal investigations into violations of state or federal drug laws, health care fraud, or insurance fraud statutes.

Probable cause, search warrant, subpoena, or other judicial process in criminal and civil cases


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Types of Authorized Recipients -‐ County Coroners, Medical Examiners, and/or State Toxicologists

1 Minnesota has started a pilot program to allow access by county coroners and medical examiners.

County coroners and/or medical examiners

State toxicologist


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Types of Authorized Recipients – Medicare, Medicaid and/or State Health Insurance Programs or Health Care Payment/Benefit Provider or Insurer

Medicare, Medicaid and/or State Health Insurance Programs

Health Care Payment/Benefit Provider or Insurer and Medicaid, Medicare, and/or State Health Insurance Programs


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Types of Authorized Recipients – Pa@ent, Parent or Guardian of Minor Child, Health Care Agent or A\orney on Behalf of Pa@ent

Patient or parent of minor child

Patient or parent of minor child and health care agent

Patient or parent of minor child and attorney on behalf of patient

Patient or parent of minor child, health care agent and third party with signed consent form

Patient or parent of minor child and third party with signed consent form


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1 Beginning July 1, 2014, Idaho will change to patient or parent of minor child and third party with signed consent form.

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States that Allow Practitioners to Designate an Authorized Agent to Access the PMP Database



1 Idaho and South Dakota only allow prescribers to designate an agent at this time.

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Unsolicited PMP Reports/Info to Prescribers, Pharmacists, Law Enforcement and Licensing En@@es

To prescribers, pharmacists, law enforcement and licensing entities (20)

To prescribers, pharmacists and law enforcement only (4)

To prescribers, pharmacists and licensing entities only (2)

To prescribers and pharmacists only (5)

To law enforcement and licensing entities only (3)

To prescribers only (3)

Law enforcement only (2)

Licensing entities only (2)

To prescribers and law enforcement only (1)



Practitioners and licensing entities only (1)

1 North Carolina provides unsolicited reports to the Attorney General who has the discretion to forward the information to law enforcement. 2 Michigan send alerts to physicians when a patient surpasses the threshold but does not send the actual report.

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Interstate Sharing of Prescrip@on Monitoring Program Data Pursuant to Statute, Regula@on, and/or Statutory Interpreta@on

States that share data with other PMPs

States that share data with authorized users in other states

States that share data with both

1 Oregon will only allow direct access to the PMP to practitioners in CA, ID, and WA.


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Where to Learn More

Email: [email protected]

Telephone: (781) 609-7741

Website: www.pdmpassist.org

RESOURCES

Controlled Substances Agency Resource Directory

State PDMP Contacts

www.pmpexcellence.org

www.namsdl.org

www.pmpalliance.org

www.nascsa.org

Jim Giglio PDMP Training and Technical Assistance Center

[email protected]

David R. Hopkins Kentucky Cabinet for Health and Family Services

[email protected]

Health & Medicine

Pdmp 1 giglio hopkins