Prescription Drugs: Issues in Treatment, Supervision and Case Management

Prescription Drugs: Issues in Treatment, Supervision and Case Management National Association of Drug Court Professionals Washington, DC July 16, 2013

Agenda Overview of prescription drug diversion and abuse PDMP processes and functions PDMPs and law enforcement PDMPs and case management

Prescription Drug Diversion and Abuse Key Points

Motor vehicle traffic, poisoning, and drug poisoning (overdose) death rates United States, 1980-2010 25 Motor Vehicle Traffic Poisoning Drug Poisoning (Overdose) Deaths per 100,000 population 20 15 10 5 0 1980 1982 1984 1986 1988 1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 Year Source: NCHS Data Brief, December, 2011, Updated with 2009 and 2010 mortality data

Drug Overdose Deaths by Major Drug Type, U.S., 1999-2010 18,000 Opioids Heroin Cocaine Benzodiazepines 16,000 14,000 Number of Deaths 12,000 10,000 8,000 6,000 4,000 2,000 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year Source: CDC, National Center for Health Statistics, National Vital Statistics System. Updated with 2010 mortality data

Rates of opioid overdose deaths, sales and treatment admissions, U.S., 1999-2010 8 Opioid Sales KG/10,000 Opioid Deaths/100,000 Opioid Treatment Admissions/10,000 7 6 5 Rate 4 3 2 1 0 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Year Source: National Vital Statistics System, DEA s Automation of Reports and Consolidated Orders System, SAMHSA s TEDS

Drug overdose death rate 2008 and opioid pain reliever sales rate 2010 Kg of opioid pain relievers used per 10,000 Age-adjusted rate per 100,000 Source: National Vital Statistics System, 2008; Automated Reports Consolidated Orders System (2010)

Past year initiates of specific illicit drugs among persons aged 12 or older: 2010 Source: SAMHSA

Past month nonmedical use of types of psychotherapeutic drugs among persons aged 12 or older: 2002-2010 Source: SAMHSA

Rates of ED visits per 100,000 population involving nonmedical use of pharmaceuticals, by age: 2011 Source: SAMHSA

Number of Forensic Cases 2001-2010 Source: DEA, 2013

Opioid Epidemic Iatrogenic Opioid overdoses and deaths rise to epidemic proportions first decade of 2000s Different than any other drug epidemic: Manufactured by pharmaceutical manufacturers Distributed throughout our health care system Prescribed by physicians and other licensed professionals Dispensed by pharmacies Challenge: Need to balance enabling medical use with preventing misuse and abuse

What do Prescription Drug Monitoring Programs do?

Prescription Drug Monitoring Program GOALS Education & Information Public Health Initiatives Early Intervention & Prevention Investigation & Enforcement Source: Alliance of States with Prescription Monitoring Programs

PDMP System Overview Dispensers Data Submitted Pharmacists Reports Sent State PDMP Reports Sent Prescribers Reports Sent Law Enforcement & Professional Licensing Agencies *Groups other than those listed may also receive reports

Prescription Information PDMPs Collect 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)

Data Collected from Pharmacies PDMPs Collect Dispensed Controlled Substances (CS) 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 Prescription Substances 8 collect tramadol (Ultram ) 1 each Butorphanol, butalbitol w/ acetamenophen Electronic Data Collection - Batch Reporting Reporting Frequency varies POS, 24 hours, 7 to 30 days

Data is Provided to: PDMP Data Doctors and other prescribers Pharmacies Health Professional Licensing Boards Law Enforcement Medical Examiners Medicaid State Agencies Data helps identify: Patients who need care and are not abusing medicine Doctor shoppers Some other forms of drug abuse and diversion Inappropriate prescribing and dispensing

What PDMPs provide when prescribers and pharmacies request a patient Rx history 3, 6 or 12 month prescription history, depending on state Prescriber: Name, address, and, some states, phone number Date Rx issued Description of drug: Drug name, quantity, strength, days supply Dispensing pharmacy: Name and address Date dispensed

Number of Prescription Drug Monitoring Programs (PDMPs) 1939-2012 60 50 50 PDMPs Number of PDMPs 40 30 20 Harold Rogers Program Started 10 0 Year

Source: PDMP Training & Technical Assistance Center, Brandeis University

Source: PDMP Training & Technical Assistance Center, Brandeis University

Number of PDMP reports produced by year 4,500,000 4,000,000 3,500,000 3,000,000 2,500,000 Harold Rogers Program Started 2,000,000 1,500,000 1,000,000 500,000-2001 2002 2003 2004 2005 2006 Est. 2007 Est. 2008

PDMP REPORTS BY TYPE OF USER 2006-2007 1 0.8 0.6 0.4 0.2 0 CA ID KY NV OH OK VA Prescribers & Pharmacists Law Enf. & Regulatory Source: Alliance of States with Prescription Monitoring Programs, 2007

PDMPs and Law Enforcement

PDMP Data Use in Investigations Typical targets of prescription drug diversion investigations using PDMP data: Suspected doctor shoppers (patients obtaining controlled substances from multiple prescribers and pharmacies), Doctors running pill mills, who knowingly prescribe medically unnecessary drugs for extra income, and Dishonest pharmacists who take advantage of their access to controlled substances.

How does law enforcement access PDMP data? Solicited reports L.E. investigators can request PDMP data in every state, but requirements vary Typically, need evidence of an active case; sometimes need court order or subpoena Unsolicited (proactive) reports Model Act recommends that all state PDMPs proactively provide PDMP reports (unsolicited reports) to L.E. 13 states proactively issue unsolicited PDMP reports to L.E. agencies based on analysis of PDMP data

Law Enforcement Request Source: Washington State PMP & PDMP Training and Technical Assistance Center

Patient Rx History Report Source: Washington State PMP & PDMP Training and Technical Assistance Center

Illinois PMP: Statute STATUTE (720 ILCS 570/318) allows the ILPMP to release information to a law enforcement officer, licensing entities or the office of Attorney General that are engaged in an investigation that involves a controlled substance The requestor must have reason to believe that a violation under any state or federal law that involves a controlled substance has occurred The requested information is reasonably related to the investigation of the violation Source: Illinois PMP and PDMP Training & Technical Assistance Center

STATISTICS Illinois PMP: Statistics Since 2008 over 2000 requests have been fulfilled for law enforcement purposes o Over 100 distinct requestors o Over 10 states The biggest requestor is the DEA o 38 Requestors o Over 1500 requests o Saves two DEA agents two weeks of traveling to pharmacies and Dr. offices per investigation Avg. 2 reports per month to drug courts Source: Illinois PMP and PDMP Training & Technical Assistance Center

How can PDMP data assist investigators in combating diversion? Doctor shopping investigations Reliably identify plausible suspicion of doctor shopping Increase efficiency of investigation by identifying pharmacies and prescribers from which to request records Increase reach of investigation by identifying more remote pharmacies and prescribers used Overall impact of use of PDMP data: enable identification and investigation of more cases, and make more evidence available, increasing likelihood of successful prosecution

How can PDMP data assist investigators in combating diversion? Investigations of dishonest prescribers PDMPs can screen data for unusual amounts and types of controlled substances prescribed by a single practitioner E.g., holy trinity of hydrocodone, Xanax, Soma E.g., pill mills Large geographic separation between patients and prescriber E.g., Oxy Express from FL to KY E.g., prescriptions written in GA and filled in AL

How can PDMP data assist investigators in combating diversion? Investigations of dishonest pharmacies Unusual patterns of dispensing and of patient location Pharmacy under-reporting of controlled substances dispensed (e.g., to conceal some sales) Can be identified by comparing prescriber and pharmacy records, a process greatly facilitated by electronic prescribing of controlled substances Also by comparing net quantities of controlled substances delivered to a pharmacy and net quantities reportedly dispensed Recently enacted policy in NY

Evidence of effectiveness of law enforcement use of PDMP data Perceived effectiveness in preventing/reducing diversion > 90% of law enforcement respondents in KY saw PDMP as effective Time saved in investigations Anecdotal evidence Suggestive findings about drug overdose death rates in selected states that provide unsolicited reports to law enforcement

Early PDMPs Impact Example: NY PMP began - 1978: NY led the nation in Schedule II stimulants & barbiturate overdoses NY had few opioid overdoses 12% of all Schedule II prescriptions were forged and/or counterfeit Within 5 years: Less than 1% Rx forged or counterfeit Stimulant & Barbiturate sales & overdoses dropped by 95% No reduction in opioid sales Net Schedule II reduction 50%

PDMPs and Case Management

PDMPs Save Law Enforcement Costs & Monitor Treatment NV Pre-Criminal Intervention Program enrolls & monitors doctor shoppers in rehab saving investigative and prosecution $ See PDMP Center of Excellence Notes from the Field Drug Treatment Programs in ME use PDMP data at patient intake and periodically thereafter to monitor compliance Medical Director Opioid Addiction Treatment Program PDMP data very important See PDMP Center of Excellence Notes from the Field Drug Courts in KY use PDMP data to monitor compliance See PDMP Center of Excellence Notes from the Field

States Providing Solicited PDMP Reports to Drug Courts State In state Out of state Authorization Mechanism Alaska Court order or participant release Idaho Under law enforcement and special prosecutors Illinois Under law enforcement and prosecutors Indiana Policy for probation officers and drug court staff Kentucky Direct statutory authority Mississippi Court order Utah Via law enforcement or participant release Wyoming Participant release (probation only) Source: Compiled from information provided by the PDMP Training and Technical Assistance Center, 2012, 2013

Prescription Drug Monitoring Program Center of Excellence Notes From the Field NF 2.4 Monitoring and Changing Behavior: The Role of PMP Data in Kentucky Drug Courts August, 2011

Kentucky PDMP Kentucky All Schedule Prescription Electronic Reporting (KASPER) is Kentucky s Prescription Drug Monitoring Program (PDMP). KASPER tracks Schedule II V controlled substance prescriptions dispensed within the state as reported by pharmacies and other dispensers. Enhanced KASPER (ekasper) is the real-time web accessed database that provides a tool to help address the misuse, abuse and diversion of controlled pharmaceutical substances. Source: KY Cabinet for Health and Family Services

KASPER OPERATION KASPER tracks most Schedule II V substances dispensed in KY. Over 11 million controlled substance prescriptions reported to the system each year. KASPER data is 1 to 3 days old. Dispensers have 1 business day to report. Vendor processes & provides data once per day. Reports available to authorized individuals. Available via web typically within 15 seconds (93% of requests). Available 24/7 from any PC with Web access. Source: KY Cabinet for Health and Family Services

Goals of KASPER KASPER was designed as a tool to help address the problem with prescription drug abuse and diversion by providing: A source of information for health care professionals. An investigative tool for law enforcement and regulatory agencies. KASPER was not designed to: Prevent people from getting prescription drugs. Decrease the number of doses dispensed. Source: KY Cabinet for Health and Family Services

Access by Law Enforcement Officers KRS 218A.202(6): The Cabinet for Health and Family Services shall be authorized to provide data to: a Kentucky peace officer; a certified or full-time peace officer of another state; a federal peace officer whose duty is to enforce the laws of this Commonwealth, of another state, or of the United States relating to drugs; and who is engaged in a bona fide specific investigation involving a designated person Source: KY Cabinet for Health and Family Services

Access by Drug Court Judges KRS 218A.202(6): The Cabinet for Health and Family Services shall be authorized to provide data to: a judge or probation or parole officer administering a diversion or probation program of a criminal defendant arising out of a violation of this chapter or of a criminal defendant who is documented by the court as a substance abuser who is eligible to participate in a court-ordered drug diversion or probation program.

Access by Drug Court Judges (cont d) Management of Reports A judge may discuss the information in a KASPER report with the Drug Court participant, but does not provide a copy of the report to anyone including the Drug Court participant. After review the judge may shred the report. Each report has a number that will allow access to the report at any time.

Kentucky Drug Courts Use of PDMP Data Used to track a participant s non-medical use or diversion of controlled substances. Rise in prescription drug diversion, abuse and addiction means that an increasing number of drug court participants are enrolled due to involvement with prescription drugs. Information on the prescription histories of participants can play a valuable role in monitoring and changing their behavior. Approximately two thirds of Kentucky drug courts currently make use of PDMP data in a variety of situations.

PDMP Data Use by Kentucky Drug Courts Source: Kentucky Administrative Office of the Courts, data collected July 2011

Kentucky Drug Courts Use of PDMP Data (cont d) Periodic and random drug tests (drug screens) that analyze hair, blood or urine samples are routinely used to detect illicit and non-medical drug use. However, these tests aren t completely reliable in detecting the presence of all prohibited substances, and are subject to evasion by resourceful and determined drug users. Courts must take other steps to monitor participant behavior to ensure they uphold agreements to remain drug free, or in the case of prescription drugs, use them only as medically indicated.

Kentucky Drug Courts Use of PDMP Data (cont d) A typical drug court program in Kentucky consists of 3 phases that gradually give participants more autonomy, plus a post-graduation aftercare phase In one drug court supervised by Vice-Chief Regional Circuit Judge Charles Hickman, PDMP reports are run on participants when they move from one phase of the program to another in order to help confirm that their purchases of controlled substances, if any, are consistent with good clinical care. PDMP data can reveal patterns of prescribing that indicate a participant might be using controlled medications non-medically or diverting them to friends, family or paying customers.

Kentucky Drug Courts Use of PDMP Data (cont d) PDMP reports are also run if, at any point in the program, a participant seems to be having unexpected or unexplained setbacks, or if evidence comes to light suggesting illicit drug use (e.g., a positive drug screen) or diversion activity (e.g., unexplained cash in hand). A participant can move on to the next phase only if their behavior as monitored by the court, including the prescription purchases listed in PDMP reports, passes muster.

Kentucky Drug Courts Use of PDMP Data (cont d) While a drug screen can t detect drug diversion, only drug use, PDMP data showing medically unnecessary prescriptions are prima facie indicator of possible diversion. PDMP reports are only indicators, not proof, of diversion or misuse. The pharmacies and doctors listed are contacted and records reviewed to confirm that the individual in question actually received the prescriptions dispensed.

Purposes of PDMP Data Use by Kentucky Drug Courts Source: Kentucky Administrative Office of the Courts, data collected July 2011

Prescription Monitoring Program Model Act of 2010 Section 7, Providing Prescription Monitoring Information (b) The [designated state agency] is authorized to provide information in the prescription monitoring program upon request only to the following persons. (VII) Personnel of the [designated state agency] for purposes of administration and enforcement of this Act, or [insert state controlled substances act], [if any other state statute is applicable, insert or and reference the other statutes]. [Note: A state may determine to authorize additional agencies to request and receive prescription information including substance abuse treatment providers, worker s compensation board reviewers who are health care professionals, drug court judges, department of corrections health care professional staff, and probation departments, if they cannot receive information under other provisions already authorized in (I) through (VII)] Source: Alliance of States with Prescription Monitoring Programs

White Paper on PDMP Best Practices Prescription Drug Monitoring Programs: An Assessment of the Evidence for Best Practices September 20, 1012 at www.pdmpexcellence.org Developed with BJA and Pew Charitable Trusts 35 Best and Promising Practices

PDMP Best Practice Recommendations Relevant to Drug Courts Enable access to PDMP data by drug courts Provide education to drug court professionals to promote awareness and utilization Link PDMPs with other public health and public safety systems, including drug courts Enact and implement interstate data sharing among PDMPs

Potential Mechanisms for Drug Court Use of PDMPs Direct statutory authority Depending upon state laws and regulations: Participant agreement Working through law enforcement Court order or subpoena Working with a participant s health care providers (i.e., prescribers and dispensers) Consult with the state agency administering the PDMP

Resources

PDMP Center of Excellence Components Web site/clearinghouse Problem Statement user friendly Evaluate PDMP effectiveness, including: Analysis of BJA performance measures Case studies of start-up PDMPs and innovative enhancements Identify best practices Develop innovative uses of PDMP data Support Substance Abuse Prevention Assist Substance Abuse Treatment Assist medical and pharmaceutical education and research Expert panel to guide Center work

www.pdmpexcellence.org

How to find contact information for a state s PDMP? Go to www.pdmpassist.org - website of PDMP Training & Technical Assistance Center at Brandeis University Go to the left column of Homepage; under State Contact Information and click on the link for State Contacts That will bring up the name of the primary PDMP contact(s) in each state. Click on a name and the individual s contact information will appear.

www.pdmpassist.org

How to find other information about a state s PDMP On the homepage of www.pdmpassist.org, click the top tab marked Resources On drop down menu, click State Profiles On the next webpage, click the state s name. For each state, there is: The state agency administering the PDMP, Information about the state, Drug schedules monitored, Who may request patient information, Legislation and regulations

Prescription Drug Monitoring Program Center of Excellence Brandeis University Supported by the Bureau of Justice Assistance www.pdmpexcellence.org

Contact Information PDMP Center of Excellence of Brandeis University www.pdmpexcellence.org 781-736-3909 John Eadie, MPA, Director jeadie@brandeis.edu 518-429-6397 Peter Kreiner, Ph.D., Principal Investigator pkreiner@brandeis.edu 781-736-3945