Government Intervention in Opioid Prescribing by PAINWeek

Government Intervention in Opioid Prescribing

Stephen Ziegler, PhD, JD Aaron Gilson, PhD Jennifer Carpenter, NADDI John Peppin, DO

Disclosure Information Stephen Ziegler, PhD, JD – Nothing to disclose Aaron Gilson, Ph.D. – Nothing to disclose

Disclosure Information (cont’d)  John Peppin, D.O. – – Consultant/Independent Contractor: AIT Laboratories, Ameritox Laboratories, Grünenthal Pharmaceuticals, INSYS Therapeutics, Salix Pharmaceuticals; – Honoraria: AIT Laboratories, Ameritox Laboratories, Depomed Pharmaceuticals, Grünenthal Pharmaceuticals, INSYS Therapeutics, Salix Pharmaceuticals; – Speaker's Bureau: Salix Pharmaceuticals

 Jennifer Carpenter, NADDI – Nothing to disclose

Learning Objectives  Describe the extent of undertreated pain and the efforts to reduce the abuse and diversion of pharmaceuticals  Identify the process by which legislation and regulation are created and their different functions and purposes  Explain the intended purpose of legislation in Florida, Washington State, and Prescription Monitoring Programs (PMPs)  Examine the potential positive and negative impacts of government intervention in opioid prescribing from multiple perspectives (e.g., legal, clinical, and law enforcement)

Two Competing Public Health Crises Undertreated pain IOM report: Impact > 100 million

Increase in M & M associated with opioids

One Solution to Crisis: Governmental Intervention in Rx Are Governmental Interventions In Prescribing Something New?

No  1906 Pure Food and Drug Act

 1914 Harrison Tax Act  Early 1900s - Medical Regulation advanced by physicians  1970 federal Controlled Substances Act (CSA)  1998: Lethal Drug Abuse Prevention Act; 1999 Pain Relief Promotion Act (failed; intervention not as it appeared)

How Legislative and Regulatory Interventions are Created  Congress (Co-equal branch but 1st Article in US Constitution no accident)  Creates the law  Provides the structure/skeleton of the intervention  Similar @ state level

Administrative/Regulatory Agencies  Executive branch enforces law  Administrative agencies create rules and regulations (further interpreting existing legislation; they clothe the legislative skeleton)  Devil in the details? Yes; opportunity to provide influence

Intervention Examples Federal: Congressional oversight committees + the elephant State: WA State Rx dosage ceiling trigger (morphine equivalent dose) (HB 2876;WAC 246-919-850) State: Florida Pill Mill legislation (Fla. HB 7095) State: PMPs Federal and State: Law Enforcement

John Peppin, D.O., F.A.C.P. Clinical Issues and Impacts

Clinical Impact  The problem: – Dramatic increase use of opioids/scheduled medications prescribing and use – Opioids/scheduled medications are abused, misused, diverted and overdose deaths do occur – Intersection of medicine, illegal activity and law enforcement • Physicians/HCPs are not trained to be law enforcement officers • Law enforcement officers are not versed in medicine or the treatment of chronic pain

– Unproven long term efficacy for opioids – Significant medical side effects from opioids – Lack of patient responsibility

Clinical Impact (cont’d) Medical Goal –Reduce overdose deaths –Reduce incidence of addiction –Reduce diversion of scheduled medications –Reduce abuse and misuse of scheduled medication –Maintain ability to treat chronic pain

Clinical Impact (cont’d) Legislative Goal –Increase votes and re-election funds •Reduce overdose deaths •Reduce incidence of addiction •Reduce diversion of scheduled medications •Reduce abuse and misuse of scheduled medication

Clinical Impact (cont’d)  Misunderstandings – Physicians are the main source of illegal scheduled drugs – Scheduled drugs have “caused” increased addiction – Scheduled drugs have “caused” an “epidemic” – Legislation will solve the problem of scheduled medication misuse, abuse, diversion and overdose deaths – “Overdose deaths” are due to increased prescribing • Death statistics from illicit drugs, prior to 2000, were poor • With all the media attention, more attention has focused on the problem, so we are looking for this

Clinical Impact (cont’d)  Irresponsible Media – “Epidemic”, “pain killers” etc.. – Goal: increase circulation and advertising revenue

 A Rational Approach:

Clinical Impact (cont’d)  How do we achieve these goals?

– Clear definitions of the terms involved:

• What is the definition of “overdose death”? • What is the definition of “pill mill” or “doctor shopper”?

– Clear understanding of the problem:

• We need good, relevant and current data bases

– Evidenced Based Legislation

• Evidence-based legislation (EBL) calls for the use of the best available scientific evidence and systematically collected data, when available, by legislatures as a basis for their formulation and writing of law • Research into both unexpected and expected outcomes

– Multidisciplinary approach

• CANNOT solve the problem with a single answer

Clinical Impact (cont’d) 1. What to measure?

– Clear Definitions:

• Cannot measure things you cannot define clearly! • Overdose deaths:

2. The problem:

– Most deaths that involve prescription drugs involve multiple CNS depressants. – Not possible, usually, to blame a single entity

– Needs assessment. • • • •

Define the problem. What do we need to understand this problem? What resources do we have and what do we need to develop? Are these resources accurate, accessible and reliable?

3. How to measure?

– Once resources defined, how will they be accessed, how will the data be processed?

4. Measuring long term outcomes:

– Must be long term outcomes, not just until the next election – Will a proposed intervention work?

Clinical Impact (cont’d)  “Chilling Effect”  Reduction in opioid prescribing  Examples from Kentucky HB4

– Poor legislation, pushed through without in-depth rational thought • We must “do something”

– Problems:

• Post-surgical opioids • Significant reduction in PCPs willing to prescribe scheduled medications of any kin. • Increased cost, not covered in the legislation – Urine drug monitoring, not covered by Medicaid and other insurance carriers

• Requiring PMP KASPAR reports

– Currently <20% of physicians in Kentucky registered – Requires every physician who prescribes scheduled medications to register » No increase in funding

Clinical Impact (cont’d)  Taking Pain, misuse, abuse, diversion and addiction seriously – Health Care Professionals • Chronic pain treatment is very complex • Requires a full evaluation and assessment • Prescribing opioids must be taken seriously • HCPs have a professional and societal responsibility

Clinical Impact (cont’d)  Taking Pain, misuse, abuse, diversion and addiction seriously – Law Enforcement • Needs to understand the treatment of pain. • Appropriate use of opioids and scheduled medications. • NADDI

– Media • Needs to report issues responsibly

Clinical Impact (cont’d)  Taking Pain, misuse, abuse, diversion and addiction seriously – Legislative • Evidence based legislation • Increase treatment option for addiction – Increased in-patient beds – Increased counseling services – Develop a foundational public health policy » Treating pain and misuse of scheduled medications is a public health problem

Jennifer Carpenter NADDI Law Enforcement Concerns and Responses

Aaron Gilson, Ph.D. PMPs

States With Operational PMP’s (N=42) WA VT ND

OR ID

MI PA

TN SC AL

RI CT DE MD

States With PMP Laws (N=50) WA VT ND

OR ID

MI PA

TN SC AL

AR AR

RI CT DE MD

Prescription Monitoring Programs Historically  Used government-issued serialized forms

– “multiple-copy prescription programs” (MCPPs)

 Applied only to Schedule II medications  Administered by law enforcement  Data were not compiled timely  MCPPs associated with drop in use of Schedule IIs – “Stigmatization,” “substitution effect” – Cost savings – Evidence of program effectiveness

 No direct evidence of decreased abuse/diversion

Prescription Monitoring Programs Recently States use electronic data transfer systems (EDTs) Applies to multiple schedules of medications – Obviates “stigmatization,” “substitution effect”

Administered by health agencies Clear statements that these programs are not meant to hinder patient care Data are compiled more timely (still not real time)

Prescription Monitoring Programs Recently (cont’d)  >50% of states established EDT since 2005 – Harold Rogers (Department of Justice) & National All Schedules Prescription Electronic Reporting Act (Department of Health and Human Services) • Interstate exchange of program data (Interoperability)

 Little evidence of effect on legitimate prescribing  Some indication of decreased diversion – Reduced investigation time – Officials’ statements – moves out of state

Prescription Monitoring Programs Empirical Evidence Studies since the late 1980s –Descriptive –Multivariate, since the mid-1990s

Difficult to determine effects with traditional research methods –Enormously heterogeneous programs

California Prescription Monitoring Program Research on PMP Data  Funding from the Robert Wood Johnson Foundation  Supported by the Regents of the: – University of California, Davis campus – University of Wisconsin, Madison campus

 Principal Investigators: – Scott Fishman, MD – Barth Wilsey, MD – Aaron Gilson, PhD

California Prescription Monitoring Program History  1939: PMP began – oldest, continually operational, MCPP – Applied only to selected “narcotics” • Opium, hashish, marijuana, cocaine

– Limited physicians to issuing no more than 100 prescriptions in 90day period

 1972: Mandated Schedule II “narcotics”  1981: Mandated any non-narcotic Schedule II drug

Gilson AM et al. Journal of Pain. 2012.

California Prescription Monitoring Program History (cont’d)  1992: Established Controlled Substances Prescription Advisory Council to study the MCPP  1996: Established an electronic system to monitor prescribing and dispensing of Schedule II meds Senate Bill 151  Repeal of triplicate prescription PMP – Effective January 1, 2005 • Required all written prescriptions for Schedule II-V controlled substances to be issued on tamper-resistant prescription forms

Gilson AM et al. Journal of Pain. 2012.

California Prescription Monitoring Program Data Content  Patient demographics  Medication

– Name – Dose – Days supply – Refills – Route of administration – Quantity supplied – Date of prescription

 Prescriber information

California PMP Opioids in Descending Order of Prescribing Frequency* DRUG NAME

1999-2007

Hydrocodone

34,793,534

Codeine

6,406,848

Oxycodone-IR

4,479,682

* Schedule II Codeine, longacting Hydromorphone, and Buprenorphine were excluded due to low count

Oxycodone-SR

2,851,864

Fentanyl-transdermal

2,745,591

Morphine-SR

2,389,252

Methadone

1,496,601

IR = immediate release; SR = sustained release

Hydromorphone

823,866

Morphine-IR

412,646

Fentanyl-Lozenge

181,288

Meperidine

125,861

Levorphanol

15,988

SCHEDULE III SCHEDULE II

Total Rx Count

56,723,021

California Prescription Monitoring Program Effects on Opioid Prescribing and Multiple Provider Episodes

 Data analyzed from prescriptions entered into the PMP database – January 1, 2000-October 31, 2006

 Series of time series models – Changing from a multiple copy prescription form for Schedule II medications to a tamper-resistance security form for Schedule II-V medications: • Opioids: Short- and Long-Acting fentanyl, morphine, and oxycodone, ShortActing hydromorphone, meperidine, methadone • Multiple provider episodes for the same opioids Gilson AM et al. Journal of Pain. 2012.

California Prescription Monitoring Program Effects on Opioid Prescribing and Multiple Provider Episodes (cont’d)

 Multiple provider episode – Same opioid from 2 or more prescribers within a 30- day period

Gilson AM et al. Journal of Pain. 2012.

California Prescription Monitoring Program Prescribing of Short-Acting Hydromorphone

Gilson AM et al. Journal of Pain. 2012.

California Prescription Monitoring Program Multiple Provider Episodes: Long-Acting Morphine

Gilson AM et al. Journal of Pain. 2012.

Prescription Monitoring Programs Model Laws  Alliance of States with Prescription Monitoring Programs* / National Association of State Controlled Substances Authorities – adopted October 2002; revised June 2010*

 National Alliance of Model State Drug Laws – adopted August 2002; revised November 2011

 American Cancer Society Cancer Action Network/University of Wisconsin Pain & Policy Studies Group – drafted September 2008

Prescription Monitoring Programs Important Characteristics: Purpose & Intent Common Among Model Laws  Explicit statement recognizing that PMP has a dual purpose regarding controlled substances – Reduce diversion and non-medical use – Assure availability for legitimate medical purposes

Prescription Monitoring Programs Important Characteristics: Data Reporting Common Among Model Laws  Covers at least Schedules II-IV – Allows reporting other medications of interest

 Requires timely electronic data submission – No more than 7 days

 Ability to identify and report data errors and security breaches, and to address these issues

Prescription Monitoring Programs Important Characteristics: Data Reporting (cont’d) Common Among Model Laws  Requires an authority to: – Oversee program operation – Assure accuracy of the data – Assure security of the data

 Establishes penalties for failure to comply with data submission requirements

Prescription Monitoring Programs Important Characteristics: Data Access Common Among Model Laws  Accessibility to prescribers and pharmacists regarding their patients’ data  Designates others to access data – Healthcare regulatory boards – Medicaid agency regarding program recipients – Patient or patient’s representative – De-identified data for research/education – Law enforcement

Under Certain Conditions

(Not Unlimited Access)

Prescription Monitoring Programs Important Characteristics: Data Access Common Among Model Laws ď&#x201A;§ Protects patient confidentiality ď&#x201A;§ Permits data sharing across programs (interoperability)

Prescription Monitoring Programs Important Characteristics: Educational Component  Recent Trends  Requires a mechanism to increase potential users’ awareness of the PMP  Requires instruction to teach database users about the programs’: – Purpose – Requirements – Potential usefulness to guide treatment decisions

Prescription Monitoring Programs Important Characteristics: Evaluation of Data  Recent Trends  Creates a multidisciplinary body to review patterns of prescribing and dispensing to differentiate legitimate from fraudulent prescribing  Requires an ongoing report of: – State diversion and abuse – State prescribing

 Requires ongoing submission of a report to the legislature about program impact on: – State diversion and abuse – State prescribing

Prescription Monitoring Programs Getting Involved in the PMP Dialogue  If… – There is no legislation (Missouri) • “Legislative Task Force”

– There is no regulation, or – Regulation is being reconsidered or re-drafted • “Regulatory Development Committee” • Public comment period

Prescription Monitoring Programs Getting Involved in the PMP Dialogue (cont’d)  If…PMP is operational – Advisory Committee • Multidisciplinary (both governmental and non-governmental stakeholders) • Design/implementation of education courses • Design/implementation of program evaluation – Determine methods & designate outcomes

• Establish relationships with and possibly enhance awareness of policy-makers

Panel Summary & Comments

Q & A?

References  Alliance of States of Prescription Monitoring Programs. Prescription Monitoring Program Model Act (2012) (Revision), Voorheesville, New York.  Behr D. Prescription Drug Control Under the Federal CSA: A Web of Administrative, Civil, and Criminal Law Controls. Washington University Journal of Urban and Contemporary Law, 1994; 41-119.  Courtwright DT. Controlled Substances Act: how a “big tent” reform became a punitive drug law. Drug and Alcohol Dependence, 2004; 76: 9-15.  Gilson AM, Fishman SM, Wilsey BL, Casamalhuapa C, Baxi H. Time series analysis of California’s prescription monitoring program: Impact on prescribing and multiple provider episodes. Journal of Pain, 2012; 13: 103-111.  Institute of Medicine. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research (2011), National Academies Press, Washington, D.C.

References  Jost TS. Regulation of the Healthcare Professions (1997), Health Administration Press, Chicago, IL.  Musto D. The American Disease: Origins of Narcotic Control (1999), Oxford University Press, New York.  National Alliance of Model State Drug Laws. Model Prescription Monitoring Program Act, November 19, 2011, Santa Fe, New Mexico.  Perrone J, Nelson LS. Medication Reconciliation for Controlled Substances- An “Ideal” PrescriptionDrug Monitoring Program. NEJM, 2012; May 30, 2012 (10.1056/NEJMp1204493).  Reifler LM, Droz D, Bailey JE, Schnoll SH, Fant R, Dart RC, Bartelson BB. Do prescription monitoring programs impact state trends in opioid abuse/misuse? Pain Medicine, 2012; 13: 434-442.

References  Rich BA. Oregon Versus Ashcroft: Pain Relief, Physician Assisted Suicide, and the Controlled Substances Act. Pain Medicine, 2002; 3 (4):353-360.  Scheb J.M. & Scheb J.M., II. An Introduction to the American Legal System (2010)(2nd ed.), Austin, Texas: Aspen.  Sigler KA, Guernsey BG, Ingrim NB, Buesing AS, Hokanson JA, Galvan E, Doutré WH. Effect of a triplicate prescription law on prescribing of Schedule II drugs. American Journal of Hospital Pharmacy, 1984; 41 (1), 108-111.  Spillane JF. Debating the Controlled Substances Act. Drug and Alcohol Dependence, 2004; 76: 17-29.  Starr P. The Social Transformation of American Medicine (1982). Basic Books, New York.  Wilsey BL, Fishman SM, Gilson AM, Casamalhuapa C, Baxi H, Zhang H, Li CS. Profiling multiple provider prescribing of opioids, benzodiazepines, stimulants, and anorectics. Drug and Alcohol Dependence, 2010; 112:99-106.

References ď&#x201A;§ Ziegler SJ, Lovrich NP. Oxycontin and the Need for Perspective. Pain and the Law, 2002 (republished and available at: http://www.doctordeluca.com/Library/WOD/OxyContinPerspective02.htm).