pain management updates and issues robert twillman, phd the university of kansas medical center

Pain Management Updates and Issues

Robert Twillman, PhDThe University of Kansas Medical Center

Pain is a major public health issue 80% of patients present for health care

because of pain Chronic pain affects 30-40% of the

population Over 40% of hospital patients report poor

pain control Unrelieved pain costs our economy over

$100 billion each year

Prescription Opioid Abuse is a Public Health Issue

2007 National Survey on Drug Use and Health (NSDUH): 33.5 million Americans had used a pain

reliever non-medically at least once in their lifetimes (13% increase from 2002)

Sources of Abused Drugs, NSDUH 2007

Source of Pain Relievers for Most Recent Nonmedical Use, Past Year, Users 12 or Older

Free from friend/relative56%

Bought/Took from friend/relative

14%

One doctor18%

More than one doctor3%

Drug dealer/stranger4%

Bought on internet1%

Other4%

“Other” includes “Wrote Fake Prescription”, “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy”, and “Some Other Way”

Sources of Abused Drugs, NSDUH 2007

Sources Where Friend/Relative Obtained Drug

One doctor80%

Drug dealer/stranger2%

Bought on internet0%

Bought/took from friend/relative

6%

Free from friend/relative7%

More than one doctor3%

Other2%

“Other” includes “Wrote Fake Prescription”, “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy”, and “Some Other Way”

NSDUH Data Are Unreliable

Definition of “nonmedical use” is problematic

Asking about source of drug is problematic High social desirability factor

Asking your research subject where he got his drug is affected by this

Asking your research subject where his source got the drug is tremendously unreliable

Prescription Opioid Abuse is a Public Health Issue

2002 Drug Abuse Warning Network data (DAWN; ED visits) : 108,320 for opioid analgesics (153% increase from

1995) 2006 Treatment Episode Data Set (TEDS):

Non-heroin opioids were primary drug of abuse for 74,750 patients entering substance abuse treatment nationwide (550% increase from 1996)

Drug Treatment Admissions, Non-Heroin Opioids as Primary Drug

16,605

74,750

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

80,000

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Number of Admissions

450% Increase over 10 years

Recent Survey

Teen-agers now say it is easier to get prescription drugs than it is to get beer

Sources of Diverted Prescription Opioids

Supply chain thefts Internet pharmacies Thefts from patients “Purchases” from patients Prescription forgery Illegal prescribing practices Prescribing to individuals who deceive

prescribers

Measuring and Controlling Drug Diversion

Due to the nature of the problem, measuring the extent of drug diversion is extremely difficult

Pharmacy thefts can be tracked, as can prescriptions

Most other sources are virtually impossible to examine

Can drug abuse statistics be used as a surrogate? Are all abused drugs diverted?

HCP-Related Reasons for Inadequate Pain Management

Survey of 1177 Oncologists: Inadequate Pain Assessment (79%) Patient Reluctance to Report Pain (62%) Patient Reluctance to Take Opioids (62%) MD Reluctance to Prescribe Opioids (61%)

Why are physicians anxious about managing chronic pain with opioids?

Uncertainty related to assessment Concern about detrimental side effects Unfamiliarity with opioids, adjuvants Fear of addiction Fear of lawsuits Fear of regulatory scrutiny

Means of Improving Pain Management

Changes to policies and standards

Education of providers and patients

Development of practice guidelines

Monitoring and continuous quality

improvement

Patient-Related Reasons forInadequate Pain Management

Fear of addiction Fear of side effects Expectations are low MD might have to choose which to treat--

disease or pain Fear of distracting the doctor Complaining about pain might annoy the

doctor

What We Hear From Patients

Many have difficulty finding physicians who will treat their pain adequately

A few report problems with pharmacies filling prescriptions for pain medications

Some have difficulty getting insurance companies and Medicaid to pay for pain treatment

Many have (incorrectly) been told they either are addicted or at high risk for addiction

National Pain Policy Issues

Current Issues

Federal legislation National Pain Care Policy Act Methadone Treatment and Protection Act

FDA activities Propoxyphene Acetaminophen recommendations REMS for long-acting opioids

Current Issues

DEA activities ePrescribing Disposal of Controlled Substances

American Geriatric Society pain treatment guidelines

National Pain Care Policy Act

Originally introduced in early 2000s In last session of Congress

Passed House near end of session Stalled in Senate HELP Committee

Current session Passed House quickly Stalled in Senate HELP Committee

Now amended to health care reform bills in both houses


Background Pain affects about 80% of people presenting for

health care Pain research funding at NIH represents 0.1% of all

NIH grant funding There are 23 review groups to evaluate pain-related

grants, which must compete against very unlike grant applications

Ongoing significant deficits in healthcare provider education related to pain management


Provisions IOM to convene a Conference on Pain ($500K

appropriated) Director of NIH encouraged to expand, through Pain

Consortium, an aggressive program of basic and clinical research

Pain Consortium to issue yearly recommendations on research initiatives

NIH to establish Interagency Pain Research Coordinating Committee


Secretary of HHS is to establish grant program for education and training in pain care ($5M annually appropriated)

Secretary shall establish and implement a national pain care education outreach and awareness campaign (focused on consumers; $2M appropriated for FY 2010, $4M for FY 2011 and FY2012)

Methadone Treatment and Protection Act

Introduced by Senator Rockefeller (D-WV) on 3/31/09

Referred to Senate HELP Committee


Background Methadone is a highly effective, very inexpensive

long-acting opioid analgesic It is difficult to use because of its pharmacological

properties It has a long half-life (up to 100 hours for some of its

metabolites) Does not produce significant euphoria Effects of dose change not completely seen for about

4 days


Methadone uses Methadone maintenance for opioid addicts

Intended to prevent withdrawal, curb cravings Administered daily at clinics Typically a life-long treatment

Management of pain Very low doses may be very effective Administered 2-4 times per day May be stopped if pain is no longer present


1998-2006: Prescriptions increased 700% In 2005, there were 4462 methadone-

related deaths, up by 468% since 1999 Other poisoning deaths increased by 66%

over same period Rate of methadone deaths in 15 to 24-

year-olds increased 11-fold, and may be underreported


Bill calls for: Consumer education campaign ($15M each

year FY2010-2014) Practitioner education (funded through portion

of DEA registration renewal fees) No use of 40 mg diskette doses outside of

maintenance programs Secretary of HHS to establish Controlled

Substances Clinical Standards Commission


Bill calls for: Funding of 1995 National All-Schedules

Prescription Electronic Reporting (NASPER) program at $25M per year for FY2010-2014

Improved reporting standards for methadone-related deaths

Food and Drug Administration Activities

Propoxyphene

Propoxyphene is an opioid analgesic Research suggests it is may be only marginally

effective, if at all, in treating pain It has a long-lived metabolite that irritates the

nervous system and causes heart rhythm disturbances

Found in Davron, Darvocet; marketed since 1957

Pain guidelines recommend not to use this drug

Propoxyphene

FDA was asked to review drug because: Insufficient evidence to suggest it is an effective

analgesic It was withdrawn from the UK market because of the

risk of deliberate and accidental overdose It is cardiotoxic and has narrow therapeutic index It is widely prescribed, especially in elderly, and is

associated with a large number of deaths

Propoxyphene

FDA advisory committee voted 14-12 to recommend withdrawal from the market

FDA decided to keep drug on the market “Benefits outweigh risks” Manufacturer required to do safety studies FDA to work with other agencies to conduct

additional studies

Acetaminophen

Active ingredient in Tylenol Found in a multitude of over-the-counter

medications Also found in some prescription medications,

combined with opioids High acute doses can cause fulminant liver

failure and death High chronic doses can cause chronic liver

failure

Acetaminophen

Frequently, problems arise because patients are prescribed medications containing acetaminophen while also taking OTC acetaminophen

FDA decided to review this medication to see if there were ways to improve its safety

Advisory panel meeting was held June 29-30 Votes taken on a number of questions

Acetaminophen

Question: Do you recommend current maximum dose be allowed? Strong yes: 11 Yes: 10 No: 16

Question: Should max single dose be 650 mg? Strong yes: 12 Yes: 12 No: 13

Acetaminophen

Question: If current doses of OTC products are lowered, should current maximum dose (2 X 500 mg) be switched to prescription-only? Strong yes: 8 Yes: 18 No: 11

Acetaminophen

Question: Do you recommend pack size limits for OTC products? Strong yes: 2 Yes: 15 No: 20

Question: Should OTC combination products be eliminated? Strong yes: 2 Yes: 11 No: 24

Acetaminophen

Question: Should only one concentration of OTC liquid be available? Strong yes: 19 Yes: 17 No: 1

Question: Should prescription combination products be eliminated? Strong yes: 10 Yes: 10 No: 17

Acetaminophen

Question: Should all prescription combination products be blister-packed? Strong yes: 5 Yes: 22 No: 10

Question: Should there be a boxed warning on prescription combination products? Strong yes: 25 Yes: 11 No: 1

Opioid Risk Evaluation and Mitigation Systems (REMS)

The FDA Amendments Act of 2007 gave FDA authority to require that drugs and biological products have a REMS to insure that the benefits of drug or product outweigh the risks

FDA has been requiring this more often Now considering applying this to long-

acting opioids

Why a REMS for Long-Acting Opioids?

Perception is that there have been massive increases in abuse of these medications

Perception is that there have been many overdose deaths due to this abuse

Considerable pressure being exerted by Congress to do something about this

What Might a REMS for Long-Acting Opioids Look Like?

Might require registration of prescribers, pharmacies, and patients

Might require specific education for prescribers and pharmacists

Might restrict outlets for medications Might require ongoing evaluation of effects

of REMS

Why is This a Concern?

Research shows that any barrier to prescribing opioids results in significant decrease it their use, regardless of the appropriateness of that use Example: Triplicate prescription forms

Provides an easy way for providers to “opt out” of prescribing

People with pain already have major issues in accessing appropriate care

The chilling effect of REMS may worsen this

What Has FDA Done So Far?

Series of meetings with Pharma and pain advocacy groups

Series of public meetings Many discussions individually with pharma

companies Threatened to withdraw all opioids from the

market Established a REMS for a new short-acting

opioid analgesic

Onsolis REMS

Onsolis is a BEMA (bioerodable mucoadhesive) product containing fentanyl

Adheres to inside of cheek and dissolves, releasing fentanyl into the bloodstream

Works very rapidly and does not require the patient to swallow

Occupies a niche in pain management that is similar to two existing drugs, Actiq and Fentora

Onsolis REMS

On July 16, 2009, FDA approved Onsolis to manage breakthrough pain in cancer patients, with a REMS

Onsolis REMS

REMS requires: Prescribers, pharmacies, and patients must register with

the manufacturer Registration program will provide educational materials to

prescribers and pharmacies Patients will receive a counseling phone call prior to

dispensing Only participating pharmacies will fill prescriptions, which

must be mailed to patients’ homes Boxed warning: no use for migraine, dental pain,

postoperative pain, or in patients not using opioids continuously

Onsolis REMS

FDA says this REMS is specifically tailored to Onsolis and should not be viewed as a model for long-acting opioids

Still, it contains many of the elements discussed for long-acting opioids

Evaluation of effects of this REMS is not mentioned in the press release

DEA: ePrescribing

DEA has undertaken a rule-making process designed to allow for the electronic transmission of prescriptions from prescriber to pharmacy

Proposed rule first issued June 27, 2008

ePrescribing

Benefits: Reduction of prescription forgery Reduction of errors caused by illegible

handwriting or misunderstood oral orders Easier integration into electronic medical

records Reduction of paperwork Improved efficiency in filling of prescriptions

ePrescribing

Concerns: Security, security, security

Are prescribers qualified? Who in the practice “signs” these? ID/password security Intermediaries may open, alter record Records held by third parties, requiring subpoena Records will need to be downloaded, translated

Cost

ePrescribing

Proposed Level 4 authentication Requires two identifying factors One of these must be stored on a “hard

token” such as a PDA, cell phone, smart card, thumb drive, or multi-factor one time password token

This is a work in progress, but has much to recommend it

Disposal of Controlled Substances

Research previously cited suggests that a major source of drug diversion is stealing from people with legitimate prescriptions

People who do not finish prescriptions frequently keep remaining doses rather than disposing of them, creating the opportunity for theft


Pharmacies are legally allowed to receive controlled substances back from patients for disposal, but doing so creates so many difficulties that it is very rarely done

Prescribers are not permitted to receive and dispose of controlled substances without doing the same paperwork


Current advice from federal agencies conflicts Some say to crush tablets/capsules, mix with

kitty litter or coffee grounds, and dispose of them in the trash

Others say to flush them down the toilet The EPA says flushing them down the toilet

causes water pollution


A simple coherent system would provide significant benefits by reducing opportunities for diversion

There is potential that some medications, if packaged appropriately, could even be reused, although there may be reasons not to risk this


DEA is working on a method to allow pharmacies and/or prescribers to take back unused controlled substances without undue paperwork

Private companies are starting to explore getting into this business as well

American Geriatric Society Guideline on Management of

Persistent Pain in Older Persons

Background

AGS previously published a guideline on management of pain in older persons in 1998 and 2002

This update is intended to include new evidence, new medications, and new techniques since 2002

What’s New?

Emphases in this guideline include the following: Acetaminophen may be preferable to

traditional NSAIDs because of a preferable side effect profile

Opioids may be preferable to NSAIDs in patients for whom they are appropriate

Conflict with FDA?

AGS recommends acetaminophen and opioids vs. NSAIDs

FDA is trying to limit use of acetaminophen and opioids

Resolution of these conflicts requires achievement of a certain kind of balanced policy

State Level Issues

Pain Management in Kansas Faces Few Actual Barriers

No major provisions in any state statute, regulation, or guideline significantly interfere with good pain management

Disciplinary actions are relatively few Per capita morphine consumption parallels

national trends Continuing education interest is high

Pain Management in Kansas Faces Perceived Barriers

Many physicians fear that peer review or peer opinions will significantly impede good pain management

Significant impact from two high-profile legal cases

Physicians perceive that they are at high risk of being investigated

The Principle of Balance

Public policy needs to strive to achieve balance, such that policies Encourage appropriate pain management,

including access to controlled substances, for those with pain, while they

Discourage and prevent access to controlled substances for individuals utilizing them solely for purposes of diversion and/or abuse

Criteria for Evaluating State Pain Policies

Formulated by Dave Joranson and staff of Pain and Policy Studies Group, University of Wisconsin

Most recent publication July, 2008 Surveys all state pain statutes,

regulations, and guidelines 8 “positive” criteria, 9 “negative” criteria

Positive Criteria

Controlled substances recognized as necessary for public health

Pain management recognized as part of general medical practice

Medical use of opioids recognized as legitimate professional practice

Pain management is encouraged

Positive Criteria

Practitioners’ fears of regulatory scrutiny are addressed

Prescription amount alone not sufficient to determine legitimacy of prescribing

Physical dependence and tolerance NOT confused with addiction

Other provisions enhancing pain management

Negative Criteria

Opioids considered treatment of last resort Medical use of opioids implied to be

outside legitimate professional practice Physical dependence or tolerance

confused with addiction Medical decisions are restricted Length of prescription validity is restricted

Negative Criteria

Practitioners subject to undue prescription requirements

Other provisions that may impede pain management

Provisions that are ambiguous

PPSG Report Card Grades, July 2008

B Grade C GradeA Grade

The Pain Policy Landscape Beyond the Report Card

PPSG Report Card has been tremendously helpful Snapshot of current situation Impetus for improvement Guidance on changes to make Covers much of what is needed to allow good pain

management But it does not cover all important areas of policy

What’s Missing?

Report Card only covers some laws and their associated regulations and licensing board guidelines

Only refers to controlled substances policy Doesn’t cover some applicable laws Doesn’t cover laws/regulations governing

managed care/worker’s comp Doesn’t cover continuing education mandates

Examples from Beyond the Report Card

Prescription monitoring programs Managed care/worker’s comp Mandated continuing education Ongoing issues with law enforcement

Prescription Monitoring Programs

Designed to track prescriptions for controlled substances as an means of identifying patterns indicative of abuse and diversion

Initially set up in 1939 in California Spreading rapidly due, in part, to federal

grant funding

PMPs Could be a Boon to Balanced Pain Policy

Detection of substance abuse through these programs could lead to greater utilization of substance abuse treatment, reducing “demand side” of diversion

Clinicians could use programs to feel more confident in their prescribing for patients

Detection of diversion is a more thorny issue because of law enforcement involvement

Prescription Monitoring Programs: Do They Work?

General Accounting Office evaluation, 2002, said these programs work because: They shorten law enforcement investigation times by

> 80% in 3 states questioned for the report They reduce OxyContin prescribing

Only 2 of top 10 OxyContin-prescribing states have PMPs, while 6 of the bottom 10 states have PMPs

When states establish programs, you see increases in diversion in adjoining states, according to law enforcement sources

Prescription Monitoring Programs: Do They Work?

Shorter investigations do not necessarily mean fewer, or more appropriate, investigations

Decreased prescribing may affect legitimate pain patients as well as diverters

Shift in diversion activities to adjoining states may reflect chilling effect on prescribing in monitored states

State PMP Status, 2003

Operating ProgramsNo PMP

States With Prescription Monitoring Programs, August 2009

PMP Pending PMP OperatingNo PMP“Current”

Legislation

Impact of PMP vs. no PMP on Retail Opioid Distribution, 2003

Drug No PMP Mean

PMP Mean

% Difference

p

Oxycodone 11292 9540 -15.5 .167

Morphine 4927 4397 -10.8 .359

Fentanyl 117 114 -2.6 .657

Hydromorphone 216 197 -8.8 .434

Meperidine 2246 1739 -22.6 .184

Codeine 6937 8451 +21.8 .026

Hydrocodone 6938 10076 +45.2 .014

All amounts expressed in grams/100,000 population

Impact of PMP vs. no PMP on Measures of Drug Abuse

Indicator No PMP Mean

PMP Mean p

TEDS 25.36 27.29 .816

NSDUH 4.51 5.31 .014

TEDS = Treatment Episode Data Base, admissions/100,000 population, non-heroin opioid as primary substance of abuse

NSDUH = National Survey on Drug Use and Health, percent of respondents > 12 years of age with non-medical use of prescription opioids in past year

Survey of State PMP Programs

Electronic survey targeting the 23 operating PMPs in 2006

18/23 (78%) responded Schedules monitored:

II-V: 6 II-IV: 3 II-III: 1 II: 7

Katz, et al., Pain Medicine, 2008:9(5), 587-594


Number providing data to clinicians: Upon request: 9 Upon request + unsolicited: 2 Not at all: 7 (5 planning to do so)

Turnaround time for requests < 1 hour: 8 1 hour – 1 day: 1 1 day – 1 week: 1



Guidelines for use: 10 said these were important 3 states had existing guidelines 4 were developing guidelines 5 were planning guidelines

Education programs: 8 had developed these



Evaluation efforts 2 states developing criteria to evaluate validity

of classifying patients into groups; 4 states said this was “not at all” important

2 had conducted evaluation of public health impact


BJA Harold Rogers Grant Requirements: Outcomes

Grants require certain “outcome” measures be reported: # of prescribers, dispensers, investigators

trained Coroner reports of Rx CS as cause of death # of reports generated from system # of individuals using multiple pharmacies # of prescribers/distributors trained to share

data

PMP Programs: Needs

Access for prescribers/dispensers Education for prescribers, dispensers,

investigators Proactive and reactive reporting Adequate provisions for referral to

substance abuse treatment

PMP Programs: Needs

Outcomes research (positive and negative impacts) Legal Public Health

Pain Addiction

Information sharing across states

Managed Care and its Impact on Pain Management

Managed care has a great stake in controlling costs of treating pain Many people have chronic pain Treatment for chronic pain can be costly Treatment for chronic pain can be indefinite

Attempts to control costs have, in many cases, fallen prey to a “silo mentality”

Managed Care’s Silo Mentality

Efficacy, safety, and cost: Which comes first?

Efforts to control costs often focus on single arenas without consideration of unintended consequences

Reducing costs in one silo may result in increased costs in other silos, and may, in fact, produce increased costs overall

Managed Care’s Silo Mentality

Strict control of prescriptions can result in: More ER visits More physician office visits More hospitalizations/hospital days More nursing home days Decreased effectiveness of pain

control/decreased quality of life Perhaps even patient deaths

Examples of Problematic Controls

Step therapies Requirements that less expensive

medications be tried and found to fail before more expensive medications can be used

May even mean that use of medications WITHOUT appropriate FDA indications is required before those WITH appropriate indications are used

Step Therapy Example

Treatment for fibromyalgia Poorly-understood, difficult to treat chronic

pain syndrome Characterized by highly sensitized nervous

system Three medications currently have FDA

indications to treat: duloxetine (Cymbalta), milnacipran (Savella), and pregabalin (Lyrica)


For any of these to be covered, one insurer requires that patients first try: One tricyclic antidepressant AND One muscle relaxant AND Non-pharmacological therapies (e.g. cognitive-

behavioral, exercise, etc.) AND At least TWO of the following:

Any SSRI, or Tramadol, or Gabapentin


Quality of evidence and estimated duration for each step: Tricyclic antidepressants: , > 2 months Muscle relaxants: , > 1 month Non-pharmacological therapies: , at least 3-4 months SSRI: , > 4 months Tramadol: , 1 month Gabapentin: , > 2 months


Requirements that more “problematic” medications are used Some programs have been known to require

use of morphine and methadone before patients can access other opioids

Methadone in untrained/inexperienced hands is a dangerous proposition

Has this resulted in harm? If so, how much?


Limitations on number of pills allowed Companies have been known to place limits

on the number of PILLS allowed in a given prescription, as opposed to the number of DOSAGE UNITS allowed

Given the need to individually titrate doses, this can create problems for patients and prescribers


Problematic controls are not limited to just medications

Consider therapies such as physical therapy, occupational therapy, psychotherapy

Some patients fall into on/off therapy patterns, with accompanying on/off symptoms and healthcare utilization

Mandated CME for Pain Management/Palliative Care

Mandates can either be legislative or non-legislative In some states, requires passage of law In other states, licensing board is free to set

CME requirements; in these states, passing a law is a way to produce this mandate

Some states have chosen to “encourage” CME rather than require it


Education alone is not sufficient to change practice

Education IS necessary to change practice, however; “You can’t do what you don’t know”.

One-time requirement vs. requirement for each license renewal period


Jury is still out with respect to effectiveness of this approach

Need to work closely with practitioner groups, as many are likely to oppose mandates if they are not part of the process

May wish to choose a step-wise approach, starting with a practitioner survey

States Mandating or Encouraging CME for Pain/Palliative Care (as of October 2005)

CME Encouraged CME Mandated

Pain Management and the Legal System

Prescribers frequently cite fear of prosecution and loss of license as reasons they fear trying to manage pain

Certainly, if this is a significant risk, it presents a barrier

But, is it a significant risk? What do the data tell us? Is this an urban myth?

Needed: balanced pain policy Physicians need to:

Know how to treat pain patients knowledgeably using opioid-based medications

Be aware of federal and state laws governing the prescribing and handling of controlled-substance pain medications

Prescribe opioids without fear of unwarranted investigation or prosecution

Law enforcement and regulatory officials need to: Make opioid-based medications available for legitimate medical use Prevent the diversion and abuse of such opioid-based medications Know how to distinguish criminal prescribing behaviors from medical

malpractice

The Balanced Pain Policy Initiative

Since 2005, a unique, ongoing partnership of three organizations:

Center for Practical Bioethics National Association of Attorneys General Federation of State Medical Boards

Purpose: develop policy-level recommendations and training opportunities to help physicians and law enforcement agencies address, and seek to resolve, prescribing- and enforcement-related problems that contribute to the undertreatment of pain.

Good ethics start with good facts

The Initiative’s first step: address the “chilling effect” of high-profilecases by obtaining factual answers to questions that include:

How many physicians actually have been prosecuted or sanctioned for opioid-prescribing or –handling offenses in recent years?

How many physicians involved in these opioid-related cases have been pain specialists?

Have the charges brought against these physicians had mostly todo with mis- or over-prescribing, or with causing harm to patients?

Have most of the physicians who have been criminally charged,pled not guilty?

Have most of the physicians brought before state medical boards for opioid-handling or –prescribing offenses, had their licenses revoked?

How the physician cases were identified

Archived news stories Agency Websites (DEA, state criminal courts, state medical boards) Organization Websites (including patient-advocacy organizations) Federal of State Medical Boards database (accessed by FSMB

staff) Drug Enforcement Administration databases (accessed by DEA

staff) Lexis/Nexis PACER (Public Access to Court Electronic Records) Federal Register Contacts with federal and state prosecutors, court clerks, offices of

state attorneys general

How physicians’ demographic characteristics and medical specialties were identified

American Board of Medical Specialties database (ABMS specialty certifications)

American Osteopathic Association database (AOA specialty certifications)

American Academy of Family Physicians database (AAFP certifications)

American Medical Association database (physician demographics, medical specialties, general workforce characteristics)

Online commercial physician-directory databases (physician-provided medical specialties, demographics, medical schools)

Numbers of Cases and Physicians

By researching opioid-related cases filed or heard over a nine-year period (1998-2006) The Balanced Pain Policy Initiative identified:

996 Cases… Criminal — 335

Federal — 157 State — 178

Administrative — 651Federal (DEA) — 126

State medical boards — 525

…involving 725 physicians

Study limitations included:

Lack of information on investigations. Medical boards and enforcement agencies are reluctant to release, and often do not retain, data and information on investigations that do not result in prosecutions or board hearings.

Limited information on physician characteristics. More information is needed on additional, potentially-relevant characteristics of study physicians, such as race/ethnicity, years in

practice, and practice settings.

Key findings: Question #1

Q. How many physicians actually have been prosecuted or sanctioned for opioid-prescribing or –handling offenses in recent years?

A. Very few. We were able to identify only 725 individual physicians who were involved in criminal or state medical board cases of this type between 1997-2006.

They represent 0.1% of approximately 700,000 active U.S. patient-care physicians.


Q. Have most of the physicians involved in these cases been pain specialists?

A. No. Almost 40% of the 725 physicians involved in these cases were general practice/family medicine specialists. Only 3.5% were board-certified or self-identified pain specialists.

These general practice/family medicine physicians involved also were over-represented (i.e., had higher prevalence rates/1,000 physicians) compared with the numbers of physicians of this type in the workforce.

Pain medicine specialists also were over-represented compared with their numbers in the workforce, but to a lesser degree.

Key findings: Question #3Q. Have most of the charges against these physicians been for

misprescribing, overprescribing, or for causing harm to patients?

A. No. Most of the criminal charges (over 75% of charges) were for diversion offenses such as drug trafficking, fraud, illegal possession, or conspiracy to obtain. Only a small percentage of charges (5%) were for murder, manslaughter, or harmful/inappropriate relationships with patients.

Most medical board charges (35% of charges) were for sloppy or falsified record-keeping or for violating practice standards (e.g., failure to give physical exams). A smaller percentage (15% of charges) were for misprescribing, overprescribing, prescribing to addicts, or harmful/inappropriate relationships with patients.


Q. Have most of the physicians who were criminally charged, pled not guilty?

A. No. Four out of five (80%) pled guilty or no contest to at least one of the criminal charges brought against them.

Ultimately, nine our of ten of the prosecuted physicians (90%) either pled guilty or subsequently were found guilty on at least one count.


Q. Have most of the physicians called before state medical boards for opioid-handling or –prescribing offenses had their medical licenses revoked?

A. No. Medical boards were more likely to impose temporary suspensions or to require temporary surrenders of medical licenses (38% of cases), usually during the time the physician attended required, relevant continuing education courses.

Boards permanently revoked or refused to renew these physicians’ licenses in only 18% of cases.

Next steps Disseminate study findings. Publicize facts identified in this study

among medical, regulatory, and enforcement audiences. Study possible additional reasons for the “chilling effect.”

Reasons may include persistent media use of terms such as “the war on pain” and “pill-mill doctors” in describing recent high-profile cases.

Educate. Physicians need to learn how to prescribe opioids safely and how to comply with laws and regulations that surround their prescribing and use. Law enforcement officials and medical board members may need to learn more about acceptable dosages and patient-caused problems involving prescribed opioids.

Encourage dialogue. Provide opportunities for physicians and enforcement officials to address and resolve prescribing- and enforcement-related problems contributing to the undertreatment of pain.

Questions and Discussion

pain management updates and issues robert twillman, phd the university of kansas medical center

Documents

unreliable slide

way slide

pain chronic pain

year slide

beer slide

drug use

source of drug

primary drug of abuse