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Pain Management Updates and Issues Robert Twillman, PhD The University of Kansas Medical Center.

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1 Pain Management Updates and Issues Robert Twillman, PhD The University of Kansas Medical Center

2 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

3 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)

4 Sources of Abused Drugs, NSDUH 2007 “Other” includes “Wrote Fake Prescription”, “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy”, and “Some Other Way”

5 Sources of Abused Drugs, NSDUH 2007 “Other” includes “Wrote Fake Prescription”, “Stole from Doctor’s Office/Clinic/Hospital/Pharmacy”, and “Some Other Way”

6 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

7 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)

8 Drug Treatment Admissions, Non- Heroin Opioids as Primary Drug 450% Increase over 10 years

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

10 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

11 Supply Chain Thefts of Prescription Opioids, 2003 Note: Data cover only 22 Eastern states, representing 53% of US population. (Joranson & Gilson, 2005)

12 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?

13 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%)

14 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

15 Means of Improving Pain Management  Changes to policies and standards  Education of providers and patients  Development of practice guidelines  Monitoring and continuous quality improvement

16 Patient-Related Reasons for Inadequate 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

17 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

18 National Pain Policy Issues

19 Current Issues Federal legislation National Pain Care Policy Act Methadone Treatment and Protection Act FDA activities Propoxyphene Acetaminophen recommendations REMS for long-acting opioids

20 Current Issues DEA activities ePrescribing Disposal of Controlled Substances American Geriatric Society pain treatment guidelines

21 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

22 National Pain Care Policy Act 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

23 National Pain Care Policy Act 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

24 National Pain Care Policy Act 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)

25 Methadone Treatment and Protection Act Introduced by Senator Rockefeller (D-WV) on 3/31/09 Referred to Senate HELP Committee

26 Methadone Treatment and Protection Act 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

27 Methadone Treatment and Protection Act 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

28 Methadone Treatment and Protection Act : 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

29 Methadone Treatment and Protection Act Bill calls for: Consumer education campaign ($15M each year FY ) 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

30 Methadone Treatment and Protection Act Bill calls for: Funding of 1995 National All-Schedules Prescription Electronic Reporting (NASPER) program at $25M per year for FY Improved reporting standards for methadone- related deaths

31 Food and Drug Administration Activities

32 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

33 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

34 Propoxyphene FDA advisory committee voted 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

35 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

36 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 Votes taken on a number of questions

37 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

38 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

39 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

40 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

41 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

42 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

43 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

44 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

45 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

46 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

47 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

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

49 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

50 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

51 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

52 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

53 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

54 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

55 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

56 Disposal of Controlled Substances 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

57 Disposal of Controlled Substances 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

58 Disposal of Controlled Substances 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

59 Disposal of Controlled Substances 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

60 American Geriatric Society Guideline on Management of Persistent Pain in Older Persons

61 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

62 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

63 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

64 State Level Issues

65 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

66 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

67 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

68 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

69 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

70 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

71 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

72 Negative Criteria Practitioners subject to undue prescription requirements Other provisions that may impede pain management Provisions that are ambiguous

73 PPSG Report Card Grades, July 2008 B GradeC GradeA Grade

74 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

75 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

76 Examples from Beyond the Report Card Prescription monitoring programs Managed care/worker’s comp Mandated continuing education Ongoing issues with law enforcement

77 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

78 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

79 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

80 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

81 State PMP Status, 2003 Operating Programs No PMP

82 States With Prescription Monitoring Programs, August 2009 PMP PendingPMP OperatingNo PMP “Current” Legislation

83 Impact of PMP vs. no PMP on Retail Opioid Distribution, 2003 DrugNo PMP Mean PMP Mean % Difference p Oxycodone Morphine Fentanyl Hydromorphone Meperidine Codeine Hydrocodone All amounts expressed in grams/100,000 population

84 Impact of PMP vs. no PMP on Measures of Drug Abuse IndicatorNo PMP Mean PMP Meanp TEDS NSDUH 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

85 Survey of State PMP Programs Electronic survey targeting the 23 operating PMPs in /23 (78%) responded Schedules monitored: II-V: 6 II-IV: 3 II-III: 1 II: 7 Katz, et al., Pain Medicine, 2008:9(5),

86 Survey of State PMP Programs 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 Katz, et al., Pain Medicine, 2008:9(5),

87 Survey of State PMP Programs 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 Katz, et al., Pain Medicine, 2008:9(5),

88 Survey of State PMP Programs 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 Katz, et al., Pain Medicine, 2008:9(5),

89 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

90 PMP Programs: Needs Access for prescribers/dispensers Education for prescribers, dispensers, investigators Proactive and reactive reporting Adequate provisions for referral to substance abuse treatment

91 PMP Programs: Needs Outcomes research (positive and negative impacts) Legal Public Health Pain Addiction Information sharing across states

92 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”

93 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

94 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

95 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

96 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)

97 Step Therapy Example 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

98 Step Therapy Example 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

99 Examples of Problematic Controls 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?

100 Examples of Problematic Controls 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

101 Examples of Problematic Controls 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

102 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

103 Mandated CME for Pain Management/Palliative Care 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

104 Mandated CME for Pain Management/Palliative Care 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

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

106 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?

107 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

108 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.

109 Good ethics start with good facts The Initiative’s first step: address the “chilling effect” of high-profile cases 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 to do 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?

110 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

111 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)

112 Numbers of Cases and Physicians By researching opioid-related cases filed or heard over a nine-year period ( ) The Balanced Pain Policy Initiative identified: 996 Cases… Criminal — 335 Federal — 157 State — 178 Administrative — 651 Federal (DEA) — 126 State medical boards — 525 …involving 725 physicians

113 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.

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

115 Key findings: Question #2 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.

116 Key findings: Question #3 Q. 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.

117 Key findings: Question #4 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.

118 Key findings: Question #5 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.

119 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.

120 Questions and Discussion


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