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Pain Management Updates and Issues. Robert Twillman, PhD The 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

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pain management updates and issues

Pain Management Updates and Issues

Robert Twillman, PhD

The University of Kansas Medical Center

pain is a major public health issue
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
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
Sources of Abused Drugs, NSDUH 2007

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

sources of abused drugs nsduh 20075
Sources of Abused Drugs, NSDUH 2007

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

nsduh data are unreliable
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 issue7
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)
recent survey
Recent Survey
  • Teen-agers now say it is easier to get prescription drugs than it is to get beer
sources of diverted prescription opioids
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
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
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
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
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 for inadequate pain management
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
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
current 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 issues19
Current Issues
  • DEA activities
    • ePrescribing
    • Disposal of Controlled Substances
  • American Geriatric Society pain treatment guidelines
national pain care policy act
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
national pain care policy act21
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
national pain care policy act22
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
national pain care policy act23
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)
methadone treatment and protection act
Methadone Treatment and Protection Act
  • Introduced by Senator Rockefeller (D-WV) on 3/31/09
  • Referred to Senate HELP Committee
methadone treatment and protection act25
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
methadone treatment and protection act26
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
methadone treatment and protection act27
Methadone Treatment and Protection Act
  • 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
methadone treatment and protection act28
Methadone Treatment and Protection Act
  • 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
methadone treatment and protection act29
Methadone Treatment and Protection Act
  • 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
propoxyphene
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
propoxyphene32
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
propoxyphene33
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
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
acetaminophen35
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
acetaminophen36
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
acetaminophen37
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
acetaminophen38
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
acetaminophen39
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
acetaminophen40
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
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
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
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
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
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 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 rems47
Onsolis REMS

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

onsolis rems48
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 rems49
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: 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
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
eprescribing52
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
eprescribing53
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
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
disposal of controlled substances55
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
disposal of controlled substances56
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
disposal of controlled substances57
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
disposal of controlled substances58
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
background
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
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
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
pain management in kansas faces few actual barriers
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
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
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
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
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 criteria69
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
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 criteria71
Negative Criteria
  • Practitioners subject to undue prescription requirements
  • Other provisions that may impede pain management
  • Provisions that are ambiguous
the pain policy landscape beyond the report card
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
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
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
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
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
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 work79
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
State PMP Status, 2003

Operating Programs

No PMP

states with prescription monitoring programs august 2009
States With Prescription Monitoring Programs, August 2009

“Current” Legislation

No PMP

PMP Pending

PMP Operating

impact of pmp vs no pmp on retail opioid distribution 2003
Impact of PMP vs. no PMP on Retail Opioid Distribution, 2003

All amounts expressed in grams/100,000 population

impact of pmp vs no pmp on measures of drug abuse
Impact of PMP vs. no PMP on Measures of Drug Abuse

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
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

survey of state pmp programs85
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), 587-594

survey of state pmp programs86
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), 587-594

survey of state pmp programs87
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), 587-594

bja harold rogers grant requirements outcomes
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
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 needs90
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 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
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 mentality93
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
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
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)
step therapy example96
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
step therapy example97
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
examples of problematic controls98
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?
examples of problematic controls99
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
examples of problematic controls100
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
mandated cme for pain management palliative care
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
mandated cme for pain management palliative care102
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
mandated cme for pain management palliative care103
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
states mandating or encouraging cme for pain palliative care as of october 2005
States Mandating or Encouraging CME for Pain/Palliative Care (as of October 2005)

CME Mandated

CME Encouraged

pain management and the legal system
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
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
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
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?

how the physician cases were identified
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
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
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 — 651

Federal (DEA) — 126

State medical boards — 525

…involving 725 physicians

study limitations included
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
Key findings: Question #1

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

  • 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.

key findings question 2
Key findings: Question #2

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

  • 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 3
Key findings: Question #3

Q. Have most of the charges against these physicians been for misprescribing, overprescribing, or for causing harm to patients?

  • 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.

key findings question 4
Key findings: Question #4
  • Have most of the physicians who were criminally charged, pled not guilty?
  • 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.

key findings question 5
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?

  • 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
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.