Download - Pain Management Updates and Issues Robert Twillman, PhD The University of Kansas Medical Center
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Pain Management Updates and Issues
Robert Twillman, PhDThe University of Kansas Medical Center
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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
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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)
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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”
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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”
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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
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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)
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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
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Recent Survey
Teen-agers now say it is easier to get prescription drugs than it is to get beer
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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
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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?
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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%)
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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
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Means of Improving Pain Management
Changes to policies and standards
Education of providers and patients
Development of practice guidelines
Monitoring and continuous quality
improvement
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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
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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
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National Pain Policy Issues
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Current Issues
Federal legislation National Pain Care Policy Act Methadone Treatment and Protection Act
FDA activities Propoxyphene Acetaminophen recommendations REMS for long-acting opioids
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Current Issues
DEA activities ePrescribing Disposal of Controlled Substances
American Geriatric Society pain treatment guidelines
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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
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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
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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
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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)
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Methadone Treatment and Protection Act
Introduced by Senator Rockefeller (D-WV) on 3/31/09
Referred to Senate HELP Committee
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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
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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
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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
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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
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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
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Food and Drug Administration Activities
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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Onsolis REMS
On July 16, 2009, FDA approved Onsolis to manage breakthrough pain in cancer patients, with a REMS
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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American Geriatric Society Guideline on Management of
Persistent Pain in Older Persons
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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
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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
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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
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State Level Issues
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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
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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
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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
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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
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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
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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
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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
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Negative Criteria
Practitioners subject to undue prescription requirements
Other provisions that may impede pain management
Provisions that are ambiguous
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PPSG Report Card Grades, July 2008
B Grade C GradeA Grade
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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
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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
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Examples from Beyond the Report Card
Prescription monitoring programs Managed care/worker’s comp Mandated continuing education Ongoing issues with law enforcement
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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
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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
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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
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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
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State PMP Status, 2003
Operating ProgramsNo PMP
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States With Prescription Monitoring Programs, August 2009
PMP Pending PMP OperatingNo PMP“Current”
Legislation
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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
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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
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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
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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
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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
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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
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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
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PMP Programs: Needs
Access for prescribers/dispensers Education for prescribers, dispensers,
investigators Proactive and reactive reporting Adequate provisions for referral to
substance abuse treatment
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PMP Programs: Needs
Outcomes research (positive and negative impacts) Legal Public Health
Pain Addiction
Information sharing across states
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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”
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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
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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
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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
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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)
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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
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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
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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?
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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
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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
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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
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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
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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
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States Mandating or Encouraging CME for Pain/Palliative Care (as of October 2005)
CME Encouraged CME Mandated
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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?
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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
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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.
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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?
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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
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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)
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Questions and Discussion