Ballantyne Plenary Panel 2014

Legislation-based solutions
Jane C Ballantyne, University of Washington, Seattle
How pain treatment became mandated in
the US
one who thinks of the early
nineteenth-century opium addicts in
terms of what their position would be
today – forced to pester reluctant
doctors …. or to pay large sums for
illicit supplies … – will be able to
understand the frame of mind of
someone like Coleridge, who had no
obstacles between him and the drug
but his own conscience and the
reproaches of his immediate family and
closest friends ……
Alethea Hayter in
Opium and the
Twentieth Century American War on Drugs
Foster Act Controlled opiates, cocaine, chloral and
cannabis. Failed in 1911.
1914 Harrison Act
Required registration and payment of an
occupational tax by all those who imported, produced, dealt in, sold
or gave away opium and coca leaves and their derivatives.
Remained the foundation of controls on narcotics until 1970.
1919 Webb versus the US Prohibited physicians from dispensing
maintenance prescriptions to people with cravings.
Immediate switch of moral
imperative from user to prescriber
• Early 20th century regulations led to gross
undertreatment of both pain and addiction in
the US
• This began to be corrected in the mid-20th
• Laws were written to protect prescribers
Institution of opioid maintenance treatment for
addiction in the US
1974 Narcotic Addict Treatment Act
1993 Approval of LAAM (l-methadyl acetate)
1999 Proposal to adopt new regulations with
provision for office-based treatment
2000 Drug Addiction Treatment Act
• “I would rather be in pain than be considered an
• by the mid 20th Century, there seemed an ethical
basis for compelling opioid treatment of pain
(relieve pain & suffering) and no ethical basis for
withholding treatment (no risk of addiction)
Protecting clinicians when prescribing for pain
1997 Intractable pain policies
1997 Federation of State Medical Board Policy
2000 DEA Policy Statement
Gilson et al Health Policy 2005;74:192-204
Joranson & Gilson APB Bulletin 1997;7:7-9
West et al Federation of State Medical Boards 1998
DEA Frequently asked questions 2005
Current quandary for the US
Institute of Medicine (IOM) Report
In the committee’s view, addressing the
nation’s enormous burden of pain will
require a cultural transformation in the
way pain is understood, assessed, and
treated. This report provides
recommendations intended to help achieve
this transformation
Medicine and public health measures have succeeded in greatly increasing
longevity. But although we live longer as a population, we do not
necessarily live better. A 2011 congressionally mandated study by the
Institute of Medicine Committee on Advancing Pain Research, Care, and
Education reported that 116 million Americans suffer from chronic pain,
costing up to $635 billion annually in treatment and lost productivity
2001 Pain management became
mandated by US accreditation body
• Mandate required that pain be recognized, assessed,
documented and treated
• Also required that systems be in place to achieve these goals
• The use of the “fifth vital sign” became instantly popular
JCAHO Pain management standards 2001
Importance of patient satisfaction as a quality metric
in US Healthcare
• Used for quality improvement as well as benchmarking
• Attention to pain, and successful treatment of pain
have become important quality metrics
• Satisfaction rating are used not only for the accreditation of healthcare
facilities, but also to assess the performance of individual clinics and individual
• Failure to comply could mean loss of institutional support, institutional failure
or loss of livelihood for individual clinicians
• Instruments used to measure patient satisfaction are notoriously unreliable
Ballantyne & Fleisher PAIN 2010;148:365-7
Zgierska et al JAMA 2012;307:1377-8
Efforts to swing the pendulum back have
become highly political
1. Washington State passes law restricting opioid dosing (2011)
2. Citizen’s petition presented to Food and Drug Administration (FDA)
requesting radical relabeling of opioids when used for chronic pain
3. Senate enquiry instigated regarding FDA’s approval of long-acting
hydrocodone, against panel’s advice (2014)
Rule 2876
1. Sets standards to use when considering state licensing disciplinary action against
2. Rules directed only to Chronic Opioid Treatment of Chronic Non-Cancer Pain
3. Requires full H & P
4. Requires 4 hrs pain CME
5. Dose criteria above which provider must consult with a pain specialist at > 120mg MED
6. Not needed if function improved, dose stable or tapering, no special risk, provider
meets certain qualifying criteria
Fears brought about by the Washington State Law
• Access to pain medications will be restricted
• Clinicians will stop prescribing
• Pain will become undertreated again
• Patients will be abandoned
• Laws should not interfere with clinical decision making
What actually happened
Provided an opportunity to educate
Necessitated development of telemedicine
Death rates have gone down
Scale of the problem of opioid dependence exposed
• Patients have been abandoned
• Some practices have instituted a “no opioid” policy
• Dependent patients who have been cut off are turning to heroin
Franklin et al Am J Ind Med 2012;51:325-31
What are the current problems with Rule 2876
• There is no consensus about what to do with the people
already on high doses, even among experts
• There are no suitable services for people with
dependence on opioid pain medications
“Complex persistent dependence”
• taper or maintain?
• strong evidence that patients who taper from high doses
improve in terms of general function and well-being
• unfortunately many relapse
• tapering is hard to achieve for all but the most motivated
• rehab setting is more successful than outpatient setting
• need pain treatment as well as dependence treatment
Ballantyne & LaForge Pain 2007;129:235-55
Ballantyne & Sullivan Arch Intern Med 2012;172:1242-3
What the Washington State Law has
1. There are a lot of individuals whose lives have been
decimated by overuse of opioids
2. These individuals need specialty care, which often is not
3. In future, opioid prescribing should be much more selective
in terms of who gets treated, for how long and at what dose
1. Source: Physicians for Responsible
Opioid Prescribing
Citizen’s petition calls for the following
changes on opioid labels
Strike the term “moderate” from the indication for
non-cancer pain.
Add a suggested maximum daily dose, equivalent
to 100 milligrams of morphine for non-cancer pain.
Add a suggested maximum duration of 90-days for
continuous (daily) use for non-cancer pain.
Zohydro – New long acting hydrocodone
Reviewed by FDA Advisory Committee on
December 2012
Advisory Committee votes 11-2 against approval
Approved by FDA October 2013
How the Opioid Industry
Frames the Problem:
Source: Slide presented at FDA meeting on
hydrocodone up-scheduling, January 25th,
Senators Question FDA’s Approval of Powerful Painkiller
The Huffington Post
WASHINGTON (AP) — Three U.S. senators are raising concerns about the Food and
Drug Administration's approval of a powerful painkiller called Zohydro, which experts
say could add to the national epidemic of prescription drug abuse.
Republicans Mitch McConnell of Kentucky, Tom Coburn of Oklahoma and Lamar
Alexander of Tennessee sent a letter to the head of the FDA Wednesday asking how
the agency will prevent misuse and abuse of Zohydro and similar drugs in
The FDA approved Zohydro from Zogenix Inc. in October, making it the first singleingredient hydrocodone drug ever cleared for U.S. patients. The pill is significantly
more potent than currently available hydrocodone combination pills, such as Vicodin.
The approval surprised many doctors, since an FDA advisory panel voted
overwhelmingly against the drug, citing its potential for abuse.
What happened in the US
1. Harrison Act in 1914 switched the moral burden to clinicians and Webb vs US in 1918
made US clinicians especially fearful of prescribing even for pain
2. The efforts of pain advocates in the 1980s made opioids more available
3. Pain management in healthcare facilities became mandated and the “fifth vital sign”
was used as a means of demonstrating attention to pain (2001)
4. Opioid use skyrocketed and so did opioid abuse. Characterized as an ‘epidemic’ by the
CDC in 2012
5. Affordable Care Act instituted IOM evaluation of the problem of uncontrolled pain
6. Laws enacted to try and control opioid overuse
7. Political means used to try and expose activities of the pharmaceutical industry in overpromoting opioids
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