Legislation-based solutions Jane C Ballantyne, University of
Washington, Seattle
Slide 2
How pain treatment became mandated in the US
Slide 3
No 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 Romantic Imagination
Slide 4
1910Foster ActControlled opiates, cocaine, chloral and
cannabis. Failed in 1911. 1914Harrison 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. 1919Webb versus the US Prohibited physicians from
dispensing maintenance prescriptions to people with cravings.
Twentieth Century American War on Drugs Immediate switch of moral
imperative from user to prescriber
Slide 5
Early 20 th century regulations led to gross undertreatment of
both pain and addiction in the US This began to be corrected in the
mid-20 th century Laws were written to protect prescribers
Slide 6
1974Narcotic Addict Treatment Act 1993Approval of LAAM
(l-methadyl acetate) 1999Proposal to adopt new regulations with
provision for office-based treatment 2000Drug Addiction Treatment
Act Institution of opioid maintenance treatment for addiction in
the US
Slide 7
I would rather be in pain than be considered an addict by the
mid 20 th 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)
Slide 8
Protecting clinicians when prescribing for pain 1997Intractable
pain policies 1997Federation of State Medical Board Policy
Statement 2000DEA 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
Slide 9
Current quandary for the US
Slide 10
In the committees view, addressing the nations 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 Institute of Medicine (IOM) Report
http://www.nap.edu
Slide 11
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 2001 Pain management became
mandated by US accreditation body
Slide 12
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 clinicians 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
Slide 13
Efforts to swing the pendulum back have become highly political
1.Washington State passes law restricting opioid dosing (2011)
2.Citizens petition presented to Food and Drug Administration (FDA)
requesting radical relabeling of opioids when used for chronic pain
(2012) 3.Senate enquiry instigated regarding FDAs approval of
long-acting hydrocodone, against panels advice (2014)
Slide 14
1.Sets standards to use when considering state licensing
disciplinary action against providers 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 Rule 2876
2010
Slide 15
Slide 16
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
Slide 17
Slide 18
What actually happened Good Provided an opportunity to educate
Necessitated development of telemedicine Death rates have gone down
Scale of the problem of opioid dependence exposed Bad Patients have
been abandoned Some practices have instituted a no opioid policy
Dependent patients who have been cut off are turning to heroin
Slide 19
Franklin et al Am J Ind Med 2012;51:325-31
Slide 20
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 NOT EASY TO FIX
Slide 21
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
Slide 22
What the Washington State Law has taught 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
available 3.In future, opioid prescribing should be much more
selective in terms of who gets treated, for how long and at what
dose
Slide 23
1.Source: Physicians for Responsible Opioid Prescribing
http://www.supportprop.org/educa tional/PROP_OpioidPrescribing.pdf
http://www.supportprop.org/educa
tional/PROP_OpioidPrescribing.pdf
Slide 24
Citizens petition calls for the following changes on opioid
labels 1. Strike the term moderate from the indication for
non-cancer pain. 2. Add a suggested maximum daily dose, equivalent
to 100 milligrams of morphine for non-cancer pain. 3. Add a
suggested maximum duration of 90-days for continuous (daily) use
for non-cancer pain.
Slide 25
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
Slide 26
How the Opioid Industry Frames the Problem: Source: Slide
presented at FDA meeting on hydrocodone up-scheduling, January 25
th, 2013.
Slide 27
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 development. The FDA approved Zohydro from Zogenix Inc. in
October, making it the first single- ingredient 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. Senators Question FDAs Approval of Powerful
Painkiller The Huffington Post
Slide 28
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
over- promoting opioids
Slide 29
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