Transcript Pain Management: Opioids, NSAID’s, & Liabilities

The Legal and Ethical
Issues in Pain
Management
November 20th, 2003
St. Francis Hospital and Medical Center
Grand Rounds
L.Jean Dunegan, M.D., J.D., FCLM
Objectives
 Review
reasons for mandating pain
management
 Discuss clinicians’ dilemmas when
treating ATC pain
 Discuss liability issues for both
treating and failing to treat pain
 Review ways of protecting both the
patient and the practitioner from
liability
Reasons for Mandated Pain
Management
 Cost
of unmanaged pain is
exorbitant
 Quality of sufferers life is abysmal
 The “old way” of treating pain has
not been effective
 Unless there are negative
consequences for not adequately
treating pain, the “old way” will
prevail
The “New Way” of Treating Pain

Use non-opioids first line for mild to moderate
pain
 Opioids are not the first line treatment for mild to
moderate pain control
 When opioids are necessary, consider the
importance of synergism for analgesia that
NSAIDs can give
 The multi-modal approach gives the best
outcomes
Guidelines for Adequate Pain
Treatment*
a plan for treatment “Success”
as regards:
Functionality
Numerical Rating Scale
 Follow the patient in a timely fashion
 Use pain treatment agreement for
patients with vulnerability to opioids
 Have
*Dunegan, LJ, The Handbook of Pain Management,
2002 edition
Classification of Pain
 Duration:
 Acute-abrupt
onset and expectation
of absence after a short time
 Chronic-with physical cause but
persistent after normal healing
timeframe
 ATC (around-the-clock) pain
Around-The-Clock (ATC) Pain
 Occurs
at certain times during the day
 Is rated as moderate to severe (by the
patient)
 Interferes with the quality of the
patient’s life
 Can not be predicted by patients activity
(in contrast with pain that can be treated
prophylactically)
The Measurement of Pain
 Assessment
using the mnemonic
WILDA strategy*
 Numerical Rating Scale (NRS)
Subjective, but when used
consistently over time, as
objective as possible
Requires patient education
Gates,AG, et al, Oncology Nursing Secrets. Henley & Beltus,
Inc., publishers, 1997. p287
Between a Rock and a Hard
Place
 Clinicians
often confused by the
absence of consensus between
medicine and law as to oversight
 Guidelines are so vague as to give
little direction
 A need to have a balanced
approach but difficulty finding it
Oxycodone Deaths Tied to Drug
Abusers, Not Patients*
 A survey
of medical examiners/coroners
concerning deaths that were said to be
related to oxycodone.
 Included 1,164 deaths in which
oxycodone was involved.
 The prevalent pattern that emerged was
polypharmacy in drug abusers.
*Clinical Psychiatry News, July, 2003, page 36
Oversight of Physician Opioid
Prescribing for Pain
 Seeking
the balance
 The role of state medical boards*
Higher threshold for patient harm
when undertreated
Clinicians often get mixed
messages
*Journal of Law,Medicine&Ethics,31,(2003):21-40
Oversight of Physician Opioid
Prescribing for Pain
 Seeking
the balance
 Criminal prosecution of clinicians*
A four state survey concluded by
encouraging better guidelines
and education for both the
medical and legal professions in
pain management
*Journal of Law,Medicine&Ethics,31(2003):75-100
Sources of Scrutiny With the
Potential for Liability
 Over-sight
in two areas:
Medical boards
Prosecutors
Where the onus to protect the
public resides
 Medical malpractice accusations
Liabilities
 For
prescribing pain medication
 Florida v Graves(criminal convictions)
 Finding niches
 For not prescribing appropriately
 Bergman v Chin(elder abuse/civil
neglience)
 Oregon v Bilder(licensure sanctions)
 Michigan v wound care specialist(elder
abuse/criminal negligence)
Liabilities
 For
prescribing pain medication*
Florida v Graves**
Finding niches
Guidelines
*Brott, LF, Everitt, KB, “Pain Control & Risk Management”, Med
Risk Management Advisor: Vol10; No3; 2002, pp 1-3.
**Albert, T, “Florida Physician Guilty of Manslaughter in Oxycontin
case”, Am Med News, March 11, 2002.
Florida v Graves
 July,
2001, indicted on 2 counts
manslaughter and a of racketeering
 July, 2002, convicted on all four
counts
 Clinician now serving a prison
sentence
 Pain specialist did no procedures
 Cash basis only practice with take
salary of $500,000/yr.
Liabilities
 For
not prescribing appropriately*
Bergman v Chin**
Michigan v wound care
specialist***
*Tucker, KL, “A New Risk Emerges: Provider
Accountability for Inadequate Treatment of Pain”, Annals of
Long-Term Care, Vol 4, No 4, April 2001, pp 52-56.
**Bergman v. Eden Medical Center, No. H205732-1
(Sup.Ct.Alameda Co., Calif.
***Albert, T, “Doctor Indicted under Michigan adult abuse
law . . .”, Am Med News, Aug 27, 2001.
Bergman v Chin



Landmark case-85 year old
California man with lung cancer
died.
First case to frame the COA as
elder abuse for not treating pain
Under Tort Reform in Calif. only the
victim can collect damages for pain
and suffering.
Bergman v Chin
The
case introduces a new legal
theory: “Civil Negligence Litigation.”
Jury found in favor of family for $1.5M
(reduced to $250,000 by applying
malpractice cap)
On appeal a new trial denied but
multiplier of 1.5 (to underscore
importance of the case) raised the
award to $375,000 to family
Mandated CME for Licensure
in California
 12
hours of CME on the topic of pain
management and end of life care
issues
 Effective 1-1-02
 Impetus, in part, was Bergman v Chin
 Sets a precedent in that the bill
mandates that physicians take a
specific CME class in pain care
James v Hillhaven Corp.
 North
Carolina landmark case 1990
 Elderly gentleman with prostate
cancer and metastases to spine/left
femur.
 Physician ordered 7.5 ml morphine
elixir every 3 hours prn pain.
 Patient died in excruciating pain and
the family members witnessed his
suffering
 Court ordered $15 million to the family
Georgia v S.Ct. Georgia
 Patient
won his right in lower court
to be disconnected from the
respirator (right to autonomy)
 Air-hunger and restart of respirator
 Recognized his right to be sedated
and have pain adequately treated
 These rights judged to be
inseparable
Landmark case against a
physician’s license:
 A board
certified pulmonologist
had license suspended for one year
 Under Oregon’s IPTA there is “no
longer any room for physicians who
will not aggressively treat pain.”
 The physician welcomed the chance
to fill in his education “gap”
Attorney General Indicts A
Physician For Elder Abuse*
 Wound
care specialist indicted on two
counts of elder abuse for failure to
manage pain of debridement of
decubitus ulcers in nursing home
patients
 Michigan’s governor joins in call for
better pain management
*Albert, T, “Doctor Indicted under Michigan adult abuse law . . .”, Am Med
News, Aug 27, 2001.
Attorney General Indicts A
Physician For Elder Abuse
4
year old law* in Michigan designed
to protect senior citizens against elder
abuse
 First physician to be criminally
charged under that law
 Conviction can result in 4 years in
prison and/or a $5,000 fine on each
count
*MI Penal Code, CH 750. Sec. 145N.(2)
“The Physician’s oath is a
sacred promise to care for
patients, never to add to their
suffering”
Jennifer M. Granholm
Governor of Michigan
DEA’s Focus Shifts to the Abuser
 Michigan
joins the states that have
eliminated triplicates
 The tracking of PATIENTS using
opioids is intended to find those
diverting or abusing legitimate
medications
 Michigan will track not just patients
using schedule II but schedule III
as well
DEA’s Focus Shifts to the Abuser
 Michigan
joins the states that have
eliminated triplicates
 The tracking of PATIENTS using
opioids is intended to find those
diverting or abusing legitimate
medications
 Michigan will track not just patients
using schedule II but schedule III
as well
Crimes Under Federal Statutes
 Abuse-misuse
of a drug for
recreational reasons not the
intended medical reasons.
 Diversion-illicit arrangements
intended to result in the the
physical delivery of controlled
drugs for non-prescribed uses.
Protecting the Clinician and the
Patient
 History
and physical looking for
clues of past abuse
 Diagnosis as best you are able
 Plan for treatment “success”
 Timely follow-up
 Education of the patient and family
when indicated
Protecting the Clinician
and the Patient
 Document
your H&P and treatment plan
 Use pain treatment “agreements” for all
patients you deem vulnerable to opioids
 Request photo Ids as needed
 Schedule diagnostic tests appropriate to
the complaint
 Refer to consultants when needed
Drug-Seeking Behavior
 Knows
exactly the only analgesics
that will work
 Unwilling to have work-up or to
obtain past medical records
 Unable to recall names of treating
physicians, places where past
records are kept
 Is always in a hurry
Drug-Seeking Behavior
 Does
not distinguish between a
patient who is addicted and one
who is “conditioned”
 Frequently goes to ED departments
or after hour urgent care centers to
get pain meds
 May be evidence of inadequate
pain management (pseudoaddiction)
Summary of Federal Law
 Federal
law does not preclude the
use of opioids as analgesics for
legitimate medical purposes,
including treating chronic pain and
treating pain in addicts
 Federal law does prohibit the use
of opioids to maintain an addicted
state without special registration as
an NTP
Four A’s for Pain Treatment
Outcome Assessment
 Analgesia
 Activities
of daily living
 Adverse events
 Aberrant drug-taking behavior
Summary of Liabilities in Pain
Management
 Medical
malpractice
 Communication
 Documentation
 Medical board and prosecutorial
oversight
 Have a “plan” for treatment success
as to functionality and NRS
 Have a timeline for success
 Document follow-up in a timely
fashion
Future Progress in Pain Care
 Both
the medical and the legal
professions strive for the same
objectives:
 Efficacious pain treatment
 Protection from harm for patients
who take potentially harmful opioids
 We are making great strides in both
those objectives as the professions
work together.
 The
Conclusion
question we should pose to
patients is the same one that can
be asked of us: Where are/were
you trying to go as you signed on to
this road of pain treatment ……The
clinician will become: the provider
of a better quality of life or the
supplier of medications with
possible, harmful side effects.
 Proper pain management is within
our reach
Available online at
www.a2pain.com
The Handbook of Pain
Management
2002 edition
By L. Jean Dunegan, MD, JD, FCLM