The Legal and Ethical Issues in Pain Management

November 20th, 2003St. Francis Hospital and Medical Center

Grand Rounds

L.Jean Dunegan, M.D., J.D., FCLM

ObjectivesReview reasons for mandating pain

managementDiscuss clinicians’ dilemmas when

treating ATC painDiscuss liability issues for both treating

and failing to treat painReview ways of protecting both the

patient and the practitioner from liability

Reasons for Mandated Pain Management

Cost of unmanaged pain is exorbitantQuality of sufferers life is abysmalThe “old way” of treating pain has not

been effectiveUnless 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*

Have a plan for treatment “Success” as regards:FunctionalityNumerical Rating Scale

Follow the patient in a timely fashionUse pain treatment agreement for patients

with vulnerability to opioids *Dunegan, LJ, The Handbook of Pain Management, 2002

edition

Classification of PainDuration:

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) PainOccurs at certain times during the day Is rated as moderate to severe (by the

patient) Interferes with the quality of the

patient’s lifeCan not be predicted by patients activity

(in contrast with pain that can be treated prophylactically)

The Measurement of PainAssessment 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 balanceThe 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 balanceCriminal 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 boardsProsecutors

Where the onus to protect the public resides

Medical malpractice accusations

LiabilitiesFor prescribing pain medication

Florida v Graves(criminal convictions)Finding niches

For not prescribing appropriatelyBergman 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 nichesGuidelines*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 GravesJuly, 2001, indicted on 2 counts

manslaughter and a of racketeeringJuly, 2002, convicted on all four

countsClinician now serving a prison

sentencePain specialist did no proceduresCash basis only practice with take

salary of $500,000/yr.

LiabilitiesFor 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 Licensurein California

12 hours of CME on the topic of pain management and end of life care issues

Effective 1-1-02Impetus, in part, was Bergman v ChinSets 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 1990Elderly 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. GeorgiaPatient won his right in lower court to

be disconnected from the respirator (right to autonomy)

Air-hunger and restart of respiratorRecognized his right to be sedated

and have pain adequately treatedThese 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 AbuserMichigan joins the states that have

eliminated triplicatesThe 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 AbuserMichigan joins the states that have

eliminated triplicatesThe 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 StatutesAbuse-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 ablePlan for treatment “success” Timely follow-upEducation of the patient and family

when indicated

Protecting the Clinician and the Patient

Document your H&P and treatment planUse pain treatment “agreements” for all

patients you deem vulnerable to opioidsRequest photo Ids as needed Schedule diagnostic tests appropriate to

the complaintRefer 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 (pseudo-addiction)

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

AnalgesiaActivities of daily livingAdverse eventsAberrant drug-taking behavior

Summary of Liabilities in Pain Management

Medical malpracticeCommunicationDocumentation

Medical board and prosecutorial oversightHave a “plan” for treatment success as

to functionality and NRSHave a timeline for successDocument follow-up in a timely fashion

Future Progress in Pain CareBoth the medical and the legal

professions strive for the same objectives:

Efficacious pain treatmentProtection from harm for patients

who take potentially harmful opioidsWe are making great strides in both

those objectives as the professions work together.

ConclusionThe 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