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The Legal and Ethical Issues in Pain Management

The Legal and Ethical Issues in Pain Management. November 20 th , 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

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The Legal and Ethical Issues in Pain Management

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  1. 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

  2. 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

  3. 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

  4. 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

  5. Guidelines for Adequate Pain Treatment* • Have 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 *Dunegan, LJ, The Handbook of Pain Management, 2002 edition

  6. 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

  7. 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)

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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)

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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

  20. Mandated CME for Licensurein 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

  21. 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

  22. 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

  23. 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”

  24. 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.

  25. 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)

  26. “The Physician’s oath is a sacred promise to care for patients, never to add to their suffering” Jennifer M. Granholm Governor of Michigan

  27. 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

  28. 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

  29. 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.

  30. 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

  31. 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

  32. 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

  33. 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)

  34. 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

  35. Four A’s for Pain Treatment Outcome Assessment • Analgesia • Activities of daily living • Adverse events • Aberrant drug-taking behavior

  36. 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

  37. 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.

  38. Conclusion • The 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 providerof a better quality of life or the supplier of medications with possible, harmful side effects. • Proper pain management is within our reach

  39. Available online atwww.a2pain.com The Handbook of Pain Management 2002 edition By L. Jean Dunegan, MD, JD, FCLM

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