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Medical-legal Risks of Prescribing Pain Medications Nevada Orthopaedic Society November 14, 2016

Learn about the risks of overprescribing and underprescribing pain medication, the growing issue of prescription drug abuse, and the pressures doctors face in prescribing these medications. Discover potential solutions to combat this problem.

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Medical-legal Risks of Prescribing Pain Medications Nevada Orthopaedic Society November 14, 2016

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  1. David H. Sohn, JD MD Chief, Shoulder and Sports Medicine Head Orthopaedic Surgeon, Toledo Football Rockets Associate Professor of Orthopaedic Surgery University of Toledo Medical Center Kristin A. Toy, MS Justin A. Julian, BS Medical-legal Risks of Prescribing Pain MedicationsNevada Orthopaedic SocietyNovember 14, 2016

  2. Risks of Prescribing Pain Medication The Problem: Prescription Drug Abuse US Physicians prescribe 82.5 opioid prescriptions per 100 people(CDC M&M weekly report 2012) So, we are prescribing a lot, and this costs money. $62 billion per year spent on prescription pain meds(CBO 2010) Much of this however gets diverted from legitimate medical purposes, and is used for nonmedical purposes.

  3. Risks of Prescribing Pain Medication The Problem: Prescription Drug Abuse Diversion is

  4. Risks of Prescribing Pain Medication The Problem: Prescription Drug Abuse Where do abusers get their narcotic drugs from? 64% from a friend or family member who had extra 4.3% from a drug dealer(Source: HHS Publication No. (SMA) 13-4795, 2013) So, we are overprescribing, and the excess finds its way into abuse. Worse, we are prescribing more and more. 1997: 670,000 prescriptions for Oxycontin 2006: 6,200,000 prescriptions for Oxycontin(Source: General Accounting Office-04-110 2003)

  5. Risks of Prescribing Pain Medication The Problem: Prescription Drug Abuse This has led to what the Center for Disease Control has called an epidemic Prescription pain meds = gateway drugs for other street drugs Prescription pain med abuse Facts: Overdose deaths have quadrupled in the last decade 1 of 4 people who receive pain meds struggle with addiction 1,000 ER visits for overdose PER DAY (Source: CDC 2016)

  6. Risks of Prescribing Pain Medication The Problem: Prescription Drug Abuse Not surprisingly, the government has reacted by instituting pressure to PRESCRIBE LESS PAIN MEDS upon doctors Federal level (DEA) State level (State Medical Boards) There are also lawsuits initiated to prescribe less pain meds Addiction lawsuits Overdose lawsuits This talk will review these pressures and review the risks of overprescription

  7. Risks of Prescribing Pain Medication Ironically, physicians actually HATE prescribing narcotics. We don’t need the government to tell us about risks taught in med school, internship, residency, fellowship, and practice Risk of addiction Risk of legal repercussions Risk of overdose and death However there are very real pressures to prescribe pain meds

  8. Risks of Prescribing Pain Medication “Pain is the 5th vital sign” In 1996, the American Pain Society introduced the phrase “Pain is the 5th vital sign” Among the core principles of pain management, they asserted “Patients have the RIGHT to appropriate assessment and management of pain” “Pain can exist even when no physical cause can be found” “Pain is always subjective. Therefore, the patient’s self report of pain is the single most reliable indicator of pain. A clinician needs to accept and respect this self report.” Source: National Pharmaceutical Council 1996 a

  9. Risks of Prescribing Pain Medication Joint Commission on Accreditation of Healthcare Organizations The problem is that JCAHO embraced these principles and institutionalized them “Patients have the right to appropriate assessment and management of pain (JCAHO Standard RI 1.2.8, 2000). This meant that for hospitals to remain accredited, they had to implement “Pain as a 5th vital sign” Narcotics had to be given until patients were satisfied. This is a problem with addictive materials Most of the numbers then, such as 10 fold increases in narcotic prescriptions, coincided with this implementation in the late 90’s and early 2000’s.

  10. Risks of Prescribing Pain Medication Joint Commission on Accreditation of Healthcare Organizations In other words, good care began to be equated with “no pain”. Patients also began to believe that if there was pain, there was something wrong. Many medical conditions however are painful, and it is unrealistic to believe that there should be no pain. Ankle fracture surgery: Netherlands vs. US US: typically receive Vicodin, yet rate their pain as 7/10 Netherlands: typically receive Tylenol, yet rate their pain as 2/10 Difference? In Netherlands, they expect surgery will be painful. In US, we now believe we have a right to be painless

  11. Risks of Prescribing Pain Medication This then creates another set of pressures When patients are in pain, they are angry and demand more pain meds “If you have a sympathetic client, you can always find a legal hook to hang your hat on.” There are now more than 16 consumer advocacy groups who exist to pressure doctors to prescribe more and more pain meds, and have found ways to successfully sue or prosecute doctors… (Source: CPATF) Even when the amounts demanded are dangerous Even when the current amounts given meet the standard of care This talk will also review these pressures and risks of underprescribing

  12. Risks of Prescribing Pain Medication “Can I have another Rx for Percocet?” Common question we hear as orthopaedic surgeons Common fears Can I be sued for prescribing too little? Can I be prosecuted for prescribing too much? Are there any guidelines to this?!?

  13. Risks of Prescribing Pain Medication Goals of presentation 1. Review risks of underprescribing 2. Review risks of overprescribing 3. Suggestions to navigate risk

  14. Risks of Prescribing Pain Medication Risks of underprescribing Case presentation 85M with terminal lung cancer, respiratory disease and suspected metastatic back pain Dr. Chin, an internist, prescribed 25-50mg demerol IV q3 prn, as well as duragesic patch Pt rated pain between 7 and 10 Family demanded a scheduled pain delivery, rather than prn

  15. Risks of Prescribing Pain Medication Risks of underprescribing Case presentation 85M with terminal lung cancer, respiratory disease and suspected metastatic back pain Dr. Chin refused, citing fear that higher and more frequent doses could cause respiratory compromise Pt left hospital, went to hospice and was prescribed around the clock morphine. He expired within 2 days

  16. Risks of Prescribing Pain Medication Risks of underprescribing Case presentation 85M with terminal lung cancer, respiratory disease and suspected metastatic back pain Family was irate at Dr. Chin, but hospital and medical board defended his actions as meeting standard of care. Plaintiffs agreed it was standard of care, but sued under elder abuse statutes for failure to deliver adequate pain control

  17. Risks of Prescribing Pain Medication Risks of underprescribing Case presentation Elder Abuse and Dependent Adult Civil Protection Act "Abuse of an elder or a dependent adult" means either of the following: (a) Physical abuse, neglect, financial abuse, abandonment, isolation, abduction, or other treatment with resulting physical harm or pain or mental suffering. (b) The deprivation by a care custodian of goods or services that are necessary to avoid physical harm or mental suffering. CAL. WIC. CODE § 15610.07 : California Code - Section 15610.07

  18. Risks of Prescribing Pain Medication Risks of underprescribing VERDICT: $1.5 million for plaintiff Defense attorney stated this was a “very scary verdict” because Dr. Chin felt if he acceded to family’s wishes, Mr. Bergman could have died of respiratory distress and he would have been sued for prescribing too much pain meds. Bergman v. Chin, No. H205732-1 (Cal. App Dept Super Ct 1999)

  19. Risks of Prescribing Pain Medication Risks of underprescribing VERDICT: “I think we are at a new place in law and medicine … [where] [f]ailure to treat pain can now be something that physicians are held accountable for.” Susan Okie, Calif. Jury Finds Doctor Negligent in Managing Pain, WASH. POST, June 15, 2001, at A2, available at 2001 WL 23174418 (quoting Kathryn Tucker, the director of legal affairs at the Compassion in Dying Federation in regards to Bergman v. Chin, No. H205732-1 (Cal. Super. Ct. June 13, 2001), and its legal impact on how the medical field treats pain).

  20. Risks of Prescribing Pain Medication Risks of underprescribing North Carolina: In a similar case, a nursing home was found guilty of under-treating pain in a patient with metastatic cancer. The jury awarded the plaintiff’s estate $15 million.Source: COLUMN ONE : How Much Painkiller Is Enough? : Health care workers are often on guard against giving too much medication. A landmark case against a nursing home has sent a warning not to provide too little.http://articles.latimes.com/1991-12-10/news/mn-154_1_nursing-home

  21. Risks of Prescribing Pain Medication Risks of underprescribing Oregon: The Oregon Board of Medical Examiners disciplined a doctor for not prescribing enough narcotics for six patients. Ordered to complete communication training Ordered to complete physician education program Ordered to undergo psychiatric evaluationSource: http://www.nytimes.com/1999/09/04/us/oregon-board-disciplines-doctor-for-not-treating-patients-pain.html

  22. Risks of Prescribing Pain Medication Risks of underprescribing Oregon (cont.): Examples include 82M with CHF stated “he could not breathe” and wanted narcotics. 35F on ventilator wanted pain meds and anxiolytics for “wheezing.” Interestingly, the mode of overdose death is typically from respiratory depression.

  23. Risks of Prescribing Pain Medication Risks of underprescribing ''I think they're going to end up driving doctors crazy. A decade ago, the board was questioning doctors for overprescribing drugs. Now all of a sudden, the fashions have changed and the board's going to start harassing doctors for not prescribing enough pain medication. It makes it extremely difficult for the average Oregon physician to know what to do to make the board happy.'' -Dr Leigh Dolin, past president of Oregon State Medical Board

  24. Risks of Prescribing Pain Medication Risks of underprescribing This is NOT a malpractice claim. Malpractice alleges a deviation from standard of care which results in damages. It is defensible by adherence to standard of care, and is covered by malpractice insurance This is a new form of liability, stemming in part from California’s Patient Bill of Rights ““[a] patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain.” “[a] patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her severe chronic intractable pain.” CAL. HEALTH & SAFETY CODE § 124960 (West 2000).

  25. Risks of Prescribing Pain Medication Risks of underprescribing Patient entitlement to pain meds “Extremely challenging behavioral issues may emerge during an opioid taper38. Behavioral challenges frequently arise when a prescriber is tapering the opioid dose and a patient places great value on the opioid he/she is receiving. In this setting, some patients may feel overwhelmed or desperate and will try to convince the prescriber to abandon the opioid taper. “ - Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An educational aid to improve care and safety with opioid therapy 2010 Update

  26. Risks of Prescribing Pain Medication Risks of underprescribing Patient entitlement to pain meds Challenges may include: Focus on right to pain relief (“You don’t believe I have real pain”) Arguments about poor quality of pain care with threats to complain to administrators Interagency Guideline on Opioid Dosing for Chronic Non-cancer Pain: An educational aid to improve care and safety with opioid therapy 2010 Update

  27. Risks of Prescribing Pain Medication What about OVER prescribing?

  28. Risks of Prescribing Pain Medication Risks of overprescribing Case presentation 1 Physician prescribed oxycodone to 75M with metastatic lung cancer. Patient fell asleep at the wheel and struck a pedestrian Pedestrian sued physician for negligently prescribing narcotics without warning of possible sedative side effects Physician defends by claiming no duty owed to third party

  29. Risks of Prescribing Pain Medication Risks of overprescribing VERDICT: for plaintiff Appeals court finds that physicians do have a duty of reasonable care to everyone foreseeably put at risk by the medications prescribed Combs v. Florio, 450 Mass 182

  30. Risks of Prescribing Pain Medication Risks of overprescribing Again, this is NOT a medical malpractice case. This is a significant expansion of liability to beyond just the patient, and now includes all those the patient might foreseeably harm Combs v. Florio, 450 Mass 182

  31. Risks of Prescribing Pain Medication Risks of overprescribing Joshua Murphy, Mayo Clinic Legal Counsel "A physician can be held liable for injuries caused by the impairing effects of medications prescribed by the physician.” "The physician may be liable to the patient or to a third party if the patient is in a car accident caused by the impairing effects of the medication prescribed by the physician".

  32. Risks of Prescribing Pain Medication Risks of overprescribing Joshua Murphy, Mayo Clinic Legal Counsel "The physician may be liable if he/she prescribed a medication or combination of medications that was inappropriate for the patient, and even if the medications were appropriate for the patient, the physician may be liable if he/she did not appropriately warn the patient of the side effects and risks associated with the medication.“ Source: American Academy of Pain Management 30th National Meeting, “Ability to Drive a Critical Concern in Opiate Prescribing”, http://www.medscape.com/viewarticle/822082

  33. Risks of Prescribing Pain Medication Risks of overprescribing So, the first medical legal risk in prescribing pain medication is liability to third parties for failure to warn of sedating effects when driving or operating heavy machines. Recommendation:Document discussions of sedating effects, either in a pain contract or in clinic notes

  34. Risks of Prescribing Pain Medication Risks of overprescribing Case presentation 2 Physician saw a patient complaining of low back pain and requesting narcotics Physician listened to lungs and performed five minute interview Physician then prescribed 120 tablets of narcotic pain medication Problem?

  35. Risks of Prescribing Pain Medication Risks of overprescribing Title 21 United States Code Controlled Substances Act “No controlled substance may be dispensed without a prescription, except when dispensed directly by a practitioner to the ultimate user” DEA interpretation of CSA Prescription must be issued for 1) a “legitimate medical purpose”, 2) by a registered physician, acting 3) within the usual course of professional practice

  36. Risks of Prescribing Pain Medication Risks of overprescribing The “patient” mentioned here was an undercover agent. The liberal dispensation of narcotics triggered an entire office search which revealed that a high percentage of the physician’s patients had criminal records, and that he had written them a large number of oxycodone prescriptions Physician was arrested and prosecuted for racketeering and drug trafficking in Florida 2012

  37. Risks of Prescribing Pain Medication Risks of overprescribing Similar case in Delaware in 2015

  38. Risks of Prescribing Pain Medication Risks of overprescribing “Detectives Steven Bannar and John Newell testified during a weeklong trial before Judge Anthony Scanlon that they were able to receive prescriptions for Xanax, Percocet and Oxycodone from Wean without having any examinations or tests performed and providing no medical history.” Source: http://www.delcotimes.com/general-news/20151002/delco-doc-convicted-of-99-drug-counts-in-pill-mill-case

  39. Risks of Prescribing Pain Medication Risks of overprescribing Similarly, some states require as part of professional standards that a physical exam accompany the dispensation of narcotics. In an interpretation of the Intractable Pain Treatment Act, [CAL. BUS. & PROF. CODE § 2241.5 (West 2000)], a physician found to prescribe controlled substances without a physical examination or indication that the drugs were therapeutically required is guilty of unprofessional conduct warranting the revocation of his license to See Kolnick v. Bd. of Med. Quality Assur., 161 Cal. Rptr. 289 (Cal. Ct. App. 1980).

  40. Risks of Prescribing Pain Medication Risks of overprescribing Overprescribing, as judged by standard of care by state medical boards, has also led to censure, fines, and restriction on license to practice medicine by state medical boards. Pain management doctor treating patients with intractable pain was placed on 2 years probation, $4000 fine, and sent to remedial courses for prescribing excessive amounts of opioids. This was based on testimony of two doctors who were not pain management experts - Hoover v. Agency for Health Care Administration,676 So. 2d 1380 (Fla. Ct. App. 1996)

  41. Risks of Prescribing Pain Medication Risks of overprescribing In another case, based on expert witness testimony stating she prescribed excessive pain medications, an Arkansas doctor was Placed on 1 year probation Required to take 50hrs of CME Restricted from prescribing narcotics Subjected to frequent medical board monitoring - Hollabaugh v. Arkansas State Medical Board,861 S.W.2d 317 (Ark. Ct. App. 1993)

  42. Risks of Prescribing Pain Medication Risks of overprescribing More cases from this year: LA Times “Doctor get 5 years in prescription drug case.”- http://www.latimes.com/local/california/la-me-doctor-sentenced-20150106-story.html Salt Lake Tribune “Utah doctor/lawyer pleads guilty in prescription drug case.”-http://www.sltrib.com/home/3079519-155/utah-doctorlawyer-pleads-guilty-in-prescript

  43. Risks of Prescribing Pain Medication Risks of overprescribing Kansas: Painkiller prescription prison sentence upheld for Kansas doctor and wifehttp://www.cbsnews.com/news/painkiller-prescription-prison-sentence-upheld-for-doctor-and-wife-in-kansas/ Alabama: Birmingham-area doctors charged in federal prescription drug crackdownhttp://www.al.com/news/birmingham/index.ssf/2015/05/birmingham-area_doctors_charge.html

  44. Risks of Prescribing Pain Medication Risks of overprescribing DEA’s Operation Pillution 2015 280 arrests, including 22 doctors 4 states – Arkanas, Alabama, Louisiana, Mississippi 15 month operation involving over 1000 federal agents

  45. Risks of Prescribing Pain Medication Risks of overprescribing DEA’s Operation Pillution 2015 Single largest pharmaceutical initiative in DEA history Search warrants were issued based on phone calls and complaints about too easy access to oxycodone, xanax and percocet Source: http://www.nbcnews.com/news/us-news/drug-enforcement-administration-raids-pill-mills-four-southern-states-n361956

  46. Risks of Prescribing Pain Medication Recommendation: Prescribe according to protocol Document a physical exam

  47. Risks of Prescribing Pain Medication Goals of presentation Unfortunately, there is a third potential form of liability Although patients are the ones who demand pain meds, they are now starting to blame physicians for “getting them addicted”

  48. Risks of Prescribing Pain Medication “When is a doctor negligent in prescribing opiates/pain killers? Imperial Beach, CA | on Jun 4 Filed under: Medical malpracticePain and suffering “I was prescribed opiates for 4 and 1/2 years by a doctor. The doctor never explained the side effects or dangers of opiate use. He never altered the prescription and never came up with a treatment plan, just kept giving out the pain killers. The doctor would not come into the same room for more than 5 minutes and wouldn't know who I am if he saw me. I stopped taking the pills and went through withdrawal thinking I was just sick. Ended up losing my job and short term memory” Source: http://www.avvo.com/legal-answers/when-is-a-doctor-negligent-in-prescribing-opiates--2212847.html

  49. Risks of Prescribing Pain Medication Goals of presentation Final liability risk of prescribing pain meds: overdose As overdose deaths rise, DEA is clamping down on doctors, viewing them as the main source of the problem. Source: http://www.ctpost.com/news/article/America-s-drug-problem-starts-in-the-doctor-s-6584975.php

  50. Risks of Prescribing Pain Medication Goals of presentation It is only a matter of time that patients who have demanded pain meds from doctors will start to be the ones who sue them “Doctors make easy targets for lawsuits because they often are seen as placing would-be weapons into patients' hands. It's a growing problem. You have suicides. You have overdoses or near-deaths. Of course, they want to blame the doctor. He is blamed for having set patients on that course.”” -Michael A. Moroney, a health law attorney at Weber Gallagher Simpson Stapleton Fires & Newby LLP in New Jerseyhttp://www.amednews.com/article/20130304/profession/130309978/4/

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