Healthcare Litigation: An Interprofessional Approach to Reducing Medical Errors.

1. Healthcare Litigation: An Interprofessional Approach to Reducing Medical Errors.

2. My Experience • Two murder cases • One manslaughter case • Two product liability cases • One animal abuse case • One workman’s compensation case • A life care plan with extensive medication list • Several malpractice cases involving • Pharmacists • Doctors • Nurse Practitioners

3. Learning Objectives 1. Recognize the costs, both human and financial, of medical errors   2. Define liability and malpractice 3. Identify problems in the delivery of healthcare especially the transition of care from one environment to another 4. Describe methods to decrease medical errors by improving interprofessional communication and medical records 5. Identify at least two classes of medication that may cause harm and result in healthcare litigation even if they are used within the established guidelines.

4. Introduction • Pharmacists are an integral part of the medical home model and can help avert costly medication-related problems by working collaboratively with other healthcare providers. • The New England Healthcare Institute estimates that annual medication-related problems in the U.S. cause: • 156 million physician visits • 23 million emergency department visits • 11 million hospitalizations in the US. • Annual cost of medication-related morbidity and mortality is $290 billion; more than the amount spent on the medications themselves. • Annual cost of medication-related problems in Maine exceeds $1.7 billion.

5. Liability • Criminal- imposed under criminal laws and by means of criminal prosecution • Civil- relating to private rights and to judicial proceedings in connection with them • Product- liability imposed on a manufacturer or seller for a defective and unreasonably dangerous product

6. Malpractice • Negligence, misconduct, lack of ordinary skill, or a breach of duty in the performance of a professional service (as in medicine) resulting in injury or loss

7. Negligence vs Intentional Act • Negligence- the failure to exercise that degree of care which a person of ordinary prudence (practical wisdom; caution)would exercise under the same circumstances. • Example- a broken nose in a car accident vs a punch • In a negligence case the plaintiff must prove four elements

8. Duty • Requirement to behave in a certain manner for the benefit of another • Duty to fill a patient’s prescription correctly • Duty to counsel patients and perform a drug regimen review

9. Breach of the Duty • A duty can be breached in one of two ways • Nonfeasance- duty is not performed • Malfeasance- activity is performed, but it is incomplete or incorrectly done • Expert witness will draw on their own experience, laws and regulations, codes of ethics, and other such items to determine if the pharmacist performed their required duties adequately.

10. Harm • A patient must prove they were injured or harmed. • Many states require a physical injury in order to make a claim for emotional injuries. • Difficult to separate the symptoms associated with the negligent act from the patient’s underlying pre-existing conditions.

11. Proximate Cause • The injury the patient suffered must have been caused by the breach of duty not some other cause or underlying condition • Very important in cases where it is not clear if the patient actually took the drug in question, or that the symptoms could be caused by some other factor • Superceding or interceding cause- another event unrelated to the negligent act causes harm or injury

12. Examples of Pharmacy Negligence • Dispensing a medication that is different than the dug ordered by the prescriber. • Correct medication is dispensed in an incorrect dose. • Dispensing the proper medication with a label containing improper use instructions. • Inadequate or erroneous warnings. • Dispensing a drug that is contraindicated with one or more of the current medications the patient is taking with no physician order approving the simultaneous use of both substances.

13. Case #1 • A 19 year old Africa American with a history of Sickle Cell Disease presented to the emergency room complaining of chest and bilateral arm pain at 1:45am • Vital signs • Within normal limits except an oxygen saturation of 93% (normal 95-100%)

14. Case #1 • Oxygen therapy via nasal cannula • Medications • Diphenhydramine 25mg IV x 2 @ 2:50am and 4:10am • Vicodin (5mg hydrocodone/500mg acetaminophen) 2 tablets by mouth @ 2:40am • Morphine Sulfate 5mg IV @ 2:52am, 10mg IV @ 3:00am, 3:10am, 3:20am, 3:30am, 3:45am, 3:55am, 4:05am (75mg over 73 minutes) • Ketorolac 30mg IV @ 3:32am • Levaquin 500mg by mouth @ 5:25am

15. Case #1 • Patient was awakened from sleep and reexamined at 5:30am • His lungs were clear and he had an oxygen saturation of 99% • He was discharged from the hospital at 5:30am • He was found unresponsive at home by his girlfriend at 5pm • Emergency Medical Technicians arrived at 5:17pm and were unable to obtain a blood pressure, pulse was 54 with sinus bradycardia, respiratory rate was 4, oxygen saturation was 48% • Patient was intubated and transported to the hospital where resuscitative efforts were unsuccessful • Patient was pronounced dead at 6pm

16. Case #1 • An autopsy was performed the next day and death was deemed natural secondary to vascular occlusion as a consequence of Sickle Cell Disease (multiple pulmonary emboli) • Toxicology- Morphine blood levels were sufficient enough to produce anesthesia and potentially toxic

17. Case #1 Additional information • Pain index initially 9 out of 10 by 3:45am the pain index is 3 out of 10 the patient is given the 3:45am injection and two more injections • They were initially unable to find a vein for the IV so an IV team was paged and they gave the two tablets of Vicodin • Patient had a history of respiratory depression after opiate administration

18. Case #1 • How did the morphine contribute to the patient’s death? • How could this death have been prevented?

19. Case #2 • A 78 year old Caucasian female admitted to the hospital (8/27) with a fractured hip two days after a fall (8/25) • History of hypertension, hyperlipidemia, depression, dementia, hypothyroidism, glaucoma, and a previous ischemic stroke two years ago. • Medications- Synthroid, metoprolol, Lexapro, Namenda, Enablex, Simvastatin, Xalatan, Darvocet, Plavix • Plavix was discontinued on 8/27 two days before the surgery on 8/29

20. Case #2 • Lovenox was prescribed to prevent deep vein thrombosis • Patient was transferred to a skilled nursing facility for rehabilitation on 9/2 • Lovenox was discontinued on 9/20 • Patient suffered a second ischemic stroke on 9/30

21. Case #2 Transition of care • Primary care physician • Admitting Emergency Room physician • Orthopedic surgeon • Cardiologist who cleared the patient for surgery • Physician at the skilled nursing facility • Nurse practitioner at the skilled nursing facility • Consulting pharmacist at the skilled nursing facility

22. Case #2 • What could have prevented the second stroke? • Who is liable? • How could the transition of care be improved?

23. Case #3 • A 48 year old Caucasian man who works as a marine propeller technician presents with diminished kidney function. • A renal biopsy confirms a diagnosis of Anti-neutrophil Cytoplasmic Autoantibody-Associated (ANCA) Glomerulonephritis • The patient had an influenza vaccine administered by a pharmacist six months prior to the impaired kidney function.

24. Case #3 • Should the pharmacist be held liable for not adequately explaining the potential adverse effects of the vaccine?

25. Case #3 • There are no manufacturer reported kidney adverse effects after immunization of influenza vaccines • A literature search found two cases of kidney related toxicity after an influenza vaccine. • One of the cases occurred four days after the vaccination and the diminished kidney function resolved itself after supportive care.

26. Case #3 • The patient presented with various symptoms including ear pain, GI pain, and flu-like symptoms (sinusitis and a cough) a few months prior to the vaccination. • Should the primary care physician be held liable for not diagnosing the ANCA glomerulonephritis?

27. Case #4 • A 60 year old female with a history of diabetes (insulin dependent), hypertension, chronic obstructive pulmonary disease, chronic back pain and possible muscular dystrophy was found dead at her home. • Other significant historical notes- patient had a recent colonoscopy to remove polyps and an artificial heart valve replacement

28. Case #4 • Autopsy findings- obesity, systemic arteriosclerosis, cerebral vascular disease, cardiomegaly, advanced peripheral vascular disease, fatty liver, degenerative joint disease of the spine, possible kidney failure and poorly controlled diabetes, and toxic levels of fentanyl • Cause of death- cardiomegaly and poorly controlled diabetes • Contributory factor- fentanyl intoxication • Classified as an accident due to drug intoxication

29. Case #4 • Current medications- Advair diskus, alprazolam, aspirin (81mg), bupropion, fenofibrate, fentanyl (50 mcg/hr), furosemide, gabapentin, Lantus, melocicam, metoprolol, Nexium, nitroglycerin pump, Novolog, oxycodone, paroxetine, Pro-Air, Vytorin, Warfarin • The attorney filed a wrongful death complaint against the manufacturer of fentanyl patches claiming the product was defective.

30. Case #4 • The patch removed from the deceased was discarded. • At autopsy, the fentanyl patch was removed from the sacral region of the lower back • Black Box Warnings for fentanyl patches and possible contributing factors • Associated risk of fatal overdose by respiratory depression • Only use the 50, 75, and 100 mcg/h dosages in patients who are already on and are tolerant of opioid therapy • 60mg of morphine/day, 30mg/oxycodone/day or 8mg hyrdomorphone/day for a week or longer • Peak fentanyl levels occur between 20 and 72 hours of treatment

31. Case #4 Patient Information (Facts and Comparisons) • Avoid exposing the fentanyl application site to direct external heat sources, such as heating pads, electric blankets, heat or tanning lamps, sunbathing, saunas, hot tubs, and heated water beds. • Potential for temperature-dependent increase in fentanyl release from the patch that could result in an overdose. Therefore, if patients develop a high fever or increased temperature due to exertion while wearing the patch, they should contact their health care provider.

32. Case #4 Warnings/Precautions (Facts and Comparisons) • Administer fentanyl with caution to patients with preexisting medical conditions predisposing them to hypoventilation. • Insufficient information exists to make recommendations regarding the use of fentanyl in patients with renal or hepatic function impairment. If the drug is used in these patients, use it with caution because of the hepatic metabolism and renal excretion of fentanyl. • Do not use soaps, oils, lotions, alcohol, or any other agents on the application site that might irritate the skin or alter its characteristics.

33. Other Cases Involving Pharmacists • A 75 year old post-leukemia patient with multiple complications including chronic pain • Pharmacist dispensed immediate release oxycodone on two separate occasions instead of sustained release • The patient called the pharmacy after the first mistake and the pharmacist told the technician to tell the client they are from a different manufacturer. • What should have been done differently to prevent this error?

34. Other Cases Involving Pharmacists • A 51 year old woman with an amoxicillin prescription for an infection. • Pharmacist dispenses Seroquel 400mg • The Seroquel prescription vial with a label for another patient was in a bag with the correct amoxicillin receipt. • What changes in the workflow would you implement to avoid these types of mistakes?

35. Interactive Case • A 17 year old with mental status changes resulting from three concussions in a short time period overdoses after the administration of two fentanyl patches stolen from a pharmacy and excessive amounts of alcohol. • Is the pharmacist liable for this wrongful death?

36. Interactive Case • A 43 year old female has been treated for soft tissue injury over the span of four years as the result of a motor vehicle accident. • Current pain medications • Fentanyl patch 100mcg every 3 days • Opana Extended Release 60mg twice a day • Opana Immediate Release 10mg 4 to 6 tablets every 4 to 6 hours quantity 672 tablets/month • Does the pharmacist have a legal obligation to assess the efficacy of her pain medication therapy and make recommendations to the prescribing physician?

37. Interactive Case • Two dosage increases were noted in her medical record • Opana IR 10mg #120 was increased to #240 • Opana IR 10mg #240 was increased to #672

38. Lessons Learned • Most mistakes are avoidable and many occur during transition of care or when healthcare professionals are overwhelmed taking care of too many patients. • Advocate for electronic medical records. • Pharmacist verified orders in an institutional facility may catch mistakes. • Document errors and use the data to implement solutions. • When you make a mistake try not to make excuses. Offer a sincere apology and let the patient know how you will change your policies and procedures to avoid similar mistakes in the future.

39. Professional Advice • Reach out to other healthcare professionals to optimize patient care • Purchase individual malpractice insurance • Read and understand the laws, rules and regulations governing your profession • Contact your professional board or inspector if you have any questions, concerns or you need interpretation of a legal problem. • If you have to appear before your professional board, bring legal counsel

40. Evaluating Patients with Chronic Pain versus the Small Percentage of Patients who Divert Pain Medications

41. The Maine Predicament of Prescription Drug Overdose:Myths and Realities Kenneth McCall, PharmD1,Christina Holt, MD, MSc2,; Chunhao Tu, PhD1; Todd Michaelis, MD2; Emily Bourret, PharmD Candidate1 , Jonathan Balk, PharmD Candidate1 1. College of Pharmacy, University of New England, Portland, ME2. Maine Medical Center, Department of Family Medicine, Portland, ME

42. Methods • Design: Retrospective data analysis of the Maine Prescription Monitoring Program (PMP) from fiscal years 2005 – 2010 linked to Medical Examiner Cases of all Prescription Drug deaths.

43. Study Population • Maine PMP (2005-2010): • 1,024,649 unique patients with 11,542,850 controlled substance prescriptions. • Rx Drug Overdose Deaths: • 1,007 decedents with 31,736 controlled substance prescriptions.

44. Maine Overdose Rate increase among highest in nation

45. Non-heroin opiate admissions by state per 100,000 population aged 12 and older: 1998-2008 Source: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration, Treatment Episode Data Set (TEDS), Data received through 8.31.09.

46. Treatment Admissions for Substance Abuse

47. Number of Deaths caused by Pharmaceuticaland Illicit Drugs, 1997-2009 † †Sorg MH. Drug-induced Deaths in Maine 1997-2008, with Estimates for 2009. Available at http://www.maine.gov/dhhs/samhs/osa/pubs/data/2011/DrugInducedDeathsReport%2097-08%20Final%202[1].pdf

48. National and Maine Federal Prosecutions Source: Chief Judge John A. Woodcock, Jr. US District Court. Prescription Drug Abuse Summit, October 2011, Camden, Maine.

49. Proportion of ME Cases with any record in PMP from 2005 -2010

50. “If someone dies of a Prescription Overdose, they must have been suicidal”