1. Malpractice Issues in IBD and How to Avoid Them: Advances in IBD 2014 Asher Kornbluth, MD Clinical Professor of Medicine The Henry D. Janowitz Division of Gastroenterology The Icahn School of Medicine at Mount Sinai

2. Medical Malpractice Issues in IBD Misdiagnosis: calling it IBD when it’s not Surgery related issues Missed Cancers Monitoring for Adverse Drug Events

3. Calling it IBD When It’s Not Beware of false positive results: The soft finding Capsule endoscopy, Serologies C.diff C.diff C.diff –Beware high rate false negatives; get PCR Drug induced –5-ASA induced can be secretory or bloody Ischemic colitis –Not just in elderly: OC, runners, hypercoaguable Diverticular colitis Infectious colitis

4. Surgery: Failure to Operate Continuing medical therapy excessively in severe colitis Perforation during colonoscopy for fulminant colitis Excessive treatment of toxic megacolon Failure to recognize perforation

5. Surgery: Post Op Complications A post op ileus and fever makes an anastamotic leak the leading diagnosis until proven otherwise Crohn’s disease HAS NEVER RECURRED within 2 weeks of a resection and primary anastamosis Insist on re-exploration, diverting stoma and a different surgeon if necessary

6. Missing the Diagnosis of Cancer Failing to survey adequately: after 8-10 years of extensive colitis, obtain biopsies at every 10 cm, or each colonic segment. –Guidelines vary as to length of time intervals between surveillance colonoscopies Consider chromoendoscopy of suspicious lesions Failure to document explicitly that clear visualization of all segments achieved, and issues of: –Prep –Cecal visualization Problem of retroflexion in rectum

7. Missing the Diagnosis of Cancer Failing to survey in Crohn’s colitis of extensive disease Small bowel surveillance in Crohn’s disease not indicated, but consider dx SB Ca if new onset obstruction after long history quiescent disease No standard exists regarding surveillance of ileoanal pouch, but reasonable to consider with history of preoperative dysplasia or carcinoma, and consider in patient with PSC ( no data for this) Think of anal cancer in anal strictures and complex chronic fistula and tags

8. Missing the Diagnosis of Cancer Chromoendoscopy increases yield of dysplasia detection, not currently standard of care Review slides by expert IBD pathologist if indefinite, LGD, HGD or cancer being read Prepare patient for possibility of finding no dysplasia in colectomy specimen Failure to make the appropriate recommendation: –HGD ---  Total proctocolectomy –LGD --  Surgery, or if continued surveillance recommendation, assure follow up

9. Missed Diagnosis of Cancer in UC: The Problem of Stricures Use gastroscope to attempt passage. The unpassable stricture in UC is cancer until proven otherwise

10. Missed Diagnosis of Cancer in UC: The Problem of Pseudopolyps

13. Inform the patient that diffuse pseudopolyps prevent an adequate surveillance exam and offer prophylactic colectomy The asymptomatic patient will almost always refuse, but document!

14. Prevention of Venous and Arterial Thrombosis Increased risk of thrombosis in hospitalized IBD patients, venous and arterial Increased risk of mortality !!! Treat with prophylactic SQ heparin doses even in active UC If recurrent thromboses, consider emergent colectomy even if colitis improving Consult with hematologist regarding underlying etiology and duration of anticoagulation

15. Failure to Monitor Medical Therapy: Mesalamines Nephrotoxicity: –Measurement of BUN/Cr at baseline FDA: “Periodic” measurement of BUN/Cr –Reduce dose if baseline renal function impaired –Reduce or eliminate if BUN/Cr progressively rise Recognition that mesalamine may be the cause of the patient’s symptoms- either secretory diarrhea or even typical bloody colitis

16. Sulfasalazine: PDR Monitoring Warning Baseline CBC and LFTS CBC and LFTs every 2 weeks for 3 months CBC and LFTs every month for 3 months CBC and LFTS every 3 months thereafter Periodic measurement of urine analysis and renal function

17. Azathioprine, TPMT and the FDA: PDR 2014 “TPMT genotyping or phenotyping can help identify patients who are at an increased risk for developing azathioprine toxicity.”

18. Azathioprine, TPMT and the FDA: PDR 2012 “ Patients with intermediate TPMT activity may be at increased risk of myelotoxicity if receiving conventional doses of azathioprine. Patients with low or absent TPMT activity are at an increased risk of developing severe, life-threatening myelotoxicity if receiving conventional doses of azathioprine.”

19. Failure to Monitor Medical Therapy: 6-MP/AZA Failure to check baseline TPMT Bone marrow suppression: Check labs, weekly or bi-weekly for 1 month then monthly for 3 months then every 3 months Recurrent pancreatitis –Don’t re-treat, don’t treat with the other thiopurine On the other hand, don’t routinely measure amylase and lipase

20. Failure to Monitor Medical Therapy: Anti-TNF drugs Infection- increased risk for any infection Take home message---- very low threshold of w/u of any fever and/or new focal symptom Check for baseline Hepatitis B status Probably not an independent risk factor for postoperative infections, i.e. don’t delay an urgent operation Neurotoxicity –MS, optic neuritis –Seizures –Diverse list of neurotoxicity

21. The Steroid Problem Is informed consent necessary? Inappropriate indication Inappropriate dose Inappropriate duration

22. The Steroid Problem Psychiatric –Psychosis –Depression –Suicide Infection Osteoporosis OSTEONECROSIS OSTEONECROSIS OSTEONECROSIS

23. The Steroid Problem Osteoporosis and its sequelae –Failure to prevent Calcium: 1200 – 1500 mg/d, Vitamin D- 600u/d –Failure to screen –Failure to treat

24. AGA, ACG, CCFA Guidelines for DEXA Screening Lifelong exposure of > 3 months prednisone Post-menopausal Other osteoporosis risk factors –Post menopausal women at greatest risk

25. Osteonecrosis (Avascular Necrosis) Related (almost always) to high cumulative steroid dose Mt. Sinai Series----23 patients with IBD and osteonecrosis –Mean duration usage = 25 months –Mean maximum daily dose = 61 mg –Mean daily dose = 21 mg –Mean cumulative dose = 9900 mg

26. Osteonecrosis No benefit to calcium and vitamin D supplementation No preventive measures (other than eliminating steroids) No value to DEXA scanning Goal is to minimize steroid use at every turn

27. Osteonecrosis: Likely to Lose This One, Unless WE DOCUMENT AT EVERY INSTANCE THAT STEROIDS WERE USED, THE PATIENT WAS INFORMED OF THE RISK OF OSTEONECROSIS, AND AN EXIT STRATEGY WAS IN PLACE TO WEAN STEROIDS

28. The “Blinders” Problem Entrenched with a long-held accurate diagnosis, without recognizing subtle (or not so subtle) change in symptoms –Get 2 nd opinion Denial that something’s just not going right –Get 2 nd opinion Patient refusal to consent to recommended treatment plan –Get 2 nd opinion

29. Our Psychological Issues: After Being Sued Denial Anger –It’s (usually) not the patients’ fault. They figure we have insurance for a reason Guilt –Greatest batter, Ty Cobb: < 4 of 10 (.367) –Greatest free throw shooter, Mark Price: 9 of 10 (.904) –Our accurate decision rate is >>> 999 of 1000 Anxiety, Depression for 7 years ( often refractory to anxiolytics and anti-depressants)

30. Some Final Suggestions Practice according to standards of care. Published Guidelines are guides, not rigid, but will be used in court Don’t hesitate in suggesting a 2 nd opinion Insist on the best expert witness Our medical malpractice should also be buying us peace of mind