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

Medical Malpractice Issues in IBD

• Misdiagnosis: calling it IBD when it’s not

• Surgery related issues

• Missed Cancers

• Monitoring for Adverse Drug Events

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

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

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

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

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

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

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

Missed Diagnosis of Cancer in UC: The Problem of Pseudopolyps

Missed Diagnosis of Cancer in UC: The Problem of Pseudopolyps

Missed Diagnosis of Cancer in UC: The Problem of Pseudopolyps

Missed Diagnosis of Cancer in UC: The Problem of Pseudopolyps

• Inform the patient that diffuse pseudopolyps prevent an adequate surveillance exam and offer prophylactic colectomy

• The asymptomatic patient will almost always refuse, but document!

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

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

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

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.”

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.”

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

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

The Steroid Problem

• Is informed consent necessary?

• Inappropriate indication

• Inappropriate dose

• Inappropriate duration

The Steroid Problem• Psychiatric

– Psychosis– Depression– Suicide

• Infection• Osteoporosis• OSTEONECROSIS OSTEONECROSIS

OSTEONECROSIS

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

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

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

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

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

The “Blinders” Problem• Entrenched with a long-held accurate diagnosis,

without recognizing subtle (or not so subtle) change in symptoms – Get 2nd opinion

• Denial that something’s just not going right– Get 2nd opinion

• Patient refusal to consent to recommended treatment plan– Get 2nd opinion

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)

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 2nd opinion

• Insist on the best expert witness

• Our medical malpractice should also be buying us peace of mind