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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