<p> Algorithm for Drug-Induced Liver Injury (Case Definition Only)</p><p>Revision history Version Author Date 0.1 Jyoti Pathak 11/23/2011 0.2 Jyoti Pathak, Jay 12/05/2011 Talwalkar, Stephanie Johnson 0.3 Jyoti Pathak, Jay 12/22/2011 Talwalkar, Stephanie Johnson</p><p>Inclusion Criteria for Case Definition</p><p>For a patient to be classified as “true DILI”, all the 4 criteria have to be satisfied (logical conjunction for the 1st three criteria, and optionally criteria 4.).</p><p>Criteria 1: The subject must be alive and the date of onset of the qualifying DILI episode must have occurred on or after January 1, 1994.</p><p>Criteria 2: Medications</p><p> The patient be on at least one of the following medications at any given time in their lifetime: see the attached document </p><p>Criteria 3: NLP/Term Spotter</p><p> All the patients should have DILI or terms referring to DILI as identified by the NLP term spotter algorithm. Attached document has the list of relevant terms.  Timeframe to consider for term spotter: We will look for DILI terms 9 months BEFORE and AFTER the 1st incidence of the drug from Criteria #2. </p><p>Criteria 4: Lab measurement</p><p> Types for labs to look for: o Total serum bilirubin > 2.5 mg/DL is required for all patients. o Unless if the patient is on Valproic Acid (one of the medications), then total serum bilirubin > 1.0 mg/DL. If total bilirubin is not available, then check for: . AST > 215, or . ALT > 135, or . INR > 1.5 o Unless if the patient is on nitrofurantoin or minocycline, either total serum bilirubin >2.5 mg/dL or documented fibrosis/cirrhosis on liver biopsy . Use the following ICD-9 codes for cirrhosis: 571, 571.5, 571.6, 571.8, 571.9  Timeframe to consider for labs: o 1 or more lab readings (need not be consecutive) within 9 months AFTER the 1st incidence of the drug from Criteria #2.</p><p>Exclusion Criteria for Case Definition </p><p> Search for the terms PBC () or PSC (). If any term is present within XXX timeframe, then exclude the patients.</p><p> Ever undertaken an allogeneic bone marrow transplant (need to identify appropriate ICD-9 or CPT-4 codes)</p><p> Ever diagnosed with a specific seizure syndrome associated with known genetic defects if the implicated drug is valproate or phenytoin transplant (need to identify appropriate ICD-9 or CPT-4 codes).</p>