California SJS/TEN drug-causation checklist

1) Confirm the medical diagnosis (and capture severity details)

• Hospital records documenting the diagnosis (SJS, TEN, or SJS/TEN overlap) and the clinical basis for it.
• Dermatology consult notes.
• Skin biopsy/pathology reports (if performed) and differential diagnosis discussion.
• ICU/burn unit records (if applicable), including percent body surface area (BSA) involvement, mucosal involvement, ocular involvement, and complications.
• Discharge summary listing suspected culprit medications and the treating team’s reasoning (if documented).

2) Build a medication exposure timeline (start to stop)

• Every prescription and over-the-counter medication taken in the weeks before symptom onset.
• Start dates, stop dates, dose changes, and missed doses (as best you can document them).
• New medications (first exposure) and re-starts after a break.
• Any medications clinicians flagged as potential culprits (do not stop any medication without medical advice).

Documents to gather:

• Pharmacy fill history (retail and mail-order) showing fill dates, drug name, strength, quantity, prescriber, and pharmacy location.
• Prescribing records from the doctor’s office (visit notes, after-visit summaries, e-prescribing logs where available).
• Medication administration record (MAR) for inpatient stays.

3) Pin down the first symptoms and progression

• The first day you noticed symptoms (and what they were).
• When the rash appeared and how quickly it spread.
• When mucosal symptoms began (mouth, eyes, genitals) and major functional impacts (e.g., painful swallowing).
• When you sought care (urgent care/ER/primary doctor) and what you were told.

Evidence sources:

• ER triage notes and nursing notes (often time-stamped symptom descriptions).
• Photos with metadata (keep original files if possible).
• Contemporaneous messages/emails describing symptoms.
• Work notes/attendance records showing abrupt functional decline.

4) Identify and document alternative causes (and why they are less likely)

• Recent infections noted in records.
• Other medications started around the same time.
• Prior history of drug eruptions or immune-related conditions (as documented).
• Viral testing, cultures, and other lab work discussed in the chart.

5) Capture what the treating team said about the suspected drug

• “Culprit drug” or “suspected medication” language in dermatology/allergy notes.
• “Drug allergy” entries added to your chart.
• Medication lists marked “discontinue” or “avoid.”
• References to adverse-event reporting (if any) in the chart.

6) Preserve the product-and-distribution trail (what exactly was taken)

• Prescription bottles, boxes, blister packs, inserts, and remaining pills (store safely; follow medical advice).
• Photos of labels showing the National Drug Code (NDC), manufacturer/labeler, and pharmacy information.
• If administered in a hospital, records that identify manufacturer/lot in the MAR or pharmacy records (if documented).

Reference: FDA: National Drug Code Directory.

7) Document damages beyond the acute hospitalization

• Follow-up specialists (e.g., dermatology, ophthalmology, OB-GYN/urology, ENT, pulmonology, mental health).
• Ocular complications and related procedures.
• Skin and nail changes (scarring, pigment changes, nail loss) as documented by clinicians.
• Chronic pain or functional limitations documented in follow-up notes.
• Lost income, reduced work capacity, and work accommodations.
• Out-of-pocket costs (travel, prescriptions, assistive devices).

8) Expect expert review

• A dermatologist or allergist/immunologist to address diagnosis and drug causation.
• A pharmacist or pharmacologist to address mechanism, labeling/warnings, and risk profile.
• Other specialists (e.g., ophthalmology) to address complication causation.

9) Avoid common pitfalls

• Missing pharmacy records or incomplete medication histories.
• Multiple new drugs started close together without clear start/stop documentation.
• Inconsistent accounts of onset dates across providers.
• Discarding bottles/packaging before documenting manufacturer/labeler information.
• Gaps in follow-up care documentation for complications.