Alizon School of Medical & Digital IntelligenceALIZON AOS · Pharmacy AI

Mar Dioscorus College of PharmacySreekariyam · Thiruvananthapuram · Kerala

Joint Practical

Pharmacy AI · Module 2 · Unit 4 · Practical 4

From ADR to VigiBase

Aim — To run a suspected adverse drug reaction as a live investigation — discovering the history question by question, working with incomplete data, deciding seriousness and causality on the evidence, building a valid ICSR, and carrying the case from a Kerala ADR Monitoring Centre through NCC-PvPI to the UMC and VigiBase, ending in signal detection.

It is 10:15 AM in Kerala

A 42-year-old woman has arrived at the emergency department of a teaching hospital with a rapidly spreading skin rash and facial swelling. She started a new medicine four days ago. You are the pharmacovigilance team. Your job is to work out what happened, document it correctly, and decide whether this case deserves to travel from a Kerala ADR Monitoring Centre all the way to the global database.

You will not be given the case. Information is released only when you ask the right question, only when you request the follow-up, and sometimes only when the patient deteriorates. That is deliberate — it is how a real investigation behaves.

Thirteen stages, run in order. Each one unlocks the next; you cannot skip ahead.
At Stage 1 you interview a patient who answers only what you actually ask. Questions you never ask are evidence you never get.
The ADR form arrives incomplete on purpose. Deciding to seek follow-up is part of the assessment, not a failure.
Your seriousness assessment will be tested by an update mid-case. Reassessing is the correct behaviour, not a change of mind.
Causality is argued in open court — the category matters less than why.
The case ends where real cases end: as a row in a global database, being looked at for a signal.

How to run it

Duration90 minutes. The on-screen clock is a guide, not a cut-off — the facilitator may pause it for discussion.

Team size4–5 students working one screen together. One student drives; the others must agree before a decision is submitted.

FormatTeam simulation with role play. Some stages ask specific team members to argue a position.

LevelPharmacy, medical and pharmacovigilance students. No prior VigiFlow experience assumed.

Take your roles now

Assign these before you begin. They matter from Stage 2 onwards, and again in the causality court at Stage 7.

Pharmacovigilance OfficerLeads the interview and owns the report. Decides when the team has enough to submit.

DoctorSpeaks to the clinical picture — what the reaction looks like and what else could explain it.

PharmacistSpeaks to the medicine — pharmacology, known reactions, timing, dose and interactions.

Drug Information OfficerHolds the product information and the evidence. Argues expectedness in court.

PatientIn the interview, answers only what is asked. At Stage 7, gives evidence about the timeline.

Assessment rubric

Assessment criteria	Marks
Asking the right patient questions	10
Correct ADR identification	10
ADR form completion	15
Handling missing information	10
Seriousness assessment — including reassessment	10
Causality reasoning	15
ICSR / VigiFlow entry and coding	15
Quality review at NCC-PvPI	5
Signal detection	10
Total	100

Pass 50. A bonus +5 is awarded by the facilitator to the team giving the clearest answer to the closing question: why is an ADR report valuable even when causality has not been proven?

Achievement badges

🔍 Good Historian📋 Valid ICSR⚖ Causality Reasoned 🔄 Reassessed Correctly🌐 Reached VigiBase📡 Signal Spotted

Register your team

Team name or number

Institution

Team lead — name

Registration no.

Alizon School of Medical & Digital Intelligence · in collaboration with Mar Dioscorus College of Pharmacy · ADR Monitoring Centre simulation

Facilitator pack

Everything below is printable. The cards are laid out to be cut out and handed over at the right moment — the practical depends on information arriving in stages, so do not print and distribute the whole pack to students. The secret cards are marked in purple.

Timing plan — 90 minutes

Minutes	Stage	What the facilitator does
0–5	Set-up	Read the story aloud. Assign roles. Hand out Card 1 only.
5–15	1–2 · ER and interview	Hold the patient card. Answer only what is actually asked, in the patient's words.
15–22	3 · Is this really an ADR?	Make each team defend its placement before revealing the direction.
22–35	4–5 · Form and follow-up	Let them hit the missing data. Hand the AMC follow-up envelope only when a team asks for it.
35–45	6 · Seriousness and the twist	Let every team commit to an answer, then release the deterioration update.
45–58	7 · Causality court	Run it as a real hearing. Insist on reasons, not categories.
58–70	8–10 · AMC, VigiFlow, coding	Watch for teams inventing data they were never given.
70–78	11–12 · Quality check and the journey	Send at least one query back so the AMC↔NCC loop is felt.
78–88	13 · Signal wall	Let them find the pattern themselves. Then ask the causation question.
88–90	Close	60-second journey challenge and the bonus question.

Cards to cut out

Card 1 · hand out at the start

Emergency Department · 10:15

Patient

Female, 42 years

Complaint

"Red itchy rash all over the body"

Also noted

Facial swelling

New medicine

An antibiotic

Started

4 days ago

Say nothing else. Ask the team: "What do you want to know?" Give them two minutes to write questions down.

Secret · patient card — facilitator or the student playing the patient only

Reveal each line only when that specific question is asked. If they never ask about breathing or mucosal involvement, never volunteer it — that omission is the point of Stage 6.

Answers held by the patient

The medicine

Amoxicillin + clavulanic acid 625 mg, three times a day

Indication

Dental abscess — prescribed by a dentist

Started

Four days ago

Onset

Rash appeared on Day 4, roughly 8 hours after the morning dose

Other medicines

Amlodipine 5 mg once daily, for two years. Nothing else — no OTC, herbal or Ayurvedic products

Previous allergy

None known — she has never reacted to any medicine

Previous exposure

Not known. She cannot recall taking this antibiotic before

Dechallenge

The medicine was stopped this morning. The rash is beginning to improve

Rechallenge

Not performed

Treatment given

An antihistamine was administered

Breathing

"No trouble breathing at the moment." (True at 10:15. It stops being true at Stage 6.)

Secret · AMC follow-up envelope — release only when a team requests follow-up at Stage 5

AMC Follow-up

• Reaction began approximately 8 hours after the morning dose.
• Generalised erythematous rash.
• Mild facial oedema.
• No respiratory distress at the time of this follow-up.
• Medicine stopped.
• Antihistamine administered.
• Symptoms improved over 48 hours.
• No rechallenge performed.
• Patient did not die. No permanent disability. Not hospitalised at this point.

Teams that submit at Stage 4 without asking for this lose the follow-up marks. Do not offer it unprompted.

Secret · deterioration update — release at Stage 6, only after every team has committed to a seriousness answer

Update · 12:20

Two hours later the patient develops difficulty breathing and is transferred back to the emergency department. She is given adrenaline and hydrocortisone, and is admitted for overnight observation. She recovers fully by the following morning.

This is the pivot of the whole practical. A case correctly assessed as non-serious at 10:15 becomes serious at 12:20 — on new facts, not because the first answer was wrong. Say that explicitly; students often think they have been tricked.

Card · signal detection wall, Stage 13 — ten reports from the global database

Case	Drug	Reaction
001	Drug A	Rash
002	Drug B	Headache
003	Drug A	Liver injury
004	Drug C	Nausea
005	Drug A	Liver injury
006	Drug A	Liver injury
007	Drug B	Rash
008	Drug A	Liver injury
009	Drug C	Headache
010	Drug A	Liver injury

Answer key and teaching points

Stage 1–2 · History. Eight questions carry marks. The one most teams miss is breathing, throat tightness or mucosal involvement — and it is the one that decides whether this is an urticarial rash or the start of anaphylaxis. Teams that never ask it will be ambushed by the Stage 6 update, which is exactly the intended lesson.

Stage 3 · Classification. Correct direction is suspected ADR. The teaching point is that suspicion is the threshold for reporting, not proof. "Insufficient information" is a defensible instinct but the wrong operational answer — you report and then investigate, never the reverse.

Stage 4–5 · Incomplete form. The correct answer is follow up first, but do not delay the report if the four minimum elements are present. Both instincts are right and they are not in conflict: send a valid report now, complete it later.

Stage 6 · Seriousness. At 10:15 the honest answer is non-serious — no death, no admission, no disability, not life-threatening. After the update it is serious on two counts: life-threatening, and hospitalisation. Reassessment on new facts is correct practice; do not let students feel they were caught out.

Stage 7 · Causality. WHO-UMC Probable is the defensible answer: plausible time relationship, positive dechallenge, a well-documented reaction for beta-lactams, and no adequate alternative cause — but no rechallenge, which is what keeps it below Certain. Accept Possible if argued on the absence of rechallenge and the concomitant amlodipine. Reject any answer given without reasons.

Stage 10 · Coding. Code what was reported, not what you infer. "Red itchy patches all over the body" is rash generalised with pruritus — not "allergy", which is a mechanism, and not "anaphylaxis", which had not happened at that point. "Face became swollen" is face oedema; upgrading it to angioedema is an interpretation the reporter did not make.

Stage 13 · Signal. The pattern is Drug A with liver injury, five of ten reports. The essential follow-up question is whether that proves Drug A causes liver injury. It does not. Disproportionate reporting generates a hypothesis; it is subject to reporting bias, notoriety bias, confounding by indication, and has no denominator. It earns an evaluation, not a conclusion.

Bonus question. Why is an ADR report valuable even when causality has not been proven? Because a single report is rarely conclusive on its own — value comes from aggregation. Certainty about a rare reaction is only ever produced by many uncertain reports accumulating in one database. A reporter who waits for proof contributes nothing to the process that generates proof.

Case report & team record

Complete the investigation to generate your team's report, then write and submit it below.