Pharmacy AI · Module 2 · Unit 4 — Digital Inventory, ADR & Compliance Systems

Electronic ADR Reporting & Pharmacovigilance Using a Digital Reporting System

Aim — To identify, document, assess and electronically report a suspected Adverse Drug Reaction (ADR) using a digital pharmacovigilance reporting system. Duration 60 minutes · One case per student · 100-mark competency rubric · Pass 50%.

Case —
Score —
Result —
◐ Theme

New to ADR reporting? Start here

An Adverse Drug Reaction (ADR) is any harmful, unintended response to a medicine taken at a normal dose. Reporting ADRs (pharmacovigilance) keeps medicines safe. In this station you will work through one patient:

  1. Read the patient's condition and the medicine they are taking.
  2. Identify the suspected reaction (the ADR) and which medicine likely caused it.
  3. Judge how serious it is — could it cause death, hospitalisation or lasting harm? Then it is serious.
  4. Assess causality — how confident are we the drug caused it? Use the WHO-UMC scale (time link, other causes, response to stopping/restarting).
  5. Complete the electronic ADR form, then counsel the patient on safety and future precautions.

Not sure on a case? Open “Need a hint?” in the station. Work through Steps 1–5 in order.

Student tasks

Patient counselling

Explain to the patient:

Learning outcomes

WHO-UMC causality categories

CategoryKey criteria
CertainPlausible time link · other causes excluded · positive dechallenge · pharmacologically definitive · rechallenge satisfactory (if performed)
Probable / LikelyReasonable time link · other causes unlikely · reasonable dechallenge · rechallenge not required
PossibleReasonable time link · could also be explained by disease or other drugs · dechallenge unclear or absent
UnlikelyTime link improbable · disease or other drugs give a plausible explanation

Faculty assessment rubric

CriteriaMarks

Objective criteria are auto-scored; the written report is graded by faculty. Mis-classifying a serious ADR as non-serious triggers a patient-safety flag.

Candidate & case assignment

Each student is assigned one unique ADR case.

Practical record & assessment

Complete the ADR reporting station and submit to generate your assessment, then write and submit your report.