Aim — To work a suspected adverse drug reaction from first report to submitted case — taking the history from the patient, classifying seriousness and expectedness, scoring causality, and filing a valid report inside the regulatory clock.
The ward has telephoned the drug information centre about a patient who has developed a rash and is unwell. You are the pharmacovigilance pharmacist. Nothing has been established yet — the history is yours to take.
Not sure how any of that is actually done? The tab is the full reporting guide — what is reportable, the four minimum elements, the seriousness criteria, the form filled section by section, where it goes and by when. It stays available while you work the desk.
| Assessment criteria | Marks |
|---|---|
| History taking — asking the questions that matter | 20 |
| Seriousness classification | 15 |
| Expectedness against the product information | 10 |
| Naranjo causality assessment | 25 |
| Valid report — all four minimum elements | 20 |
| Immediate clinical action and follow-up | 10 |
| Total | 100 |
Pass 50. Report validity and timeliness are reported separately.
This section is the reference for the practical. It is how an adverse drug reaction is actually reported in India: what counts as reportable, the four elements without which a report does not exist, how each box on the form is filled, where the form goes and by when. Read it before you take the call, and keep it open while you work the desk.
The one rule that governs everything below: you report on suspicion, not proof. You are never required to establish that the medicine caused the reaction — only that you suspect it might have. Deciding causality is the assessor's job, and it is done after your report arrives, not before you send it.
Reporting in India runs through the Pharmacovigilance Programme of India (PvPI), launched in 2010, whose National Coordination Centre is the Indian Pharmacopoeia Commission (IPC) at Ghaziabad. Reports are collected by ADR Monitoring Centres (AMCs) — usually a hospital department, and in this exercise your own — which check and code each case before forwarding it to the NCC. The NCC assesses and collates the national data and uploads it to VigiBase, the WHO global database held by the Uppsala Monitoring Centre, so that a signal too rare to see in one country can emerge from the world's data. Regulatory action in India is taken by CDSCO on the NCC's recommendation.
Anyone may report. Doctors, pharmacists, nurses, dentists and other healthcare professionals report, and so may patients and their carers on the consumer form. You do not need seniority, permission, or a diagnosis to file a report.
If you suspect a medicine has harmed a patient, it is reportable. Report it even when the reaction is well known, even when you think someone else will report it, and even when you are not sure the drug is responsible.
Report all of these:
A case is valid only if all four are present. A form missing any one of them is not entered into the database and does not count as having been reported, however much other detail it contains.
Serious is a regulatory category defined by outcome, not a description of how unpleasant the reaction is. An agonising but self-limiting reaction is not serious; a symptomless finding that lands the patient in hospital is. Seriousness decides the reporting speed, so it is settled first and independently of whether the drug is to blame.
A reaction is serious if it:
Expected means the reaction is already described in the approved reference safety information — the Summary of Product Characteristics or package insert. It does not mean common, mild or predictable. A rare and fatal reaction that is listed is expected; a trivial one that is not listed is unexpected.
Expectedness does not change whether you report. It changes the urgency, because a reaction that is serious and unexpected and suspected is the combination that triggers expedited reporting and is the most likely to represent a new signal.
Not every adverse event goes to PvPI on the ADR form. Sending a case to the wrong programme delays it and loses it.
| What happened | Where it goes |
|---|---|
| Suspected reaction to a medicine (allopathic, OTC, herbal, AYUSH), including errors and quality problems | PvPI — Suspected Adverse Drug Reaction Reporting Form, via your AMC |
| A patient or carer wishes to report themselves | PvPI — Medicines Side Effect Reporting Form (consumer version) |
| Adverse event following immunisation under the national programme | AEFI surveillance — AEFI reporting form to the district immunisation officer |
| Failure or injury caused by a medical device, implant or diagnostic kit | MvPI — Materiovigilance Programme of India, also coordinated by IPC |
| Transfusion reaction to blood or a blood product | HvPI — Haemovigilance Programme of India, NIB Noida |
| Serious adverse event in a patient enrolled in a clinical trial | Sponsor, Ethics Committee and CDSCO under the New Drugs and Clinical Trials Rules — not the spontaneous route |
The PvPI Suspected ADR Reporting Form runs in lettered sections. What each expects, and the mistake students most often make in it, is set out below. Write what you know; enter "not known" rather than leaving a box empty, so the assessor can tell the difference between missing information and information you have not yet sought.
| Section | What you write | The common mistake |
|---|---|---|
| A · Patient information Initials, age or date of birth, sex, weight | Initials only, age at the time of the event, and weight where a dose calculation matters | Writing the full name — a confidentiality breach; or giving today's age rather than the age when it happened |
| B · Suspected reaction Date started, date of recovery, description | What was observed, in clinical terms, with the date of onset and how it evolved | Writing a diagnosis you have assumed ("drug allergy") instead of describing what you actually saw |
| C · Suspect medicine(s) Name, manufacturer, batch and expiry, dose, route, frequency, therapy dates, indication | Brand and generic name, the batch number from the pack, the dates therapy started and stopped, and why it was prescribed | Omitting the batch number and the therapy start date — the two fields that make a quality investigation and a temporal assessment possible |
| Dechallenge Did the reaction settle when the drug was stopped or reduced? | Yes, no, or not applicable / not known — including when the drug was stopped too recently to tell | Answering "no" when the drug was stopped yesterday. That is unknown, and recording it as "no" wrongly argues against the drug |
| Rechallenge Did it reappear when the drug was given again? | Almost always not done — and correctly so, since deliberate rechallenge after a serious reaction is unethical | Recording "no" for a rechallenge that was never performed |
| Concomitant medicines | Everything else the patient takes, with dates — prescribed, OTC, herbal, AYUSH and supplements | Listing only the prescription chart, so the interacting product is never seen |
| D · Other relevant history | Allergies, previous reactions, comorbidities, renal or hepatic impairment, pregnancy, smoking and alcohol | Leaving it blank — this is where the alternative explanations live, and their absence is itself evidence |
| E · Seriousness and outcome | Tick every seriousness criterion that applies, then the outcome: recovered, recovering, not recovered, recovered with sequelae, fatal, or unknown | Ticking "serious" on the strength of how distressing it was, rather than against the six defined outcomes |
| F · Reporter details | Name, profession, address with PIN, telephone and email, date and signature | Leaving contact details off — which makes follow-up impossible and costs the report its validity |
Hand the completed form to your ADR Monitoring Centre. Where there is no AMC, or the reporter is a patient, any of the national routes below may be used directly.
| Who is reporting | By when |
|---|---|
| Healthcare professional, spontaneous report to an AMC | Voluntary and without a statutory deadline — but as soon as possible, and the same working day for a serious reaction, while the detail is still accurate and the batch still traceable |
| Investigator, serious adverse event in a clinical trial | To the sponsor, the Ethics Committee and CDSCO within 24 hours of becoming aware, with the detailed report following within 14 days |
| Marketing authorisation holder, serious unexpected reaction occurring in India | Within 15 calendar days of first knowledge, to CDSCO |
| Marketing authorisation holder, periodic reporting | Periodic Safety Update Reports on the schedule set in the licensing rules |
A report is a beginning. Send the outstanding items as soon as you have them: the batch number, the outcome, laboratory and histology results, and what happened after withdrawal. Respond to the AMC when it queries the case.
Causality is assessed after submission, at the AMC and the NCC, using the WHO-UMC scale — certain, probable, possible, unlikely, conditional, unassessable — supported where appropriate by the Naranjo algorithm, which you use on the desk. A case scored unassessable is almost always one whose form was too thin to assess. That is within your control.
Tick what your report actually contains. The four marked required decide whether the case is valid at all; the rest decide how useful it is.
This is the carbamazepine case from the desk, written up as it would be submitted. Dates are illustrative; note how little of it is speculation and how often "not known" appears where the answer genuinely is not known.
Alizon Teaching Hospital · Drug Information Centre · ADR Monitoring Centre link
Complete the case to generate your report, then write and submit it below.