3 Clinical psychopharmacology3.4 Therapeutics
3.4.8 Adverse event reporting
2 min read1 figure
Written by Resident Doctor Committee · Published
Terms
Term | Meaning |
|---|---|
Adverse event | Any unwanted occurrence during treatment, whatever the cause |
Suspected adverse drug reaction | A possible harmful response to a medicine |
Serious | Fatal, life-threatening, causing or prolonging admission, disabling, causing a congenital anomaly or otherwise medically important |
Severe | Intense, which is not the same as serious |
Unexpected | Inconsistent with the product information |
Medication error | A preventable failure in prescribing, dispensing, administration or monitoring |
Near miss | An error intercepted before it reaches the patient |
An intense headache may not be serious, whereas an asymptomatic but dangerous blood abnormality may be.
Clinical response first
Treat the patient first, preserve batch details and remaining product, and keep the clinical record, which a report does not replace.
A valid report
A valid report needs an identifiable patient, an identifiable reporter, a suspected medicine and a suspected reaction.
Report promptly and send missing details later.
Causality
Dechallenge is improvement after the medicine is withdrawn.
Rechallenge is recurrence on re-exposure; it strengthens an association, but never re-expose someone just to prove a serious reaction.
Weigh alternative causes: illness, infection, interactions, other substances and withdrawal.
Uncertainty should not delay a report, because suspicion is enough.
Yellow Card and local incident reporting
The Yellow Card scheme of the Medicines and Healthcare products Regulatory Agency (MHRA) takes reports from professionals, patients and carers, and records suspicion, not proven causation or fault.
Route | Question it answers |
|---|---|
Yellow Card | Is there a suspected safety problem with this medicine or product? |
Local incident report | What went wrong in care, and how can recurrence be prevented? |
A harmful medication error may need both routes, and one does not trigger the other.
Neither route replaces the duty of candour.
In England, local incident data feed the Learn from Patient Safety Events service.
What to report
Report all serious suspected reactions to established medicines, including recognised ones, and every suspected reaction to a black triangle medicine.
The inverted black triangle marks additional monitoring, not an unsafe medicine.
Reports are particularly wanted for children, older people, pregnancy, breastfeeding, delayed effects, interactions, errors and overdose.
Report suspected defective or falsified products even without patient harm.
Patients and allergy records
Tell the patient they can report directly, and record the reaction in the structured allergy and adverse reaction fields.
An inaccurate allergy label restricts treatment, while anaphylaxis recorded as intolerance allows dangerous re-exposure.
Signals and limits
The MHRA looks in pooled reports for disproportionate reporting, plausible timing and clustering, then may update warnings, restrict use or, rarely, suspend a licence.
Spontaneous reports cannot establish incidence, and under-reporting, publicity and duplicates distort counts, so raw totals cannot compare two drugs.
The scheme best detects rare, delayed or unexpected reactions, such as myocarditis with clozapine.