Paeds Vivas · clinical-pharmacology-and-therapeutics
Adverse drug reactions and pharmacovigilance — branching viva
Branching viva on ADR definition and classification, paediatric epidemiology, causality and severity assessment, management of anaphylaxis and severe cutaneous reactions, and the pharmacovigilance reporting pathway.
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Target exams
Opening (warm-up)
Examiner. A 7-year-old is admitted with a rash that began two weeks after starting lamotrigine. Take me through your first thought. [5]
Candidate. My first thought is that any new symptom with a temporal relationship to a newly started medicine puts an adverse drug reaction on the differential. Lamotrigine is an aromatic anticonvulsant with a well-recognised risk of cutaneous reactions, including rare Stevens-Johnson syndrome, and the two-week latency fits. So I would assess the child immediately, stop the lamotrigine, and characterise the rash to separate a benign exanthem from a severe cutaneous adverse reaction. [1]
You have read the opening of this viva. The complete unit — every section and its primary-source references — is part of the Paediatrics Fellowship fellowship atlas.
References7Show ledgerHide ledger
- [1]Edwards IR, Aronson JK Adverse drug reactions: definitions, diagnosis, and management Lancet (London, England), 2000.PMID 11072960
- [2]Naranjo CA, Busto U, Sellers EM, et al A method for estimating the probability of adverse drug reactions Clinical pharmacology and therapeutics, 1981.PMID 7249508
- [8]Star K, Sandberg L, Bergvall T, et al. Paediatric safety signals identified in VigiBase Pharmacoepidemiology and drug safety, 2019.PMID 30767342
- [9]Hazell L, Shakir SA Under-reporting of adverse drug reactions: a systematic review Drug safety, 2006.PMID 16689555
- [5]Gallagher RM, Mason JR, Bird KA, et al Adverse drug reactions causing admission to a paediatric hospital PloS one, 2012.PMID 23226510
- [7]Star K, Norén GN, Nordin K, et al. Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase Drug safety, 2011.PMID 21513364
- [12]Bracken LE, Nunn AJ, Kirkham JJ, et al Development of the Liverpool Adverse Drug Reaction Avoidability Assessment Tool PloS one, 2017.PMID 28046035