ArticleBMC medical informatics and decision making2024
Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia.
Article in BMC medical informatics and decision making, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Artificial intelligence and computational methods in the Asia-Pacific pharmacovigilance landscape: a systematic review.International journal of public health · 2026Pooled it
- Severe cutaneous adverse reactions linked to medications in children and adolescents: a pharmacovigilance study based on the FDA Adverse Event Reporting System database.International journal of clinical pharmacy · 2026Article
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Authors and funding
6 authors.
Funding
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Abstract
backgroundDigital solutions can help monitor medication safety in children who are often excluded in clinical trials. The lack of reliable safety data often leads to either under- or over-dose of medications during clinical management which make them either not responding well to treatment or susceptible to adverse drug reactions (ADRs).
aimThis study investigated ADR signalling techniques to detect serious ADRs in Malaysian children aged from birth to 12 years old using an electronic ADRs' database.
methodsFour techniques (Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS)) were tested on ADR reports submitted to the National Pharmaceutical Regulatory Agency between 2016 and 2020. Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the techniques were compared.
resultsA total of 31 medicine-Important Medical Event pairs were found and examined among the 3152 paediatric ADR reports. Three techniques (PRR, ROR, MGPS) signalled oculogyric crisis and dystonia for metoclopramide. BCPNN and MGPS signalled angioedema for paracetamol, amoxicillin and ibuprofen. Similar performances were found for PRR, ROR and BCPNN (sensitivity of 12%, specificity of 100%, PPV of 100% and NPV of 21%). MGPS revealed the highest sensitivity (20%) and NPV (23%), as well as similar specificity and PPV (100%).
conclusionsThis study suggests that medication safety signalling techniques could be applied on electronic health records to monitor medication safety issues in children. Clinicians and medication safety specialist could prioritise the signals for further clinical consideration and prompt response.
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