Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia
Abstract Background Digital 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...
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| Format: | Article |
| Language: | English |
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BMC
2024-12-01
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| Series: | BMC Medical Informatics and Decision Making |
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| Online Access: | https://doi.org/10.1186/s12911-024-02801-y |
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| author | Beldona Hema Rekha Shairyzah Ahmad Hisham Izyan A. Wahab Norleen Mohamed Ali Khang Wen Goh Long Chiau Ming |
| author_facet | Beldona Hema Rekha Shairyzah Ahmad Hisham Izyan A. Wahab Norleen Mohamed Ali Khang Wen Goh Long Chiau Ming |
| author_sort | Beldona Hema Rekha |
| collection | DOAJ |
| description | Abstract Background Digital 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). Aim This study investigated ADR signalling techniques to detect serious ADRs in Malaysian children aged from birth to 12 years old using an electronic ADRs’ database. Methods Four 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. Results A 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%). Conclusions This 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. |
| format | Article |
| id | doaj-art-74993203e4e64cdbb0eedc69245cd67a |
| institution | Kabale University |
| issn | 1472-6947 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Medical Informatics and Decision Making |
| spelling | doaj-art-74993203e4e64cdbb0eedc69245cd67a2024-12-22T12:30:02ZengBMCBMC Medical Informatics and Decision Making1472-69472024-12-012411910.1186/s12911-024-02801-yDigital monitoring of medication safety in children: an investigation of ADR signalling techniques in MalaysiaBeldona Hema Rekha0Shairyzah Ahmad Hisham1Izyan A. Wahab2Norleen Mohamed Ali3Khang Wen Goh4Long Chiau Ming5Faculty of Pharmacy, University of Cyberjaya, Persiaran BestariSchool of Pharmacy, University of Nottingham MalaysiaFaculty of Pharmacy, Universiti MalayaPharmacovigilance Section, Centre for Compliance and Quality Control, National Pharmaceutical Regulatory Agency, Jalan UniversitiFaculty of Data Science and Information Technology, INTI International UniversitySchool of Medical and Life Sciences, Sunway UniversityAbstract Background Digital 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). Aim This study investigated ADR signalling techniques to detect serious ADRs in Malaysian children aged from birth to 12 years old using an electronic ADRs’ database. Methods Four 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. Results A 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%). Conclusions This 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.https://doi.org/10.1186/s12911-024-02801-yPediatricsPharmacyeHealthElectronic health records |
| spellingShingle | Beldona Hema Rekha Shairyzah Ahmad Hisham Izyan A. Wahab Norleen Mohamed Ali Khang Wen Goh Long Chiau Ming Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia BMC Medical Informatics and Decision Making Pediatrics Pharmacy eHealth Electronic health records |
| title | Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia |
| title_full | Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia |
| title_fullStr | Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia |
| title_full_unstemmed | Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia |
| title_short | Digital monitoring of medication safety in children: an investigation of ADR signalling techniques in Malaysia |
| title_sort | digital monitoring of medication safety in children an investigation of adr signalling techniques in malaysia |
| topic | Pediatrics Pharmacy eHealth Electronic health records |
| url | https://doi.org/10.1186/s12911-024-02801-y |
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