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.
Methods: This study utilised a cross-sectional design and was conducted at a single centre where convenience sampling was employed to collect data from elderly patients (> 60 years) admitted to geriatric and medical wards at Hospital Tuanku Ja'afar during a 2-month period (July 2017-August 2017). Patients were excluded from this study if their hospital admission was planned for an elective procedure or if neurocognitive and hepatic impairment were diagnosed prior to the hospital admission. Medicines with Ach properties were identified and classified according to the anti-cholinergic drug scale (ADS). Univariate and multiple logistic regression statistical analyses were performed to assess its impacts on falls, confusion, and LOS.
Results: A total of 145 elderly patients with a mean age of 71.59 years old (SD = 8.02) were included in the study. Fifty-two percent of the participants were female, and the average hospital stay was 6 days (SD = 2.09). Medicines with Ach properties were administered in 62% (n = 90) of the cases. The most commonly prescribed medicine with Ach properties was furosemide (n = 59), followed by ranitidine (n = 44), warfarin (n = 23), and methylprednisolone (n = 22). Compared to patients who did not receive medicines with Ach properties, patients who received them had a significantly higher risk of falls [odds ratios (OR) = 2.61; 95%CI: 1.18, 5.78; P = 0.018], confusion (OR = 3.60; 95%CI: 1.55, 8.36; P = 0.003), and LOS (OR = 4.83; 95%CI: 2.13, 10.94; P < 0.001). Multiple comorbidities also showed a significantly increased risk of falls (OR = 3.03; 95%CI: 1.29, 7.07; P = 0.010).
Conclusion: Medicines with Ach properties had a significant impact on elderly patients' health. Strategies for rationally prescribing medicines with Ach properties to Malaysian elderly patients need to be improved and be recognised as an important public health priority.