RESEARCH DESIGN AND METHODS: All suspected ADEs associated with tocilizumab between April to August 2020 were analyzed based on COVID-19 patients' demographic and clinical variables, and severity of involvement of organ system.
RESULTS: A total of 1005 ADEs were reported among 513 recipients. The majority of the ADEs (46.26%) were reported from 18-64 years, were males and reported spontaneously. Around 80%, 20%, and 64% were serious, fatal, and administered intravenously, respectively. 'Injury, Poisoning, and Procedural Complications' remain as highest (35%) among categorized ADEs. Neutropenia, hypofibrinogenemia were common hematological ADEs. The above 64 years was found to have significantly lower odds than of below 45 years. In comparison, those in the European Region have substantially higher odds compared to the Region of Americas.
CONCLUSION: Neutropenia, superinfections, reactivation of latent infections, hepatitis, and cardiac abnormalities were common ADEs observed that necessitate proper monitoring and reporting.
METHODS: All ADR associated with the use of CAM products (including health supplements) submitted to the Malaysian Centre for ADR Monitoring, National Pharmaceutical Regulatory Agency over a 15-year period were reviewed and analysed. Multivariate logistic regression analysis was performed to identify predictors of serious ADR.
RESULTS AND DISCUSSION: From a total of 74 997 reports in the database, 930 (1.2%) involved CAM products, and 242 (26%) were serious with 36 deaths. About a third of the reports involved used CAM products for health maintenance. Most (78.1%) of the ADR reports implicated unregistered products with 16.7% confirmed to contain adulterants which were mainly dexamethasone. Of the 930 reports, the ADR involved skin and appendages disorders (18.4%) followed by liver and biliary system disorders (13.7%). The odds of someone experiencing serious ADR increased if the CAM products were used for chronic illnesses (odds ratio [OR] 1.99, confidence interval [CI] 1.46-2.71), having concurrent diseases (OR 1.51, CI 1.04-2.19) and taking concurrent drugs (OR 1.44, CI 1.03-2.02).
WHAT IS NEW AND CONCLUSIONS: The prevalence of serious ADR associated with CAM products is high. Factors identified with serious ADR included ethnicity, CAM users with pre-existing diseases, use of CAM for chronic illnesses and concomitant use of CAM products with other drugs. The findings could be useful for planning strategies to institute measures to ensure safe use of CAM products.
METHODS: Literature search using electronic databases including PubMed, Google Scholar and National Medical Research Register was conducted. Additional articles were identified by reviewing the bibliography of the retrieved articles. The articles were searched with any of the Medical Subject Headings (MeSH) terms in the title: adverse drug reaction, attitude, awareness, behaviour, experience, knowledge, Malaysia, perspectives, pharmacovigilance, practice and view. Studies were selected based on fulfilment of inclusion and exclusion criteria. The articles were scrutinised using thematic analysis.
KEY FINDINGS: Nine studies conducted among doctors, pharmacists and nurses met the inclusion criteria. Five themes emerged which included knowledge, attitude, practice, barriers and facilitators of adverse drug reaction reporting among healthcare professionals.
CONCLUSION: In general, healthcare professionals in Malaysia have good knowledge on and positive attitudes towards adverse drug reaction reporting. However, the practice of adverse drug reaction reporting was found to be unsatisfactory among healthcare professional in Malaysia. The approaches taken to enhance ADR reporting among Malaysian healthcare professionals should focus on alleviating lethargy and ignorance associated with ADR reporting.
OBJECTIVE: The aim of this study was to determine the rate, factors, and medications associated with ADR-related hospitalisations among HF patients.
SETTING: Two government hospitals in Dubai, United Arab Emirates.
METHODS: This was a prospective, observational study. Consecutive adult HF patients who were admitted between December 2011 and November 2012 to the cardiology units were included in this study. The circumstances of their admission were analysed.
MAIN OUTCOME MEASURES: ADRs-related admissions of HF patients to cardiology units were identified and further assessed for their nature, causality, and preventability.
RESULTS: Of 511 admissions, 34 were due to ADR-related hospitalisation (6.65, 95 % confidence interval 4.8-8.5 %). Number of medications taken by HF patients was the only predictors of ADR-related hospitalisations, where higher number of medications was associated with the odd ratio of 1.11 (95 % CI, 1.03-1.20, P = 0.005). More than one-third of ADR-related hospitalisations (35 %) were preventable The most frequent drugs causing ADR-related hospitalisation were diuretics (32 %), followed by non-steroidal anti-inflammatory drugs (15 %), thiazolidinediones (9 %), anticoagulants (9 %), antiplatelets (6 %), and aldosterone blockers (6 %).
CONCLUSION: ADR-related hospitalisations account for 6.7 % of admissions of HF patients to cardiac units, one-third of which are preventable. Number of medications taken by HF patients is the only predictors of ADR-related hospitalisations. Diuretic induced volume depletion, and sodium and water retention caused by thiazolidinediones and NSAIDs medications are the major causes of ADR-related hospitalisations of HF patients.
RESULTS AND DISCUSSION: Given the current lack of evidence on quality and safety improvements and on the cost-benefits associated with the introduction of eHealth applications, there should be a focus on implementing more mature technologies; it is also important that eHealth applications should be evaluated against a comprehensive and rigorous set of measures, ideally at all stages of their application life cycle.
METHODS: Using a cross-sectional design and convenient sampling, data were collected in public areas within Kuala Lumpur, Malaysia, via face-to-face interview with a structured questionnaire. Multivariate logistic regression analysis was used to identify the significant predictors of patients' confidence in ADR reporting.
RESULTS: Out of 860 consented respondents achieving a response rate of 73.5%, only 69 (8%) were aware of the Malaysian ADR monitoring system. The majority (60%) of the respondents indicated they had the confidence to report ADRs. Multivariate logistic regression analysis revealed that ease in completing the ADR reporting form was the strongest variable predictive of confidence to report ADRs (odds ratio [OR], 18.45; 95% confidence interval [CI], 10.55-32.25). Increased confidence in ADR reporting was also associated with education level. Respondents with a higher education level were more likely to be confident to report ADRs compared to those with primary or no formal education (OR, 2.49; 95% CI, 0.77-8.1).
CONCLUSIONS: Lack of awareness of the ADR monitoring system is still prevalent among Malaysian patients. The ease of completing the ADR form and education level are predictive of patient confidence to report ADRs. These factors should be considered in designing public promotional activities to encourage patient contributions to pharmacovigilance.