Displaying publications 21 - 37 of 37 in total

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  1. Elkalmi RM, Hassali MA, Ibrahim MI, Jamshed SQ, Al-Lela OQ
    J Patient Saf, 2014 Jun;10(2):81-7.
    PMID: 24618640 DOI: 10.1097/PTS.0000000000000051
    This study was designed to explore awareness and attitudes of community pharmacists toward the national ADR reporting system activities in the northern states of Malaysia.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  2. Boonmuang P, Nathisuwan S, Chaiyakunapruk N, Suwankesawong W, Pokhagul P, Teerawattanapong N, et al.
    Drug Saf, 2013 Sep;36(9):779-87.
    PMID: 23615756 DOI: 10.1007/s40264-013-0055-5
    HMG-CoA reductase inhibitors [statins], a widely prescribed cholesterol-lowering therapy, are associated with muscle-related adverse events. While characteristics of such events are well documented in Western countries, little data exists for the Thai population.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  3. Xiang YT, Kreyenbuhl J, Dickerson FB, Ungvari GS, Wang CY, Si TM, et al.
    Aust N Z J Psychiatry, 2012 Dec;46(12):1159-64.
    PMID: 22790175 DOI: 10.1177/0004867412453625
    This study examined the prescribing patterns of several first- (FGAs) and second-generation antipsychotic (SGAs) medications administered to older Asian patients with schizophrenia during the period between 2001 and 2009.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*
  4. Aziz Z, Siang TC, Badarudin NS
    Pharmacoepidemiol Drug Saf, 2007 Feb;16(2):223-8.
    PMID: 16947117
    Malaysia like many other countries worldwide uses spontaneous reporting systems as a mean of collecting data on suspected adverse drug reaction (ADR). However, compared to other countries, which use the system, the reporting rate in Malaysia is very low. Why some physicians do not report ADRs is not well understood.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*
  5. Charan J, Dutta S, Kaur R, Bhardwaj P, Sharma P, Ambwani S, et al.
    Expert Opin Drug Saf, 2021 Sep;20(9):1125-1136.
    PMID: 34162299 DOI: 10.1080/14740338.2021.1946513
    BACKGROUND: Elevated inflammatory cytokines in Coronavirus disease 2019 (COVID-19) affect the lungs leading to pneumonitis with a poor prognosis. Tocilizumab, a type of humanized monoclonal antibody antagonizing interleukin-6 receptors, is currently utilized to treat COVID-19. The present study reviews tocilizumab adverse drug events (ADEs) reported in the World Health Organization (WHO) pharmacovigilance database.

    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.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*
  6. Kow CS, Aldeyab M, Hasan SS
    Eur J Clin Pharmacol, 2021 Mar;77(3):435-437.
    PMID: 33011825 DOI: 10.1007/s00228-020-03008-6
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*
  7. Rashed AN, Wong IC, Cranswick N, Hefele B, Tomlin S, Jackman J, et al.
    Drug Saf, 2012 Jun 1;35(6):481-94.
    PMID: 22612852 DOI: 10.2165/11597920-000000000-00000
    Background: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied.

    Objective: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries.

    Methods: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia, Germany, Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs.

    Results: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and the UK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) and median length of hospital stay was 4 days (IQR 3-7). A total of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95% CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed in Malaysia and the UK. 65.3% (n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal.

    Conclusions: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*
  8. Charan J, Kaur RJ, Bhardwaj P, Haque M, Sharma P, Misra S, et al.
    Expert Rev Clin Pharmacol, 2021 Jan;14(1):95-103.
    PMID: 33252992 DOI: 10.1080/17512433.2021.1856655
    Objectives: Remdesivir has shown promise in the management of patients with COVID-19 although recent studies have shown concerns with its effectiveness in practice. Despite this there is a need to document potential adverse drug events (ADEs) to guide future decisions as limited ADE data available before the COVID-19 pandemic. Methods: Interrogation of WHO VigiBase® from 2015 to 2020 coupled with published studies of ADEs in COVID-19 patients. The main outcome measures are the extent of ADEs broken down by factors including age, seriousness, region and organ. Results: A total 1086 ADEs were reported from the 439 individual case reports up to July 19, 2020, in the VigiBase®, reduced to 1004 once duplicates were excluded. Almost all ADEs concerned COVID-19 patients (92.5%), with an appreciable number from the Americas (67.7%). The majority of ADEs were from males > 45 years and were serious (82.5%). An increase in hepatic enzymes (32.1%), renal injury (14.4%), rise in creatinine levels (11.2%), and respiratory failure (6.4%) were the most frequently reported ADEs. Conclusions: Deterioration of liver and kidney function are frequently observed ADEs with remdesivir; consequently, patients should be monitored for these ADEs. The findings are in line with ADEs included in regulatory authority documents.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  9. Shaikh Abdul Rahman S, Aziz Z
    J Clin Pharm Ther, 2020 Oct;45(5):946-958.
    PMID: 31925959 DOI: 10.1111/jcpt.13106
    WHAT IS KNOWN AND OBJECTIVE: Complementary and alternative medicine (CAM) is widely used worldwide for health maintenance, disease prevention and treatment. The objective of the study was to identify adverse drug reactions (ADR) associated with the use of CAM in Malaysia and factors which are associated with the more serious reactions.

    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.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  10. Ab Rahman AF
    Bull World Health Organ, 2019 Nov 01;97(11):730.
    PMID: 31673185 DOI: 10.2471/BLT.19.245019
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  11. Balan S
    Int J Pharm Pract, 2021 Aug 11;29(4):308-320.
    PMID: 34289016 DOI: 10.1093/ijpp/riab030
    OBJECTIVE: Healthcare professionals have an important role in ensuring that adverse drug reactions are well documented and reported. The key determinants of adverse drug reactions reporting are the knowledge, attitude and practice of healthcare professionals. A systematic review of the literature was undertaken to identify, critically evaluate and summarise the findings on the knowledge, attitude and practice of Malaysian healthcare professionals towards adverse drug reaction reporting.

    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.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  12. Ponampalam R, Anantharaman V
    Singapore Med J, 2003 May;44(5):231-42.
    PMID: 13677359
    There appears to be a significant prevalence of poisoning and adverse drug reactions in Singapore. However, the resources needed by physicians to assist them in the management of such cases are limited. This study examines the information resources currently utilised by medical professionals in assisting them in the management of poisonings and adverse drug reactions. The preferred features of an ideal Drug and Poison Information Centre in the local setting were also explored.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  13. Saheb Sharif-Askari N, Syed Sulaiman SA, Saheb Sharif-Askari F, Hussain AA
    Int J Clin Pharm, 2015 Feb;37(1):105-12.
    PMID: 25488317 DOI: 10.1007/s11096-014-0046-3
    BACKGROUND: Little is known about the adverse drug reaction (ADR) related admissions among heart failure (HF) patients.

    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.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/trends
  14. Dinesh KU, Subish P, Pranaya M, Shankar PR, Anil SK, Durga B
    Med J Malaysia, 2007 Oct;62(4):294-8.
    PMID: 18551932
    A prospective study was conducted at Manipal Teaching Hospital, Pokhara, Nepal to identify and analyze the pattern of the potential DDIs (drug-drug interaction) in diabetes patients. A total of 182 patients who were prescribed 685 drugs (average, 3.76 drugs per prescription) were enrolled. Patients 51 to 60 years of age had a higher risk [43 patients, or (23.6%)] of developing DDIs. It was found that 174 (92.1%) of the potential DDIs were of "moderate" severity. Cardiovascular drugs carried a risk of DDIs (187 drugs, or 49.5%). The most common potential DDI observed was between metformin and enalapril (n = 64).
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  15. Zyoud SH, Awang R, Syed Sulaiman SA, Sweileh WM, Al-Jabi SW
    Hum Exp Toxicol, 2010 Mar;29(3):153-60.
    PMID: 20071472 DOI: 10.1177/0960327109359642
    Intravenous N-acetylcysteine (IV-NAC) is widely recognized as the antidote of choice for acetaminophen overdose. However, its use is not without adverse drug reactions (ADR) that might affect therapeutic outcome or lead to treatment delay.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  16. Huckvale C, Car J, Akiyama M, Jaafar S, Khoja T, Bin Khalid A, et al.
    Qual Saf Health Care, 2010 Aug;19 Suppl 2:i25-33.
    PMID: 20693213 DOI: 10.1136/qshc.2009.038497
    BACKGROUND: Research on patient care has identified substantial variations in the quality and safety of healthcare and the considerable risks of iatrogenic harm as significant issues. These failings contribute to the high rates of potentially avoidable morbidity and mortality and to the rising levels of healthcare expenditure seen in many health systems. There have been substantial developments in information technology in recent decades and there is now real potential to apply these technological developments to improve the provision of healthcare universally. Of particular international interest is the use of eHealth applications. There is, however, a large gap between the theoretical and empirically demonstrated benefits of eHealth applications. While these applications typically have the technical capability to help professionals in the delivery of healthcare, inadequate attention to the socio-technical dimensions of their use can result in new avoidable risks to 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.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  17. Hariraj V, Aziz Z
    Ther Innov Regul Sci, 2018 11;52(6):757-763.
    PMID: 29714567 DOI: 10.1177/2168479017745025
    BACKGROUND: Many countries incorporate direct patient reporting of adverse drug reactions (ADRs) into their pharmacovigilance systems as patients provide a different insight into drug safety compared to health care professionals. This study aimed to examine public awareness about ADR reporting in Malaysia and patients' confidence in reporting ADRs.

    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.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
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