Displaying publications 1 - 20 of 37 in total

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  1. 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
  2. Lee FY, Wong HS, Chan HK, Mohamed Ali N, Abu Hassan MR, Omar H, et al.
    Pharmacoepidemiol Drug Saf, 2020 12;29(12):1669-1679.
    PMID: 33064335 DOI: 10.1002/pds.5153
    PURPOSE: To determine the incidence, demographic profile, background of reporters, causative agents, severity and clinical outcomes of hepatic adverse drug reaction (ADR) reports in Malaysia using the national ADR reporting database.

    METHODS: The ADR reports recorded between 2000 and 2017 were retrospectively analysed to identify hepatic ADR reports. The trend and characteristics of hepatic ADR cases were described. Multivariate disproportionality analysis of the causative agents was performed to generate signals of hepatic ADRs.

    RESULTS: A total of 2090 hepatic ADRs (1.77% of all ADRs) were reported with mortality rate of 12.7% among cases with known clinical outcomes. The incidence of hepatic ADR reporting in Malaysia increased significantly over 18 years from 0.26 to 9.45 per million population (P drugs (n = 268, 12.82%) was the most common suspected class of causative agents with a reporting odds ratio (ROR) and 95% CI of 8.39 (7.26-9.70), followed by traditional/complementary medicines or herbal/dietary supplements (TCM/HDS) (n = 235, 11.24%, ROR 3.26 [2.84-3.75]), systemic antibacterials (n = 159, 7.61%, ROR 2.65 [2.25-3.13]), lipid modifying agents (n = 142, 6.79%, ROR 2.21 [1.86-2.63]) and amiodarone (n = 137, 6.56%, ROR 35.25 [28.40-43.75]). Most (72.9%) of the TCM/HDS were not registered with the authorities.

    CONCLUSIONS: Hepatic ADR cases have increased significantly in Malaysia, with antituberculosis drugs, systemic antibacterials, and TCM/HDS being the most common causative agents reported. Most TCM/HDS reported to be associated with hepatic ADR were not registered with the authorities.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  3. 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
  4. 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*
  5. 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
  6. Ting KN, Stratton-Powell DM, Anderson C
    Pharm World Sci, 2010 Jun;32(3):339-42.
    PMID: 20336371 DOI: 10.1007/s11096-010-9382-0
    OBJECTIVES: To investigate community pharmacists' knowledge, attitudes and views on adverse drug reaction (ADR) reporting. Setting Seven community pharmacies in Malaysia.

    METHOD: Structured interviews with community pharmacists. Informed consent was obtained and interviews were audio-recorded and transcribed verbatim.

    MAIN OUTCOME MEASURES: Content analysis of themes on awareness of ADR reporting, reporting activities, attitudes and views on patient reporting.

    RESULTS: All pharmacists claimed to have some knowledge of a reporting system but only one had submitted a report directly to the regulatory authority. Despite the low level of reporting activities, all participants agreed that it was part of their professional obligation to report an ADR. Most participants were not aware of the direct patient reporting scheme and were skeptical about its success. Lack of awareness and patients' limited knowledge about their medications were viewed as barriers to patient reporting. Local attitudinal issues including pharmacists' attitude towards ADR reporting were described as possible contributing factors.

    CONCLUSION: Community pharmacists have an important role in reporting ADRs. Many Malaysian patients are still perceived to be ill-informed of their medications, an important determinant to the success of patient reporting. There is a need for further training about ADRs and ADR reporting for health professionals and further education for patients.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*
  7. Panickar R, Wo WK, Ali NM, Tang MM, Ramanathan GRL, Kamarulzaman A, et al.
    Pharmacoepidemiol Drug Saf, 2020 10;29(10):1254-1262.
    PMID: 33084196 DOI: 10.1002/pds.5033
    PURPOSE: To describe risk minimization measures (RMMs) implemented in Malaysia for allopurinol-induced severe cutaneous adverse drug reactions (SCARs) and examine their impact using real-world data on allopurinol usage and adverse drug reaction (ADR) reports associated with allopurinol.

    METHODS: Data on allopurinol ADR reports (2000-2018) were extracted from the Malaysian ADR database. We identified RMMs implemented between 2000 and 2018 from the minutes of relevant meetings and the national pharmacovigilance newsletter. We obtained allopurinol utilization data (2004-2018) from the Pharmaceutical Services Programme. To determine the impact of RMMs on ADR reporting, we considered ADR reports received within 1 year of RMM implementation. We used the Pearson χ2 test to examine the relation between the implementation of RMMs and allopurinol ADR reports.

    RESULTS: The 16 RMMs for allopurinol-related SCARs implemented in Malaysia involved nine risk communications, four prescriber or patient educational material, and three health system innovations. Allopurinol utilization decreased by 21.5% from 2004 to 2018. ADR reporting rates for all drugs (n = 144 507) and allopurinol (n = 1747) increased. ADR reports involving off-label use decreased by 6% from 2011. SCARs cases remained between 20% and 50%. RMMs implemented showed statistically significant reduction in ADR reports involving off-label use for August 2014 [χ2(1, N = 258) = 5.32, P = .021] and October 2016 [χ2(1, N = 349) = 3.85, P = .0499].

    CONCLUSIONS: RMMs to promote the appropriate use of allopurinol and prescriber education have a positive impact. We need further measures to reduce the incidence and severity of allopurinol-induced SCARs, such as patient education and more research into pharmacogenetic screening.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  8. 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
  9. 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
  10. Hussain R, Hassali MA, Ur Rehman A, Muneswarao J, Atif M, Babar ZU
    PMID: 32349339 DOI: 10.3390/ijerph17093039
    The contribution of all key healthcare professionals is vital to promote an efficient adverse drug reaction (ADR) reporting system. In this context, nurses are important as they are in a better position to observe a patient's response regarding the drug therapy and to report an ADR. The aim of the study was to explore the perspectives of nurses about ADR reporting system in Lahore, Pakistan. A total of 21 nurses were interviewed. The thematic content analysis of the qualitative interviews yielded six major themes and eight subthemes. Major themes included: (1) Knowledge about the concept of the medication safety & the ADR; (2) Knowledge regarding pharmacovigilance activities; (3) Willingness to report; (4) Practices related to the ADR reporting; (5) Barriers to the ADR reporting; (6) Facilitators to the ADR reporting. The majority of the nurses were aware of medicine safety and ADRs, but in many cases, they were unable to report these ADRs. The study pointed out considerable concerns regarding the knowledge and practices of nurses about pharmacovigilance activities in their workplace, mainly due to increased workload, due to the absence of a reporting system and legal liability. The main challenges turned out to be the lack of knowledge and training, as well as the implementation of guidelines. Based on the findings, it is suggested that outcome of this study can serve as a guide to design policies that support ADR reporting by nurses in Pakistan.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  11. 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*
  12. 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
  13. 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*
  14. Balan S, Koo K, Omar AI, Gan RY
    Res Social Adm Pharm, 2021 04;17(4):826-827.
    PMID: 33160885 DOI: 10.1016/j.sapharm.2020.10.016
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  15. 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*
  16. Aung AK, Tang MJ, Adler NR, de Menezes SL, Goh MSY, Tee HW, et al.
    J Clin Pharmacol, 2018 10;58(10):1332-1339.
    PMID: 29733431 DOI: 10.1002/jcph.1148
    We describe adverse drug reaction (ADR) reporting characteristics and factors contributing to length of time to report by healthcare professionals. This is a retrospective study of voluntary reports to an Australian healthcare ADR Review Committee over a 2-year period (2015-2016). Descriptive and univariate models were used for outcomes, employing standardized ADR definitions. Hospital pharmacists reported 84.8% of the 555 ADRs: 70.3% were hospital onset reactions, and 71.7% were at least of moderate severity. Immunologically mediated reactions were most commonly reported (409, 73.7%). The median time to submit an ADR report was 3 (interquartile range 1-10) days. Longer median times to reporting were associated with multiple implicated agents and delayed hypersensitivity reactions, especially severe cutaneous adverse reactions. A total of 650 medications were implicated that involved multiple agents in 165/555 (29.7%) reports. Antimicrobials were the most commonly implicated agents. Immunologically mediated reactions were most commonly associated with antimicrobials and radiocontrast agents (P < .0001, odds ratio [OR] 3.6, 95%CI 2.4-5.5, and P = .04, OR 4.2, 95%CI 1.2-18.2, respectively). Opioids and psychoactive medications were more commonly implicated in nonimmunological reported ADRs (P = .0002, OR 3.9, 95%CI 1.9-7.9, and P < .0001, OR 11.4, 95%CI 4.6-27.8, respectively). Due to the predominant reporting of immunologically mediated reactions, a targeted education program is being planned to improve identification and accuracy of ADR reports, with the overall aim of improved management to ensure quality service provision and patient safety.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  17. Elkalmi RM, Hassali MA, Ibrahim MI, Widodo RT, Efan QM, Hadi MA
    Am J Pharm Educ, 2011 Jun 10;75(5):96.
    PMID: 21829270 DOI: 10.5688/ajpe75596
    To assess senior pharmacy students' knowledge of and perceptions about pharmacovigilance and reporting of adverse drug reactions (ADRs) at 5 public universities in Malaysia.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/organization & administration
  18. 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*
  19. 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*
  20. Alshakka MA, Ibrahim MI, Hassali MA
    J Clin Diagn Res, 2013 Oct;7(10):2181-5.
    PMID: 24298470 DOI: 10.7860/JCDR/2013/5778.3464
    The aim of this study was to evaluate the perceptions of general practitioners (GPs) and community pharmacists (CPs) in Penang, Malaysia, towards consumer reporting of Adverse Drug Reactions (ADRs).
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
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