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. Al-lela OQ, Elkalmi RM, Jamshed SQ
    Am J Pharm Educ, 2013 Jun 12;77(5):106.
    PMID: 23788817 DOI: 10.5688/ajpe775106
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  3. 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
  4. Amin MN, Khan TM, Dewan SM, Islam MS, Moghal MR, Ming LC
    BMJ Open, 2016 08 03;6(8):e010912.
    PMID: 27489151 DOI: 10.1136/bmjopen-2015-010912
    OBJECTIVES: To assess community pharmacists'/pharmacy technicians' knowledge and perceptions about adverse drug reactions (ADRs) and barriers towards the reporting of such reactions in Dhaka, Bangladesh.

    METHOD: A cross-sectional study was planned to approach potential respondents for the study. A self-administered questionnaire was delivered to community pharmacists/pharmacy technicians (N=292) practising in Dhaka, Bangladesh.

    RESULTS: The overall response to the survey was 69.5% (n=203). The majority of the sample was comprised of pharmacy technicians (152, 74.9%) who possessed a diploma in pharmacy, followed by pharmacists (37, 18.2%) and others (12, 5.9%). Overall, 72 (35.5%) of the respondents disclosed that they had experienced an ADR at their pharmacy, yet more than half (105, 51.7%) were not familiar with the existence of an ADR reporting body in Bangladesh. Exploring the barriers to the reporting of ADRs, it was revealed that the top four barriers to ADR reporting were 'I do not know how to report (Relative Importance Index (RII)=0.998)', 'reporting forms are not available (0.996)', 'I am not motivated to report (0.997)' and 'Unavailability of professional environment to discuss about ADR (RII=0.939)'. In addition to these, a majority (141, 69.46%) were not confident about the classification of ADRs (RII=0.889) and were afraid of legal liabilities associated with reporting ADRs (RII=0.806). Moreover, a lack of knowledge about pharmacotherapy and the detection of ADRs was another major factor hindering their reporting (RII=0.731).

    CONCLUSIONS: The Directorate of Drug Administration in Bangladesh needs to consider the results of this study to help it improve and simplify ADR reporting in Bangladeshi community pharmacy settings.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/statistics & numerical data*
  5. 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*
  6. 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*
  7. 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
  8. 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
  9. Bandekar MS, Anwikar SR, Kshirsagar NA
    Pharmacoepidemiol Drug Saf, 2010 Nov;19(11):1181-5.
    PMID: 20845409 DOI: 10.1002/pds.2004
    Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*
  10. 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*
  11. 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*
  12. 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*
  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. Elkalmi R, Hassali MA, Al-Lela OQ, Jawad Awadh AI, Al-Shami AK, Jamshed SQ
    J Pharm Bioallied Sci, 2013 Jul;5(3):224-8.
    PMID: 24082699 DOI: 10.4103/0975-7406.116824
    The objective of this study was to explore the knowledge of the general population towards ADR and their reporting system.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  15. 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*
  16. 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
  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
  18. 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
  19. 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*
  20. Khan Z, Karatas Y, Martins MAP, Jamshed S, Rahman H
    Curr Med Res Opin, 2022 01;38(1):145-154.
    PMID: 34694167 DOI: 10.1080/03007995.2021.1997287
    BACKGROUND: Globally, pharmacovigilance (PV) is crucial for the patient's safety and proper use of drugs. Spontaneous reporting of adverse drug reaction (ADR) is a professional obligation of every healthcare professionals (HCPs). The purpose of this systematic review was to analyze the existing literature about the knowledge, attitude, and practices (KAP) level of HCPs regarding PV and ADRs reporting in Turkey.

    METHODS: A systematic and comprehensive articles search strategy was carried out in different seven electronic databases (PubMed, PubMed Central, Goggle Scholar, Ovid-SP, MEDLINE, Wiley Online Library, DergiPark) from 2010 to 2020. We searched to identify existing literature about cross-sectional observational studies investigating the KAP of HCPs regarding PV and ADRs reporting in different geographical regions of Turkey. Quality assessment and risk of bias were assessed among included studies.

    RESULTS: Fifteen studies were chosen for full-text analysis. Finally, according to inclusion criteria, seven research articles were selected for systematic review. Overall, the KAP of HCPs varies across the studies. The lack of a standardized validated measuring tool to evaluate the KAP and differences in questionnaire items were the main limitations in included studies. Around, 69.1% (range: 54.6-100%) of HCPs were not aware of the national pharmacovigilance center in Turkey. About, 37.5% (range: 7.1-75.7%) of HCPs believed that reporting of ADRs is not important and 87.5% (range: 69.3-100%) stated that they never reported ADR previously during their practice. The most frequently highlighted barriers to PV were lack of time, uncertainty and did not know where to report.

    CONCLUSION: This systematic review revealed a major KAP gap in Turkey towards PV activities. Low ADR reporting practice of HCPs was a major identified issue. The creation of a mandatory unified PV education intervention for future HCPs to rationally report ADR of drugs are crucial for a better healthcare system.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
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