Displaying publications 1 - 20 of 32 in total

  1. 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
  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. Rosli R, Ming LC, Abd Aziz N, Manan MM
    PLoS One, 2016;11(6):e0155385.
    PMID: 27249414 DOI: 10.1371/journal.pone.0155385
    BACKGROUND: Spontaneous reporting on adverse drug reactions (ADR) has been established in Malaysia since 1987, and although these reports are monitored by the Malaysia drug monitoring authority, the National Pharmaceutical Control Bureau, information about ADRs in the paediatric patient population still remains unexplored. The aims of this study, therefore, were to characterize the ADRs reported in respect to the Malaysian paediatric population and to relate the data to specific paediatric age groups.

    METHODS: Data on all ADRs reported to the National Pharmaceutical Control Bureau between 2000 and 2013 for individuals aged from birth to 17 years old were analysed with respect to age and gender, type of reporter, suspected medicines (using the Anatomical Therapeutic Chemical classification), category of ADR (according to system organ class) as well as the severity of the ADR.

    RESULTS: In total, 11,523 ADR reports corresponding to 22,237 ADRs were analysed, with half of these reporting one ADR per report. Vaccines comprised 55.7% of the 11,523 ADR reports with the remaining being drug related ADRs. Overall, 63.9% of ADRs were reported for paediatric patients between 12 and 17 years of age, with the majority of ADRs reported in females (70.7%). The most common ADRs reported were from the following system organ classes: application site disorders (32.2%), skin and appendages disorders (20.6%), body as a whole general disorders (12.8%) and central and peripheral nervous system disorders (11.2%). Meanwhile, ADRs in respect to anti-infectives for systemic use (2194/5106; 43.0%) were the most frequently reported across all age groups, followed by drugs from the nervous system (1095/5106; 21.4%). Only 0.28% of the ADR cases were reported as fatal. A large proportion of the reports were received from healthcare providers in government health facilities.

    DISCUSSION: ADR reports concerning vaccines and anti-infectives were the most commonly reported in children, and are mainly seen in adolescents, with most of the ADRs manifesting in skin reactions. The majority of the ADR reports were received from nurses in the public sector, reporting ADRs associated with vaccine administration. The low fatality rate of ADR cases reported could potentially be caused by reporting bias due to the very low reporting percentage from the private healthcare institutions. This study indicates that ADR rates among Malaysian children are higher than in developed countries. Constant ADR reporting and monitoring, especially in respect to paediatric patients, should be undertaken to ensure their safety.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  4. Wahab IA, Pratt NL, Ellett LK, Roughead EE
    Drug Saf, 2016 Apr;39(4):347-54.
    PMID: 26798053 DOI: 10.1007/s40264-015-0391-8
    The potential for routine sequence symmetry analysis (SSA) signal detection in health claims databases to detect new safety signals of medicines is unknown.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  5. McEwen J
    Drug Saf, 2004;27(8):491-7.
    PMID: 15154822
    This article reviews the state of adverse drug reaction monitoring in five Asian/Pacific Rim countries (Australia, Japan, Malaysia, New Zealand and Singapore). Each country has an active pharmacovigilance programme managed by a national regulatory agency. Current methods for assessing risks and current methods used for risk management and communication are compared with the 'tools' used by the US FDA. Major positive attributes of the programmes in all five countries include active involvement of independent expert clinical advisory committees in identifying and evaluating risks through the assessment of reports of serious and unusual reactions, and regular communications about risks from the national agencies to doctors and pharmacists by means of pharmacovigilance bulletins. Most components of the risk-management toolbox are currently used, in some instances without legislated support. Variations in the way risk-management tools are implemented within individual national health systems are illustrated.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/organization & administration*
  6. Hussain R, Hassali MA
    PMID: 31139421 DOI: 10.1186/s40545-019-0178-x
    Countries all around the globe are working to establish robust pharmacovigilance systems. Whereas the majority of the developed countries have established well-organized pharmacovigilance systems, the developing countries still lack the basic infrastructure to establish such systems. This commentary focuses on the need of pharmacovigilance and its current status and future trends in Pakistan.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  7. Petrovic M, Tangiisuran B, Rajkumar C, van der Cammen T, Onder G
    Drugs Aging, 2017 02;34(2):135-142.
    PMID: 28000156 DOI: 10.1007/s40266-016-0428-4
    BACKGROUND: Adverse drug reactions (ADRs) in older people are often preventable, indicating that screening and prevention programs aimed at reducing their rate are needed in this population.

    OBJECTIVE: The aim of this study was to externally validate the GerontoNet ADR risk score and to assess its validity in specific subpopulations of older inpatients.

    METHODS: Data from the prospective CRIteria to assess appropriate Medication use among Elderly complex patients (CRIME) cohort were used. Dose-dependent and predictable ADRs were classified as type A, probable or definite ADRs were defined according to the Naranjo algorithm, and diagnostic accuracy was tested using receiver operating characteristic (ROC) analyses. Sensitivity and specificity were calculated for a cut-off point of 4.

    RESULTS: The mean age of the 1075 patients was 81.4 years (standard deviation 7.4) and the median number of drugs was 10 (range 7-13). At least one ADR was observed in 70 patients (6.5%); ADRs were classified as type A in 50 patients (4.7%) and defined as probable or definite in 41 patients (3.8%). Fair diagnostic accuracy to predict both type A and probable or definite ADRs was found in subpopulations aged <70 or ≥80 years with heart failure, diabetes, or a previous ADR. Good accuracy to predict type A ADRs was found in patients with a low body mass index (BMI; >18.5 kg/m2) and a Mini-Mental State Examination (MMSE) score of >24/30 points, as well as in patients with osteoarthritis. The cut-off point of 4 points yielded very good sensitivity but poor specificity results in these subpopulations.

    CONCLUSION: This study suggests that the GerontoNet ADR risk score might represent a pragmatic approach to identifying specific subpopulations of older inpatients at increased risk of an ADR with a fair to good diagnostic accuracy.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/standards*; Adverse Drug Reaction Reporting Systems/statistics & numerical data
  8. 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
  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. 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*
  11. Palaian S, Alshakka M, Mohamed Izham
    Pharm World Sci, 2010 Feb;32(1):2-6.
    PMID: 19894139 DOI: 10.1007/s11096-009-9342-8
    The national pharmacovigilance program in Malaysia is limited to very few centers and under-reporting of adverse drug reactions (ADRs) is a major limitation. Studies from developed countries have documented the importance and usefulness of consumer reporting of ADRs. Involving consumers in ADR reporting can be very useful in improving the reporting rates in Malaysia. The present article highlights the proposed plan of initiating a consumer based pharmacovigilance program in University Wellness Center located inside the campus of the Universiti Sains Malaysia, Penang, Malaysia.
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems/organization & administration*
  12. Suwankesawong W, Dhippayom T, Tan-Koi WC, Kongkaew C
    Pharmacoepidemiol Drug Saf, 2016 09;25(9):1061-9.
    PMID: 27174034 DOI: 10.1002/pds.4023
    PURPOSE: This study aimed to explore the current landscape and identify challenges of pharmacovigilance (PV) among Association of Southeast Asian Nations (ASEAN) countries.

    METHODS: This cross-sectional survey collected data from May 2014 to December 2015. Questionnaires seeking to collect information on resources, processes, roles and responsibility, and functions of PV systems were sent to relevant persons in the ASEAN countries. Functions of PV centers were measured using the minimum World Health Organization requirements for a functional national PV system. Performances of PV centers were measured by the following: (1) the indicators related to the average number of individual case safety reports (ICSR); (2) presence of signal detection activities and subsequent action; and (3) contribution to the global vigilance database.

    RESULTS: Cambodia, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand, and Vietnam completed the survey. PV systems in four surveyed countries (Indonesia, Malaysia, Singapore, and Thailand) achieved all aspects of the World Health Organization minimum requirement for a functional national PV system; the remaining countries were deemed to have unclear communication strategies and/or no official advisory committee. Average numbers of recent ICSR national returns ranged from 7 to 3817 reports/year/million population; three countries (Malaysia, Singapore, and Thailand) demonstrated good performance in reporting system and reported signal detection activities and subsequent actions. All participating countries had submitted ICSRs to the Uppsala Monitoring Center during the survey period (2013-2015).

    CONCLUSIONS: Four participating countries had functional PV systems. PV capacity, functionality, and legislative framework varied depending on local healthcare ecosystem networks. Implementing effective communication strategies and/or technical assistance from the advisory committee are needed to strengthen PV in ASEAN. Copyright © 2016 John Wiley & Sons, Ltd.

    Matched MeSH terms: Adverse Drug Reaction Reporting Systems*
  13. 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*
  14. 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*
  15. 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*
  16. 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
  17. Kua KP, Jamil MFB, Liew MH, Si JY, Lee SWH
    Pharmacoepidemiol Drug Saf, 2019 12;28(12):1560-1561.
    PMID: 31736190 DOI: 10.1002/pds.4913
    Matched MeSH terms: Adverse Drug Reaction Reporting Systems
  18. 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
  19. 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
  20. Charan J, Kaur RJ, Bhardwaj P, Haque M, Sharma P, Misra S, et al.
    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
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