Pharmacovigilance activities in ASEAN countries

Suwankesawong, Wimon; Dhippayom, Teerapon; Tan-Koi, Wei-Chuen; Kongkaew, Chuenjid

doi:10.1002/pds.4023

Cited by 22 publications

(24 citation statements)

References 10 publications

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“…There is a number of studies on the difference between pharmacovigilance regulations and development between countries ( 17 - 22 ), but to our knowledge, this is the first study to evaluate how countries that were part of the same country can develop pharmacovigilance systems with various development levels. Limited financial resources slow down pharmacovigilance development, and countries with limited resources can have less developed pharmacovigilance systems ( 17 , 23 ).…”

Section: Discussionmentioning

confidence: 99%

Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study

Glamočlija

Tubić²,

Kondža

et al. 2018

Croat Med J

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AimTo compare individual case safety reports (ICSR) rates and characteristics between Croatia, Serbia, Montenegro, and Bosnia and Herzegovina (B&H).MethodsThis retrospective pharmacoepidemiological study used the data from ICSR received by the Agency for Medicines and Medical Devices in B&H in 2011-2016. The number, characteristics, and sources of reports, suspected drugs, and patient characteristics were analyzed. The results were compared with the publicly available data from Croatia, Serbia, and Montenegro.ResultsThe number of reported adverse drug reactions per one million of inhabitants was lowest in B&H and highest in Croatia. There were significant differences in reporter characteristics, sources of reports, and the percentage of missing data in ICSR, while the Anatomical Therapeutic Chemical product classes, patient’s sex, and adverse drug reaction System Organ Classes were similar.ConclusionDespite the historical and geographical vicinity of B&H and its neighboring countries, there were significant differences in indicators of pharmacovigilance development.

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Section: Discussionmentioning

confidence: 99%

Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study

Glamočlija

Tubić²,

Kondža

et al. 2018

Croat Med J

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“…Among those, more than 90% was sent by HCPs from healthcare facilities. However, the numbers of reports submitted to the national centre and to the Uppsala Monitoring Center remain low compared with other countries . To our knowledge, there has been no research about facilitators and barriers for HCPs' ADR reporting in the country.…”

Section: What Is Known and Objectivementioning

confidence: 92%

“…However, the numbers of reports submitted to the national centre and to the Uppsala Monitoring Center remain low compared with other countries. 8 To our knowledge, there has been no research about facilitators and barriers for HCPs' ADR reporting in the country. To address this gap, we aimed to examine the associations between knowledge-and attitude-related factors and ADR reporting in a large sample of Vietnamese HCPs.…”

Section: Vietnam Is a Member Of The Who Program For Internationalmentioning

confidence: 99%

Factors associated with spontaneous adverse drug reaction reporting among healthcare professionals in Vietnam

Nguyen

et al. 2019

J Clin Pharm Ther

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What is known and objective: Under-reporting is a major drawback of a voluntary adverse drug reaction reporting system in pharmacovigilance. However, little is known about facilitators and barriers to ADR reporting by healthcare professionals (HCPs) in developing countries. To investigate factors associated with adverse drug reaction (ADR) reporting among HCPs in Vietnam. Methods: A cross-sectional survey of 2091 HCPs was conducted in 2015 at 10 hospitals throughout Vietnam. The binary outcome was ever reporting ADRs. Healthcare professionals knowledge, attitude and practice about ADR reporting were measured. Multiple logistic regression analyses examined factors significantly associated with ever ADR reporting. Results: Overall, 29.3%, 2.2% and 68.4% of the sample were doctors, pharmacists and nurses, respectively. More than half (59.3%) had ever reported any ADR. Facilitators for ADR reporting were educational training (OR = 1.77, 95%CI = 1.42-2.22) and having better knowledge, such as awareness of ADR reporting regulation (OR = 1.63, 95%CI = 1.19-2.21), of reporting time (OR = 1.76, 95%CI = 1.35-2.29) and of necessary information in reporting form (OR = 1.94, 95%CI = 1.53-2.45).Conversely, barriers to non-reporting were unknown of reporting procedure (OR = 0.27, 95%CI = 0.22-0.35), unavailability of reporting form (OR = 0.54, 95%CI = 0.42-0.68) and lack of time (OR = 0.59, 95%CI = 0.46-0.74). What is new and conclusion: Given the low ADR reporting rate among HCPs, educational interventions to improve their knowledge and attitude should be prioritized in Vietnam. Additional interventions addressing obstacles (i.e. availability and complexity of reporting form, lack of time) should be considered to improve both the quantity and quality of ADR reporting.

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“…Subsequent surveys were conducted in the Association of Southeast Asian Nations (ASEAN), which reported that there is a substantial difference in the quality of PV provided between the ASEAN and non‐ASEAN countries: 33% of the ASEAN countries used statistical methods to detect signals, as compared with 100% of the non‐ASEAN countries . Differences in PV systems among eight ASEAN countries were found, with Indonesia, Malaysia, Singapore, and Thailand (4/8) meeting all aspects of the World Health Organization's (WHO) minimum requirements; Malaysia, Singapore, and Thailand (3/8) showing a good performance in reporting and detecting reported signals and the subsequent actions . Discrepancy in the integrity of PV is also present in East Asia, as Japan and Korea with more robust PV system compared with that of China …”

Section: Introductionmentioning

confidence: 99%

“…Malaysia, Singapore, and Thailand (3/8) showing a good performance in reporting and detecting reported signals and the subsequent actions. 6,7 Discrepancy in the integrity of PV is also present in East Asia, as Japan and Korea with more robust PV system compared with that of China. 8 However, to our knowledge, no studies to date have reported on the status of PV in the entire APEC region.…”

mentioning

confidence: 99%

Current status of pharmacovigilance regulatory structures, processes, and outcomes in the Asia‐Pacific region: Survey results from 15 countries

Shin

Jeong

et al. 2019

Pharmacoepidemiology and Drug

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Purpose Regulatory discrepancies may exist in pharmacovigilance (PV) structure, process, and outcome status worldwide. Our study's objective was to survey the current status of PV in each regulatory body in the Asia‐Pacific Economic Cooperation (APEC) region. Methods A modified questionnaire was sent to the PV team heads of 21 PV agencies based in the APEC countries, between June 28 and September 12, 2017, to gather information on the structure, process, and outcome of PV status in these countries. Results Of the 21 APEC countries, 15 responded. We found harmonized laws and regulations for general PV and risk management systems. However, variations were found in PV structure: for example, 11 out of 15 countries had national regulatory representatives responsible for PV in pharmaceutical companies, while four did not. For PV process, discrepancies were also found in the source type of adverse drug reaction (ADR) reports and reporting of medication errors and therapeutic ineffectiveness in cumulative ADR reports. With respect to PV outcomes, among countries that performed active surveillance, the United States of America was more active, with hundreds of projects including additional pharmacoepidemiological studies etc. Among the nine countries that responded, Japan had the greatest number of product label changes followed by Taiwan, Malaysia, and Korea. Conclusion We have identified substantial variations in the structures, processes, and outcomes of PV status among the countries of the APEC region. Therefore, efforts to reduce variations in the PV administration and regulation are warranted for harmonization of PV within the APEC region.

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Pharmacovigilance activities in ASEAN countries

Cited by 22 publications

References 10 publications

Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study

Adverse drug reaction reporting and development of pharmacovigilance systems in Bosnia and Herzegovina, Croatia, Serbia, and Montenegro: a retrospective pharmacoepidemiological study

Factors associated with spontaneous adverse drug reaction reporting among healthcare professionals in Vietnam

Current status of pharmacovigilance regulatory structures, processes, and outcomes in the Asia‐Pacific region: Survey results from 15 countries

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