An analysis of legal warnings after drug approval in Thailand

Sriphiromya, P; Theeraroungchaisri, Anuchai

doi:10.1016/j.yrtph.2014.10.013

Cited by 5 publications

(5 citation statements)

References 23 publications

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“…severe liver injury with telithromycin or suicidal behaviour with varenicline), but longer when ADRs were absent [22]. Other accounts report that it may take 2-12 years for drug-induced harms to be communicated to healthcare workers after marketing authorization of a medicinal product [23][24][25][26]. These studies have computed the difference between We shall hand-search the Uppsala Monitoring Centre's SIGNAL Document, the WHO Pharmaceuticals Newsletter, the Full List of WHO Medical Product Alerts, the WHO Drug Information, Australian Prescriber, Prescrire International, and other drug bulletins available in English via the International Society of Drug Bulletins' index for relevant records.…”

Section: An Important Component Of Detection Of Signals Of Adrs Is CLmentioning

confidence: 99%

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

Sartori

Aronson

Onakpoya

2020

Preprint

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Background: Signals of adverse drug reactions are the basis of some regulatory risk-minimization actions in pharmacovigilance, such as changes to the section of undesirable effects in Summaries of Products Characteristics (SmPCs). Reviews of the evidence of signals have highlighted that these are mostly supported by reports of adverse drug reactions or multiple types of evidence, but have so far been limited to specific medicinal products, time intervals, groups of adverse drug reactions and specific countries. The time that elapses between a report of a suspected adverse drug reaction and the communication of a signal has not been systematically investigated. Furthermore, difficulties in causally linking medicinal products to adverse events have been highlighted, but the elements of reports of suspected ADRs that authors used to support putative causal relationships have been rarely characterized.Methods: We plan a scoping review to chart the evidence underpinning signals in pharmacovigilance and the time that it takes to communicate a signal. We shall retrieve records from electronic databases, without language or publication restrictions; we shall apply backward and forward citation to adjust for variations in database indexing. We shall also hand-search the websites of 35 regulatory agencies/authorities, restricted publications from Uppsala Monitoring Centre, and drug bulletins in the list of International Society of Drug Bulletins. If websites do not report signals, signals will be requested from the competent stakeholder. We shall use the Oxford Centre for Evidence-Based Medicine Levels of Evidence to chart and summarize evidence. We shall use VigiBase, the World Health Organization’s Global Individual Case Safety Report database, to determine the date of reporting for reports of adverse drug reactions. Plots, or pictograms (if appropriate), will be used to represent the time from the first report of a suspected adverse drug reaction to a signal.Discussion: We expect that the findings from this exploratory investigation will be useful in better understanding global patterns of similarities or differences in regulatory decision-making in terms of evidence and timing of communications, and in identifying relevant research questions for future systematic reviews.Scoping review registration: osf.io/jtv38

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Section: An Important Component Of Detection Of Signals Of Adrs Is CLmentioning

confidence: 99%

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

Sartori

Aronson

Onakpoya

2020

Preprint

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“…Unfortunately this is not so, considering the fact that only 2,330 reports were sent to the Iranian Pharmacovigilance Centre in the year 2006" [7]. "The situation is not different in Thailand where despite the fact that it has a good ADRs reporting system, it still suffers from low reporting by health care professionals" [8] "The few studies in Malaysia that have investigated the low reporting rates of ADRs amongst the health professionals indicated that up to 40% of the physicians were unaware of the existence of the ADRs reporting system" [8]. "These low reporting rates are not only restricted to developing nations as studies have also shown that ADRs reporting rate in USA to be as low as 1 -6%" [9].…”

Section: Introductionmentioning

confidence: 99%

Effects of Health Education on Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Community Pharmacists in Anambra State, Nigeria

Osagie,

Nnebue,

Ezenyeaku

et al. 2023

JAMPS

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Background: Poor reportage of adverse drug reaction has been linked o. increase in morbidity, mortality and economic burden of diseases and health related conditions. Objective: To determine the effects of health education on knowledge, attitude and practice of adverse drug reaction (ADR) reporting among community pharmacists practicing in Anambra State. Methods: This interventional study was conducted among Community Pharmacists in Anambra State. Simple random samp\ling technique was used. Pre-tested, semi-structured self-administered questionnaire was used to collect data on respondents’ socio-demographics, knowledge of, attitude to and practice of ADR reporting Associations between variables were tested using Chi-square and Binary logistic regression at 5% level of significance. Data obtained were analyzed using SPSS version 23. Results: The mean age of the respondents was 46.5±11.2 years. Post intervention result shows that there was an increase in knowledge of ADR reporting in the intervention group from 52% to 95.3%. There was a decrease in knowledge of ADRs reporting in the control group from 47.3% to44.7%. There was a statistically significant difference between the experimental group and the control group on their attitude towards ADR reporting (p<0.05). Only 26.7% of the test group had filled a spontaneous reporting ADR form prior to this study compared to 18% from the control group and is associated with the effect of health education intervention. Conclusions: There was underreporting of ADRs, associated with gaps in the knowledge, attitude and practice among the community pharmacists studied. There is need for focused continuous health education interventions on ADR reporting among them.

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“…The information derived from this database was used as baseline data for the Thai Food and Drug Administration (FDA) in regulatory decision-making processes. 1,2 An ADR is a noxious, unintended response which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. The seriousness of an ADR outcome was measured in four scales: mild, moderate, severe and fatal.…”

Section: Introductionmentioning

confidence: 99%

Adverse Drug Reactions Associated with Dimenhydrinate, Thailand, 1993-2016

Sriphiromya

Wechwithan

2021

OSIR

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In 1984, the Health Product Vigilance Center of Thailand was established and has continuously collected adverse drug reaction (ADR) reports across the country. Severe drug-induced skin reactions with dimenhydrinate can result in death in some cases. All ADRs with dimenhydrinate from 1 Jan 1993 to 31 Dec 2016 were reviewed. Characteristics and system organ class ADRs from 7,282 patients were described. Most patients had no history of allergy (77%) and no underlying disease (83%) and the majority were female (75%). Skin appendage ADRs were the most commonly reported (52%) events and 1,431 reports were severe skin ADRs, including bullous fixed drug eruption (89%) and Stevens-Johnson syndrome (9%). Among patients who received dimenhydrinate and had ADRs, 63% completely recovered and 0.18% died. Multivariate regression analysis revealed that patients aged more than 65 years or having a history of allergy were more likely to have a serious ADR than those in the other groups. Dimenhydrinate must be avoided or used with vigilance when prescribed to the elderly or patients with a history of allergy due to its seriousness.

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An analysis of legal warnings after drug approval in Thailand

Cited by 5 publications

References 23 publications

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

Signals of adverse drug reactions communicated by pharmacovigilance stakeholders: protocol for a scoping review of the global literature

Effects of Health Education on Knowledge, Attitude and Practice of Adverse Drug Reaction Reporting among Community Pharmacists in Anambra State, Nigeria

Adverse Drug Reactions Associated with Dimenhydrinate, Thailand, 1993-2016

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