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Drug Safety Jun 2023
Review
Communicating for the Safe Use of Medicines: Progress and Directions for the 2020s Promoted by the Special Interest Group of the International Society of Pharmacovigilance.
Topics: Humans; Pharmacovigilance; Public Opinion; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions; Societies
PubMed: 37219785
DOI: 10.1007/s40264-023-01285-5 -
Drug Safety Oct 2021The use of primary care databases has been integral in pharmacoepidemiological studies and pharmacovigilance. Primary care databases derive from electronic health... (Review)
Review
The use of primary care databases has been integral in pharmacoepidemiological studies and pharmacovigilance. Primary care databases derive from electronic health records and offer a comprehensive description of aggregate patient data, from demography to medication history, and good sample sizes. Studies using these databases improve our understanding of prescribing characteristics and associated risk factors to facilitate better patient care, but there are limitations. We describe eight key scenarios where study data outcomes can be affected by absent prescriptions in UK primary care databases: (1) out-of-hours, urgent care and acute care prescriptions; (2) specialist-only prescriptions; (3) alternative community prescribing, such as pharmacy, family planning clinic or sexual health clinic medication prescriptions; (4) newly licensed medication prescriptions; (5) medications that do not require prescriptions; (6) hospital inpatient and outpatient prescriptions; (7) handwritten prescriptions; and (8) private pharmacy and private doctor prescriptions. The significance of each scenario is dependent on the type of medication under investigation, nature of the study and expected outcome measures. We recommend that all researchers using primary care databases be aware of the potential for missing prescribing data and be sensitive to how this can vary substantially between items, drug classes, patient groups and over time. Close liaison with practising primary care clinicians in the UK is often essential to ensure awareness of nuances in clinical practice.
Topics: Ambulatory Care; Drug Prescriptions; Electronic Prescribing; Humans; Pharmacovigilance; Primary Health Care
PubMed: 34296384
DOI: 10.1007/s40264-021-01093-9 -
Daru : Journal of Faculty of Pharmacy,... Jun 2024Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the... (Meta-Analysis)
Meta-Analysis Review
Educational interventions in pharmacovigilance to improve the knowledge, attitude and the report of adverse drug reactions in healthcare professionals: Systematic Review and Meta-analysis.
OBJECTIVES
Underreporting of adverse drug reactions (ADRs) limits and delays the detection of signs. The aim of this systematic review with meta-analyses was to synthesize the evidence of educational interventions (EIs) efficacy in health professionals to increase ADR reporting, attitudes, and knowledge of pharmacovigilance.
EVIDENCE ACQUISITION
A systematic literature review was carried out to identify randomized clinical trials evaluating the efficacy of EI in pharmacovigilance in health professionals to improve ADR reports, knowledge, and attitude toward pharmacovigilance. ADR reports were pooled by calculating Odds Ratio (OR) with a 95% confidence interval (95%CI), while pharmacovigilance knowledge and attitude were pooled by calculating a mean difference (MD) with 95%CI. In addition, the subanalysis was performed by EI type. Meta-analysis was performed with RevMan 5.4 software. PROSPERO registry CRD42021254270.
RESULTS
Eight hundred seventy-five articles were identified as potentially relevant, and 11 were included in the systematic review. Metanalysis showed that EI increased ADR reporting in comparison with control group (OR = 4.74, [95%CI, 2.46 to 9.12], I = 93%, 5 studies). In subgroup analysis, the workshops (OR = 6.26, [95%CI, 4.03 to 9.73], I = 57%, 3 studies) increased ADR reporting more than telephone-based interventions (OR = 2.59, [95%CI, 0.77 to 8.73], I = 29%, 2 studies) or combined interventions (OR = 5.14, [95%CI, 0.97 to 27.26], I = 93%, 3 studies). No difference was observed in pharmacovigilance knowledge. However, the subanalysis revealed that workshops increase pharmacovigilance knowledge (SMD = 1.85 [95%CI, 1.44 to 2.27], 1 study). Only one study evaluated ADR reporting attitude among participants and showed a positive effect after the intervention.
CONCLUSION
EI improves ADR reports and increases pharmacovigilance knowledge. Workshops are the most effective EI to increase ADR reporting.
Topics: Pharmacovigilance; Humans; Health Knowledge, Attitudes, Practice; Health Personnel; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 38427161
DOI: 10.1007/s40199-024-00508-z -
Pharmacoepidemiology and Drug Safety Dec 2022
Topics: Humans; Pharmacovigilance; Artificial Intelligence; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 35959980
DOI: 10.1002/pds.5524 -
Nature Reviews. Drug Discovery Jan 2023
Topics: Humans; Pharmacovigilance; Pandemics; Vaccines
PubMed: 36307650
DOI: 10.1038/d41573-022-00178-z -
International Journal of Clinical... Aug 2018
Topics: Drug-Related Side Effects and Adverse Reactions; Humans; Pharmacovigilance
PubMed: 30132234
DOI: 10.1007/s11096-018-0719-4 -
Clinical Therapeutics Feb 2021Artificial intelligence (AI), a highly interdisciplinary science, is an increasing presence in pharmacovigilance (PV). A better understanding of the scope of artificial...
Artificial intelligence (AI), a highly interdisciplinary science, is an increasing presence in pharmacovigilance (PV). A better understanding of the scope of artificial intelligence in pharmacovigilance (AIPV) may be advantageous to more sharply defining, for example, which terms, methods, tasks, and data sets are suitably subsumed under the application of AIPV. Accordingly, this article explores relevant points to consider regarding defining the scope of AIPV and offers a potential working definition of the scope of AIPV.
Topics: Artificial Intelligence; Datasets as Topic; Drug Therapy; Humans; Machine Learning; Pharmacovigilance
PubMed: 33478803
DOI: 10.1016/j.clinthera.2020.12.014 -
BMJ (Clinical Research Ed.) Apr 2023
Topics: Humans; Pharmacovigilance; Drug-Related Side Effects and Adverse Reactions; Adverse Drug Reaction Reporting Systems
PubMed: 37059463
DOI: 10.1136/bmj.p855 -
Drug Safety Oct 2021Establishing a mature pharmacovigilance system in a low-income country is a challenge. Nevertheless, Eritrea, one such low-income country, was able to achieve a fully...
Establishing a mature pharmacovigilance system in a low-income country is a challenge. Nevertheless, Eritrea, one such low-income country, was able to achieve a fully fledged pharmacovigilance system within a period of almost 9 years. In the last five years (2014-2019), the Eritrean Pharmacovigilance Centre has submitted, on average, 646 individual case safety reports (ICSRs) per million inhabitants per year to the World Health Organization (WHO) global database of ICSRs. As a result, Eritrea has been rated among the top reporting countries in Africa. The center has detected about 30 safety signals, achieved maturity level three on the WHO rapid benchmarking assessment, and gained huge political commitment. In the last few years, monitoring of product quality through the pharmacovigilance system found approximately 55 medical products that were either substandard or falsified and were subsequently recalled from the Eritrean market by the National Medicines and Food Administration. The aim of this article is to describe Eritrea's success stories, key strategies for success, challenges encountered, and lessons learned to share them with the international pharmacovigilance community and beyond.
Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Eritrea; Humans; Pharmacovigilance; World Health Organization
PubMed: 34472048
DOI: 10.1007/s40264-021-01102-x -
BMJ (Clinical Research Ed.) May 2023
Topics: Humans; Pharmacovigilance; Adverse Drug Reaction Reporting Systems; Drug-Related Side Effects and Adverse Reactions
PubMed: 37146998
DOI: 10.1136/bmj.p1032