e.g. mhealth
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The report is compiled into a source document, which is then added to an internal pharmacovigilance database by a local pharmacovigilance officer. The source document is analyzed by a case evaluator who is part of the company’s global pharmacovigilance team. Based on the global analysis, the pharmacovigilance officer is in charge of defining the final list of relevant questions to complete the case.
J Med Internet Res 2025;27:e65651
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Traditional pharmacovigilance mechanisms, reliant on clinical trials and formal reporting systems like Med Watch and Drug Bank [4-6], offer valuable but lagged information. These traditional approaches are plagued by inefficiencies, reporting biases, and a lack of timeliness, thereby lacking comprehensive coverage of the population’s sentiments and experiences [7-10].
J Med Internet Res 2025;27:e63755
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pharmacovigilanceAdverse Drug Events Detection, Pharmacovigilance and Surveillance Pharmacovigilance
JMIR Res Protoc 2025;14:e60084
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Applying AI to Structured Real-World Data for Pharmacovigilance Purposes: Scoping Review
Typically, pharmacovigilance professionals analyze data from individual case safety report (ICSR) databases (such as the Food and Drug Administration Adverse Event Reporting System, the database maintained by the US Food and Drug Administration) to identify potential pharmacovigilance signals, namely potential causal relationships between an ADR and a drug.
J Med Internet Res 2024;26:e57824
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Organizations (pharmaceutical companies, drug regulators, distributors, wholesalers, and retailers) conduct postmarket pharmacovigilance surveillance both passively and actively, using systems including postauthorization safety studies, as well as voluntary and mandatory surveillance such as the US Centers for Disease Control and Prevention (CDC) or FDA Vaccine Adverse Event Reporting System (VAERS), Med Watch, Eudravigilance, and the WHO’s Vigibase.
JMIR Infodemiology 2024;4:e53424
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Numerous studies have concluded that social media holds the potential to improve pharmacovigilance, while others, including the well-known WEB-RADR study [23], have argued against it, stating that signal detection in Twitter and Facebook “performs poorly and cannot be recommended at the expense of other pharmacovigilance activities” [24].
JMIR Public Health Surveill 2024;10:e59167
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Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, and prevention of the adverse effects of drugs or any other possible drug-related problems [2]. Essentially, a PV system aims to avert AEs resulting from medication use and implement measures to minimize the consequences of potential adverse effects [2,13].
JMIR Public Health Surveill 2024;10:e63808
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Monitoring Adverse Drug Events in Web Forums: Evaluation of a Pipeline and Use Case Study
Med DRA is an international medical hierarchical terminology comprising 5 levels used to code potential ADEs in pharmacovigilance. The highest level is the system organ class, which is further divided into high-level group terms, then into high-level terms, preferred terms (PTs), and finally lowest level terms. Typically, the PT level is used in pharmacovigilance signal detection.
The ATC classification system is a drug classification used in France for pharmacovigilance purposes.
J Med Internet Res 2024;26:e46176
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Additional studies are needed to evaluate whether such pharmacovigilance policy changes do, in fact, affect OD rates.
Second, regulatory endeavors by agencies may be insufficient to change OD incidence. Such regulatory stances can potentially result in a protracted, contrived pursuit of illicit drug traders. In this study, the second-most prevalent OTC medication mentioned by users self-administering medication was Medicon (Table 3), which has been marketed since 2021.
JMIR Form Res 2024;8:e54023
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Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems [1].
JMIR Med Inform 2024;12:e49643
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