ArticlePharmacoepidemiology and drug safety2025
Impact of Additional Monitoring on Pharmacovigilance and Pharmacists' Role: A Scoping Review.
Article in Pharmacoepidemiology and drug safety, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Multi-target-directed drugs: new additions in 2025 and post-marketing safety surveillance of drugs marketed in 2022-2024.Pharmacological reports : PR · 2026Review
- Impact of Additional Monitoring on Pharmacovigilance and Pharmacists' Role: A Scoping Review.Pharmacoepidemiology and drug safety · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
Abstract
introductionPharmacovigilance plays a critical role in ensuring the safety of medicinal products, particularly those under additional monitoring (AM). The European Union (EU) implemented AM in 2012 to enhance post-marketing surveillance. However, its impact on adverse drug reaction (ADR) reporting and pharmacists' role remains insufficiently explored. This scoping review examines the influence of AM label on ADR reporting management, and pharmacists' awareness and involvement in AM medicines.
methodsA systematic search across four scientific databases (Web of Science, Scopus, Science Direct, and PubMed) and gray literature sources, covering studies published between 2012 and 2024 in the EU, identified 17 relevant studies according to eligibility criteria: AM labeling's impact on pharmacovigilance in the EU. Relevant data (title, year of publication, country, field, design, objective, results) and relation with research questions were charted.
resultsAM label alone does not significantly increase ADR reporting rates. However, structured training programs and targeted interventions for healthcare professionals (HCPs), particularly pharmacists, lead to improved ADR reporting and patient safety outcomes. Pharmacists exhibit the highest awareness of AM among HCPs but often underutilize their role in ADR reporting. Different studies demonstrated that pharmacist-led interventions significantly increased ADR notifications. Education campaigns, standardized reporting protocols, and enhanced integration of AM into clinical practice can strengthen AM pharmacovigilance efforts.
conclusionsThis review highlights the need to implement structured AM training programs and develop systematic evaluation frameworks to assess the effectiveness of AM labeling in improving pharmacovigilance practices. Further research is required to optimize AM strategies and reinforce pharmacists' role in post-marketing drug safety.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.