ArticleBioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2018
Knowledge of Adverse Drug Reaction Reporting and the Pharmacovigilance of Biological Medicines: A Survey of Healthcare Professionals in Ireland.
Article in BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.
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Who cites it
20 citing papers in PubMed.
- Awareness and Experience of Direct Healthcare Professional Communication and Risk Management Plan Educational Material among Healthcare Professionals in Finland.Pharmaceutical medicine · 2025Article
- Impact of Additional Monitoring on Pharmacovigilance and Pharmacists' Role: A Scoping Review.Pharmacoepidemiology and drug safety · 2025Article
- The STAR Compass to Guide Future Pharmacovigilance Based on a 10-Year Review of the Strengthened EU System.Drug safety · 2024Review
- Improving ADR reporting in Jordan: a qualitative exploration of pharmacists' perspectives.Frontiers in medicine · 2024Article
- Exploring pharmacovigilance practices and knowledge among healthcare professionals: A cross-sectional multicenter study.SAGE open medicine · 2024Article
- Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring.Current oncology (Toronto, Ont.) · 2023Article
- Evaluating awareness, knowledge and practice of healthcare professionals following implementation of a revised pregnancy prevention programme for isotretinoin in Ireland: A multi-stakeholder cross-sectional study.Pharmacoepidemiology and drug safety · 2023Article
- Biosimilars in Oncology: Latest Trends and Regulatory Status.Pharmaceutics · 2022Review
- Nurses competence in the reporting of medication-related incidents: An intervention study.Nursing open · 2022Article
- The whole experience of public hospital physicians from several specialties with biopharmaceutical effectiveness, safety, adverse drug reactions and interchangeability: A qualitative study.Exploratory research in clinical and social pharmacy · 2022Article
- Under-Reporting of Adverse Drug Reactions in Finland and Healthcare Professionals' Perspectives on How to Improve Reporting.Healthcare (Basel, Switzerland) · 2022Article
- A National Survey of Community Pharmacists' Viewpoints About Pharmacovigilance and Adverse Drug Reaction Reporting in Saudi Arabia.Frontiers in pharmacology · 2022Article
- Regulation Awareness and Experience of Additional Monitoring among Healthcare Professionals in Finland.Healthcare (Basel, Switzerland) · 2021Article
- Qualitative Study of Community Pharmacists' and General Practitioners' Views toward Pharmacovigilance in Lithuania.Healthcare (Basel, Switzerland) · 2021Article
- Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data.Pharmacoepidemiology and drug safety · 2021Article
- What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?Pharmacoepidemiology and drug safety · 2021Article
- Monitoring the manufacturing and quality of medicines: a fundamental task of pharmacovigilance.Therapeutic advances in drug safety · 2021Review
- Stakeholders' knowledge, attitudes and practices to pharmacovigilance and adverse drug reaction reporting in clinical trials: a mixed methods study.European journal of clinical pharmacology · 2020Article
- Article
- Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice.Clinical pharmacology and therapeutics · 2019Article
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4 authors.
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Abstract
backgroundIn Europe, changes to pharmacovigilance legislation, which include additional monitoring of medicines, aim to optimise adverse drug reaction (ADR) reporting systems. The legislation also makes provisions related to the traceability of biological medicines.
objectiveThe objective of this study was to assess (i) knowledge and general experience of ADR reporting, (ii) knowledge, behaviours, and attitudes related to the pharmacovigilance of biologicals, and (iii) awareness of additional monitoring among healthcare professionals (HCPs) in Ireland.
methodsHospital doctors (n = 88), general practitioners (GPs) (n = 197), nurses (n = 104) and pharmacists (n = 309) completed an online questionnaire.
resultsThere were differences in mean knowledge scores relating to ADR reporting and the pharmacovigilance of biologicals among the HCP groups. The majority of HCPs who use biological medicines in their practice generally record biologicals by brand name but practice behaviours relating to batch number recording differed between some professions. HCPs consider batch number recording to be valuable but also regard it as being more difficult than brand name recording. Most respondents were aware of the concept of additional monitoring but awareness rates differed between some groups. Among those who knew about additional monitoring, there was higher awareness of the inverted black triangle symbol among pharmacists (> 86.4%) compared with hospital doctors (35.1%), GPs (35.6%), and nurses (14.9%). Hospital pharmacists had more experience and knowledge of ADR reporting than other practising HCPs.
conclusionThis study highlights the important role hospital pharmacists play in post-marketing surveillance. There is a need to increase pharmacovigilance awareness of biological medicines and improve systems to support their batch traceability.
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