ArticlePharmacoepidemiology and drug safety2021
What are the patients' and health care professionals' understanding and behaviors towards adverse drug reaction reporting and additional monitoring?
Article in Pharmacoepidemiology and drug safety, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
12 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Factors associated with underreporting of adverse drug reactions by patients: a systematic review.International journal of clinical pharmacy · 2023Pooled it
- Do consumers and healthcare professionals report the same adverse event differently? A paired analysis of duplicate vaccine safety reports in Norway.British journal of clinical pharmacology · 2026Article
- Challenges and future perspectives of enhanced passive safety surveillance of influenza vaccines in Europe.Therapeutic advances in drug safety · 2026Review
- Article
- 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
- Consumers' knowledge and experiences of adverse drug reaction reporting in Australia: a national survey.European journal of clinical pharmacology · 2024Article
- Comparative Analysis of Information Provided in German Adverse Drug Reaction Reports Sent by Physicians, Pharmacists and Consumers.Drug safety · 2023Article
- Regulation Awareness and Experience of Additional Monitoring among Healthcare Professionals in Finland.Healthcare (Basel, Switzerland) · 2021Article
- Teaching Pharmacovigilance to Healthcare Students: Identifying Gaps and Opportunities for Improvement.Pharmacy (Basel, Switzerland) · 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
- Does additional monitoring status increase the reporting of adverse drug reactions? An interrupted time series analysis of EudraVigilance data.Pharmacoepidemiology and drug safety · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe additional monitoring (AM)/black triangle concept is aimed to enhance ADR reporting for certain types of medicinal products for which the safety profile is less well established. PURPOSE: The objective of this survey was to assess (a) attitudes towards ADR reporting and reasons for not reporting an ADR and (b) awareness of AM among HCPs, patients or their careers in EU countries.
methodsAn online questionnaire which was available in all EU languages was completed by 2918 responders coming from all EEA countries.
resultsThe main factors motivating to report an ADR were severity or novelty of the reaction or novelty of the medicine. The main factors for not reporting an ADR was the fact that the ADR is already known (35%), the ADR was not serious (18%) or reporter was not sure if the ADR was related to the medicine (15%). Half of the respondents indicated that they have seen AM statement before. Thirty percent of the responders had correct understanding of the AM concept while 20 % misunderstood the concept.
conclusionUnderreporting occurs but it seems this is because of reporter's prioritisation towards certain type of ADRs. AM aims to increase reporting for certain medicines, however, approximately half of responders have seen the AM symbol before and 20% of all responders (independent of their previous awareness) misunderstood the concept.
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Registered trials
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