{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,31]],"date-time":"2025-12-31T12:21:56Z","timestamp":1767183716412,"version":"build-2065373602"},"reference-count":19,"publisher":"MDPI AG","issue":"7","license":[{"start":{"date-parts":[[2022,3,22]],"date-time":"2022-03-22T00:00:00Z","timestamp":1647907200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJERPH"],"abstract":"<jats:p>Spontaneous reports (SRs) of adverse drug reactions (ADRs) remain the basis of pharmacovigilance systems. The main objective of this study was to evaluate the quality of SRs received by the Pharmacovigilance Unit of Beira Interior, in Central Portugal. The second objective was to identify factors associated with complete SRs. SRs received between 1 January 2017 and 31 October 2019 were analyzed. SR information was classified as \u201cmandatory\u201d or \u201crecommended\u201d criteria. SR were then grouped into three categories (well, slightly, and poorly documented). Association between \u201cwell documented\u201d SR and confounding variables was estimated using a multiple logistic regression model. The results showed 22.4% of SRs are \u201cwell documented\u201d, and 41.2% are \u201cpoorly documented\u201d. Most of the complete SRs correspond to non-serious ADRs (55.8%), with a negative association between complete SRs and serious ADRs (OR = 0.595, [95% CI 0.362\u20130.977], p = 0.040). There is also a significant association between complete SRs and e-mail notification (OR = 1.876, [95% CI 1.060\u20133.321], p = 0.002). The results highlight the small amount of SR documentation sent to pharmacovigilance systems. There is an association between non-serious ADRs and complete SRs. These results reinforce the need for training for notification of ADRs and that these SRs include as much information as possible for an effective drug risk management.<\/jats:p>","DOI":"10.3390\/ijerph19073754","type":"journal-article","created":{"date-parts":[[2022,3,22]],"date-time":"2022-03-22T14:55:35Z","timestamp":1647960935000},"page":"3754","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Quality of Spontaneous Reports of Adverse Drug Reactions Sent to a Regional Pharmacovigilance Unit"],"prefix":"10.3390","volume":"19","author":[{"given":"M\u00e1rio Rui","family":"Salvador","sequence":"first","affiliation":[{"name":"Public Health Unit, Local Health Unit of Guarda, 6301-858 Guarda, Portugal"},{"name":"Pharmacovigilance Unit of Beira Interior, Faculty of Health Sciences, University of Beira Interior, 6200-506 Covilha, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5225-6222","authenticated-orcid":false,"given":"Cristina","family":"Monteiro","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit of Beira Interior, Faculty of Health Sciences, University of Beira Interior, 6200-506 Covilha, Portugal"}]},{"given":"Lu\u00edsa","family":"Pereira","sequence":"additional","affiliation":[{"name":"Department of Mathematics, University of Beira Interior, 6201-001 Covilha, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3333-5977","authenticated-orcid":false,"given":"Ana Paula","family":"Duarte","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Unit of Beira Interior, Faculty of Health Sciences, University of Beira Interior, 6200-506 Covilha, Portugal"},{"name":"The Health Science Research Centre, University of Beira Interior, 6200-506 Covilha, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2022,3,22]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1007\/s40264-015-0281-0","article-title":"Epidemiology of Adverse Drug Reactions in Europe: A Review of Recent Observational Studies","volume":"38","author":"Bouvy","year":"2015","journal-title":"Drug Saf."},{"key":"ref_2","unstructured":"(2022, March 15). Guideline on Good Pharmacovigilance Practices (GVP) Annex I\u2014Definitions (Rev 4). Available online: https:\/\/www.ema.europa.eu\/en\/documents\/scientific-guideline\/guideline-good-pharmacovigilance-practices-annex-i-definitions-rev-4_en.pdf."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1001\/jama.279.15.1200","article-title":"Incidence of Adverse Drug Reactions in Hospitalized Patients","volume":"279","author":"Lazarou","year":"1998","journal-title":"JAMA"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1001\/jama.1997.03540280045032","article-title":"The Costs of Adverse Drug Events in Hospitalized Patients","volume":"277","author":"Bates","year":"1997","journal-title":"JAMA"},{"key":"ref_5","unstructured":"Portugal Ministry of Health, and INFARMED\u2014National Medicines and Health Products Authority (2019, December 12). Farmacovigil\u00e2ncia em Portugal: 25 Anos, Available online: http:\/\/app10.infarmed.pt\/e_book_farmacovigilancia25\/index.html."},{"key":"ref_6","unstructured":"European Union (2019, December 12). European Parlament and European Council, \u201cDirective 2010\/84\/UE\u201d. Available online: https:\/\/eur-lex.europa.eu\/legal-content\/EN\/TXT\/HTML\/?uri=CELEX:32010L0084&from=PT."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"51","DOI":"10.1080\/14740338.2019.1559812","article-title":"The quality of spontaneous adverse drug reaction reports from the pharmacovigilance centre in western China","volume":"18","author":"Niu","year":"2018","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1189","DOI":"10.1007\/s40264-016-0463-4","article-title":"Completeness of Spontaneous Adverse Drug Reaction Reports Sent by General Practitioners to a Regional Pharmacovigilance Centre: A Descriptive Study","volume":"39","author":"Durrieu","year":"2016","journal-title":"Drug Saf."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1111\/bcp.12944","article-title":"Adverse drug event reporting systems: A systematic review","volume":"82","author":"Bailey","year":"2016","journal-title":"Br. J. Clin. Pharmacol."},{"key":"ref_10","unstructured":"European Medicines Agency (2019, October 02). Good Pharmacovigilance Practices, Available online: https:\/\/www.ema.europa.eu\/en\/human-regulatory\/post-authorisation\/pharmacovigilance\/good-pharmacovigilance-practices."},{"key":"ref_11","unstructured":"U.S. Department of Health and Human Services\u2014Food and Drug Administration (2020, January 13). Guidance for Industry Good. Pharmacovigilance Assessment Guidance for Industry Practices and Pharmacoepidemiologic Assessment, Available online: https:\/\/www.fda.gov\/files\/drugs\/published\/Good-Pharmacovigilance-Practices-and-Pharmacoepidemiologic-Assessment-March-2005.pdf."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1181","DOI":"10.1002\/pds.2004","article-title":"Quality check of spontaneous adverse drug reaction reporting forms of different countries","volume":"19","author":"Bandekar","year":"2010","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"21","DOI":"10.2165\/00002018-200831010-00003","article-title":"Methods for Causality Assessment of Adverse Drug Reactions","volume":"31","author":"Agbabiaka","year":"2008","journal-title":"Drug Saf."},{"key":"ref_14","doi-asserted-by":"crossref","first-page":"1329","DOI":"10.1080\/14740338.2017.1369525","article-title":"Filling quality of the reports of adverse drug reactions received at the Pharmacovigilance Centre of S\u00e3o Paulo (Brazil): Missing information hinders the analysis of suspected associations","volume":"16","author":"Ribeiro","year":"2017","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"751","DOI":"10.1007\/s00228-017-2223-5","article-title":"Lack of essential information in spontaneous reports of adverse drug reactions in Catalonia\u2014a restraint to the potentiality for signal detection","volume":"73","author":"Plessis","year":"2017","journal-title":"Eur. J. Clin. Pharmacol."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"837","DOI":"10.1007\/BF03261979","article-title":"Evaluation of Completeness of Suspected Adverse Drug Reaction Reports Submitted to the Mexican National Pharmacovigilance Centre","volume":"35","year":"2012","journal-title":"Drug Saf."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1007\/s40264-013-0131-x","article-title":"vigiGrade: A Tool to Identify Well-Documented Individual Case Reports and Highlight Systematic Data Quality Issues","volume":"37","author":"Bergvall","year":"2013","journal-title":"Drug Saf."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"19","DOI":"10.2165\/00002018-200932010-00002","article-title":"Determinants of under-reporting of adverse drug reactions: A systematic review","volume":"32","author":"Herdeiro","year":"2009","journal-title":"Drug Saf."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"385","DOI":"10.2165\/00002018-200629050-00003","article-title":"Under-Reporting of Adverse Drug Reactions: A systematic review","volume":"29","author":"Hazell","year":"2006","journal-title":"Drug Saf."}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/19\/7\/3754\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T22:40:46Z","timestamp":1760136046000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/19\/7\/3754"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3,22]]},"references-count":19,"journal-issue":{"issue":"7","published-online":{"date-parts":[[2022,4]]}},"alternative-id":["ijerph19073754"],"URL":"https:\/\/doi.org\/10.3390\/ijerph19073754","relation":{},"ISSN":["1660-4601"],"issn-type":[{"type":"electronic","value":"1660-4601"}],"subject":[],"published":{"date-parts":[[2022,3,22]]}}}