{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T15:03:09Z","timestamp":1753887789295,"version":"3.41.2"},"reference-count":47,"publisher":"FapUNIFESP (SciELO)","issue":"10","license":[{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"am","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2021,1,1]],"date-time":"2021-01-01T00:00:00Z","timestamp":1609459200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cad. Sa\u00fade P\u00fablica"],"abstract":"<jats:p>Resumo: Desde 1963 que a farmacovigil\u00e2ncia foi reconhecida como uma \u00e1rea priorit\u00e1ria na sa\u00fade p\u00fablica a n\u00edvel global pela Organiza\u00e7\u00e3o Mundial da Sa\u00fade, garantindo a monitoriza\u00e7\u00e3o permanente da seguran\u00e7a dos medicamentos. O objetivo deste trabalho foi caracterizar as rea\u00e7\u00f5es adversas a medicamentos recebidas pela Unidade de Farmacovigil\u00e2ncia do Porto (UFPorto), Portugal, ao longo de duas d\u00e9cadas de atividade. Foram consideradas todas as notifica\u00e7\u00f5es de suspeitas de rea\u00e7\u00f5es adversas a medicamentos recebidas entre janeiro de 2001 e dezembro de 2019. Foram calculadas as taxas de notifica\u00e7\u00e3o anuais, assim como a sua distribui\u00e7\u00e3o por origem, tipo de notificador e local de exerc\u00edcio da atividade, gravidade, conhecimento pr\u00e9vio e causalidade das rea\u00e7\u00f5es adversas a medicamentos notificadas. No per\u00edodo em estudo, a UFPorto recebeu 9.711 notifica\u00e7\u00f5es de suspeitas de rea\u00e7\u00f5es adversas a medicamentos. As institui\u00e7\u00f5es hospitalares s\u00e3o aquelas que mais notificam (n = 6.003; 64%), assim como o m\u00e9dico entre os profissionais de sa\u00fade (n = 5.284; 54,4%). Os eventos adversos mais frequentemente reportados s\u00e3o graves (n = 6.275; 72%) e encontram-se descritos no respectivo Resumo das Caracter\u00edsticas do Medicamento (n = 6.978; 72%). \u00c0 maioria das notifica\u00e7\u00f5es avaliadas pela UFPorto foi atribu\u00eddo o grau de causalidade \u201cprov\u00e1vel\u201d (n = 7.473; 77%), independentemente do tipo de notificador. Os resultados obtidos s\u00e3o concordantes com outros dados previamente reportados na literatura m\u00e9dica internacional e em relat\u00f3rios oficiais nacionais. Contudo, continua-se a verificar taxas de subnotifica\u00e7\u00e3o acentuadas, face ao esperado. Ao longo de aproximadamente 20 anos de atividade da UFPorto, tem-se verificado um aumento da sua atividade nas diversas vertentes da seguran\u00e7a do medicamento.<\/jats:p>","DOI":"10.1590\/0102-311x00304420","type":"journal-article","created":{"date-parts":[[2021,10,10]],"date-time":"2021-10-10T06:53:53Z","timestamp":1633848833000},"source":"Crossref","is-referenced-by-count":2,"title":["Retrospectiva de 20 anos de atividade da Unidade de Farmacovigil\u00e2ncia do Porto, Portugal"],"prefix":"10.1590","volume":"37","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6517-6021","authenticated-orcid":false,"given":"Renato","family":"Ferreira-da-Silva","sequence":"first","affiliation":[{"name":"Infarmed, I.P.\/Universidade do Porto,  Portugal; Universidade do Porto,  Portugal; CINTESIS - Centro de Investiga\u00e7\u00e3o em Tecnologia e Servi\u00e7os de Sa\u00fade,  Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3442-8158","authenticated-orcid":false,"given":"In\u00eas","family":"Ribeiro-Vaz","sequence":"additional","affiliation":[{"name":"Infarmed, I.P.\/Universidade do Porto,  Portugal; Universidade do Porto,  Portugal; CINTESIS - Centro de Investiga\u00e7\u00e3o em Tecnologia e Servi\u00e7os de Sa\u00fade,  Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2355-2310","authenticated-orcid":false,"given":"Ana Marta","family":"Silva","sequence":"additional","affiliation":[{"name":"Infarmed, I.P.\/Universidade do Porto,  Portugal; Universidade do Porto,  Portugal; CINTESIS - Centro de Investiga\u00e7\u00e3o em Tecnologia e Servi\u00e7os de Sa\u00fade,  Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1043-5078","authenticated-orcid":false,"given":"Joana","family":"Marques","sequence":"additional","affiliation":[{"name":"Infarmed, I.P.\/Universidade do Porto,  Portugal; Universidade do Porto,  Portugal; CINTESIS - Centro de Investiga\u00e7\u00e3o em Tecnologia e Servi\u00e7os de Sa\u00fade,  Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0133-7217","authenticated-orcid":false,"given":"Jorge Junqueira","family":"Pol\u00f3nia","sequence":"additional","affiliation":[{"name":"Infarmed, I.P.\/Universidade do Porto,  Portugal; Universidade do Porto,  Portugal; CINTESIS - Centro de Investiga\u00e7\u00e3o em Tecnologia e Servi\u00e7os de Sa\u00fade,  Portugal"}]}],"member":"530","published-online":{"date-parts":[[2021]]},"reference":[{"year":"1971","series-title":"Report for 1969 and 1970","key":"ref1"},{"year":"2002","series-title":"The importance of pharmacovigilance","key":"ref2"},{"year":"2010","series-title":"Diretiva 2010\/84\/EU do Parlamento Europeu e do Conselho de 15 de Dezembro","key":"ref3"},{"series-title":"Farmacovigil\u00e2ncia em Portugal: 25 anos: INFARMED","key":"ref4"},{"key":"ref5","doi-asserted-by":"crossref","first-page":"456","DOI":"10.7326\/0003-4819-122-6-199503150-00009","article-title":"Elixirs, diluents, and the passage of the 1938 Federal Food, Drug and Cosmetic Act","volume":"122","author":"Wax PM","year":"1995","journal-title":"Ann Intern Med"},{"series-title":"Act of June 25, 1938 (Federal Food, Drug, and Cosmetic Act), Public Law 75-717, 52 STAT 1040, which prohibited the movement in interstate commerce of adulterated and misbranded food, drugs, devices, and cosmetics","key":"ref6"},{"key":"ref7","doi-asserted-by":"crossref","first-page":"307","DOI":"10.1016\/S1091-8531(03)00169-1","article-title":"The fall and rise of chloramphenicol","volume":"7","author":"Isenberg SJ","year":"2003","journal-title":"J AAPOS"},{"key":"ref8","first-page":"224","article-title":"Chloramphenicol: screening and review to evaluate its potential beneficial effects in leukaemia","volume":"105","author":"Lokhande J","year":"2007","journal-title":"J Indian Med Assoc"},{"key":"ref9","doi-asserted-by":"crossref","first-page":"1358","DOI":"10.1016\/S0140-6736(61)90927-8","article-title":"Thalidomide and congenital abnormalities","volume":"278","author":"McBride WG","year":"1961","journal-title":"Lancet"},{"series-title":"Resumo das caracter\u00edsticas do medicamento: talidomida","key":"ref10"},{"key":"ref11","doi-asserted-by":"crossref","first-page":"15","DOI":"10.2174\/1574887110666150430145520","article-title":"After thalidomide - do we have the right balance between public health and intellectual property","volume":"10","author":"Feldschreiber P","year":"2015","journal-title":"Rev Recent Clin Trials"},{"series-title":"The use of the WHO-UMC system for standardised case causality assessment","key":"ref12"},{"series-title":"ICH E2A Clinical safety data management: definitions and standards for expedited reporting","key":"ref13"},{"key":"ref14","doi-asserted-by":"crossref","first-page":"247","DOI":"10.1002\/cpt1977213247","article-title":"Toward the operational identification of adverse drug reactions","volume":"21","author":"Karch FE","year":"1977","journal-title":"Clin Pharmacol Ther"},{"key":"ref15","doi-asserted-by":"crossref","first-page":"486","DOI":"10.7861\/clinmedicine.9-5-486","article-title":"Modern methods of pharmacovigilance detecting adverse effects of drugs","volume":"9","author":"Noren GN","year":"2009","journal-title":"Clin Med (Lond)"},{"series-title":"Notifica\u00e7\u00e3o de rea\u00e7\u00f5es adversas a medicamentos: desempenho do Sistema Nacional de Farmacovigil\u00e2ncia desde 2012","key":"ref16"},{"key":"ref17","doi-asserted-by":"crossref","first-page":"231","DOI":"10.1111\/ijpp.12056","article-title":"Important information regarding reporting of adverse drug reactions a qualitative study","volume":"22","author":"Rolfes L","year":"2014","journal-title":"Int J Pharm Pract"},{"key":"ref18","doi-asserted-by":"crossref","first-page":"222","DOI":"10.20344\/amp.5717","article-title":"Farmacovigil\u00e2ncia em Portugal atividade da unidade regional do centro","volume":"28","author":"Batel-Marques F","year":"2015","journal-title":"Acta Med Port"},{"key":"ref19","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1111\/ijpp.12078","article-title":"A survey of spontaneous reporting of adverse drug reactions in 10 years of activity in a pharmacovigilance centre in Portugal","volume":"22","author":"Marques J","year":"2014","journal-title":"Int J Pharm Pract"},{"key":"ref20","doi-asserted-by":"crossref","first-page":"1200","DOI":"10.1001\/jama.279.15.1200","article-title":"Incidence of adverse drug reactions in hospitalized patients a meta-analysis of prospective studies","volume":"279","author":"Lazarou J","year":"1998","journal-title":"JAMA"},{"series-title":"Proposal for a regulation amending, as regards pharmacovigilance of medicinal products for human use. Regulation (EC) No 726\/2004","key":"ref21"},{"key":"ref22","doi-asserted-by":"crossref","first-page":"5","DOI":"10.1186\/s12913-019-4651-7","article-title":"Adverse drug reactions in primary care a scoping review","volume":"20","author":"Khalil H","year":"2020","journal-title":"BMC Health Serv Res"},{"key":"ref23","doi-asserted-by":"crossref","first-page":"115","DOI":"10.1093\/intqhc\/mzq003","article-title":"Adverse events experienced by homecare patients a scoping review of the literature","volume":"22","author":"Masotti P","year":"2010","journal-title":"Int J Qual Health Care"},{"key":"ref24","doi-asserted-by":"crossref","first-page":"371","DOI":"10.1007\/s00228-002-0493-y","article-title":"Adverse drug reactions and cognitive function among hospitalized older adults","volume":"58","author":"Onder G","year":"2002","journal-title":"Eur J Clin Pharmacol"},{"key":"ref25","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1016\/j.maturitas.2015.12.013","article-title":"Adverse drug reactions in elderly patients with cognitive disorders a systematic review","volume":"85","author":"Kanagaratnam L","year":"2016","journal-title":"Maturitas"},{"key":"ref26","article-title":"Sistema Nacional de Farmacovigil\u00e2ncia no Brasil e em Portugal semelhan\u00e7as, diferen\u00e7as e desafios","volume":"36","author":"Pepe VLE","year":"2020","journal-title":"Cad Sa\u00fade P\u00fablica"},{"key":"ref27","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.2165\/11593830-000000000-00000","article-title":"Modified prescription-event monitoring studies a tool for pharmacovigilance and risk management","volume":"34","author":"Layton D","year":"2011","journal-title":"Drug Saf"},{"key":"ref28","doi-asserted-by":"crossref","first-page":"761","DOI":"10.1007\/s40264-014-0205-4","article-title":"Pharmacovigilance for a revolving world prospects of patient-generated data on the internet","volume":"37","author":"Noren GN","year":"2014","journal-title":"Drug Saf"},{"key":"ref29","series-title":"Pharmacovigilance.","first-page":"265","volume-title":"Data mining in pharmacovigilance: a view from the uppsala monitoring centre","author":"Mann RD","year":"2007","edition":"2nd Ed"},{"year":"2016","series-title":"Encyclopedia of e-health and telemedicine","author":"Cruz-Cunha MM","key":"ref30"},{"key":"ref31","first-page":"952","article-title":"Strategies for detection adverse drug reactions-comparison of hospital database and spontaneous reporting","volume":"38","author":"Marques J","year":"2015","journal-title":"Drug Saf"},{"key":"ref32","doi-asserted-by":"crossref","first-page":"350","DOI":"10.3389\/fphar.2018.00350","article-title":"Adverse drug reactions in hospitalized patients results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study","volume":"9","author":"Giardina C","year":"2018","journal-title":"Front Pharmacol"},{"key":"ref33","doi-asserted-by":"crossref","first-page":"1552","DOI":"10.1002\/pds.4800","article-title":"Adverse drug reaction reporting by community pharmacists - the barriers and facilitators","volume":"28","author":"Hughes ML","year":"2019","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"ref34","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.sapharm.2004.12.009","article-title":"The role of hospital and community pharmacists in pharmacovigilance","volume":"1","author":"van Grootheest AC","year":"2005","journal-title":"Res Social Adm Pharm"},{"key":"ref35","doi-asserted-by":"crossref","first-page":"322","DOI":"10.1111\/jonm.12003","article-title":"Nurses' spontaneous reporting of adverse drug reactions expert review of routine reports","volume":"22","author":"Mendes D","year":"2014","journal-title":"J Nurs Manag"},{"key":"ref36","first-page":"331","article-title":"Influence of pharmacists' attitudes on adverse drug reaction reporting a case-control study in Portugal","volume":"29","author":"Herdeiro MT","year":"2006","journal-title":"Drug Saf"},{"key":"ref37","first-page":"825","article-title":"Physicians' attitudes and adverse drug reaction reporting a case-control study in Portugal","volume":"28","author":"Herdeiro MT","year":"2005","journal-title":"Drug Saf"},{"key":"ref38","doi-asserted-by":"crossref","first-page":"1230","DOI":"10.1093\/ajhp\/61.12.1230","article-title":"Electronic adverse-drug-reaction-reporting program","volume":"61","author":"Lee SB","year":"2004","journal-title":"Am J Health Syst Pharm"},{"key":"ref39","doi-asserted-by":"crossref","first-page":"731","DOI":"10.1197\/jamia.M2232","article-title":"Using electronic medical records to enhance detection and reporting of vaccine adverse events","volume":"14","author":"Hinrichsen VL","year":"2007","journal-title":"J Am Med Inform Assoc"},{"key":"ref40","doi-asserted-by":"crossref","first-page":"655","DOI":"10.1007\/BF03261962","article-title":"Workshop- and telephone-based interventions to improve adverse drug reaction reporting a cluster-randomized trial in Portugal","volume":"35","author":"Herdeiro MT","year":"2012","journal-title":"Drug Saf"},{"key":"ref41","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1590\/S0034-89102010005000050","article-title":"Estrat\u00e9gias para aumentar a sensibilidade da farmacovigil\u00e2ncia em Portugal","volume":"45","author":"Ribeiro-Vaz I","year":"2010","journal-title":"Rev Sa\u00fade P\u00fablica"},{"key":"ref42","doi-asserted-by":"crossref","first-page":"387","DOI":"10.2165\/11597190-000000000-00000","article-title":"Promoting spontaneous adverse drug reaction reporting in hospitals using a hyperlink to the online reporting form an ecological study in Portugal","volume":"35","author":"Ribeiro-Vaz I","year":"2012","journal-title":"Drug Saf"},{"key":"ref43","doi-asserted-by":"crossref","first-page":"14","DOI":"10.1590\/S1518-8787.2016050006122","article-title":"Promoting adverse drug reaction reporting comparison of different approaches","volume":"50","author":"Ribeiro-Vaz I","year":"2016","journal-title":"Rev Sa\u00fade P\u00fablica"},{"series-title":"FDA Adverse Event Reporting System (FAERS) electronic submissions","key":"ref44"},{"key":"ref45","doi-asserted-by":"crossref","first-page":"815","DOI":"10.1056\/NEJMp1606884","article-title":"Accelerating innovation in health IT","volume":"375","author":"Rudin RS","year":"2016","journal-title":"N Engl J Med"},{"key":"ref46","doi-asserted-by":"crossref","first-page":"413","DOI":"10.1136\/amiajnl-2012-000930","article-title":"Combing signals from spontaneous reports and electronic health records for detection of adverse drug reactions","volume":"20","author":"Harpaz R","year":"2013","journal-title":"J Am Med Inform Assoc"},{"key":"ref47","doi-asserted-by":"crossref","first-page":"12","DOI":"10.1016\/j.artmed.2018.07.005","article-title":"Causality assessment of adverse drug reaction reports using an expert-defined Bayesian network","volume":"91","author":"Rodrigues PP","year":"2018","journal-title":"Artif Intell Med"}],"container-title":["Cadernos de Sa\u00fade P\u00fablica"],"original-title":[],"deposited":{"date-parts":[[2021,10,10]],"date-time":"2021-10-10T06:54:28Z","timestamp":1633848868000},"score":1,"resource":{"primary":{"URL":"http:\/\/www.scielo.br\/scielo.php?script=sci_arttext&pid=S0102-311X2021001005009&tlng=pt"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021]]},"references-count":47,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2021]]}},"alternative-id":["S0102-311X2021001005009"],"URL":"https:\/\/doi.org\/10.1590\/0102-311x00304420","relation":{},"ISSN":["1678-4464","0102-311X"],"issn-type":[{"type":"electronic","value":"1678-4464"},{"type":"print","value":"0102-311X"}],"subject":[],"published":{"date-parts":[[2021]]},"article-number":"e00304420"}}