{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,1]],"date-time":"2025-12-01T06:37:33Z","timestamp":1764571053738,"version":"build-2065373602"},"reference-count":44,"publisher":"MDPI AG","issue":"4","license":[{"start":{"date-parts":[[2023,4,11]],"date-time":"2023-04-11T00:00:00Z","timestamp":1681171200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"national funds from Funda\u00e7\u00e3o para a Ci\u00eancia e a Tecnologia (FCT)","award":["UIDB\/00709\/2020","UIDP\/00709\/2020"],"award-info":[{"award-number":["UIDB\/00709\/2020","UIDP\/00709\/2020"]}]},{"name":"Fundo Europeu de Desenvolvimento Regional (FEDER)","award":["UIDB\/00709\/2020","UIDP\/00709\/2020"],"award-info":[{"award-number":["UIDB\/00709\/2020","UIDP\/00709\/2020"]}]},{"name":"Programa Operacional do Centro","award":["UIDB\/00709\/2020","UIDP\/00709\/2020"],"award-info":[{"award-number":["UIDB\/00709\/2020","UIDP\/00709\/2020"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Current Oncology"],"abstract":"<jats:p>Adverse drug reactions (ADRs) are responsible for almost 5% of hospital admissions, making it necessary to implement different pharmacovigilance strategies. The additional monitoring (AM) concept has been highlighted and intended to increase the number of suspected ADRs reported, namely in medicines with limited safety data. A prospective, descriptive study of active pharmacovigilance (AP) was conducted between 2019 and 2021 in the Local Health Unit of Matosinhos (LHUM) (Porto, Portugal). A model of AP for medicines under AM, namely oral antineoplastic agents, was designed. Follow-up consultations were performed, and adverse events (AEs) data were collected. The overall response to the treatment was evaluated through the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. A total of 52 patients were included in the study, and 14 antineoplastic drugs under AM were analyzed. Of the total number of patients included, only 29 developed at least one type of toxicity. Hematological disorders were the most reported suspected ADR. However, only four patients interrupted their treatment due to toxicity. After 12 months of treatment, most patients had disease progression, which was the main reason for therapy discontinuation. This AP model played an important role in the early detection of AEs and, consequently, contributed to better management of them. Increasing the number of suspected ADR reports is crucial for drugs with limited safety data.<\/jats:p>","DOI":"10.3390\/curroncol30040315","type":"journal-article","created":{"date-parts":[[2023,4,12]],"date-time":"2023-04-12T03:49:17Z","timestamp":1681271357000},"page":"4139-4152","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring"],"prefix":"10.3390","volume":"30","author":[{"given":"Sofia Pinto","family":"Carvalho da Silva","sequence":"first","affiliation":[{"name":"Pharmaceutical Services of Local Healthcare Unit of Matosinhos, 4464-513 Senhora da Hora, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3332-7280","authenticated-orcid":false,"given":"Mafalda","family":"Jesus","sequence":"additional","affiliation":[{"name":"Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilh\u00e3, Portugal"},{"name":"Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 6200-506 Covilh\u00e3, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0169-3788","authenticated-orcid":false,"given":"F\u00e1tima","family":"Roque","sequence":"additional","affiliation":[{"name":"Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 6200-506 Covilh\u00e3, Portugal"},{"name":"School of Health Sciences, Polytechnic Institute of Guarda, 6300-749 Guarda, Portugal"},{"name":"Research Unit for Interior Development, Polytechnic of Guarda (UDI-IPG), 6300-749 Guarda, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0500-4049","authenticated-orcid":false,"given":"Maria Teresa","family":"Herdeiro","sequence":"additional","affiliation":[{"name":"Institute of Biomedicine, University of Aveiro (iBIMED-UA), 3810-193 Aveiro, Portugal"}]},{"given":"Rita","family":"Costa e Sousa","sequence":"additional","affiliation":[{"name":"Hematology Service, University Hospital Center of Coimbra, 3004-561 Coimbra, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3333-5977","authenticated-orcid":false,"given":"Ana Paula","family":"Duarte","sequence":"additional","affiliation":[{"name":"Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilh\u00e3, Portugal"},{"name":"Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 6200-506 Covilh\u00e3, Portugal"},{"name":"UFBI\u2014Pharmacovigilance Unit of Beira Interior, University of Beira Interior, 6200-506 Covilh\u00e3, Portugal"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2112-2835","authenticated-orcid":false,"given":"Manuel","family":"Morgado","sequence":"additional","affiliation":[{"name":"Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilh\u00e3, Portugal"},{"name":"Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 6200-506 Covilh\u00e3, Portugal"},{"name":"School of Health Sciences, Polytechnic Institute of Guarda, 6300-749 Guarda, Portugal"},{"name":"Research Unit for Interior Development, Polytechnic of Guarda (UDI-IPG), 6300-749 Guarda, Portugal"},{"name":"Pharmaceutical Services of University Hospital Center of Cova da Beira, 6200-251 Covilh\u00e3, Portugal"}]}],"member":"1968","published-online":{"date-parts":[[2023,4,11]]},"reference":[{"key":"ref_1","unstructured":"(2023, February 02). 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