2023
DOI: 10.3390/curroncol30040315
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Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring

Abstract: 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 med… Show more

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“…There are very few studies on real-world settings in the literature that describe data collected on the safety of AM. 25 , 26 These studies are extremely important to obtain information after commercialization for regulatory authorities and healthcare specialists. 2 The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) questionnaire reveals that nearly 60% of Member States (MS) fail to recognize ADR reports for medicines under AM in their databases.…”
Section: Discussionmentioning
confidence: 99%
“…There are very few studies on real-world settings in the literature that describe data collected on the safety of AM. 25 , 26 These studies are extremely important to obtain information after commercialization for regulatory authorities and healthcare specialists. 2 The Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) questionnaire reveals that nearly 60% of Member States (MS) fail to recognize ADR reports for medicines under AM in their databases.…”
Section: Discussionmentioning
confidence: 99%