Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring
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...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-04-01
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| Series: | Current Oncology |
| Subjects: | |
| Online Access: | https://www.mdpi.com/1718-7729/30/4/315 |
| _version_ | 1797605827204349952 |
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| author | Sofia Pinto Carvalho da Silva Mafalda Jesus Fátima Roque Maria Teresa Herdeiro Rita Costa e Sousa Ana Paula Duarte Manuel Morgado |
| author_facet | Sofia Pinto Carvalho da Silva Mafalda Jesus Fátima Roque Maria Teresa Herdeiro Rita Costa e Sousa Ana Paula Duarte Manuel Morgado |
| author_sort | Sofia Pinto Carvalho da Silva |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-11T05:06:37Z |
| format | Article |
| id | doaj.art-f63538fb84b344f9ac1e5a24d5772055 |
| institution | Directory Open Access Journal |
| issn | 1198-0052 1718-7729 |
| language | English |
| last_indexed | 2024-03-11T05:06:37Z |
| publishDate | 2023-04-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Current Oncology |
| spelling | doaj.art-f63538fb84b344f9ac1e5a24d57720552023-11-17T18:53:01ZengMDPI AGCurrent Oncology1198-00521718-77292023-04-013044139415210.3390/curroncol30040315Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional MonitoringSofia Pinto Carvalho da Silva0Mafalda Jesus1Fátima Roque2Maria Teresa Herdeiro3Rita Costa e Sousa4Ana Paula Duarte5Manuel Morgado6Pharmaceutical Services of Local Healthcare Unit of Matosinhos, 4464-513 Senhora da Hora, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalHealth Sciences Research Centre, University of Beira Interior (CICS-UBI), 6200-506 Covilhã, PortugalInstitute of Biomedicine, University of Aveiro (iBIMED-UA), 3810-193 Aveiro, PortugalHematology Service, University Hospital Center of Coimbra, 3004-561 Coimbra, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalHealth Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 Covilhã, PortugalAdverse 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.https://www.mdpi.com/1718-7729/30/4/315pharmaceutical interventionadverse drug reactionsrisk managementblack inverted trianglepatient safety and oral chemotherapy |
| spellingShingle | Sofia Pinto Carvalho da Silva Mafalda Jesus Fátima Roque Maria Teresa Herdeiro Rita Costa e Sousa Ana Paula Duarte Manuel Morgado Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring Current Oncology pharmaceutical intervention adverse drug reactions risk management black inverted triangle patient safety and oral chemotherapy |
| title | Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring |
| title_full | Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring |
| title_fullStr | Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring |
| title_full_unstemmed | Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring |
| title_short | Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under Additional Monitoring |
| title_sort | active pharmacovigilance study a follow up model of oral anti cancer drugs under additional monitoring |
| topic | pharmaceutical intervention adverse drug reactions risk management black inverted triangle patient safety and oral chemotherapy |
| url | https://www.mdpi.com/1718-7729/30/4/315 |
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