PMID- 37185428
OWN - NLM
STAT- MEDLINE
DCOM- 20230517
LR  - 20230517
IS  - 1718-7729 (Electronic)
IS  - 1198-0052 (Print)
IS  - 1198-0052 (Linking)
VI  - 30
IP  - 4
DP  - 2023 Apr 11
TI  - Active Pharmacovigilance Study: A Follow-Up Model of Oral Anti-Cancer Drugs under 
      Additional Monitoring.
PG  - 4139-4152
LID - 10.3390/curroncol30040315 [doi]
AB  - 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.
FAU - Carvalho da Silva, Sofia Pinto
AU  - Carvalho da Silva SP
AD  - Pharmaceutical Services of Local Healthcare Unit of Matosinhos, 4464-513 Senhora 
      da Hora, Portugal.
FAU - Jesus, Mafalda
AU  - Jesus M
AUID- ORCID: 0000-0003-3332-7280
AD  - Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 
      Covilha, Portugal.
AD  - Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 
      6200-506 Covilha, Portugal.
FAU - Roque, Fatima
AU  - Roque F
AUID- ORCID: 0000-0003-0169-3788
AD  - Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 
      6200-506 Covilha, Portugal.
AD  - School of Health Sciences, Polytechnic Institute of Guarda, 6300-749 Guarda, 
      Portugal.
AD  - Research Unit for Interior Development, Polytechnic of Guarda (UDI-IPG), 6300-749 
      Guarda, Portugal.
FAU - Herdeiro, Maria Teresa
AU  - Herdeiro MT
AUID- ORCID: 0000-0002-0500-4049
AD  - Institute of Biomedicine, University of Aveiro (iBIMED-UA), 3810-193 Aveiro, 
      Portugal.
FAU - Costa E Sousa, Rita
AU  - Costa E Sousa R
AD  - Hematology Service, University Hospital Center of Coimbra, 3004-561 Coimbra, 
      Portugal.
FAU - Duarte, Ana Paula
AU  - Duarte AP
AUID- ORCID: 0000-0003-3333-5977
AD  - Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 
      Covilha, Portugal.
AD  - Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 
      6200-506 Covilha, Portugal.
AD  - UFBI-Pharmacovigilance Unit of Beira Interior, University of Beira Interior, 
      6200-506 Covilha, Portugal.
FAU - Morgado, Manuel
AU  - Morgado M
AUID- ORCID: 0000-0003-2112-2835
AD  - Health Sciences Faculty, University of Beira Interior (FCS-UBI), 6200-506 
      Covilha, Portugal.
AD  - Health Sciences Research Centre, University of Beira Interior (CICS-UBI), 
      6200-506 Covilha, Portugal.
AD  - School of Health Sciences, Polytechnic Institute of Guarda, 6300-749 Guarda, 
      Portugal.
AD  - Research Unit for Interior Development, Polytechnic of Guarda (UDI-IPG), 6300-749 
      Guarda, Portugal.
AD  - Pharmaceutical Services of University Hospital Center of Cova da Beira, 6200-251 
      Covilha, Portugal.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230411
PL  - Switzerland
TA  - Curr Oncol
JT  - Current oncology (Toronto, Ont.)
JID - 9502503
RN  - 0 (Antineoplastic Agents)
SB  - IM
MH  - Humans
MH  - Pharmacovigilance
MH  - Prospective Studies
MH  - Follow-Up Studies
MH  - Adverse Drug Reaction Reporting Systems
MH  - *Drug-Related Side Effects and Adverse Reactions/etiology
MH  - *Antineoplastic Agents/adverse effects
PMC - PMC10137106
OTO - NOTNLM
OT  - adverse drug reactions
OT  - black inverted triangle
OT  - patient safety and oral chemotherapy
OT  - pharmaceutical intervention
OT  - risk management
COIS- The authors declare no conflict of interest.
EDAT- 2023/05/15 19:12
MHDA- 2023/05/17 06:42
PMCR- 2023/04/11
CRDT- 2023/05/15 13:36
PHST- 2023/02/21 00:00 [received]
PHST- 2023/04/06 00:00 [revised]
PHST- 2023/04/10 00:00 [accepted]
PHST- 2023/05/17 06:42 [medline]
PHST- 2023/05/15 19:12 [pubmed]
PHST- 2023/05/15 13:36 [entrez]
PHST- 2023/04/11 00:00 [pmc-release]
AID - curroncol30040315 [pii]
AID - curroncol-30-00315 [pii]
AID - 10.3390/curroncol30040315 [doi]
PST - epublish
SO  - Curr Oncol. 2023 Apr 11;30(4):4139-4152. doi: 10.3390/curroncol30040315.