Abstract
Rationale, aims and objectives: Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. Methods: We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. Results: This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. Conclusion: To our knowledge, few articles focus upon the importance of PV and postmarketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio.
| Original language | English |
|---|---|
| Pages (from-to) | 559-569 |
| Number of pages | 11 |
| Journal | Journal of Evaluation in Clinical Practice |
| Volume | 20 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - 2014 |
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Keywords
- Clinical safety
- Evaluation
- Pharmacovigilance
- Systematic reviews
ASJC Scopus subject areas
- Public Health, Environmental and Occupational Health
- Health Policy
- Medicine(all)
Cite this
Pharmacovigilance in oncology : Evaluation of current practice and future perspectives. / Baldo, Paolo; De Paoli, Paolo.
In: Journal of Evaluation in Clinical Practice, Vol. 20, No. 5, 2014, p. 559-569.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Pharmacovigilance in oncology
T2 - Evaluation of current practice and future perspectives
AU - Baldo, Paolo
AU - De Paoli, Paolo
PY - 2014
Y1 - 2014
N2 - Rationale, aims and objectives: Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. Methods: We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. Results: This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. Conclusion: To our knowledge, few articles focus upon the importance of PV and postmarketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio.
AB - Rationale, aims and objectives: Pharmacovigilance (PV), or drug safety monitoring, aims to improve patient safety through the detection and management of drug-related adverse reactions. It is implemented both by spontaneous reporting of adverse drug reactions (ADRs) and by careful detection of signals suggestive of drug toxicity. PV is an important clinical topic in clinical practice and pharmacotherapy, assuring the maintenance of a safe risk/benefit ratio throughout the commercial life cycle of a drug. Methods: We conducted a structured literature search on PubMed, Scopus, Cinahl and the Cochrane Library. We also performed manual searches in international databases of ADR individual reports to outline a structured profile on the topic. Our goal was to review key elements that affect safety monitoring of cancer drugs and their appropriate use, highlighting the strengths and weaknesses of PV in oncology. Results: This paper provides an understanding of the methodologies used by PV in current clinical practice and particularly in cancer drug therapy; a focus upon reporting of ADRs by health professionals and patients; and a focus upon methods used by PV to detect new signals of risk/harm related to medicines utilization. Conclusion: To our knowledge, few articles focus upon the importance of PV and postmarketing surveillance of cancer drug therapies. Structured management of spontaneous reports of ADRs and data collection is essential to monitoring the safe use of drugs in this field in which pharmacotherapy is affected by high incidence of drug-related complications and by a narrow benefit/risk ratio.
KW - Clinical safety
KW - Evaluation
KW - Pharmacovigilance
KW - Systematic reviews
UR - http://www.scopus.com/inward/record.url?scp=84927796020&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84927796020&partnerID=8YFLogxK
U2 - 10.1111/jep.12184
DO - 10.1111/jep.12184
M3 - Article
VL - 20
SP - 559
EP - 569
JO - Journal of Evaluation in Clinical Practice
JF - Journal of Evaluation in Clinical Practice
SN - 1356-1294
IS - 5
ER -