Pharmacovigilance in oncology

Evaluation of current practice and future perspectives

Research output: Contribution to journalArticle

13 Citations (Scopus)

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 languageEnglish
Pages (from-to)559-569
Number of pages11
JournalJournal of Evaluation in Clinical Practice
Volume20
Issue number5
DOIs
Publication statusPublished - 2014

Fingerprint

Pharmacovigilance
Drug-Related Side Effects and Adverse Reactions
Drug Therapy
Drug Monitoring
Odds Ratio
Pharmaceutical Preparations
Safety
Neoplasms
Patient Safety
Life Cycle Stages
PubMed
Libraries
Maintenance
Databases
Incidence
Health

Keywords

  • Clinical safety
  • Evaluation
  • Pharmacovigilance
  • Systematic reviews

ASJC Scopus subject areas

  • Public Health, Environmental and Occupational Health
  • Health Policy
  • Medicine(all)

Cite this

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title = "Pharmacovigilance in oncology: Evaluation of current practice and future perspectives",
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.",
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author = "Paolo Baldo and {De Paoli}, Paolo",
year = "2014",
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language = "English",
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AU - Baldo, Paolo

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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.

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