title: Pharmacovigilance in oncology: evaluation of current practice and future perspectives.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  To our knowledge, few articles focus upon the importance of PV and post-marketing 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.
authors.affiliation: Division of Pharmacy, Centro Di Riferimento Oncologico (CRO), Aviano, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Baldo
authors.forename: Paolo
authors.initials: P
authors.lastname: De Paoli
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects; D003142:Communication; D006801:Humans; D007256:Information Systems / Q000458:organization & administration; D010353:Patient Education as Topic; D060735:Pharmacovigilance; D057285:Precision Medicine / Q000009:adverse effects
chemical_list: D000970:Antineoplastic Agents; D059451:Biosimilar Pharmaceuticals
keywords: clinical safety; evaluation; pharmacovigilance; systematic reviews