21st century pharmacovigilance: efforts, roles, and responsibilities.
In an era when the number of expedited and conditional review pathways for newly available brand-name drugs and biosimilar medicines to treat serious and life-threatening diseases is increasing, defining pharmacovigilance has never been more crucial. 21st century pharmacovigilance is not merely about uncovering, reporting, and addressing adverse events associated with already approved and marketed agents, but can be described as the systematic monitoring of the process of pre-market review and post-market surveillance, which includes the use of medicines in everyday practice. Pharmacovigilance identifies previously unrecognised adverse events or changes in the patterns of these effects, the quality and adequacy of drug supply, and should ensure effective communication with the public, health-care professionals, and patients about the optimum safety and effective use of medicines. In this paper, the first in a Series of three about drug safety in oncology, we discuss evolving challenges in the purview, roles, and responsibilities of the US Food and Drug Administration and the European Medicines Agency with respect to pharmacovigilance efforts, with a special emphasis on oncology treatment.
Center for Medicine in the Public Interest, New York, NY, USA; École Supérieure des Sciences Économiques et Commerciales, Paris, France; École Supérieure des Sciences Économiques et Commerciales, Singapore. Electronic address: ppitts@cmpi.org.
Peter J
PJ
Pitts
Pharmacovigilance Department, Henri Mondor/Assistance Publique Hôpitaux de Paris Université Paris est Créteil, Paris, France; International Society of Pharmacovigilance, Créteil, France.
Hervé Le
HL
Louet
Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada; International Society of Pharmacovigilance, Créteil, France.
Yola
Y
Moride
Health Economics and Policy Departments of Pediatrics Hematology/Oncology and Public Health Sciences, University of Chicago, Chicago, IL, USA.
Rena M
RM
Conti
D059451:Biosimilar Pharmaceuticals / Q000009:adverse effects; D016568:Drugs, Generic / Q000009:adverse effects; D006801:Humans; D060735:Pharmacovigilance; D011358:Product Surveillance, Postmarketing; D040242:Risk Reduction Behavior; D061108:Social Media; D014481:United States; D014486:United States Food and Drug Administration
D059451:Biosimilar Pharmaceuticals; D016568:Drugs, Generic