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21st century pharmacovigilance: efforts, roles, and responsibilities.
Lancet Oncol. 2016 Nov; 17(11):e486-e492.LO

Abstract

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.

Authors+Show Affiliations

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.Pharmacovigilance Department, Henri Mondor/Assistance Publique Hôpitaux de Paris Université Paris est Créteil, Paris, France; International Society of Pharmacovigilance, Créteil, France.Faculty of Pharmacy, Université de Montréal, Montreal, QC, Canada; International Society of Pharmacovigilance, Créteil, France.Health Economics and Policy Departments of Pediatrics Hematology/Oncology and Public Health Sciences, University of Chicago, Chicago, IL, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

27819246

Citation

Pitts, Peter J., et al. "21st Century Pharmacovigilance: Efforts, Roles, and Responsibilities." The Lancet. Oncology, vol. 17, no. 11, 2016, pp. e486-e492.
Pitts PJ, Louet HL, Moride Y, et al. 21st century pharmacovigilance: efforts, roles, and responsibilities. Lancet Oncol. 2016;17(11):e486-e492.
Pitts, P. J., Louet, H. L., Moride, Y., & Conti, R. M. (2016). 21st century pharmacovigilance: efforts, roles, and responsibilities. The Lancet. Oncology, 17(11), e486-e492. https://doi.org/10.1016/S1470-2045(16)30312-6
Pitts PJ, et al. 21st Century Pharmacovigilance: Efforts, Roles, and Responsibilities. Lancet Oncol. 2016;17(11):e486-e492. PubMed PMID: 27819246.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 21st century pharmacovigilance: efforts, roles, and responsibilities. AU - Pitts,Peter J, AU - Louet,Hervé Le, AU - Moride,Yola, AU - Conti,Rena M, PY - 2016/02/17/received PY - 2016/06/30/revised PY - 2016/07/07/accepted PY - 2016/11/8/entrez PY - 2016/11/8/pubmed PY - 2017/5/27/medline SP - e486 EP - e492 JF - The Lancet. Oncology JO - Lancet Oncol. VL - 17 IS - 11 N2 - 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. SN - 1474-5488 UR - https://www.unboundmedicine.com/medline/citation/27819246/21st_century_pharmacovigilance:_efforts_roles_and_responsibilities_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S1470-2045(16)30312-6 DB - PRIME DP - Unbound Medicine ER -