Clinical Therapeutics – December 2016 Volume 38, Issue 12, p2509-2710

Clinical Therapeutics
December 2016 Volume 38, Issue 12, p2509-2710
http://www.clinicaltherapeutics.com/issue/S0149-2918(16)X0012-4

Pharmacovigilance Update: Pharmacovigilance in the New Millemium
Pharmacovigilance in the New Millennium
Paul Beninger, MD, MBA
Public Health and Community Medicine, Tufts University School of Medicine, Boston, Massachusetts

Modern pharmacovigilance (PV) is very much a creature of the new millennium. Yes, we usually recognize the thalidomide tragedy as it unfolded in the 1950s as the pivotal event on both sides of the Atlantic that triggered the development of an international systematic approach to managing drug safety issues. (The reader is referred to an excellent detailed chronology of this subject up to and including the thalidomide tragedy by Myles Stephens, The Dawn of Drug Safety.1) This led to the World Health Organization-led consensus document International Drug Monitoring: The Role of National Centres.2 There was traction and “drug safety” took off, evolving over several decades as a discipline and as an organizational structure.

The larger trans-national infrastructure of PV, including its definitions and activities, was gradually shaped by the ground-breaking activities of CIOMS (The Council for International Organizations of Medical Sciences) and ICH (The International Conference on Harmonisation). These can be viewed as dyadic “content and process”—CIOMS creating much of the content through consensus, and ICH working through the various governmental jurisdictions to create the regulatory processes that implemented the content created by CIOMS.

Yet, to return to the New Millennium, to meet the needs of wholly new areas of PV, the full spectrum of the modern professional landscape has only taken shape since the beginning of this millennium: case management, signal management, and benefit risk management, each with two dimensions of medical and operational activities. In larger companies, these are distinct professional areas. They are complemented with experts in database management, periodic report preparation, and tracking activities that have all become their own specialties. In many, if not most, regions of the world, there is also the Qualified Person for Pharmacovigilance (QPPV), a role that evolved into its own discipline. Thus, departments in large companies now have hundreds of professionals employed in PV.

In recognition of the substantive evolution and growth in the field of PV, Clinical Therapeutics is presenting two Specialty Updates, this month and in April 2017, to highlight some of the advances and challenges in present-day PV. This month, we are publishing “Pharmacovigilance and Biomedical Informatics: A Model for Future Development,” which examines how the ad hoc interactions between these two disciplines have advanced PV processes over the past decade and also shows how a systematic approach can facilitate many new opportunities for potential advances in PV.3 The article “What Can Big Data Offer the Pharmacovigilance of Orphan Drugs?” emphasizes that new technologies cannot be applied carte blanche but require more subtle consideration. Finally, the article “The US FDA’s Risk Evaluation and Mitigation Strategy (REMS) Program – current status and future directions” shows that the introduction of new regulatory disciplines can benefit from mid-course correction as new information becomes available.4, 5 We hope you enjoy these articles.