Ticking time bomb: Poorly managed product safety

Greg Meline
Chris Albani

DOI:https://doi.org/10.5912/jcb178

Abstract:

A key paradigm of the pharmaceutical industry has changed. With increased attention towards ensuring the safety of drugs and medical devices, the ability of firms to conduct risk management based on high-quality pharmacovigilance (PV) – starting early on in clinical development – is becoming increasingly important to the successful marketing of pharmaceutical products. Indeed, the repercussions of recent litigation regarding the Cox-II class of compounds are just an example of how safety management will continue to impact the marketability of both existing and future drugs and medical devices. Firms without satisfactory safety data handling and reporting operations in place are now vulnerable to significant business risks with potential long-term drug safety issues. While this has often been considered a necessity, a small proportion of companies have actively pursued excellence in this area. Companies are taking different approaches to address the increasing demands in this area – from focusing on efficiency to driving higher levels of rigorousness in their PV practices. PRTM various has identified a number of key practices common among firms demonstrating excellence within PV. Results of a pioneering study of 23 top Western and Japanese pharmaceutical companies confirm that, overall, the industry has yet to achieve both a high-level of quality and productivity in firms' PV operations. As the burden for conducting efficient, effective PV becomes increasingly difficult, senior management will seek targeted improvement strategies in order to balance a high level of efficiency with a high level of rigorousness among their safety data handling practices. With this in mind, this article seeks to demonstrate how a company can most effectively comply with ever-changing requirements, strategically improve the thoroughness of the practices within their PV operations and achieve greater efficiency. In addressing these challenges, top management will be focusing a greater amount of attention on one more thing – pharmacovigilance.

Keywords:product safety ,pharmacovigilance ,adverse events ,risk management ,drug safety ,surveillance ,en ,