Safety On A Budget: Four Strategies For Cost-Effective Pharmacovigilance

By Elizabeth E. Garrard, PharmD, RPh

Amid the pharma industry's concerns surrounding the urgent and increasingly complex issue of drug safety under difficult economic conditions, the most prominent topic of discussion is the question of outsourcing. Does outsourcing make sense for our company? How do we choose the right outsourcing partner? Can we be certain that outsourcing will not compromise our drug safety standards and leave us exposed to greater risks in the name of cutting costs?

Certainly, the trend in drug safety is to selectively outsource to qualified resources. But outsourcing is not the only possible measure you can take to maintain safety as a top priority while still controlling costs. Following is a list of four areas of focus in which pharma companies large and small can take steps to make every dollar count. Some of these topics may seem elementary, but all are worthy of closer scrutiny and can contribute to an overall strategy for wisely allocating limited resources under escalating regulatory pressure to detect risks.

Drug safety ideally begins with an assertive safety plan that focuses not only on efficacy but also on safety data and risk-benefit information from early stage trials. Historically, product development and clinical trial methodologies were mainly concerned with efficacy – we all want our medicine to solve the problem for which it was designed. But in a tightening regulatory environment, putting safety on a backburner until later stage trials can cost millions of dollars and waste precious time in resubmissions required to satisfy safety issues.