| Increased regulations and worried consumers are just two of the factors driving trends in drug safety and risk management today. Examining the present situation, Deborah Gold at WCI Consulting Ltd predicts a new, pro-active pharmacovigilance environment for the future
Heads of pharmacovigilance (PV) are currently undergoing something of a rite of passage. In the youth of their careers the focus for their drug safety (DS) teams was compliance with operational regulations. And it worked. Most drug safety teams now have both their compliance and their basic operational processes well under control. However, times and regulations are changing. The focus of the regulators has expanded: DS teams have to prove they have a structured approach to mitigating risk in place. If not, the regulators are ready to enforce the penalties strongly. Worried consumers, alarmed by media reports of big pharma’s rumoured preference for profits over patient safety, are adding to the call for the industry to take a wider and more proactive approach to PV. The spotlight on safety is brighter than ever: and PV heads are now required to take a more holistic view going forward; it is time to find and develop opportunities for building safety into the wider drug development process.
In a way it’s good timing. With the operational side well controlled, the maturing PV teams are ready to move their attentions from the operational to the analytical. Since most companies are also resource constrained, they must accomplish increased focus on the expanded drug safety activities without a corresponding increase in total resources. These factors are driving five trends in drug safety and risk management, which are both structural and organisational.
TREND 1: GETTING PV INVOLVEMENT EARLIER IN THE PRODUCT LIFE CYCLE
PV groups are increasingly responsible for safety activities within clinical teams, in early- and late-phase development of drugs and, as discussed, there is a focus on getting safety risk management activities initiated earlier in the product life cycle. This shift is driven, in part, by impending regulatory changes that will mandate that benefit-risk management must begin in early phase development. It is also consistent, however, with companies’ migration toward proactive PV, as it affords a more complete view of a product’s safety profile throughout its lifecycle.
These issues introduce and reinforce the challenge to appropriately ‘skill up’ PV resources so that they can establish and maintain their credibility within the clinical sector. DS needs staff who have a deep knowledge of early phase processes and tools can make convincing risk management decisions and can use aggregate data and mining techniques that enable proactive PV. |
