Pharmacovigilance is evolving faster than ever before. What are the implications?

Increasing pressure is being placed on pharmacovigilance across the globe. While it is known for its rapid pace of advancement in best practice and technology, more is now being demanded in terms of the scope of traditional roles for employed staff and contractors.

In a modern pharmaceutical industry where specialisms are dynamic and roles fluidly change, PV professionals are under increasing expectation to provide solutions in terms of leadership, strategy and more in addition to their core duties. The steady rise in globalisation and a market that is increasingly competitive have led to a widening of the role of PV within the pharmaceutical industry, leaving professionals concerned at their ability to meet an increased set of requirements for many key roles and positions. In this blog we look at three areas the impact is being felt.

1) Beyond regulatory compliance

Traditionally the mainstay of a pharmacovigilance professional’s role, the pharmaceutical industry is reacting to increased commercial pressure by expecting more than just this area of work. With the rate of inspections worldwide on the rise there is a need for greater quality control in areas of drug production as well as in ways of working.

A greater emphasis on leadership and strategic skills has become the norm for senior roles within pharmacovigilance. As the scope of the role becomes larger, the value it provides to the business in question will become higher. With greater requests placed on PV departments and professionals in terms of risk minimisation, safety and predictions of cost, what was already a demanding skillset has already seen further widening to meet the requests for comprehensive answers by clients and industry.

2) Quality control

Recent pressure from the FDA on the matter of drug quality is an example of a greater expectation. With the Indian market increasingly disrupting the global pharmaceutical industry with severe reductions in drug prices and the provision of altered and rebranded products, the need for stringent quality was aptly demonstrated when Matthew Thomas, the FDA’s director within India, gave voice to concerns over quality control at a recent Indian Pharmaceutical Alliance meeting in Mumbai.

Thomas described his recent obtaining of drug samples which were tested with a rapid test tool. With samples including simple paracetamol, alarming results were found with key medical ingredients being entirely absent in test results in some cases. With further lab tests scheduled to better understand the scope of the issue, the message from the director to drug companies in India and worldwide is clear: “…they need to take the onus of developing quality products, and investigate and follow up on complaints”.

3) Automation

The global trend towards greater automation within the industry is a further contributing factor to the widening of scope. With large databases and bespoke analytics tools becoming critical to managing and accessing critical information on drug safety, more is required in the understanding and proactive maintenance in this area. This is of critical importance to modern medicines which innovate in their respective areas.

With reducing costs and improving efficiency a further driver behind the transition to automated pharmacovigilance, the role of professionals in the collating of patient data and appropriate input into software is a field of work that is still emerging within the industry.

This added pressure to accurately manage databases and consistently input sensitive and unique data into a widening range of software will require ever more from staff and contractors, adding further burden and expecting more in performance and accuracy.