Pharmacovigilance - Risk Management in Practice

At present ADRs are the sixth largest cause of death in the US. Drug safety is a huge issue facing the industry today and the risk is high with the possible loss of a key revenue producing drug coupled with potentially damaging litigation. The financial risk facing Merck on the withdrawal of Vioxx was considerably beyond the loss of its $2.5 bn yearly revenues.

On the announcement of the withdrawal of Vioxx from the market, Merck immediately lost 27% of its market capitalisation – $27bn was lost in share value in one day. The exposed health risk was devastating with over 80 million prescriptions written in the five years that Vioxx was on the market. FDA analysts estimated that Vioxx caused between 88,000 and 139,000 heart attacks. The situation with Vioxx has been the catalyst for increased attention to drug safety and the reassessment of risk management within the pharmaceutical industry.

It was pharmacovigilance that made the risks associated with Vioxx apparent. However, were the checks adequate? Could the risks have been detected earlier? And what is being done to improve the risk-benefit assessment for a drug?

A large part of pharmacovigilance is the detection and appropriate assessment of safety signals. New technologies are enabling more accurate assessment of signal detection, and better analysis of large sets of data in a database. The early identification of a health safety signal is an important aspect of pharmacovigilance. A more accurate risk-benefit assessment can be made if there is a significant quantity of good quality safety data.

Although the FDA appears to favour policies that suggest it is increasingly risk averse, both it and the EMEA are faced with the apparently opposing challenge of encouraging the pharmaceutical industry to produce more drugs. Incentives for innovative drugs that increase the medical options and improve healthcare are being developed. An important aspect of the role of the regulatory authorities will be the accurate and effective communication of safety related information.

Pivotal period of change…

The pharmaceutical market is entering a pivotal period of change that could well see altered working patterns with a greater emphasis on pharmacovigilance. The impact of the Vioxx case has been significant. This visiongain report contains 147 pages of high level research and analysis. The Vioxx case is examined and the consequent changes in both the FDA and EMEA’s pharmacovigilance requirements assessed. Strategies for optimising pharmacovigilance activities are considered as the focus on drug safety increases.

Why you should buy this report

> The risks associated with a drug withdrawal are too large to ignore.

> Pharmacovigilance inspections are a challenge but a vital part of drug development

> Various anticipated changes in aspects of pharmacovigilance are examined in detail to enable accurate assessment of each.

> The key differences of the US and European systems are outlined.

> The potential for the improved paediatric incentives to encourage paediatric drug development in Europe is discussed.

> How the anticipated changes will impact pharmacovigilance budgets is assessed.

Lead Analyst: Tristan Heath Publication Date: 17/07/06 Pages: 159

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