Introduction

High profile drug withdrawals and negative public attention has placed drug safety at the top of the pharmaceutical industry's agenda. This report will examine pharmacovigilance technology solutions designed to alleviate the challenges in drug safety management faced by the pharmaceutical industry and the regulatory agencies.

Report Highlights
Highlights

Pharma companies must adapt to constantly changing government regulations to ensure compliance and eventual approval of their drug products, and response to these new rules is driving the adoption of pharmacovigilance solutions. It is essential for pharma companies to implement proactive pharmacovigilance strategies which encompass strong data management systems, signal detection technologies, and adverse event reporting systems to ensure production of a safe and effective drug that will be approved and will maintain a favorable risk-benefit ratio post-approval. The industry is still skeptical of the benefits provided by signal detection technologies. IT vendors must take an active role in educating companies about these technologies, and position signal detection as an essential tool for developing comprehensive risk management strategies which will not only benefit the company, but ultimately the public.
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Figure 1: Balance between risks and benefits for drugs to be approved 6
Figure 2: A typical pharmacovigilance system utilizing technology and strategy 8
Figure 3: Sources of risk from a drug, leading to an adverse drug reaction 9
Figure 4: Key drug safety-related events in FDA history 10
Figure 5: Stock price for Merck on NYSE for 2004, US$ 14
Figure 6: Stock price for GlaxoSmithKline on NYSE for 2007, US$ 15
Figure 7: Drug discovery and development process 16
Figure 8: Challenges facing the pharmaceutical industry 19
Figure 9: Adverse event reporting systems in North America and Europe 22
Figure 10: An example of a complete PV system 25
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