Pharmaceutical Technologist - May 2008 - (Page 14)

Pharma’s need for integrated safety In the future, the pharmaceutical industry is likely to move closer to the healthcare industry, which could aid the search for, and development of, new targeted therapies, as well as improve postmarketing drug safety surveillance. Dinesh Kasthuril Partha Chakraborty Rick Kite from Cognizant. atient safety has been at the forefront of the minds of patients, regulators and pharmaceutical companies during recent years. Several high-profile drug withdrawals have led to increased scrutiny and to regulatory authorities raising the bar in safety standards. The number of adverse drug reactions (ADRs) has also increased, resulting in a need for better systems to effectively process large volumes of data. Pharmaceutical companies are increasingly turning to external sources of information to make better and more informed decisions regarding the safety of their drugs. In this context, they are looking at patient health information to aid both the development of new targeted therapies and to improve postmarketing drug safety surveillance. These efforts could detect safety signals earlier in the product life cycle, which seems to be the future direction for drug safety. According to the US President’s Information Technology Advisory Committee: “The same EHR P systems critical for improving patient care can also help accelerate clinical research and its impact on practice, and improve pharmaceutical safety (pharmacovigilance) and biosurveillance for public health a dual use of EHR systems that could reduce total system costs.” Proactive pharmacovigilance can be greatly facilitated through access to an integrated safety infrastructure that combines biomarker data, clinical trial data, postmarketing safety data and EMRs. Presently, safety scientists and epidemiologists have limited access to the individual data sources, and it is rarely in an integrated manner. The reporting, processing and analysis of ADRs by physicians occurs on the basis of skeletal information about the patient, symptom and the drug. In some cases, pharmaceutical companies attempt to retrieve the patient’s heath history, which then involves the time-consuming process of contacting the patient’s physician, accessing their medical history and then 14 MAY 2008 PHARMACEUTICAL TECHNOLOGIST Stockbyte/Getty Images

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Pharmaceutical Technologist - May 2008 Contents Industry Highlights Morpheus Market Watch Pharma’s Need for Integrated Safety Is Pharma’s Future Mobile? Facing the CRO Behemoths Q&A

Pharmaceutical Technologist - May 2008

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