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New FDA patient safety scheme

The US FDA and the Centres for Medicare & Medicaid Services (CMS) have revealed plans for a new electronic reporting system to track the performance and adverse effects of medicinal products.

The US Food and Drug Administration (FDA) and the Centres for Medicare & Medicaid Services (CMS) have revealed plans for a new electronic reporting system to track the performance and adverse effects of medicinal products.

A white paper published by the two agencies outlines their vision for the Sentinel System, an electronic nation wide programme allowing them to monitor drugs negative side effects and their impact on the market. It will combine existing claims and medical record databases maintained by the government and private sector companies.

Plans for the centralised reporting system are part of President George Bush's aims to give most Americans access to electronic health records by 2014.

"The era of 'wait and see' is going to become the era of ëtell me right now'," said FDA commissioner, Dr Andrew Eschenbach. "With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people."

The original recommendation of the Sentinel System came from the Institute of Medicine in a report published in 2006 which detailed ways for the US to improve drug safety. The FDA and CMS white paper, A National Strategy for Monitoring Medical Product Safety, calls for publicñprivate collaboration for implementation of the information network.

Department of Health and Human Services secretary, Mike Leavitt, explained that Sentinel will utilise information held on the Medicare database, currently protected by commercial and beneficiary laws. It will give academic and government researchers access to data crucial in the effort to raise the level of drug safety and the quality of healthcare services in the US.

"We are moving from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market," said Leavitt. "This initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market."

23rd May 2008

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