Managing Drug-Risk Information — What to Do with All Those New Numbers  

Oleh:

Avorn, Jerry ; Schneeweiss, Sebastian

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: The New England Journal of Medicine (keterangan: ada di Proquest) vol. 361 no. 07 (Aug. 2009), page 647-648.
Topik: Drug risk

Ketersediaan

Perpustakaan FK Nomor Panggil: N08.K.2009.04 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

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Isi artikel

In the late 1970s, many pharmacies and governmental and private insurers began electronically recording patient-specific data from filled prescriptions, as physicians, hospitals, and insurers began capturing computerized information on diagnoses, admissions, office visits, and procedures. By the mid-1980s, researchers began trying to use these data to relate drug exposures to adverse events. Since then, the volume, clinical detail, and accuracy of such information have increased dramatically, as has the sophistication of methods for discerning patterns of causality in these collections of data. Despite the increasing availability of information on medication use and clinical outcomes in tens of millions of patients, the Food and Drug Administration (FDA) has relied primarily on analysis of individual case reports submitted by health care professionals or pharmaceutical manufacturers to assess side effects of approved drugs. Critics, including the Institute of Medicine and the Government Accountability Office, argued that this method was inadequate for systematic postmarketing safety surveillance, and in 2007 Congress passed a law instructing the FDA to develop a system to make use of the terabytes of data on drug exposure and clinical events that the health care system generates. Nearly 2 years later, the FDA requested proposals to build such a "Sentinel" system, to be restricted to private-sector U.S. health insurers and funded at a level somewhere between $7 million and $120 million over 5 years.

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