Possibility of FDA regulation of health information technology looms large: pharmacies and their vendors worry about quality.

The push for hospitals to implement health information technology (HIT) systems, driven in part by Medicare and Medicaid incentives (and penalties), has affected pharmacy systems. It will continue to do so, as the defi nition of “meaningful use” is expanded to incorporate more required tasks related to medications. Everyone who works in a hospital pharmacy will be affected by how the federal government regulates these new technologies, including both hardware and software. Retail pharmacies, even though they are not being pressured by incentives, are also concerned about how new regulations would affect mobile medical devices (e.g., glucose monitors for diabetes management and home-based monitors for hypertension), medication management, and medication reconciliation at transitions of care. Organizations such as the Pharmacy e-Health Information Technology (e-HIT) Collaborative are communicating with a work group within the Department of Health and Human Services (DHHS) Offi ce of the National Coordinator for Health Information Technology (ONC), which will soon be making recommendations to Congress concerning HIT; the FDA will be paying close attention too. Surescripts is also concerned about the failure of some pharmacy system vendors to oversee the quality of their products. The company provides the electronic prescribing (e-prescribing) backbone that software vendors “plug into.” Those vendors sell “plugged-in” e-prescribing systems directly to end-user pharmacies. David Yakimischak, Executive Vice President and General Manager of e-prescribing at Surescripts, says that the company has worked hard to encourage its vendors to adopt quality programs in an effort to reduce pharmacy errors. He explains: