Emerging Issues

The expanded use of health information technology is an important focus for improving medical product safety. HHS is coordinating across the Federal executive branch the development of a nationwide interoperable national health information technology infrastructure that would include electronic medical records, digital prescribing programs, and electronic decision-support programs.¹⁴ The system is intended to improve health care quality and patient safety by the following:

• Reducing medical errors.
• Improving communication to better inform and empower consumers.
• Enhancing the capacity of postmarket surveillance to expeditiously detect previously unknown problems with medical products.

Within the realm of blood transfusions, FDA has established protective measures to reduce the risk of transfusion-transmitted infections. However, these measures also have the effect of reducing the number of eligible donors. FDA's Blood Product Advisory Committee assesses the possible impact on the blood supply of all new interventions implemented in response to emerging blood safety threats. A number of emerging risks have recently resulted in actions that may affect blood donations. These actions include measures to reduce the risks of infection with the bloodborne variant of Creutzfeldt-Jakob disease (vCJD), the human form of "Mad Cow Disease"; severe acute respiratory syndrome (SARS); and West Nile virus. In particular, FDA's recommendation to defer potential donors because of specific dietary practices related to vCJD risk has resulted in an estimated 7 percent loss of otherwise eligible donors since 1999.¹⁸

However, FDA also regularly reviews new scientific information that would support reentering donors who had previously been deferred because of a potential infectious disease risk. As a result, persons who tested falsely positive and have shown no signs or symptoms of infection with HIV or hepatitis C have been readmitted into the pool of approved donors.

In summary, although progress has been made toward implementing linked, automated information systems, continuing efforts are necessary to reach the targets of the objectives and subobjectives in the Medical Product Safety focus area. The analyses of the data concerning patients' receipt of useful written information from pharmacies must be completed so that a single baseline measure is available to assess progress. Continued and expanded collaborative efforts to encourage blood donation and expanded patient counseling about prescription medicines are needed.

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