Late Additions

ASCP, Other Groups Urge Selection of Juhl to Head FDA

In an unusual display of solidarity, ASCP and the nation's other major pharmacy organizations have joined together to urge the appointment of University of Pittsburgh School of Pharmacy Dean Randy Juhl, PharmD, as commissioner of the U.S. Food and Drug Administration. Former FDA chief David Kessler resigned last month to take over as dean of Yale University School of Medicine. Michael Friedman, MD, is currently serving as interim commissioner.

In a letter sent last month to Secretary of Health and Human Services Donna Shalala, ASCP and the other groups called on the secretary to advise President Clinton to nominate Juhl for the top FDA post.

The letter cites Juhl's strong leadership during previous service as chair of FDA's Nonprescription Drugs Advisory Committee, as well as his extensive background in pharmaceutical research and his instrumental role in creating a variety of innovative programs at the University of Pittsburgh.

"Dr. Juhl is an effective and visionary manager who will provide the necessary leadership to bring the FDA into the 21st century," the letter stated.

Bill Would Create Data Bank on Medication-Related Deaths

Legislation introduced in Congress last month calls for a new national data bank on medication-related deaths, with stiff penalties imposed for failure to report such deaths to federal authorities.

The "Safe Medications Act of 1997," introduced by Rep. William Coyne (D-Pa.), would require that any death resulting from medication "prescribing, dispensing, or administration" be reported to the Department of Health and Human Services within 10 working days of discovery.

In addition, the legislation (H.R.524) calls for HHS Secretary Donna Shalala to oversee creation of a national data bank of all death reports. HHS would monitor the compiled information with an eye toward mandating product labeling changes or disseminating revised safety and usage standards to pharmacists, physicians, and other health care professionals.

A variety of detailed information would be required on all death reports, including the name and address of the person filing the report; the name and address of the facility where the drug was prescribed, dispensed, or administered; the name, dosage form, lot number, and type of container of the drug involved; and patient information such as age, sex, and the diagnosis for which the drug was prescribed.

Those submitting reports would also be asked to indicate when and how the error was discovered, and describe the type of error that led to the death-for example, oral miscommunication, misinterpretation or misreading of a written prescription, product misidentification, or confusion resulting from the drug name or product packaging.

Penalties for individuals or entities failing to submit reports would be severe: a $15,000 fine and/or mandatory exclusion from Medicare and Medicaid participation.

Representative Coyne's bill echoes many provisions of similar legislation proposed in 1994 that failed to garner broad support.