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New FDA Commissioner, New Push for Safety?

March 20, 2009 – 4:30 pm

I just sent the following inquiry to the White House:

“I am editor of Pharmaceutical & Medical Packaging News and have been following President’s Obama’s interest in curbing medical errors. With the appointment of Dr. Margaret Hamburg as FDA Commissioner and given her past election to the Institute of Medicine, will the new leadership mandate some of the IOM’s advice, such as use of unit-dose packages, which can reduce calculation, measurement, preparation, and handling errors and provide a fully labeled package that stays with the medication up to its point of use? Will bar codes or other automatic identification technologies be mandated to reduce identification errors? Will bedside drug identification be required to ensure right drug, right patient, right route, right time, and right caregiver? What roles can packaging and labeling technologies play in preventing medical errors and disease?”

Could FDA, under her leadership, call for radical changes in packaging? FDA right now is looking at mistakes associated with naming, and we applaud those efforts.

For instance, best practices for labeling and packaging are underway as part of the Prescription Drug User Fee Act (PDUFA) IV, Drug Safety Five-Year Plan.  According to an FDA spokesperson, a draft guidance on “good naming, labeling, and packaging of drugs and biologics to reduce medication errors is planned to be published by the end of fiscal year 2010. This draft guidance will provide industry with best practices on how to label, package, and name products to minimize the likelihood of medication errors based on lessons learned from post-marketing experience. When finalized, this draft guidance is intended to promote the prevention of medication errors by facilitating an understanding of the factors that lead to medication errors and by applying past lessons learned to the development of their products.”

The FDA spokesperson explains that the best practices will be put to the test in a pilot program later this year. Participating drug firms will be able to evaluate proposed proprietary names and to submit the data generated from those evaluations to FDA for review. Based on an industry-reviewed concept paper, the pilot will be looking at naming issues. Enrollment in the pilot program is expected to begin by the end of fiscal year 2009; the pilot will run for two years.

Dr. Hamburg’s resume suggests that prevention is one of her priorities, so she will fit right in. Not only did she serve as the assistant secretary for planning and evaluation, U.S. Department of Health and Human Services, but as health commissioner of New York City she worked to halt the spread of tuberculosis.

A lot can be prevented by better packaging and labeling. In addition to addressing errors caused by name similarities and placement, though, we hope that Dr. Hamburg will consider those errors caused by a lack of packaging, for instance. When drugs require repackaging in hospital pharmacies, for instance, the chances for handling and administration errors have been shown to increase.

I also sent my question to FDA, but it is too soon for comment, I am told. I will keep you posted!

Daphne Allen

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