Computerized EMMA can manage patients' pills

High error rates in dispensing and taking prescription medications prompted efforts to automate the process.

By Susan J. Landers, AMNews staff. July 23/30, 2007.

Washington -- Mary Anne Papp, DO, director of the heart failure program at the Medical College of Wisconsin in Milwaukee, was frustrated by the hours she and her staff spent calling elderly patients who had new medication instructions they could barely comprehend and carry out correctly. So she resolved to do something about it.

Flash forward nearly seven years. Dr. Papp's idea for an automated pill dispenser has taken shape as EMMA -- the Electronic Medication Management Assistant device. It was cleared by the Food and Drug Administration June 21 for marketing.

This computerized medication box stores, adjusts dosages and dispenses prescription drugs in patients' homes, under the supervision of physicians and pharmacists. EMMA is intended to be particularly helpful to aging patients, those with severe brain injuries and those with complicated medication regimens, such as patients with HIV and tuberculosis.

Its approval was the first ever to be granted under a de novo classification added to the 1997 FDA Modernization Act as a way for the agency to approve novel, but less-risky devices. The machine likely will be available for purchase next year.

The approval places an "important safety tool directly in the hands of patients and their health care providers," said Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health.

Drug safety assumed greater importance in all health care sectors after a 2006 Institute of Medicine report estimating that at least 1.5 million people in the U.S. are harmed each year by medication errors.