Computerized EMMA can manage patients' pills

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.

How it works

EMMA is programmable, about the size of the proverbial breadbox and plugs into any household outlet. It resembles a small combination television/DVD player. Blister cards with patients' medications are inserted in a slot the same way a CD goes into a car stereo, said Christopher Bossi, president of INRange Systems, the Altoona, Pa.-based manufacturer of EMMA.

Pills, capsules and small injectables all can be loaded into the machine by patients or their caregivers.

Two-way communication software built into the machine allows a health care professional to manage patients' drugs remotely, including changing doses. Patients are alerted to the need to take medicines by vibrations and beeps from a wrist bracelet. EMMA's screen also flashes, and, when the patient touches it, medication is dispensed. Physicians can monitor this process to ensure patient adherence.

The bracelet also contains a special code that allows another physician, for example, in an emergency department, to determine, via a secure Internet site, which medications a patient has been prescribed. "This is a true medication record," Dr. Papp said.

Dr. Papp began developing the system to provide a more efficient and accurate way to change her patients' warfarin doses. She soon realized that the concept was applicable well beyond this medicine.

"Our pharmacists and nurses were constantly filling patients' pill boxes," she said."It occurred to me that the usual way of dispensing pills in amber bottles was useless. Pills were being dispensed in those bottles with instructions that were never meant to be followed. What does the instruction 'take warfarin once a day for the next 30 days' mean for a person who is going to have the dose adjusted once or twice a week?"

She noted that hospitals employ a variety of automated and sophisticated methods for assisting nurses in administering medications, and still there is a sizeable delivery error rate. "Why then do we discharge an 80-year-old to go home and do it themselves? To me, this was a mismatch."

But questions revolved around making the machine small and convenient enough to use in patients' homes, she said.

Prototype units are costly -- $4,000 each. But the price is expected to drop, perhaps to about $800 when they arrive on the market next year.

Orders already are in from the military, which ordered thousands of the machines to help brain-injured veterans manage medications at home.