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FDA Grants Clearance to INRange System’s Electronic Medication Management Assistant


Posted June 25, 2007

INRange Systems, Inc. recently announced that the Food and Drug Administration (FDA) (h has granted clearance for the Company to market and sell its Electronic Medication Management Assistant device, known as EMMA.

EMMA is the first and only medical device commercially available for in-home medication management that can select, and deliver individual doses of medicine much like an ATM selects and delivers dollar bills. Unlike automated pill boxes, reminder systems, and other similar devices, EMMA is web-enabled pharmacy, giving pharmacists, nurses, doctors, or other licensed practitioners the ability to schedule medications and alter individual doses with the click of a mouse.

“Chronic disease management often means medication management, and proper medication management is an enormous problem facing the healthcare industry. With an impending shortage of both pharmacists and nurses, a product such as INRange’s is essential to reduce the cost of healthcare treatment and may be the only solution to serving an aging population,” says Thomas Thielke, MS, FASHP, R.Ph., a Pharmacist and Vice President, Professional and Support Services at the University of Wisconsin Hospital and Clinics.

EMMA is a patient-friendly device that resides in the home, holding a month’s supply of up to ten prescriptions per EMMA unit. Multiple EMMA units may be connected together to increase the number of managed prescriptions. EMMA is wirelessly linked to software that allows the pharmacist to remotely schedule, monitor compliance, and make real-time adjustments in the dose, or the timing of medications from their office. EMMA is expected to reduce the cost of in-home medication management and the number of preventable injuries caused each year by medication errors and patient non-compliance. Furthermore, EMMA eliminates the labor intensive and inherently inaccurate practice of manually filling and reorganizing pill boxes.

“My goal was to create an electronic nurse who would sort the patient’s medications, reorganize them when they change, and deliver them to the patient,” says Dr. Mary Anne Papp, a cardiologist, cofounder and inventor of INRange’s innovative new system. “EMMA is that electronic nurse. She is stationed in the home 24 hours a day, 7 days a week. She works nights, weekends, holidays and takes no vacations. Now home nurses can concentrate on what they do best; caring for the patients, while EMMA manages the medications.” Dr. Papp is currently Director of the Heart Failure Clinic at Froedtert Hospital in Milwaukee, Wisconsin and an Associate Professor of Medicine at the Medical College of Wisconsin.

INRange System’s Electronic Medication Management Assistant

How Does EMMA Work?
When it is time for the patient to take their scheduled medications, EMMA (pictured right) automatically provides both a visual and audible alert. A simple touch of the screen dispenses the correct prescription medications into the built-in tray.

Prescriptions and refills, packaged in standard sized blister cards (pictured left) can be sent automatically to the patient.

INRange System’s Electronic Medication Management Assistant

These blister cards are loaded into EMMA much like a CD is loaded into a car or home stereo. EMMA identifies each medication by its barcode and no input is required by the patient. No inhome visit is required. Based upon the programmed schedule entered at the pharmacy or clinic, EMMA removes the required number of individual doses out of the blister card and drops them onto the tray. A single electronic Medication Administration Record (eMAR) ensures that multiple caregivers can be alerted to change a dose or medication.

The Urgent Need for In-Home Medication Therapy Management (MTM) A recent report by the Institute of Medicine (IOM) estimates that there are 1.5 million preventable injuries annually caused by medication errors. The IOM estimates that every year, 218,000 people die because of prescription drug errors and adverse drug events (ADE). Fatalities aside, recent estimates place the total annual cost of “medication misadventures” at over $177 billion. In response to increasing ADE’s, many managed care organizations send home nurses into the patient’s home to manually fill and reorganize pill boxes. As the population continues to age, this practice will become unsustainable. Currently, there are more than 35 million Americans that are over the age of 65.

Another 78 million baby boomers are entering their 60’s at a rate of 7,918 per day. As a result of this enormous burden on the healthcare system, it is projected that by 2020, there will be a shortage of more than 1 million nurses and 150,000 pharmacists.

Senior citizens are not the only patients requiring MTM. Patients with Traumatic Brain Injury (TBI) and Post Traumatic Stress Syndrome (PTSD) can benefit from EMMA in the treatment of these severe brain injuries. Current estimates reveal that at least 5.3 million Americans require long-term or lifelong assistance in performing activities of daily living as a result of TBI.


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