FDA grants clearance to INRange System's Electronic Medication Management Assistant - EMMA

Altoona 21 June 2007The Food and Drug Administration (FDA) has granted clearance for INRange Systems Inc. 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.

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"Chronic disease management often means medication management, and proper medication management is an enormous problem facing the health care industry. With an impending shortage of both pharmacists and nurses, a product such as INRange's is essential to reduce the cost of health care treatment and may be the only solution to serving an aging population", stated 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 labour 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", stated 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.

When it is time for the patient to take their scheduled medications, EMMA 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 can be sent automatically to the patient. 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.

A recent report by the Institute of Medicine (IOM) estimates that there are 1,5 million preventable injuries annually caused by medication errors (The National Academies, July 20, 2006 - Medication Errors Injure 1,5 million People and Cost Billions of Dollars Annually. http://www8.nationalacademies.org/onpinews/newsitem.aspx?recordid=11623. The IOM estimates that every year, 218.000 people die because of prescription drug errors and adverse drug events (ADE)(Ernst, Frank R., Grizzle, Amy J.: "Drug-Related Morbidity and Mortality: Updating the Cost of Illness Model"; Journal of American Pharmaceutical Association 2001: 41(2)192-199). Fatalities aside, recent estimates place the total annual cost of "medication misadventures" at over $177 billion (See: Ernst, Frank R., Grizzle, Amy J.).

In response to increasing ADE's, many managed care organisations 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 7918 per day (US Census Bureau, CB06-FFSE.01-2, January 3, 2006, http://www.census.gov/Press-Release/www/releases/archives/facts_for_features_special_editions/006105.html). As a result of this enormous burden on the health care system, it is projected that by 2020, there will be a shortage of more than 1 million nurses (US Department of Health and Human Services, What is Behind HRSA's Projected Supply, Demand, and Shortage of Registered Nurses? http://bhpr.hrsa.gov/healthworkforce/reports/behindrnprojections/2.htm) and 150.000 pharmacists (Pharmacy Manpower Project, http://www.pharmacymanpower.com/).

Senior citizens are not the only patients requiring Medication Therapy Management (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 (House Committee on Veterans' Affairs Statement of Thomas Zampieri, Ph.D., Director of Government Relations, Blinded Veterans Association, Testimony Before the Subcommittee of Health the House Committee on Veterans' Affairs, March 15th 2007, http://veterans.house.gov/hearings/schedule110/mar07/03-15-07/3-15-07zampieri.shtml).

INRange received FDA De Novo clearance of its device on June 13, 2007. "We are proud to have received our FDA clearance. It is a real accomplishment for our company and for the dedicated employees that have put their heart and soul into the design and development of EMMA", stated Christopher E. Bossi, President of INRange Systems Inc. "Most of us have experienced the heartache associated with caring for a loved one and the confusion of organizing their medications. INRange will play a significant role in improving the health and independence of both patients and their families while reducing the cost of in-home medication management."

Founded in 2001, INRange Systems Inc. is located in Altoona, Pennsylvania. INRange currently plans to begin pilot programmes with a select number of organizations during 2007 and anticipates that the device will be available for commercial use in early 2008.

More information about the costs of medication management errors may be found at:

  1. The Journal of the American Medical Association Vol. 296 No. 15 October 18, 2006 - Abstract: National Surveillance of Emergency Department Visits for Outpatient Adverse Drug Events
  2. Seniors face risk of taking wrong pills, By Bruce Taylor Seeman, Newhouse News Service
  3. Beard, Keith. "Adverse Reactions as a Cause of Hospital Admissions in the Aged." Drug Aging. 2:356-61, 1992.
  4. Bootman, J. Lyle; Harrison, LTC Donald L., and Cox, Emily. "The Health Care Cost of Drug-Related Morbidity and Mortality in Nursing Facilities." Arch Intern Med. 157(18):2089-2096, 1997.
  5. National Academy of Sciences' Institute of Medicine, "To Err is Human; Building a Safer Health System", November, 1999. p. 28
  6. National Academy Press, Preventing Medical Errors, The Centers for Medicare and Medicaid Services sponsored this study by the Institute of Medicine (IOM) http://www.nap.edu/openbook.php?record_id=11623&page=1
  7. Gorman Health Group, White Paper by Rick Bowles, Special Needs Plans Practice Leader, "Medicare Chronic Condition Special Needs Plans: Background and Overview" http://www.gormanhealthgroup.com/download/SNP_Chronic_Conditions_White_Paper_October_2006.pdf


Leslie Versweyveld

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