With the Institute of Medicine (Washington) reporting that errors in medication harm at least 1.5 million and result in the deaths of 218,000 annually, INRange Systems (Altoona, Pennsylvania) believes it is on an important path to assist in reducing that number.
Most of these medication errors are tracked in hospitals, of course, and there is no telling how many more of such errors occur in the home. And they are certainly substantial, given the numbers of elderly, the depressed, those with complicated drug regimens – and the general absence of a caregiver in the home to oversee drug dispensing.
Hoping to have a huge impact on reducing in-home medication errors, INRange has just won FDA clearance of its EMMA system (for Electronic Medication Management Assistant), aimed at reducing potential drug identification and dosing mishaps.
EMMA — dubbed by INRange as "the electronic medication nurse" — is a computerized medication box designed to be used under the supervision of a licensed healthcare provider. The device stores prescription medications and emits an audible alert to the patient when the prescribed medications are scheduled to be taken and releases them onto a delivery tray when activated by the patient at the appropriate time.
Importantly, "It's very easy to use," Chris Bossi, president of INRange, told Medical Device Daily. "To get FDA approval we had to do a usability test [for ages 25 and up]."
EMMA was named by an INRange electrical engineer as the result of a company-wide contest, with the name meaning "universal" in Latin, "mother" in Hebrew.
"My goal was to create an electronic nurse who would sort the patients medications, reorganize them when they change and deliver them to the patient," said Mary Anne Pap, MD, a co-founder and inventor of the system, in a company statement. "EMMA is that electronic nurse. She is stationed in the home 24 hours a day, seven days a week. She works nights, weekends, holidays and takes no vacations."
Cube-shaped, approximately bread-box size and plugging into a standard outlet, the device can hold up to a month's supply of 10 prescriptions per unit. If need be, multiple units can be connected together to increase the number of managed prescriptions.
The system is wirelessly linked to software that allows pharmacists to remotely schedule, monitor compliance and make real-time adjustments to the dose or timing of medications from their office.
Patients are alerted through an audio and visual signal when it's time to take the medication. A touch on the screen of EMMA, dispenses the correct prescription medications into a tray. The medications are loaded into the system much like – and just as simply as — a CD is loaded into a car stereo.
The device requires about two hours worth of training for the pharmacist.
Based on the programmed medication scheduled 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. An electronic medication administration record ensures that multiple caregivers can be alerted to a change in medication.
The company is also touting the effectiveness of the device in particular in its ability to manage disease states that require multiple medications, and therefore could result in wrong medications administrations and dosages. These states include cardiac care, mental health, diabetes, oncology, organ transplants, HIV and AIDS.
"We're gearing EMMA toward those patients who have chronic illness — with complex drug regimens," Bossi told MDD.
INRange was founded in 2001 and has received several grants since its inception, including two seed-stage financings from the Life Science Greenhouse (Philadelphia) in 2006: $250,000 (MDD, Feb. 10, 2006) and then $500,000 (MDD, Sept. 25, 2006).
While EMMA suggests broad potential as the first of a variety of home-based systems for home management and oversight of healthcare delivery, Bossi said that the company is entirely focused on EMMA.
"Right now this is our principle project," he said. "This is the product we want to launch our company with."
"Chronic disease management often means medication management, and proper medication management is an enormous problem facing the healthcare industry," said Thomas Thielke, a pharmacist and VP of professional and support services at the University of Wisconsin Hospital and Clinics (Madison). "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."
Now that EMMA has received FDA clearance, INRange plans to begin pilot programs to demonstrate its effectiveness and is looking for the device to be available for commercialization in early 2008.
Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, in a statement announcing the clearance, said the system "puts an important safety tool directly in the hands of patients and their healthcare providers. It will help take away some of the confusion patients can experience when taking prescription medications and allow care providers to more closely monitor their patients' medications between office vests."
The agency said it reviewed safety; and effectiveness information for EMMA under the de novo classification process. The ability to petition for de novo initial classification was added under the FDA Modernization Act of 1997 to establish an additional way for novel, but less risky, devices to get to market.