Thursday, July 05, 2007



FDA Week via NewsEdge Corporation :

Groups debated this week the usefulness of recently FDA-approved software that lets health care professionals use the Internet to see if patients are taking medications properly. A former member of an Institute of Medicine panel on reducing medication errors does not think the system is the best way to reduce drug identification and dosing errors. But another group that collaborated with IOM on its study gives the Electronic Medication Management Assistant (EMMA) a more favorable review.

EMMA lets health care professionals monitor patient regimens online. A pharmacist, doctor or nurse enters the medication schedule into a Web-based application; EMMA downloads the regimen.

The system also gives the programmer a history of each time a patient accesses their medicines.

EMMA holds up to 10 prescriptions, which are bar-coded and individually labeled, says Mark Drummey, the executive vice president of the device manufacturer INRange Systems in Pennsylvania. Patients receive the prescriptions through mail-order and load them into the bread box-sized device.

EMMA's screen will flash and beep at the time a prescription should be taken. Patients touch the screen and the prescription is dispensed.

IOM said Web-based medication boxes could be a tool for patient populations that have compliance issues, such as the elderly, but did not look at the devices as the ultimate safeguard against medication errors, says former committee member Wilson Pace.

Pace also worries the box could contribute to the erosion of the relationship between home-health care providers and patients. The box may only be available to only few patients because of its cost. Doctors may not want the extra work. And insurance companies may become less likely to reimburse home-health care visits if EMMA becomes available in many homes.

The 2006 report by IOM "Preventing Medication Errors" estimated the average hospital patient is subject to at least one medication error per day. The report urged FDA to meet with other stakeholders to minimize errors and develop guidance documents on drug naming and another for labeling and packaging.

FDA has since addressed naming and labeling and packaging concerns.

The report followed a 1999 IOM study that reported 7,000 deaths occur yearly due to medication errors.

Judy Smetzer, vice president at the Institute of Safe Medicine Practices, which collaborated with IOM on their 2006 report, says EMMA could help practitioners link adverse events in patient to medication non-compliance at home. But she also worries patients could load blister packs incorrectly and she is unsure how the system would work if a patient's regimen is unexpectedly interrupted.

"We need to have more information to see how it's going to work," she says. "Any time you introduce new technology there is a new source of error you may not suspect ahead of time."

But a public health group says the device seems to be a good way to track patient prescription compliance.

Georges Benjamin, executive director of the American Public Health Association, says EMMA would be useful in households where multiple people are taking multiple medications or for medical practices that have older patients taking numerous medications.

Drummey says the product will be available next year. Right now the company is in pilot trials with the Veterans Administration and the Department of Defense. The pilot uses EMMA with patients who have severe brain injuries and take several medications. The company is working with insurance companies on coverage.


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John Mack said...

Couple of problems:

(1) It's not really an online tool -- it's a device that is monitored via the Internet. It's really bigger than a bread box!

(2) It costs $200 per month!

(3) Tt's subject in to the GIGO problem.

To see what I mean, see my post "Can an In-home Electronic Pillbox Solve Our Medication Error Problem?"