“Since 2000, the US Food and Drug Administration (FDA) has received more than 95,000 reports of medication errors. These reports are voluntary, so the number of actual medication errors is believed to be higher,” says Carol Holquist, director of the division of medication error prevention in the FDA’s Center for Drug Evaluation and Research.
The FDA works with many partners to track medication errors, one of which is the Institute for Safe Medication Practices (ISMP), based in a Philadelphia suburb. They review drug names, rejecting some 25% of the 400 submitted each year; and they examine drug labelling and packaging.
Occupying the same building as the ISMP, and a wholly-owned subsidiary of the Institute, is a company called Med-E.R.R.S – the letters standing for Error Recognition and Revision Strategies. The company’s CEO, pharmacist Susan Proulx (pictured left), says that while they don’t invent drug names – that’s a whole other speciality – they do work with names, to test for possible confusion, and therefore error. She cites as examples the similar-sounding cholesterol drug Omacor and the anti-bleeding drug Amicar. They also had similar dosages. Eventually, in concert with the FDA, Omacor became Lovaza.
Similarly, Med-E.R.R.S works with graphics people to ensure that labelling and packaging are designed for maximum information and minimal likelihood of confusion. As Proulx puts it: “We put great emphasis on the design of the package label; it must be unambiguous… and the first priority is the name of the drug and the dosage.”
The company has worked with over a hundred pharma companies in its ten-year history, and relies on a group of doctors, nurses, pharmacists, and other professionals to review and assess names and labels. They work mainly online and receive a small honorarium for their involvement. One test is to produce a handwritten version of a new drug name and show it to pharmacists who assess its potential to be confused with another product.
Med-E.R.R.S uses a sophisticated analytical tool called FMEA. It’s commonly used in the aviation and automotive industries, as well as by NASA, and stands for Failure, Mode, Effect, Analysis. Says Proulx: “If a car’s steering wheel failed, you’d look at that; then see how it happened; then see the result (such as loss of control) and then find out why.”
Check www.fmeainfocentre.com for more details of how this works.
Medication errors can be approached along the same lines. Most occur for a variety of reasons, such as miscommunication of drug orders through poor handwriting, confusion between drugs with similar names, poor packaging design, and confusion of metric or other dosing units. The FDA’s Holquist says that they “usually occur because of multiple complex factors. All parts of the healthcare system – including health professionals and patients – have a role to play in preventing medication errors.”
And a major part of that role is played by organisations like ISMP and Med-ERRS.