Drug Name Mix-Ups Could Be Worsened By Computerized Order Systems - USP

Pharmaceutical industry stakeholders seeking to prevent medication errors due to look-alike and sound-alike product names should take note of potential name confusion in computerized direct prescription ordering systems, the U.S. Pharmacopeia suggests in a recent report.

The report outlines findings from the USP's Medmarx program, a voluntary system for reporting and collating adverse drug events and medication errors in hospitals and health care systems.

After reviewing more than 26,000 records, USP says it "identified 1,470 unique drugs implicated in these medication errors due to brand and/or generic names that looked and/or sounded alike." The report lists all of those names.

USP estimates that 1.4 percent of the errors "resulted in patient harm, including seven errors that may have caused or contributed to patient deaths."

While it does not document the extent of the problem, USP says its analysis detected an emerging trend that look-alike drug names in computerized direct order entry systems are becoming a "source of confusion."

This trend "likely will continue as these systems become a standard of practice," USP predicts. "The problem of look-alike and/or sound-alike errors is further compounded by the indiscriminant use of suffixes, look-alike packaging, and labeling."

One challenge in remedying problems caused by confusing names is that generally, "no one knows how well any of the existing prevention techniques work," and further, there is a lack of reliable methods for detecting name confusion.

USP points to one study suggesting that, at least in hospital and other facility settings, taking advantage of bar coding on products may hold promise. Reported recently in the Annals of Internal Medicine, the study found that bar coding resulted "in impressive reductions (60 percent to 96 percent) in dispensing error rates and adverse drug events" in a hospital that adopted bar coding scanning throughout the facility, according to USP's summary of those findings.

FDA's requirement that most kinds of prescription products include a bar code on the label was established in a 2004 regulation (¹ (Also see "FDA Bar Code Rule Expands List Of Exempt Products" - Pink Sheet, 1 Mar, 2004.), p. 7). The USP report does not discuss the role of electronic prescribing technology in either exacerbating or preventing name confusion.

Regarding the names themselves, USP notes that the Institute for Safe Medication Practices, with industry support, is working on a report on ways to improve on name-related error prevention strategies. The organization convened a conference last fall on drug name confusion.

USP also notes provisions in last year's FDA Amendments Act and user fee reauthorization that could lead to "significant changes" in how FDA and stakeholders "deal with safety issues" related to brand names.

The statute mandates a pilot program giving industry more responsibility to test and evaluate drug names (² (Also see "Brand Names In 2008: Can Industry Pilot Its Way Out Of Trouble?" - Pink Sheet, 14 Jan, 2008.), p. 15). Also in the works are three guidances for industry on naming issues.

The USP report outlines six recommendations to reduce errors from look-alike or sound-alike names, including:

Convening a national forum to resolve discrepancies in the use of drug suffixes,

Including on all prescriptions the indication for use,

Wider facility adoption of any proven prevention technologies,

Urging ambulatory patients to take advantage of pharmacist counseling at the point-of-sale as a final way to catch errors,

Using human factors principles and similarity detection software early in the drug approval process to identify potential weaknesses in drug names, drug labels and drug packaging, and

Encouraging health care practitioners to report name confusion errors, so that more name pair issues can be publicized to increase awareness of stakeholders.

- Gregory Twachtman ([email protected])