Healthy Skepticism Library item: 14103

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Publication type: news

Cohen R.
Mix-ups spur FDA to do more to avoid sound-alike medications
The New Jersey Star-Ledger 2008 Aug 8
http://www.nj.com/business/index.ssf/2008/08/mixups_spur_fda_to_do_more_to.html

Full text:

Three years ago, Johnson & Johnson changed the name of its Alzheimer’s drug Reminyl because it was being confused by doctors and pharmacists with the diabetes medicine Amaryl. Mix-ups were linked to two deaths and some serious health problems for patients.

Changing the name of a drug already on the market is unusual, but the case highlights a growing dilemma facing the pharmaceutical industry, doctors, pharmacists and patients — drug names that look or sound so much alike they can lead to medication errors.

“This is a very urgent problem,” said Diane Cousins of U.S. Pharmacopeia, the official standard-setting authority for prescription and over-the-counter medicines. “What we have seen is that the number of reports of similar-named drugs is increasing, and the number of different products implicated in medication errors is increasing.”

The Food and Drug Administration, under a congressional mandate, is now preparing a pilot project aimed at changing the way it reviews and approves drug names in hopes of improving safety and streamlining the process.

The agency rejects 35 percent to 40 percent of the names initially proposed by drugmakers, but even with the current level of scrutiny, data show the system is badly flawed.

According to U.S. Pharmacopeia, a nonprofit public-health organization, nearly 1,500 brand-name and generic drugs have been implicated in medication errors because their names looked or sounded like some other drug. The organization recently compiled 3,170 pairs of drug names that have close similarities, nearly double the number from its previous survey in 2004.

A 2006 study by the Institute of Medicine, a branch of the National Academy of Sciences, found medication errors injure 1.5 million people annually, and it attributed 25 percent of all errors to confusion caused by similar drug names.

Stuart Keil of Keil’s Pharmacy in Montclair said the problem is real, and requires pharmacists to be vigilant and to pay attention to the details.

“It often requires entering into conversations with a patient to assure ourselves that everything is correct. But that can’t happen with mail-order pharmacies,” he cautioned.

Keil said he remembers one case in which a prescription for what appeared to be a cholesterol-lowering drug came from a pediatrician. “I knew that could not be correct,” he said.

Name Game
Under current regulations, drugmakers submit proposed names, often with marketing in mind, and the FDA conducts an independent review as part of the drug-approval process. A small FDA staff examines whether a drug sounds, looks or is spelled like another medication. It also tries to determine if the name overstates the drug’s effectiveness, minimizes its risks, broadens its indications, implies unsubstantiated superiority to other medications or is simply too fanciful.

The pilot project now under way will shift the initial burden from the FDA to the drugmakers. Companies would have to submit a detailed analysis and data on their proprietary name proposals for the agency to review, rather than have the FDA do its own research.

Susan Proulx, president of Med-E.R.R.S., a firm that helps pharmaceutical companies evaluate medication names, packages and labels to minimize medication errors, said she is “happy to see the FDA moving forward.”

“Time will tell,” she said. “We are all looking forward to working with the FDA and the pharmaceutical companies to develop the best methods to reduce medication errors. No one wants medication errors to occur.”

Proulx said her organization and others do name tests for drugmakers to determine if there is a risk of confusion, and engage in pre-market testing with doctors and pharmacists based on spelling, pronunciation, writing samples and other indicators.

“There are only 26 letters in the alphabet, and the chance of a name being incorrectly pronounced or written or confused for another product is high,” Proulx said.

She said companies generally start with hundreds of names, do trademark and marketing reviews, then whittle them down before picking one.

MANY MIX-UPS
The drug most commonly confused with others during a recent three-year period, according to U.S. Pharmacopeia, was Cefazolin, an antibiotic. The organization found it has been confused with 15 other drugs, most of them antimicrobials. Similar names include Cephalexin, Ceftriaxone, Cefoxtin and Cefotaxime.

Other drugs on the watch list include Navane, an antipsychotic medicine, and Norvasc, a hypertension drug; Cisplatin and Carboplatin, both oncology drugs; Celexa, an antidepressant, and Cerebyx, a seizure drug; and Lamictal, an epilepsy medication, and Lamisil, a drug for fungus infections.

Jerry Phillips of the Drug Safety Institute, a company that helps develop drug and health care product brand names, said the industry strives to get a name that is “memorable” while also passing trademark and legal clearances in the United States, Europe and Canada.

Phillips, a former FDA official who worked on labeling and naming issues, said some companies do a through job of avoiding look-alike and sound-alike names, while others do not. He said he hopes the FDA pilot program will provide better guidance and standards, and “lead to a more consistent approach and a lower rejection rate.”

“I don’t think the FDA is admitting it has a flawed process, but the industry probably could do it better, and that’s the reason to turn over more responsibility to the drugmakers,” he said.