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Drug names can fool travelers abroad Mich. man's health
scare highlights 'glaring problem' of identical, sound-alike nomenclature
The Wall Street
Journal Doctors in the U.S. are becoming concerned about a coincidence that puts travelers at risk for dangerous mix-ups in prescription medications: Drugs in foreign countries sometimes have the same brand name as U.S. medications, but contain completely different ingredients. A safety alert issued to hospitals and doctors this year by the Institute for Safe Medication Practices, a nonprofit group, identified several drugs in the U.S. that have the same name as very different drugs sold by different manufacturers in European countries. For instance, Norpramin, which is an antidepressant in the U.S., is the name of an ulcer drug in Spain. Flomax for prostate disease has the same name as a pain medication in Italy. And Vivelle, which in the U.S. is a hormone treatment for menopause and osteoporosis, is a birth-control pill in Austria. The group says it has encountered more matches in Asia, South America and elsewhere. In Brazil, for example, the brand name Dilacor refers to verapamil for irregular heart rhythm and hypertension. But in the U.S., Dilacor is a blood-pressure drug known generically as diltiazem. And in Serbia, Dilacor is the brand name for digoxin, used to treat heart failure. For travelers who refill prescriptions abroad, brand-name mix-ups could result in patients not getting a life-saving drug, getting the wrong drug or suffering unexpected drug interactions -- especially elderly people who take multiple medications. Patients who seek to import less expensive medications from foreign countries could encounter similar problems. It isn't known how long such name-sharing has been going on, but the problem came to light only recently after a serious mix-up was reported at a hospital in Michigan. Because there is no regulatory body that keeps track of names globally, there is the potential for more and deadlier cases to occur. The Food and Drug Administration, which approves drug names in the U.S., acknowledges that the danger exists, but says its regulatory authority doesn't extend to drugs in other countries. "Our brand-name review is focused on preventing medical errors in this country so the name doesn't look or sound like any other [U.S.] drug. This doesn't get at the very real issue described by ISMP," says Paul Seligman, the FDA's director of the office of pharmaco-epidemiology and statistical sciences. International brand-name mix-ups are a new wrinkle in the long-standing problem of drug-name confusion. Though the FDA works to ensure names are unique here, some generic and brand names are still very similar. For example, the U.S. Pharmacopeia, a nonprofit that sets standards for drugs and other health products, lists hundreds of confusing sound-alikes, such as the generics bisacodyl, a laxative, and bisoprolol, a blood-pressure drug. Similar drug names have been known to trip up tired or overworked hospital workers, leading to medication errors. The problem of identical brand names, however, potentially raises bewilderment to a new level. The case that helped spark awareness of the issue occurred last year, when a Michigan man refilled a prescription while traveling in the former Yugoslavia, and wound up with serious complications from taking the wrong drug. Selman Cacaj, 61 years old, sought to refill his Dilacor XR prescription for high-blood pressure. In Kosovo, a pharmacy sold him the Serbian Dilacor. After taking the pills back in the U.S., Cacaj didn't feel they were working, so he increased his dosage. He then felt nausea, headache and chest pains. Doctors at William Beaumont Hospital in Royal Oak, Mich., found high levels in his system of the Serbian version of Dilacor -- the heart-failure drug. Looking at the small print on his medication, they discovered that his Dilacor wasn't the same drug as the U.S. brand. Cacaj recovered, but the mix-up alarmed Mark Lutz, a doctor of pharmacy and drug information specialist at Beaumont Hospital, whose business is to detect and report medication errors. He reported the brand-name confusion to the Institute for Safe Medication Practices, which notified the FDA and issued an alert in January to the 2.1 million subscribers to the drug-safety newsletters it publishes. Cacaj's case sheds light on "a glaring problem that needs to be addressed," Dr. Lutz says. Drug mix-ups pose widely variable risks, some greater than others. For instance, the over-the-counter sleep aid Sominex (a brand name for the generic antihistamine diphenhydramine) shares its name with a different medication in the United Kingdom. The U.K. Sominex (promethazine) also is a sleep aid, but the two drugs could cause very different side effects. Some brand name duplications are potentially more serious, such as the differences in the Dilacor brands. The universe of drug names is huge, and the problem of mix-ups is only likely to grow. There are about 10,800 drugs -- branded and generic -- prescribed on the U.S. market, says the Pharmaceutical Research and Manufacturers of America, a trade group. The roster is expanding all the time. Including over-the-counter drugs, PhRMA estimates the number swells to about 16,000. Global tallies are even harder to come by, but some experts who have studied the field believe there may be hundreds of thousands of drugs worldwide. The World Health Organization works to harmonize generic drug nomenclature with standardized International Nonproprietary Names that are recognized worldwide. But this is only for the generic ingredients of medications, and there is no such global convention for brand names. A spokeswoman for Watson Pharmaceuticals Inc., which markets Dilacor XR in the U.S., said the company acquired the product years ago from a predecessor of French drug-maker Sanofi-Aventis, and wasn't sure of the origin of the name. U.S. companies may do global searches if they wish to market a drug worldwide, but otherwise a manufacturer may not bother, as such searches can be expensive. Companies, hospitals and doctors can rule out some global name mix-ups by consulting reference books such as Martindale: The Complete Drug Reference, and electronic databases such as Micromedex, a subscription service of Thomson Corp. But while these resources have considerable international information, they may not be exhaustive or up-to-date. Until U.S. and foreign regulators collaborate, or companies ensure their labels are unique worldwide, Mike Cohen, president of the safe-medicine group, urges travelers to protect themselves. This includes packing enough medication for their whole trip, and noting both brand and generic names -- with dosages -- of all drugs.
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