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New dangers in the drug reimportation process: Will we know what our patients are taking?

From the January 27, 2005

In our January 13, 2005 issue, we introduced the problem with brand name medications that may contain different active ingredients in another country. In the event previously mentioned, a patient who was traveling to Serbia ran out of DILACOR XR (diltiazem extended release), marketed by Watson Labs in the US. A Serbian pharmacist filled the prescription with digoxin 0.25 mg. In Serbia, DILACOR, marketed by a local company, is a brand name for digoxin. The patient continued to take digoxin without realizing it and was hospitalized after his return to the US with life-threatening toxicity. We suggested reminding patients who are traveling abroad to carry an adequate supply of medications along with a list of their medications by both generic and brand name so they could confirm that the correct drug has been dispensed if supplies become depleted.

As we further investigated this problem, we quickly learned that the circumstances leading to this patient's harm have wider implications. There are a number of instances where brand names for US medications exist in some countries with totally different ingredients. Table I (appears in attached PDF version) provides a few examples of US branded medications that represent different ingredients in Europe. Keep in mind: the problem is far more widespread than represented in the table. Many other examples are listed in Index Nominum and Martindale (available by subscription through Micromedex). Furthermore, the brand name used for a foreign product may be available simultaneously in several countries, or it may represent additional unique medications in countries other than those listed. For example, while Dilacor is a brand name for diltiazem in the US and digoxin in Serbia, it's also a brand name for barnidipine in Argentina and verapamil in Brazil. As a result, this problem adds complexity and danger to drug reimportation.

Companies planning to market a drug only in the US might not perform a comprehensive search worldwide to assure that the proposed brand name isn't used elsewhere. If marketing the drug outside the US, most large companies will perform searches in the major markets served because there's an interest in adopting a single global brand name. However, the proposed brand name might not be evaluated in every market, especially since the necessary information may not be available.

On occasion, generic names of products in another country might be different than those used in the US. However, there are world authorities, like the World Health Organization's International Non-proprietary Name system, that control these situations and offer ongoing efforts to harmonize generic names worldwide. This is not so with brand names. Once a brand is marketed in certain countries, there is no universal system to monitor or prevent the same brand name from being used in other countries for different products. As such, the problem is larger than not recognizing a foreign, unfamiliar generic name. That, by itself, would likely stimulate further research. More importantly, the problem with brand names that represent different active ingredients rests squarely on the shoulders of patients (who may have no idea that the wrong drug has been dispensed) and their healthcare providers (who may not know what their patients are really taking).

The issue of "same brand name, different drug" has major safety implications, especially in light of the growing interest in drug reimportation to help consumers save money. Although against US laws and regulations, several states are actively facilitating drug reimportation, even operating state-run websites that refer citizens to Canadian pharmacies. Now, with Canada threatening regulatory change to make it difficult or impossible to fill prescriptions for US patients, some states are looking to import medications from Europe. As with the patient who took the wrong Dilacor, the opportunity for error is substantial unless we adopt good naming practices endorsed by global health authorities that minimize or prevent use of the same brand name for different products. Most are well aware of some of the dangers in importing drugs (e.g., counterfeiting, lax regulatory drug approval processes in some countries), but the situation described above is a previously unmentioned danger.

Have we overlooked other dangers related to reimportation? Two additional problems quickly come to mind. With a wide range of drug name suffixes used in the US for various dosage forms (CD, CR, ER, LA, SA, SR, TD, XL, etc.), frequent errors occur right here due to the lack of standardization. If obtaining a product with a drug name suffix from a foreign country, errors seem inevitable, even if the active ingredient is the same in branded US and foreign medications! Next, while verbal orders are less likely when importing drugs from abroad, look- and sound-alike brand names can also play a role in errors. For example, AMYBEN is one branded product for amiodarone in the United Kingdom. A supply of Amyben in place of AMBIEN (zolpidem tartrate) in the US could have disastrous results! Perhaps a thorough failure mode and effects analysis (FMEA) on drug importation is a critical first step before further consideration of this seemingly cost-effective alternative. With all the political discussions on the topic, we need to step back and really look at safety. How could these issues go unnoticed until now? An FMEA might reveal a host of additional safety issues.

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