Celebrex prompts safety guidelines

Searle and Pfizer are searching for ways to avoid medication mix-ups surrounding Celebrex, the COX-2 inhibitor drug comarketed by the two companies.

Since the product entered the market in February, the Food and Drug Administration has received more than 50 reports of product mix-ups. Celebrex has been confused with sound-alikes such as the antidepressant Celexa, comarketed by Forest and Warner-Lambert, and Cerebyx, an intravenous anti-epileptic drug marketed by Parke-Davis. Twenty of those mix-ups resulted in product substitutions, although no one was seriously injured as a result.

Ironically, Searle chose the name Celebrex over its original choice, Celebra, in an attempt to avoid confusion between Celexa and its new product.

According to the Warminster, PA-based Institute of Safe Medication Practices, most of the errors have been the result of misinterpreted written orders. However, the FDA MedWatch partner added that "the potential for sound-alike errors in verbal orders is also high," especially for prescribers for whom English is a second language and whose accents might make it "difficult to differentiate between the 'l' and 'r' sound in the middle of words."

The Institute of Safe Medication Practices issued a warning to health care practitioners and consumers to take special care in prescribing, dispensing and using Celebrex and similar-sounding products because of the potential for confusion. It also urged the FDA and Searle and Pfizer to consider renaming the drug; a recommendation the institute made twice to Searle and Pfizer; in October 1998 and in January, just prior to the product's launch.

Reportedly, Searle has several other names registered for anti-inflammatory drugs, one of which may prove a less confusing substitute for the otherwise successfully launched product.

Other possible solutions to the problem include sending a "Dear Doctor" letter or stepping up educational efforts about the product and its sound-alike/look-alike medicines.

Safety guidelines

As the companies and the FDA weighed their options, the Institute of Safe Medication Practices responded quickly with safety guidelines for prescribers, pharmacists and patients who deal with the medicine:

• Prescribers should include the purpose of the medication on the prescription order for Celebrex, Celexa and Cerebyx.

• Prescribers should print prescriptions for the product clearly.

• Prescribers should use both brand and generic names for Celebrex, Celexa and Cerebyx.

• An alert should be added to pharmacy and hospital computer systems, warning pharmacists and other practitioners to question indication for the drug if it is not stated on the prescription form.

• Pharmacists, nurses and other practitioners should repeat verbal orders back to the prescriber and communicate an understanding of the indication.

• Patients who are prescribed Celexa, Celebrex or Cerebyx should double-check with their pharmacists to ensure that they have received the right medication.

• Before dispensing, pharmacists should counsel patients on the use of Celebrex, Celexa and Cerebyx.

Although these guidelines will help stem some short-term errors, a far-reaching, private-sector-driven solution initiated by Searle and Pfizer - in cooperation with the FDA - is likely. PR