Caution: Dulcolax Name Extensions
Physicians (including gastroenterologists), nurses,office staff, as well as pharmacists, may be unawarethat there are several over-the-counter (OTC) productsusing the brand name Dulcolax. For example, one containsbisacodyl, a laxative, as its main ingredient, while anothercontains docusate sodium, a stool softener (Figure). There isalso a liquid formulation available that contains the laxative/antacid magnesium hydroxide. Recently, a patientneeding a colonoscopy was handed a printed instructionsheet from a nurse at his physician's office. In preparationfor the colonoscopy, the instructions directed patients topurchase and use 1 bottle of magnesium citrate and 2tablets of "Dulcolax"each day for 2 days before thecolonoscopy. Although bisacodyl is specifically needed forthe bowel prep, only the brand name Dulcolax appeared inthe printed instructions. Later, at the drugstore, the patientwas directed to the laxative aisle where he purchased theDulcolax stool softener. On the first day, he took 2 Dulcolax,but on the second day, his son, a pharmacist, recognizedthat his father was taking the stool softener (docusatesodium), not the laxative. The patient's son later drove tothe drugstore to purchase bisacodyl and found the 2 Dulcolaxproducts side-by-side. His father completed the bowelprep properly and successfully underwent the colonoscopy.If this error is not detected, however, a second colonoscopymay be required due to ineffective bowel cleansing.
Please notify physicians and associated office staff aboutthis problem. Ask them to warn patients about possibleconfusion between these Dulcolax products and emphasize,in oral and printed instructions, that only bisacodyl shouldbe used for bowel preparation. It is possible that, in the past,practitioners have simply assumed that patients were notcompliant with bowel preps when, in reality, they wereusing the wrong medication! Alert pharmacy staff to thispotential problem and be sure to get involved whenpatients inquire about OTC medications used for bowelpreparation.
The Institute for Safe Medication Practices often has writtenabout safety issues when the same brand name is usedfor products with different ingredients. Unfortunately, aloophole in the Code of Federal Regulations (CFR) allowscompanies to market designated OTC products withoutspecific approval of the product names by the FDA. A newdrug application (NDA) or abbreviated new drug application(ANDA) does not have to be filed for designated monographdrugs in the CFR. Without the FDA's review, companiescan capitalize on a well-known, trusted, brand nameand use it for any product, including an entire line of OTCproducts with different ingredients. At least 7 productscarry the Dulcolax brand name. Unfortunately, marketingconsiderations can sometimes override safety considerationsand, unless harm is well documented, the FDA can donothing to require a name change. As previously stated,brand name extensions for OTC products should not beallowed unless at least 1 ingredient from the original productis present in the new or modified product. This incidentoffers more evidence that the regulations should bechanged to provide the FDA with the opportunity to ensuredrug name safety for OTC products.
Drs. Kelly and Vaida are both with the Institute for Safe MedicationPractices (ISMP). Dr. Kelly is the editor of ISMP Medication SafetyAlert! Community/Ambulatory Care Edition, and Dr. Vaida is theexecutive director of ISMP.
Report Medication Errors
The reports described here were received through the USP MedicationErrors Reporting Program, which is presented in cooperation with theInstitute for Safe Medication Practices (ISMP). ISMP is a nonprofitorganization whose mission is to understand the causes of medicationerrors and to provide time-critical error-reduction strategies to the healthcare community, policy makers, and the public. Throughout this series,the underlying system causes of medication errors will be presented tohelp readers identify system changes that can strengthen the safety oftheir operation.
If you have encountered medication errors and would like to reportthem, you may call ISMP at 800-324-5723 (800-FAILSAFE) or USP at800-233-7767 (800-23-ERROR). ISMP's Web address is www.ismp.org.
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The ISMP Medication Safety Alert! Community/Ambulatory CareEdition is a monthly compilation of medication-related incidents,error-prevention recommendations, news, and editorial content designedto inform and alert community pharmacy practitioners topotentially hazardous situations that may affect patient safety. Individualsubscription prices are $45 per year for 12 monthly issues. Discountsare available for organizations with multiple pharmacy sites.This newsletter is delivered electronically. For more information, contactISMP at 215-947-7797, or send an e-mail message to community@ismp.org.
