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Caution: Dulcolax Name Extensions

Kate Kelly, PharmD, and Allen J. Vaida, PharmD, FASHP
Published Online: Saturday, January 1, 2005   [ Request Print ]

Physicians (including gastroenterologists), nurses, office staff, as well as pharmacists, may be unaware that there are several over-the-counter (OTC) products using the brand name Dulcolax. For example, one contains bisacodyl, a laxative, as its main ingredient, while another contains docusate sodium, a stool softener (Figure). There is also a liquid formulation available that contains the laxative/ antacid magnesium hydroxide. Recently, a patient needing a colonoscopy was handed a printed instruction sheet from a nurse at his physician's office. In preparation for the colonoscopy, the instructions directed patients to purchase and use 1 bottle of magnesium citrate and 2 tablets of "Dulcolax"each day for 2 days before the colonoscopy. Although bisacodyl is specifically needed for the bowel prep, only the brand name Dulcolax appeared in the printed instructions. Later, at the drugstore, the patient was directed to the laxative aisle where he purchased the Dulcolax stool softener. On the first day, he took 2 Dulcolax, but on the second day, his son, a pharmacist, recognized that his father was taking the stool softener (docusate sodium), not the laxative. The patient's son later drove to the drugstore to purchase bisacodyl and found the 2 Dulcolax products side-by-side. His father completed the bowel prep properly and successfully underwent the colonoscopy. If this error is not detected, however, a second colonoscopy may be required due to ineffective bowel cleansing.

Please notify physicians and associated office staff about this problem. Ask them to warn patients about possible confusion between these Dulcolax products and emphasize, in oral and printed instructions, that only bisacodyl should be used for bowel preparation. It is possible that, in the past, practitioners have simply assumed that patients were not compliant with bowel preps when, in reality, they were using the wrong medication! Alert pharmacy staff to this potential problem and be sure to get involved when patients inquire about OTC medications used for bowel preparation.

The Institute for Safe Medication Practices often has written about safety issues when the same brand name is used for products with different ingredients. Unfortunately, a loophole in the Code of Federal Regulations (CFR) allows companies to market designated OTC products without specific approval of the product names by the FDA. A new drug application (NDA) or abbreviated new drug application (ANDA) does not have to be filed for designated monograph drugs in the CFR. Without the FDA's review, companies can capitalize on a well-known, trusted, brand name and use it for any product, including an entire line of OTC products with different ingredients. At least 7 products carry the Dulcolax brand name. Unfortunately, marketing considerations can sometimes override safety considerations and, unless harm is well documented, the FDA can do nothing to require a name change. As previously stated, brand name extensions for OTC products should not be allowed unless at least 1 ingredient from the original product is present in the new or modified product. This incident offers more evidence that the regulations should be changed to provide the FDA with the opportunity to ensure drug name safety for OTC products.

Drs. Kelly and Vaida are both with the Institute for Safe Medication Practices (ISMP). Dr. Kelly is the editor of ISMP Medication Safety Alert! Community/Ambulatory Care Edition, and Dr. Vaida is the executive director of ISMP.


Report Medication Errors

The reports described here were received through the USP Medication Errors Reporting Program, which is presented in cooperation with the Institute for Safe Medication Practices (ISMP). ISMP is a nonprofit organization whose mission is to understand the causes of medication errors and to provide time-critical error-reduction strategies to the health care community, policy makers, and the public. Throughout this series, the underlying system causes of medication errors will be presented to help readers identify system changes that can strengthen the safety of their operation.

If you have encountered medication errors and would like to report them, you may call ISMP at 800-324-5723 (800-FAILSAFE) or USP at 800-233-7767 (800-23-ERROR). ISMP's Web address is www.ismp.org.


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Pharmacy Times and the Institute for Safe Medication Practices (ISMP) would like to make community pharmacy practitioners aware of a publication that is available.

The ISMP Medication Safety Alert! Community/Ambulatory Care Edition is a monthly compilation of medication-related incidents, error-prevention recommendations, news, and editorial content designed to inform and alert community pharmacy practitioners to potentially hazardous situations that may affect patient safety. Individual subscription prices are $45 per year for 12 monthly issues. Discounts are available for organizations with multiple pharmacy sites. This newsletter is delivered electronically. For more information, contact ISMP at 215-947-7797, or send an e-mail message to community@ismp.org.

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