/publications/issue/2005/2005-03/2005-03-9396

New Product Alerts

Author: Kate Kelly, PharmD

In some instances, it does not take long before the error potential of a newly marketed medication is realized. In an effort to prevent errors with a few newer products, the Institute for Safe Medication Practices (ISMP) offers the following alerts and safe practice recommendations.

Shire Pharmaceuticals Group plc recently announced that Fosrenol (lanthanum carbonate), used to reduce serum phosphate levels in patients with end-stage renal disease (ESRD), has been approved by the FDA and will soon be available. In January 2003, ISMP became aware that this medication was undergoing FDA review. At that time, we alerted our newsletter subscribers that the generic name could look like lithium carbonate when poorly handwritten. The names could also sound similar. This could contribute to a great deal of confusion, especially at sites where prescribing by the generic name is encouraged. The risk of error is increased because the dosage ranges for these drugs are similar and may overlap. Lanthanum carbonate is a chewable tablet that will be available in 250 mg and 500 mg tablets. It should be administered in divided doses with meals, and patients will generally require 750 mg to 3000 mg daily. Lithium carbonate doses typically range from 300 mg to 1800 mg daily and also may be administered in divided doses with meals.

A mix-up could be harmful, given that lanthanum will be used in ESRD patients where the risk of lithium toxicity is high. Including the indication, as well as both the brand and generic name, on prescriptions will help to minimize this problem. If this information is not provided, pharmacists should verify the purpose of the medication with the patient before it is dispensed.

Solvay Pharmaceuticals Inc recently announced the availability of EstroGel (estradiol gel) 0.06%, the first transdermal estrogen gel for the treatment of moderate-to-severe vasomotor menopausal symptoms. It is available only by prescription. However, an OTC product manufactured by Dixie Health has previously been available with the same name, before being changed to Estrogyn. This product is a phytoestrogen complex, touted as "a natural alternative to Premarin and Provera."Despite the name change, confusion is still possible between the 2 products. To avoid confusion, prescribers should include the strength on all EstroGel prescriptions. Patients who receive the prescription EstroGel product should be alerted about the availability of the OTC product. Otherwise, they might confuse the 2 if they seek information about their medication or try to obtain a price for it on the Internet.

Shortly after the approval of the hypercholesterolemia drug Vytorin (ezetimibe/simvastatin), ISMP began receiving reports from practitioners of concern about name similarity with the analgesic Vicodin (hydrocodone /acetaminophen). It is too early to tell if name confusion will occur and result in errors, but both products are combination drugs with several different strengths. Vytorin doses should be expressed as 10/10 mg, 10/20 mg, 10/40 mg, or 10/80 mg, which should help reduce the chance of confusion with Vicodin, Vicodin ES, and Vicodin HP.

Another concern with Vytorin that has been brought to ISMP's attention is the packaging similarity among the various strengths, especially with unitdose products. Similar packaging configurations have been used on other Merck products (eg, Singulair) and have contributed to product selection errors. We have reported these errors to Merck.

Unfortunately, the same label design has been used on the multiple strengths of Vytorin. Some packaging similarity also exists among the bulk products. Please notify ISMP when errors or near misses occur with Merck products due to package labeling, so we can continue our dialogue with the company and encourage label changes. Vytorin is marketed as a joint venture of Merck and Schering- Plough.

Dr. Kelly is the editor of ISMP Medication Safety Alert! Community/Ambulatory Care Edition.


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.

Subscribe to Newsletter 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.