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Transcript
May 2015 IMPORTANT PRESCRIBING INFORMATION Injection 50 mg/5 mL and 100 mg/10 mL Dear Health Care Provider: The purpose of this letter is to announce changes to the Vazculep (phenylephrine hydrochloride) Injection 50 mg/5 mL and 100 mg/10 mL labeling. Vazculep is indicated for the treatment of clinically important hypotension resulting from vasodilation in the setting of anesthesia. The labeling revision was -ups involving undertaken in response to reports of medication errors Bloxiverz (neostigmine methylsulfate) Injection and Vazculep (phenylephrine hydrochloride) Injection. According to some of the medication error reports, Vazculep 50 mg/5 mL and Bloxiverz 10 mg/10 mL were inadvertently substituted for one another due to similarities in packaging and labeling; however, due to secondary checking of the preparation, no patient received the wrong drug. Both products utilized similar colors on their vial labels and carton labeling. To minimize the risk for wrong drug errors Pharmaceuticals has revised the vial label and carton labeling for Vazculep 50 mg/5 mL by changing a red box containing the product strength to a gold box, and adding yellow highlighting to the pharmacy bulk package statement. This is intended to further differentiate Vazculep Bloxiverz To enhance safe use of Vazculep bulk packag also added to the 100 mg/10 ml strength as well. Figure 2: Vial Labels Figure 1: Cartons: Original 50mg/5mL Carton Revised 50mg/5mL Carton Original 50mg/5mL Vial Label Revised 50mg/5mL Vial Label In one -miss where the Vazculep 50 mg/5 mL pharmacy bulk package was confused with Bloxiverz in the operating room (OR) setting. We remind health care providers that the Vazculep 50 mg/5 mL and 100 mg/10 mL pharmacy bulk packages should be stored and used ONLY in the pharmacy to mitigate the potential for serious adverse events. See section 2.5 of the attached Vazculep prescribing information for directions for dispensing from the pharmacy bulk vial. t Pharmaceuticals intends to implement this change with our next printing. However, we recognize there is current inventory in pharmacies and warehouses that still retain the previous labeling. Thus, we Before have enclosed with this letter alert stickers that Use.” These stickers should be applied on the top flap of the cartons of your current stock of Vazculep™ 50 mg/5 mL so as to not obscure other important drug information. These stickers can also be applied to shelving or bins where Vazculep™ and Bloxiverz® are stored as needed to further alert users. Additional stickers can be obtained free of charge by calling toll free 1-844-827-5007 or via email to [email protected]. Recommended Actions to Prevent Medication Errors • Double check the name and strength of your product before preparation and administration. • Use provided alert stickers on all Vazculep™ 50 mg/5 mL vial cartons currently in stock. • Use provided alert stickers on shelving and bins where Vazculep™ and Bloxiverz® are stored. • Contact Éclat Pharmaceuticals to receive additional alert stickers as needed until newly labelled stock is received. Reporting Adverse Events Heath care providers and patients are encouraged to report adverse events in patients taking Vazculep™ to Éclat Pharmaceuticals at 1-877-622-2320. You are encouraged to report side effects of Vazculep™ and Bloxiverz® to the FDA MedWatch program. Visit www.fda.gov/medwatch, or call 1-800-FDA1088. Please note that this letter is not intended as a complete description of the risk profile for Vazculep™. Please refer to the enclosed full prescribing information for a complete discussion of the risks associated with Vazculep™. For additional information, please call Éclat Pharmaceuticals at 1-844-827-5007 or visit www.vazculep.com. Sincerely, Heather R. Kruchowski Director, Quality Operations Enclosures: Vazculep™ Full Prescribing Information Alert stickers