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Medication errors or potential errors may be reported in confidence to FDA's medWatch program (call 1-(800) FDA-1088 or fax the medWatch form to 1-(800) FDA-0178). When reporting a medication error to medWatch, the "Product Problem" portion of the form should be completed with a description of the packaging, labeling, or device problem. FDA knows that confidentiality is extremely important, especially in the area of reporting errors. Current federal regulations protect the identities of reporting individuals and institutions from disclosure.
Esmolol HCl is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in the perioperative, postoperative, or other emergent circumstances when short-term control of ventricular rate with a short-acting agent is desirable. It is also indicated in noncompensatory sinus tachycardia when in the physician's judgment the rapid heart rate requires specific intervention and for the treatment of tachycardia and hypertension that occur during induction and tracheal intubation during surgery, on emergence from anesthesia, and in the postoperative period. Most esmolol HCl use occurs in the operating room, often under emergent circumstances.
Esmolol HCl is available in a 10 mg/mL, 10-mL vial (100 mg total) to be used for direct intravenous (IV) administration. This vial is used to administer an appropriate loading dose while the maintenance infusion is being prepared.
Esmolol HCl is also available in a 250 mg/mL, 10-mL ampul (2,500 mg total) to be used ONLY for the preparation of IV infusion solutions. Serious adverse events (and deaths) have occurred when the more concentrated product, intended ONLY for preparation of infusion solutions, was used instead of the less concentrated product intended for bolus doses, giving a 25-fold overdose. Causes of these errors include improper storage, (e.g., the two dosage forms being stored in proximity), failure to read the label properly, and imprecise ordering by the prescribing physician (e.g., ordering the product as 10 mL or 1 vial rather than 100 mg).
In 1995, in response to adverse events resulting from the mix-up of the two dosage forms of esmolol HCl, Ohmeda Pharmaceutical Products Division, in conjunction with FDA, instituted several labeling and packaging changes. The strength on the concentrated product marketed in an ampul was expressed in mg and grams, and the "Must Be Diluted" warning statement was boxed and printed in red ink. A red warning flag stating "MUST BE DILUTED" was also applied directly to the upper tip of the ampul bulb. The adhesive used for this sticker is such that the flag cannot be separated from the ampul without breaking off the bulb. (All ampuls currently in use should have the adhesive red flag on them.) A "Dear Hospital Pharmacist and Health Care Professional" letter was issued in July 1995 warning the medical community of the potential infusion error and impending changes in labeling.
Despite the above measures, bolus use of the concentrated product continues to be reported. Ohmeda is currently evaluating ready-to-use formulations, including premixed infusion bags or Monovials (a system designed to transfer the contents of a vial directly into an IV bag) to replace the concentrated ampuls. Until such a change is made, however, practitioners must be aware of the importance of using the concentrated product properly (i.e., as a dilute solution). Hospital pharmacists should ensure that all operating room personnel are instructed in the proper use of each dosage form. The concentrated ampul form of the drug should not be stored near the less concentrated form. Physicians who order the product must also be aware of the possibility of error. All doses should be ordered in mg (not mL), and the dose should be confirmed before administration.
FDA/Website Management Staff