10/08/2018
Product Labels from Compounding Pharmacies Lead to Dosing Errors
Summary
The U.S. Food and Drug Administration has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products. Conventional manufacturers label their injectable products with the strength per total volume as the primary and prominent expression of strength on the label, whereas some compounders label their injectable products differently. Below is a description of the case reports received by FDA. The case reports illustrate how differences in the product labels of conventional manufacturers and compounders may lead to dosing errors.
Case Reports
FDA received two MedWatch reports concerning medication errors associated with overdoses of compounded injectable products. In the first report, a patient was prescribed 50 mcg of fentanyl. The product administered to the patient was compounded by an undisclosed facility location owned by Central Admixture Pharmacy Services. According to the report, the fentanyl IV bag was labeled with the strength per milliliter (50 mcg/mL) in large font and the strength per total volume (2,500 mcg/50 mL) below in smaller font. The patient was inadvertently administered 2,500 mcg of fentanyl (equivalent to 50 times their prescribed dose). The report noted that the cause of the error was attributed to the prominently stated 50 mcg/mL strength, which was misunderstood as the total amount of fentanyl in the bag.
In the second report, a patient was prescribed 5 to 10 mg of ketamine as needed for pain. The ketamine injection administered to the patient was compounded by QuVa Pharma, Inc., located in Sugar Land, Texas. According to the report, the product was labeled as Ketamine HCl 10mg/mL, highlighted in yellow. The strength per total volume in the syringe was printed beneath the highlighted text in smaller font (see Fig. 1). The patient inadvertently received 50 mg of ketamine (equivalent to 5 to 10 times their prescribed dose) and became somnolent (abnormally drowsy). The report noted that the cause of the error was attributed to the prominently stated 10 mg/mL strength, which was misunderstood as the total amount of ketamine in the syringe.
Risk Summary
As these case reports illustrate, there are differences in labeling practices between conventional manufacturers and compounders in their display of strength on the product label. This may lead to dosing errors when health care professionals, who are more familiar with conventional expression of strength information, are administering compounded drugs.
Fighting For You
Webb Cason, P.C. fights for all individuals that have been the victim of misleading drug labels and other dangerous products. If you believe that you or a loved one are the victim of a misleading drug label, you should seek an opinion from a qualified attorney as to what your rights are as soon as possible. If you have a case that we can handle, we will do so on a contingency fee basis with no up-front cost to you.
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