Drug Shortages Raise Concerns For CVD Patients and Procedures
In recent weeks, cardiologists have reported increasing concerns related to ongoing shortages of epinephrine, sodium bicarbonate and dextrose. As part of its ongoing advocacy efforts, the College has engaged in discussions with the U.S. Food and Drug Administration (FDA) to reiterate the importance of these drugs for patients with cardiovascular disease and ensure the FDA is taking the necessary steps to resolve these shortages.
To address the shortage of sodium bicarbonate, the FDA has approved importation of the drug from an Australian supplier for as long as is necessary. To ensure your patients' safety, familiarize yourself with the differences between the U.S. registered product and the imported version through information provided by the manufacturer and posted on FDA.gov.
According to the FDA, the emergency epinephrine syringe shortage is the result of a problem in the supply chain for one of the two domestic manufacturers of the drug. Because one domestic manufacturer does not have the capacity to replace the production capacity of the other, and the FDA has not been able to identify a foreign source of the product, the Agency is working with the manufacturer to identify solutions. At the present time, the FDA is advising providers to:
- Consider drawing epinephrine from vials. While this is not an ideal solution, there are existing supplies of epinephrine in vials that should assist in alleviating the shortage.
- Maintain supplies of expired emergency epinephrine syringes. The Agency is working with the manufacturer to determine if the expiration dates can be extended. Information will be posted online if and when such a determination is made.
Find more information on the emergency epinephrine syringe shortage here.
Additionally, the FDA is working with the dextrose manufacturer to determine whether those expiration dates can be extended as well. Find more information on the dextrose shortage here.
In both the epinephrine and dextrose situations, tables will be made available that identify affected product lot numbers, original expiration dates and new expiration dates to address any compliance issues that may arise from retaining expired lots.
The FDA maintains a website detailing current and resolved drug shortages and steps the Agency is taking to address them. The College will continue communications with the FDA on this important issue until the shortages are resolved.
Keywords: Cardiovascular Diseases, Epinephrine, Patient Safety, Pharmaceutical Solutions, Sodium Bicarbonate, United States Food and Drug Administration
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