There are no commercially available solutions of compounded cardioplegia, a drug used to temporarily stop the heart during surgery, after the FDA cited the nation's only pharmacy that compounded the medication.
In 2022, an FDA inspection uncovered quality and safety infractions at Central Admixture Pharmacy Services' Phoenix facility, including a failure to check whether a batch has been distributed, a chemist team lead deleting assay testing data, missing calculations, and airflow and sterilization problems.
"The quality system [at CAPS] for reporting and documenting quality issues is out of control," the FDA's report said.
The year prior, similar issues were found at its Harahan, La., location, and the FDA said in mid-2022 the company promised to correct the issues and the state board of pharmacy could take over the follow-up.
"They were temporarily halting the supply and distribution of this really critical product," said Andrew Salzillo, PharmD, a pharmacy supply chain manager at Providence, R.I.-based Lifespan.
The lack of compounded cardioplegia from CAPS is requiring hospitals to compound their own solutions — which causes more problems, Dr. Salzillo said.
Compounding a drug in-house means hospital pharmacy teams have to figure out short-dating and appropriate storage. Plus, ingredients used in a compounded solution may fall into shortage, and pharmacy departments might not have enough personnel.
The FDA's and the American Society of Health-System Pharmacists' drug shortage databases do not currently list a shortage of any cardioplegic solutions. Pfizer, Fresenius Kabi and Baxter make cardioplegic solutions.