8/9/2013
The Food and Drug Administration (FDA) today advised healthcare professionals to immediately stop using any sterile products supplied by Specialty Compounding in Cedar Park, Texas.
According to an agency news release, this alert is being issued after the FDA received reports of adverse events experienced by 15 patients in two hospitals. The patients all received an infusion of calcium gluconate 2 grams in sodium chloride 0.9% for injection, which was supplied by Specialty Compounding. The patients then developed bacterial bloodstream infections caused by Rhodococcus equi. Cultures from an intact sample of calcium gluconate compounded by Specialty Compounding show bacteria growth consistent with Rhodococcus species.
In light of this alert, ASHP members should take the following steps:
- Immediately stop using any sterile products supplied by Specialty Compounding.
- Report any actual or suspected adverse events related to the use of these products to the FDA’s MedWatch program.
The FDA and the Centers for Disease Control and Prevention (CDC) are working with Texas state officials to investigate the cause of these bacterial infections.
Specialty Compounding supplies a number of products that are listed on ASHP’s Drug Shortages Resource Center. ASHP urges members to report any new shortages atwww.ashp.org/shortages.
This incident and others in recent weeks emphasize the critical need for legislation that will ensure that FDA and state boards of pharmacy have the clear authority and accountability necessary to ensure that patients are not harmed by products prepared by compounding outsourcers.
ASHP strongly urges all members to contact their two senators and ask for support of the Pharmaceutical Quality, Security, and Accountability Act of 2013 (S. 959).
The Society continues to follow this issue closely and will provide updates and resources as new information becomes available.
quoted from the ASHP website
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