Recommendations and current practices for the reconstitution and storage of botulinum toxin type A.

Abstract

Current guidelines from the Centers for Disease Control and Prevention (CDC) regarding the reconstitution and storage of botulinum toxin type A (BT-A) differ from those of the Centers for Medicare and Medicaid Services and current clinical practice. CDC guidelines require single-patient use of BT-A vials. Strict adherence to these guidelines creates waste and a significant financial impediment, and does not confer increased protection from infection, assuming standard safe injection practices are followed. This study examines current clinical practices and provides expert consensus recommendations regarding the reconstitution and storage of BT-A. A review of the literature on the sterility and efficacy of BT-A stored beyond the recommended time period of 4 hours is also presented. An Internet-based survey was used to analyze the current practices of physician members of the American Society for Dermatologic Surgery who administer botulinum type A toxins. After reconstitution, the majority of physicians (68.6%) routinely store BT-A for a period of greater than 1 week and safely use each toxin vial for more than one patient. Not a single case of infection was observed. This was a single survey with a 32.2% response rate. A single vial of BT-A can be safely administered to multiple patients, assuming standard safe injection techniques are followed. After reconstitution, Our data suggest that BT-A can be stored beyond the recommended time period of 4 hours.