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Recommendations and current practices for the reconstitution and storage of botulinum toxin type A - 11/08/12

Doi : 10.1016/j.jaad.2011.10.008 
Austin Liu, MD a, Alastair Carruthers, MD, FRCPC b, Joel L. Cohen, MD c, William P. Coleman, MD d, Jeffrey S. Dover, MD, FRCPC, FRCP e, C. William Hanke, MD f, Ronald L. Moy, MD g, David M. Ozog, MD a,
a Department of Dermatology, Division of Mohs Micrographic Surgery, Henry Ford Hospital, Detroit, Michigan 
b Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada 
c AboutSkin Dermatology and DermSurgery, Englewood, Colorado 
d Departments of Dermatology and Plastic Surgery, Tulane Health Sciences Center, New Orleans, Louisiana 
e SkinCare Physicians, Chestnut Hill, Massachusetts 
f Laser and Skin Surgery Center of Indiana, Carmel, Indiana 
g David Geffen School of Medicine, the University of California at Los Angeles, Los Angeles, California 

Reprint requests: David M. Ozog, MD, Department of Dermatology, Division of Mohs Micrographic Surgery, Henry Ford Hospital, 3031 W Grand Blvd, Suite 800, Detroit, MI 48202.

Abstract

Background

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.

Objective

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.

Methods

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.

Results

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.

Limitations

This was a single survey with a 32.2% response rate.

Conclusion

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.

Il testo completo di questo articolo è disponibile in PDF.

Key words : Botox, Botox reconstitution, Botox storage, botulinum toxin, botulinum toxin consensus recommendations, botulinum toxin reconstitution, botulinum toxin storage

Abbreviations used : BT-A, CDC, CMS


Mappa


 Funding sources: None.
 Conflicts of interest: None declared.
 Disclosure: Dr Hanke served as an investigator for Allergan, Medicis, Merz, and Galderma, receiving grants. Dr Coleman served as a consultant for Allergan and Merz, receiving grants. Dr Carruthers has been on the advisory board and served as an investigator for Allergan and Merz, receiving honoraria. Dr Cohen served as a consultant and investigator for Allergan, Medicis, and Merz, receiving grants and honoraria. Dr Moy served as an investigator for Inamed, receiving grants and is a stockholder of Claro. Dr Dover served as an investigator for Allergan, receiving grants. Drs Liu and Ozog have no conflicts of interest to declare.


© 2011  American Academy of Dermatology, Inc.. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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