In its newsletter of September, 2018 the Board of Medicine reminded us of its 2005 legislation mandate to do periodic audits assess compliance with the regulations. They announced that it is time for another audit and all physicians who mix, dilute, or reconstitute drugs for administration will be audited. Since we all reconstitute neurotoxins, we must be in compliance with these regulations. The most important provisions include:
Neurotoxins must be administered within 10 hours of reconstitution.
All personnel involved in reconstitution must be “properly trained.”
If the neurotoxin is not reconstituted by the physician, procedures for verification of reconstituting accuracy by the physician must be in place.
Document in the patient record the Botox reconstitution and date of administration.
Maintain written policies and procedures to be followed, for the reconstitution of the neurotoxin, and for the training of personnel.
We must comply with all applicable requirements of the USP Chapter 797.
A current copy of USP Chapter 797 shall be maintained where the reconstitution is performed.
Doctors reconstituting neurotoxins shall disclose this information to the board and are subject to unannounced inspections by its agents.
Although Allergan, the maker of Botox, states in its insert that the product is stable, may be refrigerated, and should be used within 24 hours of reconstitution, the board remains firm in its declaration that neurotoxin must be used within 10 hours of reconstitution.
We have the option of petitioning for a rule change on the Town Hall online. This is the link: http://townhall.virginia.gov/um/petitions.cfm I will be speaking to our legislative consultant to see if we can extend the storage of our reconstituted neurotoxins to the 24 hours that Allergan includes in its inserts.