Proposed Vial Mixing Standard May Have Adverse Effects for Otolaryngologists

TORONTO-Standards proposed by the United States Pharmacopeia (USP) for the compounding of sterile medication could be applied to vial mixing in the office. This would represent a radical change that won’t make many otolarygnologists happy, according to panelists at the recent annual meeting of the American Academy of Otolaryngic Allergy (AAOA).

Although the changes would represent a significant effect on practice, not many otolaryngologists seem to be aware of them, yet they could actually happen, panelists warned.

One of the significant problems with the proposed USP standards is that they state that mixing must be performed in a dedicated clean room with a laminar flow hood. The specially built rooms would cost an estimated minimum of $21,000-a figure that some participants at the AAOA speculated would be significantly higher in reality. The standards would apply to physicians of all specialities who perform sterile medication compounding.

Aside from the cost, another key issue panelists discussed is how the standards would affect otolaryngologists if they are adopted by regulatory agencies.

Indeed, when it comes to vial mixing performed by otolaryngologists who provide patients with immunotherapy, there is no evidence showing any safety problems with the way things are done now, according to Sandra Lin, MD, Assistant Professor of Otolaryngology at Johns Hopkins University School of Medicine in Baltimore. She is working to make sure that any standards or regulations will be both relevant and evidence-based for otolaryngology practice.

The USP and Its Standard

Sandra Lin, MD

As background, Dr. Lin explained that the USP is a nonprofit, volunteer standard-setting organization. Generally, standards are needed to ensure quality, safety, and the correct use of medications, she said.

The USP is not a regulatory agency and has no enforcement powers, yet the FDA does adopt USP standards if a specific USP monograph exists for a product. However, many state boards of pharmacy do follow USP guidelines, and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) adopts many of them too, Dr. Lin said.

The vial mixing standard of concern, USP-797 Sterile Compounding Rules, was issued in the spring of 2004 and addressed everything from the need for mixing to be done in a clean room to risks, the length of time for which compounds can be stored, employee training, and what centers should have in their written procedures.

According to a recent JCAHO publication regarding USP-797, an organization must follow state laws if they have their own, or have guidelines based on expert opinion and scientific evidence, said Dr. Lin.

Compliance Requirements

Compliance with the standards would require extensive training of staff, plus yearly written tests and observation visits by expert personnel to confirm adherence to procedures. Environmental monitoring, including monthly air sampling, would also be needed. Further, mixed vials would have to be discarded after one week, instead of the typical 12-week remixing that is now common.