Proposed Vial Mixing Standard May Have Adverse Effects for Otolaryngologists

Estimates for building a clean room start at about $150 per square foot. Such rooms need stainless steel frames, specialized airflow systems, HEPA air filtration, humidity control, and more.

There would be costs behind building the room, training and certifying staff, and the frequent remixing, and questions arise about how to bill or get reimbursed for vials mixed outside if a center has no clean room.

This seems like a lot of trouble and cost for the otolaryngology profession, especially taking into account that there is no evidence in the medical literature showing an increase in infection from immunotherapy from the way mixing is done currently.

There are no papers published on the topic of infections and immunotherapy, Dr. Lin said. To determine whether there was a risk to patients, Dr. Lin and colleagues launched their own study on the topic. Findings were presented by Chase Lay, MD, a resident in otolaryngology at Southern Illinois School of Medicine in Springfield, Ill.

About 10 million immunotherapy injections are administered annually, and vials are prepared in the office. Yet, there is a lack of literature showing patients are at significant risk of local or systemic infection, Dr. Lay said.

A retrospective chart review was done of 284 patients who received a cumulative 13,576 injections from the years 2000 to 2006. Vials were prepared under sterile techniques in designated space without use of a ventilated hood or clean room, he said.

For the study, researchers examined data pertaining to the antigens that were in the vials, the date of mixing and injection, injection site, and whether there were any local or systemic reactions-and, if there were, their causes, treatments, and outcomes.

A total of 23 local reactions in 11 patients occurred, but there were no systemic reactions, patients had no fever or other indication of iatrogenic infection from the injections, and no antibiotics were given. The findings suggest that current mixing practices do not pose an infectious risk for patients, he said.

Additional Immunotherapy Issues

In another presentation on the panel, Byon Yeatts, a principal at the health care consulting company DK Pierce & Associates in Kennebunk, Maine, provided highlights from two studies on immunotherapy and practice by the US Department of Health and Human Services Office of Inspector General (OIG), an office whose overall mission is to detect fraud, waste, and abuse in health care.

The study showed that when it comes to immunotherapy in general, there have been some problems related to issues other than safety of the compounds. One was the 2002 Antigen Preparation report, which provided recommendations for practice expense re-evaluation and Medicare education for providers. The other was the 2006 Immunotherapy for the Medicare Beneficiary report, which stated a need for a national Medicare policy on immunotherapy.