Safety organizations call on FDA to regulate allergy shots

To help prevent infections and other health problems caused by contaminated allergy shots administered to patients during immunotherapy treatments, several organizations are pushing for the U.S. Food and Drug Administration (FDA) to adopt regulations that will hold physicians accountable for such poor conditions.

Negative outcomes can occur in patients if physicians mix solutions in non-sterile environments with sick patients nearby. Lack of educated supervision, sloppy documentation and ill-trained staff can also contribute to these problems and put patients at risk for infection and other negative outcomes.

Right now, the FDA has no official regulations, and physicians are responsible for ensuring their work spaces and medications are sterile.

One of the organizations calling for reform, the Association for Precision Pharmacy Services (APRXS), is calling for health inspectors to monitor physician-made solutions.

"Our association is certainly not opposed to the physician's ability to store and mix allergens in their own offices," said Noah Hanson, executive director of APRXS. "We simply want to ensure that they follow the same sterility regulations as precision pharmacies in order to protect patients, both adults and children, from the prospect of infection from injections with tainted, adulterated, outdated or incorrectly compounded drugs. Consumers deserve to know the sterility conditions of their doctor's office when they go there for compounded allergy injections and our advice is don't be hesitant to ask."