By Robert Y. Lin, MD
The American Academy of Allergy, Asthma and Immunology has raised the specter of new requirements for the preparation of allergen extracts in the United States. The U.S. Federal Food, Drug, and Cosmetics Act designates the United States Pharmacopeia and The National Formulary (USP–NF) as official compendia for drugs marketed in the United States. A drug product in the U.S. market must conform to the standards in USP–NF to avoid possible charges of adulteration and misbranding. One of the key aspects of the requirements is safety related to improper medication handling.
Immunotherapy extracts are typically prepared by allergy offices and are customized for each patient based on documented sensitivity, prior treatments, clinical relevance and patient goals. Allergen extracts are most frequently administered in the allergy office, where adjustments of dosing can be made based on side effects, and deviations from the scheduled injections. The proposal by the USP-NF would require allergen preparations to be made with shorter expiration dates despite the fact that significant infections from allergen immunotherapy has not in fact been documented and bacteriologic studies relating to infection risk to shorter expiration dates has not been published.
The concept of discarding opened vials after a given period of time relates to the possibility of contamination, for example with multidose vials for use in different patients. Some medications that are typically provided as a multi-dose vial for different patients include purified protein derivative (a skin test for tuberculosis) and influenza vaccine. A vial may have an expiration date in the next calendar year, but the vial will have a label, “discard within 30 days after opening”. Hospitals typically have this 30-day requirement for all opened vials.
There is a concept in modern medicine called “evidence-based medicine”. It means that our practice of medicine should be grounded in proven outcomes. Does the discarding of vials opened for more than 30 days result in less contamination than discarding allergy vials after 60 days or 90 days or 180 days? Are individual patients vials that are 6 months old prone to infection? There is no evidence that this is the case. Should patients and the health case system have to bear the cost of preparing new vials every month when they can be prepared every 6 months for a fraction of that cost without any risk of infection? Would this requirement increase the labor for preparation requirement/costs and force allergists to use third-party companies to prepare the vials? Wastage from unfunded mandates and policies not grounded in evidence is not in the interest of allergy patients.
Dr. Robert Y. Lin, completed his bachelor’s degree at University of California, Berkeley and received his medical degree from SUNY-Downstate, where he also completed clinical training in internal medicine and allergy/immunology. He has been professor of medicine at New York Medical College since 1995 and was appointed professor of clinical medicine at Weill-Cornell Medical College in 2012. He also served as president of the New York Allergy & Asthma Society. He has a master’s degree in biostatistics and is involved with medical care utilization. For 20 years he headed allergy and immunology at St Vincent’s Hospital, where he researched and published in many areas including sepsis, asthma, allergic rhinitis, AIDS, food allergy and anaphylaxis. He is editor-in-chief of The Internet Journal of Asthma, Allergy, and Immunology and has lectured extensively. Now at New York Presbyterian – Lower Manhattan Hospital, he treats both adults and children in both outpatient and inpatient settings. His offices are at or near the hospital. Dr. Lin is also a consultant and speaker.