Expert Recall

By Mike Rozembajgier

The production and distribution of the H1N1 vaccine in 2009 began as the most ambitious immunization campaign in the history of the United States. By spring 2010, however, the Centers for Disease Control and Prevention (CDC) and state health departments realized that supplies of the vaccine greatly exceeded the rapidly diminishing demand. Hospitals and healthcare providers all across the country found themselves with large supplies of expiring H1N1 vaccine.

In order to safely recover and dispose of the surplus doses of H1N1 vaccine, state health departments have the option of offering healthcare providers in their states a swine flu vaccine return program. Ideally the program will provide adequate notification to healthcare professionals and facilities, call center capabilities to answer their questions about the return process, and proper return and disposal services.

Since most state health departments probably don’t have direct experience with vaccine returns, it is critical that they understand the potential complexity of the process. There are three critical areas on which they must focus:

1. Provide vaccine return services to healthcare providers. This is probably not the first or last time health agencies will be asked to manage a vaccine return. In order to best manage the process, it is critical the agencies put programs and plans in place to handle product return issues whenever they arise.
2. Track the product throughout the return process. In order to protect public health, state health departments must be able to track the surplus vaccine throughout the return process. This includes processing and storage until the product can be disposed of properly.
3. Safely dispose of the surplus vaccine. There are right and wrong ways to dispose of returned pharmaceutical products such as vaccines. It is critical that state health departments properly dispose of the surplus H1N1 vaccine in order to protect public health and the environment.

Surplus H1N1 vaccine doesn’t pose any significant health hazard. There is simply excess supply. This requires a vaccine return – not a recall or withdrawal. While there are differences in the process, the goals are all the same. Remove the product from the market and dispose of it safely.

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