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The Issue: Burdensome plasma center regulations in Ohio

Primary immunodeficiencies (PIs) include more than 400 types of rare, chronic disorders in which part of the body's immune system functions improperly because of genetic or intrinsic defects. Fortunately, most people with PI can live healthy and productive lives if they receive lifelong immunoglobulin (Ig) replacement therapy to replace the antibodies their body is unable to sufficiently produce. However, because Ig is made from human plasma, it cannot be produced without a continuous supply of source plasma from donors. It takes approximately 130 plasma donations to produce enough immunoglobulin to treat a single adult with PI for one year. As a result, the PI community relies on an adequate number of plasma donors and donation centers across the country. While Ohio currently has plasma donation centers across the state, burdensome regulations placed on these centers limit their efficiency. These burdens hinder the productivity of healthcare professionals during plasma collection in Ohio, and in turn negatively impact the success of plasma centers themselves.

The Solution: Raise awareness about plasma donation and urge legislators to introduce legislation to synchronize Ohio’s regulations with those in much of the rest of the country.

Presently, Ohio’s regulations for plasma donation centers are out of sync with those present in many of the 44 states across the country where plasma is donated. While there are just over 40 plasma collection centers currently functioning throughout the state, Ohio Law strictly limits which licensed healthcare workers can supervise plasmapheresis at these centers. This burdensome regulation effectively prevents healthcare professionals from being utilized to their highest ability, resulting in a less efficient plasma collection process. To rectify this, legislation must be introduced and passed in the Ohio Legislature that expands the list of qualified professionals who are permitted to supervise this practice in plasma donation centers. A similar measure was considered by the Ohio Department of Health this spring at the dawn of the COVID-19 pandemic, but was unfortunately unsuccessful. Addressing this unreasonable regulation and synchronizing Ohio’s code with federal law will assist healthcare professionals in their administration of essential activities, reduce the pressure on an already strained workforce, and supply the plasma needed for essential treatments and therapies.

Why Supporting Adequate Plasma Donation is Important to Our Community

Updating the governance surrounding plasma donation in Ohio can help meet the need for plasma and plasma-derived products which is growing each year in the U.S. and globally. The plasma donations in Ohio are the first step to manufacturing therapies primarily used in the treatment of PI and other genetic, chronic, life-threatening conditions. Therefore, instituting reasonable plasma center regulations in the state that support a more efficient collection process, will promote plasma donation in Ohio without sacrificing the safety of plasma donors and users.