The Food and Drug Administration (FDA) is the primary regulatory body for food products, pharmaceutical drugs, and many medical products in the United States. You might be wondering, though, how exactly the Food and Drug Administration interacts with hospitals and other healthcare providers. What kinds of decisions rest with hospital administrators and which are made by the FDA? How much control does the FDA have over day-to-day operations in a modern hospital?
Many hospitals have their own pharmacies to deal with the high volume of pharmaceutical drugs prescribed during patient treatments. As with any FDA-sanctioned pharmacy, hospital pharmacies operate with fully trained and licensed pharmacists. The pharmacies themselves are subject to the same standards as pharmacies operating outside a hospital. This means that the FDA is responsible for regulating, testing, and distributing all the pharmaceutical drugs that hospital pharmacies stock. Hospital pharmacists operate in a medical climate that is perhaps even less forgiving of error than traditional or retail pharmacies, so many hospitals also employ software network programs to help reduce physician error.
You might be wondering: what about healthcare reform legislation? Did Obamacare make sweeping changes to how the FDA operates in hospitals? The Affordable Care Act of 2010 (also known as Obamacare or the ACA) intersects with healthcare providers in unique ways, given that its original purpose was to expand US citizens’ access to healthcare services. The ACA is the largest piece of healthcare reform legislated in the United States since the creation of Medicare (a form of socialized health insurance available to all citizens over the age of 65). Perhaps unsurprisingly, the Affordable Care Act created a massive controversy by mandating that all companies with 50 or more full-time employees would be required to provide health insurance for their full-time staff. The ACA also created the Small Business Health Options Program (SHOP) to give small business owners an option when it comes to purchasing healthcare benefits.
When it comes to hospitals and the Food and Drug Administration, the Affordable Care Act’s role may be more difficult to discern. After a revision made by the ACA, the Social Security Act, 42 U.S.C 1301 received a new section: 6004. This portion of the Social Security Act now requires pharmaceutical drug distribution information from all authorized US distributors. The legislation is geared toward better tracking of drug sample requests and requires signatures from all persons who sign for the request along the way. Hospital administrators will use this information to track where their drug sample requests are coming from, as well as which institutions employ the people who are requesting the pharmaceutical drugs in question