Anyone who has gotten a prescription probably knows that there are patient information sheets included in that information. Some patients might have also seen that there are information sheets in prescription packaging that are meant for medical professionals. If the Food and Drug Administration has its way, that information would soon be handed to medical professionals in an electronic format instead of in paper form.
The change to electronic drug labeling has some people concerned. Some legislators and patient safety groups say that the electronic format could put patients at risk.
The FDA says that the electronic format actually helps to protect patients because the electronic format allows for new information to be disbursed. With the paper format, updated information isn’t readily available if the drug is on a shelf when the update is made. For this reason, drugs on the shelves might not have the most accurate and up-to-date information.
Pharmaceutical companies agree with the FDA. They have been fighting for electronic distribution for a long time. Electronic distribution of the physician materials could save considerable money.
Under the proposed regulation, distributing the information on paper would be barred. Pharmaceutical companies would have to set up a 24-hour toll-free line that allows health care professionals the option of getting paper information, which could be useful if there isn’t any Internet access or during a power outage.
Improving prescription drug safety is extremely important. Improperly prescribed medications can lead to serious patient harm. Patients who are given incorrect medications can often suffer from long-term, negative effects. In those cases, the patients are often left to worry about mounting medical bills and other problems.
Source: Regulatory Affairs Professionals Society, “FDA’s Electronic Drug Labeling Proposal Comes Under Fire,” Alexander Gaffney, RAC, March. 25, 2015