Currently the FDA is collecting comments for a Federal Register notice to amend labeling regulations to make electronic distribution of prescribing information for healthcare professionals the norm. The FDA wants to hear from stakeholders since a GAO report from 2013 failed to find consensus on whether eliminating the paper insert would prove advantageous or not. Drug manufacturers have been in support of the change since it will save them money from printing the inserts, but others are concerned the public health could be affected when Internet access is not available.
Let’s take a trip in our DeLorean for a minute and recognize that the package insert has been a part of pharmacy since long before we could use a computer to find out what time a movie was playing or if that weird mole on our arm might be cancer. The insert has been revised multiple times to its current version, with added features such as a highlights section, benefits and risks, and an Internet address. The modern insert contains more information than the original format, and sometimes the layout and font can make finding information a challenge.
Another issue with the paper based package insert is that the information contained within is usually outdated by the time it accompanies a product FDA research found that the time for new inserts to reach the market ranged from 3 months to as long as 39 months. The time for a new label to appear is a culmination of change processes that start with FDA approval of changes. The new version then has to be printed, assembled, and folded. Then the document is has to be applied to products that are packaged and distributed based on fluctuating market demands. The current FDA effort attempts to put a Flux Capacitor into the package insert and make the real time data exchange of the Internet the norm for healthcare providers. Changing the standard for provision of information to a Web-based repository eliminates the lag time for information to the market, which has patient safety impacts.
Beyond the time improvements, healthcare providers could subscribe to features such as RSS feeds that would alert them of black box warnings or other significant labeling changes. Let’s go one step further: What if the website was built with mobile users in mind from inception? The Pew Research Center estimates that 63% of adults use their phones to go online and half of them almost exclusively search the Internet using a smartphone. Since 58% of adults have a smartphone, many pharmacists could benefit if the FDA considered that the package insert searches might be mobile and thus should support app-based inserts.
The GAO report cited concerns over impacting pharmacist workflow in changing from a paper insert to Web based format. But one of the great things about mobile apps is that they focus on the flow a user takes to interact with the app, and in the case of a mobile based package insert a pharmacist could jump straight to pregnancy warnings, side effects, or pediatric dosing in a manner similar to booking a hotel room. An app could also allow user defined preferences for allowing updated information like new indications to push directly to the user through the app. Or a pharmacist could scan the barcode on a bottle to jump straight to the FDA package insert for product(s), making the search even more efficient. The comment period for the notice closes on March 18, 2015, so there is still time to have your voice heard and tell the FDA that you need one more reason to not be able to put down your smartphone.
Dr. Marc Young, Pharm.D., M.S., B.C.P.S, P.M.P., F.A.S.H.P. is chief strategy officer for Nationwide Pharmaceutical, which focuses on four core areas: business consulting (pharmaceuticals and technology); data analytics and audits; litigation support; and pharmaceutical repackaging. Marc was commissioned as a naval officer and served 20 years under various assignments in critical care settings before moving into the informatics arena as a project and program manager.