A joke inside the FDA is that the Brief Summary is like the Holy Roman Empire: neither brief nor a summary. But it's an important jump start for a serious question—namely, how can safety information be made more user-friendly? For an answer, I turn to one of my favorite doctors, Dr. Seuss: “Sometimes the questions are complicated and the answers are simple.”
The theory behind safe use is that the most effective way to make a drug safer is to be sure it's used as directed. That means putting safety information in places and formats most accessible to patients. In 2015, that means mobile apps. According to a study from Adherent Health, nearly 75% of prescription-takers use mobile apps, including most older adults and seniors. Indeed, mobile-app adoption rates are high across all medication-taking adult age groups. Plus, new-user data from app-based safe use and outcomes support platform Mobile Health Library (MHL) confirms that, when Important Safety Information is mobile-friendly, it's regularly accessed by on-treatment patients.
Safety information is knowledge. And, in pursuit of public health, knowledge is power.
Consider one year's worth of data for MHL's patient-support app for generic Exemestane: Of all engagement activities available to users, those concerning “side effects and safety” are most popular (at 28%), followed by “savings and refills” (16%), “about condition” (15%), “about Exemestane” (14%) and “dosing reminder” (13%). The safe-use numbers for branded medicines are even higher. For one medicine (a branded epilepsy treatment), patients are accessing the MedGuide at 90%+ rates.
When you match this with data showing the benefits that prescribing physicians (and nurse prescribers) want from patient-support apps, it's an almost-perfect fit. Ninety-four percent of primary care providers list “take Rx as directed” as their number one app priority, with “Rx and disease understanding” a close second (91%) and “conversation reinforcement” third (83%). Again, it's all about the base.
So if the business is truly serious about giving patients what they want, then it needs to convey safety information in the ways they want it. When it comes to safety, it's time for both the FDA and Big Pharma to start saying “App-y New Year.”