Satisfy the Curious Consumer
When preparing your package inserts, be advised that pharmacists and doctors aren’t the only ones reading them—patients are, too. A recent study by Accenture (New York City) found that more than half of the respondents (57%) always read the package insert supplied with their new prescriptions. Given the fact that such inserts are usually written in scientific terminology meant for the professional, “it’s a much higher percentage than I thought it would be,” says Philip George, a partner in Accenture’s Health & Life Sciences practice. Only 2% of respondents said they never read inserts.
The insert isn’t the main source of patient information, of course. The study found that the three top “trusted” sources for information are the physician (61%), the pharmacist (16%), and online medical sites (13%). “Our study confirms that the physician is the trusted source for information,” says George.
But patients are hungry for drug information. Accenture reports that respondents “conduct more research today than they did five years ago . . . to identify potential safety risks and side effects related to medications prescribed for them (cited by 81%) and to educate themselves so that they can play a larger role in their medical care (cited by 76%).”
FDA even advises consumers to read inserts. “Ask your pharmacist for the package insert for each prescription drug you take. The package insert provides more information about potential drug interactions,” FDA tells consumers on its Web site.
FDA’s new requirements for package inserts will certainly make them more patient friendly. “With a drug summary up front, the FDA guidelines will help,” says George. “But drug companies should use this opportunity to check with patients about layout and font size. The examples I have seen still use a small font.” (For more on these rules, visit www.fda.gov/cder/regulatory/physLabel/default.htm.)
Font size continues to be a sticking point. Including all the formulation and clinical data in a manageably sized insert is an ongoing challenge, so increasing font sizes would be even more taxing. But suppliers like Vijuk Equipment Inc. (Elmhurst, IL), with its MV-2005 outsert system, and Fraser Papers, with its specialty pharmaceutical-grade insert papers, offer machinery and material solutions, respectively, for handling longer inserts with more panels. So there may be no more excuses.
With so many patients reading inserts, “more work needs to be done to get patient-friendly information out there,” advises George. “It needs to be easy to read and easy to digest.” Supplements to package inserts, such as Medication Guides, may also be in order.
Consider the insert an opportunity to inform, not intimidate, patients. Clearly stated instructions for use in a patient-friendly font and format are just what the doctor ordered.