With FDA’s most recent action regarding NSAIDs, the agency is looking to you, the packaging professional, to help educate patients.

For instance, FDA has asked Pfizer to print boxed warnings on its Celebrex labels. The agency is also asking manufacturers of all other prescription NSAIDs to revise their labeling to include boxed warnings on the increased risks of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Medication Guides will also need to be produced for these drugs to explain these risks to patients in greater detail. Finally, FDA is asking manufacturers of all over-the-counter NSAIDs to change their labels to address CV and GI risks.

Of course, printed warnings on drug packaging are hardly new, and medication guides have been required for a number of drugs. So what is newsworthy about such labeling, you ask? FDA believes that these warnings and medication guides will help the millions of Americans who use NSAIDs daily make life-and-death decisions. Rather than take any blanket action to remove all these products from the market (only Vioxx and Bextra are off the market), FDA is turning to patient education, leaving the question of NSAID use up to patients and their doctors.

FDA realizes that patients need the full story from manufacturers—not just pharmacists or other healthcare practitioners—to make such decisions. The best way manufacturers can tell that story is through consistent, detailed labeling provided on unit-of-use packaging. While the educational materials that pharmacists provide can serve as useful additions, they should not be the only written materials that patients receive. You have a vested interest in making sure that your customer—the patient—understands your product’s risks and benefits. Patient safety—and product success—is on the line.

FDA stresses the importance of written drug information. “Increasing the percentage of patients who receive both oral and written prescription medicine information has been included in objectives for the nation’s medical safety in Healthy People 2010,” concludes CDER after a survey on prescription medicine information received by consumers. FDA is also participating in Healthy People 2010. According to the group’s Web site, "Available data have not established that oral counseling of patients about medications is more effective than written instructions. Indeed, the advent of new avenues for acquisition of medications (e.g., by mail order or by purchase through the Internet) has highlighted the importance of accurate written information."

FDA, however, has not directed manufacturers to provide written drug information with every prescription. But pharmaceutical manufacturers should consider doing so. Switching to unit-of-use packages that can carry complete warnings and product information is a significant investment. But you will best serve your customer with them.