A Dose Of Information

CURE, Winter 2007, Volume 6, Issue 6

Cancer patients encounter some direct-to-consumer advertising in print, and the safety information such as side effects and adverse reaction details required by the Food and Drug Administration can be difficult and overwhelming to try to understand.

Cancer drug ads don’t appear on television, with the exception of those for some treatment-related side effects. But cancer patients do encounter direct-to-consumer advertising in print, and the safety information required by the Food and Drug Administration can be daunting to understand.

The FDA requires a brief summary called the prescribing information, commonly referred to as the PI, to accompany all advertisements to provide detail on the drug’s approved use and side effects. In print ads, the safety information required by the FDA appears on the page or pages following the ad.

Cheryl Perkins, MD, senior clinical advisor for Susan G. Komen for the Cure, says the PI gives patients additional information about the drug they have been prescribed and its possible side effects, as well as how to take the drug and when they should contact their doctor—say if they read about an adverse reaction with another drug they are taking that they forgot to mention to their doctor.

“Patient information helps inform and educate the patient,” says Dr. Perkins. “With the doctors as busy as they are, it’s another tool. Because sometimes a patient doesn’t have time to ask all the questions, such as, ‘Why am I taking this drug? What does it do, and what are the benefits?’ ”

Most importantly, Dr. Perkins adds, the PI lists side effects that are both common and uncommon, and, while the patient probably won’t have all the side effects, they can be aware of and prepared for what may occur. “In this case, the doctor may have an alternative he or she can prescribe. So if you have a problem taking it, a conversation with the doctor can get you an alternative drug.”

Dr. Perkins, also a registered pharmacist, says the same information is on the package insert of every drug, and it’s a good idea for patients to ask their pharmacists to include the insert with any prescription. The pharmacist, she says, is also an important resource for discussing side effects.

Some drug companies are submitting new consumer-friendly and consumer-tested print summaries, the part of the print ad that lists the risks of a medication. Dr. Perkins says the patient materials should be written for those who didn’t go to medical school, adding that attention needs to be paid to the ways people get and use information.

Dr. Perkins says when reading the PI, patients should look for the specific use of the drug, benefit information, common side effects, and risks. Learn the order of the information and then scan for the information that is of specific importance, such as drug reactions. If the information isn’t included, it should be on the product’s website. The PI also provides detail on the typical dose and schedule, as well as whether the drug is oral, intravenous, or injected.

Any questions not answered in the PI can be directed to the patient’s doctor, which may make the discussion more meaningful than simply asking, “Is this drug right for me?”