In the United States more money is spent each year to treat the complications of home medication errors than to pay for prescribed medications. Why? Patients don’t receive enough information – or the right kind of information – to manage their medications safely and effectively.
A recent conference sponsored by FDA and the National Patient Safety Foundation, “Safe Medical Treatments: Everyone Has A Role,” brought consumers and health care providers together to discuss ways to improve patient safety. The message was loud and clear. No medication is safe and unless the patient uses it correctly. It’s not a matter of blame. Conferees agreed that consumers need adequate information so they can manage their medications safely.
Research shows that home medication errors can be cut in half if patients are given high quality education – particularly about the side effects that may lead to inappropriate patient decisions – throughout their therapy. The question is: “Can DTC ads make an important contribution to patient safety and help reduce home medication errors?”
How much do consumers need to know about side effects? An FDA study found that almost half of the public believe DTC ads offer insufficient side-effect information. Consumers need more than just a simple list of potential side effects. They need to know what to do if they develop any of the initial symptoms.
Advertising Age recently reviewed how DTC advertisers are handling the thorny side-effect information issue. Quotes from ad agencies and pharmaceutical companies seem to reflect a growing appreciation of consumer demands for accurate and practical information about pharmaceutical products:
“Consumers want to be fully informed, and that includes both benefits and risks.”
“It’s to the consumer’s benefit that we share with them what are the most common side effects.”
Ad Age illustrated the article with an ad for Bristol-Myers Squibb’s anxiety drug BuSpar to show how DTC ads give side effects “equal time.” The copy on the ad’s front does, in fact, advise readers of possible drug interactions and that “some people may experience side effects such as excitement, dizziness, nausea, headache, lightheadedness, and nervousness.”
Unfortunately, those are the only useful comments the ad gives, because the next line tells them to turn the page for “additional important information.” There, readers find a Package Insert written for health professionals and presented in a block of fine print shoehorned into two-thirds of the page. Thus, although the ad satisfies FDA’s requirements to disclose possible risks, it fails to answer questions consumers are certain to have.
- How likely is it the product will make me dizzy or lightheaded?
- Will this keep me from driving my car or going to work?
- How can I manage these side effects?
Consumers have a unique perspective on medication risk management that is valuable to postmarketing surveillance programs.
A 1999 article, “Understanding Adverse Drug Reaction Symptoms,” published by the Journal of the Drug Information Association, verified that “patients want to share information about the drug reactions they experience.” The article revealed that
- more than 40 percent of ADR reports submitted to FDA are from consumers, and the number is growing.
- nearly one-third of reports originating from physicians may be prompted by patient reports of symptoms and their attribution to a medication.
The article concluded, “The information patients have to share about adverse drug reactions does contribute to our knowledge of drug safety.”
If encouraged to report those experiences to their health professionals and FDA, consumers will become allies in their own care, enabling pharmaceutical companies to develop more accurate and practical risk management information for patients.
DTC ads are a key avenue through which to deliver that information. Consumers who read the ads will learn to identify the early symptoms of adverse drug reactions and can perhaps minimize those effects. And as companies, in turn, gather more adverse drug reaction information from consumers, DTC ads will become an increasingly useful tool to improve patient safety.
Dr. Dorothy L. Smith is a consumer education expert and president of Consumer Health Information Corporation. The full-service company specializes in patient labeling, program development, and strategic planning for DTC campaigns.
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Published in Pharmaceutical Executive, June 2000. Copyrighted material; All rights reserved.