“What do they all mean?” my mother asked me as she points to a section called “Brief Summary of Prescribing Information” in the February 2004 issue of Reader’s Digest magazine.

“It took me an hour, one magnifying glass and a medical dictionary to read just one page and I still don’t know what they’re talking about!” Frustrated, she looked at me, “You’re in pharmacy school. Maybe you can understand this language better. This was a waste of my time!”

I picked up the magazine as I watched my mother walk away. The ad was for Celebrex® (celecoxib), a medicine used to treat pain and swelling. The heading, “One pill. 24 hours. If the joint pain of osteoarthritis is holding you back, ask your doctor about Celebrex®.” appeared boldly on top.

Then I turned to the back of the ad to read the medicine information called the “Brief Summary” that my mother was having trouble understanding. The page was filled with tiny print letters and hard medical words like those above. A few minutes into reading the page, I realized the reason for my mother’s frustration.

As a pharmacist, my first thoughts were:

• There must be a better way to explain this information.
• How does anyone find this information useful if they can’t understand it?
• Why do drug companies put this technical information on the back of Direct-To-Consumer ads?

In the search for the answers, I turned to the Food and Drug Administration.

FDA’s guidelines
The FDA requires that drug companies provide consumers with risks and benefits information with every drug ad. Drug companies have a choice. They can either print the FDA-approved Brief Summary (developed for health professionals) or a FDA-approved Patient Package Insert (PPI) (developed for consumers) on the back of each drug ad.

The Pitfalls of the Brief Summary from the Consumer’s View
When a prescription drug is approved by FDA, the company must develop a Brief Summary that contains technical information about the drug for doctors, pharmacists and other health professionals. It was never intended to be given to patients.

Many critics say the Brief Summary contains no useful information for consumers. A person needs some medical background to understand it. For example, in 2002, FDA did a survey of consumers and found that about 73% of people read little or none of this Brief Summary. This is a serious problem since many consumers are relying on this information to determine whether they want to ask their doctor about the drug being advertised.

So why do drug companies still use Brief Summaries in their ads? One reason is that the Brief Summary has already been approved by FDA and it is cheaper to use this document rather than develop one in language that patients can understand. Some companies used to be concerned that it was risky to select important information and translate it for consumers. However, the courts are starting to challenge this and warning that it is too risky for consumers to receive drug information they cannot understand.

Consumers need drug information they can understand!
More and more drug companies are convinced that consumers need information about their medicines in language they can understand. Drug companies are not required to have PPIs. However, some companies have developed PPIs to replace Brief Summaries because they know that it is important to provide information that consumers can understand. They are willing to invest the time and money it takes to develop a Patient Package Insert (PPI) and get FDA to approve its use as a replacement for the Brief Summary in DTC ads.

In the long run, it is very important to a drug company that people taking their medicines know how to manage them safely and wisely. This means they need to understand how to take the medicine, what to tell the doctor, the common side effects and what to do if they happen, what to do if an overdose is taken, and how to know if the drug is working as it should.

How do I know which drug ad has a PPI?
You can tell just by looking at how it is written. If it is written in language that a non-medical person can understand, it is probably a PPI. You can also visit a drug company’s website or call the 800 number that is often listed on the front of the ad and ask for a copy if available.

What is the FDA doing to make sure consumers receive information they can understand?
On February 4th 2004, the FDA issued new guidelines for drug companies to improve their Brief Summaries. Companies are encouraged to make information clear and easy to understand. Only the most important information should be provided. “Less is more for the consumers,” said FDA Commissioner, Mark McClellan. He also believes information for consumers should be explained in language that is easy to read and understand.

What can I do to make sure I understand information about my medicine?

• When you come across something you don’t understand in a drug ad, write it down
  or draw a circle around it.
• Ask your doctor or pharmacist to explain this information to you.
• Every drug has side effects. It’s important to know what they are. If you do not understand any of the side effects listed in the Brief Summary, ask your doctor or pharmacist to explain and describe these side effects to you. Do not leave until you fully understand the information.
• Write down the information.
• Some side effects are more dangerous than others. Ask your doctor or pharmacist which side effects you should be most concerned about.
• Report any side effects that bother you to your pharmacist and doctor.
• The advertised drug is not for everyone. Discuss with your doctor if the medicine is right for you. Make sure you understand how to take your medicine correctly.

The FDA and many drug companies have tried to improve the information that we get about our medicines. But we can help by taking an active role and seeking answers for ourselves. Take control of your health and ask questions until you understand the information that is given to you.