Your Patient Package Insert: Does It Help or Hinder?


advertisements require precise wording to meet the different needs of the consumer, the product manager, the regulatory division, and FDA. Companies put great effort into making sure the front of the ad catches the consumer’s attention. The ultimate goal is to persuade the consumer to take the next step–whether that involves calling an 800 number or going to the doctor.

But what about the back of the ad? Is the technical information presented there helping or hindering the company’s marketing goals? How many consumers are confused, frightened, or turned off by what they read there?

The Patient Package Insert influences the impact of both the DTC advertising and the entire patient compliance program. It should function as the foundation of the consumer information and compliance programs. Pharmaceutical companies are already working to deliver two basic DTC ad requirements–accuracy and attention-getting.


The Patient Package Insert should be so solid clinically that its content provides a good roadmap for handling FDA regulatory issues or concerns later. Achieving that level of accuracy requires the ability to review Professional Labeling with an eye to both what is important for the consumer to know and what FDA will demand to see.


That’s a fine line. It is easy to err on the side of providing too much irrelevant information “just to be safe,” but doing so will not inform consumers and may frighten them. It is also easy to err on the side of providing too little information, which will cause problems with FDA and may result in potentially expensive problems that delay the product launch.

At the same time, the DTC ad must use effective design and graphics to grab the consumers’ attention or they won’t read it. The design and graphics must be germane to the health concerns of the targeted consumer audience. In other words, a DTC ad for an anti-arthritic medication must be meaningful to that specific patient population, or that group will disregard it. It is true that a picture can be worth a thousand words, but only if it is integrated with and reinforces the written message.

Maximizing the DTC Opportunity

DTC ads are expensive to develop and place. Consumers don’t trust ads that are obviously designed only to sell them something. To gain their trust, pharmaceutical companies must provide practical information that will help them understand why they should take the next step. The Patient Package Insert offers companies their best opportunity to do that. Thus, pharmaceutical companies should address three additional issues: readability, comprehensibility, and recall.


Literacy research has proven that consumers cannot understand the Professional Brief Summaries used in many DTC ads. They need Patient Package Inserts that present the FDA-mandated information at the Grade 6 to 8 reading level. That means writing high blood pressure instead of the medical term hypertension, because the majority of the population will not understand it.


Consumers may be able to read the ad, but will they understand what it means? For example, product information may advise consumers not to eat red meat with some medications. Many consumers do not know which foods to classify as red meat. Think about it … often, beef is not red after it is cooked. Many consumers might not consider that to be red meat. What about hot dogs? Swedish meatballs? Hamburgers? Ribs?


The Patient Package Insert can be the foundation for all the patient education messages to come. Pharmaceutical companies want the consumer to remember seeing their DTC messages in a very competitive media environment. If they skillfully incorporate patient behavioral modification techniques into both the content and design, they will have a better chance of maximizing their DTC opportunity.

Further, if the doctor can hand the patient a pamphlet or tearsheet that builds upon the Patient Package Insert at the time of prescription, it will reinforce the main product message and become an effective part of the patient compliance strategy. A consistent and integrated message can even help motivate the patient to take the medication correctly and get it refilled on time.

Today’s consumers are becoming more and more educated about their health. A company’s return on investment depends heavily on the impact that its DTC ads have on consumer behavior and how well those ads motivate consumers to request more information. Pharmaceutical companies cannot afford to ignore the importance of the Patient Package Insert in their overall DTC strategy.

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, May 1999. Copyrighted material; All rights reserved.