Patient Labeling is Here to Stay

They represent only a small part of a prescription drug’s budget, but the patient instructions developed for a medication can have a tremendous impact on the success of a DTC campaign, product launch, or refill compliance program. To place “consumer-friendly” instructions on the back of a DTC ad, a company must submit a Patient Package Insert (PPI) to FDA for approval. The pharmaceutical companies that have taken the extra step to develop PPIs recognize that it is in their best interests to make sure people know how to take their products correctly and have them refilled on time.

Consider the facts:

  • Consumers need more information about medications because the health care system is forcing them to take more responsibility for their health care.
  • Patient noncompliance with medications continues to cost the United States more than $100 billion a year. Taxpayers and employers pay the additional costs of increased health care, time lost from work, and side-effect-related accidents at work.
  • When consumers receive information they can believe and understand, they start to take their medications correctly, refill their prescriptions on time, lose less time from work–and health care costs go down while product sales go up.

Call to Action

For years, FDA has been one of the strongest proponents of patient information. The agency has consistently pushed for medication information that is in language consumers can understand and that provides a fair balance in presenting the benefits and risks.

Several pharmaceutical companies have voluntarily developed PPIs for some of their products, and FDA has approved them. Some PPIs are exceptionally well done in content and design. Some companies have even incorporated illustrations to help consumers understand how the medication works. That is useful because research has shown that people will be more likely to take a medication initially if they can understand why they need it. Otherwise, 10 percent decide right in the doctor’s office not to fill the initial prescription.

Well-done PPIs not only meet the patient’s needs, but companies can successfully integrate them into the marketing strategy for the product. Obviously, too few companies have stepped up to the plate in this regard–at least in FDA’s opinion.

On 1 December 1998, FDA issued “Medication Guide” requirements, to take effect 1 June 1999, which will give FDA the authority to require patient labeling for medications that FDA believes “pose a serious and significant public health concern.” FDA anticipates that an average of “no more than 5 to 10 products per year” will require that type of labeling. Although those regulations do not apply to every prescription drug–and FDA will decide that on a case-by-case basis–they certainly send a message to companies that FDA considers the need for “consumer-friendly” information critical and will intervene when it believes it is necessary.

FDA is explicit about the format of the labeling for the “selected” products. For instance, FDA’s rules will require that the first heading on the sheet be called: “What is the most important information I should know about (the product)?” That is where the company must spell out the “particular serious and significant public health concerns that has created the need for the Medication Guide.” That section will detail information on “weighing particular risks against the benefits of the drug, avoiding particular behaviors (e.g., activities, drugs), observing certain events (e.g., symptoms, signs) that could prevent or mitigate a serious adverse effect, or engaging in particular behaviors (e.g., adhering to the dosage regimen).”

Negative Impressions


Frankly, the labeling format is going to create problems for consumers. For example, when a physician decides that a patient needs surgery because the benefits outweigh the risks, the surgeon does not begin the discussion by presenting the risks of dying while in surgery. That is important, of course–at the proper time–for the patient to know. But if all surgeons began their initial explanations that way, nobody would opt for surgery, even if the need for it was clear.

Similarly with a medication, patients want to know how the drug will help them and then want to be able to decide if the benefits outweigh the risks. Physicians never tell patients the risks before they tell them the benefits. It puts everything out of context.

By listing negative issues at the outset, consumers could become needlessly anxious. Once people become anxious, they forget half of all information given to them. That can only lead to even more people not taking their medicines correctly, which is the exact opposite of what FDA and health professionals want to achieve.

Companies cannot effectively standardize patient instructions for every medication. That is because patient compliance problems that apply to one disease do not necessarily apply to every disease–or every drug, or every patient population. If you want people to read your DTC ads and you want the ads to mean something, you must develop PPIs that answer the consumers’ questions that are unique to the medication, the disease, and its administration.

The order in which the company presents the information is critical. The goal is to motivate patients to take the medication correctly–not frighten them with a long list of risks right at the outset. Companies have to put those risks into context. In addition, companies must use different patient counseling techniques to develop the PPIs for a product used to treat schizophrenia versus a product used to treat arthritis.

Sound Principles


The key is to develop the DTC campaign so it is based on principles similar to the counseling techniques that health professionals use in one-on-one situations. Simply rewriting the “professional labeling” in nontechnical language is inadequate. Comprehension–the ability of consumers to understand the message–plays a significant role in the DTC ad’s success.

But comprehension is only part of it. The next, and perhaps most important, step is to spur the consumer to act. The companies that have been successful are those that recognize that standardized information cannot accomplish that. Those companies realize the importance of skillfully applied behavior-modification techniques that are developed for a specific target group of consumers, a specific drug, and the specific disease being treated.

Even though the recent FDA regulations don’t apply to every product, FDA has clearly shown that it means business–on about 5 to 10 products per year. My question as a consumer is: “Why should I expect that the information provided about the product is going to be of more benefit to me because it follows the strict format developed by FDA?”

Wouldn’t it make more sense to ensure that consumers receive information on each product tailored to all the unique patient education needs of the people who will be taking it? Consumers definitely need the information FDA is requiring. There is no argument about what information companies should give to consumers–the question is how companies should present the information so that consumers receive it in a logical sequence and tone that will help promote patient compliance.

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, January 1999. Copyrighted material; All rights reserved.