Patient Education vol6


By Dr. Dorothy L. Smith

Internationally recognized expert in patient education, patient compliance, and behavior modification programs and author of 23 books for consumers on prescription drugs.

Improving Compliance by Informing Patients

Vol.6 No.2

peu_smith2Dr. Dorothy L. Smith is an internationally recognized expert in patient education, patient information; patient compliance, and behavior modification programs. She has devoted her career to helping people make informed decisions about health care and use of medications. Dr. Smith is the author of 23 books and has appeared on radio and television programs across the country to increase awareness of the important role consumers play in their prescription drug therapy.In 1983, she founded Consumer Health Information Corporation, a company internationally recognized for its innovative patient information programs. The organization has produced a broad range of print and audiovisual programs that have helped millions of people learn to make wise decisions about their health and medications. The company is a teaching site for several schools of pharmacy across the United States and a member of the Board of Directors of the National Council on Patient Information and Education.The consumer will be the final judge of all the patient communication materials you produce for them. If you can develop information that is written in language that patients can understand and incorporates behavior modification techniques, you will be able to convince the patient that the information is important to their own personal health. Patients will start taking their medications correctly. The health care system will start working as it should .. and I can guarantee that the product’s ROI will increase because patients will not drop out of therapy and will refill their prescriptions.



Companies with whom we have worked with that have replaced their highly technical Brief Summaries with Patient Package Inserts (PPIs) have a headstart on a strong patient compliance program as well as a brilliant competitive edge.


Diminishing the Fear Factor Ray Bullman, executive director of the National Council on Patient Information and Education (NCPIE), underlines the importance of managing side effects in the long-term prescription lifecycle. He says, “Many patients prematurely drop out of therapy because they don’t know what to do if they experience a side effect.” To address that problem and foster better patient compliance, NCPIE and CHIC recently developed a patient information pamphlet that pharma companies and health organizations can brand and distribute to patients. It contains easy-to-read, understandable steps people can take to deal with minor side effects. It also describes what patients should do if the side effects are serious.

While patients in a clinical trial may be slightly more compliant than the post-launch patients, there is still a great deal of uncertainty over how often patients are missing or forgetting doses. The study design and participation of health professionals may be flawless… but if the patient does not understand the medication instructions and any required record keeping, there is a high probability that the patient will make medication errors. These errors can have a severe negative impact on the clinical trial results… including the dosage. Click here to find out how to improve the adherence rate in your clinical trials

2003 Gold Award for DTC program Consumer Health Information Corporations wins Gold Award in the 2003 National Health Information Awards for Fujisawa’s Kidney and Liver Transplant Journal. This multi-component DTC educational program won the Gold Award for the best DTC direct mail piece in the Consumer-Decision Making category. “Fujisawa’s DTC educational program for kidney and liver transplant patients is a good example of what companies can do to take patient education beyond the norm.”

P3C CHIC president, Dr. Dorothy Smith has been appointed to the Advisory Board of the newly formed Pharmacists for the Protection of Patient Care Coalition (P3C). To read the full story, click here.

Why Refills… Not Office Visits… Should be your DTC Goal

DTC’s New Job: Boosting Compliance Dorothy L. Smith, Pharm.D.

Read why “Refills, not office visits, should be the goal of consumer communications,” in the September 2003 Health Literacy Supplement to Pharmaceutical Executive Magazine. In this article, Dr. Dorothy Smith explains how DTC ads can reinforce pharma company messages when patients enter the long-term treatment cycle, help patients stay with that treatment as long as the condition persists -and increase pharma’s profits.

FDA Direct-to-Consumer Promotion: Public Meeting

On September 22 and 23, 2003, the FDA held their Direct-To-Consumer Promotion: Public Meeting. Two important topics include “Brief Summaries” and DTC effect on consumer behavior, summarized below.

Guidelines for “Brief Summaries”The FDA is preparing new draft guidance for direct-to-consumer advertising that addresses the need to improve the effectiveness of “Brief Summaries” in response to an FDA-commissioned study of written information disseminated during 2001. Four widely-used prescription drugs reported the average “usefulness” of the information was only about 50 percent. The statute’s goal for 2006 is that 95 percent of individuals receiving new prescriptions would receive useful written information. Another survey conducted by the Department of Psychiatry at Louisiana State University Medical Center in 2000 showed that almost half of all patients were unable to understand pharmacy printouts.

Commenting that most FDA-mandated “Brief Summaries” in DTC advertising are neither “brief” nor “summaries”, CDER Office of Medical Policy Director Robert Temple, MD, acknowledged the need for improvements. The new draft guidance is expected by year’s end.

According to Dr. Temple, readability and consistency must be improved, and the relative risks and benefits of prescription drugs need to be presented with more balance.

Consumer Health Information Corporation (CHIC) applauds the sentiment, as our emphasis has always been about improving health literacy through readable, consistent, and understandable consumer drug messages.

More effective DTC materials will help consumers make more informed decisions about their medications and learn how to prevent and manage potential side effects.

DTC Effect on Consumer Behavior

CDER Office of Medical Policy Director Robert Temple called for further study of the effect of DTC advertising on consumer behavior.

Presentations at the FDA session examined the effect of DTC advertising on consumer behavior, with results ranging from inconclusive to positive.

The Pink Sheet quoted Temple’s remark that “It’s hard to feel that it’s not reasonable to let people know about conditions they might have but have never explored, and about conditions that they didn’t know could be treated with prescription drugs, in some cases, better than OTC.”

The potential impact of DTC advertising on the improvement of patient compliance is definitely an area that needs to be researched.

As discussed in the September 2003 Health Literacy Supplement to Pharmaceutical Executive, DTC’s New Job: Boosting Compliance, “To persuade patients to remain in therapy, pharma marketers must develop a compliance strategy that meets the varying needs of consumers, patients, and health professionals through all stages of treatment. It must take into account the specific product, disease, and patient population. A patient compliance strategy must be part of the DTC program and subsequent patient information materials.”

DTC programs that are tied to an overall compliance strategy might be able to reverse the alarming patient dropout statistics. For example, 25 percent of patients taking cholesterol medications stopped therapy in the first month and 50 percent quit within three months of starting treatment.

Incorporate Agencies into Early FDA Discussions of DTC Advertising

At the October 2003 Pharmaceutical Marketing Congress, the FDA encouraged pharmaceutical companies to directly involve their marketing and advertising agencies early in the process of developing DTC ad campaigns.

This FDA recommendation underscores the need to bridge the gap between marketing laypeople and the regulatory process. Regulatory issues such as adequate provision and fair balance are at stake – “it is really as much a regulatory discussion as a communications and marketing one” said Associate Commissioner for External Relations Peter Pitts.

Pitts also challenged DTC marketers to strive for balance in their delivery of risk and benefit information. He said, “Challenge yourselves and your ad agencies to address and redress this critical public health disconnect.”

Consumer Health Information Corporation urges pharmaceutical companies to seriously address the impact of patient compliance on clinical trial results. Waiting until prior to product launch usually puts a company in a tailspin. There are several advantages to developing patient information materials early in the product development process:

  • Patient compliance will be improved during the clinical trial
  • The clinical trial results will be more accurate
  • The patient compliance strategy and patient materials can be pre-tested during Phase III and refined for the product’s NDA

Every product entering Phase III needs the following:

  • Patient instructions that meet the requirements for an FDA-approved Patient Package Inserts (PPI) when the NDA is submitted;
  • Educational materials for clinical trials;
  • “Patient-friendly” informed consent documents;
  • Integrated instructional materials for clinical investigators that outline each step of a carefully standardized educational process


Consumer Health Information Corporation is an internationally recognized leader in the development and production of patient education programs for pharmaceutical companies, managed care organizations, and consumers.

Consumer Health Information Corporation (703) 734-0650 | Fax (703) 734-1459

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