Consumer Health specializes in the development of Patient Package Inserts (PPIs) for pharmaceutical companies. The PPIs contain "patient friendly information" for a specific medication and must meet all the clinical, legal, regulatory, marketing and consumer research requirements of the pharmaceutical company. The PPI must be submitted to FDA for approval before it can be distributed with the product for distribution to patients as a counseling tool or before it can be used in any patient education materials or Direct-to-Consumer materials. After FDA approval, Consumer Health works with the company to develop entire patient education programs and DTC programs for the product launch.

The "selected" medical terminology is then translated into language the average consumer can understand (Grade 6 to Grade 8 level). The student will learn the various criteria involved in meeting patient comprehension and readability requirements. The student will learn how to present the early signs and symptoms of an adverse reaction into language that patients can use to detect ADR's. The student will learn how to use graphic design to illustrate complicated concepts, such as how a specific medication works or how to simplify a complicated dosage schedule.

Depending on the specific activities of the company during the clerkship, the student may be involved in the development of patient counseling tools for health professionals to use in their clinical practices. The student will work with our clinical experts, medical writers and editorial staff, production team, graphic designers and patient education experts.

The student may be involved in literature searches for the development of DTC collateral materials that are distributed to consumers through 1-800 numbers, health fairs, TV mailings, etc. There could be an opportunity to work with the graphic design team and learn how important design can be to the effectiveness of consumer programs. There could be an opportunity to participate "behind the glass" and watch a consumer research group respond to a program that the student has helped write.

The student may be involved in electronic literature searches and development of creative web site manuscripts to educate consumers about specific medical conditions, lifestyle changes (diet, exercise, stress reduction), specific medications and other types of therapies used to treat these conditions. Behavior modification and patient compliance techniques will be integrated throughout. Methods of keeping web sites up-to-date and accurate will be discussed.

The student may be involved in the development of "how to use" instructions for these products.

The student may be involved in the development of "package inserts" and pamphlets that will accompany an OTC product. If there is a call for comments in the Federal Register, the student will be involved in helping to prepare comments and testimony.

The student will learn the difference between writing medication instructions for patients and writing general articles for a consumer audience. Students will write an article for their hometown newspaper and submit it to the editor for publication. Consumer Health Information Corporation will support publication of the article with a letter documenting the accuracy and authenticity of the article. The article will be published under the student's name.

The student will conduct electronic retrieval of clinical research articles that are required in the development of patient education programs and updating of clinical reference sources. The student will receive experience in evaluating these articles to determine whether they are appropriate references for the patient/consumer program being developed.

The student will learn how to translate complicated medical terminology into language that the average patient/consumer can understand. The patient compliance problems that can be expected to occur in the specific program audience will be addressed and the student will learn the importance of behavioral psychology and counseling techniques in the development of patient education programs. Depending on the activities of the company, the student will learn the issues that must be addressed in the development of written medication instructions that are clinically accurate, motivate patients and meet the marketing and legal requirements of the client. These techniques can be directly applied by the student to patient counseling in hospital and ambulatory practice.