Preceptor

Robert W. Pfeifer, M.S., R.Ph.
Manager, Drug Regulatory Affairs

Description

In a final rule published in the Federal Register on August 27, 1997, the FDA established the Geriatric Use subsection of the labeling for human prescription drug and biological products to provide pertinent information about the use of those products in the elderly (persons aged 65 and over). As a result, companies are required to submit geriatric labeling supplements containing information on the use of these products in the elderly.

Sources of data on use in the elderly can include the company's clinical trial data (if any), adverse event reports, and the medical literature. In Roxane's case, the majority of the information will most likely come from a comprehensive literature search and review. The submission should state how the medical literature was searched (e.g., Medline), the beginning and ending dates covered by the search (month/year to month/year) and the date(s) the search was performed. A complete listing of the literature reports reviewed by the company should be included, but a summary of each article is not necessary. Only those articles that support the labeling change should be summarized, and a copy of the article should be included in the submission.

Objectives

1. Conduct effective literature search strategies and proficiency in the use of computerized information databases.

2. Review existing clinical trial and adverse event databases for information concerning use and outcomes of a prescription drug product's use in the elderly population.

3. Collate a potentially large amount of information (clinical trials, adverse events, and literature) into a concise and effective statement on the use of a prescription drug product in the elderly for inclusion into the drug's prescribing information (i.e., "package insert").

4. Develop the skills to assemble an effective Labeling Supplement for submission to the FDA.
   

Requirements and Activities

1. To be present at the site for a minimum of 40 hours per week, or at off-site location as dictated by the nature of the work being completed and agreed upon by the preceptor and the resident.

2. Perform literature searches, obtain references and review safety information (clinical studies and post-marketing adverse event reports) to geriatric labeling claims for the prescription drug being evaluated.

3. Take the information obtained in #2 above and prepare a labeling supplement in accordance with the guidelines and regulations of the FDA.

4. A weekly review meeting will be held with the preceptor to review the status of the project.
   

Required Readings

Federal Register, August 27, 1997 (62 FR 45313)

Code of Federal Regulations, 21 CFR 201.57(f)(10)

Code of Federal Regulations, 21 CFR 314.70

DRAFT Guidance for Industry: Content and Format for Geriatric Labeling (December 1998)