The FDA announces new prescription drug information format.

In January 2006, the Food and Drug Administration unveiled a major revision to the format of prescription drug information, commonly called the package insert. To manage the risks of medication use and to reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format also will make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.

The Electronic Report on Adolescent Pregnancy (ERAP).

PURPOSE: To create a data management system that: (1) standardizes antecedent, program, and outcome variables relevant to the shared goals of adolescent-oriented maternity programs while allowing users to add variables pertaining to unique aspects of their work; (2) cues providers to physiologic and psychosocial characteristics that predispose teenagers to adverse pregnancy and parenting outcomes, (3) standardizes patient care by guiding providers through adolescent-oriented prenatal, postpartum, and well baby visits, and (4) establishes the infrastructure to collect data from a nationally representative sample of pregnant and parenting teens. METHOD: We adapted a powerful, state-of-the-art relational database framework (Microsoft Access 2000) to create an easy-to-use data management system-The Electronic Report on Adolescent Pregnancy (ERAP)-that requires minimal training to use on a personal computer. RESULTS: ERAP is designed to meet the administrative and analytic needs of adolescent-oriented maternity programs. It consists of six linked core data tables (teen, pregnancy, prenatal visits, child, interconception interval, and interconception interval visits), that allow users to analyze data from these multiple views while preserving the family structure. In addition, the database standardizes methods for collecting and storing the information and automatically computing the variables needed to monitor and evaluate an adolescent-oriented maternity program. Since by adding variables and appending supplementary tables, users can modify the core database to accommodate unique aspects of their programs and/or research, ERAP is also an ideal conduit for translating research findings into clinical practice. Similarly, because ERAP actually structures the care patients receive, the database provides the infrastructure needed to develop and implement best practice guidelines for treating teen-headed families. Finally, the confidentiality of all subject data is assured because ERAP is password-protected and automatically prepares files for batched external analyses by removing personal identifiers. CONCLUSIONS: ERAP provides the infrastructure needed to create a teen-pregnancy databank at the national level and an efficient patient monitoring system at the program level. By standardizing variable definitions and data collection techniques, serving as a repository for data collected at multiple sites, and tracking the multidisciplinary aspects of the care patients receive, ERAP has the potential to facilitate collaboration between adolescent-oriented maternity programs, increase the scientific rigor of teen pregnancy research, and improve the quality of care individual teen-headed families receive by prompting compliance with best practice guidelines.