The discontinuance of innovations in pharmaceutical labeling.

摘要

This dissertation is about the discontinuance of innovations affecting the labeling for pharmaceutical products. Current FDA regulations in the Code of Federal Regulations (CFR) state that the "Labeling on or within the package from which the drug is dispensed bears adequate information for its use..." (21 CFR 201.100) Since it is physically attached to the product, full prescribing information is available to the pharmacist dispensing the drug.; In 1999, a proposal was submitted to the FDA by the Pharmaceutical Research Manufacturers of America, (PhRMA) a lobby representing the country's leading research-based pharmaceutical and biotechnology companies to replace the paper labeling with an electronic version of the full prescribing information. This document is labeled Appendix A. The innovations recommended by this proposal are intended to improve the timeliness of drug information delivered to dispensing sites.; Also, the innovations are intended to eliminate much of the material costs associated with the production, storage and distribution of drug labeling. If adopted, the PhRMA paperless labeling proposal may require a change to the federal regulation governing food and drug labeling. This dissertation researches the adoption response by the pharmaceutical dispensing community for this innovation suggested to improve pharmaceutical labeling.; Consistent with Rubin, (1995) qualitative interviewing was used in this dissertation due to the richness of knowledge gained from documentation, archival records, interviews, direct observations, participative observations, and physical artifacts within and governing the pharmaceutical labeling community. This research has also used a grounded theory approach as the basis for this research. According to Strauss and Corbin, (1994) this utilizes "the development or generation of a theory closely related to the context of the phenomenon being described." Pharmacists were examined using a questionnaire and others in the industry were examined through in-depth interviews. The findings from both approaches were congruent and support the null hypothesis that Rogers five and Moore Benbasat's two factors are predictors for the innovation's adoption.