Development and validation of a generalizable model for constructing nonprescription drug formularies
Abstract
The purpose of this study was to develop and validate a generalizable process for creating a nonprescription drug formulary. Specifically, the study sought to determine whether (1) a group of experts could achieve consensus on therapeutic criteria to be used in the selection of nonprescription analgesic and gastrointestinal drugs for formulary inclusion and, (2) the criteria could be consistently applied by independent panels of experts to the formulary selection process. The Delphi consensus building process was adapted for this project. Fourteen experts were recruited to serve on each of two panels, one for each therapeutic class. The first task before each 14-member committee was to achieve consensus on the evaluative criteria that would be used to operationalize the concept of "significant therapeutic advantage" in each therapeutic class. Virtual consensus (all, or all but one expert voting in favor) was achieved over five iterations, on eighteen and twenty-five criteria for analgesic and gastrointestinal drugs, respectively. Nine of the analgesic criteria also appeared on the list of gastrointestinal drug criteria. The next task was to apply the consensus criteria to the selection of analgesic and gastrointestinal agents that possessed a significant therapeutic advantage over others considered for the formulary. Both the analgesic and the gastrointestinal panel were divided into two independent seven-member sub-panels for this task. Virtual consensus on the formularies was accomplished over three iterations. Ibuprofen and acetaminophen were selected by the two independent analgesic sub-panels and aluminum hydroxide-magnesium hydroxide combination, famotidine, psyllium, loperamide and electrolyte replacement therapy by the two gastrointestinal sub-panels. Fisher's exact test was used to test the association between the choices of the sub-panels within each therapeutic class. The results indicate that the consensus criteria were being applied in a consistent and reproducible fashion to formulary selection. It is concluded that this model of formulary development could be applied by hospitals, managed care organizations, and Medicaid programs to guide drug product selection in nonprescription and prescription drug formularies. Applied to other therapeutic classes, a national nonprescription drug formulary could be developed to aid patients and providers in self-care decisions. Pharmacy Benefit Management companies could use this process to develop valid and defensible formularies.
Degree
Ph.D.
Advisors
Rupp, Purdue University.
Subject Area
Pharmaceuticals|Public health|Health care
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