ABSTRACT
Objective: We examined the descriptions of reference information regarding the dispensing process in the interview form (IF). If there was no description, we determined the test data’s availability from the pharmaceutical company.Methods: The survey targeted 78 drugs that complied with the new description IF guidelines, for regular tablets and capsules launched from April 2018 to December 2021. The survey was conducted between March 13th and June 14th, 2022. We investigated the reference information regarding the stability of the medications during the crushing and simple suspension method during dispensing.Results: Regarding the data related to the stability of medications during the crushing process, ten drugs were described as having “data available,” 18 drugs were to be “inquired individually,” 31 drugs had “no applicable data,” and 14 drugs had “no items.” Regarding the status of descriptions on the simple suspension method, ten drugs were described as having “data available,” 18 drugs had data that was to be “inquired individually,” 32 drugs had “no applicable data,” and 14 drugs had “no items.” Regarding the 35 drugs for which both the stability during crushing and the simple suspension method were listed as either “no applicable data” or “no items,” we contacted the pharmaceutical companies to inquire about the test data for the stability during the crushing and simple suspension method. We found that four drugs had “data available” on the stability of medications during the crushing process, while six drugs had “data available” on the simple suspension method.Conclusion: Many IFs that complied with the new description guidelines had items for reference information regarding dispensing. However, the test data’s description was not sufficient. Furthermore, even if there is no description of reference information regarding dispensing in the IF, we confirmed that the pharmaceutical company owns the test data.