Regulatory Measures for Modern Drugstores Undergoing Litigation Process

Abstract

Objective: To analyze the policies and measures for controlling the modern pharmacy undergoing litigation process for suggesting the development of appropriate policies and measures. Method: This research was a qualitative study by reviewing relevant documents and summary of litigation together with in-depth interviews with stakeholders involving in the regulation and prosecution of pharmacies during September–December 2017 Results: At present, the measures used to regulate the pharmacies under the process of proceedings, including those on duty were without no clear operational guideline. In addition, there were no measures to accelerate the process in each step of litigation. The issuance of a suspension order or revocation of pharmacy licenses must be advised by the Drug Committee, resulting in the long duration to complete legal enforcement for the wrongdoing pharmacies. In some cases, it took more than two years. Such situation was considered important gaps with potential risks to consumers. Stakeholders involving in regulating and prosecuting pharmacies still lacked the skills and experience to perform the duty. Conclusion: In order to improve the regulation of the pharmacies in the process of litigation, the Secretary General of the Food and Drug Administration should therefore establish rules and conditions for suspension or revocation of the pharmacy license. This will allow the provincial governor to use it as a guideline for timely suspending, or revoking the pharmacy license for those committing an offense in order to reduce the risk for people receiving the service from those drugstores. In addition, a manual for prosecution and regulation of pharmacies should be developed for officers as a guideline for the correct and consistent practice.