Objective: This paper aims to establish an independent reporting interface and evaluation system for therapeutic inequivalence, and the corresponding reward system to help to increase the willingness of clinicians to report therapeutic inequivalence to ensure quality.
Methods: From May 1, 2012 to December 31, 2019, we extracted information from the database of a medical center’s drug therapeutic inequivalence reporting system that meets the definition of drug efficacy. If the number of established reports reaches the number of reports set by the Pharmaceutical Affairs Committee, the special reports mechanism will be activated. Suppliers are requested to provide relevant information before they are brought to the Pharmaceutical Committee meeting for discussion.
Results: A total of 204 reports were collected, and 49 reports were excluded, 129 reports of therapeutic inequivalence, 21 reports of adverse reactions, and 5 reports of therapeutic inequivalence and adverse reactions. The top three categories for therapeutic inequivalence are medications for nervous system (n = 59), digestive system and metabolism (n = 40), and hormone (n = 29). After evaluation, a total of 4 medications have activated the special case mechanism, of which 2 items have changed their generic brands due to therapeutic inequivalence.
Conclusions: Establishing a reporting system for therapeutic inequivalence and tracking reporting cases can allow clinicians to quickly respond to the clinical status and impact of patients after drug replacement, and significantly increase the willingness to report. Dedicated pharmacists can follow-up treatment based on the evaluation results, which can improve patient’s medication quality and safety.
Summited for publication: 2020.10.12; Accepted for publication: 2020.12.15