Drug utilization patterns of flupirtine following implementation of risk minimization measures in Germany

Abstract

Objectives: This report characterizes flupirtine prescribing patterns before and after the implementation of risk minimization measures (RMM) in Germany as a complementary analysis to support previous study findings.

Methods: A retrospective analysis was conducted using a patient-level longitudinal prescription database (IMS LRx) in Germany. The study population included patients who were prescribed flupirtine-containing products. One-year periods before (2012) and after (April 2015–March 2016) RMM implementation were assessed for the following measures: flupirtine use of up to two weeks, flupirtine use when other analgesics are contraindicated and concomitant use of drugs with a known potential to induce liver injury.

Results: The number of flupirtine users decreased by 41.0% from 248,738 patients in the pre-RMM implementation period to 146,764 in the post-implementation period. The proportion of patients prescribed flupirtine for up to 14 days increased significantly by 22.7%, from 67.9% to 90.6% in the pre- to post-implementation periods, respectively. Over half the patients received long-term medications for conditions contraindicated with the use of other analgesics within 12 months prior to the first flupirtine prescription in the pre- and post-implementation periods (57.1% and 52.3%, respectively). Concomitant prescriptions of drugs with known potential hepatotoxic effects were recorded in 36.6% and 34.2% of flupirtine prescriptions during the pre- and post-implementation periods, respectively.

Conclusions: While physicians generally restricted flupirtine prescriptions to the short-term treatment duration recommended in the labeling, the other labeling recommendations were not as stringently adopted. Findings of this investigation support a previous study conducted in an electronic medical record database.

Keywords:

• Drug utilization
• flupirtine
• prescribing patterns
• risk minimization measures

Transparency

Declaration of funding

This manuscript was funded by Teva Pharmaceutical Industries Ltd.

Author contributions: S.K.: study conception and design, interpretation of the data, drafting the paper. B.E.: study conception and design, interpretation of the data. X.H.: interpretation of the data. All the authors critically reviewed and approved the final manuscript and agree to be accountable for all aspects of the work.

Declaration of financial/other relationships

S.K. has disclosed that she is an employee of Teva Pharmaceuticals Industries Ltd. B.E. has disclosed that she is an employee of IQVIA (formerly IMS Health). IMS Health (now IQVIA) had received financial support for the execution of the study. X.H. has disclosed that she is an employee of Ratiopharm GmbH, an affiliate of Teva Pharmaceuticals Europe BV. CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgements

The authors would like to express their appreciation to Christiane Sommer PhD and Margarita Shlaen MPH for their contributions to and involvement in the study.