Evaluation of diclofenac utilization patterns before and after digital risk minimization intervention in outpatient settings in Montenegro.

Introduction: Risk minimization measures are one of the most important tools in ensuring safe use of medicines. The evaluation of their effectiveness in clinical practice is a big challenge. Diclofenac is a medicine indicated for relief of all grades of pain and inflammation, in a wide range of conditions. Certain cardiovascular diseases are contraindications, whilst certain diseases require precautions for diclofenac prescribing. Objective: The aim of this study is to measure impact of the new digital risk minimization tool, introduced at the level of diclofenac prescribing, on patterns of its prescription in outpatient settings in Montenegro. Methods: Regulatory impact before/after drug utilization study, using electronic health records of patients with cardiovascular contraindications/precautions for diclofenac prescribing, was conducted. The period of observation was 1 year before and 1 year after introduction of the digital risk minimization tool. Results: Introduction of the digital risk minimization tool was associated with significant decrease in number of patients on diclofenac and the number of diclofenac prescriptions/packages, in a cohort of patients who were prescribed diclofenac before the digital intervention. Decrease in diclofenac prescription was more obvious in patients with contraindications, as expected, compared with patients with precautions. Decrease in diclofenac prescriptions in patients with other heart diseases, cerebrovascular diseases, and ischemic heart diseases (contraindications) was 38.79%, 37.62%, and 29.85% respectively. There was also a decrease in diclofenac prescriptions in patients with hypertension (22.86%), hyperlipidemia (23.61%), and diabetes mellitus (26.32%; precautions). After the digital intervention, initiation of diclofenac in diclofenac-naive patients was significantly decreased compared with patients who were prescribed diclofenac before the digital intervention. Conclusions: Although a significant decrease in diclofenac prescription in both cohorts occurred, diclofenac is still prescribed, even in diagnoses contraindicated for its use. Further improvements of existing tools and the creation of new ones are necessary for minimization of cardiovascular and other risks related to diclofenac. [ABSTRACT FROM AUTHOR]