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

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Abstract

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.

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Acknowledgements

We would like to thank Partner in project—IT company MGSOFT—one of the largest IT companies in Montenegro included in establishment and development of the integral healthcare information system in Montenegro.

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Authors and Affiliations

  1. Institute for Medicines and Medical Devices (CInMED), Podgorica, Montenegro

    Maja Stankovic & Nemanja Turkovic

  2. Faculty of Medicine, University of Montenegro, Podgorica, Montenegro

    Maja Stankovic & Nemanja Turkovic

  3. Faculty of Medicine of the Military Medical Academy, University of Defence, Belgrade, Serbia

    Silva Dobric & Nemanja Rancic

  4. Center for Clinical Pharmacology, Military Medical Academy, Belgrade, Serbia

    Nemanja Rancic

Authors
  1. Maja Stankovic
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  2. Nemanja Turkovic
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  3. Silva Dobric
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  4. Nemanja Rancic
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Corresponding author

Correspondence to Maja Stankovic.

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Funding

Financial assistance for conducting the study and analysis described in the manuscript was obtained through a project named “Collaborative grant scheme for innovative project ideas—monitoring the prescription of diclofenac with the aim of optimisation of its safe use” within the budgetary line of IPA II—Multi-annual Programme for Montenegro on Employment, Education and Social Policies, reference EuropeAid/162456+7/ID/ACT/ME.

Conflicts of interest

The authors have no competing interests.

Ethics approval

The permission to use patient medical data from PHCIS was obtained from the MNE Health Insurance Fund (number of consent: 04-2294, dated 04 June 2020), in accordance with national regulations on the conditions for using data from PHCIS. The permission for the introduction of the digital tool into PHCIS was obtained from the Ministry of Health of MNE (number of consent: 1-427/21-2450/3, dated 24 September 2021), the competent institution in MNE for the development of PHCIS. The personal data of patients included in study were unknown (anonymous data).

Consent to participate

Not applicable.

Consent for publication

Not applicable.

Availability of data and material

The availability of data from Primary Healthcare Institutions are subject to the restrictions in accordance with applicable regulations in Montenegro.

Code availability

Not applicable.

Author contributions

All authors contributed to the study conception and design, including the methods used. Maja Stanković and Nemanja Turković were in charge of data collection and processing. Statistical analysis was performed by Nemanja Rančić. The first draft of the manuscript was written by Maja Stanković, and all authors critically reviewed and interpreted the data in previous versions of the manuscript. All authors read and approved the final version of the manuscript.

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Stankovic, M., Turkovic, N., Dobric, S. et al. Evaluation of diclofenac utilization patterns before and after digital risk minimization intervention in outpatient settings in Montenegro. Drugs Ther Perspect 40, 90–100 (2024). https://doi.org/10.1007/s40267-024-01049-w

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  • DOI: https://doi.org/10.1007/s40267-024-01049-w

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