Monitoring the prescription of diclofenac with the aim of optimisation of its safe use

Project approach

The proposed methodological approach, which involves scientific analysis of the data on prescription of diclofenac in PHC, obtained thanks to Innovative Information solutions and depends on results of analysis, taking appropriate measures by CInMED is fully compliant with recommendations of the EMA Committee (Pharmacovigilance Risk Assessment Committee - PRAC) and CInMED. Namely, as risk minimization measures for rational use of diclofenac, recommended by PRAC and formalized by the European Commission's decision, did not give expected results in terms of rationalization and safe of use of this medicine, PRAC recommendation is to approach this problem in the following manner - "The PRAC considered that the prescription data available is presently limited, and it may not accurately represent actual patient exposure. A drug utilisation study could be useful in examining trends in diclofenac use and collect information on the extent of use, the populations in which diclofenac is being used (age, newly contraindicated populations), dose and duration of use.

In accordance with the PRAC recommendations, CInMED will conduct diclofenac utilisation study in order to obtain data on prescribing of diclofenac in PHC. Conducting of this study and taking appropriate measures, depending on obtained results, is of public health interest, given the significant consumption of this medicine in Montenegro.

Having in mind numerous activities envisaged by the project, which will to the highest extent engage the scientific, technical and expert potential in CInMED and MG SOFT, improve their knowledge and skills in using innovative IT solutions in the interests of human health, three key pillars in the project were identified:

Pillar I scientific analysis of the prescription of diclofenac in Montenegro in the light of EMA and CInMED recommendations on its safe use.

Pillar II development and piloting of innovative information technology in rationalisation of prescribing of medicines.

Pillar III spreading skills, knowledge and competencies in CInMED and MG SOFT.

 

Partners capacity

CInMED is equipped with the up-to-date research infrastructure needed to implement the proposed research. Researchers have access to ICT, CInMED Information System and reference databases. The following elements will also be used during proposed research and training: Server room, Network infrastructure, work stations…

MG Soft as one of the largest ICT company at national level will provide experienced team of software developers with significant experience in developing healthcare applications, data warehouse and business intelligence. Most of MG Soft software developers are in the company for up to 15 years, and have been involved in development of Integral Healthcare system of Montenegro, from its early beginnings.