WHAT ARE THE REASONS FOR UNREASONABLY HIGH USE OF DRUGS WITH UNCERTAIN CLINICAL BENEFIT IN SERBIA?!

J Calasan, A Sabo, Z Tomic, O Horvat, M Ban. Faculty of Medicine in Novi Sad, Department of Pharmacology, Toxicology and Clinical Pharmacology 21000, Serbia

Drug consumption should be based on the latest pharmacotherapeutic guidelines. However, in Serbia the consumption of so-called drugs with uncertain clinical benefit (pentoxifylline, dihydroergotoxine, nicergoline, deproteinized calf blood extract (DCBE) and cinnarizine) was not in line with the latest pharmacotherapeutic guidelines and was unusually high compared to countries with well developed pharmacotherapeutic practice.

The aim of this study was to analyze the amount of these medicines’ consumption in Serbia in 2010., compare these parameters with those found in Nordic countries, as well as to its neighbouring country Croatia and to provide recommendations regarding this issue.

The analysis covered medicines consumption in Serbia, Croatia, Denmark, Norway and Finland in 2010. Data were retrieved from the annual reports of the Medicines and Medical Devices Agency of Serbia (ALIMS) and the Agency for Medicinal Products and Medical Devices of Croatia (HALMED), and for Nordic countries from the annual reports that are regularly issued in electronic form. The number of defined daily doses per 1000 inhabitants per day (DDD/1000 inh/day) was calculated using ATC/DDD methodology.

Table 1 Comparison of consumption of medicines with uncertain clinical benefit between Serbia, Croatia, Denmark, Norway and Finland in the year of 2010.

Total consumption of analyzed drugs with uncertain clinical benefit in Serbia in 2010. was 14.79 DDD/1000inh/day which is several times higher than their consumption in Croatia, and even several dozens of times higher than the one in Nordic countries.

Pentoxifylline consumption in Serbia was more then 10 times higher than in Croatia, and comparing to Denmark, Norway and Finland it was even several tens of times higher.

Similar results were observed regarding dihidroergotoxine, with significantly higher consumption in Serbia than in Finland. There were no available data on dihidroergotoxine consumption in Croatia, Denmark or Norway. Moreover, Serbia was the only one of the five countries in our study where nicergoline and DCBE were used. Cinnarizine consumption in Serbia is twice the consumption of this medicine in Croatia and several dozen of times higher than the one in Denmark.

In recent years there have been only few studies and clinical trials of rather low quality with little evidence that suggest that any of these medications are as effective as to be that commonly and highly consumed. Although these medications may have some beneficial effects for improving conditions where they are indicated, they are not mentioned in the guidelines produced by relevant scientific societies and apart from few reports no study has systematically evaluated the efficacy of these drugs, nor their consumption in other European countries with well developed pharmacotherapeutic practice is as high as it is in Serbia.

In conclusion, these results suggest that consumption of analyzed drugs of uncertain clinical efficacy in Serbia is significantly higher than in other European countries, therefore pointing to the need for examining the causes of such high consumption of pentoxifylline, dihydroergotoxine, nicergoline, DCBE and cinnarizine in Serbia, as well as expending resources into the education of both the general population as well as healthcare providers with the aim of optimizing the use of these medicines.