Each medicinal product on the market of the Republic of Slovenia (RS) must have a marketing authorization, a marketing authorization for a parallel imported medicinal product or a certificate of parallel distribution or authorization for compassionate use of medicinal products. In exceptional cases, the Public Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) may also endorse the marketing of medicinal products that are not authorized. The purpose of the master's thesis is to evaluate the importance of medicinal products without marketing authorization and their consumption in the outpatient care in the Republic of Slovenia.
The necessary data on selected medicinal products without marketing authorization were obtained from the Central Database of Medicinal Products, the Essential Medicines Lists, and the JAZMP Medicinal Product Database. The latter contains information on the disorder prediction or withdrawal of marketing authorization, as well as data on the consumption of outpatient prescription medications. Based on the data obtained from the listed databases, the medicinal products without marketing authorization were defined according to the following parameters: their legal status, activity, the ATC Classification System and classification on listings, their availability on the market and release regime. We also identified the most represented groups of medicinal products without marketing authorization and the most common active substances in each group. The prices of the medicinal products without marketing authorization were evaluated as well.
On the cut-off date, 3 March 2019, there were 21.061 medicinal products listed in Central Database of Medicinal Products. Among them, 58% were active, other were unactive. Among all 21.061 medicinal products, there were 2,934 (13.9%) unauthorized medicinal products. 1,122 (38.2%) of these were active and the rest were inactive. They represent all groups at the first level of the Anatomical Therapeutic Chemical (ATC) Classification System and are dominated by group »various drugs« (ATC V) whereas there are the fewest »dermatological drugs« (ATC D). Among the group »various medicines«, allergy tests, allergen extracts and sodium iodide are the most prevalent. For the 99,0% of active unauthorized medicinal products, there is no information on the process, by which the marketing authorization was obtained, for 91,3% there is no information about their listing, for 74,0% we do not have information about their market presence, the market situation and for 81,6 % of active unauthorized medicinal products there is no information about the release regime. For all medicines without marketing authorization, however, there is data on their availability. On the cut-off date, for 74,1% of such active unauthorized medicinal products a supply disruption or for 0,3% of them temporary suspension of market supply was predicted. This means that the problem of disruption in the supply of unauthorized medicines in the Republic of Slovenia is very large, which can pose a threat to the quality of health care and calls for more than necessary action by the JAZMP. 32,2% of active drugs without the authorization do not have a fixed price, and among those who do, there are 46,4% with a much higher allowable price (MHAP) and 21,4% drugs with the maximum allowable price (MAP).
Medicines without marketing authorization include both outpatient and hospital medicines, this master's thesis focused exclusively on outpatient.Outpatient prescription drugs without marketing authorization make up only 5% of the 2,934 medicines reviewed. They represent all groups at the first level of ATC classification, with the exception of group »dermatological« (ATC D) and »respiratory system« (ATC R) drugs. Most of them are in the group »nervous system drugs« (ATC N) and the most prominent active substances in this group are diazepam and phenobarbital. 5% of active outpatient prescription medicines without marketing authorization do not have a fixed price; of the drugs that do, 64,3% have a MHAP and 30,6% the MAP. In the last eight years, the total value of compulsory health insurance for outpatient prescription drugs without marketing authorization has approximately doubled (in 2010 it was € 2,396,336 and in 2018 it was € 4,786,730).