| Popis: |
Motnje v preskrbi z zdravili v zadnjih letih postajajo vse večji problem na globalni ravni. Zakon o zdravilih jih definira kot stanje na trgu, kjer poslovni subjekti, odgovorni za preskrbo trga Republike Slovenije, ne uspejo zagotoviti potrebnih količin zdravila v ustreznem času. Zbiranje podatkov o spremembi stanja zdravila na trgu je v pristojnosti Javne agencije Republike Slovenije za zdravila in medicinske pripomočke (JAZMP). Namen magistrske naloge je ovrednotiti motnje v preskrbi zdravil v Sloveniji v letih 2019 in 2020. Proučili bomo njihovo številčnost, lastnosti, trajanje, poiskali vzroke zanje, oceno tveganja za javno zdravje in verjetnost za ponovni prihod na trg. Rezultate in slovenski sistem poročanja bomo primerjali z ostalimi državami in jih umestili v širši kontekst, saj je preskrba z zdravili globalna in odvisna od številnih dejavnikov na globalni ravni. Osnova za analize je bila podatkovna zbirka, ki vsebuje popis vseh signalov o spremembi stanja na trgu posameznih zdravil v letih 2019 in 2020, ki jih od imetnikov dovoljenja za promet z zdravilom pridobiva JAZMP. Dodatno smo določili kategorije za priglašene razloge in ocene tveganja ter nato vsako motnjo tudi ovrednotili glede na te kategorije. JAZMP je v letu 2019 prejela 1786 obvestil o spremembi stanja zdravil na trgu, leto kasneje pa je bilo teh 1712. V letu 2019 je bilo prisotnih 565 motenj v preskrbi, od tega jih je bilo novo prijavljenih 418. Leta 2020 pa smo zabeležili 672 motenj, od tega jih je bilo 347 prijavljenih na novo v tem letu. Največji delež zdravil v motnji je spadalo med zdravila z delovanjem na živčevje (18 %), sledijo pa zdravila za bolezni srca in ožilja (16 %) ter zdravila z delovanjem na novotvorbe in imunomodulatorji (16 %). Znotraj našega celotnega obdobja je 420 motenj trajalo manj kot 3 mesece, 274 pa jih je bilo prisotnih več kot leto dni. Kot glavni razlog so poročevalci navedli težave v proizvodnji (37 % in 33 % v posameznih letih), sledijo jim ekonomske odločitve, ki predstavljajo 25 % vseh motenj v preskrbi z zdravili. Rezultati kažejo, da so motnje v preskrbi z zdravili v Sloveniji relativno pogoste, zato bi bilo smiselno začeli z izgradnjo sistemov, ki bi olajšali upravljanje z motnjami. Izzive z motnjami je potrebno nasloviti celostno in nadalje raziskati, kakšne ukrepe lahko Slovenija v sodelovanju z ostalimi članicami Evropske Unije sprejme, da zagotovi bolj stabilno preskrbo z zdravili v prihodnosti. In the recent years, medicine shortages have become a growing problem on a global level. The Slovenian Medicines Act defines them as a state on the market where entities, responsible for supplying the market of the Republic of Slovenia, fail to provide the necessary quantities of medicine in a timely manner. The collection of data on changes of availability of the medicinal product on the market is the responsibility of Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP). The aim of the masters’ thesis is to evaluate medicines shortages in Slovenia in the years 2019 and 2020. We will present their figures, describe their characteristics, look in duration of individual shortage, find and address their root causes, the risk they are posing to public health and perform survival analysis. We are going to compare the results and the Slovenian reporting system with other countries and place them in broader picture as pharmaceutical industry is present globally and depends on multiple factors on a global level. Database, containing an inventory of all signals received in 2019 and 2020, was used. Marketing authorization holders are obliged to notify JAZMP on any change of the availability of registered pharmaceutical products. Categories for notified causes of shortages and their provided risk assessments to public health were also set up and shortages were evaluated based on these categories. In 2019, JAZMP received 1786 notifications of change in the state of medicine on the market, and a year later there were 1712. In 2019, there were 565 medicine shortages, of which 418 were newly reported in that year. In 2020, 672 shortages were present, of which 347 were reported that year. Nervous system drugs (18 %) had the highest percentage of medicines in shortage, followed by cardiovascular drugs (16 %) and antineoplastic and immunomodulating agents (16 %). Within our entire period, 420 shortages lasted less than 3 months and 274 were present for over a year. The main reason given by the Marketing Authorisation Holder (MAH) was production problems (37 % and 33 % in both individual years), followed by economic decisions, which accounted for 25 % of all shortages. Results show that medicine shortages Slovenia are relatively common, thus starting to build up systems, which would ease the management of the shortages, would be desirable. The problem needs to be addressed holistically and it is necessary to further investigate what actions can Slovenia, in cooperation with other EU Member States, introduce to ensure a more stable supply of medicine in the future. |
