Potrošnja diklofenaka i zdravstveni ishodi kod ambulantnih bolesnika obolelih ili sa visokim rizikom od kardiovaskularnih bolesti u Crnoj Gori nakon implementacije inovativnog digitalnog alata za minimizaciju rizika
Sažetak
Uvod/Cilj. Mere za minimizaciju rizika (risk minimization measures – RMMs) za lekove su jedna od najvažnijih intervencija u održavanju pozitivnog odnosa korist–rizik i omogućavanju njihove bezbedne upotrebe. Sistemske formulacije diklofenaka su lekovi sa rutinskim i dodatnim RMMs zbog njihovog dobro utvrđenog kardiovaskularnog (KV) bezbednosnog rizika. U crnogorski Informacioni sistem primarne zdravstvene zaštite je 2021. godine implementirana inovativna digitalna alatka (IDA). Cilj rada bio je da se analizira potrošnja diklofenaka kod bolesnika sa KV rizikom koji nisu koristili diklofenak pre uvođenja nove IDA za RMM (diclofenac-naïve bolesnici) uzimajući u obzir njihove demografske (pol i starost) i kliničke karakteristike [KV bolesti (KVB)/faktori rizika od KVB]. Metode. Oboleli od KVB/bolesti koje predstavljaju rizik od razvoja KVB (stanja koje su kontraindikacije/stanja koja zahtevaju mere predostrožnosti za propisivanje diklofenaka) odabrani su nakon automatizovanog skrininga svih dijagnoza, klasifikovanih u skladu sa Međunarodnom klasifikacijom bolesti, 10. revizija, iz njihove elektronske medicinske dokumentacije. Ovi bolesnici imali su i medicinske dijagnoze koje su bile indikacije za propisivanje nesteroidnih antizapaljenskih lekova kao što je diklofenak. Bolesnici su praćeni u periodu od godinu dana nakon uvođenja IDA (4. oktobar 2021 – 4. oktobar 2022). Potrošnja diklofenaka analizirana je po standardnoj metodologiji Svetske zdravstvene organizacije na osnovu broja definisanih dnevnih doza na 1 000 stanovnika dnevno i Anatomsko terapijsko-hemijske klasifikacije lekova, kao i ukupnog broja recepata i propisanih pakovanja leka, uzimajući u obzir pol, godine života i dijagnoze bolesnika sa visokim KV rizikom. Rezultati. Pokazano je da se diklofenak češće propisivao ženama i bolesnicima starosti 45–64 godina. Kada je reč o medicinskim dijagnozama koje su kontraindikacije/ zahtevaju mere predostrožnosti za primenu diklofenaka, lek je najčešće bio propisivan bolesnicima sa ishemijskom bolešću srca (38,15%), odnosno hipertenzijom (71,00%). Nakon uvođenja leka u terapiju povećao se broj bolesnika sa dijagnozama (KVB) koje su kontraindikacije za primenu diklofenaka. Najveći porast zabeležen je kod bolesnika sa bolestima arterija, malih arterija i kapilara (41,77%) i kongestivnom srčanom insuficijencijom (28,57%). Zaključak. Nakon uvođenja IDA kao nove RMM od neželjenih KV efekata diklofenaka u Informacioni sistem primarne zdravstvene zaštite Crne Gore, kod bolesnika sa bezbednosno rizičnim KV dijagnozama koji ga ranije nisu primali, lek se najčešće propisivao diclofenac-naïve bolesnicama, osobama starosti 45-64 godine i onima koji su imali dijagnoze koje su zahtevale mere opreza prilikom njegove upotrebe. Upotreba diklofenaka dovela je do povećanja broja bolesnika sa KVB što ukazuje na potrebu uvođenja novih mera za smanjenje rizika od njegovih štetnih KV efekata.
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