RIZICI U LANCU SNABDEVANJA PRILIKOM OFF-LABEL UPOTREBE LEKOVA U TERAPIJI GOJAZNOSTI I PRIMERI

JUSK ICQ 2024,  (str. 77-92)

АУТОР(И) / AUTHOR(S): Jasmina Kariklić, Valentina Marinković

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DOI: 10.46793/JUSK-ICQXX.077K

САЖЕТАК / ABSTRACT:

Off-label upotreba se definiše kao upotreba leka za neodobrenu indikaciju ili u neodobrenoj starosnoj grupi, dozi ili načinu primene. Upotreba Off-label u većini slučajeva se ne smatra nezakonitom, neprikladnom, eksperimentalnom, obično nedostaje samo detaljna analiza koristi i rizika. Jedna od odobrenih off-label upotreba leka Metformin je u lečenju gojaznosti, koji postiže svoj efekat smanjenja telesne težine putem uobičajenih i vrlo čestih neželjenih efekata (probavnih problema). Iako je trenutno FDA odobren samo za dijabetičare, Ozempic se koristi kao off-label, zbog popularnosti na društvenim mrežama, da pomogne pacijentima koji nemaju dijabetes da smanje težinu. Na osnovu rezultata FMEA metode možemo odrediti i proceniti prioritet u kontroli i proceni rizika. Potrebno je precizno definisati deskriptivne pojmove pojave (O), ozbiljnosti (S), detekcije (D), sa pripadajućim kvantitativnim vrednostima, kao i pregled sistema rangiranja rizika.

КЉУЧНЕ РЕЧИ / KEYWORDS:

rizici u lancu snabdevanja, off lable upotreba, gojaznost, FMEA

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