Trudnoća i primjena lijekova izvan uvjeta odobrenja za stavljanje u promet

master's thesis

• Title (english): Off-label prescribing during pregnancy
• Author: Katarina Rydzak
• Mentor: Alenka Boban Blagaić (mentor)
• Committee member: Predrag Sikirić (predsjednik povjerenstva)
• Committee member: Lovorka Batelja-Vuletić (član povjerenstva)
• Committee member: Alenka Boban Blagaić (član povjerenstva)
• Granter: University of Zagreb; School of Medicine; (Department of Pharmacology); Zagreb
• Defense date and country: 2022-07-15, Croatia
• Scientific / art field, discipline and subdiscipline: BIOMEDICINE AND HEALTHCARE; Basic Medical Sciences; Pharmacology

Abstract

Opće je prihvaćeno mišljenje o potrebi izbjegavanja primjene lijekova u trudnoći, no
istraživanja pokazuju da većina žena tijekom trudnoće koristi neki lijek. U trudnoći je neka
stanja neophodno liječiti zbog opasnosti ne samo za zdravlje i dobrobit majke već i za
zdravlje fetusa te ishod trudnoće. Primjena lijekova u trudnoći može biti indicirana za
liječenje kroničnih bolesti, za liječenje akutno nastalih bolesti nepovezanih s trudnoćom, za
liječenje bolesti povezanih s trudnoćom te za prevenciju i liječenje fetalnih bolesti. Provedena
klinička studija u Francuskoj pokazuje da je 50% primijenjenih lijekova u trudnoći bilo izvan
uvjeta odobrenja za stavljanje u promet (off-label), dok je studija provedena u Britaniji
pokazala da je udio istih čak 83%. Off-label upotreba odnosi se na namjerno korištenje lijeka
u medicinske svrhe koje nisu u skladu s informacijama o lijeku iz Sažetka opisa svojstva
lijeka tj. lijek se koristi za drugu indikaciju, populaciju pacijenata, drugačijom dozom,
frekvencijom ili putem primjene. U nekim članicama EU-a postoje zakonske odredbe koje
pobliže određuju način upotrebe off-label lijekova. Takvu upotrebu treba razlikovati od
neispravnog korištenja lijeka i liječničke pogreške. Propisivanje off-label terapije
svakodnevna je praksa, a za neke pacijente i jedina opcija. Liječnici ginekolozi/opstetričari
primorani su, zbog manjka drugih terapijskih opcija, koristiti off-label lijekove te time često
stavljaju sebe u pravno upitni i zakonski nezaštićen položaj. Potrebno je više resursa usmjeriti
u istraživanja lijekova na trudnicama te stvaranje i povezivanje javno dostupnih registara o
primjeni lijekova u trudnoći. Veliku ulogu u zaštiti pacijenata i kliničara imaju klinički
farmaceuti, povjerenstva za lijekove i stručna društva koja odobravanjem off-label primjene
lijeka za određenog pacijenata/grupu pacijenata i izradom smjernica mogu znatno unaprijediti
kliničku praksu i položaj pacijenata i liječnika.

Abstract (english)

There is a generally accepted opinion about the need to avoid the use of drugs during
pregnancy, but research does show that most women use pharmaceuticals during pregnancy.
In pregnancy, it is necessary to treat some conditions because of the risk for the health and
well-being of the mother, for the foetus and on the outcome of the pregnancy. The use of
drugs during pregnancy is indicated for the treatment of chronic diseases, the treatment of
acute diseases, and for the treatment of diseases related to pregnancy. Pharmacotherapy can
also be used for prevention and treatment of foetal diseases. A UK study shows that as many
as 83% of drugs prescribed during pregnancy were used off-label, while in France 50 % of
drugs used during pregnancy were used off-label. Off-label use refers to the use of a drug
outside of the terms of marketing authorization. The drug is administered to a different patient
population or used for an indication, dose, frequency or route of administration that is not
officially approved. Off-label use refers to the intentional use of the drug for medical
purposes that are not in accordance with the information on the drug from the Summary of
Product Characteristics. In some EU member states, special legal acts determine off-label
drug prescribing. Such use should be distinguished from medicinal and medical error.
Prescribing off-label therapy is a very common practice, and for some patients, it is the only
option. Gynaecologists and obstetricians are forced, due to fewer therapeutic options, to use
off-label drugs, thus putting themselves in an precarious position. It is necessary to direct
more resources to the research of the effect of drugs on pregnant women and the formation
and linking of publicly available registers on the use of drugs in pregnancy. Clinical
pharmacologists and drug committees have a large role in off-label use of pharmaceuticals.

• Keywords: lijekovi; off-label primjena lijekova; trudnoća
• Keywords (english): off-label drug use; pharmaceuticals; pregnancy
• Language: croatian
• URN:NBN: urn:nbn:hr:105:762434
• Study programme: Title: Medicine; Study programme type: university; Study level: integrated undergraduate and graduate; Academic / professional title: doktor/doktorica medicine (doktor/doktorica medicine)
• Type of resource: Text
• File origin: Born digital
• Access conditions: Open access
• Created on: 2023-02-10 12:56:54