| Sažetak | Cilj istraživanja: Rastući trend tržišta biljnih proizvoda nije popraćen porastom njihove
sigurnosti i učinkovitosti u pacijenata. Biljni lijekovi mogu uzrokovati nuspojave kao i
konvencionalna terapija te je nužno da se prijavljuju sve sumnje na nuspojave ove skupine
lijekova. Cilj ovog istraživanja bio je procijeniti znanje o biljnim proizvodima u studenata
farmacije, dentalne medicine i medicine te njihovo korištenje izvora informacija visoke razine
dokaza. Također, istražene su učestalost i karakteristike prijava sumnji na nuspojave biljnih
lijekova Agenciji za lijekove i medicinske proizvode (HALMED-u) u razdoblju od 2008. do
2017. te raznolikost registracije biljnih proizvoda i uputa o lijeku za ginko, sikavicu, gospinu
travu i ginseng u Velikoj Britaniji, Njemačkoj, Hrvatskoj te Bosni i Hercegovini
Metode: Istraživanje u studenata farmacije, medicine i dentalne medicine ustrojeno je kao
anketno presječno istraživanje. Podaci o spontano prijavljenim sumnjama na nuspojave
bezreceptnih i biljnih lijekova dobiveni su od strane HALMED-a te su analizirane obzirom na
godinu prijave, prijavitelja, spol i dob pacijenta, ozbiljnost, djelatnu tvar, broj lijekova u
istodobnoj primjeni i klasifikaciji organskih sustava Medicinskog rječnika za regulatorne
poslove (engl. Medical dictionary for Regulatory Activities, MedDRA). Upute o lijeku
registriranih biljnih lijekova u Velikoj Britaniji, Njemačkoj, Hrvatskoj te Bosni i Hercegovini
uspoređene su s biljnim monografijama EU lista ginka, ploda sikavice, zeleni gospine trave i
korijena ginsenga.
Rezultati: U istraživanju je sudjelovalo 506 studenata Medicinskog fakulteta Sveučilišta u
Splitu koji su ispunili anketni upitnik. U usporedbi sa studentima svih studijskih programa i
svih godina studija, najvišu razinu znanja pokazali su studenti pete godine studija farmacije. U
usporedbi sa studentima medicine (7%), studenti farmacije (3%) i dentalne medicine (2%) su
u manjem broju koristili rezultate randomiziranih kontroliranih kliničkih pokusa kao izvor
informacija o dodacima prehrani (p=0,045). Najveći je udio prijava sumnji na nuspojave biljnih
lijekova zaprimljen u razdoblju od 2013. do 2017. godine, 73%. Kao i za ostale bezreceptne lijekove, najveći su broj sumnji na nuspojave biljnih lijekova prijavili ljekarnici (42%). Upute
o lijeku registriranih biljnih proizvoda lista ginka, ploda sikavice i zeleni gospine trave u
Velikoj Britaniji su u potpunosti odgovarale propisima biljnih monografija EU dok u
Njemačkoj, Hrvatskoj i BiH nisu svi biljni proizvodi lista ginka, ploda sikavice, zeleni gospine
trave i korijena ginsenga registrirani na tržištu odgovarali propisima biljnih monografija EU.
Zaključci: Istraživanje je pokazalo da studenti farmacije imaju više razine znanja o biljnim
proizvodima, u usporedbi sa studentima dentalne medicine i medicine. Međutim, u usporedbi
sa studentima medicine, studenti farmacije rjeđe koriste rezultate randomiziranih kontroliranih
kliničkih pokusa ili sustavnih pregleda, kao izvore informacija o biljnim proizvodima. Nadalje,
unatoč nedostacima u edukaciji studenata farmacije, istraživanje je pokazalo da su ljekarnici
najčešći prijavitelji sumnji na nuspojave biljnih lijekova u Hrvatskoj. Također, istraživanje je
pokazalo kako su Upute o lijeku dostupne biljnim lijekovima u uključenim državama bile
neusklađene s propisima biljnih monografija EU te kako su biljni proizvodi lista ginka, ploda
sikavice, zeleni gospine trave i korijena ginsenga različito registrirani na tržištu. Rezultati svih
istraživanja upućuju na zakonodavnu nereguliranost tržišta biljnih proizvoda koji su još
nedovoljno istraženo područje sa znanstvenog aspekta. |
| Sažetak (engleski) | Objectives: The growing market of the herbal products is not accompanied with an increase
in their safety and efficacy in patients. Furthermore, herbal products can cause adverse drug
reactions as well as conventional therapy and it is necessary to report any suspected adverse
drug reaction of this group of drugs. The aim of this research was to assess the knowledge of
herbal products in pharmacy, dental and medical students, and their use of high-quality sources
of information. Also, this study includes the number and characteristics of reports of suspected
adverse reactions to herbal products to the Agency for Medicinal Products and Medical Devices
(HALMED) in the period from 2008 to 2017 and the diversity of herbal product registrations
and Patient information leaflet for ginkgo, milk-thistle, St. John's wort and ginseng in Great
Britain, Germany, Croatia and Bosnia and Herzegovina.
Methods: The research in students of pharmacy, dental medicine and medicine was organized
as a cross-sectional survey study. Data on spontaneously reported suspected adverse reactions
to over-the-counter and herbal products were obtained from HALMED and analyzed according
to the year of report, reporter, sex and age of patient, severity, active substance, number of
concomitant medications and System Organ Classes according to Medical dictionary for
Regulatory Activities. The Patient information leaflet on the medicinal products of registered
herbal medicines in United Kingdom, Germany, Croatia and Bosnia and Herzegovina were
compared with herbal monographs of ginkgo leaf, milk-thistle fruit, St. John's wort and ginseng
root.
Results: The study involved 506 students at the University of Split School of Medicine who
completed the questionnaire. Compared to students of all study programs and all years of study,
the highest level of knowledge was shown by fifth year pharmacy students. Compared to
medical students (7%), pharmacy students (3%) and dental medicine students (2%) used the
results of randomized controlled clinical trials less frequently as a source of information on
dietary supplements (p=0.045). The largest share of reports of suspected adverse drug reactions of herbal products was received in the period from 2013 to 2017, 73%. As for other over-thecounter
drugs, the largest number of suspected adverse drug reactions of herbal products were
reported by pharmacists (42%). The Patient information leaflet for the registered herbal
products of ginkgo leaf, milk-thistle fruit and St. John's wort in the United Kingdom fully
complied with the regulations of EU herbal monographs, while in Germany, Croatia and Bosnia
and Herzegovina not all herbal products of ginkgo leaf, milk-thistle fruit, St. John's wort and
ginseng root registered on the market were registered according to the regulations of EU herbal
monographs.
Conclusions: This study has shown that pharmacy students have higher levels of knowledge
about herbal products, compared to dental and medical students. However, compared to
medical students, pharmacy students are less likely to use the results of randomized controlled
clinical trials or systematic reviews as sources of information on herbal products. Furthermore,
despite the shortcomings in the education of pharmacy students, the research showed that
pharmacists are the most frequent reporters of suspected adverse drug reactions for herbal
products in Croatia. Furthermore, the study has shown that the Patient information leaflet
available in herbal products in the included countries was not in line with EU herbal
monographs and that herbal products of ginkgo leaf, milk-thistle fruit, St. John's wort and
ginseng root were differently registered on the market. |
