| Abstract | ilj istraživanja: U ovom istraživanju je napravljena analiza sumnji na nuspojave vezane uz lijekove s djelatnom tvari sildenafil koje su zaprimljene u Agenciji za lijekove i medicinske proizvode (HALMED) u vremenskom razdoblju od 21. ožujka 2009. do 20. travnja 2020. godine.
Materijal i metode: Od Agencije za lijekove i medicinske proizvode (HALMED) zatraženi su podatci o zaprimljenim sumnjama na nuspojave za lijekove koji sadrže djelatnu tvar sildenafil prijavljene u Hrvatskoj. Od dobivenih podataka su analizirani dob i spol pacijenta, struka prijavitelja nuspojave, ozbiljnost nuspojave i nuspojave navedene prema MedDRA klasifikaciji po organskim sustavima.
Rezultati: U promatranom vremenskom razdoblju prijavljeno je ukupno devetnaest sumnji na nuspojave, a od toga su petnaest slučajeva prijavile osobe muškog spola. Od ukupnog broja prijava, devet (47,37%) je okarakterizirano kao ozbiljna nuspojava. Liječnici su prijavili 47,37%, farmaceuti 31,58%, pacijenti 15,79%, a ostali zdravstveni djelatnici 5,26 % sumnji na nuspojave. Većina pacijenata pripadaju dobnoj skupini od 30 do 70 godina (73,68%). Najviše sumnji na nuspojavu, prema MedDRA klasifikaciji, odnosilo se na skupinu poremećaja živčanog sustava (18,37%), srčane poremećaje (16,33%) te opće poremećaje i reakcije na mjestu primjene (14,29%).
Zaključci: Nuspojave najčešće prijavljuju liječnici za pacijente muškog spola, od čega je ozbiljnih 40%. Obzirom da je broj prijava od 2009. godine samo devetnaest, trebalo bi potaknuti zdravstvene djelatnike i pacijente na češće prijavljivanje sumnji na nuspojave lijekova. |
| Abstract (english) | Objective: In this study an analysis was made of suspected drug-related side effects with the active substance sildenafil received at the Agency for Medicinal Products and Medical Devices (HALMED) in the period from 21 March 2009 to 20 April 2020.
Patients and Methods: The Agency for Medicinal Products and Medical Devices (HALMED) was requested to provide information on suspected side effects for medicine containing the active substance sildenafil reported in Croatia. From the obtained data, the age and sex of the patient, the profession of the reporters, the severity of the adverse reaction and the adverse reactions listed according to the MedDRA classification by organ systems were analyzed.
Results: In the observed time period, a total of nineteen suspected adverse reactions were reported, of which fifteen cases were reported by males. Of the total number of reports, nine (47.37 %) were characterized as serious side effects. Doctors reported 47.37%, pharmacists 31.58%, patients 15.79%, and other health professionals 5.26% of suspected side effects. Most patients belong to the age group of 30 to 70 years (73.68%). According to the MedDRA classification, the most suspected side effects were related to the group of nervous system disorders (18.37%), cardiac disorders (16.33%) and general disorders and reactions at the site of application (14.29%).
Conclusion: Side effects are mostly reported by doctors for male patients, of which 40% are serious. Given that the number of reports since 2009 is only nineteen, healthcare professionals and patients should be encouraged to report suspected adverse drug reactions more frequently. |
