Cilj istraživanja: Cilj ovog istraživanja je ispitati opravdanost reklasifikacije bezreceptnih lijekova koji
sadrže djelatnu tvar acetilsalicilatnu kiselinu registriranih u RH u lijekove s odobrenjem za izdavanje u ljekarni i
specijaliziranim prodavaonicama. Materijal i metode: Sastavljen je usporedni pregled regulacijskog statusa OTC
lijekova koji sadrže djelatnu tvar ASK registriranih u izabranim zemljama članicama EU. Pregledana je legislativa
koja regulira promet i distribuciju OTC lijekova u RH te je napravljena usporedba prijavljenih sumnji na nuspojave
lijekova koji sadrže djelatnu tvar ASK i lijekova koji sadrže djelatnu tvar paracetamol ili ibuprofen zaprimljenih
u RH u 2015. godini. Rezultati: Lijekovi s odobrenjem za izdavanje u specijaliziranim prodavaonicama imaju
dopuštenje za oglašavanje prema stanovništvu, OTC lijekovi koji sadrže djelatnu tvar ASK također imaju
dopuštenje za oglašavanje prema stanovništvu. Usporedbom prijava sumnji na nuspojave lijekova koji sadrže
djelatnu tvar ASK, ibuprofen ili paracetamol utvrđeno je da nije bilo značajne razlike u ozbiljnosti prijava sumnji
na nuspojave lijekova. Također nije pronađena statistički značajna razlika u ishodu nuspojava za spomenute
lijekove. Zaključci: Nisu pronađene razlike u prijavljenim sumnjama na nuspojave lijekova koji sadrže djelatnu
tvar ASK i lijekova koji sadrže djelatnu tvar ibuprofen ili paracetamol, stoga nema ograničenja za promjenu mjesta
izdavanja bezreceptnih lijekova u RH koji sadrže djelatnu tvar ASK. Potrebno je definirati zakonski okvir za
spomenutu reklasifikaciju bezreceptnih lijekova.Objectives: The aim of this study was to examine the justification for the deregulation of Over-the-
Counter (OTC) medicinal products containing active substance acetylsalicylic acid (ASA), registered in the
Republic of Croatia, from Pharmacy Only to Pharmacy and Drug Outlet Medicinal Products. Material and
Methods: A comparative review was made of the regulatory status of OTC medicinal products containing active
substance ASA in a selected number of EU member states. We analysed the legislation on distribution of OTC
medicinal products in the Republic of Croatia and compared reported adverse reactions of medicinal products with
active substances ASA, ibuprofen or paracetamol reported in the Republic of Croatia in the year 2015. Results:
Medicinal products classified as Pharmacy and Drug Outlet Medicinal Products have permission to advertise to
the general public. OTC medicinal products containing the active substance ASA also have permission to advertise
to the general public. Analysis of adverse events reported with medicinal products containing active substances
ASA, ibuprofen or paracetamol found that there were no significant differences in the number of reported adverse
reactions classified as serious. There was no statistically significant difference in the outcome of the adverse
reactions among these medicinal products. Conclusions: There was no difference in reported adverse reactions
among medicinal products containing active substance ASA, ibuprofen or paracetamol, therefore there is no
obstacle for the deregulation of OTC medicinal products containing active substance ASA, registered in the
Republic of Croatia, from Pharmacy Only to Pharmacy and Drug Outlet Medicinal Products. A reagulatory
framework should be developed to address this deregulation
