Analysis of the suspected adverse drug reaction reports of drugs used for digestive system

Cilj istraživanja: Cilj istraživanja bio je analizirati podatke prijavljenih sumnji na nuspojave lijekova iz ATK klasifikacije A – lijekovi s djelovanjem na probavni sustav i mijenu tvari, koje su zaprimane u Agenciji za lijekove i medicinske proizvode (HALMED) u razdoblju od 1. siječnja 2014. godine do 31. prosinca 2018. godine. Materijali i metode: Izvor podataka o nuspojavama lijekova bila je VigyBase, globalna baza podataka Svjetske zdravstvene organizacije (SZO). Iz dobivenih podataka o sumnji na nuspojave lijekova analizirani su slijedeći podatci: dob i spol pacijenta, ozbiljnost nuspojave, prijavitelj nuspojave, najčešće nuspojava te klasifikacija nuspojava prema organskim sustavima Medicinskog rječnika za regulatorne poslove, MedDRA. Rezultati: U promatranom vremenskom razdoblju prijavljeno je ukupno 1527 nuspojava lijekova, a najviše nuspojava prijavljeno je 2017. godine (25, 3%). Prijavitelji su u 41% slučajeva bili farmaceuti, u 40% slučajeva liječnici, a ostalo pacijenti te drugi zdravstveni djelatnici. Osobe kod kojih je postojala sumnja na nuspojavu lijeka su dominantno bile ženskog spola, a većina pacijenata pripadala je dobnoj skupini od 45 i 64 godine (30%). Od ukupno 1527 prijavljenih sumnji na nuspojavu 276 (18%) je okarakterizirano kao ozbiljna nuspojava, odnosno 1250 (82%) nije zadovoljilo kriterij ozbiljne nuspojave. Prema MedDRA klasifikaciji najviše sumnji na nuspojavu se odnosilo na skupinu poremećaja probavnog sustava (40%), među kojima se ističu mučnina i povraćanje. Iz cijele ATK klasifikacije A, najviše sumnji na nuspojavu je prijavljeno za lijekove pantoprazol (13, 9%) i metformin (13, 5%). Zaključak: Najviše prijava sumnji na nuspojave lijekova se odnosilo na osobe ženskog spola, a prijavitelji su dominantno bili farmaceuti. Unatoč dobrom sigurnosnom profilu i učinkovitosti, lijek s najviše prijava sumnji na nuspojavu je bio pantoprazol zbog široke i česte upotrebe.Objective: The aim of this study was to analyse the dana on reported suspected adverse drug reactions for ATK classification A - drugs with effects on the digestive system and metabolism, which were received by the Agency for Medicinal Products and Medical Devices (HALMED) in the period from 1 January 2014 to 31 December 2018. Materials and Methods: The source of data of suspected adverse drug reaction was VigyBase, the global database of the World Health Organization (WHO). From the obtained data on suspected drug reaction, the following data were analyzed: age and sex of the patient, severity of side effects, reporter qualification, most common side effects and adverse drug reaction classification according to MedDRA system organ classification. Results: In the observed time period, a total of 1527 adverse drug reactions were reported, and the biggest number of adverse reactions was reported in 2017 (25, 3%). The reporters were pharmacists in 41% cases, doctors in 40% cases, and the rest were patients and other health professionals. People with suspected drug adverse drug reaction were predominantly female, and most patients belonged to the age groups of 45 and 64 years (30%). Out of a total of 1527 reported suspected adverse drug reaction, 276 (18%) were characterized as a serious side effect, ie 1250 (82%) did not fulfill the demands of a serious side effect. According to the MedDRA classification, the most suspected adverse drug reaction were related to disorders of the digestive system (40%), among which nausea and vomiting standed out. Of the total ATK classification A group, the most suspected adverse reactions were reported for pantoprazole (13, 9%) and metformin (13, 5%). Conclusion: Most reports of suspected adverse drug reaction were related to the females, and predominantly reporters were pharmacists. Despite efficacy and a good safety profile, drug with the most reports of suspected adverse drug reactions was pantoprazole due to its widespread and frequent use