Analysis of the suspected adverse drug reaction reports of drugs used for treatment of systemic infections in a period of 10 years

Cilj istraživanja: Cilj ovog istraživanja je bio analizirati prijavljene sumnje na nuspojave lijekova iz ATK klasifikacije J – lijekovi za liječenje sustavnih infekcija, koje je zaprimala Agencija za lijekove i medicinske proizvode (HALMED) od 1. siječnja 2011. godine do 31. prosinca 2020. godine. Materijali i metode: Izvor podataka bila je VigiBase, jedinstvena svjetska baza podataka Svjetske zdravstvene organizacije (SZO). Iz prijava sumnji na nuspojave lijekova analizirani su sljedeći podatci: dob i spol pacijenata, lijekovi s najvećim brojem prijava, ozbiljnost nuspojave, prijavitelji nuspojava, najčešće nuspojave i klasifikacija nuspojava prema organskim sustavima Medicinskog rječnika za regulatorne poslove, MedDRA. Rezultati: U određenom razdoblju od 10 godina ukupno je zaprimljena 6441 prijava sumnji na nuspojave. Osobe za koje su se prijavljivale sumnje na nuspojavu lijeka bile su u 57 % slučajeva ženskog spola, a najveći broj pacijenata pripadao je dobnoj skupini od 18 do 44 godine (21,7 %). Najčešći prijavitelji bili su liječnici (55,8 %), zatim farmaceuti (26,2 %), a ostalo su bili pacijenti/korisnici lijeka te drugi zdravstveni radnici. Od ukupno prijavljenih sumnji na nuspojave, 31,3 % opisano je kao ozbiljna nuspojava, a 64,8 % nije opisano kao ozbiljna nuspojava. Prema klasifikaciji nuspojava po organskim sustavima MedDRA, od ukupnih prijava sumnji na nuspojave, najviše ih je zabilježeno u skupini VIII. Opći poremećaji i reakcije na mjestu primjene (40,4 %), zatim u skupini XXIII. Poremećaji kože i potkožnog tkiva (29 %), te u skupini VII. Poremećaji probavnog sustava (28,8 %). Najviše sumnji na nuspojave prijavljeno je za lijek amoksicilin/klavulanska kiselina (10,8 %), a za cjepiva su najčešće sumnje na nuspojave prijavljivali liječnici. Zaključak: Najviše prijava sumnji na nuspojave zaprimljeno je za osobe ženskog spola. Prijavitelji su većinom bili liječnici, a potom farmaceuti. Prijave sumnji na nuspojave većinski su se odnosile na skupinu općih poremećaja i reakcija na mjestu primjene, poremećaje kožnog i potkožnog tkiva te gastrointestinalne poremećaje. Lijek s najviše prijavljenih sumnji na nuspojave bio je amoksicilin/klavulanska kiselina.Objective: The aim of this research was to analyze the reported suspected adverse drug reactions from ATC group J - drugs for the treatment of systemic infections, which were received by the Agency for Medicines and Medical Products (HALMED) from January 1, 2011 to December 31, 2020. Materials and Methods: The data source was VigiBase, the unique global database of the World Health Organization (WHO). The following data were analyzed from suspected adverse drug reaction reports: age and sex of patients, drugs with the highest number of reports, severity of adverse reactions, adverse reaction reporters, most common adverse reactions and adverse drug reaction classification according to MedDRA system organ classification. Results: In the observed period of 10 years, a total of 6441 reports of suspected adverse drug reactions were received. People for whom suspected adverse drug reactions were reported were female in 57 % of cases, and the largest number of patients belonged to the age group of 18 to 44 years (21,7 %). The most frequent reporters were physicians (55,8 %), followed by pharmacists (26,2 %), and the rest were patients/drug users and other health professionals. Of the total reported suspected adverse drug reactions, 31,3 % were described as serious adverse drug reactions and 64,8 % were not described as serious adverse drug reactions. According to the MedDRA classification of adverse drug reactions by organ system, of the total reports of suspected adverse drug reactions, most of them were recorded in group VIII. General disorders and administration site conditions (40,4 %), then in group XXIII. Skin and subcutaneous tissue disorders (29 %), and in group VII. Gastrointestinal disorders (28,8 %). The most suspected adverse drug reactions were reported for the drug amoxicillin/clavulanic acid (10,8 %), and suspected adverse drug reactions for vaccines were most often reported by physicians. Conclusion: Most reports of suspected adverse drug reactions were received for women. The reporters were mostly physicians, and then pharmacists. Reports of suspected adverse drug reactions were mostly related to the group of general disorders and reactions at the site of application, skin and subcutaneous tissue disorders, and gastrointestinal disorders. The drug with the most reports of suspected adverse drug reactions was amoxicillin/clavulanic acid