Prepoznavanje in poročanje neželenih učinkov zdravil pri bolnikih, obravnavanih v ambulanti internistične prve pomoči Univerzitetnega kliničnega centra Ljubljana

Simončič, Urban (author), Kerec Kos, Mojca (mentor), Dobravc Verbič, Matej (comentor)

Neželeni učinki zdravil spadajo med pogoste težave zdravljenja z zdravili, saj se pojavljajo pri 3˗10 % bolnikih. Poleg negativnega vpliva na počutje in zdravje bolnikov povečajo verjetnost za obravnavo bolnikov v ambulanti internistične prve pomoči in tudi finančno obremenijo zdravstveni sistem. Z neintervencijsko, retrospektivno raziskavo smo želeli ovrednotiti pojavnost in vrsto neželenih učinkov zdravil pri bolnikih, ki so bili v obdobju 2 mesecev obravnavani v ambulanti Internistične prve pomoči, Urgentnega bloka, Univerzitetnega kliničnega centra Ljubljana. Od 3453 obravnavanih bolnikov smo pri 227 bolnikih (6,6 %) zaznali neželeni učinek zdravila. Potrdili smo značilno povezavo med pojavom neželenih učinkov zdravil in starostjo, številom pridruženih bolezni, številom sočasno uporabljanih zdravilnih učinkovin in prisotnostjo jetrne ter ledvične okvare. 160/227 (70,4 %) bolnikov je bilo v ambulanti internistične prve pomoči obravnavanih zaradi neželenih učinkov zdravil, 42 izmed teh je bilo zaradi neželenih učinkov napotenih na nadaljnjo obravnavo na Interno kliniko. 74/273 (27,1 %) neželenih učinkov smo potrdili, ostali so ostali nepotrjeni. 194/273 (71,1 %) neželenih učinkov zdravil smo ocenili kot resne in 21/273 (7,7 %) kot hude. Po metodi Naranjo smo 252/273 ( 92,3 %) neželenih učinkov ocenili kot možnih in le 1/273 (0,4 %) kot gotovih. Največ neželenih učinkov zdravil je bilo iz skupine presnovnih in prehranskih motenj (91 primerov ali 33,3 %) in iz skupine prebavnih bolezni (89 primerov ali 32,6 %). Najpogostejši neželeni učinki so bili GIT krvavitev (30 primerov), melena (27 primerov), hiponatriemija (26 primerov). Zdravilne učinkovine, ki so najpogosteje povzročile neželene učinke zdravil, so bile varfarin (42 primerov), acetilsalicilna kislina (26 primerov) in indapamid (22 primerov). Prepoznali smo 169 potencialnih interakcij, a smo ocenili, da so se klinično izrazile le v 13 primerih neželenih učinkov. Varfarin je bil najpogosteje udeležen v potencialnih interakcijah med zdravili. Najpogostejši ukrep za odpravo ali ublažitev neželenega učinka je bila ukinitev zdravila, ki je bilo sprejeto pri 107/273 (53,2 %) primerov NUZ. Samo 2 (0,7 %) primera neželenih učinkov sta imela ustrezno dodeljeno klasifikacijsko šifro in le 3 (1,1 %) primeri so bili poročani preko bolnišničnega sistema.

• Language: Slovenian
• Keywords: neželeni učinki zdravil, zdravilne učinkovine, interakcije med zdravili, potrjenost, resnost, poročanje
• Work type: Master's thesis/paper
• Organization: FFA - Faculty of Pharmacy
• Year: 2022
• PID: 20.500.12556/RUL-136303
• Publication date in RUL: 23.04.2022

Secondary language

• Language: English
• Title: Recognition and reporting of adverse drug reactions in ambulatory patients at the Medical Emergency Department, University Medical Centre Ljubljana

Abstract

Adverse drug reactions are one of common problems during drug treatment, they occur in 3-10 % of all patients. In addition to the negative impact on well-being of patients health, they increase the likelihood of treating patients in an internal medicine first aid clinic, as well as the quality of treatment and the financial burden on the health care system. With a non-interventional, retrospective study, we wanted to evaluate the incidence and type of side effects of drugs in patients, who were treated for 2 months in the internist first aid clinic, Emergency unit, University clinical centre Ljubljana. Of the 3453 patients included in the study, 227 patients (6.6 %) experienced adverse drug reactions. We confirmed a significant association between the occurrence of adverse drug reactions and age, the number of comorbidities, the number of drugs and the presence of liver or renal impairment. 160/227 (70.4 %) of all patients were treated in the internist first aid clinic due to adverse drug reactions and among them 42 patients were referred to the Internal medicine clinic for further treatment. 74/273 (27.1 %) of adverse reactions were confirmed, with the remaining only suspected. 194/273 (71.1 %) of adverse drug reactions were assessed as serious and 21/273 (7.7 %) as severe. According to the Naranjo method, 252/273 (92.3 %) side effects were assessed as possible and only 1/273 (0.4 %) as certain. The majority of adverse drug reactions were from the group of metabolism and nutritional disorders (91 cases or 33.3 %) and from the group of gastrointestinal disorders (89 cases or 32.6 %). The most common side effects were GIT bleeding (30 cases), melena (27 cases), hyponatremia (26 cases). The active substances that most commonly caused adverse drug reactions were warfarin (42 cases), acetylsalicylic acid (26 cases) and indapamide (22 cases). We identified 169 potential drug-drug interactions, but we estimated that they were clinically expressed in only 13 cases of adverse drug reactions. Warfarin was most commonly involved in drug interactions. The most common measure to eliminate or alleviate the side effect was discontinuation of the drug, which was taken in 107/273 (53.2 %) cases of adverse drug reactions. Only 2 (0.7 %) cases of adverse reactions had a properly assigned classification code and only 3 (1.1 %) cases were reported through the hospital system.

• Keywords: adverse drug reactions, drugs, drug-drug interactions, certainty, severity, reporting