Резюме: У навчальному посібнику висвітлено актуальні питання менеджменту побічної дії ліків у системі вітчизняного та міжнародного фармакологічного нагляду, принципи моніторингу безпеки лікарських засобів на етапах до- і післяреєстраційних досліджень. Особлива увага присвячена менеджменту сигналів, ризиків і медикаментозних помилок, а також оцінці співвідношення користь/ризик в царині застосування ліків. Подано новітню інформацію стосовно менеджменту комунікації та інформування у фармаконагляді з акцентом на проблеми громадського здоров’я, сучасні засоби комунікації та джерела інформації. Насичення розділів посібника відповідає навчальній програмі Львівського національного медичного університету імені Данила Галицького з побічної дії ліків. Посібник призначений для лікарів усіх спеціальностей, фармацевтів, клінічних фармацевтів, викладачів, студентів вищих медичних (фармацевтичного) закладів, слухачів системи медичної та фармацевтичної післядипломної освіти.

Summary: The training manual covers topical issues of side effect management of drugs in the system of Ukrainian and international pharmacovigilance, principles of drug safety monitoring at the stages of pre- and post-registration studies. Special attention is devoted to the management of signals, risks, and medication errors, as well as to the assessment of the benefit/risk ratio in the field of medication use. The latest information on communication and information management in pharmacovigilance with an emphasis on public health issues, modern tools of communication, and information sources is presented. The content of the sections of the manual corresponds to the curriculum of the DanyloHalytskyLviv National Medical University on drugs side effects.

The manual is intended for doctors of all specialties, pharmacists, clinical pharmacists, teachers, students of higher medical (pharmaceutical) institutions, and students of the system of medical and pharmaceutical postgraduate education.

This study aimed to assess the antibiotic therapy of community-acquired pneumonia (CAP) in adults. A single-center, retrospective study was conducted in one of Lviv city hospitals, Ukraine. Adults with CAP (n=181) were enrolled. Fluoroquinolones (45.3%), cephalosporins (27.8%), and macrolides (16.1%) were the most common antibiotics. Antibiotic-associated drug-related problems (DRPs) were found in 87.3% (95%CI 81.5%:91.8%) of the participants. 4 items of antibiotic-associated DRPs were identified: potential drug-drug interactions (76.6%), inappropriate dosing (14.0%), inappropriate length of therapy (7.5%), and contraindicated usage (1.9%). Spiramycin, metronidazole, levofloxacin, azithromycin, and cefoperazone were associated with the highest risk of DRPs. Age of patients (p<0.001), number of antibiotics (p<0.001), length of antibiotic therapy (p=0.036), and the total number of antibiotic-associated DRPs (p=0.005) were defined as factors that statistically contribute to the patient’s health status on discharge. Antibiotics should be the drug class most commonly involved in the interventions to improve the safety and quality of CAP therapy.

Results. Antibiotics were administered for 44.2% (95%CI 34.9%–53.9%) of patients. The main reasons for antibiotic prescriptions were acute tonsillitis (30.0%) and acute upper respiratory tract infections (26.0%). Macrolides, cephalosporins, penicillins, and sulfonamides with trimethoprim presented 40.0%, 36.0%, 20.0%, and 4.0% of antibiotic prescriptions, respectively. Antimicrobials from the Access group accounted for 26.0% of antibiotic prescriptions (instead of at least 60.0%, WHO) and antibiotics from the Watch group constituted 74.0% (instead of a maximum of 40.0%, WHO). Antibiotics were prescribed to 61.9% of outpatients with acute upper respiratory tract infections, 93.7% of patients with acute tonsillitis, and 45.5% – with otitis media instead of recommended 0-20% (ESAC-Net). The first-line antibiotics were used in 23.1% of cases of acute upper respiratory infections, 26.7% of cases of acute tonsillitis, and 40.0% of otitis media, which is below the acceptable range (80–100%, ESAC-Net). In total, 22 antibiotic-associated drug-related problems (DRPs) were found in 34.0% of written doctor’s prescriptions with antimicrobials. The most common were: (1) excessive length of therapy (36.4%) and (2) potential drug-drug interactions (31.8%). Conclusions. The rate of antibiotic prescriptions for children is high and associated with different DRPs. The majority of antibiotic prescription quality indicators are outside the recommended ranges. Thus, effective interventions and campaigns to improve antibiotic therapy in children are needed.


Background. Antimicrobial therapy is a common practice in pediatrics. Aim. The main objective was to determine and characterize the profile of antibiotic
prescriptions in pediatric outpatients. Methods. This was a retrospective observational study performed in two pharmacies in Lviv (October 2021). 113 written doctor’s prescriptions for outpatient children were collected. Results. Antibiotics were administered for 44.2% (95%CI 34.9%–53.9%) of patients. The main reasons for antibiotic prescriptions were acute tonsillitis (30.0%) and acute upper respiratory tract infections (26.0%). Macrolides, cephalosporins, penicillins, and sulfonamides with trimethoprim presented 40.0%, 36.0%, 20.0%, and 4.0% of antibiotic prescriptions, respectively. Antimicrobials from the Access group accounted for 26.0% of antibiotic prescriptions (instead of at least 60.0%, WHO) and antibiotics from the Watch group constituted 74.0% (instead of a maximum of 40.0%, WHO). Antibiotics were prescribed to 61.9% of outpatients with acute upper respiratory tract infections, 93.7% of patients with acute tonsillitis, and 45.5% – with otitis media instead of the recommended 0-20% (ESAC-Net). The first-line antibiotics were used in 23.1% of cases of acute upper respiratory infections, 26.7% of cases of acute tonsillitis, and 40.0% of otitis media, which is below the acceptable range (80–100%, ESAC-Net). In total, 22 antibiotic-associated drug-related problems (DRPs) were found in 34.0% of written doctor’s prescriptions with antimicrobials. The most common were: (1) excessive length of therapy (36.4%) and (2) potential drug-drug interactions (31.8%). Conclusions. The rate of antibiotic prescriptions for children is high and associated with different DRPs. The majority of antibiotic prescription quality indicators are outside the recommended ranges. Thus, effective interventions and campaigns to improve antibiotic therapy in children are needed.

Новину відредагував: library-lnmu - 7-03-2024, 11:52