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.

The study aimed to analyse the adverse drug reactions report form data received by the State Expert Center of the Ministry of Health of Ukraine from healthcare professionals in the Lviv region in 2022. Regarding specific types of medicines, the ones with proven cause-and-effect relationships that caused the highest frequency of adverse drug reactions incidents were chemotherapeutic agents (35.5%), medicines affecting the cardiovascular system (20.3%), and non-steroidal antiinflammatory drugs (8%). Within the penicillin class, amoxicillin potentiated by clavulanate (67%) and amoxicillin (29%) were the dominant drugs showing the highest incidence rate of adverse reactions. Among cephalosporins, ceftriaxone (46%) and cefixime (15%) were found to take the lead in terms of adverse reaction frequency. The highest proportion among all adverse drug reactions caused by penicillins and cephalosporins was attributed to allergic reactions. To confirm or rule out immediate or delayed type allergies in patients, as well as in patients with a history of immediate-type allergic reactions to β-lactams and planned administration of another β-lactam, it is necessary to conduct skin testing (skin prick test, or, in the case of parenteral administration, intradermal test) with the planned β-lactam antibiotic. The second highest proportion of induced adverse drug reactions was attributed to drugs affecting the cardiovascular system (20.3%). The leading medications in the angiotensin-converting enzyme inhibitors category were enalapril (47%) and the combination of lisinopril with hydrochlorothiazide (24%). In the angiotensin II receptor blockers category of medications, valsartan (30%) and telmisartan-hydrochlorothiazide combination (20%) ranked highest. In the category of CCB drugs, amlodipine (66%) and nifedipine (20%) held the leading positions. among angiotensinconverting enzyme inhibitors, enalapril caused the most prevalent and predicted adverse reaction, that of cough, affecting 10.5% of patients, whereas, with the combination therapy of lisinopril and hydrochlorothiazide, the cough was observed in only 5.2% of patients. Angiotensin II receptor blockers have a better safety profile, particularly concerning cough. Analysis of adverse drug reactions reports for angiotensin II receptor blockers showed no cases of cough with valsartan and telmisartan-hydrochlorothiazide combination. Among calcium channel blocker medications, amlodipine emerged to rank highest, causing one of the predicted adverse drug reactions, that of lower extremity oedema in 64% of patients. The second position was taken by the combination of amlodipine with valsartan, which showed a statistically significant reduction of 14.3% (p≤0.05) in the incidence of oedema. Using amlodipine at a dose of 5 mg in combination with sartan medicines as angiotensin receptor blockers is an effective therapeutic alternative not only for enhancing blood pressure control in hypertensive patients but also for improving the safety profile of amlodipine. Among all the non-steroidal anti-inflammatory drugs prescribed to patients in the Lviv region in 2022, the highest number of adverse reactions was associated with the administration of diclofenac, ibuprofen, paracetamol, and nimesulide, causing adverse drug reactions in 22%, 19%, 17%, and 10% of cases, respectively. The most common systemic manifestations of adverse reactions with these non-steroidal anti-inflammatory drugs were allergic reactions (63.4%) and gastrointestinal disorders (26.8%). From an evidence-based medicine perspective, the most justified approach for primary and secondary prevention of gastrointestinal complications is the use of proton pump inhibitors.

Cultural impact on the Polish and Ukrainian results of the TSIDAV vignette (Thrombocytopenia Symptoms Impact on patients Daily Activities Assessment Vignette) was analyzed. The impact of the disease symptoms was assessed using TSIDAV vignette and the main research was followed by the analysis related to the cultural impact on the results. The cultural impact analysis was based on Hofstede’s national culture model.
49 Ukrainian and 61 Polish patients participated. Mean Ukrainian TSIDAV value was 0.31 (SD 0.83). Gender values ranged <0 to -1.0, and according to the key for results interpretation it confirmed high disease impact on daily activities. Higher disease impact among men than among women (mean TSIDAV value 0.18, SD 0.95; and 0.44, SD 0.69 respectively). Mean Polish TDSIDAV value was 0.68 (SD 0.69). Among Polish women mean value was -0.85 (SD 0.54), within men mean -0.35 (SD 0.83). Applying G. Hofstede’s cultural model Ukrainian Power Distance score 92 reflects power holders societal distance. Low scores of Individualism and Masculinity dimensions. Uncertainty avoidance score 95, meaning feeling threatened by ambiguous situations. Long term
orientation dimension score 86 reflects Ukrainian society pragmatism. Polish results shown hierarchical (scoring 68), individualist (score 60), masculine society (score 64). Avoidance dimension scores 93 in Poland, meaning avoid uncertainty preference. Long Term Orientation dimension scored 38, defining more normative than pragmatic society.

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.

The purpose of this section is to highlight the opportunities for digitizing important processes in the healthcare system to improve the efficiency of population health management. The introduction of these digital processes will increase patient satisfaction with the healthcare system, as well as provide a holistic outlook of patient health through access to data and give patients more control over their own health. Healthcare managers will also be using the developed Internet applications to conduct clinical audits and monitor health problems in the administrative district. It is proposed to develop and use free Internet applications and computer programs, namely: 1) Drug Compatibility Test online application, which is designed primarily for students. This app is designed to test knowledge of drug compatibility and
certain aspects of diet and behavioral habits; 2) electronic individual antenatal drug passport for a promising way to predict, prevent and reduce the risk of allergic reactions; and 3) Medical Intelligence app using the artificial intelligence technologies to develop an individual educational trajectory for doctors and pharmacists.