Abstract

The research aims at improving the quality assessment of clinical audit results in Ukraine using the complex of statistical methods and studying statistical methods in foreign reports of the clinical audit and personal experience.

Materials and Methods. The research was performed by analyzing the reports of clinical audit (n=62), held during 2021 by the Healthcare Quality Improvement Partnership. The spectrum of statistical methods was extended by the analysis of the example of a sociological survey of patients (n=405) regarding the quality assessment of medical care. The methods applied in the current study included systemic approach and analysis, structural and logical analysis, correlation and regressive analysis, calculation of relative values.

Results and Discussion. All 100% clinical audit reports, carried out by the Healthcare Quality Improvement Partnership were based on the results of the statistical calculations. The most common method of processing results is the epidemiological statistics (93.5%), ratio of chances/risks (30.6%), probability assessment by Х² Pearson's method (21.0%). It is noteworthy that for pointing the central tendency almost in half of the cases (46.8 %) the median and the Interquartile Range were used. Complex mathematical methods such as the survival assessment by Kaplan- Meier and method multiple regression were used in 6.5 % та 4.8 % reports, accordingly.

Conclusions. Based on our own experience, we suggested implementation of standardization methods, a detailed correlation and regressive analysis, neuro networks and power analysis into the methodology (technique) of the clinical audit. Implementation of spectrum of evidentially substantiated methods of statistical analysis will allow to increase the evidence level and to deepen the statistical analysis of databases when conducting the clinical audit, аnd therefore, the quality assessment of clinical audit results will increase.

The aim of the work. Comparative analysis of the educational programs' components of higher education institutions of different subordination, which train specialists for the pharmaceutical industry, and study the experience of design and assessment of the similarity level of the components of these programs.Materials and Methods. The educational and professional programs "Pharmacy, Industrial Pharmacy" of higher education institutions, namely Lviv Polytechnic National University and Danylo Halytsky Lviv National Medical University, have been used. The research was conducted using content analysis, comparative analysis, decomposition, and modeling methods.Results and Discussion. The analysis of educational programs of specialty 226 "Pharmacy, Industrial Pharmacy," which provides training of specialists at the Lviv Polytechnic National University (bachelors and masters in pharmacy, industrial pharmacy) and Danylo Halytsky Lviv National Medical University (Masters of Pharmacy) testifies to a significant amount of similar educational components, especially the pharmaceutical directions, which is a positive sign for the creation of future Education Standards. However, it should be noted that in the educational-professional bachelor's program in pharmacy, industrial pharmacy provides a large number of disciplines for general and vocational training. These disciplines are necessary and compose a basis for future educational program components that directly affect the specialist's becoming in industrial technology of medicines. The acquired competencies will allow performing qualitative work qualitatively and successfully implementing the acquired knowledge in the conditions of industrial pharmaceutical production.Conclusions. The creation and approval at the state level of the Education Standard for specialty 226 "Pharmacy, Industrial Pharmacy" is an essential and relevant element in the development of pharmaceutical education in Ukraine, which will harmonize and lead to a single format and content list of components of educational programs, unify state certification and guarantee competitiveness in the labor market for all higher education applicants.

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.