Comparative Analysis of Legislative Requirements About Patients' Access to Biotechnological Drugs for Rare Diseases in Central and Eastern European Countries.

Objectives: The aim of the study was to compare the access of patients with rare diseases (RDs) to biotechnological drugs in several Central and Eastern European countries (CEECs). We focused on the legislative pricing and reimbursement requirements, availability of biotechnological orphan medicinal products (BOMPs) for RDs, and reimbursement expenditures. Methods: A questionnaire-based survey was conducted among experts from 10 CEECs: Bulgaria, Croatia, Estonia, Greece, Hungary, Poland, Romania, Slovakia, Serbia, and Macedonia. The legal requirements for reimbursement and pricing of BOMPs were collected. All BOMPs and medicines without prior orphan designations were extracted from the European list of orphan medicinal products, 2017. The reimbursement status of these medicinal products in 2017 in the public coverage of the included CEECs as well as the share of their costs in relation to the total public pharmaceutical spending for the period from 2014 to 2016 were defined. Results: Our survey revealed that some differences in the legal requirements for pricing and reimbursement of BOMPs amongst the countries included in the study. All European Union countries have developed and implemented pharmacoeconomic guidelines with or without some specific reimbursement requirements for orphan medicinal products. Cost-effectiveness analysis, cost-utility analysis, Markov models, meta-analysis, and discount levels of costs and results were required only in Bulgaria, Poland and Hungary. The number of reimbursed BOMPs and biotechnological medicinal products for RDs without prior orphan designation was the highest in Hungary (17 and 40, respectively). Patient-based reimbursement schemes were available only in Hungary for 11 out of 17 BOMPs. Poland and Greece have the highest pharmaceutical expenditure of reimbursed BOMPs with are ~214 million and 180 million EUR, respectively in the observed period from 2014 to 2016. High proportion of the pharmaceutical expenditure on the reimbursed biotechnological medicinal products for RDs for the observed period 2014-2016 is presented in Bulgaria and Slovakia. Conclusions: The non-European Union CEECs face a significant delay in the legal implementation of pharmacoeconomic guideline for assessment of BOMPs. The access to BOMPs is similar among the observed CEECs and the countries with the best access are Hungary and Greece. The influence of BOMP expenditures on the budget in the individual countries is significant.

Change in parental knowledge, attitudes and practice of antibiotic use after a national intervention programme.

Background: Nation-wide multifaceted interventions to improve antibiotic use were undertaken in the former Yugoslav Republic of Macedonia in September 2014. This study aimed to assess the parental knowledge and attitudes about antibiotics, and self-medication practices in children, and evaluate the impact of interventions on these parameters. Methods: Pre-post-intervention surveys were conducted in May 2014-16 in three administrative regions in the country. Data were collected by interviewing parents of children younger than 15 years of age through a questionnaire. The analysis of knowledge, attitudes and antibiotic use involved descriptive quantitative statistics. The effects of interventions were assessed by a logistic and linear regression analysis. Results: Data from 1203 interviewees showed that 80% of parents knew that antibiotics could kill bacteria, while 40% believed antibiotics could kill viruses. One third of parents expressed potential dissatisfaction with doctors who would not agree with them on antibiotic use. More parents received information about not taking antibiotics unnecessarily after the interventions, but the rates decreased one year later. At baseline, 20% of the parents and 10% of the children who received antibiotics in previous year, took them without prescriptions. Parental self-medication rates did not change over time, while children rates decreased only in 2015. Conclusion: The insignificant and short-term changes in knowledge, attitudes and self-medication demonstrate that interventions need to be implemented for a longer period of time, at a large scale, with active health providers' engagement, and accompanied by inspections to promote appropriate use of antibiotics and discourage self-medication.

Antibiotics for upper respiratory infections: public knowledge, beliefs and self-medication in the Republic of Macedonia.

Self-medication as part of the irrational use of antibiotics contributes to the spread of antimicrobial resistance. The aim of this community-based survey in Macedonia was to determine public knowledge, beliefs and self-medication with antibiotics for upper respiratory infections. A cross-sectional study was conducted in three administrative regions in Macedonia in April 2012. 402 eligible participants answered an anonymous questionnaire. The analysis of answers involved descriptive quantitative statistics (frequencies and percentages). We also tested for significant associations between demographic characteristics and non-prescription use of antibiotics. Our respondents demonstrated a relatively low level of public knowledge about antibiotics and upper respiratory infection treatments in comparison to the EU countries. The study found that 71.4% of participants stored antibiotics at home, and 43.3% purchased antibiotics over-the-counter in the last year, despite national regulation that restricts antibiotics as prescription-only medicines. Actual self-medication with antibiotics for a recent upper respiratory infection episode was reported in 17.8% of adults and 1.8% of children aged 0-4 years. We did not find any significant association between participants demography and non-prescription use of antibiotics. Our results put in the group of eastern and southern EU countries with the highest rates for non-prescription use of antibiotics in Europe. Multifaceted interventions are needed to prevent self-medication with antibiotics, including: enforcement of regulations that restrict over-the-counter sales of antibiotics, monitoring of antibiotic use and antimicrobial resistance rates and combined public education strategies.

Health Organization in Republic of Macedonia-the place of preventive health care in the medical health system: advantages and disadvantages.

The health system in Macedonia is organized by public or private property health institutions divided on three levels: primary, secondary and tertiary health care. According to the legal regulations and their acts, regulatory authorities for preventive care are the health institutions of primary health care (whether they have private or public character), heath care establishments and some of the hospitals. In the period of transition starting from 1991 up to this day, numerous health system modifications have been made concerning health reforms: common alterations in health legislation change in property of health institutions, realignment of authorities etc. The adjustment of the system to the new circumstances and constant changes has provoked partial disruption in the established system for preventive health care activity.