Evaluation of potentially inappropriate medication in older patients with cardiovascular diseases-STOPP/START-based study.

Objective: This study aims to evaluate the use of STOPP/START criteria in the identification of Potentially inappropriate medication and potential prescribing omissions in older patients with cardiovascular diseases in Bulgaria. Excessive morbidity and mortality has been linked to drug-related problems and increased use of healthcare services and is an understudied problem for Bulgaria. Materials and methods: A prospective, questionnaire-based study was conducted among 543 older patients across 25 pharmacies in Bulgaria. Socio-demographic characteristic, disease profile, symptoms, and medication data were collected. The questionnaire was developed for the purposes of the EUROAGEISM project. Out of all 543 patients, only those with documented cardio-vascular diseases were extracted and the medication profile per patient was evaluated for Potentially inappropriate medication (PIMs) and potentially prescribing omissions (PPOs) using STOPP/START criteria version 2. In addition, several risks for potentially inappropriate prescribing (PIPs), PPOs and PIMs were calculated with the focus being on the Odds and Risks to develop a PIP. Results: Four hundred and twenty eight from 531 patients with known therapy for cardiovascular diseases (CVDs) were included in the analysis of PIP (40.52% aged 65-69 years, 61.88% female, 64% had up to 6 comorbidities, and 21.72% presenting with polypharmacy). A total of 71 PIMs in 64 patients with polypharmacy were identified during applying STOPP criteria. 56% of patients taking above five medicines daily had PIMs. The majority of PIMs (31%) were related to CVDs treatment, followed by PIMs in the treatment of endocrine diseases (22.54%), duplication of medicines (8.46%) and prolonged treatment with benzodiazepines (8.46%). Forty four PPOs were identified with START criteria. 22.72% were related to lack of proton pump inhibitors (PPI) in the presence of gastroesophageal disorders, and the same percentage was for lack of Calcium-vitamin D supplementation in osteoporosis. Applying the methodology of risks calculation the sample risk for PPO was 2.1% and for PIM 3.4%. At sample level the relative risk for PPO was 62% out of the risk for PIM and at population level varied between 42.8 and 89.8% and it is statistically significant. The number needed to treat for the event to happen is 77.5, meaning that at every 78 prescriptions there is a chance to appear PIP. Conclusion: Application of methodologies for detection of potentially inappropriate prescribing is not part of routine clinical practice in Bulgaria. Our study demonstrates a high percentage of potentially inappropriate medication among older patients with polypharmacy. Along with the aging population in Bulgaria, economic burden of polypharmacy and the prevalence of cardiovascular diseases, it is especially important to address potentially inappropriate medication use in cardiovascular patients. There is a considerable necessity for implementation of measures for early detection of potentially inappropriate medication and potentially prescribing omission as a part of de-prescribing strategies in older patients.

Analysis of the Household and Health Care System Expenditures in Bulgaria.

Health care systems worldwide are experiencing tremendous financial pressure because of the introduction of new targeted health technologies and medicines. This study aims to analyze and compare public and household healthcare expenditures in Bulgaria during the period 2015-2019, as well as present the major cost-containment measures implied by the government and their probable influence on the overall health care cost. Regulatory analysis of the endorsed cost-containment measures, budget analysis of public and household health care expenditures, and their extrapolations were performed. The regulatory analysis reveals that a large number of measures are introduced and valid until January 2021, considering pharmaceuticals, medical devices, and negotiations between the National Health Insurance Fund (NHIF) and Marketing authorization holders (MAHs). NHIF costs due to pharmaceuticals, food supplements, and medical devices are rising from 2015 to 2019. The overall health expenditures average per household and the average per person also grow in this period. The cost extrapolation reveals that an increase in 3-year periods is expected. Despite the implementation of variety of cost-containment measures in Bulgaria, such as HTA, ERP, discounts, and annual negotiations, The National Health Insurance Fund's (NHIF) spending on pharmaceuticals continues to rise in recent years, and further increases are expected in the next 3 years. The average expenditure per household and per person also increased, which confirms the global trend of rising medicine and outpatient services value.

Development of transferability guidance for integrated care models with special focus on Central and Eastern European countries.

AIM: To develop pragmatic recommendations for Central and Eastern European (CEE) policymakers about transferability assessment of integrated care models established in higher income European Union (EU) countries. METHODS: Draft recommendations were developed based on Horizon 2020-funded SELFIE project deliverables related to 17 promising integrated care models for multimorbid patients throughout Europe, as well as on an online survey among CEE stakeholders on the relevance of implementation barriers. Draft recommendations were discussed at the SELFIE transferability workshop and finalized together with 22 experts from 12 CEE countries. RESULTS: Thirteen transferability recommendations are provided in three areas. Feasibility of local implementation covers the identification and prioritization of implementation barriers and proposals for potential solutions. Performance measurement of potentially transferable models focuses on the selection of models with proven benefits and assurance of performance monitoring. Transferability of financing methods for integrated care explores the relevance of financing methodologies and planning of adequate initial and long-term financing. CONCLUSIONS: Implementation of international integrated care models cannot be recommended without evidence on its local feasibility or scientifically sound and locally relevant performance assessment in the country of origin. However, if the original financing method is not transferable to the target region, development of a locally relevant alternative financing method can be considered.

Comparative analysis of the access to health-care services and breast cancer therapy in 10 Eastern European countries.

AIM: The aim of this study is to compare the differences in breast cancer therapy, health-care service practices, and their availability in ten European countries-Albania, Bosnia and Herzegovina, Bulgaria, Kosovo, Montenegro, Republic of North Macedonia, Croatia, Romania, Slovenia, and Republic of Serbia. METHODS: An inquire survey was conducted among oncologists in the participating countries. The questionnaire was of qualitative character and focused on several key areas as screening practices, diagnosing, treatment, and health-care procedures utilization. The results were processed through comparative and percentage analysis. RESULTS: All of the observed countries have national registries for breast cancer, but only in five, a mechanism of controlled action of early detection is implemented. Ninety percent of the countries have implemented in the national guidelines the European Society of Medical Oncology recommendations, while National Comprehensive Cancer Network is considered in only 50%. In all countries, digital mammography is a universal diagnostic method. Pathohistological analysis, including HER2 receptor expression and determination of the level of progesterone and estrogen receptors, is routinely performed in all countries prior to therapy. Some differences are observed in terms of FISH/CISH methods, determination of Ki-67 volume, and prognostic molecular assays. Trastuzumab is used as neo-adjuvant therapy in HER2-positive disease in all countries, while in Bosnia and Herzegovina and Croatia, only pertuzumab is used. Psychological support is integrated into the professional guidelines for treatment and monitoring in Bosnia and Herzegovina, Bulgaria, and Serbia. CONCLUSIONS: The international guidelines should be followed strictly, and some improvements in the health policies should be made in order to decrease the differences and inequalities in the availability of the breast cancer (BC) health services in the Central and Eastern European countries.

'Without data, you're just another person with an opinion'.

Introduction: Given the recent impressive digital transformation worldwide, the importance of data has reached a new dimension. It is, therefore, provocative to ask whether data can save healthcare systems from bankruptcy.Areas covered: We reviewed published examples in the search for the evidence on how the growing amount of data could change the way we used to assess the value of healthcare technologies, ensuring a more holistic approach in the decision-making process while reducing the waste in the healthcare.Expert opinion: The growing amount of data will continue to provide a multitude of valuable insights that can save healthcare systems from bankruptcy. Electronic medical records, IoT, wearables, and mobile applications generate constant data streams that can be utilized endlessly thanks to methodological advancements such as SNA, unsupervised and supervised machine learning, and natural language programming. However, interoperability across these multiple data sources still pose a challenge for the future development of data-driven healthcare. Already today however, decision makers can utilize Big Data to develop conditional coverage schemes for very expensive and complicated health technologies suitable for personalized healthcare. More advanced payers may utilize even data analytics even further and develop AI-based pricing schemes.

Use of complementary and alternative medicine by children in Europe: published data and expert perspectives.

INTRODUCTION: Few data document the use of complementary and alternative medicine (CAM) in Europe, with even fewer investigating use by children. METHODS: A narrative, non-systematic review of CAM use in Europe was performed by combining data from published surveys with expert perspectives. Limitations created by a lack of representative studies, varying definitions of CAM use, and what qualifies as CAM in different countries was partially overcome by integrating local experts to summarise information available only in the national language and provide their perspectives about CAM availability, quality, use and popularity in their countries using a semi-structured questionnaire. Local and international published surveys were summarised, and the prevalence of CAM use was extrapolated. RESULTS: Data from 20 European countries were available, representing 69% of the European population. Some data about CAM use by the general population were available for 90% of the examined countries, whereas peer-reviewed published surveys were available for only 60%. We extrapolated that 56% (range: 10-90%, adjusted for population size) of the European population in general had used CAM at least once in the past year. Surveys in CAM use by children were available for 55% of the investigated countries. The extrapolated prevalence of CAM use by children in Europe was 52% (range: 5-90%, adjusted for population size). Paediatric CAM experts reported an increasing awareness for and use of CAM in healthcare institutions. CONCLUSION: This precursor for further surveys indicates that CAM appears to be popular not only among adults in Europe, but also for children. Development of a pan-European definition of CAM use and CAM therapies are required to achieve surveys comparable between European countries. Additionally, more research investigating the efficacy and potential adverse effects of CAM therapies is needed because of increasing CAM use by children in Europe.

Safety assessment of newly marketed herbal medicines--methodological approach (Ginkgo biloba example in Bulgaria).

This study presents a proposal for the methodological approach for postmarketing safety profile assessment based on sales data and information for adverse drug reactions of newly introduced herbal medicinal products in the market. The study covers all herbal medicinal products containing dry extract of Ginkgo biloba leaves allowed for sale in Bulgaria. The methodological approach we create should be used for the establishment of the national herbal drugs policy complying with the recent European regulatory changes and specificity of the therapeutic practice in the country.