Pilot Study on the Cost of Some Oncohematology Diseases in Bulgaria

The goal of the current study is to perform a pilot study of the cost of some oncohematology diseases in Bulgaria. This is a pilot broader burden of disease research. The official report of the National health insurance fund provided information about the total expenditures paid for medicines, ambulatory services, and hospitalizations in 2015 and 2016. To evaluate the costs from a patient perspective, an internet inquiry was organized with the support of the patient organization. The inquiry contained questions regarding the patients' demography, type of oncohematology disease, year of diagnosis, quality of life (EuroQol v5D), and additional out of pocket expenditures. Quality of Life data were statistically analyzed and Kruskal-Wallis analysis of variance was performed. From 2015 to 2016 the number of patients with oncohematological diseases decreased by approximately 3000 people. Less than 30% were hospitalized and the hospitalization cost decreased, but the cost for medicines increased by nearly 1.5 million Euros. Cost for medicines almost tripled the hospitalization cost. The reported mean quality of life was 0.749 (SD 0.203). There was positive correlation between QoL and current disease state (p = 0.008) and age (p = 0.025). 42% reported to have additional expenditures related to their oncohematology disease, 22% reported other expenditures (diet, change of everyday habits etc.) and 42% reported to have productivity loses due to loss of employment or change of work, 44% of the respondents reported additional payment for medicines for concomitant diseases. Thus, the total cost (public funds and patients) accounted for 37,708,764 Euro. Despite the high public expenditures, the indirect costs due to productivity loses are higher. Costs for medicines are higher than costs of inpatient treatment, but this tendency is observed in all European countries. The increases in the costs of medicines are compensated by reduced costs of hospitalization. Despite their higher costs, newer medicines are an effective and reasonable investment from a societal perspective. Currently the higher levels of copayment increase the burden on the patients

Evaluating potentially inappropriate medications in elderly patients in a pharmacy setting in Bulgaria: A pilot study utilizing the EU (7)-PIM List

Objective: The primary aim of this study was to evaluate, for the first time, the use of the EU-7 PIM List in identifying potentially inappropriate medications among older patients. Researchers have firmly established the connection between drug-related problems, which include increased morbidity and mortality rates and the heightened utilization of healthcare services. While previous studies have focused on methodologies for identifying potentially inappropriate medications in Bulgaria, further research is warranted to explore the applicability of the widely recognized EU(7)- PIM List. Materials and methods: A prospective review was conducted on patient prescriptions aligned with the National Health and Insurance Fund, explicitly focusing on patients aged over 65 years from a single pharmacy in Veliko Turnovo City, Bulgaria. The review spanned from November 2022 to April 2023. The prescriptions analyzed in this study exclusively comprised medications covered by the insurance fund. The pharmacy manager provided patient prescription data in a coded form, which included information on the patients’ age, corresponding medications, and accompanying ICD codes. Results: The study analyzed a sample of 255 patients. Healthcare providers prescribed 2,623 medications, and 61.96% of the patients had polypharmacy, taking more than five medications daily. Among the study population, 67% with polypharmacy had at least one PIM based on the EU (7)-PIM List criteria. In total, 173 potentially inappropriate medications (PIMs) were identified. The main PIMs were categorized into four groups: alimentary tract and metabolism, blood and blood-forming organs, cardiovascular system (CVS), and nervous system. Most PIMs (75.72%) were in the ATC cardiovascular system. Within the CVS category, 11 PIMs were associated with digoxin intake and 11 with antiarrhythmics such as propafenone, flecainide, and amiodarone. In addition, trimetazidine was linked to 9 PIMs, and centrally acting antiadrenergic agents had 22 PIMs, with moxonidine being the most prevalent (n=16). Peripherally acting agents were linked to 22 PIMs, primarily doxazosin. The study identified 24 PIMs related to diuretics, specifically spironolactone, and 18 PIMs related to selective calcium channel blockers such as verapamil. The antithrombotic agent category had the highest share, with 30 identified PIMs, including acenocoumarol, dabigatran, rivaroxaban, and apixaban. Furthermore, the examination of ICD codes confirmed that most PIMs occurred within CVS, with patients having ICD I11.0 and ICD I11.9 being associated with 40 and 47 PIMs, respectively. Conclusion: This study highlights many PIMs among patients with cardiovascular diseases. Using the EU (7)-PIM List as a pilot study demonstrates its effectiveness in managing adult patients’ conditions. Given the significant role of PIMs in deprescribing strategies for older patients with polypharmacy, there is a need for prescribers, educators, and drug regulatory institutions to show increased interest in regulatory measures and specific aspects related to PIM use. This is important because the demographic trend of population ageing continues, and organizations increasingly focus on the elderly population

Author Correction: Prevalence of potentially inappropriate prescribing in older adults in Central and Eastern Europe: a systematic review and synthesis without meta‑analysis

Link to the corrected article: [https://farfar.pharmacy.bg.ac.rs/handle/123456789/4286

Prevalence of potentially inappropriate prescribing in older adults in Central and Eastern Europe: a systematic review and synthesis without meta-analysis

We aimed to systematically review the prevalence of potentially inappropriate prescribing (PIP) in older adults in Central and Eastern Europe (CEE) in all care settings. We searched Embase and MEDLINE (up to June 2019) and checked the reference lists of the included studies and relevant reviews. Eligible studies used validated explicit or implicit tools to assess the PIP prevalence in older adults in CEE. All study designs were considered, except case‒control studies and case series. We assessed the risk of bias using the Joanna Briggs Institute Prevalence Critical Appraisal Tool and the certainty of evidence using the GRADE approach. Meta-analysis was inappropriate due to heterogeneity in the outcome measurements. Therefore, we used the synthesis without meta-analysis approach—summarizing effect estimates method. This review included twenty-seven studies with 139,693 participants. Most studies were cross-sectional and conducted in high-income countries. The data synthesis across 26 studies revealed the PIP prevalence: the median was 34.6%, the interquartile range was 25.9–63.2%, and the range was 6.5–95.8%. The certainty of this evidence was very low due to the risk of bias, imprecision, and inconsistency. These findings show that PIP is a prevalent issue in the CEE region. Further well-designed studies conducted across countries are needed to strengthen the existing evidence and increase the generalizability of findings

Cost‑of‑illness studies in nine Central and Eastern European countries

Background To date, a multi-country review evaluating the cost-of-illness (COI) studies from the Central and Eastern European (CEE) region has not yet been published. Our main objective was to provide a general description about published COI studies from CEE. Methods A systematic search was performed between 1 January 2006 and 1 June 2017 in Medline, EMBASE, The Cochrane Library, CINAHL, and Web of Science to identify all relevant COI studies from nine CEE countries. COI studies reporting costs without any restrictions by age, co-morbidities, or treatment were included. Methodology, publication standards, and cost results were analysed. Results We identifed 58 studies providing 83 country-specifc COI results: Austria (n=9), Bulgaria (n=16), Croatia (n=3), the Czech Republic (n=10), Hungary (n=24), Poland (n=11), Romania (n=3), Slovakia (n=3), and Slovenia (n=4). Endocrine, nutritional, and metabolic diseases (18%), neoplasms (12%), infections (11%), and neurological disorders (11%) were the most frequently studied clinical areas, and multiple sclerosis was the most commonly studied disease. Overall, 57 (98%) of the studies explicitly stated the source of resource use data, 45 (78%) the study perspective, 34 (64%) the costing method, and 24 (58%) reported at least one unit costs. Regardless of methodological diferences, a positive relationship was observed between costs of diseases and countries’ per capita GDP. Conclusions Cost-of-illness studies varied considerably in terms of methodology, publication practice, and clinical areas. Due to these heterogeneities, transferability of the COI results is limited across Central and Eastern European countries

Recommendations for wider adoption of clinical pharmacy in Central and Eastern Europe in order to optimise pharmacotherapy and improve patient outcomes

Clinical pharmacy as an area of practice, education and research started developing around the 1960s when pharmacists across the globe gradually identified the need to focus more on ensuring the appropriate use of medicines to improve patient outcomes rather than being engaged in manufacturing and supply. Since that time numerous studies have shown the positive impact of clinical pharmacy services (CPS). The need for wider adoption of CPS worldwide becomes urgent, as the global population ages, and the prevalence of polypharmacy as well as shortage of healthcare professionals is rising. At the same time, there is great pressure to provide both high-quality and cost-effective health services. All these challenges urgently require the adoption of a new paradigm of healthcare system architecture. One of the most appropriate answers to these challenges is to increase the utilization of the potential of highly educated and skilled professionals widely available in these countries, i.e., pharmacists, who are well positioned to prevent and manage drug-related problems together with ensuring safe and effective use of medications with further care relating to medication adherence. Unfortunately, CPS are still underdeveloped and underutilized in some parts of Europe, namely, in most of the Central and Eastern European (CEE) countries. This paper reviews current situation of CPS development in CEE countries and the prospects for the future of CPS in that region

Potential Barriers of Patient Involvement in Health Technology Assessment in Central and Eastern European Countries

Patients' perspectives are important to identify preferences, estimate values and appreciate unmet medical needs in the process of research and development and subsequent assessment of new health technologies. Patient and public involvement in health technology assessment (HTA) is essential in understanding and assessing wider implications of coverage and reimbursement decisions for patients, their relatives, caregivers, and the general population. There are two approaches to incorporating the patients' voice in HTA, preferably used in a mix. In the first one, patients, caregivers and/or their representatives directly participate at discussions in different stages of the HTA process, often at the same table with other stakeholders. Secondly, patient involvement activities can be supported by evidence on patient value and experience collected directly from patients, caregivers and/or their representatives often by patient groups Patient involvement practices, however, are limited in Central and Eastern European (CEE) countries without clear methodology or regulatory mechanisms to guide patient involvement in the HTA process. This poses the question of transferability of practices used in other countries, and might call for the development of new CEE-specific guidelines and methods. In this study we aim to map potential barriers of patient involvement in HTA in countries of the CEE region

Guidance on using real-world evidence from Western Europe in Central and Eastern European health policy decision making

Aim: Real-world data and real-world evidence (RWE) are becoming more important for healthcare decision making and health technology assessment. We aimed to propose solutions to overcome barriers preventing Central and Eastern European (CEE) countries from using RWE generated in Western Europe. Materials & methods: To achieve this, following a scoping review and a webinar, the most important barriers were selected through a survey. A workshop was held with CEE experts to discuss proposed solutions. Results: Based on survey results, we selected the nine most important barriers. Multiple solutions were proposed, for example, the need for a European consensus, and building trust in using RWE. Conclusion: Through collaboration with regional stakeholders, we proposed a list of solutions to overcome barriers on transferring RWE from Western Europe to CEE countries. Plain language summary: Collecting real-world data and generating real-world evidence from it is becoming more important for making better decisions in healthcare. We investigated the main barriers which prevent using real-world evidence in Central and Eastern Europe, originally generated in Western Europe. After identifying the nine most important barrier, with the help of local experts we proposed solutions to overcome those barriers. Several possible solutions were proposed, many of them highlighting the need for a European consensus on these matters and building trust in new methods. Our results can hopefully serve as a guidance document to help overcome the barriers. Tweetable abstract: Research investigating ways to overcome barriers preventing Central and Eastern European countries from using Western European real-world evidence for healthcare decision making, using a multi-methods approach to create a list of solutions in collaboration with local stakeholders

Recommendations for patient involvement in health technology assessment in Central and Eastern European countries

IntroductionMeaningful patient involvement in health technology assessment (HTA) is essential in ensuring that the interests of the affected patient population, their families, and the general public are accurately reflected in coverage and reimbursement decisions. Central and Eastern European (CEE) countries are generally at less advanced stages of implementing HTA, which is particularly true for patient involvement activities. As part of the Horizon2020 HTx project, this research aimed to form recommendations for critical barriers to patient involvement in HTA in CEE countries. MethodsBuilt on previous research findings on potential barriers, a prioritisation survey was conducted online with CEE stakeholders. Recommendations for prioritised barriers were formed through a face-to-face workshop by CEE stakeholders and HTx experts. ResultsA total of 105 stakeholders from 13 CEE countries completed the prioritisation survey and identified 12 of the 22 potential barriers as highly important. The workshop had 36 participants representing 9 CEE countries, and 5 Western European countries coming together to discuss solutions in order to form recommendations based on best practices, real-life experience, and transferability aspects. Stakeholder groups involved in both phases included HTA organisation representatives, payers, patients, caregivers, patient organisation representatives, patient experts, health care providers, academic and non-academic researchers, health care consultants and health technology manufacturers/providers. As a result, 12 recommendations were formed specified to the CEE region's context, but potentially useful for a broader geographic audience. ConclusionIn this paper, we present 12 recommendations for meaningful, systematic, and sustainable patient involvement in HTA in CEE countries. Our hope is that engaging more than a hundred CEE stakeholders in the study helped to spread awareness of the importance and potential of patient involvement and that the resulting recommendations provide tangible steps for the way forward. Future studies shall focus on country-specific case studies of the implemented recommendations