Quality management in hospitals: analysis of the prescribing practice of cardiovascular medicines

The goal of this study is to analyse the prescribing practice and risk of drug related errors in a Cardiology clinic of University Hospital. Semistructured open-ended interview aiming to reveal the risk of potential errors was performed with physicians, nurses, pharmacists, and hospital managers. Observational analysis of 915 prescriptions, prescribed by the physicians in two cardiology departments was conducted. Prescribing practice was evaluated by the means of its complexity, frequency of prescribing of particular pharmacology groups, and the related costs. Most often gaps detected in prescribing and dispensing of medicinal products were associated with missing or incorrect dosages, and unspecified quantity. Our analysis showed preference to combination therapies. Monotherapy was given only in 24.82% of the acute cases treated and in 24% of the cases treated in the internal ward. Two medicinal products were identified in 24.48% of the prescriptions (intensive care unit) and in 19.24% of the prescriptions from the internal ward. The most prescribed medicinal products were bisoprolol and glyceryl trinitrate in a combination. Approximately 45% of the patients were prescribed up to 3 medicinal products.The increase of therapy complexity leads to increase of probability for drug-drug interactions and nearly 30% of prescriptions were evaluated as potentially risky for interactions. The relative shares of potentially risky combinations vary from 4% to 32% out of all prescriptions reviewed. The likelihood of drug-related problems in the observed Cardiology clinic was determined as high but no practice for recording of ADRs was found in place

Pharmaceutical biotechnology in pharmacy education: USA pharmacy schools

ABSTRACT Pharmaceutical biotechnology, pharmacogenomics, pharmacogenetics, combinatorial chemistry, in close relation to highthroughput screening technologies, and bioinformatics are major advances that give a new direction to pharmaceutical sciences and education. Biotechnology influenced not only the pharmaceutical science and education but also the practice in pharmacies. The aim of our study was to review the scientific literature on biotechnology inclusion in pharmacy curriculum and to systematize the approaches that the colleges and schools of pharmacy in the United States of America (USA) apply to address this education. For the period 1989-2010 a total of 18 publications satisfying the search criteria were found. The articles were systematized in historical order following the date of publication. The developments in modern pharmacy practice are taken into account and implemented in the pharmacy curriculum in the colleges and schools of pharmacy in the United States. In 78% of the USA universities this is achieved by integrating biotechnology content in the PharmD curriculum. Together with the development of biotechnology science the educational programs are improving but they still delay providing knowledge, especially for undergraduate students

Comparative Price Analysis of Biological Products for Treatment of Rheumatoid Arthritis

Biological products for treatment of rheumatoid arthritis usually are cost effective for healthcare systems in Europe, but they are huge financial burden due to the high number of patients and the significant budget impact. The expected saving from introduction on the market of biosimilars are significant and are linked to better access and affordability. The aim of this study was to conduct comparative price analysis of biological products for rheumatoid arthritis therapy among seventeen EU countries. The point of view is that of the Bulgarian pricing and reimbursement system and the chosen countries are those from external reference basket for prices comparison at manufacturing level. All authorized biological products by EMA with therapeutic indication rheumatoid arthritis were selected. The access for treatment is evaluated as the availability of the product on the market and the prices level. We assessed the availability of all trade names in the price lists of the observed countries. The prices data was obtained from the official web pages of the responsible institutions up to date December 2017. The results show that four out of all six INNs have authorized biosimilars in EMA. Despite its earlier authorization biosimilar adalimumab is not present in any of the price lists of countries. From all eighteen countries only in Lithuania and Estonia there were no published prices of any of the selected medicinal products. Countries with higher number of biosimilar prices are Spain and France. Differences in manufacturers’ prices of reference biological products in selected countries in comparison with the lowest manufacturer price are higher with 22 to 69% while the retail prices between 62 and 95%. Differences are mostly notable for rituximab, and less notable for tocilizumab. Manufacturers’ and retail prices of biosimilar products were established only for three INNs (etanercept, rituximab, and infliximab). Manufacturers’ prices differ between 26 and 75%, while retail prices differ between 40 and 92% for biosimilars. Comparison of the differences between manufacturer prices of reference biological product and biosimilars shows 36% difference for etanercept, 39% for rituximab, and 31% for infliximab, while at retail level the differences are 11, 86, and 143%, respectively. The limitation of the study is that the prices are the official ones without discounts due to confidentiality and the real prices may be lower. The second limitation is that the methodology for pricing differs in the countries and this could also influence the prices on both levels (manufacturer and retail). Introduction of biosimilars on the national markets led to significant decrease in reimbursed prices paid by public funds and thus might benefit the patients’ access to biological therapy. The decrease of prices after biosimilars entrance on the market is not as notable as for commodity generics

The health related quality of life for kidney transplant patients in Bulgaria - A pilot study

The aim of the present study was to analyze the pharmacotherapy cost and quality of life of patents after kidney transplantation compared to those with chronic kidney disease in Bulgaria. This retrospective pharmacotherapy cost study and prospective health related quality of life (QoL) study was performed during 2010 - 2011 at the biggest Sofia hospital serving all transplant patients. The cost of pharmacotherapy was analyzed after reviewing patients' records. The health related quality of life was evaluated with the multi-attributable questionnaire SF-36, which measures 9 health domains. Forty-two percent of the patients with chronic kidney disease, and 26% of those with kidney transplant were female. The average age of the transplanted patients was 39.7 for male patients and 42.2 for female ones, while in the group suffering from chronic kidney disease the average male age was 48.3 and that of female patients, 51.2. No statistically significant difference was observed among the mean monthly cost of therapy per patient during the two-year period. The QoL was with lower values in the role limitations domain for patients with chronic kidney diseases and this difference was statistically significant. We found a correlation among the mean cost of pharmacotherapy and mean QoL in both groups of patients. In the group of patients with kidney transplantation the place of living and general health state were positively correlated. The cost of pharmacotherapy and the health state in comparison with the previous year were also positively correlated. This is the first Bulgarian study of the quality of life of kidney transplant patients. It shows that the SF-36 could be successfully used in this group of patients as well as for comparison with the QoL of patients with chronic kidney disease

A health-related quality of life and pharmacotherapy costs study for patients with cystic fybrosis, gaucher disease and chronic myeloid leukemia in Bulgaria

The aim of the present study was to analyze the cost of pharmacotherapy and quality of life of patients with cystic fibrosis (CF), Gaucher disease (GD) and chronic myeloid leukemia (CML) in Bulgaria. Data for the pharmacotherapy cost were compiled retrospectively. The second part of the study included a prospective quality-of-life survey (conducted at the Medical University Hospital "Alexandrovska" in 2010 and 2011). We estimated the average monthly pharmacotherapy costs according to data from the hospital registries. The quality-of-life survey was done through interviews based on the short form of SF-36, which measures 9 health domains. The total number of patients was 18, of which 10 were with CML, 5 with cystic fibrosis and 3 with Gaucher disease. The average age of the male and female patients with CML was 49.1 years and 48.3 years, respectively; 25 and 24 years in the group with GD, respectively; and 29.5 and 35.3 years in CF group, respectively. No statistical difference between the average monthly pharmacotherapy costs for the observed period was revealed In all patients the quality of life was below the maximum possible value, which is equal to 100 points. The lowest values for the different indicators of quality of life were observed in the CF patients, most likely due to the chronic progression of this particular rare disease. The average range of quality of life for this group was 53.75. We found a statistical correlation between the pharmacotherapy costs and the quality of life. The Spearman correlation analysis revealed a correlation between the drug therapy costs and some quality-of-life indicators only in the patients with CIVIL. The correlation between the pharmacotherapy costs and physiological functions in patients with CIVIL was positive, i.e. higher costs improved this indicator The pharmacotherapy costs were high, the average values for the three groups of patients being: BGN 9221.61 for 2010 and BGN 8254.64 for January March 2011 for patients with CF, BGN 32954.08 for those with GD, and BGN 6389.38 for 2010 and BGN 6591.19 for the second period for the CML patients. The quality of life was significantly reduced for the observed patients: the average value for quality of life were 53.75, 65.03 and 67, respectively, from a maximum of 100

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 similar to 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

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

An Overview of the Reimbursement Decision-Making Processes in Bulgaria As a Reference Country for the Middle-Income European Countries

BackgroundPolicy makers face a lot of challenges in the process of drug reimbursement decision-making, especially in the context of entering the market of more and more innovative medicinal products (MPs). The aim of the current study is to make an overview of the reimbursement system development and to evaluate the access of innovative medicines, which have entered the EU-market in the period 2015–2017, in Bulgaria as reference example for middle-income European country.MethodsA literature and a legislative systematic review regarding the Bulgarian reimbursement system as well as a defining the number of available innovative reimbursed MPs in 2017 in Bulgaria was made.ResultsThe reimbursement legislation in Bulgaria is quite unstable due to constant changes, which have been made, especially in the recent years. Despite this fact, the reimbursement process in Bulgaria is in accordance with the Transparency Directive. Bulgarian patients have a relatively delayed access to innovative medicines as only 5% of centrally authorized MPs in 2017 are available in the positive drug list (PDL), 16% of all in 2016 and 18%—in 2015. This could be explained by the long procedure for their appraisal in Bulgaria: the first step is issuing an opinion by the HTA Committee, followed by negotiation of discounts between the marketing authorization holder and the National Health Insurance Fund and making a final decision by the National Council on Prices and Reimbursement (NCPR) for the inclusion into the PDL.ConclusionOptimization of the procedure for issuing reimbursement status for innovative MPs is needed, such as improvements in the process of conducting HTA reports and their appraisal, incorporation of adequate systems for following the effectiveness and safety of MPs in the real-world conditions, value-based pricing implementation, and increasing the financial control over the health insurance system

Reimbursed orphan medicines in Bulgaria and the share of biotechnology-derived products

Rare diseases are life-threatening or chronically debilitating conditions affecting no more than 5 in 10,000 people in the European Union. Most of the people suffering from rare diseases are actually affected by less frequently occurring diseases affecting one in 100,000 people or fewer. Almost 80% of the rare diseases have identified genetic origins and lots of them are treated with biotechnology-derived medicinal products. The aim of our study was to evaluate the access to orphan medicines in Bulgaria based on the analysis of the Positive Drug List (PDL) and the share of biotechnology-derived products reimbursed for rare diseases in Bulgaria. Only 21 out of 56 medicines with European orphan designation and European marketing authorisation are available and funded in Bulgaria. 29% of them are biotechnology-derived. Another 17 (out of 47) orphan medicines with European marketing authorisation and without prior orphan designations in the EU are reimbursed and 59% of them are biotechnology-derived. Thus approximately just 37% of the orphan medicines (both with and without prior orphan designation) are available and funded in Bulgaria. Evidently the centralised marketing authorisation is not supported by the national regulatory requirements for price setting and inclusion into the PDL, which are necessary for guaranteeing medicines availability on the national market. The regulators and payers still do not ensure balance between the needs of patients and resources allocation