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

biotechnology in the production of pharmaceutical industry ingredients amino acids

ABSTRACTAmino acids play an important role in human nutrition and health maintenance. Nowadays amino acids are used as animal feed additives, flavor enhancers, ingredients in cosmetic and pharmaceutical products and as specialty nutrients in the medical field, and the production capacity requirements are constantly increasing. This paper reviews the manufacturing methods for the production of some amino acids used in the pharmaceutical industry and outlines the main achievements of biotechnology in this field. It also summarizes the weaknesses and strengths of the biotechnological methods used for the industrial production of the studied amino acids. Literature search was done through MEDLINE/PubMed, Scopus Database, Web of Knowledge search as well as an Internet-based search with predefined keywords. The present mini review is based on a total of 66 publications. Out of 15 amino acids included in our study, 14 are routinely manufactured applying biotechnology methods mostly from specially developed mutan..

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

Pharmacy network and access to medicines in selected eastern European countries: comparative analysis

Aim To analyze the pharmacy network (structure and resources) in Bulgaria, Croatia, Serbia, and Slovenia and its relation to public expenditures for medicines. Methods We performed a cross-sectional study using the officially published data for the period 2003-2008 in four selected countries. Data sources were relevant national institutions. Results In 2008, Serbia had 27.5, Bulgaria 66.8, Croatia 59.5, and Slovenia 71.2 pharmacists per 100 000 inhabitants. There was a significant difference in the number of pharmacists per 100 000 inhabitants between all countries except between Bulgaria and Slovenia. The number of inhabitants per one pharmacy was significantly different between all observed countries. The expenditures for medicines per capita in 2008 were between €30.34 in Bulgaria to €137.03 in Slovenia, with a significant difference between all countries except between Bulgaria and Serbia. The number of pharmacists per 100 000 inhabitants and expenditures for medicines per capita were positively correlated in all observed countries, except in Bulgaria. Conclusion There were significant difference in the structure and availability of the pharmacy service in all selected countries. Expenditures for medicines were positively correlated with the number of pharmacists in all countries, except in Bulgaria. Our findings could be valuable to national regulatory bodies for the creation of national drug policies

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

QUALITY MANAGEMENT IN HOSPITALS: ANALYSIS OF THE PRESCRIBING PRACTICE OF CARDIOVASCULAR MEDICINES

ABSTRACT 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 a

Analysis of good distribution practice inspection deficiency data of pharmaceutical wholesalers in Bulgaria

The current study analyses the regulatory inspection findings of the wholesalers in Bulgaria in 2017 and compares the results with the findings from some other EU member-states. In total, 48 GDP inspections were performed in 2017. 50% of the inspections were performed in relation with issuing an authorization for wholesale of medicines, the rest half were related to changes in already granted authorizations. During the inspections, 17 non-conformities (NCs) have been documented. The NCs were identified in 3 wholesalers and 6 deficiencies were classified as major. No critical deficiencies were found. NCs were found in 6.25% of the inspected companies. No critical NCs were identified and only 6 NCs were classified as major which demonstrated high level of compliance of distributions sites in Bulgaria with the requirements of GDP

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

Economic analysis of the cost savings after implementation of antibiotic policy in hospital

ABSTRACT: The antibiotic policy is an essential part of the hospital pharmacy activities. It leads to decrease in the microbial resistance, optimisation of the medicine utilisation, and cost savings. The goal of the study is to analyse the results of implementation of antibiotic policy on the medicine utilization and related cost savings in a city hospital in Sofia. The study is a comparative retrospective and prospective analysis of the antibiotic prescribing and cost of therapy, before and after the introduction of the antibiotic policy. There were gathered and systematized 2582 prescriptions for hospitalized patients in 3 hospital departments (surgical, urology, and internal wards). For the evaluation of the most often prescribed combination, the sample was made for 30 patients from each unit. The selection of patients was made at random for the most common diagnoses in the studied wards. The antibiotic utilization was also measured in monetary terms and cost savings were calculated for the period after the antibiotic policy introduction. The comparison of the cost of antibiotic therapy in urology, surgical and internal wards for 2004 and 2005, after the introduction of AB policy showed that in all three studied wards significant savings were realized. Reduction of costs in 2005 compared to 2004 was in total 26 832 BGN (28.48%). Total expenditures on medicines in the studied hospital were 447 810 BGN for 2004 and 396 659 BGN for 2005. Savings of 51 151 BGN were realized, which is a significant value and a significant proportion of the total costs (28.48%). Analysis of the results of the implementation of antibiotic drug policy confirmed that the optimization of drug administration leads to positive economic results. It also confirms the usefulness of measurement of utilization and cost saving, especially in hospital wards with high cost services. The antibiotic policy should be an obligatory part of drug policy in the hospitals with scarce resources. Measuring the impact of antibiotic policy implementation is a useful tool for optimization of the general hospital medicines policy and realization of cost savings. It gives possibility for practical solutions on medicines utilization optimization. Introduction of antibiotic policy in hospitals leads to the reduction of their usage, saves money and improves therapeutic options