journal of applied pharmaceutical science, May 5, 2022
The COVID-19 pandemic expansion in Bulgaria imposed a significant burden on population status and... more The COVID-19 pandemic expansion in Bulgaria imposed a significant burden on population status and disease diagnostics, control, and treatment. The goal of our study is to analyze the impact of the COVID-19 pandemic on utilization of antidepressants in the outpatient treatment of depression and public spending on their reimbursement. The study is a cross-sectional, retrospective, observational, macroeconomic analysis of National Health Insurance Fund (NHIF) expenditures of antidepressants, reference price per defined daily dose (DDD), and utilization. The results reveal that the costs and reference value per DDD decreased or remained almost the same during 2019-2020. The utilization increased slightly for six international nonproprietary names (INNs) and decreased for four of them. Statistical analysis confirms that there are no significant differences. The highest utilization rate found is for escitalopram (both 2019 and 2020), followed by paroxetine and venlafaxine. The COVID-19 pandemic and social isolation lead to worsening of mental health and require health system reorganization to ensure the treatment of patients with chronic diseases. The measures implemented in Bulgaria at the beginning of the pandemic led to a stable level of medicine utilization and outpatient treatment of depression as well as a similar rate of NHIF expenditure compared with those from the previous year.
Background: Elderly-onset rheumatoid arthritis (EORA) has been increasing along with the ageing s... more Background: Elderly-onset rheumatoid arthritis (EORA) has been increasing along with the ageing society. EORA is believed to be different from young-onset RA (YORA) in clinical characteristics, however, it is unknown whether the characteristics of recent EORA are similar with those in the past. Objectives: To elucidate recent characteristics of recent EORA patients. Methods: Consecutive patients who were newly diagnosed with RA in our institution from November 2015 until May 2017 (group 1), and those from February 2011 until December 2012 (group 2) were enrolled. Each group was divided into EORA and YORA according to the onset age of 65 years old. Clinical data were collected from their medical records and compared. Results: In group 1, 176 patients with newly diagnosed RA were identified; EORA 37% and YORA 63%. The mean age was 74.0±1.5 and 46.3±2.4 years old, and female was 73.9% and 84.7%, respectively. The duration from onset to first visit was significantly shorter in the EORA compared to the YORA (4.7±3.0 to 13.9±5.9 months; p=0.038). Disease activity was significantly higher in EORA than the YORA (DAS28-CRP; 4.47±0.35 vs 3.49±0.27, p<0.001; CDAI, 20.5 ±3.6 vs 15.1±2.2, p=0.009). Inflammatory biomarkers at the first visit were also significantly higher in the EORA than the YORA; CRP (2.6±0.7 vs 1.2±0.5 mg/dl, p<0.001), ESR (68±9 vs 38±6 mm/hr, p<0.001), and serum ferritin (173.3 ±36.7 vs 102.3±18.8 ng/ml, p<0.001). RF and anti-CCP antibody were less positive in EORA than in YORA (RF 55.4 vs 72.1%, p=0.024; anti-CCP 40.0 vs 63.1%, p=0.003). Large joints were more involved in EORA, but small joint involvement was not different between EORA and YORA. In group 2, 255 patients with newly diagnosed RA were enrolled, EORA 44% and YORA 56%, and female was 85.3% and 84.6%, respectively. The mean age at onset of RA was not different between group 1 and group 2 (58.3±2.4 vs 58.9±2.0, p=0.512). Conclusions: EORA developed more rapidly and showed severer inflammatory signs with more large joints involved. Conflicting with previous reports, the age at onset of RA did not increase between the patients in 2015-2017 and in 2011-2012.
To evaluate the vision-related quality of life (QOL) after implantation of a new trifocal intraoc... more To evaluate the vision-related quality of life (QOL) after implantation of a new trifocal intraocular lens (IOL), by using the National Eye Institute Visual Function Questionnaire-14 (VF-14 QOL questionnaire).
Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs... more Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national colla...
The aim of the current study is to analyze the legislation and reimbursed market of medical devic... more The aim of the current study is to analyze the legislation and reimbursed market of medical devices in Serbia and Bulgaria. Comparative legislation analysis was performed focusing on the European Directives, National legislative acts and regulations endorsing the rules for medical devices authorization, classification, quality control, and reimbursement of medical devices. First was analyzed the development and major requirements of European legislation on medical devices since 1990 when the first EU Directive was issued. Next was analyzed the national laws on medicines in both countries and related regulations and institutions for medical devices authorization and quality control. Then was reviewed the legislative requirements for medical devices reimbursement and payment in both countries under consideration. Market analysis was performed towards the officially published data by the health insurance authorizes in both countries for the reimbursed cost by type of medical devices an...
Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most... more Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most common neurodegenerative disorder. Despite the broad spectrum of PD manifestations and high disease prevalence, there are insufficient data on medicine utilization and prescription strategies. The purpose of the current study was to analyze published data concerning treatment approaches and to compare them with Bulgarian therapeutic practice. Design and methods We conducted a systematic review of the PubMed and Google Scholar databases, and we calculated medicine utilization in Bulgaria during 2018 and 2019 using the WHO methodology. Results The literature search identified a total of 311 publications, but only 12 met the inclusion criteria. Eleven studies pointed out that levodopa-containing medicine are the most frequently used, followed by dopamine agonists. The highest rate was found for levodopa-containing products and decarboxylase inhibitor (1.06 and 1.33 DDD/1000 inh/day), follo...
A71 20 (2.9%) were judged to be actual, 330(47.8%) potential and 341(49.3%) prescribing errors wi... more A71 20 (2.9%) were judged to be actual, 330(47.8%) potential and 341(49.3%) prescribing errors with no harm. Prescribing errors were significantly most common in surgical unit compared to the other study units (P< 0.001) with small effect size (Eta = 0.089) and (Carmer's v = 0.089). There was a significant differences in the mean length of hospital stay between those who had prescribing errors 5.42 (±6.26) days and those who didn't 4.04 (±4.01) days (p< 0.001). ConClusions: The study has identified important prescribing errors and their associated factors and based on these findings strategies to prevent future errors should be developed.
To evaluate the impact on costs of treating complications derived from chronic kidney disease (CK... more To evaluate the impact on costs of treating complications derived from chronic kidney disease (CKD) in patients undergoing hemodialysis in the private health care system in Brazil. METHODS: Owing to the lack of local databases, a survey with experts was conducted to collect data about the main causes of hospital admissions which resulted from complications during the dialysis period of CKD patients. A universe of 600 patients from reference centers in Brazil was studied. Later, the experts answered to a questionnaire about the procedures needed to manage complications. Then, a micro-costing was performed, only direct costs were considered: length of staying, medical procedures, physician fees and drugs. Sources used for costing were: CBHPM 2009 v.5 (physicians fees list), Revista Kairos (January 2009) (drugs price list) and Guia Farmacêutico Brasíndice (January 2009) (materials price list). The time horizon of this analysis was 1 year, thus no discount rate was assumed. The perspective assumed was that of the private payer. RESULTS: The 3 most frequent causes of hospital admissions and their respective costs in the studied centers were: cardiac complications (33.
Analyzing the health economic results of the centralized procurement is important for critical as... more Analyzing the health economic results of the centralized procurement is important for critical assessment of the level of achievment of health goals during the tender process. OBJECTIVE : To compare the procurement legislation and its impact on the prices and quantities of procured medicines in the public sector. METHODS: legislation analysis of both procurement laws and regulations for medicines supply issued during 1997 - 2003. Calculation of price and quantities indexes of procured oncology medicines via centralized tenders for the period 2000 - 2003. RESULTS : The tenders are organized in Macedonia by the Health insurance fund for all levels of health care and all medicines included in the procurament list while in Bulgaria Ministry of health is organizing a central drug procurament for 121 INN life - saving and expensive medicines dispensed via specialized clinics. Changes in the price and quantity indexes for oncology products in Bulgaria shows increase in quantity index till ...
Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in... more Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.
Introduction: High prevalence rate of CVD and high rate of CVD deaths attributed to high choleste... more Introduction: High prevalence rate of CVD and high rate of CVD deaths attributed to high cholesterol leads to increased statins utilization. The aim of this study is to analyse the difference in prices between generic and innovator and utilization of INNs of statins available in Bulgaria and Ukraine. Materials and methods: The study is retrospective and observational analysis of changes in prices. On total, 7 INN and 18 dosage forms are included in the study. Utilization of statins has been measured in DDD/1000 inh/d. Results: The results reveal considerable price differences in the prevailing part of the observed dosage forms between 2013 and 2016 and higher price variations. Two of the lowest and three of the highest prices have not been changed in Bulgaria. For the same period in Ukraine ten lowest and five highest prices have decreased, while one lowest and six highest have increased. Statins utilization is much higher in Bulgaria than that in Ukraine. Conclusions: Prices of statins tend to decrease in Bulgaria more than in Ukraine. In both countries there is a slight tendency of reduced utilization, whereas the consumption of statins in Bulgaria is much higher than that in Ukraine. The study confirms that medicine utilization depends on prices and the health policy in the countries.
Access to orphan drugs (In EU regulation Orphan Drugs are refered as Orphan Medicinal Products (O... more Access to orphan drugs (In EU regulation Orphan Drugs are refered as Orphan Medicinal Products (OMP)) is a key role in determining whether patients with rare diseases (RDs) will receive adequate and efficient treatment. The objective of this article is to identify differences in patient access to orphan drugs in 3 pharmaceutical markets: Serbia, Croatia and Macedonia. Patient access was defined: as the market access (availability) and affordability (financial accessibility). We analysed the legislative requirements for the authorisation process and made a cross country comparison. Retrospective cross-sectional analysis was done on drug lists in selected countries and a cross-comparison between the List of Orphan Drugs in Europe (LODE) for a six-month period (May 2014-October 2014). We included all 179 OMPs marketed in EU in our analysis, which had received market authorization in Croatia upon its membership in the EU. Total number of marketed drugs in Serbia was 59 (32.96%) drugs and in Macedonia 52 (29.05%) drugs. However, market authorization does not guarantee patient access to any given drug, so only 39.11% of OMPs could be accessed by Croatian patients (70 drugs).The number of refunded drugs in Serbia and Macedonia was smaller (32 and 20, respectively) which makes respectively, 17.88% and 11.17% of drugs on the LODE. The present study showed some variations between countries in selected indicators of availability and access to orphan drugs. Patients in Croatia had greater number of registered and refunded drugs, but in Serbia more than a half of registered OMPs could be refunded from National Health Insurance Fund. Macedonia had smaller number of inhabitants and also had the smaller number of patients from certain RDs which results in lower total number of OMPs.
European Journal of Hospital Pharmacy: Science and Practice, 2013
2007-2009 two new substances were introduced, tacrolimus and everolimus, which led to the increas... more 2007-2009 two new substances were introduced, tacrolimus and everolimus, which led to the increase in prescribing costs. For the period 2010-2011 generic immunosuppressants were introduced and the prescribing costs declined. The drug costs of kidney transplantation vary between 17.43% and 30.66% of the hospital's drugs budget. Conclusions To our knowledge this is the first Bulgarian study of prescribing practise and changes in the cost of drugs for kidney transplant patients. It reveals that prescribing costs are varying and dependent on the introduction of new molecules or generic products. The study shows that the introduction of the new immunosuppressive molecules leads to an increase in pharmacotherapy costs, while the introduction of generic products significantly reduces drug costs. No conflict of interest. Risk AnAlysis of Medicines PRoduced in HosPitAl PHARMAcy-A tool foR ensuRing oPtiMAl suPPly
The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedon... more The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedonia and Bosnia Herzegovina (BiH). The study discusses the relevance between prescription and morbidity and the rationality of the drug prescription in terms of Essential Drug Concept (EDC). For the assessment of the morbidity influence on the prescription official statistical information was reviewed and prevailing causes of diseases in the observed countries were calculated. To study the patterns geographically selected regions from the countries under consideration were observed during 1998-2000. In all the countries under consideration respiratory tract, nervous system and cardiovascular diseases are playing the leading role. The prescription of cardiovascular drugs, anti-infectious nervous and respiratory system drugs also predominate. Comparison between prescription and morbidity patterns shows a significant relationship between the morbidity and prescription patterns. Prescription m...
Twenty-eight instruments measuring pain, clinical, functional, and global characteristics were ad... more Twenty-eight instruments measuring pain, clinical, functional, and global characteristics were administered to 303 patients in a six-month randomized clinical trial of auranofin and placebo in the treatment of patients with rheumatoid arthritis. The instruments were compared with respect to their responsiveness in detecting a treatment effect, the time involved in administering the instrument, the need for the presence of an interviewer, and ease of administration. The instruments' ability to detect a treatment effect was the deciding characteristic in the clinical, pain, and global categories in choosing the preferred instrument. The counts of tender and swollen joints were found to be the most responsive clinical measures, the 10-cm pain line was the most responsive and the fastest to administer of the pain instruments, and the categorical self-assessment of arthritis was the most responsive global measure. In the functional ability category, the Health Assessment Questionnaire (HAQ), the Keitel Functional Assessment, and the Quality of Well-Being (QWB) Questionnaire were equally responsive. The HAQ was the shortest and the only self-administered questionnaire. The QWB has had the most extensive validation work but was a complex instrument requiring intensive interviewer training. The Keitel was the most timeconsuming instrument, but had the advantage of high interobserver agreement. The design of future trials can be guided by the information obtained in this study on their relative efficiencies and ease of use.
Objectives: To show how a simple tablet program can be successfully used with minimal supervision... more Objectives: To show how a simple tablet program can be successfully used with minimal supervision and instruction to collect pain data from patients. MethOds: The data collection method was an Android application, designed to be run on a tablet. There was a tutorial to explain how to enter data, and a nurse was present to activate the survey and support the patient, if necessary. The application displayed a timer and prompted the patient to report their pain level at each time point, and within a set window, using a sliding scale (0-10). Patient data were stored on an internal database within the application and subsequently uploaded to a local database server. Results: The primary objective of the study was to determine the time to onset of significant pain relief in patients applying ibuprofen gel, ibuprofen gel with levomenthol, or diclofenac gel to treat soft tissue injuries. Significant pain relief was defined as a reduction of 2 points on an 11 point numeric rating scale (NRS) for pain. One patient was affected by a bug in the data collection system, but the problem was discovered and resolved before the next patient was scheduled. The remaining 181 patients used the tablets to input data on their pain levels at 17 time points over a 2 hour period following gel application, allowing the primary study objective to be assessed. Excluding the patient affected by the bug, who was not assessed, only thirteen patients had some missing time point data and there were only 18 missing data points from a total of 3,077 (0.6%). cOnclusiOns: The tablet program was easy to use, resulting in high completion rates. Electronic prompting meant that data could be reliably collected at precise time points, and patients could input data themselves, which reduced labour costs.
The aim of this paper is to identify the barriers that are specifically relevant to the use of Ar... more The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse—from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified ...
The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arth... more The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arthritis as a source of information. The point of view is that of the patients and society and the time horizon is one year. It is a micro costing study calculating the direct health care cost of pharmacotherapy. The pharmacotherapy includes 6 main therapeutic groups of medicines as corticosteroids (per os or intraarticular injections), disease modifying antirheumatics (DMAR), biological, non-steroidal anti-inflammatory drugs (NSAID), medicines improving bone density, and proton pump inhibitors (PPI).Monthly cost of pharmacotherapy per patient on average is 815.05 (SD 1104.25) BGN, and biological therapy is the most expensive one 2961.03 (SD 1435.46). 25% of the patients are on it. 58 per cent of the patients reported regular physicians' visits at least ones quarterly with average yearly cost of 111.60 BGN (9.30 BGN per month). 56 people were out of work and for 13 of them it was for mo...
journal of applied pharmaceutical science, May 5, 2022
The COVID-19 pandemic expansion in Bulgaria imposed a significant burden on population status and... more The COVID-19 pandemic expansion in Bulgaria imposed a significant burden on population status and disease diagnostics, control, and treatment. The goal of our study is to analyze the impact of the COVID-19 pandemic on utilization of antidepressants in the outpatient treatment of depression and public spending on their reimbursement. The study is a cross-sectional, retrospective, observational, macroeconomic analysis of National Health Insurance Fund (NHIF) expenditures of antidepressants, reference price per defined daily dose (DDD), and utilization. The results reveal that the costs and reference value per DDD decreased or remained almost the same during 2019-2020. The utilization increased slightly for six international nonproprietary names (INNs) and decreased for four of them. Statistical analysis confirms that there are no significant differences. The highest utilization rate found is for escitalopram (both 2019 and 2020), followed by paroxetine and venlafaxine. The COVID-19 pandemic and social isolation lead to worsening of mental health and require health system reorganization to ensure the treatment of patients with chronic diseases. The measures implemented in Bulgaria at the beginning of the pandemic led to a stable level of medicine utilization and outpatient treatment of depression as well as a similar rate of NHIF expenditure compared with those from the previous year.
Background: Elderly-onset rheumatoid arthritis (EORA) has been increasing along with the ageing s... more Background: Elderly-onset rheumatoid arthritis (EORA) has been increasing along with the ageing society. EORA is believed to be different from young-onset RA (YORA) in clinical characteristics, however, it is unknown whether the characteristics of recent EORA are similar with those in the past. Objectives: To elucidate recent characteristics of recent EORA patients. Methods: Consecutive patients who were newly diagnosed with RA in our institution from November 2015 until May 2017 (group 1), and those from February 2011 until December 2012 (group 2) were enrolled. Each group was divided into EORA and YORA according to the onset age of 65 years old. Clinical data were collected from their medical records and compared. Results: In group 1, 176 patients with newly diagnosed RA were identified; EORA 37% and YORA 63%. The mean age was 74.0±1.5 and 46.3±2.4 years old, and female was 73.9% and 84.7%, respectively. The duration from onset to first visit was significantly shorter in the EORA compared to the YORA (4.7±3.0 to 13.9±5.9 months; p=0.038). Disease activity was significantly higher in EORA than the YORA (DAS28-CRP; 4.47±0.35 vs 3.49±0.27, p<0.001; CDAI, 20.5 ±3.6 vs 15.1±2.2, p=0.009). Inflammatory biomarkers at the first visit were also significantly higher in the EORA than the YORA; CRP (2.6±0.7 vs 1.2±0.5 mg/dl, p<0.001), ESR (68±9 vs 38±6 mm/hr, p<0.001), and serum ferritin (173.3 ±36.7 vs 102.3±18.8 ng/ml, p<0.001). RF and anti-CCP antibody were less positive in EORA than in YORA (RF 55.4 vs 72.1%, p=0.024; anti-CCP 40.0 vs 63.1%, p=0.003). Large joints were more involved in EORA, but small joint involvement was not different between EORA and YORA. In group 2, 255 patients with newly diagnosed RA were enrolled, EORA 44% and YORA 56%, and female was 85.3% and 84.6%, respectively. The mean age at onset of RA was not different between group 1 and group 2 (58.3±2.4 vs 58.9±2.0, p=0.512). Conclusions: EORA developed more rapidly and showed severer inflammatory signs with more large joints involved. Conflicting with previous reports, the age at onset of RA did not increase between the patients in 2015-2017 and in 2011-2012.
To evaluate the vision-related quality of life (QOL) after implantation of a new trifocal intraoc... more To evaluate the vision-related quality of life (QOL) after implantation of a new trifocal intraocular lens (IOL), by using the National Eye Institute Visual Function Questionnaire-14 (VF-14 QOL questionnaire).
Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs... more Background: Rising expenditure for new cancer medicines is accelerating concerns that their costs will become unsustainable for universal healthcare access. Moreover, early market access of new oncology medicines lacking appropriate clinical evaluation generates uncertainty over their cost-effectiveness and increases expenditure for unknown health gain. Patient-level data can complement clinical trials and generate better evidence on the effectiveness, safety and outcomes of these new medicines in routine care. This can support policy decisions including funding. Consequently, there is a need for improving datasets for establishing real-world outcomes of newly launched oncology medicines.Aim: To outline the types of available datasets for collecting patient-level data for oncology among different European countries. Additionally, to highlight concerns regarding the use and availability of such data from a health authority perspective as well as possibilities for cross-national colla...
The aim of the current study is to analyze the legislation and reimbursed market of medical devic... more The aim of the current study is to analyze the legislation and reimbursed market of medical devices in Serbia and Bulgaria. Comparative legislation analysis was performed focusing on the European Directives, National legislative acts and regulations endorsing the rules for medical devices authorization, classification, quality control, and reimbursement of medical devices. First was analyzed the development and major requirements of European legislation on medical devices since 1990 when the first EU Directive was issued. Next was analyzed the national laws on medicines in both countries and related regulations and institutions for medical devices authorization and quality control. Then was reviewed the legislative requirements for medical devices reimbursement and payment in both countries under consideration. Market analysis was performed towards the officially published data by the health insurance authorizes in both countries for the reimbursed cost by type of medical devices an...
Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most... more Background Parkinson's disease (PD), which occurs in 1% of the population, is the second most common neurodegenerative disorder. Despite the broad spectrum of PD manifestations and high disease prevalence, there are insufficient data on medicine utilization and prescription strategies. The purpose of the current study was to analyze published data concerning treatment approaches and to compare them with Bulgarian therapeutic practice. Design and methods We conducted a systematic review of the PubMed and Google Scholar databases, and we calculated medicine utilization in Bulgaria during 2018 and 2019 using the WHO methodology. Results The literature search identified a total of 311 publications, but only 12 met the inclusion criteria. Eleven studies pointed out that levodopa-containing medicine are the most frequently used, followed by dopamine agonists. The highest rate was found for levodopa-containing products and decarboxylase inhibitor (1.06 and 1.33 DDD/1000 inh/day), follo...
A71 20 (2.9%) were judged to be actual, 330(47.8%) potential and 341(49.3%) prescribing errors wi... more A71 20 (2.9%) were judged to be actual, 330(47.8%) potential and 341(49.3%) prescribing errors with no harm. Prescribing errors were significantly most common in surgical unit compared to the other study units (P< 0.001) with small effect size (Eta = 0.089) and (Carmer's v = 0.089). There was a significant differences in the mean length of hospital stay between those who had prescribing errors 5.42 (±6.26) days and those who didn't 4.04 (±4.01) days (p< 0.001). ConClusions: The study has identified important prescribing errors and their associated factors and based on these findings strategies to prevent future errors should be developed.
To evaluate the impact on costs of treating complications derived from chronic kidney disease (CK... more To evaluate the impact on costs of treating complications derived from chronic kidney disease (CKD) in patients undergoing hemodialysis in the private health care system in Brazil. METHODS: Owing to the lack of local databases, a survey with experts was conducted to collect data about the main causes of hospital admissions which resulted from complications during the dialysis period of CKD patients. A universe of 600 patients from reference centers in Brazil was studied. Later, the experts answered to a questionnaire about the procedures needed to manage complications. Then, a micro-costing was performed, only direct costs were considered: length of staying, medical procedures, physician fees and drugs. Sources used for costing were: CBHPM 2009 v.5 (physicians fees list), Revista Kairos (January 2009) (drugs price list) and Guia Farmacêutico Brasíndice (January 2009) (materials price list). The time horizon of this analysis was 1 year, thus no discount rate was assumed. The perspective assumed was that of the private payer. RESULTS: The 3 most frequent causes of hospital admissions and their respective costs in the studied centers were: cardiac complications (33.
Analyzing the health economic results of the centralized procurement is important for critical as... more Analyzing the health economic results of the centralized procurement is important for critical assessment of the level of achievment of health goals during the tender process. OBJECTIVE : To compare the procurement legislation and its impact on the prices and quantities of procured medicines in the public sector. METHODS: legislation analysis of both procurement laws and regulations for medicines supply issued during 1997 - 2003. Calculation of price and quantities indexes of procured oncology medicines via centralized tenders for the period 2000 - 2003. RESULTS : The tenders are organized in Macedonia by the Health insurance fund for all levels of health care and all medicines included in the procurament list while in Bulgaria Ministry of health is organizing a central drug procurament for 121 INN life - saving and expensive medicines dispensed via specialized clinics. Changes in the price and quantity indexes for oncology products in Bulgaria shows increase in quantity index till ...
Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in... more Medication non-adherence is associated with almost 200,000 deaths annually and €80–125 billion in the European Union. Novel technological advances (smart pill bottles, digital inhalers and spacers, electronic pill blisters, e-injection pens, e-Health applications, big data) could help managing non-adherence. Healthcare professionals seem however inadequately informed about non-adherence, availability of technological solutions in daily practice is limited, and collaborative efforts to push forward their implementation are scarce. The European Network to Advance Best practices and technoLogy on medication adherencE (ENABLE, COST Action 19132) aims to 1) raise awareness of adherence enhancing solutions, 2) foster knowledge on medication adherence, 3) accelerate clinical application of novel technologies and 4) work collaboratively towards economically viable policy, and implementation of adherence enhancing technology across healthcare systems.
Introduction: High prevalence rate of CVD and high rate of CVD deaths attributed to high choleste... more Introduction: High prevalence rate of CVD and high rate of CVD deaths attributed to high cholesterol leads to increased statins utilization. The aim of this study is to analyse the difference in prices between generic and innovator and utilization of INNs of statins available in Bulgaria and Ukraine. Materials and methods: The study is retrospective and observational analysis of changes in prices. On total, 7 INN and 18 dosage forms are included in the study. Utilization of statins has been measured in DDD/1000 inh/d. Results: The results reveal considerable price differences in the prevailing part of the observed dosage forms between 2013 and 2016 and higher price variations. Two of the lowest and three of the highest prices have not been changed in Bulgaria. For the same period in Ukraine ten lowest and five highest prices have decreased, while one lowest and six highest have increased. Statins utilization is much higher in Bulgaria than that in Ukraine. Conclusions: Prices of statins tend to decrease in Bulgaria more than in Ukraine. In both countries there is a slight tendency of reduced utilization, whereas the consumption of statins in Bulgaria is much higher than that in Ukraine. The study confirms that medicine utilization depends on prices and the health policy in the countries.
Access to orphan drugs (In EU regulation Orphan Drugs are refered as Orphan Medicinal Products (O... more Access to orphan drugs (In EU regulation Orphan Drugs are refered as Orphan Medicinal Products (OMP)) is a key role in determining whether patients with rare diseases (RDs) will receive adequate and efficient treatment. The objective of this article is to identify differences in patient access to orphan drugs in 3 pharmaceutical markets: Serbia, Croatia and Macedonia. Patient access was defined: as the market access (availability) and affordability (financial accessibility). We analysed the legislative requirements for the authorisation process and made a cross country comparison. Retrospective cross-sectional analysis was done on drug lists in selected countries and a cross-comparison between the List of Orphan Drugs in Europe (LODE) for a six-month period (May 2014-October 2014). We included all 179 OMPs marketed in EU in our analysis, which had received market authorization in Croatia upon its membership in the EU. Total number of marketed drugs in Serbia was 59 (32.96%) drugs and in Macedonia 52 (29.05%) drugs. However, market authorization does not guarantee patient access to any given drug, so only 39.11% of OMPs could be accessed by Croatian patients (70 drugs).The number of refunded drugs in Serbia and Macedonia was smaller (32 and 20, respectively) which makes respectively, 17.88% and 11.17% of drugs on the LODE. The present study showed some variations between countries in selected indicators of availability and access to orphan drugs. Patients in Croatia had greater number of registered and refunded drugs, but in Serbia more than a half of registered OMPs could be refunded from National Health Insurance Fund. Macedonia had smaller number of inhabitants and also had the smaller number of patients from certain RDs which results in lower total number of OMPs.
European Journal of Hospital Pharmacy: Science and Practice, 2013
2007-2009 two new substances were introduced, tacrolimus and everolimus, which led to the increas... more 2007-2009 two new substances were introduced, tacrolimus and everolimus, which led to the increase in prescribing costs. For the period 2010-2011 generic immunosuppressants were introduced and the prescribing costs declined. The drug costs of kidney transplantation vary between 17.43% and 30.66% of the hospital's drugs budget. Conclusions To our knowledge this is the first Bulgarian study of prescribing practise and changes in the cost of drugs for kidney transplant patients. It reveals that prescribing costs are varying and dependent on the introduction of new molecules or generic products. The study shows that the introduction of the new immunosuppressive molecules leads to an increase in pharmacotherapy costs, while the introduction of generic products significantly reduces drug costs. No conflict of interest. Risk AnAlysis of Medicines PRoduced in HosPitAl PHARMAcy-A tool foR ensuRing oPtiMAl suPPly
The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedon... more The objective of the study is analysis of the prescription patterns in Bulgaria, Romania, Macedonia and Bosnia Herzegovina (BiH). The study discusses the relevance between prescription and morbidity and the rationality of the drug prescription in terms of Essential Drug Concept (EDC). For the assessment of the morbidity influence on the prescription official statistical information was reviewed and prevailing causes of diseases in the observed countries were calculated. To study the patterns geographically selected regions from the countries under consideration were observed during 1998-2000. In all the countries under consideration respiratory tract, nervous system and cardiovascular diseases are playing the leading role. The prescription of cardiovascular drugs, anti-infectious nervous and respiratory system drugs also predominate. Comparison between prescription and morbidity patterns shows a significant relationship between the morbidity and prescription patterns. Prescription m...
Twenty-eight instruments measuring pain, clinical, functional, and global characteristics were ad... more Twenty-eight instruments measuring pain, clinical, functional, and global characteristics were administered to 303 patients in a six-month randomized clinical trial of auranofin and placebo in the treatment of patients with rheumatoid arthritis. The instruments were compared with respect to their responsiveness in detecting a treatment effect, the time involved in administering the instrument, the need for the presence of an interviewer, and ease of administration. The instruments' ability to detect a treatment effect was the deciding characteristic in the clinical, pain, and global categories in choosing the preferred instrument. The counts of tender and swollen joints were found to be the most responsive clinical measures, the 10-cm pain line was the most responsive and the fastest to administer of the pain instruments, and the categorical self-assessment of arthritis was the most responsive global measure. In the functional ability category, the Health Assessment Questionnaire (HAQ), the Keitel Functional Assessment, and the Quality of Well-Being (QWB) Questionnaire were equally responsive. The HAQ was the shortest and the only self-administered questionnaire. The QWB has had the most extensive validation work but was a complex instrument requiring intensive interviewer training. The Keitel was the most timeconsuming instrument, but had the advantage of high interobserver agreement. The design of future trials can be guided by the information obtained in this study on their relative efficiencies and ease of use.
Objectives: To show how a simple tablet program can be successfully used with minimal supervision... more Objectives: To show how a simple tablet program can be successfully used with minimal supervision and instruction to collect pain data from patients. MethOds: The data collection method was an Android application, designed to be run on a tablet. There was a tutorial to explain how to enter data, and a nurse was present to activate the survey and support the patient, if necessary. The application displayed a timer and prompted the patient to report their pain level at each time point, and within a set window, using a sliding scale (0-10). Patient data were stored on an internal database within the application and subsequently uploaded to a local database server. Results: The primary objective of the study was to determine the time to onset of significant pain relief in patients applying ibuprofen gel, ibuprofen gel with levomenthol, or diclofenac gel to treat soft tissue injuries. Significant pain relief was defined as a reduction of 2 points on an 11 point numeric rating scale (NRS) for pain. One patient was affected by a bug in the data collection system, but the problem was discovered and resolved before the next patient was scheduled. The remaining 181 patients used the tablets to input data on their pain levels at 17 time points over a 2 hour period following gel application, allowing the primary study objective to be assessed. Excluding the patient affected by the bug, who was not assessed, only thirteen patients had some missing time point data and there were only 18 missing data points from a total of 3,077 (0.6%). cOnclusiOns: The tablet program was easy to use, resulting in high completion rates. Electronic prompting meant that data could be reliably collected at precise time points, and patients could input data themselves, which reduced labour costs.
The aim of this paper is to identify the barriers that are specifically relevant to the use of Ar... more The aim of this paper is to identify the barriers that are specifically relevant to the use of Artificial Intelligence (AI)-based evidence in Central and Eastern European (CEE) Health Technology Assessment (HTA) systems. The study relied on two main parallel sources to identify barriers to use AI methodologies in HTA in CEE, including a scoping literature review and iterative focus group meetings with HTx team members. Most of the other selected articles discussed AI from a clinical perspective (n = 25), and the rest are from regulatory perspective (n = 13), and transfer of knowledge point of view (n = 3). Clinical areas studied are quite diverse—from pediatric, diabetes, diagnostic radiology, gynecology, oncology, surgery, psychiatry, cardiology, infection diseases, and oncology. Out of all 38 articles, 25 (66%) describe the AI method and the rest are more focused on the utilization barriers of different health care services and programs. The potential barriers could be classified ...
The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arth... more The goal of this pilot study is to perform a cost analysis by using patients with rheumatoid arthritis as a source of information. The point of view is that of the patients and society and the time horizon is one year. It is a micro costing study calculating the direct health care cost of pharmacotherapy. The pharmacotherapy includes 6 main therapeutic groups of medicines as corticosteroids (per os or intraarticular injections), disease modifying antirheumatics (DMAR), biological, non-steroidal anti-inflammatory drugs (NSAID), medicines improving bone density, and proton pump inhibitors (PPI).Monthly cost of pharmacotherapy per patient on average is 815.05 (SD 1104.25) BGN, and biological therapy is the most expensive one 2961.03 (SD 1435.46). 25% of the patients are on it. 58 per cent of the patients reported regular physicians' visits at least ones quarterly with average yearly cost of 111.60 BGN (9.30 BGN per month). 56 people were out of work and for 13 of them it was for mo...
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Papers by Guenka Petrova