Analysis of the Professional Aspects of Medical Drugs Industry in the Republic of Serbia in Times of COVID-19 Pandemic

The research subject of this paper is the analysis of the attitudes of employees in pharmaceutical companies towards the business aspects of the pharmaceutical industry during and after the end of the pandemic in the Republic of Serbia. The aim is to examine the differences in the attitudes of employees, as well as to determine which variables predict the situations of endangering the professional reputation of pharmaceutical companies during the COVID-19 pandemic. The research was conducted by means of a survey during 2021 on a sample of 27 innovative and generic pharmaceutical companies. We used the SPSS program for descriptive statistics analysis, chi square test and binary logistic regression models. The findings show that there is a statistically significant difference in the expressed attitudes of employees in innovative and generic pharmaceutical companies in terms of coming to the office during the pandemic; the lack of medicines and medical devices used in the treatment of COVID-19 infections; the patient access to a chosen doctor; the expectations of the employees to continue working from home after the outbreak of the COVID-19 pandemic. The findings of the binary regression models show the slowdown in the supply chain, the access to doctors and working from the home office have not been perceived as creating situations of endangering professional reputations, that is, they contribute to the sustainable economic success. On the other hand, the introduction of digital technologies decreases the occurrence of conditions in which their professional reputation has been threatened

The Instruments Used to Assess Health Literacy and Pharmacotherapy Literacy of Diabetes Mellitus Type 2 Patients: A Scoping Review

Background: Patients with chronic diseases, like diabetes need to continuously perform tasks associated with self-management especially with medications they use. It is shown that the patients with diabetes with limited HL and PTHL cannot read medication labels correctly, may misuse their medications, spend much more on therapy and generally have difficulties in understanding printed care instructions and perceiving health advice and warnings. There has been an increasing demand for valid and reliable instruments for HL and PTHL assessment in this population. This review aims to search and critically discuss instruments used to assess HL and PTHL in people with type 2 diabetes and propose their use in different settings. Methods: Authors conducted a comprehensive, electronic search of original studies using a structured approach of the Scopus and PubMed databases, during November and the first 2 weeks of December 2020 to find relevant papers. The review was conducted in accordance with the Cochrane guidelines and the reporting was based on the PRISMA-ScR. The comparison of instruments was made by utilizing a comparison model related to their structure, measurement scope, range, psychometric properties, validation, strengths, and limitations. Results: The final number of included studies was 24, extracting the following identified instruments: Korean Functional Test HL, NVS, FCCHL, HLS-EU-47, TOFLHA, S-TOFHLA, REALM-R, 3-brief SQ, REALM, HLQ and DNT-15. In all, FCCHL and 3-brief SQ are shown with the broadest measurement scopes. They are quick, easy, and inexpensive for administration. FCCHL can be considered the most useful and comprehensive instrument to screen for inadequate HL. The limitation is that the English version is not validated. Three-brief SQ has many advantages in comparison to other instruments, including that it is less likely to cause anxiety and shame. These instruments can be considered the best for measuring functional HL in patients with diabetes mellitus type 2 and other chronic diseases. PTHL instruments (REALM and DNT-15) did not find the best application in this population. Conclusions: The future research should be directed in validation of the FCCHL in English and establishing of the structural validity of this questionnaire. Developing a specific PTHL questionnaire for this population will be of great help in management of their disease

Cross-Cultural Adaptation and Validation of the Functional, Communicative and Critical Health Literacy Instrument (FCCHL-SR) for Diabetic Patients in Serbia

Thoroughly validated instruments can provide a more accurate and reliable picture of how the instrument works and of the level of health literacy in people with type 2 diabetes mellitus (T2DM). The present work aimed at cross-cultural adaptation and validation of the Functional, Communicative and Critical Health Literacy Instrument (FCCHL) in patients with T2DM in Serbia. After translation and back-translation, views from an expert group, one cognitive interview study (n = 10) and one survey study (n = 130) were conducted among samples of diabetic patients. Item analysis, internal consistency, content validity, confirmatory factor analysis (CFA) and reliability testing were performed. When all 14 items were analyzed, loading factors were above 0.55, but without adequate model fit. After removing two items with the lowest loadings FHL1 and IHL2 the fit indexes indicated a reasonable normed χ2 (SB scaled χ2/df = 1.90). CFI was 0.916 with SRMR = 0.0676 and RMSEA = 0.0831. To determine internal consistency, Cronbach’s alpha coefficient was 0.796 for the whole FCCHL-SR12. With only minor modifications compared to the English version, the 12-item FCCHL instrument is valid and reliable and can be used to measure health literacy among Serbian diabetic patients. However, future research on a larger population in Serbia is necessary for measuring the levels of HL and their relationship with other determinants in this country

Farmakoekonomska evaluacija fakoemulzifikacije i ekstrakapsularne ekstrakcije u operaciji katarakte

Background/Aim. Cataract surgery is one of the most often performed surgical interventions. The predominant method in Western countries is phacoemulsification, while in developing countries, the extracapsular cataract extraction (ECCE) method remains popular. The aim of the study was to evaluate the cost- effectiveness of these two cataract surgery techniques from the provider’s perspective if operation complications were the out- come of the interest. Methods. The data were obtained from the Department of Ophthalmology of the General Hospital Kruševac during a one-year period. A total of 1,179 surgeries by five surgeons were performed. The cost-effectiveness was evaluated using the decision tree. All probabilities were calcu- lated based on the likelihood of the occurrence during the study period. Only direct costs were considered, and values were taken from the documentation at the hospital and the of- ficial price list of health services. One- and two-way sensitivity analyses were performed. Results. The total cost per patient in the phacoemulsification group was 71,008.70 Serbian dinars (RSD), while the total cost in the ECCE group was 74,340.36 RSD. At the same time, phacoemulsification shows higher ef- fectiveness than the ECCE method, with 87% and 57% of pa- tients without complications, respectively. With these results, phacoemulsification was the dominant strategy compared to ECCE. The sensitivity analysis revealed that the results are sen- sitive to the number of performed operations per year. Con- clusion. The phacoemulsification technique seems to be the preferred technique for cataract surgery. All the investment in phacoemulsification equipment and consumables is justified if the number of surgeries per year exceeds 350.Uvod/Cilj. Operacija katarakte predstavlja jednu od najčešće primenjivanih hirurških intervencija. U zapadnim zemljama, dominantna tehnika je fakoemulzifikacija, dok je u zemljama u razvoju najzastupljenija tehnika ekstrakapsularne ekstrakcije (ECCE). Cilj rada bio je da se proceni ekonomska isplativost te dve tehnike operacije katarakte iz perspektive pružaoca usluge, ukoliko se kao ishod posmatraju komplikacije. Metode. Podaci su dobijeni sa Očnog odeljenja Opšte bolnice Kruševac tokom jednogodišnjeg perioda. Ukupno je izvedeno 1 179 operacija od strane pet hirurga. Ekonomska isplativost je procenjena primenom „drveta odlučivanja“. Verovatnoće za događaje su izračunate na osnovu verovatnoće pojavljivanja tokom navedenog perioda. U analizi su razmatrani samo direktni troškovi, a vrednosti su preuzete iz prateće dokumentacije i zvaničnog cenovnika zdravstvenih usluga. Sprovedena je jednosmerna i dvosmerna analiza osetljivosti. Rezultati.Ukupni troškovi u grupi koja je bila podvrgnuta fakoemulzifikaciji iznosili su 71 008.70 srpskih dinara (RSD), dok su u ECC E grupi oni iznosili 74 340.36 RSD. Istovremeno, fakoemulzifikacija je pokazala višu efikasnost u odnosu na ECCE, 87% i 57% bolesnika bez komplikacija, redom. Na osnovu dobijenih rezultata, fakoemulzifikacija je bila dominantna strategija u poređenju sa ECCE. Analiza osetljivosti pokazala je da su rezultati osetljivi na broj izvršenih intervencija na godišnjem nivou. Zaključak. Fakoemulzifikacija je ekonomski isplativija tehnika operacije katarakte u odnosu na ECCE. Sva ulaganje u opremu i potrošni materijal za fakoemulzifikaciju opravdani su ukoliko je broj izvedenih operacija na godišnjem nivou preko 350

The Cost-Effective Laboratory: Implementation of Economic Evaluation of Laboratory Testing

Laboratory testing as a part of laboratory in vitro diagnostic (IVD) has become required tool in clinical practice for diagnosing, monitoring and prognosis of diseases, as well as for prediction of treatment response. The number of IVD tests available in laboratory practice has increased over the past decades and is likely to further increase in the future. Consequently, there is growing concern about the overutilization of laboratory tests and rising costs for laboratory testing. It is estimated that IVD accounts for between 1.4 and 2.3% of total healthcare expenditure and less than 5% of total hospital cost (Lewin Group report). These costs are rather low when compared to pharmaceuticals and medical aids which account for 15 and 5%, respectively. On the other hand, IVD tests play an important role in clinical practice, as they influence from 60% to 70% of clinical decision-making. Unfortunately, constant increases in healthcare spending are not directly related to healthcare benefit. Since healthcare resources are limited, health payers are interested whether the benefits of IVD tests are actually worth their cost. Many articles have introduced frameworks to assess the economic value of IVD tests. The most appropriate tool for quantitative assessment of their economic value is cost-effectiveness (CEA) and cost-utility (CUA) analysis. The both analysis determine cost in terms of effectiveness or utilities (combine quantity and quality of life) of new laboratory test against its alternative. On the other hand, some investigators recommended calculation of laboratory test value as product of two ratios: Laboratory test value = (Technical accuracy/Turnaround time) x Utility/Costs). Recently, some researches used multicriteria decision analysis which allows comparison of diagnostic strategies in terms of benefits, opportunities, costs and risks. All analyses are constructed to identify laboratory test that produce the greatest healthcare benefit with the resources available. Without solid evidence that certain laboratory tests are cost-effective, laboratory services cannot be improved. Consequently, simple policy measures such as cost cutting may be imposed upon many laboratories while patients will have limited access to laboratory service

Predictors of Inadequate Health Literacy among Patients with Type 2 Diabetes Mellitus: Assessment with Different Self-Reported Instruments

INTRODUCTION: Obtaining, understanding, interpreting, and acting on health information enables people with diabetes to engage and make health decisions in various contexts. Hence, inadequate health literacy (HL) could pose a problem in making self-care decisions and in self-management for diabetes. By applying multidimensional instruments to assess HL, it is possible to differentiate domains of functional, communicative, and critical HL. OBJECTIVES: Primarily, this study aimed to measure the prevalence of inadequate HL among type 2 diabetes mellitus patients and to analyze the predictors influencing health literacy levels. Secondly, we analyzed if different self-reported measures, unidimensional instruments (Brief Health Literacy instruments (BRIEF-4 and abbreviated version BRIEF-3), and multidimensional instruments (Functional, Communicative and Critical health literacy instrument (FCCHL)) have the same findings. METHODS: The cross-sectional study was conducted within one primary care institution in Serbia between March and September 2021. Data were collected through Serbian versions of BRIEF-4, BRIEF-3, and FCCHL-SR12. A chi-square test, Fisher's exact test, and simple logistic regression were used to measure the association between the associated factors and health literacy level. Multivariate analyses were performed with significant predictors from univariate analyses. RESULTS: Overall, 350 patients participated in the study. They were primarily males (55.4%) and had a mean age of 61.5 years (SD = 10.5), ranging from 31 to 82 years. The prevalence of inadequate HL was estimated to be 42.2% (FCCHL-SR12), 36.9% (BRIEF-3) and 33.8% (BRIEF-4). There are variations in the assessment of marginal and adequate HL by different instruments. The highest association was shown between BRIEF-3 and total FCCHL-SR12 score (0.204, p < 0.01). The total FCCHL-SR12 score correlates better with the abbreviated BRIEF instrument (BRIEF-3) than with BRIEF-4 (0.190, p < 0.01). All instruments indicated the highest levels for the communicative HL domain and the lowest for the functional HL domain with significant difference in functional HL between the functional HL of FCCHL-SR12 and both BRIEF-3 and BRIEF-4 (p = 0.006 and 0.008, respectively). Depending on applied instruments, we identified several variables (sociodemographic, access to health-related information, empowerment-related indicators, type of therapy, and frequency of drug administration) that could significantly predict inadequate HL. Probability of inadequate HL increased with older age, fewer children, lower education level, and higher consumption of alcohol. Only high education was associated with a lower probability of inadequate HL for all three instruments. CONCLUSIONS: The results we obtained indicate that patients in our study may have been more functionally illiterate, but differences between functional level could be observed if assessed by unidimensional and multidimensional instruments. The proportion of patients with inadequate HL is approximately similar as assessed by all three instruments. According to the association between HL and educational level in DMT2 patients we should investigate methods of further improvement

Pharmacotherapy Literacy and Parental Practice in Use of Over-the-Counter Pediatric Medicines

Background and objectives: Pharmaceutical literacy skills of parents are crucial for appropriate and safe medication use in pre-school children (ages 1-7 years). A recent study on pharmacotherapy literacy from Serbia showed that one in five parents have difficulty understanding common information about the use of medicines. Because antipyretics are considered to be the most frequently used group of over-the-counter (OTC) medications during the pre-school period, we aimed to: (i) examine parental practice and expectations in antipyretic medication use, and (ii) analyze associations of parental practice and expectations related to socio-economic status and pharmacotherapy literacy. Materials and methods: A cross-sectional survey using a self- report validated specific instrument was conducted with the parents of pre-school children in kindergartens in Belgrade, Serbia. Pharmacotherapy literacy refers to the knowledge and personal skills needed to meet the complex demands of medicine use in both healthcare and non-healthcare settings. A comprehensive literature review, expert-focus group consultation, and pre-testing were employed in 4-item multiple-choice test development to explore practice and expectations related to the use of OTC pediatric antipyretic medicines. Results: The final analytical cohort was comprised of 813 participants, the majority (63.3%) chose a medicine based on a physician's suggestion and only 15.4% of parents reported they would follow the advice of a pharmacist. More than a half of parents (54.1%) would need advice about antipyretic medicine from a pharmacist, firstly in a simpler language. Parents satisfied with the information given by a pharmacist had higher pharmacotherapy literacy, compared to parents with lower levels (OR-0.718, 95%CI (0.597-0.865), p lt 0.001). Men had a higher expectation of pharmacists to explain medicine use in a simpler language (OR-1.630, 95%CI (1.063-2.501), p = 0.025), as well as parents with three or more children (OR-2.527, 95%CI (1.43-4.459), p = 0.001). Parents with higher knowledge about medicine use were less likely to ask for simpler information (OR-0,707; 95%CI (0,583-0,856), p lt 0,001). Conclusions: Our main finding is that practice in antipyretic OTC medicine use was associated with levels of parental pharmacotherapy literacy. The expectations of pharmacists were higher among parents with lower levels of pharmacotherapy literacy, who expected more information in a simpler and more precise language. This study highlighted the need for pharmacists to identify risks in parental practice and to provide information about medicines to parents of pre-school children in a simpler and more appropriate way

Pharmacotherapy literacy of parents in the rural and urban areas of Serbia-are there any differences?

Background and objectives: Pharmacotherapy literacy (PHTL) is an individual’s capacity to obtain, evaluate, calculate, and comprehend basic information about pharmacotherapy and pharmacy-related services necessary to make appropriate medication-related decisions, regardless of the mode of content delivery (e.g., written, oral, visual images and symbols). It is already proven that low PHTL of parents can cause serious problems in the treatment of a pediatric population. We aimed to identify the dierences in parental PHTL levels, socio-demographic and health-related characteristics (chronic disease of a child, breastfeeding of a child, annual visits to a pediatrician, parental-self-estimation of health status) between rural and urban areas and to investigate the influence of living in rural areas on a low PHTL level. Materials and methods: Our study was cross-sectional with a validated 14-item instrument (“Parental pharmacotherapy literacy questionnaire—Serbian”), which assessed overall PHTL and its three domains of knowledge, understanding and numerical skills necessary for the safe use of medicines. We analyzed 250 parents of pre-school children (1–7 years old) in rural areas and 182 parents from urban areas in Serbia. Results: Every tenth parent from rural and every fourth parent from urban areas had the highest PHTL level or more than 85% correct answers. However, 51% and 28% of parents in rural and urban areas, respectively, had a low PHTL level (less than 65% correct answers), [Õ2(1, n = 432) = 33.2; p < 0.001]. Parents from dierent areas statistically diered in age, education level, employment, breastfeeding and annual visits to pediatrician rate. Those from rural areas had almost twice the probability of low PHTL levels (ORa = 2.033; p = 0.003) than their urban counterparts, independently of other examined parental characteristics. Conclusions: Parents from rural areas have more diculties to obtain, evaluate, calculate and comprehend basic information related to pharmacotherapy than parents from urban areas

Therapeutic drug monitoring of monoclonal antibodies in chronic inflammatory diseases: A snapshot of laboratories and applications across Europe

The European Cooperation in Science and Technology (COST) action ENOTTA (The European Network on Optimising Treatment with Therapeutic Antibodies in chronic inflammatory diseases) was launched in 2022. To pave the way for harmonization of analytical methods for quantitation of serum levels of therapeutic antibodies in research and clinical settings, ENOTTA recently performed an online survey mapping laboratories in the field. The survey, which contained 30 questions surrounding therapeutic drug monitoring of relevant drugs and anti-drug antibodies, was distributed via the ENOTTA and European Federation of Clinical Chemistry and Laboratory networks. Among 63 respondents across Europe, 45 reported analytical activity, with a range of utilized methods. Future engagement of as many sites as possible will enable comparison of methodologies and facilitate progress in the field

Farmakoekonomska evaluacija pružanja farmaceutske usluge pacijentima na antikoagulantnoj terapiji varfarinom

It has been determined that Pharmacist-Managed Anticoagulation Service (PMAS) for patients on warfarin improves anticoagulation control and decreases the rate of bleeding, thus reducing the overall health care costs. This study aims to compare the cost-effectiveness of providing pharmaceutical care (PC) and usual medical care (UMC) to patients on warfarin, from the perspective of the National Health Insurance Fund (NHIF) in Serbia. The cost-effectiveness analysis was conducted, with a time horizon of 10 days. Decision tree modeling combined data on efficacy from eligible studies, while the costs were taken from NHIF Drug and Service fee lists. Additionally, the budget impact analysis was performed, aiming to project annual savings by implementing PMAS as a part of anticoagulation clinics. PC has been perceived to be cost-effective strategy, since it enables a higher probability of well controlled INR value (additional effectiveness 0,154), along with lower costs (-374,51 RSD), compared to UMC. Negative incremental cost-effectiveness ratio additionally demonstrated cost-effectiveness of PC, as dominant strategy. Sensitivity analysis confirmed the model robustness, and budget impact analysis has also demonstrated significant annual savings, in the total amount of 50.863.313 RSD for a five year period 2016-2020. Providing PC to patients on warfarin represents a more cost-efficient strategy than UMS, in addition to better safety profile, which is why it should be implemented in the national health care system in the future.Utvrđeno je da sprovođenje menadžmenta terapije varfarinom od strane farmaceuta značajno unapređuje kontrolu antikoagulacije i smanjuje broj slučajeva krvarenja, a time i pridružene troškove lečenja. Cilj ovog rada je farmakoekonomska evaluacija pružanja farmaceutske zdravstvene zaštite (FZZ) pacijentima na varfarinu u odnosu na standardnu zdravstvenu zaštitu (SZZ), iz perspektive Republičkog fonda za zdravstveno osiguranje (RFZO). Sprovedena je analiza isplativosti primenom drveta odlučivanja, za period od 10 dana. U modelu su kombinovani podaci za posmatrane ishode iz odgovarajućih studija, dok su direktni medicinski troškovi preuzeti iz važećih cenovnika zdravstvenih usluga, kao i Liste lekova RFZO. Dodatno je sprovedena analiza uticaja na budžet, radi projektovanja potencijalnih ušteda u slučaju implementacije ove farmaceutske usluge. FZZ je troškovno isplativija strategija, obzirom na veću efektivnost (+0,154), a manji trošak (-374,51 RSD) u odnosu na SZZ. Negativna vrednost inkrementalnog odnosa troškova i efektivnosti za FZZ dodatno potvrđuje njenu isplativost, kao dominantne strategije. Analiza osetljivosti je potvrdila robusnost modela, dok su analizom uticaja na budžet projektovane značajne uštede, od 50.863.313 RSD za petogodišnji period 2016.-2020. Pružanje FZZ pacijentima na antikoagulantnoj terapiji varfarinom predstavlja troškovno-isplativiju strategiju u odnosu na SZZ u Republici Srbiji, zbog čega je poželjno da se implementira u nacionalni zdravstveni sistem u budućnosti