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The corrosion of high level nuclear waste containers under permanent disposal conditions can occur via a number of processes which change in importance as the environment within a deep geologic repository evolves from oxic to anoxic. The container design involves a copper coating on a steel vessel. The characteristics of these coatings are being assessed using standard analytical methods, including microscopy and electron backscatter diffraction. The corrosion processes on the surface of the coatings and at through-coating defects are also being investigated electrochemically. Although minor differences exist, the surface corrosion of cold sprayed and electrodeposited coatings generally exhibited similar corrosion behaviour to standard wrought copper. Corrosion at the base of a simulated through-coating defect in a cold-sprayed coating was found to proceed via galvanic coupling to oxygen reduction on the coating surface. Besides accumulating damage at the base of the defect, corrosion propagated along the copper/steel interface, most likely a consequence of the damage inflicted during the deposition process. [ABSTRACT FROM AUTHOR]

Background: In 2014, a qualitative multi-country research project was launched to study the reasons behind the high use of antibiotics in regions of Southeast Europe by using previously untrained national interviewers (who were engaged in other antibiotic microbial resistance-related investigations) to conduct qualitative interviews with local patients, physicians and pharmacists. Little knowledge exists about how to implement qualitative multi-country research collaborations involving previously untrained local data collectors. The aim of this paper was therefore to contribute to the knowledge regarding how to conduct these types of research projects by evaluating a pilot study of the project. Methods: Local data collectors conducted the study according to a developed protocol and evaluated the study with the responsible researcher-team from University of Copenhagen. The pilot study focused on 'local ownership', 'research quality' and 'feasibility' with regard to successful implementation and evaluation. The evaluation was achieved by interpreting 'Skype' and 'face to face' meetings and email correspondence by applying 'critical common sense'. Results: Local data collectors achieved a sense of joint ownership. Overall, the protocol worked well. Several minor challenges pertaining to research quality and feasibility were identified, in particular obtaining narratives when conducting interviews and recruiting patients for the study. Furthermore, local data collectors found it difficult to allocate sufficient time to the project. Solutions were discussed and added to the protocol. Conclusions: Despite the challenges, it was possible to achieve an acceptable scientific level of research when conducting qualitative multi-country research collaboration under the given circumstances. Specific recommendations to achieve this are provided by the authors. [ABSTRACT FROM AUTHOR]

Objective: Brucellosis became a remarkable disease in Kosovo. But there is not a comprehensive epidemiological study about epidemiology and clinical course of this disease from Kosovo. The aim of our study is to present demographic and clinical data of patients with brucellosis at University Clinical Center of Kosovo. Methods: A retrospective study was performed for the patients with brucellosis treated in our clinic during years 2011-2012. The data about demography, history of the disease, clinical presentations, serological test, serum biochemistry and treatment were collected from hospital medical records. The diagnosis of brucellosis based on clinical and laboratory findings. Results: This descriptive study included 47 patients, who 33 of them (70.2%) were males. The mean age was 37.9 ± 19.3 years. The route of transmission of the disease was known in 28 (59.5%) of them. Direct contact with livestock in 22 (46.8%) and ingestion of dairy products in six cases (12.7%) were reported as the transmission route. The majority of patients (27 patients, 57.4%) were from rural area. The main presenting symptoms were fatigue, fever and arthralgia. Osteoarticular manifestations were the common forms of localized disease. Regarding to the therapy, 45 (95.7%) of patients were treated with streptomycin and doxycycline for the first three weeks. Conclusion: Human brucellosis is not a common in Kosovo but there is a potential risk. Osteoarticular symptoms were the most common presentation reasons. The most effective and preferred treatment regimen was Streptomycin plus Doxycycline for the first three weeks, and Doxycycline plus Rifampicin thereafter. [ABSTRACT FROM AUTHOR]

Aim: to present the epidemiological, clinical and diagnostic characteristics and treatment of patients with brucellosis treated at the Clinic for Infectious Diseases of the University Clinical Center of Kosovo during 2012. Materials and Methods: we used the medical records to obtain anamnesis of the disease, clinical presentations, serological test, serum biochemistry and treatment of 17 patients with brucellosis treated at the Clinic for Infectious Diseases in Prishtina. Results: this descriptive study included 17 patients, of which 76.5% were male. The mean age of the patients was 36.9 '} 19.9 years (range 9-69). In 58.8% of patients (41.2% had no known risk factors) there was a known route of Brucellosis transmission; direct contact with livestock in 47.1% and consumption of dairy products in 11.7% of patients. The main presenting symptoms were; fatigue (76.5%), fever and arthralgia (70.6%) with an identical frequency ratio. Osteoarticular manifestations were the common forms of localized disease which affected 58.8% of patients. Regarding the therapy, 94.2% of patients were treated with streptomycin and doxycycline for the first three weeks. Therapy was continued with doxycycline and rifampicin for at least 6 weeks thereafter. Conclusion: we found osteoarticular symptoms to be the most common presentation amongst the cohort. The most effective and preferred treatment regimen was with streptomycin and doxycycline for the first three weeks, and doxycycline and rifampicin thereafter. [ABSTRACT FROM AUTHOR]

Abstract: β-Catenin is a multifunctional protein stimulating as oncogenic transcription factor several genes important for cell proliferation. β-Catenin-regulated genes include the serum- and glucocorticoid-inducible kinase SGK1, which is known to stimulate a variety of transport systems. The present study explored the possibility that β-catenin influences membrane transport. To this end, β-catenin was expressed in Xenopus oocytes with or without SGLT1 and electrogenic transport determined by dual electrode voltage clamp. As a result, expression of β-catenin significantly enhanced the ouabain-sensitive current of the endogeneous Na+/K+-ATPase. Inhibition of vesicle trafficking by brefeldin A revealed that the stimulatory effect of β-catenin on the endogenous Na+/K+-ATPase was not due to enhanced stability of the pump protein in the cell membrane. Expression of β-catenin further enhanced glucose-induced current (Ig) in SGLT1-expressing oocytes. In the absence of SGLT1 Ig was negligible irrespective of β-catenin expression. The stimulating effect of β-catenin on both Na+/K+ ATPase and SGLT1 activity was observed even in the presence of actinomycin D, an inhibitor of transcription. The experiments disclose a completely novel function of β-catenin, i.e. the regulation of transport. [ABSTRACT FROM AUTHOR]

Abstract: The measurement campaigns have been done in the rural community of Niška Banja, a spa town located in southern Serbia, to evaluate population exposure to natural radioactivity. After a screening survey in 200 houses, annual radon and thoron concentrations were measured in 34 houses, and in 2004 a detailed investigation was carried out at six houses with elevated indoor radon concentrations. The paper presents the results of these detailed measurements. The complementary techniques were applied to determine radon and thoron concentrations in indoor air, in soil gas, radon exhalation from soil, soil permeability, and indoor and outdoor gamma doses. Soil and water samples were collected and analysed in the laboratory. Indoor radon and thoron concentrations were found to be more than 1kBqm−3 and 200Bqm−3, respectively. Extremely high concentrations of soil-gas radon (>2000kBqm−3) and radon exhalation rates (1.5mBqm−2 s−1) were observed. These results will be utilised to set up the methodology for a more systematic investigation. [Copyright &y& Elsevier]

Background: Diabetes mellitus rates and associated costs continue to rise across Europe enhancing health authority focus on its management. The risk of complications is enhanced by poor glycaemic control, with long-acting insulin analogues developed to reduce hypoglycaemia and improve patient convenience. There are concerns though with their considerably higher costs, but moderated by reductions in complications and associated costs. Biosimilars can help further reduce costs. However, to date, price reductions for biosimilar insulin glargine appear limited. In addition, the originator company has switched promotional efforts to more concentrated patented formulations to reduce the impact of biosimilars. There are also concerns with different devices between the manufacturers. As a result, there is a need to assess current utilisation rates for insulins, especially long-acting insulin analogues and biosimilars, and the rationale for patterns seen, among multiple European countries to provide future direction. Methodology . Health authority databases are examined to assess utilisation and expenditure patterns for insulins, including biosimilar insulin glargine. Explanations for patterns seen were provided by senior-level personnel., Results: Typically increasing use of long-acting insulin analogues across Europe including both Western and Central and Eastern European countries reflects perceived patient benefits despite higher prices. However, activities by the originator company to switch patients to more concentrated insulin glargine coupled with lowering prices towards biosimilars have limited biosimilar uptake, with biosimilars not currently launched in a minority of European countries. A number of activities were identified to address this. Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups., Conclusions: There are concerns with the availability and use of insulin glargine biosimilars among European countries despite lower costs. This can be addressed., Competing Interests: The authors have no relevant conflicts of interest to declare. However, a number of the coauthors work for health authorities or are advisers to them., (Copyright © 2021 Brian Godman et al.)

Background: Community pharmacies deliver an essential healthcare service, which is broadly established, encompassing the favored and primary contact for community members. The COVID-19 pandemic is continuing to shift the pharmacy roles and services in order to meet the needs of customers. The important value of community pharmacies was more underlined during the pandemic crisis when they were supposed to undertake abundant precautions to avoid cross-infection among users of the space. Their responsibility is also to create a compatible, efficient, and safe environment inside their premises during this outbreak. The built environment is an important share of pandemic solutions and emergency planning preparations., Objectives: The aim of this paper was to explore the preparedness of community pharmacies in Kosovo for the COVID-19 outbreak in regards to pharmacy design modifications while ensuring adequate medicine management, information, and public health. Consequently, at what stage can the pandemic affect the physical and built environment of pharmacies., Methods: The methods for this study include a cross-sectional survey of 104 community pharmacies operating in seven municipalities in Kosovo during the pandemic. Data collection was conducted from October 1 to October 14, 2021, using self-administered online questionnaires. The questionnaire consisted of a combination of closed and open-ended questions, optional statements, and multiple answers. Data were analyzed in SPSS for Windows version 20 using descriptive statistics., Results: The results show that communities should be prepared ahead in regard to the emergency situations and some of these preparations might be also part of the legislation requirements. Although the pandemic exposed many errors in the Kosovo community pharmacy system, it has also discovered a unique possibility for collaboration and novelty., Conclusions: The study concludes with the recommendation for the architectural design of pharmacies to be positioned as an active mediator in the fight against the COVID 19, with a critical lesson aimed at the flexibility of the space to accommodate emergent situations and create alternative areas for use., (Copyright: © Pharmacy Practice.)

Introduction : There are growing concerns among European health authorities regarding increasing prices for new cancer medicines, prices not necessarily linked to health gain and the implications for the sustainability of their healthcare systems. Areas covered : Narrative discussion principally among payers and their advisers regarding potential approaches to the pricing of new cancer medicines. Expert opinion : A number of potential pricing approaches are discussed including minimum effectiveness levels for new cancer medicines, managed entry agreements, multicriteria decision analyses (MCDAs), differential/tiered pricing, fair pricing models, amortization models as well as de-linkage models. We are likely to see a growth in alternative pricing deliberations in view of ongoing challenges. These include the considerable number of new oncology medicines in development including new gene therapies, new oncology medicines being launched with uncertainty regarding their value, and continued high prices coupled with the extent of confidential discounts for reimbursement. However, balanced against the need for new cancer medicines. This will lead to greater scrutiny over the prices of patent oncology medicines as more standard medicines lose their patent, calls for greater transparency as well as new models including amortization models. We will be monitoring these developments.

Background: Diabetes mellitus rates continue to rise, which coupled with increasing costs of associated complications has appreciably increased global expenditure in recent years. The risk of complications are enhanced by poor glycaemic control including hypoglycaemia. Long-acting insulin analogues were developed to reduce hypoglycaemia and improve adherence. Their considerably higher costs though have impacted their funding and use. Biosimilars can help reduce medicine costs. However, their introduction has been affected by a number of factors. These include the originator company dropping its price as well as promoting patented higher strength 300 IU/ml insulin glargine. There can also be concerns with different devices between the manufacturers. Objective: To assess current utilisation rates for insulins, especially long-acting insulin analogues, and the rationale for patterns seen, across multiple countries to inform strategies to enhance future utilisation of long-acting insulin analogue biosimilars to benefit all key stakeholders. Our approach: Multiple approaches including assessing the utilisation, expenditure and prices of insulins, including biosimilar insulin glargine, across multiple continents and countries. Results: There was considerable variation in the use of long-acting insulin analogues as a percentage of all insulins prescribed and dispensed across countries and continents. This ranged from limited use of long-acting insulin analogues among African countries compared to routine funding and use across Europe in view of their perceived benefits. Increasing use was also seen among Asian countries including Bangladesh and India for similar reasons. However, concerns with costs and value limited their use across Africa, Brazil and Pakistan. There was though limited use of biosimilar insulin glargine 100 IU/ml compared with other recent biosimilars especially among European countries and Korea. This was principally driven by small price differences in reality between the originator and biosimilars coupled with increasing use of the patented 300 IU/ml formulation. A number of activities were identified to enhance future biosimilar use. These included only reimbursing biosimilar long-acting insulin analogues, introducing prescribing targets and increasing competition among manufacturers including stimulating local production. Conclusions: There are concerns with the availability and use of insulin glargine biosimilars despite lower costs. This can be addressed by multiple activities., Competing Interests: MW and JR work for HTA Consulting and MH works for Square Toiletries Limited. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Godman, Haque, Leong, Allocati, Kumar, Islam, Charan, Akter, Kurdi, Vassalo, Bakar, Rahim, Sultana, Deeba, Khan, Alam, Jahan, Kamal, Hasin, Munzur-E-Murshid, Nahar, Haque, Dutta, Abhayanand, Kaur, Rwegerera, Nascimento, Dias Godói, Irfan, Amu, Matowa, Acolatse, Incoom, Sefah, Acharya, Opanga, Njeri, Kimonge, Kwon, Bae, Khuan, Abubakar, Sani, Khan, Hussain, Saleem, Malande, Piloya-Were, Gambogi, Hernandez Ortiz, Alutuli, Kalungia, Hoxha, Marković-Peković, Tubic, Petrova, Tachkov, Laius, Harsanyi, Inotai, Jakupi, Henkuzens, Garuoliene, Gulbinovič, Wladysiuk, Rutkowski, Mardare, Fürst, McTaggart, MacBride-Stewart, Pontes, Zara, Tagoe, Banzi, Wale and Jakovljevic.)

Background: From October 2018, adalimumab biosimilars could enter the European market. However, in some countries, such as Netherlands, high discounts reported for the originator product may have influenced biosimilar entry. Objectives: The aim of this paper is to provide a European overview of (list) prices of originator adalimumab, before and after loss of exclusivity; to report changes in the reimbursement status of adalimumab products; and discuss relevant policy measures. Methods: Experts in European countries received a survey consisting of three parts: 1) general financing/co-payment of medicines, 2) reimbursement status and prices of originator adalimumab, and availability of biosimilars, and 3) policy measures related to the use of adalimumab. Results: In May 2019, adalimumab biosimilars were available in 24 of the 30 countries surveyed. Following introduction of adalimumab biosimilars, a number of countries have made changes in relation to the reimbursement status of adalimumab products. Originator adalimumab list prices varied between countries by a factor of 2.8 before and 4.1 after loss of exclusivity. Overall, list prices of originator adalimumab decreased after loss of exclusivity, although for 13 countries list prices were unchanged. When reported, discounts/rebates on originator adalimumab after loss of exclusivity ranged from 0% to approximately 26% (Romania), 60% (Poland), 80% (Denmark, Italy, Norway), and 80-90% (Netherlands), leading to actual prices per pen or syringe between €412 (Finland) and €50 - €99 (Netherlands). To leverage competition following entry of biosimilar adalimumab, only a few countries adopted measures specifically for adalimumab in addition to general policies regarding biosimilars. In some countries, a strategy was implemented even before loss of exclusivity (Denmark, Scotland), while others did not report specific measures. Conclusion: Even though originator adalimumab is the highest selling product in the world, few countries have implemented specific policies and practices for (biosimilar) adalimumab. Countries with biosimilars on the market seem to have competition lowering list or actual prices. Reported discounts varied widely between countries., Competing Interests: AGV is involved in consulting, advisory work and speaking engagements for a number of companies, a.o. AbbVie, Accord, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz. RP runs a consulting company and previously worked with, a.o., Abbvie, Biogen, Sandoz, Pfizer, MSD, Roche, GSK, Sanofi. IM is involved in consulting and advisory work and recently worked with I&S Hungary, Ewopharma, Genesis Pharma, GSK. RP was employed by HTA Consulting at the time of the study. TN was employed by ZEM Solutions at the time of the study. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Moorkens, Godman, Huys, Hoxha, Malaj, Keuerleber, Stockinger, Mörtenhuber, Dimitrova, Tachkov, Vončina, Palčevski, Achniotou, Slabý, Popelková, Kohoutová, Bartels, Laius, Martikainen, Selke, Kourafalos, Magnússon, Einarsdóttir, Adams, Joppi, Allocati, Jakupi, Viksna, Greičiūtė-Kuprijanov, Vella Bonanno, Suttorp, Melien, Plisko, Mardare, Meshkov, Novakovuc, Fürst, Zara, Marković-Peković, Grubiša, Befrits, Puckett and Vulto.)

Background: Tuberculosis (TB) remains a significant worldwide social and life-threatening epidemiological problem. Because this disease requires multiple drug treatment and prolonged therapy for several months, followed by a high probability of adverse effects (AEs), we assessed AE monitoring for anti-TB drugs in the Health Care System of Kosova., Methods: This survey was a cross-sectional analysis performed at the primary, secondary and tertiary health care levels in Kosova. We included 930 registered tuberculosis patients within three levels of this health system in our study. Furthermore, we interviewed 62 physicians and 71 nurses at TB health facilities. Data were collected from official TB registers and personal contact with patients for 12 months., Results: The representative age group was 19 to 29 years (30.49%), followed by a group of patients aged >60 years (23.23%). Among 930 patients treated with TB drugs, the total incidence of adverse AEs was 29.03%. Female TB patients had a higher rate of AEs than did male patients (33.56% vs 28.84%, respectively). The highest incidence of registered AEs was recorded in the gastrointestinal system (270, 80.83%), followed by the central nervous system (CNS, 7.50%) and was lower in other organ systems. The reporting of anti-TB drug effects by medical staff (TB medical doctor and TB medical nurse) at different levels of TB medical settings occurred among 62.90% of medical doctors and 81.69% of nurses. Only 53.23% of medical doctors and 46.48% of nurses completed pharmacovigilance training., Conclusion: The pharmacovigilance approach in Health System of Kosova is not comprehensible and not systematic. The relatively low incidence of AEs among TB patients is due under reporting of these by medical staff. The knowledge, attitudes, and adherence of medical staff reveal low awareness for pharmacovigilance activities, and this concern should be addressed to reinforce this important issue for the safe treatment of TB patients., (© 2020 John Wiley & Sons Ltd.)

Background An infectious disease caused by a novel coronavirus (later called COVID-19) reached pandemic levels in 2020 and community pharmacists were involved in responding to this pandemic, also in Kosovo. Objectives To explore the experiences of community pharmacists in relation to provision of community pharmacy services during COVID-19 pandemic. Setting Community pharmacists in Kosovo. Methods This was a cross-sectional study where data was collected via a self-administered online questionnaire, from 264 pharmacists actively practicing in Kosovo during the pandemic. The questionnaire consisted of a combination of closed and open-ended questions, optional statements and statements on a five-point Likert scale, derived at least in part from the Transtheoretical Model. One-way analysis of variance was used to analyze differences in responses to Likert-type items whereas categorical variables were analyzed using Chi square testing. Main outcome measures Community pharmacists' perceptions on COVID-19 related preventative measures. Results A response rate of 40.6% was achieved. Sufficient and adequate COVID-19-related preventative measures were being implemented by a majority of pharmacies (n = 232; 87.9%), and over two-thirds of respondents agreed/strongly agreed that their pharmacies were sufficiently prepared with protective equipment for their personnel. Implementation of preventative measures was associated with respondents' perception that pharmacists and the pharmacy profession were valued more by patients during the pandemic and to a lesser degree, by other health professionals. Most commonly stated pros dealt with employee and patient safety, while key cons dealt with increased costs and running out of the necessary protective equipment. Key barriers to pharmacy activities were price increases by wholesalers, and patients' panic and excessive buying, whereas drivers dealt with professional obligation to assist and opportunity to prove inseparable to other health professionals. The most popular means of accessing COVID-19 related information by pharmacists was via mobile devices and information from professional organizations was considered most useful by pharmacists. Conclusions Community pharmacies actively implemented various measures as precautions to mitigate the spread of COVID-19. Our findings highlight the value of continuous provision of information by professional organizations and use of mobile devices as key means to access information by pharmacists.

Background: Kosovo is a new state and has a high consumption of antibiotics in relation to other European countries. Existing quantitative studies have shown that practices exist that is not optimal when it comes to antibiotic use in Kosovo, this includes citizens' use of antibiotics, pharmacy practices of selling antibiotics without prescriptions and physicians' prescribing behaviours. To address these problems, there is a need for a deeper understanding of why antibiotics are handled in a suboptimal way., Objective: The objective was to explore antibiotic users', community pharmacists' and prescribers' attitudes towards, experiences of, and knowledge about antibiotics in Kosovo., Methods: Semi-structured interviews were conducted with patients who recently received an antibiotic prescription for an upper respiratory tract infection (URTI), patients who recently received antibiotics for a URTI without a prescription, community pharmacists, and physicians. Interviews were recorded, translated into English, and analysed using deductive content analysis., Results: In total, 16 interviews were conducted in the period from 2015-2016. Five themes were identified: Obtaining antibiotics, Choice of antibiotics, Patient information, Patients' knowledge and views on when to use antibiotics, and Professionals' knowledge and attitudes towards antimicrobial resistance. Antibiotics were sometimes obtained without a prescription, also by patients who currently had received one. The specific antibiotic could be chosen by a physician, a pharmacist or the patient him/herself. Former experience was one reason given by patients for their choice. Patients' knowledge on antibiotics was mixed, however health professionals were knowledgeable about e.g. antimicrobial resistance., Conclusions: There is currently a culture of antibiotic use in Kosovo, including attitudes and behaviours, and hence also experiences, which is possibly underlying the high consumption of antibiotics in the country. The culture is reproduced by patients, pharmacists and physicians. There is, however, an awareness of the current problematic situation among practitioners and policy makers; and as Kosovo is a new country, opportunities to effectively tackle antimicrobial resistance exist., Competing Interests: CONFLICT OF INTEREST The WHO was not involved in writing the manuscript; hence, we declare no conflict of interest., (Copyright: © Pharmacy Practice.)

Introduction: In January 2018 the European Commission published a Proposal for a Regulation on Health Technology Assessment (HTA): 'Proposal for a Regulation on health technology assessment and amending Directive 2011/24/EU'. A number of stakeholders, including some Member States, welcomed this initiative as it was considered to improve collaboration, reduce duplication and improve efficiency. There were however a number of concerns including its legal basis, the establishment of a single managing authority, the preservation of national jurisdiction over HTA decision-making and the voluntary/mandatory uptake of joint assessments by Member States. Areas covered: This paper presents the consolidated views and considerations on the original Proposal as set by the European Commission of a number of policy makers, payers, experts from pricing and reimbursement authorities and academics from across Europe. Expert commentary: The Proposal has since been extensively discussed at Council and while good progress has been achieved, there are still divergent positions. The European Parliament gave a number of recommendations for amendments. If the Proposal is approved, it is important that a balanced, improved outcome is achieved for all stakeholders. If not approved, the extensive contribution and progress attained should be sustained and preserved, and the best alternative solutions found.

Objectives: There are no reliable data on antibiotic use in Kosovo hospitals. The aim of this survey was to monitor volumes and patterns of antibiotic use in hospitalised patients in order to identify targets for quality improvement., Methods: Data on antimicrobial use were collected from seven hospitals in Kosovo during 2013 using the standardised point prevalence survey (PPS) methodology as developed by the ESAC (European Surveillance of Antimicrobial Consumption) and ARPEC (Antibiotic Resistance and Prescribing in European Children). The survey included all inpatients receiving an antimicrobial agent on the day of the PPS., Results: Overall, 1667 patients were included in the study: adults 1345 (81%) and children 322 (19%). Of the hospital inpatients, 579/1345 (43%) adults and 188/322 (58%) children received at least one antibiotic during a hospital stay. The top three antibacterial subgroups (ATC level 3) were β-lactam antibiotics, cephalosporins and aminoglycosides. In all hospital centres, the most commonly prescribed antibiotic was ceftriaxone (39% for adult and 36% for children). Antibiotics were administered mainly parenterally in 74% of adults and 94% of children. Empirical prescribing was higher in adults 498/579 (86%) and children 181/188 (96%), compared with targeted treatment based on susceptibility testing-81 (14%) and 8 (4%), respectively., Conclusions: Antibiotic use in Kosovo's hospitals is very high. Gathered data will be an important tool to identify targets for quality improvement and will support preparation of guidelines and protocols for the prudent use of antibiotics., Competing Interests: Competing interests: None declared.

Introduction: Surveillance of antimicrobial medicines consumption is central to improving their use and reducing resistance rates. There are few published data on antibiotic consumption in Eastern Europe and Central Asia. To address this, 18 non-European Union (EU) countries and territories contribute to the WHO Regional Office for Europe (WHO Europe) Antimicrobial Medicines Consumption (AMC) Network. Objectives: (i) Analyze 2015 consumption of J01 class antibacterials for systemic use from 16 AMC Network members; (ii) compare results with 2011 data and 2015 ESAC-Net estimates; (iii) assess consumption against suggested indicators; (iv) evaluate the impact of planned changes to defined daily doses (DDDs) in 2019 for some commonly used antibiotics; and (v) consider the utility of quantitative metrics of consumption for policy action. Methods: Analysis methods are similar to ESAC-Net for EU countries. The Anatomical Therapeutic Chemical (ATC) classification and DDD methodology were used to calculate total consumption (DDD/1000 inhabitants/day [DID]), relative use measures (percentages), extent of use of WHO Watch and Reserve group antibiotics and impact of DDD changes. Findings: Total J01 consumption in 2015 ranged 8.0-41.5 DID (mean 21.2 DID), generally lower than in 2011 (6.4-42.3 DID, mean 23.6 DID). Beta-lactam penicillins, cephalosporins, and quinolones represented 16.2-56.6, 9.4-28.8, and 7.5-24.6% of total J01 consumption, respectively. Third-generation cephalosporins comprised up to 90% of total cephalosporin consumption in some countries. Consumption of WHO Reserve antibiotics was very low; Watch antibiotics comprised 17.3-49.5% of total consumption (mean 30.9%). Variability was similar to 2015 ESAC-Net data (11.7-38.3 DID; mean 22.6 DID). DDD changes in 2019 impact both total and relative consumption estimates: total DIDs reduced on average by 12.0% (7.3-35.5 DID), mostly due to reduced total DDDs for commonly used penicillins; impact on rankings and relative use estimates were modest. Discussion: Quantitative metrics of antibiotic consumption have value. Improvements over time reflect national activities, however, changes in total volumes may conceal shifts to less desirable choices. Relative use measures targeting antibiotics of concern may be more informative. Some, including WHO Watch and Reserve classifications, lend themselves to prescribing targets supported by guidelines and treatment protocols.

Introduction: There is continued unmet medical need for new medicines across countries especially for cancer, immunological diseases, and orphan diseases. However, there are growing challenges with funding new medicines at ever increasing prices along with funding increased medicine volumes with the growth in both infectious diseases and non-communicable diseases across countries. This has resulted in the development of new models to better manage the entry of new medicines, new financial models being postulated to finance new medicines as well as strategies to improve prescribing efficiency. However, more needs to be done. Consequently, the primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective. Methods: A narrative review of pharmaceutical policies and implications, as well as possible developments, based on key publications and initiatives known to the co-authors principally from a health authority perspective. Results: A number of initiatives and approaches have been identified including new models to better manage the entry of new medicines based on three pillars (pre-, peri-, and post-launch activities). Within this, we see the growing role of horizon scanning activities starting up to 36 months before launch, managed entry agreements and post launch follow-up. It is also likely there will be greater scrutiny over the effectiveness and value of new cancer medicines given ever increasing prices. This could include establishing minimum effectiveness targets for premium pricing along with re-evaluating prices as more medicines for cancer lose their patent. There will also be a greater involvement of patients especially with orphan diseases. New initiatives could include a greater role of multicriteria decision analysis, as well as looking at the potential for de-linking research and development from commercial activities to enhance affordability. Conclusion: There are a number of ongoing activities across countries to try and fund new valued medicines whilst attaining or maintaining universal healthcare. Such activities will grow with increasing resource pressures and continued unmet need.

Background and Objective: The Ministry of Health (MoH) leads and organizes health policy in Kosovo, which includes procurement and provision of medicines, including anti-cancer medicines, which compose a special group of medicines. However, there has been limited analysis of the utilization and expenditure on anti-cancer medicines in Kosovo; consequently, the objective of this study is to undertake research to provide future guidance on the use of anti-cancer medicines., Method: National drug utilization data is available in Kosovo. Utilization and expenditure on anti-cancer medicines [Anatomical Therapeutic Chemical (ATC) code L], initially from 2011 to 2013, especially for anti-cancer medicines on the essential medicines list was analysed from national data. In addition, current systems for procuring and managing anti-cancer medicines in Kosovo was documented., Results: There was appreciable variability in the utilization of anti-cancer medicines over the years, with low or limited use of some anti-cancer medicines on the Essential Medicine List. This is a concern in view of their essential medicine status. From 2011 to 2013, €16.49 million was spent on anti-cancer medicines (ATC L). The process of selection of new medicines begins with suggestions from doctors at the University Clinical Centre in Kosovo., Conclusion: The analysis has shown appreciable variation with current utilization patterns for anti-cancer medicines in Kosovo. This needs to be addressed as part of improving the drug management process to optimize patient care within available resources. Future years and reforms need to be assessed to improve current utilization and expenditure patterns.

Drug shortages have been identified as a public health problem in an increasing number of countries. This can negatively impact on the quality and efficiency of patient care, as well as contribute to increases in the cost of treatment and the workload of health care providers. Shortages also raise ethical and political issues. The scientific evidence on drug shortages is still scarce, but many lessons can be drawn from cross-country analyses. The objective of this study was to characterize, compare, and evaluate the current systemic measures and legislative and organizational frameworks aimed at preventing or mitigating drug shortages within health care systems across a range of European and Western Asian countries. The study design was retrospective, cross-sectional, descriptive, and observational. Information was gathered through a survey distributed among senior personnel from ministries of health, state medicines agencies, local health authorities, other health or pharmaceutical pricing and reimbursement authorities, health insurance companies and academic institutions, with knowledge of the pharmaceutical markets in the 28 countries studied. Our study found that formal definitions of drug shortages currently exist in only a few countries. The characteristics of drug shortages, including their assortment, duration, frequency, and dynamics, were found to be variable and sometimes difficult to assess. Numerous information hubs were identified. Providing public access to information on drug shortages to the maximum possible extent is a prerequisite for performing more advanced studies on the problem and identifying solutions. Imposing public service obligations, providing the formal possibility to prescribe unlicensed medicines, and temporary bans on parallel exports are widespread measures. A positive finding of our study was the identification of numerous bottom-up initiatives and organizational frameworks aimed at preventing or mitigating drug shortages. The experiences and lessons drawn from these initiatives should be carefully evaluated, monitored, and presented to a wider international audience for careful appraisal. To be able to find solutions to the problem of drug shortages, there is an urgent need to develop a set of agreed definitions for drug shortages, as well as methodologies for their evaluation and monitoring. This is being progressed.

Setting: The poor patient adherence in tuberculosis (TB) treatment is considered to be one of the most serious challenges which reflect the decrease of treatment success and emerging of the Multidrug Resistance-TB (MDR-TB). To our knowledge, the data about patients' adherence to anti-TB treatment in our country are missing., Objective: This study was aimed to investigate the anti-TB treatment adherence rate and to identify factors related to eventual nonadherence among Kosovo TB patients., Design: This study was conducted during 12 months, and the survey was a descriptive study using the standardized questionnaires with total 324 patients., Results: The overall nonadherence for TB patient cohort was 14.5%, 95% CI (0.109-0.188). Age and place of residence are shown to have an effect on treatment adherence. Moreover, the knowledge of the treatment prognosis, daily dosage, side effects, and length of treatment also play a role. This was also reflected in knowledge regarding compliance with regular administration of TB drugs, satisfaction with the treatment, interruption of TB therapy, and the professional monitoring in the administration of TB drugs., Conclusion: The level of nonadherence TB treatment in Kosovar patients is not satisfying, and more health care worker's commitments need to be addressed for improvement.

We reconstructed the flora of a European region at a historical point in time from historical topographical maps that contain rather precise information about the condition and composition of habitats. The ecological information obtained from these maps can be enriched through the potential of broadly diversified archival information. This study is confined to grassland communities. Considerations in terms of phytosociology make historical lists of plant species a good starting point for the reconstruction of grassland communities. The combination of historical and scientific methods proves suitable for reconstructing specific historical environmental conditions. Taking into account the frequency of relevant historical sources in European archives as well as in archives abroad, this approach claims for far-reaching application to ecosystem restoration matters, especially if ecological information from natural sources is missing.