Introduction: There are concerns with rising rates of antimicrobial resistance (AMR) across countries with appreciable impact on morbidity, mortality and costs. Amongst low- and middle-income countries, a key driver of AMR is the excessive use of antibiotics in ambulatory care, with a critical area being the appreciable selling of antibiotics without a prescription often driven by patient demand and limited knowledge. There is currently conflicting evidence in South Africa regarding this practice. Consequently, there is a need to explore these critical issues amongst patients, especially in more rural areas of South Africa. A pilot study was undertaken to address this. Methods: A two-step descriptive approach was undertaken. This involved two questionnaires amongst patients exiting chain and independent community pharmacies followed by cognitive interviews. Results: Overall, 21 patients were approached for an interview, including 11 for Part 1 of the questionnaire with 3 declining, and 10 for Part 2, with 2 declining. Subsequently 8 patients completed each part of the questionnaire.. On average, it took 2 min 13 s to complete both parts. 3 of the 5 patients being dispensed an antibiotic were dispensed one without a prescription, with all 3 patients exiting from independent pharmacies. Key reasons for self-purchasing included money and convenience. There was mixed knowledge regarding antibiotics and AMR amongst the 8 patients interviewed with Part 2. Overall, there was a satisfactory understanding of the Part 1 questions, although some modifications were suggested. Some participants had difficulty with fully understanding the questions in Part 2, with a number of suggestions made to improve this for the main study. Conclusion: There were concerns with the extent of purchasing antibiotics without a prescription in this pilot study as well as the knowledge of patients regarding antibiotics and AMR. Both areas need addressing and will be explored further in the main study.

Introduction: There is considerable concern with rising rates of antimicrobial resistance (AMR) with its subsequent impact on morbidity, mortality and costs. In low- and middle-income countries, a key driver of AMR is the appreciable misuse of antibiotics in ambulatory care, which can account for up to 95% of human utilisation. A principal area is the selling of antibiotics without a prescription. There is conflicting evidence in South Africa regarding this practice alongside rising AMR rates. Consequently, there is a need to explore this further, especially in more rural areas of South Africa. A pilot study was undertaken to address this. Materials and Methods: A two-step descriptive approach involving a self-administered questionnaire amongst pharmacists and their assistants followed by cognitive interviews with some of the participants. Results: Twenty-one responses were obtained from nine of the 11 community pharmacies invited to participate. Participating pharmacies were all independently owned. Ten of the 21 participants admitted dispensing antibiotics without a prescription, including both adults and children, representing five of the nine participating pharmacies. A minority dispensed antibiotics before recommending suitable over-the-counter medicines. These high rates were exacerbated by patient pressure. There were issues with the length of the questionnaire and some of the phraseology, which will be addressed in the main study. Conclusion: There were concerns with the extent of purchasing antibiotics without a prescription in this pilot in South Africa study. Key issues will be explored further in the main study.

ABSTRACT Introduction Antimicrobial resistance (AMR) is a global concern. Currently, the greatest mortality due to AMR is in Africa. A key driver continues to be high levels of dispensing of antibiotics without a prescription. Areas covered A need to document current rates of dispensing, their rationale and potential ways forward including antimicrobial stewardship programmes (ASPs). A narrative review was undertaken. The highest rates of antibiotic purchasing were in Eritrea (up to 89.2% of antibiotics dispensed), Ethiopia (up to 87.9%), Nigeria (up to 86.5%), Tanzania (up to 92.3%) and Zambia (up to 100% of pharmacies dispensing antibiotics without a prescription). However, considerable variation was seen with no dispensing in a minority of countries and situations. Key drivers of self-purchasing included high co-payment levels for physician consultations and antibiotic costs, travel costs, convenience of pharmacies, patient requests, limited knowledge of antibiotics and AMR and weak enforcement. ASPs have been introduced in some African countries along with quality targets to reduce inappropriate dispensing, centering on educating pharmacists and patients. Expert Opinion ASP activities need accelerating among community pharmacies alongside quality targets, with greater monitoring of pharmacists’ activities to reduce inappropriate dispensing. Such activities, alongside educating patients and healthcare professionals, should enhance appropriate dispensing of antibiotics and reduce AMR.

Background In last two decades, there have been substantial changes in the pattern of lipid-modifying medicines utilisation following the new treatment guidelines based on clinical trials. The main purpose of this study was to analyse the overall utilisation and expenditure of lipid-modifying medicines in the Republic of Srpska, Bosnia and Herzegovina during an 11-year follow-up period and to express its share in relation to the total cardiovascular medicines (C group) utilisation. Methods In this retrospective, observational study, medicines utilisation data were analysed between 2010 and 2020 period using the ATC/DDD methodology and expressed as the number of DDD/1000 inhabitants/day (DDD/TID). The medicines expenditure analysis was used to estimate the annual expenditure of medicines in Euro based on DDD. Results During the analysed period, the use of lipid-modifying medicines increased almost 3-times (12.82 DDD/TID in 2010 vs 34.32 DDD/TID in 2020), with a rise in expenditure from 1.24 million Euro to 2.15 million Euro in the same period. This was mainly driven by an increased use of statins with 163.07%, and among these, rosuvastatin increased more than 1500-fold, and atorvastatin with 106.95% increase. With the appearance of generics, simvastatin showed a constant decline, while the other lipid-modifying medicines in relation to the total utilisation had a neglecting increase. Conclusion The use of lipid-modifying medicines in the Republic of Srpska has constantly increased and strongly corresponded to the adopted treatment guidelines and the positive medicines list of health insurance fund. The results and trends are comparable with other countries, but still the utilisation of lipid-lowering medicines represents the smallest share of total medicines use for the treatment of cardiovascular diseases, compared to high-income countries.

[This corrects the article DOI: 10.1155/2021/9996193.].

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 collaboration to improve data collection and inform decision-making. Methods: A mixed methods approach was undertaken through a cross-sectional questionnaire followed-up by a focus group discussion. Participants were selected by purposive sampling to represent stakeholders across different European countries and healthcare settings. Descriptive statistics were used to analyze quantifiable questions, whilst content analysis was employed for open-ended questions. Results: 25 respondents across 18 European countries provided their insights on the types of datasets collecting oncology data, including hospital records, cancer, prescription and medicine registers. The most available is expenditure data whilst data concerning effectiveness, safety and outcomes is less available, and there are concerns with data validity. A major constraint to data collection is the lack of comprehensive registries and limited data on effectiveness, safety and outcomes of new medicines. Data ownership limits data accessibility as well as possibilities for linkage, and data collection is time-consuming, necessitating dedicated staff and better systems to facilitate the process. Cross-national collaboration is challenging but the engagement of multiple stakeholders is a key step to reach common goals through research. Conclusion: This study acts as a starting point for future research on patient-level databases for oncology across Europe. Future recommendations will require continued engagement in research, building on current initiatives and involving multiple stakeholders to establish guidelines and commitments for transparency and data sharing.

Background: In last 2 decades, there have been substantial changes in the utilization patterns of antihypertensive medicines following new clinical trials and the introduction of new treatment guidelines. The aim of this study was to analyze utilization and prescribing patterns regarding antihypertensive medicines in the Republic of Srpska, Bosnia and Herzegovina during an 11-years follow-up according to national and European treatment guidelines. Methods: In this retrospective, observational study, medicine utilization data were analyzed between 2009–2019 period using the ATC/DDD methodology and expressed as the number of DDD/1,000 inhabitants/day (DID/TID). The medicine utilization 90% (DU90%) method was used for determine the quality of prescribing. Results: During the observed period, the use of antihypertensive medicines increased more than 3-times (125.97 DDD/TID in 2009 vs 414.95 DDD/TID in 2019), corresponding to a rise in the prevalence of hypertensive patients from 91.7/1,000 to 186.3/1,000 in the same period. This was mainly driven by increased use of angiotensin converting enzyme inhibitors with 241.69%, beta blockers with 146.87%, calcium channel blockers with 251.55%, and diuretics with 178.95%. Angiotensin receptor blockers were the fastest growing group of antihypertensive medicines in this period and their utilization increased nearly 40 times. Conclusions: The overall antihypertensive medicines utilization was largely influenced by national and ESH/ESC guidelines and strongly corresponded to the positive medicine list of the national health insurance fund. Antihypertensive medicines utilization is comparable with medicine utilization trends in other countries.

Background / Aim: Up until ten years ago stage four melanoma was considered a disease with extremely poor prognosis. Standard therapy during this period of time was dacarbazine chemotherapy. Patients with better performance status were treated with immunotherapy cytokine IL-2. In the last ten years eight medications have been approved by the FDA for the therapy of melanoma. The goal of this study was to determine objective response rate (ORR), median overall survival (OS), median progression free survival (PFS) and safety in patients with advanced and metastatic cutaneous melanoma treated with targeted therapy and immunotherapy at the University Clinical Centre of the Republic of Srpska (Centre). Methods: A non-randomised observational retrospective/prospective trial was conducted to investigate first experiences with the use of targeted therapy and immunotherapy at the Centre and compare the results with the literature data. A total of 23 patients received BRAF targeted therapy for the treatment of metastatic cutaneous melanoma in the first line of treatment. Nine patients received vemurafenib, fourteen patients received a combination of BRAF/MEK inhibitor. Nine patients were treated with pembrolizumab immunotherapy. The trial was performed in a period from May 2017 until December 2020. Results: In patients receiving vemurafenib ORR was 44.4 %, median PFS was 5 months (95 % CI, 1 to 11) and the median OS was 9 months (95 % CI, 2 to 17). In the vemurafenib/cobimetinib group ORR was 71.4 %. Median PFS was 9 months and median OS was 12 months. ORR in patients receiving pembrolizumab was 22.9 %, median PFS was 3 months (95 % CI, 1 to 11) and the median OS was 4.5 months (95 % CI, 2 to 12). Results in all three groups were inferior compared to the results from the literature except for ORR in patients receiving vemurafenib and vemurafenib/cobimetinib. Adverse events were tolerable and manageable and were similar to those described in the literature. Conclusion: Based on the experience with the targeted and immunotherapy in the Centre, which was presented in this study, it was concluded that in conditions when there is limited access to drugs, the greatest benefit have the patients who meet the inclusion criteria in clinical trials.

Background/Aim: With the adoption of legislation over the Austro-Hungarian rule (1878-1918) apothecary in Bosnia and Herzegovina (B&H) became a regulated profession, which enabled the arrival of graduated pharmacists. The aim of the paper was to present in which towns on the B&H territory public pharmacies were opened over this period and their owners. Methods: A retrospective and descriptive research was conducted at the Archives of the Republic of Srpska, the Museum of the Republic of Srpska and the Archives of Bosnia and Herzegovina. The method of the qualitative secondary data analysis was applied. Results: With the arrival of Masters of Pharmacy from all parts of the Austro-Hungary, an increasing number of public pharmacies began to open. Concessions for the opening pharmacies were initially granted to foreigners and among the settlers, pharmacists there were mostly Czechs, Croats, Poles, Hungarians, Slovaks, who completed pharmacy studies at universities in Vienna, Zagreb, Prague, Lviv, Graz, Innsbruck, Krakow. In the beginning, there were no locally educated pharmacists and the first appeared at the end of the 19th and the beginning of the 20th century. During this period at least one pharmacy was opened in many towns, two worked in Banja Luka, Mostar, Tuzla and Bijeljina and seven in Sarajevo. In the first years, each pharmacy was staffed by only one pharmacist and over time there were more pharmacy staff in the pharmacies. Twenty years after the occupation, public pharmacies owned by Masters of Pharmacy were opened in thirty three towns around B&H and in 1918 there were forty eight public pharmacies in thirty eight towns. Conclusion: The number of public pharmacies and qualified pharmacy staff in B&H increased over the Austro-Hungarian rule from 1878 to 1918, which contributed to the improvement of the profession, health and social conditions in the country during this period.

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.

Introduction and Objectives: There have been concerns with the level of misinformation regarding coronavirus disease 2019 (COVID-19) and its treatment, drug shortages, as well as increased use and prices of anti-malarials, antibiotics and hygiene products during the recent pandemic. Community pharmacists can play a significant role in disease prevention and treatment in the fight against COVID-19 including providing hygiene information and medicine availability across Africa and generally. Consequently, there is a need to review the role of community pharmacists in preventing unintended consequences during any pandemic as well as the impact of COVID-19 on the demand, availability and prices of suggested medicines for its management. Materials and Methods: Multiple approaches involving a qualitative review of the management of COVID-19 across countries coupled with a pilot study in Ghana among six purposely selected community pharmacists during the early stages of the pandemic assessing patterns of demand, availability and prices of medicines suggested for the management of COVID-19. Alongside this, pharmacists' future role enhancing appropriate medicine use in Ghana and wider combined with the help of senior level co-authors. Results: The majority (five out of six) of pharmacists in Ghana reported increased demand for hydroxychloroquine, antibiotics and vitamins as immune boosters resulting in shortages with price increases particularly for anti-malarials. Conclusion: The global lockdown had impacted on the supply and prices of medicines in Ghana similar to other countries. Community pharmacists can play a key role with encouraging safe medicine use, reducing self-purchasing of medicines and planning workflows during future pandemics including vaccinations. They can also help address potential misinformation and its consequences as well as the unintended consequences of pandemics including better management of non-communicable diseases.

Aim To present the regulations governing the operation of pharmacies in Bosnia and Herzegovina over the Austro-Hungarian rule (1878-1918). Methods Qualitative secondary data analysis was used. Results The Austro-Hungarian government had found poor population's health, insufficient health facilities and qualified staff. For a long time, population was treated by old methods of medicine and pharmacy, and directed to folk doctors, healers and herbalists. As early as 1879, orders requesting mandatory possession of a university diploma to practice pharmacy and medicine, thus taking the initial steps to combat quackery. The production and dispensing of medicines became the exclusive competence of pharmacists. The Law on Pharmacies adopted in 1907 comprehensively regulated the apothecary activity. Pharmacy Gremium was founded, the first association of pharmacists with the task of protecting professional interests. All types of quackery were explicitly forbidden to pharmacy staff. Apothecary activity was regulated as a craft, not as a health activity. During this period, pharmacy became a regulated profession with educated and qualified personnel. The number of public pharmacies and qualified staff was growing. In 1878 only one graduated pharmacist was found, while in 1910 in 47 pharmacies there were 79 pharmacy staff. At the end of 1918, the masters of pharmacy were the owners of 48 pharmacies, in 38 cities. Conclusion All enacted regulations contributed to the development and improvement of the apothecary activity over the observed period, and laid the foundations for the future development of the profession.

Aim: Global expenditure on medicines is rising up to 6% per year driven by increasing prevalence of non-communicable diseases (NCDs) and new premium priced medicines for cancer, orphan diseases and other complex areas. This is difficult to sustain without reforms. Methods: Extensive narrative review of published papers and contextualizing the findings to provide future guidance. Results: New models are being introduced to improve the managed entry of new medicines including managed entry agreements, fair pricing approaches and monitoring prescribing against agreed guidance. Multiple measures have also successfully been introduced to improve the prescribing of established medicines. This includes encouraging greater prescribing of generics and biosimilars versus originators and patented medicines in a class to conserve resources without compromising care. In addition, reducing inappropriate antibiotic utilization. Typically, multiple measures are the most effective. Conclusion: Multiple measures will be needed to attain and retain universal healthcare.

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.