11-Year Trend in Antibiotic Consumption in a South-Eastern European Country; the Situation in Albania and the Implications for the Future.

There are growing concerns with rising antimicrobial resistance (AMR) across countries. These concerns are enhanced by the increasing and inappropriate utilization of 'Watch' antibiotics with their greater resistance potential, AMR is further exacerbated by the increasing use of antibiotics to treat patients with COVID-19 despite little evidence of bacterial infections. Currently, little is known about antibiotic utilization patterns in Albania in recent years, including the pandemic years, the influence of an ageing population, as well as increasing GDP and greater healthcare governance. Consequently, total utilization patterns in the country were tracked from 2011 to 2021 alongside key indicators. Key indicators included total utilization as well as changes in the use of 'Watch' antibiotics. Antibiotic consumption fell from 27.4 DIDs (defined daily doses per 1000 inhabitants per day) in 2011 to 18.8 DIDs in 2019, which was assisted by an ageing population and improved infrastructures. However, there was an appreciable increase in the use of 'Watch' antibiotics during the study period. Their utilization rose from 10% of the total utilization among the top 10 most utilized antibiotics (DID basis) in 2011 to 70% by 2019. Antibiotic utilization subsequently rose after the pandemic to 25.1 DIDs in 2021, reversing previous downward trends. Alongside this, there was increasing use of 'Watch' antibiotics, which accounted for 82% (DID basis) of the top 10 antibiotics in 2021. In conclusion, educational activities and antimicrobial stewardship programs are urgently needed in Albania to reduce inappropriate utilization, including 'Watch' antibiotics, and hence AMR.

Potential approaches for the pricing of cancer medicines across Europe to enhance the sustainability of healthcare systems and the implications.

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.

The Expiry of Humira® Market Exclusivity and the Entry of Adalimumab Biosimilars in Europe: An Overview of Pricing and National Policy Measures.

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.

Are pharmacists' good knowledge and awareness on antibiotics taken for granted? The situation in Albania and future implications across countries.

OBJECTIVES: Irrational use of antibiotics is a major driver of antimicrobial resistance (AMR), exacerbated by dispensing of antibiotics without a prescription especially for typically viral infections. Such dispensing is common despite legislation. Pharmacists play a key role in advising on medicines, especially in countries where most patients seek pharmacist help as they cannot afford both physician fees and medicines. Consequently, our objective was to ascertain pharmacists' skills and knowledge regarding antibiotics when patients present to them with typically viral infections. METHODS: This was a qualitative cross-sectional survey among 370 community pharmacists in Albania, with carefully selected and validated topics. The main outcome measure was knowledge of antibiotics and current legislation. RESULTS: Variable knowledge regarding antibiotics among community pharmacists. 55% knew colds are caused by viruses and 93% that antibiotics are ineffective against influenza. However, 18% believed if colds last >4 days an antibiotic can bring a patient back to work, and only 13% stated antibiotics are ineffective against viruses. Encouragingly, 93% knew penicillins can cause anaphylactic shock, 74% that antibiotics kill bacteria causing infections, and only 7% that antibiotic misuse cannot cause AMR. However, 13% stated the main disadvantage of antibiotics is that they are ineffective against viruses and 93% admitted they had no treatment protocols to consult in their daily work to direct patient care. CONCLUSION: Encouraging signs regarding pharmacists' knowledge of antibiotics in Albania; however, concerns. Instigating educational programmes among patients and pharmacists and greater enforcement of legislation should reduce AMR rates in Albania and across countries.

Antibiotic knowledge, attitudes and behaviours of Albanian health care professionals and patients - a qualitative interview study.

BACKGROUND: The inappropriate use of antimicrobials is a problem worldwide. To target future interventions, a thorough understanding of the reasons behind this current behaviour is needed. Within the EU, the culture of antimicrobial use has been intensely studied, but this is not the case in non-EU southeastern European countries, despite the frequent use of (broad-spectrum) antibiotics (ABs) in this region. The aim of this study was to explore AB knowledge, attitudes and behaviours of health care professionals (HCPs) and patients in one southeastern European country, Albania. METHODS: In total, 16 semi-structured interviews were carried out with four groups of interviewees: physicians, community pharmacists, and patients with and without AB prescriptions. Interviews were used to investigate participants' recent practices with four specific antibiotics for upper respiratory tract infections, along with their typical behaviours, knowledge and attitudes towards the use of antimicrobials. A directed content analysis was applied. RESULTS: The patients showed little awareness of the differences between viruses and bacteria; however, they often self-diagnosed, which led them to request ABs from pharmacies without a prescription. Pharmacists felt pressured to give in to patients' demands. All of the participants (including HCP) showed suboptimal beliefs about illness severity as they all believed that 'flu complications', i.e. flu/cold symptoms that persisted after 2-3 days, should be treated with ABs. Physicians usually had no rapid tests to guide them in their practice; however, they were not concerned about this fact. HCPs acknowledged AMR, but only a few of them seemed to consider its risk in their daily practice. CONCLUSIONS: Patients had high levels of trust in and desire for ABs, and HCPs did not often negotiate with patients' demands. Suggested initiatives to improve the prudent use of ABs in Albania include higher reimbursement for prescribed antibiotics (to reduce illegal sales), academic detailing as well as implementing public awareness campaigns.

Systemic Measures and Legislative and Organizational Frameworks Aimed at Preventing or Mitigating Drug Shortages in 28 European and Western Asian Countries.

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.

Experiences from a pilot study on how to conduct a qualitative multi-country research project regarding use of antibiotics in Southeast Europe.

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.

Antibiotic use in Albania between 2011 and 2012.

INTRODUCTION: Health institutions in Albania have recently reported an increase in antibiotic misuse and microbial resistance. Until now, there have been no comprehensive studies that analyzed the overall use of antibiotics in Albania. The aim of this study was to analyze the overall antibiotic use in Albania between 2011 and 2012, using standardized methodology of measurement, based on World Health Organization guidelines. METHODOLOGY: Data from 2011 and 2012 on antibiotic use from ambulatory and hospital sector were examined. Antibiotics were divided based on anatomic therapeutic chemical classification. Defined daily dose (DDD) for each drug was assigned, and DDD per 1,000 inhabitants per day (DID) was used as a measurement unit. In cases of antibiotic combinations for which DDD were not available, unit doses were assigned. RESULTS: In 2011-2012, total antibiotic use decreased from 24.25 to 20.66 DID. Penicillin's were the most used antibiotic class, with 10.62 DID (2011) and 10.51 DID (2012). Tetracycline use decreased from 5.45 DID (2011) to 0.98 DID (2012). Macrolides increased from 1.36 to 1.88 DID, quinolones from 1.72 to 2.51 DID. The overall antibiotic use was significantly higher than the reimbursed antibiotic use ­ 3.17 DID (2011) and 2.79 DID (2012) ­ based on the official data for the same period. CONCLUSIONS: This study enables policymakers to further analyze the quality of antibiotic prescriptions and draw comparisons to other countries. The analyzed data suggest there are different factors influencing out-of-pocket use of antibiotics and wrongly prescribed antibiotics. Further studies are necessary to evaluate these factors.