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

Variation in the prices of oncology medicines across Europe and the implications for the future

Introduction/ Objectives: There are increasing concerns among health authorities regarding the sustainability of healthcare systems with growing expenditure on medicines including new high-priced oncology medicines. Medicine prices among European countries may be adversely affected by their population size and economic power to negotiate. There are also concerns that prices of patented medicines do not change once the prices of medicines used for negotiations substantially change. This needs to be investigated as part of the implications of low-cost generic oncology medicines. Methodology: Analysing principally reimbursed prices of patented oral oncology medicines (imatinib, erlotinib and fludarabine) between 2013 and 2017 across Europe and exploring correlations between GDP, population size, and prices. Comparing the findings with previous research regarding prices of oral generic oncology medicines. Results: The prices of imatinib, erlotinib and fludarabine did vary among European countries but showed limited price erosion over time in the absence of generics. There appeared to be no correlation between population size and prices. However, higher prices were seen among countries with higher GDP per capita which is a concern for lower income countries referencing these. Discussion and Conclusion: It is likely that the limited price erosion for patented oncology medicines will change across Europe with increased scrutiny over their prices and value as more medicines used for pricing decisions lose their patents combined with growing pressures on the oncology drug budget. In addition, discussions will continue regarding fair pricing for new oncology medicines and other approaches given ever rising prices with research showing substantial price reductions for oral oncology medicines (up to -97.8% for imatinib) once generics become available. We are also seeing appreciable price reductions for biosimilars further increasing the likelihood of these developments

SURVEY ON HOW ANTIBIOTICS ARE DISPENSED IN COMMUNITY PHARMACIES IN ALBANIA

Objective: To evaluate pharmacists' tendency to dispense antibiotics without prescription.Methods: A random survey was conducted for this study. Statistical analyses were made with Open Epi. Research group personnel were instructed to ask the question "I need to get a package of amoxicillin", when posing as simulated patients in pharmacies. The main outcome of the study was considered percentages of approval of this request.Results: Out of 450 pharmacies visited in this survey. In 259 pharmacies tested the request for dispensing antibiotic without production was approved (80% of tested pharmacies, Confidence Levels 75.57%-84.26%). Generally some questions (like age or possible allergies) were asked from pharmacists before approving the request of dispensing the antibiotic without prescription. The results of the survey suggest that dispensing of antibiotics without prescription is very common in Albania. The research group personnel were generally asked for further information before approving the request.Conclusion: Different actions should be taken in the country to enhance compliance with regulation and protocols regarding dispensing antibiotics. These actions can be focused on regulatory enforcement and also in enhancement of awareness on antibiotic misuse and microbial resistance through public campaigns or targeted messages to professionals. Â

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

Abstract 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

11-year trend in antibiotic consumption in a South-Eastern Europe European country; the situation in Albania and the implications for the future

There are growing concerns with rising antimicrobial resistance (AMR) across countries enhanced by increasing and inappropriate utilization of ‘Watch’ antibiotics. These concerns have been exacerbated by increasing use of antibiotics to treat patients with COVID-19 despite little evidence of bacterial infections. To date, little is known about antibiotic utilization patterns in Albania in recent years, including the pandemic years, with 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. Overall, antibiotic consumption fell from 27.4 DIDs in 2011 to 18.8 DIDs in 2019, assisted by an ageing population and improved infrastructures. However, there was an appreciable increase in the use of ‘Watch’ antibiotics. Their utilization rose from 10% of top 10 antibiotic utilization (DID basis) in 2011 to 70% by 2019. Antibiotic utilization subsequently rose after the pandemic to 25.1DIDs in 2021, reversing previous trends. Alongside this, there was increasing use of ‘Watch’ antibiotics, accounting for 82% (DID basis) of the top 10 antibiotics in 2021. Educational activities and antimicrobial stewardship programs are urgently needed in Albania to reduce inappropriate utilization including ‘Watch’ antibiotics and hence AMR. 33 This could be part of National Action Plans

Additional file 1: of Antibiotic knowledge, attitudes and behaviours of Albanian health care professionals and patients – a qualitative interview study

Interview-guides. (DOCX 31 kb

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 advising on medicines especially in countries where most patients seek pharmacist help as they cannot afford both physician fees and medicines. Consequently, the objective was to ascertain skills and knowledge of pharmacists regarding antibiotics when patients present to them with typically viral infections. Methods: Qualitative cross-sectional survey among 370 community pharmacists in Albania. Topics carefully selected and validated. Main outcome measure was current knowledge of antibiotics and current legislation. Results: Variable knowledge regarding antibiotics among community pharmacists. 54% knew colds are caused by viruses and 93% that antibiotics are ineffective against influenza. However, 18% believed if colds last for more than 4 days an antibiotic can bring a patient back to work, and only 13% stated antibiotics are ineffective against viruses. Encouragingly, 92.5% knew penicillins can cause anaphylactic shocks, 74% that antibiotics kill bacteria that cause infections and only 7% that antibiotic misuse cannot cause AMR. However, 13% stated the main disadvantage of antibiotics is 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

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

Effectiveness of 7-valent pneumococcal conjugate vaccine: A meta-analysis of post-marketing studies

AIM: To investigate the 7-valent pneumococcalconjugate vaccine (PCV7) effectiveness. METHODS: A systematic literature review of studies which evaluated the effectiveness of PCV7 vaccine was performed searching the keyword \u201cheptavalent pneumococcal conjugate vaccine\u201d in PubMed and Scopus until March 16, 2013. The selection of potential eligible articles was done by two researchers independently on the basis of abstract and title and only post-marketing studies were included in the systematic review. Data extraction was carried out by two researchers with respect to invasive pneumococcal diseases due to both all and vaccine serotypes in pre-vaccine and postvaccine periods in children less than 5 years. Results of studies which were considered suitable for meta-analysis were combined by means of relative risk (RR) with 95%CI. Vaccine effectiveness was calculated as (1-RR) 7 100. Heterogeneity was assessed by I 2 and a random effects model was used to combine data in the case of heterogeneity. RevMan 5 was used to pool data. RESULTS: On the whole, 757 eligible papers were identified from the literature search in PubMed and Scopus. Of them, 62 were finally considered in the systematic review and 38 were included in the meta-analysis. In all post-marketing studies included in the systematic review the incidence of invasive pneumococcal diseases due to vaccine serotypes declined significantly with the exception of few studies showing stability or a slight, but not significant, increase. Furthermore most of studies highlighted also a reduction in the incidence of invasive pneumococcal diseases due to all serotypes. With regards to meta-analysis, a random effects model was used to combine data because of the high heterogeneity. Data combination showed that the effectiveness of PCV7 in reducing invasive pneumococcal diseases due to vaccine serotypes and to all serotypes was 84% (95%CI: 74%-90%) and 53% (95%CI: 46%-59%) respectively. These results are confirmatory with respect to the efficacy of PCV7 against invasive pneumococcal diseases due to vaccine serotypes. CONCLUSION: PCV7 implementation determines a significant decrease of invasive pneumococcal diseases