October 2024
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39 Reads
ACS Infectious Diseases
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October 2024
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39 Reads
ACS Infectious Diseases
March 2024
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188 Reads
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1 Citation
BMJ Open
Objectives Lockdowns and border closures impacted medicine availability during the COVID-19 pandemic. This study aimed to assess the availability of essential, generic medicines for chronic diseases at public pharmaceutical supply agencies in Ethiopia. Design Comparative cross-sectional study. Setting The availability of essential, generic medicines for chronic diseases was assessed at two public pharmaceutical supply agency hubs. Participants The current study included public supply agency hub managers, warehouse managers and forecasting officers at the study setting. Outcomes The assessment encompassed the availability of chronic medicines on the day of data collection, as well as records spanning 8 months before the outbreak and 1 year during the pandemic. A total of 22 medicines were selected based on their inclusion in the national essential drug list for public health facilities, including 17 medicines for cardiovascular disease and 5 for diabetes mellitus. Results The results of the study indicate that the mean availability of the selected basket medicines was 43.3% (95% CI: 37.1 to 49.5) during COVID-19, which was significantly lower than the availability of 67.4% (95% CI: 62.2 to 72.6) before the outbreak (p<0.001). Prior to COVID-19, the overall average line-item fill rate for the selected products was 78%, but it dropped to 49% during the pandemic. Furthermore, the mean number of days out of stock per month was 11.7 (95% CI: 9.9 to 13.5) before the outbreak of COVID-19, which significantly increased to 15.7 (95% CI: 13.2 to 18.2) during the pandemic, indicating a statistically significant difference (p<0.001). Although the prices for some drugs remained relatively stable, there were significant price hikes for some products. For example, the unit price of insulin increased by more than 130%. Conclusion The COVID-19 pandemic worsened the availability of essential chronic medicines, including higher rates of stockouts and unit price hikes for some products in the study setting. The study’s findings imply that the COVID-19 pandemic has aggravated already-existing medicine availability issues. Efforts should be made to develop contingency plans and establish mechanisms to monitor medicine availability and pricing during such crises.
January 2024
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6 Reads
May 2023
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220 Reads
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9 Citations
BMC Health Services Research
Background COVID-19 pandemic posed a major impact on the availability and affordability of essential medicines. This study aimed to assess the knock-on effects of the COVID-19 pandemic on the supply availability of non-communicable chronic disease (NCD) medicines and paracetamol products in Ethiopia. Methods A mixed methods study was conducted to assess the supply and availability of twenty-four NCD drugs and four paracetamol products listed on the national essential medicines list for hospitals. Data were collected from twenty-six hospitals located in seven zones of Oromia region in the southwestern part of Ethiopia. We extracted data on drug availability, cost and stock out for these drugs between May 2019 and December 2020. The quantitative data were entered into Microsoft Excel and exported to statistical package software for social science (SPSS) version 22 (IBM Corporation, Armonk, NY, USA) software for analysis. Results The overall mean availability of selected basket medicines was 63.4% (range 16.7% to 80.3%) during the pre-COVID-19 time. It was 46.3% (range 2.8% to 88.7) during the pandemic. There was a relative increase in the availability of two paracetamol products [paracetamol 500 mg tablet (67.5% versus 88.7%) and suppository (74.5% versus 88%)] during the pandemic. The average monthly orders fill rates for the selected products range from 43 to 85%. Pre-COVID-19, the average order fill rate was greater or equal to 70%. However, immediately after the COVID-19 case notification, the percentage of order(s) filled correctly in items and quantities began decreasing. Political instability, shortage of trained human resources, currency inflation, and limited drug financing were considered as the major challenges to medicine supply. Conclusion The overall stock out situation in the study area has worsened during COVID-19 compared to pre-COVID-19 time. None of the surveyed chronic disease basket medicines met the ideal availability benchmark of 80% in health facilities. However, availability of paracetamol 500 mg tablet surprisingly improved during the pandemic. A range of policy frameworks and options targeting inevitable outbreaks should exist to enable governments to ensure that medicines for chronic diseases are consistently available and affordable.
December 2021
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77 Reads
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5 Citations
The objective of the proposed hybrid simulation modeling framework is to improve the understanding and operation of medicine supply chains, to strengthen their resilience to ensure the availability of medicines. The framework draws upon hybrid simulation, supply chain resilience and medicine supply chain literature. The utility of the proposed framework is presented through the development of a case model of a generic (off-patent) case medicine in the Norwegian system to perform scenario-based experiments on disruption events and interventions. Two disruption scenarios are evaluated a demand shock e.g., hoarding, and a supply shock, e.g., a major disruption at a key supplier. The effect of these disruptions on the system without interventions is compared with proactive and reactive interventions, namely prepositioned stock, and flexible ordering. Future directions for framework development have been identified.
August 2020
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3,249 Reads
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25 Citations
Antimicrobial Resistance & Infection Control
Background: Infection prevention and control (IPC) is one of the most cost-effective interventions against antimicrobial resistance (AMR). Yet, IPC knowledge gaps often receive little prominence in AMR research agendas. In this article, we construct IPC research priorities, in order to draw attention to these critical research needs. Methods: We developed a 4-step framework to identify IPC knowledge gaps from literature (narrative review). These gaps were then translated into research priorities and sent to two groups of European IPC experts for validation and critique through an online survey. Results: Seventy-nine publications were retrieved from the literature review, identifying fifteen IPC research gaps. Forty-four IPC experts, clustered in two groups, vetted them. The experts classified all research gaps as medium or high priority. Overall agreement between both groups was average (Kendall's τ = 0.43), with strong alignment on the highest priorities: (i) the assessment of organizational, socio-economic, and behavioural barriers/facilitators for the implementation of IPC programmes, (ii) the impact of overcrowding on the spread of infections and (iii) the impact of infrastructural changes, at facility level, on the reduction of infections. Feedback from experts also identified an additional research gap on the interaction between the human and hospital microbiomes. Conclusions: We formulated a list of sixteen research priorities and identified three urgent needs. Now, we encourage researchers, funding agencies, policymakers and relevant stakeholders to start addressing the identified gaps.
February 2020
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158 Reads
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24 Citations
Clinical Infectious Diseases
Antibiotic innovation is in serious jeopardy as companies continue to abandon the market due to a lack of profitability. Novel antibiotics must be used sparingly to hinder the spread of resistance, but small companies cannot survive on revenues that do not cover operational costs. When these companies go either bankrupt or move onto other therapeutic areas, these antibiotics may be no longer accessible to patients. While significant research efforts have detailed incentives to stimulate antibiotic innovation, little attention has been paid to the financing of these incentives. In this article, we take a closer look at four potential financing models (diagnosis-related group carve-out, stewardship taxes, transferable exclusivity voucher, and a European-based "pay or play" model) and evaluate them from a European perspective. The attractiveness of these models and the willingness for countries to test them are currently being vetted through the European Joint Action on AMR and Healthcare-Associated Infections (EU-JAMRAI).
June 2019
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429 Reads
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29 Citations
Background Medicines regulatory harmonization has been recommended as one way to improve access to quality-assured medicines in low- and middle-income countries. The rationale is that by lowering barriers to entry more manufacturers will be enticed to enter the market, while the capacity at the national medicines regulatory authorities is strengthened. The African Medicines Regulatory Harmonization Initiative, agreed in 2009, is developing regional platforms with harmonized regulatory procedures for the registration of medicines. The first region to implement medicines regulatory harmonization was the East African Community (EAC). The harmonization was based on the existing EAC Free Trade Agreement, which officially launched the free movement of goods and services in 2010. Methods and findings In this study we conducted semi-structured interviews and performed document reviews. The main target group for our interviews was pharmaceutical companies. We interviewed 18 companies, including 64% of the total companies who had experienced the EAC joint product assessment procedure, and two EAC-based national medicines regulatory authorities. We found that generally pharmaceutical companies are supportive of the African-based MRH efforts and appreciative of the progress being achieved. However, many companies are now hesitant to use the joint product assessment procedure until efficiency improvements are made. Common frustrations were the length of time to receive the actual marketing authorization; unexpectedly higher quality standards than national procedures; and challenges in getting all EAC countries to recognize EAC approvals. Smaller, less attractive markets have not yet become more attractive from a corporate perspective, and there is no free trade of pharmaceuticals in the EAC region. Conclusions Pharmaceutical companies agree that medicines regulatory harmonization is the way forward. However, regulatory medicines harmonization must actually result in quicker access to the harmonized markets for quality-assured medicines. At this time, improvements are required to the current EAC processes to meet the vision of harmonization.
September 2018
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150 Reads
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12 Citations
Clinical Infectious Diseases
Antibiotic resistance is a growing threat to global public health. The WHO Global Action Plan on Antimicrobial Resistance recommends engaging multisectoral stakeholders to tackle the issue. However, so far, few studies have addressed barriers to antibiotic development, equitable availability and responsible antibiotic use from the perspective of stakeholders outside healthcare facilities or patient communities: the so-called third-party stakeholders. Third-party stakeholders include, inter alia, governments, regulatory agencies and professionals working in antibiotic research and development (R&D) and medical ethics. This viewpoint provides an overview of barriers to antibiotic development, equitable availability of effective antibiotics and their responsible use. The barriers were identified in an exploratory qualitative interview study with an illustrative sample of twelve third-party stakeholders. Next, recommendations to lift these barriers are presented together with examples of recently made progress. The recommendations should guide future antibiotic policies and multisectoral policy action.
October 2017
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83 Reads
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31 Citations
Clinical Infectious Diseases
New alternative market models are needed to incentivize companies to invest in developing new antibacterial drugs. In a previous publication, the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) summarized the key areas of consensus for economic incentives for antibacterial drug development. That work determined that there was substantial agreement on the need for a mixture of push and pull incentives and particularly those that served to delink the revenues from the volumes sold. Pull incentives reward successful development by increasing or ensuring future revenue. Several pull incentives have been proposed that could substantially reward the development of new antibacterial drugs. In this second article authored by representatives of TATFAR, we examine the advantages and disadvantages of different pull incentives for antibacterial drug development. It is TATFAR's hope that this analysis, combined with other related analyses, will provide actionable information that will shape policy makers' thinking on this important issue.
... The interviews were carried out from September to December 2022. The secondary data included information on paracetamol availability and supply chain disruptions obtained from health facilities and public pharmaceutical supply agencies [22,23]. ...
March 2024
BMJ Open
... The interviews were carried out from September to December 2022. The secondary data included information on paracetamol availability and supply chain disruptions obtained from health facilities and public pharmaceutical supply agencies [22,23]. ...
May 2023
BMC Health Services Research
... Although research agendas have been successfully developed in other public health areas, [12][13][14] initiatives aimed at bridging gaps in the research on drug-resistant bacterial infections in human health have fallen short of identifying key research priorities owing to the complex, multifaceted nature of AMR. 15,16 Some initiatives focused solely on specific aspects of AMR 15,[17][18][19][20] or exclusively on the One Health interface, 21 and priorities specifically relevant to low-resource settings were generally overlooked. ...
August 2020
Antimicrobial Resistance & Infection Control
... An important research priority is related to evaluation of the effect of regulatory frameworks, marketing incentives (including pull incentives), and sustainable financing models on antimicrobial R&D pipelines, considering that push incentives alone are deemed insufficient to ensure a healthy pipeline. 38,39 Although countries such as Sweden and the UK have been experimenting with novel economic incentives, [40][41][42] ensuring equitable access to antimicrobials globally would require research into mechanisms that are feasible even in low-resource settings. ...
February 2020
Clinical Infectious Diseases
... Because of the EAC's expertise with regulatory harmonization, regulatory science has improved due to the rigorous review process and consequently higher quality requirements than those of national procedures. Consequently, there has been less effort duplication and a decrease in the total regulatory load [16][17][18][19]. ...
June 2019
... The DIVULSUPERBAC project encompasses a series of outreach activities aimed at transmitting information about a health problem of growing importance, the threat of superbugs, among pre-university students in the Valencian Community (Spain). The two main objectives of this project are: a) to involve university students from the Faculty of Biology of the Universitat de València (UV), who will act to stimulate the vocation of pre-university students for scientific training/research in Experimental and Health Sciences, and b) to raise awareness among the educational community (students, teachers, families) about the health problem posed by bacteria that are multiresistant to antibiotics [2,10,11]. The project involves university students in a Service Learning (SL) activity [12], which continues previous activities carried out by members of our team, Small World Initiative-Tiny Earth-MicroMundo [13]. ...
January 2015
... In southern sub-Saharan Africa, carbapenems was the second-ranked antibiotic class, while in other sub-Saharan Africa areas (central, eastern, and western), third-generation cephalosporins was the second-ranked antibiotic class. This discrepancy may be due to differences in the availability and affordability of different antibiotics in regions with differing economic development [33]. Additionally, factors such as awareness and knowledge of appropriate antimicrobial use, sanitation and hygiene practices, and government regulation might also in uence the use and resistance of antibiotics [34]. ...
September 2018
Clinical Infectious Diseases
... An important research priority is related to evaluation of the effect of regulatory frameworks, marketing incentives (including pull incentives), and sustainable financing models on antimicrobial R&D pipelines, considering that push incentives alone are deemed insufficient to ensure a healthy pipeline. 38,39 Although countries such as Sweden and the UK have been experimenting with novel economic incentives, [40][41][42] ensuring equitable access to antimicrobials globally would require research into mechanisms that are feasible even in low-resource settings. ...
October 2017
Clinical Infectious Diseases
... 39 MERs would be awarded to successful developers of novel antibiotics with a predefined criteria of unmet needs, keeping in balance access and stewardship. 40 The award could be a lump-sum amount or in the form of regular payments. There are two variations of MER: fully delinked and partially delinked. ...
March 2017
Infectious Disease Reports
... Currently, there are more than 100 different active substances on the market, classified as antibiotics. Taking into account the form of release and dosages, the number of drugs exceeds 1,700 names [32]. According to statistics, the volume of consumption of PBX-group "Antibacterial drugs for systemic use" in 2020 amounted to 82 billion rubles, which corresponds to 548 million packages of drugs. ...
October 2016
Journal of Pharmaceutical Policy and Practice