Antimicrobial Sales Research Articles

Changes in revenues associated with antimicrobial reimbursement reforms in Germany

Policy declarations from the G7 and other high-level meetings call for increased incentives for antimicrobial research and development (R&D). Governments fund push incentives like CARB-X and GARDP, and G7 countries are now designing pull incentives—financial rewards given to manufacturers post-market authorization that are intended to encourage the creation and introduction of novel antimicrobials. Germany has declared previously at the G7 that it has developed a pull incentive that will increase revenues from sales of important new antimicrobials, principally by exempting them from some aspects of health technology benefit assessments and reference pricing, which should result in higher prices. This policy move is the latest in a series of reforms that aim to improve the marketability of antimicrobials in Germany. This paper examines Germany’s reforms and contributes to the ongoing debate about the merits of its approach in light of R&D and access issues impacting the country, particularly in comparison to pull incentives such as revenue guarantees or subscriptions that delink revenue from sales volume. We find that in order for Germany to produce the same impact on antimicrobial revenues as a delinked pull incentive, it either needs to increase the volume of antimicrobials used or increase prices for these drugs by as much as 3.3-times current values.

The Transition Issue: What Do We Change (or Not) When We Change Antimicrobial Use?

SummaryThe various policies and initiatives to reduce antimicrobial use in livestock production in Europe over the last ten years have been successful. In many countries, reduction targets have been met (a reduction in antimicrobial sales of between 30–50 per cent). But when it comes to larger‐scale or longer‐term objectives, namely those of shifting to more sustainable or resilient agriculture, the picture is far less clear. The success of the fight against antimicrobial resistance must not mask the fact that to date, little progress has been made on transition issues. Intensive and industrial forms of livestock production are maintained and sometimes strengthened by the strategies developed to reduce antimicrobial use. Reducing and replacing antimicrobials has been an important step but the reflection has not been connected to the issue of rethinking the production system, as European policies suggested in the first place. It is now essential to link the current efforts in the fight against antimicrobial resistance to far‐reaching changes and breakthrough innovations. AMR is one problem among many others. They must be tackled globally thanks to transitions towards forms of agriculture that are less intensive, less industrial, and more mindful of their impact on health, the environment and society.

Identifying Specific Targets for the Member States to Achieve the European Union's Goal of 50 per cent Reduction in Sales of Veterinary Antimicrobials by 2030

SummaryThis article proposes a tailored approach to reduce antimicrobial use (AMU) in livestock among EU countries, in alignment with the EU Farm‐to‐Fork initiative that targets a 50 per cent reduction by 2030. We argue against a one‐size‐fits‐all target and introduce country‐specific targets based on individual factors such as current antimicrobial sales, GDP, and livestock and human densities. Using data from the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC), the article identifies countries with high densities of animals and humans, as well as high levels of AMU per livestock unit, such as Germany, Belgium, Italy, Spain and Poland, as needing to prioritise greater reduction efforts. The article also underlines the need for a more precise EU‐level indicator of AMU, as sales do not directly represent use. It suggests that specific targets and regulations should apply to antimicrobials classified as ‘Highest Priority Critically Important Antimicrobials’ by the WHO. The article recommends extending these targets to different sectors and even individual farms, with high‐consumption sectors and poorly performing farms making greater efforts. By considering these factors, the article aims to provide a fair and effective approach to reducing AMU, mitigate the risks associated with antimicrobial resistance, and contribute to achieving the Farm‐to‐Fork strategy AMU reduction target.

The 2030 Veterinary Antimicrobial Sales Reduction Target in Europe: Where Are We?

The 2030 Veterinary Antimicrobial Sales Reduction Target in Europe: Where Are We?

Global restriction of the over-the-counter sale of antimicrobials: does it make sense?

Global restriction of the over-the-counter sale of antimicrobials: does it make sense?

Identifying veterinary surgeons' barriers to, and potential solutions for, improving antimicrobial stewardship among sheep farmers in Northern Ireland.

In order to improve antimicrobial stewardship (AMS), including changes in antimicrobial prescribing and use, an enhanced understanding is needed of the barriers that veterinary surgeons (vets) encounter to institute such change. A qualitative approach, using grounded theory, was followed. Interviews and discussion groups, with vets and farm industry stakeholders in Northern Ireland (NI), were undertaken to identify and explore attitudes and behaviours surrounding AMS, with a particular emphasis on the barriers vets encountered and the context within which they were working. Seven inter-related themes associated with improving AMS among their sheep farming clients were identified. The first six addressed barriers were working under commercial and practical constraints, farmer behaviour, multiple medicine sources, poor prescribing practice, a perceived lack of incentive or facilitation to improve AMS and a perceived lack of action by regulators to challenge poor AMS. The seventh theme revealed suggestions vets considered that may improve AMS in NI, including greater state intervention in recording and regulating medicine sales. Improving AMS will require vets and their client farmers to change behaviour. This will involve concerted effort over an extended period of time to enact and embed change. Veterinary surgeons believe that further action by the industry and state to develop centralised antimicrobial sales recording and by the state to enforce prescribing regulations will aid their efforts. However, critical to achieving this is the development of a sustainable and funded mechanism to create more meaningful farmer-vet consultation around flock health prior to every prescription to improve AMS and sheep welfare.

Animal drug shortages limit veterinary therapeutic options and introduce artifacts in antimicrobial sales reporting.

Supply chain issues disrupt veterinary care and cause downstream consequences that alter the practice of veterinary medicine. Antimicrobials are just 1 class of pharmaceuticals that have been impacted by supply chain issues over the last couple of years. Since February 2021, 2 sponsors/manufacturers of penicillin products have reported shortages in the active pharmaceutical ingredient. With the release of the 2021 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals by the FDA, a key finding was a 19% decrease in penicillin sales and distribution from 2020 to 2021. Herein, we provide our clinicians' professional perspective regarding how drug shortages, specifically that of penicillin, might contribute to misconstrued patterns in antimicrobial use and what can be done by veterinarians and the FDA to minimize the impact of an antimicrobial drug shortage on animal health and well-being.

“The end of the era of antibiotics” — myth or reality: what the past COVID-19 pandemic has shown

BACKGROUND: During the coronavirus disease 2019 pandemic, the sale of antimicrobials (AMPs) in the pharmacy network and their purchases by healthcare facilities of the Russian Federation have significantly increased. Microbiological monitoring conducted at the City Clinical Hospital No. 67 named after L.A. Vorokhobov of the Moscow Health Department in 2020–2021 revealed an urgent problem: gram-negative bacteria, which are dominated by multidrug-resistant (MDR) strains, are now mainly isolated from patients with healthcare-associated infections (HAIs). Pharmacoeconomic studies have shown that the cost of one course of targeted antibiotic therapy for HAIs can increase by 6–12 times compared with a similar course of therapy in the absence of nosocomial MDR and extensively drug-resistant (XDR) pathogens.
 AIM: To increase the effectiveness of preventive measures aimed at preventing the spread of hospital-acquired pathogen strains in the intensive care unit (ICU) using effective bacteriophages against MDR strains of Klebsiella pneumoniae, Pseudomonas aeruginosa, Staphylococcus aureus, and Acinetobacter baumannii, which were selected in accordance with an individualized algorithm.
 MATERIALS AND METHODS: The study included two groups, totaling 20 patients, who were on prolonged mechanical ventilation in the ICU of City Clinical Hospital No. 67 named after L.A. Vorokhobov of the Moscow Health Department in 2022. The second group received 20 mL of bacteriophages via an intragastric tube for five consecutive days. The concept of a personalized approach to phage therapy for various forms of HAIs caused by nosocomial MDR pathogens in patients of a multidisciplinary hospital has been proposed and tested.
 RESULTS: With this medical technology, the effectiveness of phage therapy for various nosological forms of HAIs caused by nosocomial MDR and XDR strains increased by 30%, and the effectiveness of the initial antibiotic therapy regimen was ≥70%. The economic effect of the combination of antibiotic therapy and phage therapy (booster therapy) amounted to more than 3 million rubles compared with the use of AMP alone for treating patients with HAIs caused by nosocomial MDR/XDR strains.
 CONCLUSIONS: Booster therapy as a variant of IIB therapy reduces the cost of treatment of AMPs of various forms of HAIs by ≥2.5 times compared with AMPs alone.

Limitations of Reporting Requirements under California's Livestock Antimicrobial Restriction Law.

Antimicrobial use in livestock production is considered a key contributor to growing antimicrobial resistance in bacteria. In 2015, California became the first state to enact restrictions on routine antimicrobial use in livestock production via Senate Bill 27 (SB27). SB27 further required the California Department of Food and Agriculture (CDFA) to collect and disseminate data on antimicrobial use in livestock production. The goal of this report is to assess whether CDFA's data release allows us to evaluate how antimicrobial use changed after the implementation of SB27. We combine the CDFA data with feed drug concentration ranges from the Code of Federal Regulation to evaluate the spread of plausible antimicrobial use trends. We also estimate antimicrobial consumption rates using data from the National Agricultural Statistical Service (NASS) and compare these to changes in medicated feed production reported by the CDFA. We show that CDFA's reported data are insufficient to reliably estimate whether antimicrobial usage has increased or decreased, most notably because no information is provided about the mass of antimicrobials approved for use or medicated feed drug concentrations. After incorporating additional external data on feed drug concentrations, one can at best provide uninformative bounds on the effect of SB27. We find some evidence that antimicrobial use has decreased by incorporating data on national sales of antimicrobials for food-producing animals, but the weakness of this inference underlines the need for improved data collection and dissemination, especially as other states seek to implement similar policies. We provide recommendations on how to improve reporting and data collection under SB27. https://doi.org/10.1289/EHP13702.

The threat of Antimicrobial Resistance in Developing Countries: Causes and Control Strategies

The causes of antimicrobial resistance (AMR) in developing countries are complex and may be rooted in practices of health care professionals and patients’ behavior towards the use of antimicrobials as well as supply chains of antimicrobials in the population. Some of these factors may include inappropriate prescription practices, inadequate patient education, limited diagnostic facilities, unauthorized sale of antimicrobials, lack of appropriate functioning drug regulatory mechanisms, and non-human use of antimicrobials such as in animal production. Considering that these factors in developing countries may vary from those in developed countries, intervention efforts in developing countries need to address the context and focus on the root causes specific to this part of the world. Here, we describe these health-seeking behaviors that lead to the threat of AMR and healthcare practices that drive the development of AMR in developing countries and we discuss alternatives for disease prevention as well as other treatment options worth exploring. Keywords: Antimicrobial resistance, Causes and Control Strategies

Monitoring progress on Antimicrobial Resistance (AMR) response in the World Health Organization African region: Insights from the Tracking AMR Country Self-Assessment Survey (TrACSS) 2021 results for the human health sector.

Antimicrobial resistance (AMR) is a major 21st century global health challenge. The WHO African Region Member States committed to develop and implement multisectoral national action plans (NAPs) that address AMR, in line with the Global Action Plan on AMR (GAP). The aim of this paper is to present the progress of AMR response in the WHO African Region based on the annual Tracking AMR Country Self-Assessment Survey (TrACSS), with a focus on human health indicators. This was a secondary data analysis of responses from forty-one countries that participated in the 2021 TrACSS. Of the 41 countries that responded to the 2021 TrACSS, 35(85%) have developed NAPs. Fifteen 15(37%) of countries have functional AMR multisector working groups. 55% (21/41) of countries are collating data nationally on AMR surveillance. Forty nine percent of countries conducted small-scale AMR awareness campaigns and 53% (21/41) covered AMR in some pre- and in-service training for human health workers. While 83% of countries reported having laws and regulations on the prescription and sale of antimicrobials, only 32% (13/41) have national systems for monitoring antimicrobial use. Twenty-three (58%, 23/41) reported having Infection Prevention and Control (IPC) programs at select health facilities. Countries have developed and are implementing AMR NAPs. Gaps still exist across key indicators monitored through TrACSS. Effective AMR response requires established functional multisectoral governance mechanisms in the One Health approach; political commitment, sustainable funding, and clear monitoring and reporting is critical.

Antimicrobial Sales Comparison before and after the Implementation of Nationwide Restriction Policy in Saudi Arabia.

Antimicrobial dispensing without a prescription has been identified as a significant contributor to the burgeoning crisis of antimicrobial resistance. To combat this, the Saudi Ministry of Health introduced a stringent antimicrobial restriction policy in mid-2018, mandating prescriptions for all antimicrobial drug dispensations at pharmacies. Therefore, this study aimed to assess the immediate impact of this policy on retail antimicrobial sales. To do so, we analyzed annual sales data from 2017 to 2019 sourced from the IQVIA-MIDAS® database, which included a range of antimicrobials, such as antibiotics, antifungals, and other related agents. The analysis revealed a notable reduction in overall antimicrobial sales by 23.2%, decreasing from 818.9 million SAR in 2017 to 648.4 million SAR in 2019. While the Wilcoxon signed-rank test indicated a statistically significant median reduction in total antimicrobial sales post-policy implementation (p = 0.0397), it is important to acknowledge that the long-term effects and adherence to the policy require further investigation. Notably, sales of amoxicillin dropped by 70% in 2019 compared to 2017, contributing largely to the decline. Conversely, a continuous increase in sales of some antimicrobial drugs following the restriction policy was observed, led by amoxicillin/clavulanic acid. Our data support the implementation of antimicrobial restriction measures as an effective means of controlling excessive antimicrobial sales and dispensing without prescriptions.

Public Good Agricultural Practices Certification Schemes in Chosen EU Countries

Abstract In line with the Farm to Fork strategy and the European Green Deal plan for creating a sustainable food system, the European Commission has set goals for 2030: reducing the use of pesticides and the risks associated with their use by 50%, the use of fertilizers by at least 20%, the sale of antimicrobials used in animal husbandry and aquaculture by 50% and 25% of agricultural land used for organic farming. Implementation of these assumptions requires institutional support and providing farmers with a specific framework. Certification Schemes (CSs) in agriculture are one way to achieve these goals. The number of CSs that support the strategy in the EU member states is 170 intra-EU and 198 including associated countries. Together with Organic farming, the CSs on Good Agricultural Practices (GAP) seem to be particularly important in reducing the use of pesticides and fertilizers. The aim of the article is to present selected issues related to CSs implementing the strategy of reducing the use of pesticides and fertilizers. These include the well-known Organic farming, but also the public, national level CS "Haute Valeur Environnementale" (France), CS "Sistema di Qualità Nazionale di Produzione Integrata per le Produzioni Agricole" (Italy) and CS "Integrowana Produkcja" (Poland), implementing GAP.

Prevalence of Hospital Bacterial Resistance from 2016 to 2018 in Northwest Mexico

In Mexico, antimicrobial resistance, a public health problem, is difficult to address because of the absence of a regulatory body to effectively control the use and sale of antimicrobials; the low surveillance of prescription and self-medication; and the lack of information. This study aimed to determine the prevalence of resistance to antibiotics in bacteria isolated from hospital clinical samples in northwest Mexico. This study consisted of collecting the information from the logs of the cultures that were carried out in the Microbiology area of ​​the Clinical Analysis Laboratory and its resistance to antibiotics, from December 2016 to January 2018, in Hospital in Northwest Mexico. Escherichia coli, Klebsiella pneumoniae, and Staphylococcus aureus infections were the most common among patients from all care services. Klebsiella pneumonia Pseudomonas aeruginosa, Enterobacter cloacae, S. aureus, Staphylococcus epidermidis, and E. coli showed antibiotic resistance up to 90 and 100%. Benzylpenicillin was the antibiotic to which a high resistance was observed in the intensive care unit service (100%). High bacterial resistance to antibiotics was found from December 2016 to January 2018 in the present study and, in comparison with few Mexican studies, it has remained unchanged.

Occurrence of Tet Gene-Bearing Antimicrobial-Resistant Escherichia coli From Dairy Farms in Nigeria

Abstract This study focused on antibiotic resistance genes as emerging contaminants with potential global human health implications. Intensive livestock farming has been identified as a major contributor to the spread of resistant bacteria and genes. The study examined antimicrobial-resistant Escherichia coli and tetracycline-resistant genes in raw milk from commercial dairy farms in Kano State. Out of 300 registered farms, 54 (18 %) were purposively sampled for the study. A total of 313 milk samples were collected and processed through enrichment and inoculation on selective media for Escherichia coli isolation. The antibiogram pattern of the isolated Escherichia coli strains was assessed using the disk diffusion method. The results revealed resistance to various antimicrobial agents, with no resistance to quinolones but high resistance to ampicillin (100 %), erythromycin (73.3 %), and tetracycline (46.7 %), among others. The multiplex polymer-ase chain reaction was conducted on all Escherichia coli isolates to detect tet genes (tet A, B, C, D, and M), and one isolate carried the tet M resistance gene, while six (40 %) others carried the tet A resistance gene. The study concludes that a significant proportion of the cultured Escherichia coli strains were resistant to one or more tested antibiotics, indicating a potential public health threat associated with Escherichia coli contamination in raw milk. We recommend implementing robust regulatory policies governing the use and sales of antimicrobials in animal production. Furthermore, we suggest further investigation into other resistant genes that these isolates might carry to better understand the extent of antibiotic resistance in the region.

Blood culture findings as tools for clinical management and patient safety

Introduction: Healthcare-associated Infections (HAI) have a significant impact on public health, and the use of indicators is a common practice for assessing and improving healthcare services. Aim: This study aimed to describe the utilization of blood culture results to develop indicators for hospital management and evaluate antimicrobial resistance. Outlining: This cross-sectional study was conducted at a teaching hospital. Blood cultures were performed during two periods: pre-implementation of antimicrobial sales restrictions in Brazil (05/2010-10/2010 - first period) and post-implementation (02/2011-07/2011 - second period). Computerized system reports were used to develop indicators, including infection incidence rates and antimicrobial resistance. Results: A higher infection rate (1.97/100 person-days) and a lower resistance rate (0.62/100 person-days) were observed in the second period, with the microorganism Staphylococcus sp. being more frequently identified in both periods. Implications: This study demonstrates the use of indicators to evaluate governmental actions related to HAIs, which can contribute to patient safety and healthcare management.

On-farm antimicrobial usage in commercial turkey production in the United States, 2013-2021.

A key component of antimicrobial stewardship is the ability to collect antimicrobial use data and ultimately use this information to ensure that administrations are necessary and effective. National antimicrobial sales data cannot help in this capacity because the data lack context, for example, details concerning target species and disease indication. The objective of this study was to continue the development of a system for collecting flock-level on-farm antimicrobial use data from the U.S. turkey industry and to have it be representative of national turkey production in the U.S. This study utilized a public-private partnership to enable collection and protection of sensitive flock-level data from an extremely large industry while releasing deidentified and aggregated information regarding the details of antimicrobial use on U.S. turkey farms over time. Participation was voluntary. Data were collected for the period 2013 through 2021 and are reported on a calendar year basis. Using production statistics from USDA:NASS as a denominator, the data supplied by participating companies represented approximately 67.3% of turkey production in the U.S. in 2013, approximately 69.1% in 2017, and approximately 71.4% in 2021. The data that were submitted for 2021 are based on approximately 149,000,192 turkeys slaughtered and 4,929,773,506 pounds liveweight produced. Detailed prescription records representing approximately 60-70% of the birds were available for the 2018-2021 dataset. The estimated percentage of turkey poults placed that received hatchery antimicrobials decreased from 96.9% in 2013 to 40.5% in 2021. The use of in-feed antimicrobials was practically eliminated, with in-feed tetracycline being the only medically important antimicrobial used in 2021. Use of in-feed tetracyclines decreased approximately 80% between 2013 and 2021. Water-soluble antimicrobial use declined over the study period. Between 2013 and 2021, water-soluble penicillin use decreased approximately 41% but water-soluble tetracycline use increased approximately 22%. Key diseases that were treated with water-soluble antimicrobials included bacterial poult enteritis and clostridial dermatitis. Efforts to reduce the incidence of these diseases would reduce the need for antimicrobial therapy, thereby enabling continued decreases in antimicrobial use without sacrificing animal welfare. However, this will require an investment in research to find efficacious and cost-effective mitigation strategies.

Antimicrobial resistance in Democratic Republic of Congo: the way forward

Antimicrobial resistance in Democratic Republic of Congo: the way forward

Antimicrobial resistance in food-producing animals: towards implementing a one health based national action plan in Israel

BackgroundDevelopment of antimicrobial resistance poses a major threat to human and animal health worldwide. Antimicrobials are frequently used in animal husbandry, making food-producing animals a widespread and important source of antimicrobial resistance. Indeed, recent evidence demonstrates that antimicrobial resistance in food-producing animals poses a threat to the health of humans, animals and the environment. To address this threat, national action plans have been implemented based on a ‘One Health’ approach, which integrates actions across human and animal health sectors to combat antimicrobial resistance. Although under development, Israel has yet to publish a national action plan against antimicrobial resistance, despite alarming findings of resistant bacteria in food-producing animals in the country. Here we review several national action plans against antimicrobial resistance around the world in order to suggest approaches to develop a national action plan in Israel.Main bodyWe investigated worldwide national action plans against antimicrobial resistance based on a ‘One Health’ approach. We also conducted interviews with representatives of relevant Israeli ministries to understand antimicrobial resistance policy and regulatory frameworks in Israel. Finally, we present recommendations for Israel towards implementing a ‘One Health’ national action plan against antimicrobial resistance. Many countries have developed such plans, however, only a few are currently funded. Furthermore, many countries, especially in Europe, have taken action to reduce the use of antimicrobials and the spread of antimicrobial resistance in food-producing animals by banning the use of antimicrobials to promote growth, reporting data on the use and sales of antimicrobials in food-producing animals, operating centralized antimicrobial resistance surveillance systems and preventing the use of antimicrobials important to human medicine to treat food-producing animals.ConclusionsWithout a comprehensive and funded national action plan, the risks of antimicrobial resistance to the public health in Israel will escalate. Thus, several actions should be considered: (1) Reporting data on the use of antimicrobials in humans and animals. (2) Operating a centralized surveillance system for antimicrobial resistance in humans, animals and the environment. (3) Improving awareness regarding antimicrobial resistance in the general public and in health practitioners from both human and animal sectors. (4) Composing a list of critically important antimicrobials to human medicine that’s use should be avoided in food-producing animals. (5) Enforcing best practices of antimicrobial use at the farm-level. (6) Reducing incidence of infection through farm biosecurity. (7) Supporting research and development of new antimicrobial treatments, vaccines and diagnostic tools.

Antimicrobial usage in broiler chicken production in the United States, 2013-2021.

Although efforts to improve antimicrobial stewardship should include the collection of antimicrobial use data, most antimicrobial datasets collected at the national level consist of antimicrobial sales data which cannot inform stewardship. These data lack context, such as information regarding target species, disease indication, and regimen specifics like dose, route and duration. Therefore, the goal of this study was to develop a system for collecting data on the use of antimicrobials in the U.S. broiler chicken industry. This study utilized a public-private partnership to enable collection and protection of sensitive data from an extremely large industry while releasing deidentified and aggregated information regarding the details of antimicrobial use on U.S. broiler chicken farms over time. Participation was voluntary. Data were collected for the period 2013 through 2021 and are reported on a calendar year basis. Using production statistics from USDA:NASS as a denominator, the data supplied by participating companies represented approximately 82.1% of broiler chicken production in the U.S. in 2013, approximately 88.6% in 2017, and approximately 85.0% in 2021. The data that were submitted for 2021 are based on approximately 7,826,121,178 chickens slaughtered and 50,550,817,859 pounds liveweight produced. Granular flock-level treatment records were available for 75-90% of the birds represented in the 2018-2021 dataset. There was no use of antimicrobials in the hatchery for the years 2020 and 2021. Medically important in-feed antimicrobial use decreased substantially, with all in-feed tetracycline use being eliminated by 2020, and the use of virginiamycin being reduced by more than 97% since 2013. Medically important water-soluble antimicrobials are used for the treatment of disease in broiler production. Use decreased substantially for most water-soluble antimicrobials. The most important diseases necessitating treatment were necrotic enteritis and gangrenous dermatitis as well as E. coli-related disease. A focus on reducing the incidence of these diseases would reduce the need for antimicrobial therapy but will require an investment in research to find efficacious and cost-effective interventions for these diseases.