ESCMID 2024: Newer Antibiotics in the Absence of Diagnostic Capacity: How to Balance Access and Stewardship?
The issue of balancing access to antibiotics and antimicrobial stewardship (AMS) in low- and middle-income countries (LMICs) is critical due to their limited diagnostic capacity and other resource constraints. The challenge is to use new antibiotics responsibly to avoid rapid loss of efficacy while ensuring quick access for those who need them. Globally, capacity building through the World Health Organisation's (WHO's) guidance on antimicrobial resistance (AMR) and AMS is essential. A recent WHO resolution on strengthening diagnostic capacity emphasizes integrated diagnostic networks and avoiding siloed approaches, aiming to improve infection management and expand diagnostics in LMICs. The COVID-19 pandemic influenced this resolution, signaling a need for more comprehensive approaches to health issues. The Global Leaders Group on AMR emphasizes boosting diagnostic capacity to improve surveillance. However, data collection must address both surveillance and clinical management, with an emphasis on clinical needs.
The WHO AWARE categorization classifies antibiotics into "Access," "Watch," and "Reserve" for stewardship. The "Reserve" category includes the most critical antibiotics, usually newer or high-risk ones, requiring careful use to prevent resistance. Although not all new antibiotics fall into this category, many critical ones do due to their potential for resistance. WHO provides an antibiotic guidebook and app for healthcare providers, emphasizing stewardship and empirical treatment. These resources offer clinical examination insights, aiding complex decision-making. Clinical guidelines often lack comprehensive diagnostic and therapeutic algorithms. Effective algorithms should use rapid diagnostic tools like point-of-care tests, particularly in LMICs, and consider prior antibiotic use. This approach must adapt to various healthcare settings, local resistance patterns, public health needs, and antibiotic availability to ensure effective antibiotic use and combat resistance.
Clinical decision support systems (CDSS) offer healthcare providers guidance on symptoms, diagnostic tests, and treatment options, often using electronic formats for efficiency and ease of use. These systems can integrate diagnostic algorithms, point-of-care tests, and mentorship for managing cases. A Tanzanian study involving over 44,000 children tested a digital CDSS with point-of-care tests. The results revealed high adoption of CDSS (76%), a significant reduction in antibiotic prescribing, and no difference in clinical failure or safety outcomes, indicating that the CDSS was safe and effective. Another article proposed a target product profile for an electronic CDSS with point-of-care tests created with WHO and FIND to guide future development. Limited diagnostic capacity complicates clinical management, especially in LMICs. Syndromic-based approaches may be used, but local epidemiology and microbiology must be considered. Lack of robust diagnostic capacity impacts patient outcomes, AMR, and disease surveillance, emphasizing the need for effective diagnostic tools and support systems.
In LMICs, developing a strategy requires balancing available resources with long-term goals. A solid start involves leveraging global resources like WHO guidance, sharing best practices among countries, and establishing networks for regional and national coordination. Combating AMR demands that access and stewardship be central to national action plans, focusing on improved diagnostic systems and comprehensive approaches over disease-specific tactics. Essential diagnostics and medicine lists based on WHO recommendations are useful at the national level, while WHO's AWARE categorization can inform drug formularies, accompanied by careful planning to monitor access and resistance. Locally, efforts should build on national initiatives, ensure access to essential diagnostics, and integrate WHO's AWARE categorization into formularies with a stewardship focus. Effective coordination across all levels is key to implementing successful AMR strategies while preserving access to essential medicines.
Introducing a new antibiotic requires tailored strategies for access and stewardship, depending on whether it's a rarely used hospital drug, a frequently prescribed hospital-based drug, or one available in all settings. The strategy depends on the antibiotic's role and risk of misuse. A checklist can guide adding new antibiotics to formularies. It has two parts: assessing the new antibiotic and preparing a stewardship toolkit to ensure proper use. During assessment, a committee evaluates clinical needs, coordinates with institutions, and minimizes conflicts of interest. The stewardship toolkit outlines where the antibiotic is available, who can prescribe it, and restrictions on over-the-counter sales. It should include monitoring plans for antibiotic use, quantity, and resistance. A network-based approach can help share resources across facilities, especially those with fewer resources. Continuous quality improvement ensures adaptability, with periodic reassessment to meet changing needs. Therefore, balancing access with stewardship, a network-based approach offers flexibility and support.
An article by Jennifer and Mark proposes a stewardship model for LMICs, emphasizing evidence-based guidance, specific drug labelling to promote appropriate use (like "reserve"), and public-private partnerships for antibiotic guidance and monitoring. Their approach also includes controlled sales to specific health facilities, limiting new antibiotics to selected hospitals or facilities, and promoting stewardship measures such as pre-authorization or prospective audit and feedback. The model introduces a "hub-and-spoke" network, supported by digital communication, for managing antibiotic distribution, along with an interdisciplinary national advisory team involving various stakeholders. This concept reflects an expert group providing large-scale support to smaller facilities.
Therefore, to improve antimicrobial stewardship, key areas must be addressed. First, enhancing the diagnostic process should be a priority, with guidelines featuring decision algorithms integrated into stewardship practices. Effective diagnostics are critical for responsible antibiotic use. Additionally, guidance, a checklist, and a toolkit are needed to support antimicrobial stewardship when a new antibiotic is launched. Organizations like WHO or Global Antibiotic Research & Development Partnership (GARDP) could lead this effort, assisting countries in developing customized stewardship approaches. The ideal scenario for new antibiotics includes companion diagnostics and computerized decision support systems to ensure proper use. Though this might seem ambitious, advancing these technologies could significantly improve antimicrobial stewardship in the future.
European Society of Clinical Microbiology and Infectious Diseases (ESCMID) 2024, 27th April–30th April 2024, Barcelona, Spain
