Like every year, the World Antimicrobial Awareness Week (WAAW) – taking place from 18th to 24th of November 2021 – will be used to strengthen awareness about antimicrobial resistance (AMR). In Europe, the 18th of November traditionally marks the occasion of the European Antibiotic Awareness Day (EAAD). Both WHO and the European Centre for Diseases Prevention and Control (ECDC) will prepare materials that can be used during EAAD and WAAW to raise awareness about AMR.
This year’s WAAW campaign will encourage stakeholders, including policymakers, health care providers, and the general public to recognize that everyone can be an AMR Awareness champion. Participants are encouraged to spread awareness about what AMR is, share stories about its consequences, and demonstrate how the actions of individuals, families, professionals, and communities affect the spread of AMR.
EAAD provides a platform for and support to national campaigns on prudent use of antibiotics, with over 43 countries having had campaigns since its initiation in 2008. The 2021 edition will focus on the theme ‘In times of COVID-19, don’t forget about antimicrobial resistance. Stay united to preserve antimicrobials’.
European Health Emergency preparedness and Response Authority launched
On 16 September, the European Commission shared its plans for the European Health Emergency preparedness and Response Authority (HERA). It is a key pillar of the European Health Union that will help fill a gap in the EU’s health emergency response and preparedness.
It is HERA’s task to anticipate threats and potential health crises, through intelligence gathering and building the necessary response capacities and to ensure the development, production and distribution of medicines, vaccines and other medical countermeasures when a health emergency hits. HERA will be set up as an internal Commission structure. It will be fully operational early in 2022. Its functioning will be reviewed and adapted on an annual basis until 2025 when a full review will be carried out.
FIP releases new Statement on Digital Health
In mid-September, the Council of the International Pharmaceutical Federation (FIP) adopted a Statement of Policy on Digital Health. The Statement contains several specific recommendations to academic institutions, government and policymakers, FIP member organisations and pharmacists in order to support digital transformation.
The Statement of Policy of FIP looks at the impact of the digital transformation on the pharmacy profession, explores the importance of interoperability and the potential that digital tools can bring for the pharmacy workforce. It underlines that the digital transformation of healthcare may allow for more inclusive, equitable and ethical use of healthcare resources, can improve health outcomes and reduce healthcare costs, and is often more environmentally friendly.
AI recommendations by the International Coalition of Medicines Regulatory Authorities
In mid-August, the International Coalition of Medicines Regulatory Authorities (ICMRA) published recommendations to help regulators to address the challenges that the use of artificial intelligence (AI) poses for global medicines regulation.
AI includes various technologies (such as statistical models, diverse algorithms and self-modifying systems) that are increasingly being applied across all stages of a medicine’s lifecycle: from preclinical development, to clinical trial data recording and analysis, to pharmacovigilance and clinical use optimisation. This range of applications brings with it regulatory challenges, including the transparency of algorithms and their meaning, as well as the risks of AI failures and the wider impact these would have on AI uptake in medicine development and patients' health.
The report identifies several key issues linked to the regulation of future therapies using AI and makes specific recommendations for regulators and stakeholders involved in medicine development to foster the uptake of AI. Some of the main findings and recommendations include:
Regulators may need to apply a risk-based approach to assessing and regulating AI, which could be informed through exchange and collaboration in ICMRA;
Sponsors, developers and pharmaceutical companies should establish strengthened governance structures to oversee algorithms and AI deployments that are closely linked to the benefit/risk of a medicinal product;
Regulatory guidelines for AI development, validation and use with medicinal products should be developed in areas such as data provenance, reliability, transparency and understandability, pharmacovigilance, and real-world monitoring of patient functioning.
The report is based on a horizon-scanning exercise in AI, conducted by the ICMRA Informal Network for Innovation working group and led by the European Medicines Agency (EMA). The goal of this network is to identify challenging topics for medicine regulators, to explore the suitability of existing regulatory frameworks and to develop recommendations to adapt regulatory systems in order to facilitate safe and timely access to innovative medicines.
ECDC helps you boost your knowledge on antimicrobial stewardship
The European Centre for Disease Prevention and Control (ECDC) offers an e-learning course on antimicrobial resistance, focusing on antimicrobial stewardship as an approach to address healthcare-associated infections (HAI) resulting from multi-drug resistance organisms in acute care settings. The course is self-paced and takes approximately 2 hours to complete.
After completing this course, the participants will be able to understand the challenges related to antimicrobial resistance and how antimicrobial stewardship can be used as an intervention to address this burden. Healthcare professionals with responsibility for prevention and control of HAIs working at national or local level within the EU/EEA member states are the target audience for the course.
The objectives of this course are:
understanding the challenges related to antibiotic prescription, burden of anti-microbial resistance (AMR) and the principles of antibiotic stewardship;
identifying guidelines for treatment of specific conditions and formularies both at the national and local level;
understanding the implementation of antibiotic policies;
understanding measurement of drug usage and the prescribing indicators in relation to structure, process and outcomes;
identifying drug usage over time and interpret prescribing surveillance data;
understanding the elements and performance measurement for an antimicrobial stewardship programme (AMS), and;
identifying interventions to improve antibiotic prescribing practices for hospitalised patients and measure intervention effect, barriers, and possible solutions.
The antimicrobial stewardship online course can be accessed via ECDC’s website.
Footnotes
Competing interests: None declared.
Provenance and peer review: Commissioned; internally peer reviewed.