Optimizing use of quality antimicrobial medicines in humans GILLES FORTE POLICY, ACCESS AND USE ESSENTIAL MEDICINES AND HEALTH PRODUCTS 1 TITLE from VIEW and SLIDE MASTER 21 October 2016
Objectives Objective I: Monitoring antimicrobial consumption and use in humans in different settings. Develop/adapt indicators and tools; support countries for data collection & analysis. Objective II: Evidence-based selection and responsible use of quality antimicrobials; Develop global standards e.g. EML and support countries for implementation of policies and best practices for responsible use & stewardship. Objective III: Development and enforcement of regulations to ensure that antimicrobials are quality assured, safe and effective and to prevent supply of SSFFC medicines. Objective IV: Improve access to essential antimicrobials, through efficient supply and affordable prices. 2 TITLE from VIEW and SLIDE MASTER 21 October 2016
Approaches Sharing and analysis of information on consumption & use of antimicrobials and on resistance in humans; contribute to an information repository; promote collaboration at country level Support the establishment of inter-country collaborations and networks for sharing information and expertise on human antimicrobial consumption and use Collaboration with other AMR streams of work e.g. R&D, IPC, knowledge and training etc. Work with FAO and OIE, on consumption and use of antimicrobials and resistance in humans and animals ; one health approach Collaborate with ECDC (ESAC-Net), EMA, Civil Society, WHO CC etc. 3 TITLE from VIEW and SLIDE MASTER 21 October 2016
Activities 2016-2017 Monitoring of antimicrobial use Update of the chapter on antibiotics of the Essential Medicines List Development and dissemination of policies and best practices for use Quality and regulation Collaboration with FAO and OIE
Update of the antibiotic chapter of the Essential Medicines List Set up of a working group to prepare the applications for the update of the list Syndromic approach for the applications common syndromes (hospital or community infections) systematic reviews and guidelines of antibiotics use to treat the most common infectious diseases syndromes
Priority Pathogens List To develop a priority list of antibiotic resistant bacteria Aim is providing an essential guide for planning, implementing, and monitoring research and development (R&D) in the field of new antibiotics The priority pathogens list complements the EML
Awareness Campaigns Comprehensive review of the most recent antibiotic awareness campaigns in high- and middle-low income countries Appropriateness of the messages for national and local awareness campaign messages Evidence base of messages
Guidelines recommendations and resistance patterns Study to evaluate if guidelines consider resistance patterns as a driver of the clinical decision making How resistance influences recommendations Better incorporating resistance in recommendations
Policies and best practices Workshop to discuss future actions in term of policies and best practices using antimicrobial consumption data (EURO) Development of a program for antimicrobial stewardship training in hospitals; Development of online courses (WPRO) Development of materials for World Antibiotic Awareness Week, WAAW (WPRO)
Collaboration with FAO and OIE Strengthening collaboration between WHO, FAO and OIE on the use of antimicrobials OIE was invited by WHO to discuss the protocol for monitoring antimicrobial consumption during a meeting in March 2016 WHO invited by OIE in meetings of the OIE working group for the OIE database on antimicrobial use in animals WHO internal collaboration between Essential medicines and Food safety
Contents of the presentation WHO EML: a quick history EML role in AMR & AB use Review of EML antibiotics chapter (March 2017), 20 syndromes guidances AB Drug utilization and monitoring Stewardship and implementing change A global Priority Pathogens List Approach and methodology Timeline
Update of the antibiotic chapter of the Essential Medicines List EML working group to prepare the AB applications for the update of the list Syndromic approach for the applications common syndromes (hospital or community infections) systematic reviews and guidelines of antibiotics use to treat the most common infectious diseases syndromes
EML AB update: 20 syndromes
Update of the antibiotic chapter of the Essential Medicines List EML working group to prepare the AB applications for the update of the list Syndromic approach for the applications common syndromes (20 hospital or community infections) systematic reviews and guidelines of antibiotics use to treat the most common infectious diseases syndromes Not any more a List: towards a tripartite listing? Core, unreserved Targeted, specific Restricted: niche, last resort, for preservation
EML and Awareness Campaigns Comprehensive review of the most recent antibiotic awareness campaigns in high- and middle-low income countries Appropriateness of the messages for national and local awareness campaign messages Evidence base of main messages reviewed
Monitoring of the consumption of antimicrobials Methodology for monitoring national antimicrobial consumption: Based on sales of antimicrobial medicines In hospital and community sectors Provides information on the level of use and types of antimicrobials used at country level Targets are policy makers and prescribers Pilot survey: Antimicrobial consumption in 20 countries (AFRO, EMRO, SEARO, WPRO) Regional/National workshops: To train countries to the methodologies (AFRO, WPRO, SEARO Nov 2016) To present and discuss the results (2017)
Policies, best practices and implementing change Stewardships programs and comprehensive national policies What do we mean for stewardship? What would implementation programs be like? Different approaches for different prescribers? Implementing the new EML and change: developing programs and quality indicators
Contents of the presentation EML role in AMR & AB use Review of EML antibiotics chapter (March 2017), 20 syndromes guidances AB Drug utilization and monitoring Stewardship and implementing change A global Priority Pathogens List Approach and methodology Timeline
Priority Pathogens List for R&D To develop a priority list of antibiotic resistant bacteria Aim: providing an essential guide for planning, implementing, and monitoring research and development (R&D) in the field of new antibiotics The priority pathogens list complements the EML and the R&D blueprint for action to prevent epidemics
WHO Global Priority Pathogens List: approach Public tender for the selection of a partner based on explicit criteria
Prioritization Tool 1. Hierarchic structure of the problem 2. Criteria Weighting Combine 2&3 the Results of the online Criteria classification by the Weighting of the 2015 WHO Consultation for Prioritization criteria survey and of Pathogens the pathogens 3. Pathogens Weighting for each criterion 4. Prioritized list of pathogens
Prioritization Tool - AHP 1. Hierarchic structure of the problem The objective Prioritize the pathogens C 1 C 2 C 3 C 4 C 5 C 6 C 7 C 8 C 9 Prioritization Criteria P 1 P 2 P 3 P 4 P 5 P 6 P 7 P 8 P 9 P 10 Pathogens to be prioritized
Prioritization Tool -AHP 1. Hierarchic structure of the problem Prioritize the pathogens C 1 C 2 C 3 C 4 C 5 C 6 C 7 C 8 C 9 P 1 P 2 P 3 P 4 P 5 P 6 P 7 P 8 P 9 P 10
Prioritization Tool - AHP 1. Hierarchic structure of the problem 2. Criteria Weighting: pairwise comparison of the criteria 35% 30% 25% 20% 15% 10% 5% 0%
Prioritization Tool - AHP 1. Hierarchic structure of the problem 2. Criteria Weighting: pairwise comparison of the criteria 3. Pathogen weighting for each criterion : pairwise comparison 4. Compute the multi-criteria score: prioritized list of 25% pathogens 20% Simulation of Pathogen Prioritization 15% 10% 5% 0% P1 P2 P3 P4 P5 P6 P7 P8 P9 P10
Global PPL: timeline Jun-Aug 2016 Oct-Nov 2016 Dec-Jan 2017 Feb 2017 Public tender June: Tender preparation July: tender publication August: evaluation and appointment September: signing and start 26 Essential Medicines List: Concept and Procedures
Global PPL: timeline Jun-Aug 2016 Oct-Nov 2016 Dec-Jan 2017 Feb 2017 Protocol development and coordination Developing the protocol (building on existing activities) Sharing methodologies and approaches Define feasibility of deliverables 27 Essential Medicines List: Concept and Procedures
Global PPL: timeline Jun-Aug 2016 Oct-Nov 2016 Dec-Jan 2017 Feb 2017 Draft PPL and draft report Verify firsst round applications (the early the better) for full adoption of systematic reviews and GRADE approach 28 Essential Medicines List: Concept and Procedures
Global PPL: timeline Jun-Aug 2016 Oct-Nov 2016 Dec-Jan 2017 Feb 2017 PPL web publication End of February unedited version published Mid-March: full publication 29 Essential Medicines List: Concept and Procedures
Contents of the presentation WHO EML: a quick history EML role in AMR & AB use Review of EML antibiotics chapter (March 2017), 20 syndromes guidances AB Drug utilization and monitoring Stewardship and implementing change A global Priority Pathogens List Approach and methodology Timeline Conclusions
WHO Global PPL It will be a bit of a rush (in less than 6 months) We ll build and coordinate with current WHO work on R&D blueprint for action to prevent epidemics We ll be inclusive, explicit and transparent