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Guide for establishing laboratory-based surveillance for antimicrobial resistance Dr Jean Bosco NDIHOKUBWAYO, MD Regional Adviser, Laboratories &Clinical Technologies [email protected] ASLM and WHO‐AFRO Joint meeting on Global Health Security Agenda, Freetown, Sierra Leone, 15‐16 October 2015 Presentation Outline Background/introduction Current situation of AMR in the WHO‐AFR Guide for establishing laboratory‐based surveillance for antimicrobial resistance Take away messages Conclusion 2 Background Critical role of antimicrobials in reducing the burden of communicable diseases all over the world. The curative power of infectious diseases by drugs or drug efficacy is not infinite. AMR threatens the effectiveness of successful treatment of infections and is a public health issue with national and global dimensions. In low‐income countries, AMR frequently occurs in microorganisms that are likely to be transmitted in the community: organisms causing pneumonia, diarrheal diseases, TB, STDs and malaria. Drug resistance has dramatically increased the costs of fighting TB and malaria, and slowed gains against childhood dysentery and pneumonia. AMR also threatens the push to treat people living with HIV/AIDS effectively. Political momentum to tackle AMR Since 2011, WHO increased efforts across the Organization to scale up the fight against AMR http://www.who.int/drugresistance/activities/en/ Resolution WHA67.25 on AMR on the 24th of May 2014 Global Health Security Agenda 4 Current situation of AMR in the WHO African Region Inadequate data as surveillance of drug resistance is limited to a few countries resulting in complete data of the true extent and magnitude of this problem Despite limited laboratory capacity to monitor AMR, available data suggest that the African Region shares the worldwide trend of increasing drug resistance. Significant resistance has, for example, been reported for diseases such as cholera, dysentery, typhoid, meningitis, gonorrhea, TB, malaria and AIDS. Current situation of AMR in the WHO African Region‐TB Since 2006, the AFR has witnessed the increasing emergence of MDR/XDR‐TB 2004‐2011, a total of 3 231 XDR‐TB cases were reported from eight countries. Most African countries lack the laboratory capacity to confirm drug‐resistant TB and so the true burden is not well known Reported cases of RR‐/MDR‐TB in 2013‐ WHO AFRO region Cases tested for RR‐/MDR‐TB • • • New Retreatm ent Total 5083 (<1%)§ 9925 (7.1%)§ 292,797 Lab confirmed RR‐/MDR‐TB cases 34480 Patients started on MDR‐TB treatment 14418 (41.8%) §§ DST capacity in the region is a limiting factor in achieving UNIVERSAL ACCESS ǂ for testing XDR is reported in all WHO‐Regions. Globally, the average proportion of MDR‐TB cases with XDR‐ TB** was 9.0% (95% CI: 6.5–11.5%), in 2013. All countries, in the region, need capacity to • Scale up rapid testing and detection of all MDR‐TB cases • Strengthen the Lab and Referral Networks for MDR‐TB/ XDR‐TB detection/confirmation • Initiate continuous surveillance of DR‐TB § Among total notified cases in the region; §§ among lab confirmed + empiric treatment **XDR‐TB is defined as MDR‐TB plus resistance to at least one fluoroquinolone and a second‐ line injectable ǂ The World Health Assembly (WHA) resolution on M/XDR‐TB in 2009; ‐Post 2015 STOP TB strategy *Global TB report, 2014, WHO‐Regional profiles Current situation of AMR in the WHO‐AFR‐Enterics Percentage of resistance among Shigella 2008 to 2011 Trimethoprim-sulfamethoxazole • 82% resistant to primary drug (SXT) 191 8 954 S I R 82% • AMR data disseminated to improve treatment protocols Introduction of other drugs (e.g CIP) with increased effectiveness Source: Member States Ciprofloxacin 14 15 1330 98% Disk diffusion testing S I R Current situation of AMR in the AFR-meningitis Meningitis: 500 million people at risk in 21 countries Pathogens identified by labs in the meningitis belt countries Week 01‐35, 2015 Country Number Contam. CSF In process CSF Benin 19 Burkina Faso 1 419 Cameroun 62 Centrafrique 283 Côte d'Ivoire 126 Ethiopia ‐ Ghana 160 Guinea 93 Gambia 17 Kenya ‐ Mali 254 Mauritania 1 Niger 4 079 Nigeria 32 RD Congo 161 Senegal 375 South Sudan ‐ Sudan ‐ Tchad 69 Togo 152 Uganda ‐ Total 7 302 0 0 0 0 2 ‐ 0 0 0 ‐ 0 0 0 0 3 0 ‐ ‐ 6 0 ‐ 11 0 0 0 0 0 ‐ 0 0 0 ‐ 0 0 40 3 0 0 ‐ ‐ 1 0 ‐ 44 CSF negative NmA 17 0 783 3 48 0 269 0 107 0 ‐ ‐ 108 0 13 74 16 0 ‐ ‐ 200 0 0 0 2 583 0 9 0 127 0 362 0 ‐ ‐ ‐ ‐ 51 0 125 0 ‐ ‐ 4 818 77 NmB NmC NmX 0 0 0 0 6 4 0 0 0 0 0 0 0 1 1 ‐ ‐ ‐ 1 0 0 0 0 0 0 0 0 ‐ ‐ ‐ 0 7 13 0 0 0 01 087 1 0 20 0 0 0 0 0 0 0 ‐ ‐ ‐ ‐ ‐ ‐ 0 0 0 0 0 0 ‐ ‐ ‐ 11 121 19 NmY Nm W135 0 0 0 0 0 ‐ 0 0 0 ‐ 0 0 0 0 0 0 ‐ ‐ 0 0 ‐ 0 1 217 6 0 0 ‐ 27 0 1 ‐ 3 1 196 0 0 5 ‐ ‐ 1 8 ‐ 466 Other Nm ind. S.Pneum 0 3 0 1 3 ‐ 1 0 0 ‐ 0 0 65 0 0 0 ‐ ‐ 0 7 ‐ 80 1 390 8 5 7 ‐ 23 5 0 ‐ 23 0 101 0 6 6 ‐ ‐ 6 12 ‐ 593 Hib 0 11 0 0 4 ‐ 0 1 0 ‐ 3 0 5 0 1 2 ‐ ‐ 1 0 ‐ 28 Other Pathogens 0 2 0 8 1 ‐ 0 0 0 ‐ 5 0 1 0 24 0 ‐ ‐ 3 0 ‐ 44 Meningitis in Africa: Map of meningitis ppathogens identified in the meningitis belt, Week 01‐35, 2015 Current situation of AMR in the WHO‐AFR‐meningitis Resistance rates to oxacillin among Neisseria meningitidis using the disc diffusion testing in 2008-2009 78 35% 146 65% S R AMR rates suggest that ATCC strains is not regularly used for quality control and MIC is not performed in most Member states Disc diffusion tests are unreliable 11 countries • In 2008‐2009, MIC were determined for 83 isolates from 6 countries using Etest on MH + 5% sheep blood (EMGM) • Only eight isolates (10%) were less susceptible to penicillin (0.094≤MIC≤0.25) Source: WHO CC on Meningococci in Marseille [7th Meningitis annual revue and planning meeting 2009] Guide for establishing laboratory‐based surveillance for antimicrobial resistance http://apps.who.int/medicinedocs/documents/s20135en/s201 5en.pdf 13 Main objectives of the guide 1/2 To provide background information and define the key steps for the countries to conduct AMR surveillance for meningitis, bacteraemia and common enteric epidemic‐prone diseases in a national bacteriology reference laboratory To support IDSR implementation and global health security agenda as envisaged by IHR (2005) through strengthening laboratory services and sharing information on AMR To promote discussion on a step‐by‐step approach for involving multidisciplinary teams from hospitals, laboratories, universities, national surveillance units and veterinary sector in containment of AMR. To contribute to the improvement of surveillance of antimicrobial resistance at the country level 14 Main objectives of the guide 2/2 To facilitate establishing of laboratory‐based surveillance for priority bacterial diseases in the WHO African Region. To promote the development of a plan for implementing and strengthening laboratory‐based AMR surveillance and strengthening the capacity of laboratories responsible for isolation and identification of selected bacterial diseases. To improve the standardization process used by bacteriology reference laboratories to confirm the bacterial causative agents of severe diseases such as bacteraemias, enteritis and meningitis To strengthen the capacity of bacteriology reference laboratories to monitor AMR; improve the quality of AMR data by harmonizing laboratory techniques; and enhance the regional database on AMR. 15 Regional antimicrobial resistance network Goals To Build national laboratory capacity in African countries to conduct AST Provide access to standardized practices for conducting laboratory‐based surveillance of AMR Promote advanced and specialized testing on selected pathogens by regional reference laboratories or collaborating centres Build the foundation for future studies on the containment of AMR. Key steps and activities in implementing the Guidance (1/2) Step Key point to consider Roles of WHO and partners Adoption of the generic laboratory‐based surveillance guide on AMR • Technical meeting for adoption of the key elements of the guide. This will allow staff involved in AMR surveillance to learn and comply with its objectives and content even though CLSI or CA-SFM guidelines are subject to change annually Technical support in adaptation or adoption of the guide • Dissemination of the guide as appropriate Designation of the national reference laboratory for AMR Selection of one national reference bacteriology laboratory with capacity for AST for meningitis and enteric and other pathogens Define or update the terms of reference of the national reference laboratory related to AMR surveillance (see Section VII) Assessment of the capacity for Self-assessment of laboratory capacity using existing AMR surveillance, identification WHO standardized tools and proposed key activities of the gaps and development on a need to be supported based on findings of the national plan assessment and the requirements of the national guidelines on AMR Advocacy To help develop an appropriate plan Key steps and activities in implementing the Guidance (2/2) Step Key point to consider Roles of WHO and partners Implementation of laboratorybased surveillance of AMR Key actions may include but are not limited to: Technical support to Member States through the AMR laboratory network activities • Updating or creating new SOPs • Procuring essential reagents and supplies for the national reference laboratory • Ensuring the laboratory has adequate personnel and ongoing training of staff • Active participation in EQA Programs on AMR testing and reporting • Collection and sharing of data on AMR for MoH and WHO • Providing regular annual reports on AMR • Monitoring, evaluating and improving the implementation process Take away messages Develop comprehensive national policies and plans to prevent and combat AMR Establish national policy platform for management of antibiotic resistance Build clinical and public health laboratory capacity Improve antimicrobial surveillance systems by collecting and sharing information on AMR across national/regional networks of laboratories Establish Regional framework for collaborative surveillance of antibiotic resistance Strengthen national medicines regulatory capacities in the African Region 19 Conclusion Left unchecked, the uncontrolled rise in resistant germs threatens lives and wastes limited resources. Urgent and coordinated action is required at all levels to ensure the preservation of these life‐saving drugs for future generations. Laboratory capacity for AMR testing and reporting should be strengthened as key element of AMR surveillance for action to limit the evolution and possible spread of resistant germs. 20 Mahatma Gandhi and a lab tool in 1946 Thank you 21