Encouraging AWaRe-ness and discouraging inappropriate antibiotic use—the new 2019 Essential Medicines List becomes a global antibiotic stewardship tool
The AWaRe groups are now explicitly linked to the WHO Priority Pathogens List.7 New antibiotics eligible for the Reserve category must be active, at least in vitro, against organisms of critical or high priority on the Priority Pathogens list.7 Fourth-generation cephalosporins in the AWaRe list were...
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| Veröffentlicht in: | The Lancet infectious diseases 2019-12, Vol.19 (12), p.1278-1280 |
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| creator | Sharland, Mike Gandra, Sumanth Huttner, Benedikt Moja, Lorenzo Pulcini, Celine Zeng, Mei Mendelson, Marc Cappello, Bernadette Cooke, Graham Magrini, Nicola Aziz, Zeba Cavalli, Franco De Vries, Elisabeth Genazzani, Armando Imi, Monica Kearns, Gregory Kokwaro, Gilbert Prutsky, Gabriela J Sarrafzadegan, Nizal Sri Ranganathan, Shalini Suleman, Fatima Yoongthong, Worasuda Harbarth, Stephan Loeb, Mark Mertz, Dominik Tacconelli, Evelina Villegas, Maria V |
| description | The AWaRe groups are now explicitly linked to the WHO Priority Pathogens List.7 New antibiotics eligible for the Reserve category must be active, at least in vitro, against organisms of critical or high priority on the Priority Pathogens list.7 Fourth-generation cephalosporins in the AWaRe list were reclassified from the Reserve group to the Watch group, but were removed from the EML as they were not recommended by the Expert Committee as first-choice or second-choice therapies in any of 26 infectious syndromes reviewed.4,8 Similarly, other antibiotics such as aztreonam, ceftaroline, daptomycin, and tigecycline were removed because they were not deemed to be of sufficiently high priority for multidrug-resistant infections (aztreonam and tigecycline), because of safety concerns (eg, tigecycline has a black-box warning from the US Food and Drug Administration), or because EML-listed alternatives were available, such as linezolid for meticillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci (ceftaroline and daptomycin). Recognising the need to stop the inappropriate use of antibiotics, the EML Committee recommended that WHO add a group to the AWaRe classification tool for antibiotics that are not used on the basis of sound evidence or recommended in high-quality international guidelines, particularly for fixed-dose combinations of multiple broad-spectrum antibiotics. The EML Committee noted that there was “very limited clinical trial evidence” comparing the efficacy of the newly added antibiotics against infections caused by carbapenem-resistant bacteria and their approval was based on small individual clinical studies.4 The Committee was very concerned that the current regulatory approval process for new drugs targeting the Critical group of the Priority Pathogens does not adequately meet the major public health need for clear evidence-based guidance on the optimal management of carbapenem-resistant infections. |
| doi_str_mv | 10.1016/S1473-3099(19)30532-8 |
| format | Article |
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Recognising the need to stop the inappropriate use of antibiotics, the EML Committee recommended that WHO add a group to the AWaRe classification tool for antibiotics that are not used on the basis of sound evidence or recommended in high-quality international guidelines, particularly for fixed-dose combinations of multiple broad-spectrum antibiotics. The EML Committee noted that there was “very limited clinical trial evidence” comparing the efficacy of the newly added antibiotics against infections caused by carbapenem-resistant bacteria and their approval was based on small individual clinical studies.4 The Committee was very concerned that the current regulatory approval process for new drugs targeting the Critical group of the Priority Pathogens does not adequately meet the major public health need for clear evidence-based guidance on the optimal management of carbapenem-resistant infections.</description><identifier>ISSN: 1473-3099</identifier><identifier>EISSN: 1474-4457</identifier><identifier>DOI: 10.1016/S1473-3099(19)30532-8</identifier><identifier>PMID: 31782385</identifier><language>eng</language><publisher>United States: Elsevier Ltd</publisher><subject>Anti-Bacterial Agents - therapeutic use ; Antibiotic resistance ; Antibiotics ; Antimicrobial Stewardship - methods ; Aztreonam ; Cephalosporins ; Committees ; Daptomycin ; Drug delivery ; Drug dosages ; Drugs, Essential ; FDA approval ; Global Health ; Humans ; Inappropriate Prescribing ; Infections ; Infectious diseases ; Life Sciences ; Linezolid ; Methicillin ; Multidrug resistance ; Pathogens ; Public health ; Regulatory approval ; Santé publique et épidémiologie ; Tigecycline ; Vancomycin</subject><ispartof>The Lancet infectious diseases, 2019-12, Vol.19 (12), p.1278-1280</ispartof><rights>2019 Elsevier Ltd</rights><rights>2019. Elsevier Ltd</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c474t-219b5cf9da0a8de90a0950395a4b17919ced0843bc0f7a87e15b90909dc366bd3</citedby><cites>FETCH-LOGICAL-c474t-219b5cf9da0a8de90a0950395a4b17919ced0843bc0f7a87e15b90909dc366bd3</cites><orcidid>0000-0001-8626-8291 ; 0000-0002-1749-9464</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.sciencedirect.com/science/article/pii/S1473309919305328$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>230,314,776,780,881,3537,27901,27902,65306</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31782385$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://hal.univ-lorraine.fr/hal-02438464$$DView record in HAL$$Hfree_for_read</backlink></links><search><creatorcontrib>Sharland, Mike</creatorcontrib><creatorcontrib>Gandra, Sumanth</creatorcontrib><creatorcontrib>Huttner, Benedikt</creatorcontrib><creatorcontrib>Moja, Lorenzo</creatorcontrib><creatorcontrib>Pulcini, Celine</creatorcontrib><creatorcontrib>Zeng, Mei</creatorcontrib><creatorcontrib>Mendelson, Marc</creatorcontrib><creatorcontrib>Cappello, Bernadette</creatorcontrib><creatorcontrib>Cooke, Graham</creatorcontrib><creatorcontrib>Magrini, Nicola</creatorcontrib><creatorcontrib>Aziz, Zeba</creatorcontrib><creatorcontrib>Cavalli, Franco</creatorcontrib><creatorcontrib>De Vries, Elisabeth</creatorcontrib><creatorcontrib>Genazzani, Armando</creatorcontrib><creatorcontrib>Imi, Monica</creatorcontrib><creatorcontrib>Kearns, Gregory</creatorcontrib><creatorcontrib>Kokwaro, Gilbert</creatorcontrib><creatorcontrib>Prutsky, Gabriela J</creatorcontrib><creatorcontrib>Sarrafzadegan, Nizal</creatorcontrib><creatorcontrib>Sri Ranganathan, Shalini</creatorcontrib><creatorcontrib>Suleman, Fatima</creatorcontrib><creatorcontrib>Yoongthong, Worasuda</creatorcontrib><creatorcontrib>Harbarth, Stephan</creatorcontrib><creatorcontrib>Loeb, Mark</creatorcontrib><creatorcontrib>Mertz, Dominik</creatorcontrib><creatorcontrib>Tacconelli, Evelina</creatorcontrib><creatorcontrib>Villegas, Maria V</creatorcontrib><creatorcontrib>EML Expert Committee and Antibiotic Working Group</creatorcontrib><title>Encouraging AWaRe-ness and discouraging inappropriate antibiotic use—the new 2019 Essential Medicines List becomes a global antibiotic stewardship tool</title><title>The Lancet infectious diseases</title><addtitle>Lancet Infect Dis</addtitle><description>The AWaRe groups are now explicitly linked to the WHO Priority Pathogens List.7 New antibiotics eligible for the Reserve category must be active, at least in vitro, against organisms of critical or high priority on the Priority Pathogens list.7 Fourth-generation cephalosporins in the AWaRe list were reclassified from the Reserve group to the Watch group, but were removed from the EML as they were not recommended by the Expert Committee as first-choice or second-choice therapies in any of 26 infectious syndromes reviewed.4,8 Similarly, other antibiotics such as aztreonam, ceftaroline, daptomycin, and tigecycline were removed because they were not deemed to be of sufficiently high priority for multidrug-resistant infections (aztreonam and tigecycline), because of safety concerns (eg, tigecycline has a black-box warning from the US Food and Drug Administration), or because EML-listed alternatives were available, such as linezolid for meticillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci (ceftaroline and daptomycin). Recognising the need to stop the inappropriate use of antibiotics, the EML Committee recommended that WHO add a group to the AWaRe classification tool for antibiotics that are not used on the basis of sound evidence or recommended in high-quality international guidelines, particularly for fixed-dose combinations of multiple broad-spectrum antibiotics. The EML Committee noted that there was “very limited clinical trial evidence” comparing the efficacy of the newly added antibiotics against infections caused by carbapenem-resistant bacteria and their approval was based on small individual clinical studies.4 The Committee was very concerned that the current regulatory approval process for new drugs targeting the Critical group of the Priority Pathogens does not adequately meet the major public health need for clear evidence-based guidance on the optimal management of carbapenem-resistant infections.</description><subject>Anti-Bacterial Agents - therapeutic use</subject><subject>Antibiotic resistance</subject><subject>Antibiotics</subject><subject>Antimicrobial Stewardship - methods</subject><subject>Aztreonam</subject><subject>Cephalosporins</subject><subject>Committees</subject><subject>Daptomycin</subject><subject>Drug delivery</subject><subject>Drug dosages</subject><subject>Drugs, Essential</subject><subject>FDA approval</subject><subject>Global Health</subject><subject>Humans</subject><subject>Inappropriate Prescribing</subject><subject>Infections</subject><subject>Infectious diseases</subject><subject>Life Sciences</subject><subject>Linezolid</subject><subject>Methicillin</subject><subject>Multidrug resistance</subject><subject>Pathogens</subject><subject>Public health</subject><subject>Regulatory approval</subject><subject>Santé publique et épidémiologie</subject><subject>Tigecycline</subject><subject>Vancomycin</subject><issn>1473-3099</issn><issn>1474-4457</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNqFkc1uEzEUhS0EoiXwCCBLbNrFUHtsZ8YrFFWhRQqqxI9YWh77JnE1GYexp1V3PASbvl6fpDeZUhAb5IV_7udj33MIec3ZO8749OQLl5UoBNP6iOtjwZQoi_oJOcRjWUipqqf79YgckBcpXTLGK87kc3IgeFWXolaH5HbeuTj0dhW6FZ19t5-h6CAlajtPfUh_aqGz220ft32wGbCcQxNiDo4OCe5-_sproB1c05JxTecpAQK2pZ_ABxdQkS5CyrQBFze4sXTVxgbrf-mkDNe292kdtjTH2L4kz5a2TfDqYZ6Qbx_mX0_Pi8XF2cfT2aJw2GkuSq4b5ZbaW2ZrD5pZphUTWlnZ8Epz7cCzWorGsWVl6wq4ajTD4Z2YThsvJuR41F3b1mB7G9vfmGiDOZ8tzO6MlVLUciqvOLJHI4tO_BggZbNBj6BtbQdxSKYUJROVquoa0bf_oJfoZYedIMU1V5ohOyFqpFwfU-ph-fgDzswuZ7PP2exCNFybfc5mp_7mQX1oNuAfb_0OFoH3IwBo3VWA3iQXoEMzQg8uGx_Df564B1vluTc</recordid><startdate>201912</startdate><enddate>201912</enddate><creator>Sharland, Mike</creator><creator>Gandra, Sumanth</creator><creator>Huttner, Benedikt</creator><creator>Moja, Lorenzo</creator><creator>Pulcini, Celine</creator><creator>Zeng, Mei</creator><creator>Mendelson, Marc</creator><creator>Cappello, Bernadette</creator><creator>Cooke, Graham</creator><creator>Magrini, Nicola</creator><creator>Aziz, Zeba</creator><creator>Cavalli, Franco</creator><creator>De Vries, Elisabeth</creator><creator>Genazzani, Armando</creator><creator>Imi, Monica</creator><creator>Kearns, Gregory</creator><creator>Kokwaro, Gilbert</creator><creator>Prutsky, Gabriela J</creator><creator>Sarrafzadegan, Nizal</creator><creator>Sri Ranganathan, Shalini</creator><creator>Suleman, Fatima</creator><creator>Yoongthong, Worasuda</creator><creator>Harbarth, Stephan</creator><creator>Loeb, Mark</creator><creator>Mertz, Dominik</creator><creator>Tacconelli, Evelina</creator><creator>Villegas, Maria V</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><general>New York, NY : Elsevier Science ; The Lancet Pub. 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| ispartof | The Lancet infectious diseases, 2019-12, Vol.19 (12), p.1278-1280 |
| issn | 1473-3099 1474-4457 |
| language | eng |
| recordid | cdi_hal_primary_oai_HAL_hal_02438464v1 |
| source | MEDLINE; Elsevier ScienceDirect Journals |
| subjects | Anti-Bacterial Agents - therapeutic use Antibiotic resistance Antibiotics Antimicrobial Stewardship - methods Aztreonam Cephalosporins Committees Daptomycin Drug delivery Drug dosages Drugs, Essential FDA approval Global Health Humans Inappropriate Prescribing Infections Infectious diseases Life Sciences Linezolid Methicillin Multidrug resistance Pathogens Public health Regulatory approval Santé publique et épidémiologie Tigecycline Vancomycin |
| title | Encouraging AWaRe-ness and discouraging inappropriate antibiotic use—the new 2019 Essential Medicines List becomes a global antibiotic stewardship tool |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2025-02-09T05%3A59%3A44IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_hal_p&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Encouraging%20AWaRe-ness%20and%20discouraging%20inappropriate%20antibiotic%20use%E2%80%94the%20new%202019%20Essential%20Medicines%20List%20becomes%20a%20global%20antibiotic%20stewardship%20tool&rft.jtitle=The%20Lancet%20infectious%20diseases&rft.au=Sharland,%20Mike&rft.aucorp=EML%20Expert%20Committee%20and%20Antibiotic%20Working%20Group&rft.date=2019-12&rft.volume=19&rft.issue=12&rft.spage=1278&rft.epage=1280&rft.pages=1278-1280&rft.issn=1473-3099&rft.eissn=1474-4457&rft_id=info:doi/10.1016/S1473-3099(19)30532-8&rft_dat=%3Cproquest_hal_p%3E2319159020%3C/proquest_hal_p%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=2319159020&rft_id=info:pmid/31782385&rft_els_id=S1473309919305328&rfr_iscdi=true |