21 st Expert Committee on Selection and Use of Essential Medicines Peer Review Report Antibiotics Review

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1 (1) Have all important studies/evidence of which you are aware been included in the application? Yes No Please provide brief comments on any relevant studies that have not been included: (2) For each of the infectious syndromes reviewed in the application, please comment in the table below on the proposed classification of antibiotics as core or targeted : INFECTIOUS SYNDROMES COMMENTS (use as much space as you need) : Core: Amoxicillin Targeted: Co-amoxiclav, Penicillin G, Clarithromycin, Piperacillin-tazobactam, Ceftriaxone, Levofloxacin, Doxycycline, Vancomycin : Community acquired pneumonia (CAP) Core: Amoxicillin Targeted: Co-amoxiclav, Penicillin G, Clarithromycin, Ampicillin, Cefotaxime, Ceftriaxone, Gentamicin, Vancomycin Core: Penicillin V, Amoxicillin Targeted: Clarithromycin : Pharyngitis Core: Penicillin V, Amoxicillin Targeted: Clarithromycin Core: Amoxicillin, Co-Amoxiclav, Ceftriaxone Targeted: Levofloxacin, moxifloxacin Sinusitis : Core: Amoxicillin, Co-Amoxiclav, Ceftriaxone

2 Otitis Media 21 st Expert Committee on Selection and Use of Essential Medicines Hospital acquired pneumonia (HAP) & Ventilator associated pneumonia (VAP) Sepsis in children Urinary tract infections Catheter associated urinary tract infections Core: Amoxicillin, Co-Amoxiclav, Targeted: Ceftriaxone : Core: Amoxicillin, Co-Amoxiclav Targeted: Cefuroxime-axetil, Ceftriaxone Core: Amoxicillin, Co-Amoxiclav, Piperacillin-tazobactam, Cefotaxime, ceftriaxone Targeted: Levofloxacin, moxifloxacin, ciprofloxacin, ceftazidime, aztreonam, meropenem, imipenem, amikacin, gentamicin, tobramycin Notably, piperacillin-tazobactam and meropenem are recommended by the reviewers but are not listed in the current EMl. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of lifethreatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any other antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of piperacillin-tazobactam and meropenem to the Essential Medicines List. Core: Ampicillin, Benzylpenicillin, Gentamicin Core: Amoxicillin, Co-Amoxiclav, Targeted: Ampicillin, Gentamicin, Ceftriaxone Complementary: Trimethoprim/ sulfamethoxazole, Nitrofurantoin, Fosfomycin : Core: Amoxicillin, Co-Amoxiclav, Targeted: Ampicillin, Gentamicin, Ceftriaxone Complementary: Trimethoprim/ sulfamethoxazole, Nitrofurantoin Fosfomycin is recommended but not found in the current EML. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). or complementary. Inclusion of antibiotics recommended in this application would require addition of fosfomycin to the Essential Medicines List. No systematic reviews for the antibiotic therapy of catheter-associated UTI were found. As a result, specific recommendations were made by the reviewers. Endocarditis Targeted: Amoxicillin, Ampicillin, Ceftriaxone, Oxacillin, Penicillin G, Ciprofloxacin, Gentamicin, Streptomycin, Doxycycline, Linezolid, Daptomycin, Rifampicin, Vancomycin

3 Daptomycin is recommended but not found in the current EML. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). or complementary. Inclusion of antibiotics recommended in this application would require addition of daptomycin to the Essential Medicines List. Meningitis Central catheter infections Complicated intra-abdominal infections Core: ampicillin, ceftriaxone, penicillin G Targeted: ceftazidime, meropenem, amikacin, gentamicin, vancomycin Core: ampicillin, ceftriaxone, cefotaxime, penicillin G Targeted: ceftazidime, meropenem, amikacin, gentamicin, vancomycin Meropenem is listed but not a core antibiotic in the current EML. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of life-threatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any other antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of meropenem to the Essential Medicines List. Core: vancomycin Targeted: piperacillin-tazobactam, meropenem Core: vancomycin Targeted: piperacillin-tazobactam, meropenem Notably, piperacillin-tazobactam and meropenem are recommended by the reviewers but are not listed in the current EMl. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of lifethreatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any other antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of piperacillin-tazobactam and meropenem to the Essential Medicines List. Community-acquired ciai, not severe Core: co-amoxiclav, cefotaxime, ceftriaxone, metronidazole Targeted: levofloxacin, ciprofloxacin Core: cefotaxime, ceftriaxone, metronidazole Targeted: ciprofloxacin Severe community-acquired ciai and all hospital-acquired ciai Core: piperacillin-tazobactam, cefotaxime, ceftriaxone, metronidazole Targeted: ampicillin, levofloxacin, ciprofloxacin, ceftazidime, meropenem, gentamicin, tobramycin, vancomycin Core: cefotaxime, ceftriaxone, metronidazole Targeted: ampicillin, ciprofloxacin, ceftazidime, meropenem, gentamicin,

4 tobramycin, vancomycin Skin and soft tissue infections (incl. cellulitis and surgical site infections) Acute infectious diarrhoea Piperacillin-tazobactam, levofloxacin, meropenem and tobramycin are recommended but not found in the current EML. Meropenem is listed but not a core antibiotic in the current EML. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of life-threatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of piperacillin-tazobactam, levofloxacin, meropenem and tobramycin to the Essential Medicines List. Mild skin and soft tissue infections (impetigo, uncomplicated cellulitis, mild diabetic foot infection, bites Core: co-amoxiclav, dicloxacillin, cefurome, cephalexin Targeted: clindamycin, doxycycline, levofloxacin, ciprofloxacin, moxifloxacin, trimethoprim/sulphamethoxazole Core: co-amoxiclav, dicloxacillin, cephalexin Targeted: clindamycin, trimethoprim/sulphamethoxazole Severe community-acquired ciai and all hospital-acquired ciai Core: Penicillin G, co-amoxiclav, oxacillin, cloxacillin, cefazolin, cefoxitin, ceftriaxone, cefotaxime, clindamycin, metronidazole Targeted: piperacillin-tazobactam, levofloxacin, ciprofloxacin, moxifloxacin, meropenem, vancomycin Core: Penicillin G, co-amoxiclav, oxacillin, cefazolin, cefoxitin, ceftriaxone, clindamycin, metronidazole Targeted: piperacillin-tazobactam, ciprofloxacin, meropenem, vancomycin Dicloxacillin, cefuroxime, cephalexin, levofloxacin, meropenem and moxifloxacin are recommended but not found in the current EML. Meropenem is listed but not a core antibiotic in the current EML. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of life-threatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of dicloxacillin, cefuroxime, cephalexin, levofloxacin, meropenem and moxifloxacin to the Essential Medicines List. Core: doxycycline, trimethoprim/sulfamethoxazole, ceftriaxone, metronidazole, vancomycin Targeted: levofloxacin, ciprofloxacin, azithromycin Core: trimethoprim/sulfamethoxazole, ceftriaxone, metronidazole, vancomycin Targeted: ciprofloxacin, azithromycin Levofloxacin is recommended but not found in the current EML. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015).

5 or complementary. Inclusion of antibiotics recommended in this application would require addition of levofloxacin to the Essential Medicines List. Sexually transmitted diseases Exacerbations of COPD Bone and joint infections Febrile neutropenia Core: ceftriaxone, cefixime, benzathine penicillin G, Penicillin G, procaine penicillin G, doxycycline, metronidazole Targeted: azithromycin Core: amoxicillin, co-amoxiclav, cefuroxime, cephalexin, doxycycline, clarithromycin, levofloxacin Targeted: doxycycline, clarithromycin, levofloxacin Cefuroxime, cephalexin and levofloxacin is recommended but not found in the current EML. Clarithromycin is recommended but not 5 th WHO Model List of Essential Medicines for Children (2015). All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of cefuroxime, cephalexin and levofloxacin to the Essential Medicines List. Core: ampicillin, penicillin G, cephalexin, cefazoline, dicloxacillin, ceftriaxone, levofloxacin, meropenem, ciprofloxacin, trimethoprim/sulfamethoxazole, doxycycline, vancomycin Levofloxacin and meropenem is recommended but not found in the current EML. Meropenem is listed but not a core antibiotic in the current EML. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of life-threatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of levofloxacin and meropenem to the Essential Medicines List. : Core: Amoxicillin-clavulanate, Piperacillin-tazobactam, Ciprofloxacin Targeted: Meropenem, Amikacin, Gentamicin, Vancomycin Children: Core: Amoxicillin-clavulanate Targeted: Meropenem, Amikacin, Gentamicin, Vancomycin Piperacillin-tazobactam, meropenem and amikacin is recommended but not found in the current EML. Meropenem is listed but not a core antibiotic in the current EML. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of life-threatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. All other recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any antibiotic as core or complementary. Inclusion of antibiotics recommended in this application would require addition of piperacillin-tazobactam, meropenem and

6 amikacin to the Essential Medicines List. 201 (3) Please comment on the final proposed antibiotic listings across syndromes, specifying which antibiotics should be listed on the EML and/or EMLc, including the proposal for conserved antibiotics. Piperacillin-tazobactam and meropenem have been recommended in several infectious syndromes. Inclusion for these is recommended to the EML. Conserved antibiotics identified by the reviewers are linezolid, tigecycline, cefepime, colistin, daptomycin, moxifloxacin, aztreonam, rifampin, ertapenem and chloramphenicol. Linezolid, moxifloxacin and chloramphenicol are listed in the 19th WHO Essential Medicines List (2015). The inclusion of tigecycline, cefepime, colistin, daptomycin, aztreonam, rifampin andertapenem would require amendment of the Essential Medicines List. (4) Please frame the decisions and recommendations that the Expert Committee could make. As noted above, piperacillin-tazobactam and meropenem have been recommended in several infectious syndromes. In the current EML and EMLc, meropenem is noted as an alternative to imipenem + cilastatin, only for the treatment of life-threatening hospital-based infection due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of meningitis and is licensed for use in children over the age of 3 months. It is recommended that the committee consider amending the EML and EMLc to include piperacillin-tazobactam and meropenem. (5) References (if required) Please see individual applications for full references (

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