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Home , Ampicillin, Cefuroxime axetil, Dicloxacillin, Piperacillin, Tazobactam

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

(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)

Adults: . Core: . Targeted: Co-amoxiclav, G, Clarithromycin, -, , Levofloxacin, Doxycycline, Paediatric:

Community acquired (CAP) . Core: Amoxicillin . Targeted: Co-amoxiclav, Penicillin G, Clarithromycin, , , Ceftriaxone, , Vancomycin Recommended antibiotics are found in the 19th WHO Essential Medicines List (2015). This document does not propose changing the classification of any as core or complementary. Inclusion of antibiotics recommended in this application do not require amendment of the current Essential Medicines List. Adults . Core: Penicillin V, Amoxicillin . Targeted: Clarithromycin Paediatric:

Pharyngitis . Core: Penicillin V, Amoxicillin . Targeted: Clarithromycin 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 do not require amendment of the current Essential Medicines List. Adults . Core: Amoxicillin, Co-Amoxiclav, Ceftriaxone . Targeted: Levofloxacin, moxifloxacin Paediatric: . Core: Amoxicillin, Co-Amoxiclav, Ceftriaxone 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 do not require amendment of the current Essential Medicines List. 21st Expert Committee on Selection and Use of Essential Medicines Peer Review Report – Antibiotics Review Adults . Core: Amoxicillin, Co-Amoxiclav, . Targeted: Ceftriaxone Paediatric:

Otitis Media . Core: Amoxicillin, Co-Amoxiclav . Targeted: -axetil, Ceftriaxone 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 do not require amendment of the current Essential Medicines List. Adults . Core: Amoxicillin, Co-Amoxiclav, Piperacillin-tazobactam, Cefotaxime, ceftriaxone . Targeted: Levofloxacin, moxifloxacin, ciprofloxacin, , , , , , gentamicin, 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 Hospital acquired pneumonia (HAP) & noted as an alternative to imipenem + cilastatin, “only for the treatment of life- Ventilator associated pneumonia (VAP) threatening hospital-based due to suspected or proven multidrug-resistant infection. Meropenem is indicated for the treatment of 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. Paediatric . Core: Ampicillin, , Gentamicin

Sepsis in children 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 do not require amendment of the current Essential Medicines List. Adults . Core: Amoxicillin, Co-Amoxiclav, . Targeted: Ampicillin, Gentamicin, Ceftriaxone . Complementary: Trimethoprim/ sulfamethoxazole, Nitrofurantoin, Paediatric: . Core: Amoxicillin, Co-Amoxiclav, Urinary tract . 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). 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 fosfomycin to the Essential Medicines List. No systematic reviews for the antibiotic therapy of catheter-associated UTI were Catheter associated urinary tract found. As a result, specific recommendations were made by the reviewers. infections

Adults . Targeted: Amoxicillin, Ampicillin, Ceftriaxone, , Penicillin G, Ciprofloxacin, Gentamicin, Streptomycin, Doxycycline, , , , Vancomycin 21st Expert Committee on Selection and Use of Essential Medicines Peer Review Report – Antibiotics Review Daptomycin is recommended but not found in the current EML. 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 daptomycin to the Essential Medicines List. Adults . Core: ampicillin, ceftriaxone, penicillin G . Targeted: ceftazidime, meropenem, amikacin, gentamicin, vancomycin Paediatric . Core: ampicillin, ceftriaxone, cefotaxime, penicillin G . Targeted: ceftazidime, meropenem, amikacin, gentamicin, vancomycin Meningitis 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. Adults . Core: vancomycin . Targeted: piperacillin-tazobactam, meropenem Paediatric . Core: vancomycin . Targeted: piperacillin-tazobactam, meropenem Notably, piperacillin-tazobactam and meropenem are recommended by the reviewers Central catheter infections 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 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 piperacillin-tazobactam and meropenem to the Essential Medicines List. Community-acquired cIAI, not severe Adults . Core: co-amoxiclav, cefotaxime, ceftriaxone, metronidazole . Targeted: levofloxacin, ciprofloxacin Paediatric . Core: cefotaxime, ceftriaxone, metronidazole . Targeted: ciprofloxacin Complicated intra-abdominal infections Severe community-acquired cIAI and all hospital-acquired cIAI Adults . Core: piperacillin-tazobactam, cefotaxime, ceftriaxone, metronidazole . Targeted: ampicillin, levofloxacin, ciprofloxacin, ceftazidime, meropenem, gentamicin, tobramycin, vancomycin Paediatric . Core: cefotaxime, ceftriaxone, metronidazole . Targeted: ampicillin, ciprofloxacin, ceftazidime, meropenem, gentamicin, 21st Expert Committee on Selection and Use of Essential Medicines Peer Review Report – Antibiotics Review tobramycin, vancomycin 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 (, uncomplicated , mild diabetic foot infection, bites Adults . Core: co-amoxiclav, , cefurome, cephalexin . Targeted: , doxycycline, levofloxacin, ciprofloxacin, moxifloxacin, trimethoprim/sulphamethoxazole Paediatric . Core: co-amoxiclav, dicloxacillin, cephalexin . Targeted: clindamycin, trimethoprim/sulphamethoxazole Severe community-acquired cIAI and all hospital-acquired cIAI Adults . Core: Penicillin G, co-amoxiclav, oxacillin, , , , ceftriaxone, cefotaxime, clindamycin, metronidazole . Targeted: piperacillin-tazobactam, levofloxacin, ciprofloxacin, moxifloxacin, Skin and soft tissue infections (incl. meropenem, vancomycin cellulitis and surgical site infections) Paediatric . 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. Adults . Core: doxycycline, trimethoprim/sulfamethoxazole, ceftriaxone, metronidazole, vancomycin . Targeted: levofloxacin, ciprofloxacin, azithromycin Acute infectious diarrhoea Paediatric . 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). 21st Expert Committee on Selection and Use of Essential Medicines Peer Review Report – Antibiotics Review 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 to the Essential Medicines List.

Adults . Core: ceftriaxone, , benzathine penicillin G, Penicillin G, procaine penicillin G, doxycycline, metronidazole . Targeted: azithromycin Sexually transmitted diseases 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 do not require amendment of the current Essential Medicines List. Adults . 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 Exacerbations of COPD EML. Clarithromycin is recommended but not 5th 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. Adults . 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 Bone and joint infections 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. Adults: . 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 Febrile 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 21st Expert Committee on Selection and Use of Essential Medicines Peer Review Report – Antibiotics Review 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, , , , daptomycin, moxifloxacin, aztreonam, rifampin, and . 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 (http://www.who.int/selection_medicines/committees/expert/21/applications/antibacterials- mch_rev/en/).