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Proposal to adapt AWaRe Categorization for the registered in Jordan.

Rational Drug Use and Pharmacovigilance Department

December - 2020

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AWaRe Categorization

INTRODUCTION

Most medicines remain effective even if used by many people for prolonged periods. Unfortunately, antibiotics are an important exception as they can become ineffective because of antimicrobial resistance.

In order to keep antibiotics effective, we need to take them only when needed and strictly as directed by the doctor.

So, there is a need to select the right antibiotic for a given infection when they are needed, privileging those antibiotics that offer the best therapeutic advantage minimizing the risk of resistance.

The aim of the AWaRe Antibiotic Categorization is to build a safe way to use antibiotics.

The AWaRe categorization illustrates which are the preferred antibiotic options for each syndrome, balancing benefits, harms and the potential for resistance.  Provides recommendations for 21 common infective diseases: In 2017 WHO reviewed twenty one common infective syndromes, and selected the most appropriate first and second-choice antibiotic choices for each of the syndrome.  Differentiates in three groups to minimize resistance  Identifies antibiotics that are priorities for monitoring and use surveillance

WHO developed a framework based on three different categories – Access, Watch and Reserve – which all together forms the AWaRe categorization of antibiotics and reflected on the Essential Medicine List (EML):

ACCESS GROUP This group includes antibiotics that have activity against a wide range of commonly encountered susceptible pathogens while also showing lower resistance potential than antibiotics in the other groups.  first or second choice antibiotics  offer the best therapeutic value, while minimizing the potential for resistance

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WATCH GROUP This group includes antibiotics that have higher resistance potential and includes most of the highest priority agents among the Critically Important Antimicrobials for Human Medicine and/or antibiotics that are at relatively high risk of selection of bacterial resistance  first or second choice antibiotics  only indicated for specific, limited number of infective syndromes  more prone to be a target of antibiotic resistance and thus prioritized as targets of stewardship programs and monitoring

RESERVE GROUP This group includes antibiotics and antibiotic classes that should be reserved for treatment of confirmed or suspected infections due to multi-drug-resistant organisms.  “last resort”  highly selected patients (life-threatening infections due to multi-drug resistant bacteria)  Closely monitored and prioritized as targets of stewardship programs to ensure their continued effectiveness.

OTHER Some high-priority bacterial infections (such as tuberculosis) and parasitic infections (such as malaria) are addressed by other WHO guidelines.

Are there differences in how antibiotics from the different groups are administered?

Generally, antibiotics in ACCESS group are more often available as oral formulations (nearly 60% of them), while this percentage is lower in the two other groups. 40% of WATCH antibiotics have oral formulations; the number is only 10% in the RESERVE group.

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AWaRE Categorization of Antibiotics in Jordan:

This document aims to categorize the registered antibitoics in Jordan to maximize the following:

1. Reduction the evolution of antimicrobial resistance. 2. Synchronization with published clinical practice guidelines for management of common and/ or serious infections. 3. Integration of cost parameters. 4. Encouragement of responsible prescription practices among physicians and dispensing among pharmacists. 5. Assignment of multi-level prescription responsibility.

The List will have the version No. : JO-AWaRE-Nov2020-V1.0

4/7 Jordan Food and Drug Administration Rational Drug Use & Pharmacovigilance Department www.jfda.jo JO-AWaRE-Dec2020-V1.0

REGISTERED ATCCODE National AWaRE Categorization Amikacin J01GB0 Access Amikacin J01GB06 Access J01CA04 Access Amoxicillin , J01CR02 Access J01CA01 Access Ampicillin, J01CA51 Watch Ampicillin, Cloxacillin J01CF02+J01CA04 Watch Anhydrous J01DB01 Access Azithromycin (as Dihydrate) J01FA10 Watch Benzathine J01CE08 Access Benzyl J01CE01 Access J01DA08 Watch Cefaclor J01DC04 Watch J01DA09 Access Cefadroxil J01DB05 Access J01DB24 Access Cefazolin J01DB04 Access J01DD15 Watch J01DD16 Watch J01DE01 Watch J01DD08 Watch J01DA10 Watch Cefotaxime J01DD01 Watch J01DC01 Watch J01DA33 Watch Cefpodoxime J01DD13 Watch J01DC10 Watch Ceftaroline Fosamil J01DI02 Reserve J01DD02 Watch

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Ceftazidime, J01DD52 Reserve J01DD07 Watch J01DI01 Reserve J01DD04 Watch J01DA06 Watch Cefuroxime ( Axetil) J01DC02 Watch Cilastatin, J01DH51 Watch Ciprofloxacin J01MA02 Watch Clarithromycin J01FA09 Watch Clindamycin J01FF01 Access Cloxacillin J01CF02 Access Colistimethate J01XB01 Reserve J01XX09 Reserve Doxycycline J01AA02 Access J01DH03 Watch Erythromycin (as J01FA01 Access ethylsuccinate) J01CF05 Access J01XX01 Reserve Fusidic Acid J01XC01 Watch Gemifloxacin J01MA15 Watch Gentamicin J01GB03 Access Josamycin J01FA07 Watch Levofloxacin J01MA12 Watch Lincomycin J01FF02 Watch Linezolid J01XX08 Reserve Lomefloxacin J01MA07 Watch J01DH02 Watch Metronidazole J01XD01 Access Metronidazole P01AB01 , J01XD01 Access Metronidazole, Spiramycin J01RA04 Watch Minocycline J01AA08 Reserve Moxifloxacin J01MA14 Watch

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Norfloxacin J01MA06 Watch Ofloxacin J01MA01 Watch Pefloxacin J01MA03 Watch Penicillin V Potassium J01CE02 Access , J01CR05 Watch Piperacillin, Tazobactam J01CG02 Watch Procaine , Benzathine J01CE08 Access Benzylpenicillin , Benzylpenicillin Roxithromycin J01FA06 Watch Spectinomycin J01XX04 Access Tazobactam , Ceftolozane J01DI54 Reserve J01XA02 Watch Tetracycline J01AA07 Access Tigecycline J01AA12 Reserve Tobramycin J01GB01 Watch Trimethoprim , J01EA01 Access Sulfamethoxazole Trimethoprim , J01EE01 Access Sulfamethoxazole J01XA01 Watch

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