Colistin

Colistin is arguably the first case in the antibacterial field where substantial “re-development” activities have been driven by academic and clinical investigators, rather than a sponsoring company. As a result of these activities, there is rapidly evolving new non-clinical and clinical knowledge on colistin and it is essential that clinicians are provided with up-to-date information to promote safe and effective use of the drug.

Updating and harmonising the product information in regard to optimised dosing regimens is especially important for colistin as this drug has a very low therapeutic index and is used as a last resort option for the treatment of infections caused by Gram-negative pathogens in severely ill patients. Inappropriate dosing may impact the probability of survival, development of nephrotoxicity and emergence of bacterial resistance.

The 1st International Conference on Polymyxins was held in Prato, Italy from 2 to 4 May 2013 to promote reflection, discussion and dissemination of new scientific information on the polymyxins. Based on these discussions and the recently published accumulating knowledge a community interest referral (Article 31 referral) has been initiated by the European Council with the objective to thorougly assess the product information of colistin products, update and harmonise it across Europe. Additionally, an assessment procedure has been triggered by EMA regarding the need to establish limits/ranges for the colisitimethate sodium subcomponents and on the adequacy of the Ph. Eur. Monograph and the control and bioassay methods described therein.

Currently the Summary of Product Characteristics (SPC) and usage of colistin products differ widely in European countries. In this study forty current SPCs of approved intravenous colistin products in 20 EU member states and Norway where retrieved from publicly accessible websites of national regulatory authorities, The Heads of Medicines Agencies as well as professional contacts in the medical field, national drug agencies, and distributing companies. The SPCs were translated from 17 languages to English and the information regarding dosing, indications and pharmacokinetic data compared (U. Theuretzbacher, JAC 2014). The results are summarised in this table.

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