Amoxicillin is an aminopenicillin used to treat a number of infections. In recent years (particularly during the winter months), several member states have reported major difficulties in procuring amoxicillin-containing products, with paediatric forms of the antibiotic especially affected.

In line with the European Pharmacopoeia Commission’s decision to trial and refine its recently proposed medicine shortage mitigation strategies on two ongoing shortages, the European Drug Shortages Formulary (EDSForm) Working Party has compiled existing knowledge on extemporaneous oral formulations of amoxicillin that have been or are being used to alleviate the lack of age-appropriate licensed products.

The information provided in the resulting expert opinion is intended to help healthcare professionals in their risk assessment and decision-making processes when faced with the temporary unavailability of paediatric forms of amoxicillin.

The EDQM and the EDSForm Working Party remind users that, wherever possible, it remains preferable to use a licensed medicine rather than an unlicensed pharmaceutical preparation and that it is the responsibility of the healthcare professionals involved to carry out the risk analysis for each patient.

See also:

• Amoxicillin, paediatric: Expert opinion on extemporaneous unlicensed formulations
• EDQM initiatives on medicine shortages