Abstract

The recent withdrawal in the United Kingdom (UK) of applications to reclassify two separate systemic antibiotics for uncomplicated cystitis in women as ‘P’ medicines (pharmacy only sale), marks the probable end of a 15 year discussion. The reasons for these withdrawals are not known, but they ended what had become a protracted regulatory process.

The potential for increased microbial resistance in the community following unsupervised use of antimicrobial agents raises important concerns. Illegal sales of systemic antibiotics in European pharmacies remain a substantial problem, and this ‘Over the Counter (OTC)’ antibiotic misuse, has sometimes prejudiced the debate about proposals for regulated self medication. The abandoned applications, for selected antibiotics in a restricted indication, argued that such de-regulation had the potential to improve antibiotic usage in these limited circumstances. This proposition will remain untested in the absence of prospective studies following an approval. However existing data on self medication of recurrent episodes of cystitis in women and known patterns of antibiotic use in this indication support the contention that not all self-medication with antibiotics would inevitably lead to misuse and worsening resistance.

The removal of two applications to re-classify systemic antibiotics has been seen as an important victory for the principle that systemic antibiotics should be restricted to prescription only use. This paper explores an alternative view that this move may represent a missed opportunity to encourage some responsible self care with antibiotics and to contrast that with the widespread misuse which currently prevails.