Lack of eye drop refrigeration a problem

The inadequate refrigeration of chloramphenicol generics in India could be contributing to the evolution of resistant organisms and impacting the quality of Indian-made products available in Europe, according to a study published in the May 2008 issue of the British Journal of Ophthalmology.

Jonathan Aboshiha, MD of the Institute of Ophthalmology, University College London, UK and colleagues measured levels of chloramphenicol thermal breakdown product in samples of generic eye drops (n=48) purchased in Delhi and Madras, India. Storage conditions were also noted.

The team found that no samples had been refrigerated prior to purchase and that, consequently, these samples contained high levels of chloramphenicol thermal breakdown product.

As the levels of breakdown product found in the samples were significantly higher than levels permitted under UK quality assurance standards, the researchers concluded that the recent deregulation of OTC purchasing of chloramphenicol eye drops in Europe could lead to complications with product quality.