rss
Br J Ophthalmol 2008;92:609-611 doi:10.1136/bjo.2006.106518
  • Global issues

To what extent does a lack of refrigeration of generic chloramphenicol eye-drops used in India decrease their purity and what are the implications for Europe?

  1. J Aboshiha1,
  2. R Weir1,2,
  3. P Singh3,
  4. P Ewings4,
  5. A Lovering5
  1. 1
    Institute of Ophthalmology, University College London, London, UK
  2. 2
    Ophthalmology Department, Royal Devon and Exeter Hospital, Exeter, UK
  3. 3
    Ophthalmology Department, Furness General Hospital, Barrow in Furness, UK
  4. 4
    Statistical Department, Musgrove Park Hospital, Taunton, UK
  5. 5
    Bristol Centre for Antimicrobial Research and Evaluation, Bristol, UK
  1. Dr J Aboshiha, 33 Turketel Road, Folkestone CT20 2NZ, UK; jonathan.aboshiha{at}gmail.com
  • Accepted 2 February 2008

Abstract

Background/aims: Thermal degradation of chloramphenicol occurs at a faster rate when stored in unrefrigerated conditions. This study measures the concentration of the principal thermal breakdown product of generic chloramphenicol eye-drops being sold over the counter in chemists in different locations in India.

Methods: Forty-eight samples of generic chloramphenicol eye-drops were collected form Delhi and Chennai (Madras) in India. Conditions of storage of chloramphenicol eye-drops were recorded at the time of purchase. Concentrations of a hydrolytic degradation product of chloramphenicol were measured using validated high-pressure liquid chromatography. Results were compared with accepted UK standards.

Results: Significantly higher levels of chloramphenicol thermal breakdown product were found in collected samples. All samples purchased were being stored in unrefrigerated conditions in the chemists sampled. Shelf lives exceeded UK equivalents, varying considerably between manufacturers.

Conclusion: Inadequate refrigeration and prolonged shelf lives of chloramphenicol generics collected from Delhi and Chennai are associated with very high levels of chloramphenicol thermal breakdown product. These levels substantially exceed UK quality-assurance standards undermining product reliability, possibly contributing to the positive selection of resistant organisms and product toxicity effects. The principals of quality-assurance breakdown described are particularly relevant to Europe, following recent deregulation of chloramphenicol eye-drops purchased over the counter.

Footnotes

  • Competing interests: None.

This Article

  1. Abstract
  2. Full text
  3. PDF

Responses

  1. Submit a response
  2. No responses published

Register for free content

The full back archive is now available for all BMJ Journals. Institutional subscribers may access the entire archive as part of their subscription. Personal subscribers will also have access to all content when logged in. Non-subscribers who register have free access to all articles published before 2006 right back to volume 1 issue 1. Register here to access the free archive of all BMJ Journals.

Don't forget to sign up for content alerts so you keep up to date with all the articles as they are published.