Published

Ciprofloxacin ear drops (Ciloxan) were listed on the Pharmaceutical Benefits Scheme on 1 April 2007. The authority listing allows prescribing for chronic suppurative otitis media (CSOM) in Aboriginal and Torres Strait Islander people.1

CSOM is a common cause of preventable hearing impairment. Because CSOM usually occurs in the first 5 years of life — when most speech and language development occurs — it may contribute to delayed speech, language and learning2, with negative consequences for socialisation, education and employment. The prevalence of CSOM in Aboriginal and Torres Strait Islander people is about 15%, compared with about 1% for other Australians.

The Pharmaceutical Benefits Advisory Committee (PBAC) considered a study of Aboriginal and Torres Strait Islander children (in northern WA and Qld) showing a trend towards a higher rate of cure with ciprofloxacin ear drops compared with dexamethasone/framycetin/gramicidin (Sofradex, Otodex) ear drops. The study was stopped early (because of resource constraints) and did not include enough children to detect a difference in cure rates in the intention-to-treat population.3 Despite the study limitations, the PBAC considered this listing appropriate, given the prevalence of CSOM in Aboriginal and Torres Strait Islander people.

The PBAC recommended this listing under the 2004-05 Budget measure that allows PBS listing of medicines specifically for Aboriginal and Torres Strait Islander people. For more information, refer to the NPS RADAR In Brief 'Medicines listed on the PBS for Indigenous Australians' or the Department of Health and Ageing website.

References

  1. Pharmaceutical Benefits Advisory Committee. July 2006 positive recommendations. Canberra: Australian Government Department of Health and Ageing, 2006. http://www.health.gov.au/internet/wcms/publishing.nsf/Content/pbacrec-pbacrecjul06-positive#ciprofloxacin (accessed 23 January 2007).
  2. Macfadyen CA, Acuin JM, Gamble C. Topical antibiotics without steroids for chronically discharging ears with underlying eardrum perforation. Cochrane Database Syst Rev 2005:(4);CD004618.
  3. Couzos S, Lee T, Mueller R, et al. Effectiveness of ototopical antibiotics for chronic suppurative otitis media in Aboriginal children: A community-based, multicentre, double-blind randomised controlled trial. Med J Aust 2003;179:185-90.