C 2.4.1 Chloramphenicol
Chloramphenicol.
Registered dispensing opticians are able to supply chloramphenicol under the following circumstances.
C 2.4.1 In the case of acute bacterial conjunctivitis ONLY, the sale and supply of 0.5% Chloramphenicol drops [1% ointment] may now be instigated by all dispensing opticians. The restrictions of the pharmacy classification limit the supply to:
· a maximum pack size of 10ml [drops]/ 4gms [ointment]
· only in adults and children over 2 years of age
· for a maximum of 5 days. https://www.abdo.org.uk/regulation-and-policy/advice-and-guidelines/clinical/use-and-supply-of-drugs/
Earlier in 2021 we were made aware that some manufacturers had updated their product information to include a possible contraindication which would affect children under the age of two- (NOTE – this falls outside of the permissions on supply by dispensing opticians as detailed above). This contraindication stated that chloramphenicol drops must not be given to children under two years old due to it containing the excipient boron which may cause infertility. This contraindication did not apply to the ointment which does not contain boron
The Royal College of Ophthalmologists along with other professional bodies requested that the Medicines and Healthcare Regulatory Agency (MHRA) review the advice and in July 2021 the MHRA published new guidance linked below: https://www.gov.uk/drug-safety-update/chloramphenicol-eye-drops-containing-borax-or-boric-acid-buffers-use-in-children-younger-than-2-years
It is important to note:
1. Dispensing opticians can only supply chloramphenicol to children over two years of age and only in the case of acute bacterial conjunctivitis.
2. Parents presenting for advice and guidance for children under two should be directed to their GP.
References: 1. https://www.gov.uk/drug-safety-update/chloramphenicol-eye-drops-containing-borax-or-boric-acid-buffers-use-in-children-younger-than-2-years 2. https://www.rcophth.ac.uk/2021/04/safety-alert-boron-additives-in-chloramphenicol-drops/