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Submissions and TGA response: Chloramphenicol, propamidine, dibromopropamidine and sulfacetamide for ophthalmic use: proposed advisory statements for medicines

4 March 2014

The TGA would like to thank the organisations who have submitted written comments or made submissions in response to the consultation: Consultation: Chloramphenicol, propamidine, dibromopropamidine and sulfacetamide for ophthalmic use: proposed advisory statements for medicines.

Submissions received

A total of five submissions were received.

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TGA response

1. Advisory statement: 'Contact lens wearers should not use this product except on the advice of a doctor or optometrist'

Summary of issues

The respondents supported the proposed advisory statement. However, one respondent considered that the statement should be amended to 'Contact lens wearers should not use this product except on the advice of a doctor, optometrist or pharmacist'.

Another respondent requested clarification that sponsors will be allowed some flexibility with wording of the statement, so that the statement can be used with the 'Do not use' subheadings commonly used in consumer focussed labelling.

TGA response

The TGA does not support the addition of the words '...or pharmacist'.

  • The TGA considers that it is important that contact lens wearers with eye infections be referred promptly to a doctor or optometrist for correct diagnosis and treatment, not only because contact lens wearers are at increased risk of eye infections compared to the general population, but also because it is more likely that infections in the eyes of contact lens wearers will not be susceptible to this preparation.
  • The use of antibacterial ophthalmic preparations while wearing contact lenses can result in delayed diagnosis of potentially sight-threatening eye conditions.
  • The proposed statement, as currently worded, is consistent with Australian Pharmacist Guidelines1, which require pharmacists to refer contact lens wearers with eye infections to an optometrist or general practitioner.

The RASML allows for use of alternative wording provided that the intent of the statement is not changed. Any proposed alternative wording will be evaluated by the TGA on a case by case basis.

Outcome

The advisory statement 'Contact lens wearers should not use this product except on the advice of a doctor or optometrist' is proposed for inclusion on the labelling of chloramphenicol, propamidine, dibromopropamidine and sulfacetamide when included in non-prescription medicines for ophthalmic use.

Footnote

  1. Pharmaceutical Society of Australia: Provision of chloramphenicol for ophthalmic use as a Pharmacist Only medicine, April 2010

2. Advisory statement: 'If your eye infection does not start to improve within 48 hours, seek immediate medical advice'

Summary of issues

The respondents supported the proposed advisory statement. However, one respondent recommended that the words 'start to' should be deleted, on the basis that deletion of these words makes the statement more concise and may reduce the likelihood that patients with serious eye conditions will delay seeking treatment.

TGA response

The TGA supports the proposed amendment, for the reasons given by the respondent.

Outcome

The amended advisory statement 'If your eye infection does not improve within 48 hours, seek immediate medical advice' is proposed for inclusion on the labelling of chloramphenicol, propamidine, dibromopropamidine and sulfacetamide when included in non-prescription medicines for ophthalmic use.

3. Advisory statement 'Do not use on children under 2 years of age except on medical advice'

Summary of issues

The respondents supported the proposed advisory statement for chloramphenicol.

In addition, a respondent proposed that this advisory statement should also be required on the labelling of non-prescription medicines containing propamidine, dibromopropamidine and sulfacetamide for ophthalmic use.

TGA response

The TGA does not support the respondent's recommendation that the statement be required on the labelling of non-prescription medicines containing propamidine, dibromopropamidine and sulfacetamide for ophthalmic use.

  • The proposed statement would be more restrictive than the advice in the current Product Information for these products, which states that sulfacetamide eye drops should not be used in children under 2 months of age, and that propamidine and dibromopropamidine eye drops should not be used in infants (i.e. children under 12 months of age) except on medical advice.
  • This proposal would be inconsistent with the advice of the September 2013 meeting of the Advisory Committee on Non-prescription Medicines (ACNM), which recommended that the warning only be included on the labels for medicines containing chloramphenicol. This is because the risk of 'grey baby syndrome' that is associated with use of chloramphenicol does not apply to propamidine, dibromopropamidine and sulfacetamide.

Outcome

The advisory statement 'Do not use in children under 2 years of age except on medical advice' is proposed for inclusion on the labelling of chloramphenicol when included in non-prescription medicines for ophthalmic use.

4. Respondent proposals for additional advisory statements

Summary of issues

Other issues raised by respondents included proposals to require statements regarding maximum duration of use, worsening of symptoms, and use by individuals with a history of allergic reaction.

TGA response

The TGA does not support the proposals to require these additional statements on the labels of these medicines.

The TGA considers that the current and proposed advisory statements, together with the inclusion of adequate directions for use in the labelling, Consumer Medicine Information and Product Information, should be sufficient to ensure appropriate and safe use of these Schedule 3 and Schedule 2 medicines.

Final proposal

The following advisory statements are proposed for chloramphenicol, propamidine, dibromopropamidine and sulfacetamide when supplied as a non-prescription medicine under the conditions stated.

Table 1. Proposed advisory statements for chloramphenicol
Conditions Required advisory statements
In medicines for ophthalmic use Contact lens wearers should not use this product except on the advice of a doctor or optometrist
If your eye infection does not improve within 48 hours, seek immediate medical advice
Do not use in children under 2 years of age except on medical advice
Table 2. Proposed advisory statements for propamidine
Conditions Required advisory statements
In medicines for ophthalmic use Contact lens wearers should not use this product except on the advice of a doctor or optometrist
If your eye infection does not improve within 48 hours, seek immediate medical advice
Table 3. Proposed advisory statements for dibromopropamidine
Conditions Required advisory statements
In medicines for ophthalmic use Contact lens wearers should not use this product except on the advice of a doctor or optometrist
If your eye infection does not improve within 48 hours, seek immediate medical advice
Table 4. Proposed advisory statements for sulfacetamide
Conditions Required advisory statements
In medicines for ophthalmic use Contact lens wearers should not use this product except on the advice of a doctor or optometrist
If your eye infection does not improve within 48 hours, seek immediate medical advice