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Consultation: Chloramphenicol, propamidine, dibromopropamidine and sulfacetamide for ophthalmic use: proposed advisory statements for medicines

Related information

22 November 2013

This consultation closed on 10 January 2014

The TGA sought comments from interested parties on advisory statements for chloramphenicol, propamidine, dibromopropamidine and sulfacetamide, when included in non-prescription medicines for ophthalmic use, which are proposed for inclusion in the Required Advisory Statements for Medicine Labels (RASML) when it is next updated.

Timetable

Document released for consultation on 22 November 2013.

Interested parties responded by close of business 10 January 2014.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

The proposed advisory statements would be required on the 'labels' of non prescription medicines containing chloramphenicol, propamidine, dibromopropamidine and sulfacetamide for ophthalmic use.

Through the consultation process, the TGA requested comment that will help ensure that the proposed advisory statements are appropriate and support the quality use of medicines for non-prescription products containing chloramphenicol, propamidine, dibromopropamidine and sulfacetamide for ophthalmic use.

This consultation will contribute to the update of the RASML.

Background

The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP) sets out the level of control on the availability of medicines and poisons in Australia. The majority of medicines that are included in the SUSMP fall under one of the following classifications.

Schedule 2 - Pharmacy Medicine (available from a pharmacy without a prescription)

Schedule 3 - Pharmacist Only Medicine (available from a pharmacist without a prescription)

Schedule 4 - Prescription Only Medicine (available from a pharmacist with a prescription)

Medicines that are not included in the SUSMP are freely available from both pharmacies and other retail outlets, and are referred to as 'unscheduled' medicines. Medicines that are unscheduled or included in Schedule 2 or Schedule 3 of the SUSMP are collectively referred to as 'non-prescription' or 'over-the-counter' (OTC) medicines.

Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively. In the case of non prescription medicines, the label of the medicine contains information and directions for appropriate use, as well as any advisory statements (warnings) that are needed for safe and effective use of the medicines.

The need for a new advisory statement might arise from:

  • The registration of a new medicine
  • When new risks for currently available medicines have been identified
  • A request from stakeholders and/or expert advisory committees is received
  • When a medicine undergoes a change in scheduling, hence reducing the level of control and making it more widely available to consumers for self-selection or available without a prescription.

Under these circumstances there may be a need to ensure that appropriate advisory statements are included on the labelling of these medicines to ensure consumers are able to self-select (where applicable) and use these medicines safely and effectively.

Chloramphenicol, propamidine, dibromopropamidine and sulfacetamide

At its meeting in October 2009, the National Drugs and Poisons Scheduling Committee (NDPSC) decided to include chloramphenicol for ophthalmic use in Schedule 3 of the Standard for Uniform Scheduling of Drugs and Poisons (SUSDP)1. Chloramphenicol for ophthalmic use was included in Schedule 3 of the SUSDP in May 2010.

In February 2013, following further consideration by the Advisory Committee on Medicines Scheduling (ACMS), the TGA medicines scheduling delegate decided that inclusion of chloramphenicol for ophthalmic use in Schedule 3 remained appropriate; but that there is a 'Need to ensure labelling is appropriate regarding contraindication for use in contact lens wearers'.

The following antibiotic / antibacterial ophthalmic substances are also included in OTC schedules:

  • Propamidine and dibromopropamidine are each in Schedule 2 for ophthalmic use.
  • Sulfacetamide is in Schedule 3 in preparations for ophthalmic use containing 10% or less of sulfacetamide.

The RASML does not currently include any requirements for advisory statements for chloramphenicol, propamidine, dibromopropamidine or sulfacetamide.

At its meeting on 5 September 2013, the Advisory Committee on Non-prescription Medicines (ACNM) considered a request from the TGA for advice as to whether the RASML should require advisory statements for OTC chloramphenicol medicines for ophthalmic use; including advice in relation to use by people who wear contact lenses and by young children, as well as appropriate duration of use.

People who wear contact lenses are at increased risk of eye infections compared to the general population, and it is more likely that infections in the eyes of contact lens wearers will not be susceptible to chloramphenicol. The use of antibacterial ophthalmic preparations while wearing contact lenses can result in delayed diagnosis of potentially sight-threatening eye conditions. The ACNM advised that the RASML should require a label statement such as 'Contact lens wearers should not use this product except on the advice of a doctor or optometrist'. The ACNM also advised that the concerns regarding increased risks for contact lens wearers applied to all antibiotic / antibacterial ophthalmic preparations. The ACNM therefore advised that the statement should also apply to OTC products containing propamidine, dibromopropamidine or sulfacetamide for ophthalmic use.

In relation to duration of use, the ACNM advised that the RASML should require a label statement such as 'If your eye infection does not start to improve within 48 hours, seek medical advice' for OTC products containing chloramphenicol, propamidine, dibromopropamidine or sulfacetamide for ophthalmic use.

In relation to use by young children, the ACNM noted that chloramphenicol preparations should only be used by children under two years of age on medical advice, primarily due to the risk of 'grey baby syndrome' (due to bone marrow suppression), and to exclude serious causes of red eye that can lead to permanent impairment of vision, particularly when the eyes of infants are developing. The ACNM advised that the RASML should require a label statement such as 'Do not use in children under 2 years of age except on medical advice' for ophthalmic products containing chloramphenicol.

However, based on the information in the currently approved labels, Product Information and Consumer Medicine Information for ophthalmic propamidine, dibromopropamidine or sulfacetamide products, the ACNM did not consider it necessary to require any specific RASML statement in relation to use by young children for ophthalmic propamidine, dibromopropamidine or sulfacetamide products.

Content of submissions

Submissions & TGA response

Submissions may address any, or all, of the proposed advisory statements and other identified issues. In addition, submissions might include:

  • Whether or not you support the wording of the advisory statement. If you do not support the wording of the statement you may make suggestions for an alternative acceptable to you.
  • An assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

>What will happen

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA's Internet site.

It is proposed that the advisory statements will then be included in the next update of the RASML.

Confidentiality

All submissions will be placed on the TGA website unless marked confidential. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.

Enquiries

Enquiries should be directed via email to rasml@tga.gov.au


Proposal

The TGA proposes that the RASML should include the following new entries for chloramphenicol, propamidine, dibromopropamidine and sulfacetamide when included in non prescription medicines for ophthalmic use (See Tables 1, 2, 3 and 4).

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 start to 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 start to 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 start to 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 start to improve within 48 hours, seek immediate medical advice

Footnote

  1. The SUSDP was subsequently replaced by the SUSMP