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Consultation: Esomeprazole: proposed advisory statements for medicines
This consultation closed on 10 October 2014
The TGA sought comments from interested parties on proposed advisory statements for esomeprazole when included in non prescription medicines for oral administration, which are proposed for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated.
Document released for consultation on Friday 12 September 2014.
Interested parties should respond by close of business on Friday 10 October 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 medicines containing esomeprazole for oral administration.
Note: 'label' means a display of printed information upon, or securely affixed to, the container and any primary pack containing the goods.
Through the consultation process, the TGA is requesting comments that will help ensure that the proposed advisory statements are appropriate and support the quality use of the medicines.
This consultation will contribute to the next update of the RASML.
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, a review of an existing medicine, or when new risks for currently available medicines have been identified.
- A request from stakeholders and/or expert advisory committees.
- A change in the SUSMP scheduling that reduces the level of control and makes the medicine 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.
Esomeprazole is a proton pump inhibitor (PPI). It is the S-isomer of omeprazole.
On 1 June 2014 esomeprazole was down-scheduled from Schedule 4 to Schedule 3 of the SUSMP when in oral preparations containing 20 mg or less of esomeprazole per dosage unit for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease in packs containing not more than 14 days' supply.
The reasons for this scheduling decision included the following:
- The safety profile of the substance is well-established, supported by good clinical trial evidence, and appropriate for a Schedule 3 entry.
- The first-line use of PPIs in general, and esomeprazole in particular, for typical symptoms of gastro-oesophageal reflux disease (GORD) is recognised and supported by good clinical trial evidence and meta-analyses (Cochrane reviews).
- The safety profile of esomeprazole is comparable to the other PPIs, lansoprazole, omeprazole, pantoprazole and rabeprazole, all of which are listed in SUSMP Schedule 3 (with the same restrictions on indications and pack size).
- As supported by the evidence, there should be consistency of scheduling with the other PPIs for short-term use for symptomatic relief on the advice of a pharmacist.
RASML 2 (Schedule 2 of the Medicines Advisory Statement Specifications 2014) includes entries with mandatory advisory statements for the four other OTC PPIs. As the safety profile of esomeprazole is comparable to the existing OTC PPIs, it is considered appropriate to include a RASML entry for esomeprazole with the same condition and warning statements.
With this consultation, the TGA is seeking comments on the following new entry for esomeprazole in medicines for oral use:
- CAUTION - This preparation is for the relief of minor and temporary ailments and should be used strictly as directed.
- If symptoms persist or recur within two weeks of completing the course, consult a doctor.
- Ask your doctor or pharmacist before use if you are taking other medicines regularly.
Submissions may address 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.
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 cover sheet.
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 cover sheet.
Enquiries should be directed via email to email@example.com.
The TGA proposes that the RASML should include the following new separate entry for esomeprazole when included in medicines for oral use (See Table 1).
The TGA also proposes that the RASML class entry for 'Proton pump inhibitors' should be amended to include esomeprazole in the list of substances (see Table 2).
Table 1. Proposed advisory statements for esomeprazole
The TGA proposes to introduce a new entry for esomeprazole with the condition and warning statements listed in the table below.
Proton pump inhibitors including:
|In medicines for oral use||
Table 2. Proposed amendment to class entry for advisory statements for proton pump Inhibitors
The TGA proposes that the RASML class entry for proton pump inhibitors should be amended to include esomeprazole in the list of substances in Column 1 in the Table below. This will maintain consistency of the warning statements across all OTC medicine labels for this class of medicines.
Proton pump inhibitors including:
|In medicines for oral use||