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Consultation: Metoclopramide: proposed advisory statements for medicines

10 March 2015

This consultation closed on 7 April 2015

The TGA sought comments from interested parties on proposed advisory statements for metoclopramide when included in non-prescription medicines for oral administration.

It is proposed that the new statements will be incorporated into the next update to the Required Advisory Statements for Medicine Labels (RASML).

Timetable

Document released for consultation on Tuesday 10 March 2015.

Interested parties should respond by close of business on Tuesday 7 April 2015.

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

About the consultation

It is proposed that the advisory statements in Table 1, below, would be required on the labels of non-prescription medicines containing metoclopramide for oral administration.

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; and that the label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.

Background

Scheduling of medicines

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.

Metoclopramide is included in Schedule 4 to the SUSMP, except when combined with paracetamol in divided preparations, packed and labelled only for the treatment of nausea associated with migraine, in packs containing not more than 10 dosage units, when it is included in Schedule 3.

Advisory statements

Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively.

The enhanced access and availability of OTC medicines means that consumers may not receive comprehensive advice from a health practitioner or pharmacist. Therefore, the label needs to contain the directions and advisory statements that are needed for safe and effective use of the medicines.

The need for particular advisory statements on the labels of OTC medicines is typically identified by the TGA as a result of circumstances such as: the registration of a new medicine; 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; or a review of an existing medicine when new safety risks have been identified.

The RASML

The RASML was established in July 2004 so that there could be one single source document that other items of legislation such as the Labelling Order1 could refer to when specifying mandatory advisory statements for medicine labels. The RASML is defined in the Labelling Order as 'the document made under section 3(5A) of the Therapeutic Goods Act 1989 by the Therapeutic Goods Administration'. This section 3(5A) Legislative Instrument, the Medicines Advisory Statements Specification 2014 was registered on the Federal Register of Legislative Instruments (FRLI) in June 2014. The instrument incorporates the RASML No. 1 and RASML No. 2 as its Schedules 1 and 2, respectively.

Safety assessment of metoclopramide - risk of neurological side effects

The TGA has recently carried out a safety assessment of metoclopramide (see Medicines Safety Update, Vol 6 (1) February 2015) following communication from international regulators that:

  • the use of metoclopramide is associated with the following safety concerns:
    • extrapyramidal symptoms (including tardive dyskinesia) which may not resolve with cessation of the medication
    • cardiac arrhythmias which may be fatal
  • the risks of these adverse events increase with prolonged use or the use of higher doses
  • the risk of adverse events appears to be increased in the very young.

As a result of the safety assessment, the TGA published a number of changes to the Australian product information for prescription metoclopramide in the Medicines Safety Update, Vol 6 (1) February 2015. These include the following changes that are also relevant to OTC medicines:

  • Restrictions on use in children and adolescents.
  • A maximum recommended treatment duration of five days in all age groups.

OTC metoclopramide - proposed label advisory statements

There is currently no RASML entry for metoclopramide.

In light of the new safety information, as published in the Medicines Safety Update, Vol 6 (1) February 2015, and in line with the prescription PI changes for metoclopramide, the TGA proposes that the RASML should require the following label statements for OTC metoclopramide preparations.

  • Do not use in children and adolescents aged under 18 years
  • Tell your doctor or pharmacist before use if you are taking other medicines
  • Do not use if you have epilepsy (fits)

The proposed statement 'Do not use in children and adolescents aged under 18 years' is consistent with the proposed change to the prescription PI (as first-line therapy, metoclopramide will now only be indicated for use in adults), and with the normal age classification for 'adults'.

The proposed statement 'Tell your doctor or pharmacist before use if you are taking other medicines' is consistent with the existing prescription PI advice that: 'Metoclopramide should not be administered to patients receiving other drugs which are likely to cause extrapyramidal reactions, since the frequency and severity of extrapyramidal reactions may be increased'.

The proposed statement 'Do not use if you have epilepsy (fits)' is consistent with the current contraindication in the prescription PI.

No label changes are proposed in relation to the five-day maximum treatment duration. This is because the current SUSMP Schedule 3 metoclopramide entry is restricted to 'metoclopramide when combined with paracetamol...'; so the labels are required to contain the paracetamol RASML warning statement "Keep to the recommended dose. Do not use for longer than a few days at a time unless advised to by a doctor." The TGA considers that this existing RASML warning for paracetamol is already adequate for OTC metoclopramide-paracetamol combination products. The OTC product information will, however, be required to include the explicit maximum duration of five days.

1 currently Therapeutic Goods Order 69 General requirements for labels for medicines (TGO 69)

Proposal

The TGA proposes that the RASML should include the following new entry for metoclopramide when included in non-prescription medicines for oral use:

Table 1. Proposed advisory statements for metoclopramide

Substance(s) Conditions Proposed statement(s)
Metoclopramide In preparations for oral use
  • Do not use in children and adolescents aged under 18 years
  • Tell your doctor or pharmacist before use if you are taking other medicines
  • Do not use if you have epilepsy (fits)

Submissions

See: Submissions and TGA response

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, with a transition period of 12 months to allow affected sponsors time to update their labels.

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.