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Consultation: cimetidine, famotidine, nizatidine and ranitidine: corrected advisory statement for medicines

30 September 2015

This consultation closed on 29 October 2015

The TGA sought comments from interested parties on a proposed correction to the mandatory advisory statements for cimetidine, famotidine, nizatidine and ranitidine when included in non-prescription medicines for oral administration.

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

Timetable

Document released for consultation on Thursday, 1 October 2015.

Interested parties responded by close of business on Thursday, 29 October 2015.

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

About the consultation

The TGA proposes to correct the statement currently required by the RASML for medicines containing cimetidine, famotidine, nizatidine and ranitidine for oral administration as set out in in Table 1, below.

Note: This correction will not introduce any new label requirement for any currently registered medicine.

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 Poisons Standard (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.

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 RASML

The Required advisory statements for medicine labels (RASML):

The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified via pharmacovigilance activities, testing, adverse event reports or other scientific or clinical information.

The current version of the Specification is the Medicines Advisory Statements Specification 2014 (MASS 2014). The MASS 2014 incorporates two versions of the RASML (currently RASML No. 1 and RASML No. 2) as schedules 1 and 2, respectively, to allow for a transition period for adoption of new advisory statements onto medicine labels. RASML No. 1 is the current version. RASML No. 2 will come into effect on 12 December 2015.

The advisory statements in the RASML and the conditions of their application to particular medicines need to be updated from time to time. Changes can include addition of new requirement(s), amendment to the wording of existing requirement(s), or removal of the requirement for advisory statement(s).

Cimetidine, famotidine, nizatidine and ranitidine - proposed amended label advisory statement

Famotidine, nizatidine and ranitidine, in packs containing not more than 14 days' supply, are included in schedule 2 to the SUSMP - except that ranitidine is unscheduled when in divided preparations for oral use containing not more than 7 days' supply. Cimetidine is included in schedule 3 to the SUSMP when sold in a primary pack containing not more than 14 days' supply.

RASML currently requires the following statement to be present on the labels of medicines containing cimetidine, famotidine, nizatidine and ranitidine:

  • 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.

However, OTC cimetidine, famotidine, nizatidine and ranitidine medicines are only permitted to be indicated for symptomatic relief (of gastro-oesophageal reflux/heartburn), and the labelling is required to specify taking the medicine 'as needed' rather than as a 'course'. For example, the OTC medicine monograph for ranitidine hydrochloride specifies directions for use (in adults and children 12 years and over) as follows:

  • 150 mg tablet and 15mg/mL oral liquid: Take [one tablet/10 mL] at the first sign of symptoms. If symptoms return or persist for more than one hour, take another [tablet/10 mL]. Do not take more than [2 tablets/2 doses] in 24 hours.
  • 300 mg tablet (for use by patients who routinely require two 150 mg ranitidine tablets for relief of their symptoms): Take one tablet at the first sign of symptoms. Do not take more than 1 tablet in 24 hours.

It would be inappropriate for a label for a non-prescription cimetidine, famotidine, nizatidine or ranitidine medicine to include directions for use that specify a course of treatment. Consequently, it is inappropriate for the RASML to require an advisory statement that refers to such a course.

It is proposed that the RASML statement will be corrected as follows (words that will be deleted are indicated by strikethrough):

  • 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.

Note: For any crrently registered meduicine, the current RASML statement will be considered to have the same intent as the proposed corrected RASML statement. Consequently, although it is expected that sponsors will correct the advisory statement on their labels as part of their next scheduled label update, this proposed amendment to the RASML will not introduce any requirement to amend the labels of any currently registered medicine.

Proposal

The TGA proposes that the RASML should include the following corrected statement for cimetidine, famotidine, nizatidine and ranitidine when included in non-prescription medicines for oral use.

Note: other current RASML requirement(s) for these medicine(s) have not been reproduced in the table below.

Table 1. Proposed amended advisory statement for cimetidine, famotidine, nizatidine and ranitidine
Column 1
Substances
Column 2
Condition
Column 3
Proposed corrected statement
Cimetidine, famotidine, nizatidine and ranitidine In medicines for oral use If symptoms persist or recur within two weeks, consult a doctor.

Submissions

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 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

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