Therapeutic Goods Administration
Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)Version 1.0, March2015
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Therapeutic Goods Administration
About the Therapeutic Goods Administration (TGA)
- The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health, and isresponsible for regulating medicines and medical devices.
- The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk managementapproach designed to ensure therapeutic goods supplied in Australia meet acceptable standardsof quality, safety and efficacy (performance), when necessary.
- The work of the TGA is based on applying scientific and clinical expertise to decision-making, toensure that the benefits to consumers outweigh any risks associated with the use of medicinesand medical devices.
- The TGA relies on the public, healthcare professionals and industry to report problemswith medicines or medical devices. TGA investigates reports received by it to determine anynecessary regulatory action.
- To report a problem with a medicine or medical device, please see the information on the TGA website
Copyright
© Commonwealth of Australia 2015
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to <
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All submissions received will be placed on the TGA’s Internet site, unless marked confidential. Any confidentialmaterial 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 TGAsubmission coversheet.For submission made by individuals, all personal details, other than your name, will be removed from yoursubmission before it is published on the TGA’s Internet site.In addition, a list of parties making submissions will be published. If you do not wish to be identified with yoursubmission you must specifically request this in the space provided on the submission coversheet.
Version history
Version / Description of change / Author / Effective dateV1.0 / Original publication / OTC Medicines Evaluation Section/ Medicines Authorisation Branch / March 2015
Contents
Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)
Invitation to comment
Timetable
About the consultation
Background
Scheduling of medicines
Advisory statements
The RASML
Background to the proposal
Proposal
Content of submissions
How to respond
What will happen
Privacy information
Enquiries
Consultation: Proposed Medicines Advisory Statements Amendment Specification 2015 (corrections and minor changes to the RASML)
Invitation to comment
The TGA is seeking comments from interested parties onproposed minor changes and corrections to the Required Advisory Statements for Medicine Labels (RASML) documents.
No change will be required to any currently approved medicine label as a result of these proposals.
Timetable
Document released for consultation on Monday 16 March 2015.
Interested parties should respond by close of business on Friday 10 April 2015.
Feedback will be released following consideration of submissions. (see'What will happen').
About the consultation
The TGA proposes to correct some minor errors and inconsistencies in the current RASML documents, and make associated changes that improve the consistency and useability.
It is proposed that the corrections and changes listed under the heading Proposal, below, will be published as the Medicines Advisory Statements Amendment Specification 2015 (No. 1), which will amend Schedule 1 (‘RASML No. 1’) and Schedule 2 (‘RASML No. 2’) to the current Medicines Advisory Statements Specification 2014.
In summary, the corrections and changes are as follows:
- RASML No.2: correction of the ‘Conditions’ for the entries for non-steroidal anti-inflammatory drugs (NSAIDs) indicated for use in children, to include the age of the affected children (under 12 years of age)
- RASML No.2: correction of the entries for dermal/external indomethacin and ketoprofen preparations to include the correct wording ‘Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly’ for the statement regarding use with other medicines
- RASML No. 2: correction of the entries for selenium compounds to require the correct statement‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded’ (instead of ‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not be exceeded. Not suitable for use by children under 15 years’)
- RASML No. 2: correction of the entries for hydroxyanthracene derivatives from ‘Not recommended for use by children aged 12 years or under’ to ‘Not recommended for use by children under 12 years of age’
- RASML No. 1 and RASML No. 2: removal of ‘Additional Presentation’ requirement [j] where it requires the affected statement(s) to be grouped immediately preceding the directions for use (this requirement is currently inconsistently applied, and incorrectly applied in a few cases)
- RASML No. 1 and RASML No. 2: editorial changes in regards to the way the requirements currently indicated by ‘Additional Presentation’ requirements [a], [e] and [h] are indicated in the RASML (removal of these square bracketed letters from the RASML – but with no actual change to the respective requirements).
No new requirements will be introduced by these proposed amendments.
With this consultation the TGA is requesting stakeholder comment to help ensure that the identified errors and inconsistencies in the RASML are corrected in the most convenient, cost-effective way.
Background
Scheduling of medicines
The Standard for Uniform Scheduling of Medicines and Poisons (SUSMP)[1] sets out classifications (‘Schedules’) which determine 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 either Schedule 2, 3, 4, 5 or 6, as shown below.
Schedule 2 - available from a pharmacywithout a prescription (PHARMACY MEDICINE)
Schedule 3 - available from a pharmacist without a prescription (PHARMACIST ONLY MEDICINE)
Schedule 4 - available from a pharmacist with a prescription (PRESCRIPTION MEDICINE)
Schedule 5 –substances with low potential for causing harm (CAUTION)
Schedule 6 –Substances with moderate potential for causing harm (POISON)
The SUSMP requires that these medicines are labelled on the first line of the main label with the appropriate ‘signal heading’, indicating the medicine’s schedule (e.g. PHARMACY MEDICINE), together with the words KEEP OUT OF REACH OF CHILDREN written immediately below the signal heading.
Medicines that are not included in the SUSMP may be available from both pharmacies and other general retail outlets, and are referred to as 'unscheduled' medicines.
Medicines that are either unscheduled or included in Schedule 2, 3, 5 or 6 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/or medicine label in order to use medicines safely and effectively. The enhanced access and availability of OTC medicines means that consumers may not always receive comprehensive advice from a health practitioner or pharmacist. Therefore, the label needs to contain the directions and advisory statements that are appropriate for the safe and effective use of the medicine.
The need for new advisory statements to be present on the labels of particular medicines is typically identified as a result of circumstances such as the registration of a new medicine,or a review of the safety of an existing medicine; or 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.
The RASML
TheRASML was established in July 2004 so that there could be one single source document that other items of legislation such as the Labelling Order[2] could refer to when specifying mandatory advisory statements for medicine labels.
The RASML is defined in the legislation 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 2014was 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.
RASML ‘Additional presentation requirements for some advisory statements’
In some cases the RASML applies specific presentation requirements to advisory statements - such as font, letter size etc. Where such additional requirements apply to a statement in a RASML entry, they may be indicated by letters in square brackets shown next to the statement (the reader of the RASML needs to cross-reference to the introductory section titled ‘Addition presentation requirements for some advisory statements’ on the first page of the RASML to find the meaning of each of these letters).
The square-bracketed letters[a], [e], [h] and [j] are affected by the currently proposed RASML amendment. The meaning of these square-bracketed letters, as currently stated in the RASML, is set out below:
[a]: Statement(s) must be included on the label in capital letters.
[e]:Statement(s) must be included on the label in bold face letters.
[h]: The heading ‘SAFETY DIRECTIONS’, written in bold-face capital letters, must preface this/these statements, which are to be grouped together as a distinct section of the label.
[j]: Statement(s) must:
(i)be grouped with any other statements marked with this additional requirement; and
(ii)if the heading ‘SAFETY DIRECTIONS’ is required on the label, be included immediately after that heading; or
(iii)if the heading ‘SAFETY DIRECTIONS’ is not required on the label, be included immediately preceding the directions for use.
The RASML also includes requirements designated by the letters [c], [f], [g], [k] and [l] that are not affected by this current proposal.
In other cases the RASML simply indicates the requirement in the statement itself, for example by use of the relevant fonts (e.g. ‘WARNING – This medication may be dangerous when used in large amounts or for a long period’).
Background to the proposal
The background to the proposed corrections and changes is as follows.
Oral NSAIDs indicated for use in children – correction of error in RASML No. 2
The RASML No. 2 currently requires the OTC NSAIDs diclofenac, flurbiprofen, ibuprofen, ketoprofen and naproxen to carry the advisory statement ‘Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and vomiting’ if they are for oral use in children. The TGA proposes to correct this to only require this statement if the medicine is for oral use in children under 12 years of age.
This age limit was inadvertently omitted from the ‘Conditions’ in column 2 of the entries in RASML No. 2. Its inclusion will be consistent with advice the TGA gave to industry during consultation (in the 2012 TGA response to submissions for RASML updates 5 & 6), that the statement would only apply to medicines that have paediatric doses.
To correct this error in column 2 of RASML No. 2, it is now proposed that
- the word ‘children’ will be replaced with ‘children under 12 years of age’, and
- the word ‘adults’ will be replaced with ‘adults and children 12 years of age and over’ (or similar wording as appropriate).
The TGA already interprets ‘children’ to mean ‘children under 12 years of age’ in the context of the application of this statement. Therefore, any currently approved labels that are labelled in accordance with the current conditionsshould already comply with this proposal.
Indomethacin and ketoprofen – correction of error in RASML No. 2
In the 2012 TGA response to submissions for RASML updates 5 & 6, it was agreed that the statement ‘Unless a doctor has told you to, do not use [this product /insert name of product] with other medicines that you are taking regularly’ would apply to diclofenac, ibuprofen, indomethacin and ketoprofen, in medicines for dermal/external use.
However, for indomethacin and ketoprofen the RASML No. 2unintentionallysubstituted the more extensive statement that is required for oral NSAID medicines (‘Unless advised by your doctor or pharmacist, do not use [this product/insert name of product] with products containing indomethacin/ketoprofen, aspirin, or other anti-inflammatory medicines, or with medicines that you are taking regularly’ ).
It is now proposed to correct this statement, in line with the current wording for the other dermal/external NSAID entries (diclofenac and ibuprofen), to
‘Unless a doctor or pharmacist has told you to, do not use this product with other medicines that you are taking regularly’.
The proposed corrected statement is less extensive that the current statement, but is in line with it. Consequently any labels that include the more extensive statement will be considered to already comply with this proposal.
Selenium – correction of error in RASML No. 2
In relation to selenium compounds, the RASML No. 2 has inadvertently incorporated the outdated requirements of the 2004 RASML instead of the updated requirements of the 2008 RASML.
It is now proposed to correct the statements from ‘A daily dose of 100 micrograms for adults of selenium from dietary supplements should not be exceeded’ and ‘Not suitable for use by children under 15 years’ to
‘A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded’
Correction of this error is not expected to have any impact, as the correct statements were in force for six years between 2008 and June 2014.
In the unlikely case that any sponsor has changed a selenium medicine label since July 2014 to be compliant with the incorrect requirements, the TGA would consider the label to also be compliant with the correct (less restrictive) requirements.
Hydroxyanthracene derivatives
In relation to hydroxyanthracene derivatives, the RASML No. 2 incorrectly includes the statement ‘Not recommended for children aged 12 years and under’ rather than the correct statement ‘Not recommended for children under 12 years of age’.
The requirement for a statement to the effect that ‘Use in children under 12 years is not recommended’ was originally recommended by the TGA’s Complementary Medicines Evaluation Committee (CMEC) in August 2006, and proposed in the RASML Update 5 consultation. In the 2012 TGA response to submissions for RASML updates 5 & 6 it was then concluded that the following statement would be adopted:
‘RASML statement 4: “Use in children under 12 years is not recommended”.
Consequently, ‘statement 4’ of the 2008 RASML was adopted in RASML No. 2. However, the definition of statement 4 in the 2008 RASML is ‘Not recommended for children aged 12 years and under’ . This error was unintentional.
The proposed corrected statement is less restrictive that the current statement, but is in line with it. Consequently any labels that include the more restrictive statement will be considered to already comply with this proposal.
Removal of [j] - where it requires the affected statements to be grouped immediately preceding the directions for use
The [j] requirement is incorrectly applied in RASML No. 2 in a few cases. In particular, it has inadvertently been incorrectly omitted from ibuprofenentries 1, 3 and 5, as well as from oxymetazoline entries 3 and 4, and from the entry for pantoprazole. It has also incorrectly been includedin the entry for cetirizine.
The [j] requirement is also inconsistently applied in the RASML. This situation has arisen because the [j] requirementshave their origins in the SUSDP. Consequently they typically apply to statements for SUSMP-scheduled medicines, or to medicines that are specifically excluded from the schedules to the SUSMP. RASML entries and statements that do not have their origins in the SUSDP are typically not subject to these requirements.
The TGA and its Expert Committees have not considered it necessary to apply the [j] requirement to other advisory statements that were included in the original version of the RASML in 2004, or to any statements that have been subsequently included.
Consistency with the requirements of the SUSDP was necessary in 2004 because the SUSDP Appendix F (the list of warning statements required by the SUSDP) had not yet adopted the exclusion in relation to ‘medicines for human use when compliant with the RASML’ that applies to these requirements in Appendix F of the current SUSMP.This need for consistency no longer applies in the context of the current SUSMP and the Medicines Advisory Statements Specification.
The function of the [j] requirement is to ensure that warning statements relating to the use of the product are grouped together, and placed in a position on the label where they are likely to be read by the consumer prior to use. The TGA does not intend that removal of the [j] should imply a change to the expectation that statements are appropriately placed and grouped on medicine labels. However, the position immediately before the directions for use is not the only location on a medicine label that canserve this function.
Appropriate placement of advisory statements is important for all medicines. The current inconsistent application of the [j] requirement in the RASML could be taken to imply that the need for appropriate placement and grouping of statements is only important for the scheduled medicines to which the [j] requirement currently applies. This implication is unintentional - and is not the case.
OTC medicine labels are typically complex in design, and subject to multiple requirements for mandatory content. In the absence of comprehensive guidelines regarding labelling design, the most appropriate placement of any required advisory statements is expected to be considered by the applicant when the label is designed, and is assessed by the TGA prior to approval.