From 1 February 2018 medicines containing codeine will no longer be available without a prescription from a doctor or other suitably qualified health professional such as a dentist or a nurse practitioner.
This guidance document sets out information for therapeutic goods sponsors and health professionals to consider when preparing information for pharmacy assistants and consumers to ensure that the information and education material is not promotional and so will not be considered advertising.
If you are intending to do some advertising this document also contains tips to help you to comply with therapeutic goods advertising legislative requirements.
Compliance with the therapeutic goods advertising framework
There is a need to consider the context and the type of information given to the public or to patients in deciding whether the information is on one hand educational or training material or if the material on the other hand would be considered promotional and therefore fits the definition of an advertisement for a therapeutic good.
We recognise that there is a need for a factual dialogue around the decision to up-scheduling of codeine to a prescription-only medicine and the impact this may have on consumers, patients and care providers.
There is significant scope to have a factual discussion around the codeine up-scheduling decision, including providing education and training on what the changes may mean for patients without this discussion or any informational material presented being regarded as promotional.
If the information, however is promotional, it is likely that it would constitute an 'advertisement' within the meaning of the Therapeutic Goods Act 1989 if it is likely to be taken that the material presented promotes the supply or use of a particular therapeutic good.
Advertisements to the public for therapeutic goods are subject to the requirements of the Act, the Therapeutic Goods Regulations 1990, the Therapeutic Goods Advertising Code and other relevant laws.
Educating patients and the public
A range of information for consumers about codeine up-scheduling is available on the TGA Codeine Information Hub; this can be reproduced or adapted without TGA's permission in presenting information to the public or in undertaking discussions with patients. In addition, a range of pharmacy and medical professional bodies and consumer and patient organisations will also be conducting educational activities.
Educating pharmacy assistants
An information sheet Tips for talking about codeine: Guidance for pharmacy assistants is available on the Codeine Information Hub.
Pharmacy assistants generally do not have the educational qualifications or experience of a pharmacist. Importantly for the purposes of the therapeutic goods legislation around advertising, they are considered as part of the general public. As codeine-containing analgesics cannot be advertised to the public, they cannot be advertised to pharmacy assistants. Further, any advertising materials directed to pharmacy assistants for other types of over-the-counter pain-relief products must comply with the Act and the Code.
There can be a fine line between the presentation of educational material and if the content and presentation of the information is not impartial. Care is needed to ensure that educational materials do not inadvertently promote therapeutic goods.
To assist in ensuring that educational materials are not promotional and therefore unlikely to be considered advertising:
- A list of products that will no longer be available over the counter from 1 February 2018 can be provided.
- A list of analgesic options that will continue to be available over-the-counter after 1 February 2018 can be provided.
- Non-medicinal options like lifestyle changes or devices for pain management can and should be included as options.
- When listing products, include multiple products from a range of sponsors and you should also feature prominent information to the effect that the inclusion of specific products in the presentation is illustrative of options available and in no way implies or endorses the use of a particular product(s).
- Include information that encourages patients to discuss their specific needs with the pharmacist.
- Ensure content is factual and balanced and is unlikely to encourage a pharmacy assistant to use or recommend a specific product(s).
The following should be avoided in preparing or delivering educational material for pharmacy assistants:
- Material should not be delivered and/or branded by a person who sponsor products mentioned in or covered by the material.
- Product listings must not give prominence to any one particular product, or range of products from a particular sponsor.
- Content must not provide opinion on the efficacy of the products and superlatives should not be used to describe product performance.
- Price information should not be included.
Advertising to consumers
Unlike educational material, material that promotes the supply or use of pain-relief products (including medical devices) to the public (which includes pharmacy assistants) is considered to be a consumer advertisement under the Act.
Advertisements for therapeutic goods directed to consumers must comply with additional regulatory requirements.
By following the guidance in the previous section it is unlikely that your educational material will be considered to be promotional. However, where material becomes promotional advertisers need to ensure that the advertisement complies with the Act and the Code.
You can mention that there will be changes to the way some pain medicines are accessed from 1 February 2018 provided that:
- the information is presented in a responsible manner that complies with the Act and the Code, and
- a prominent statement such as 'If you regularly rely on medication to relieve strong pain, you should consult your doctor or pharmacist before purchasing this product' is included in the advertisement.
Don't specifically reference Codeine in an advertisement for therapeutic goods.
- References to Schedule 3 substances that are not included in Appendix H of the Poisons Standard in an advertisement for any therapeutic good (even if the substance is not contained in the advertised product) are prohibited under paragraph 42DL(1)(f) of the Act.
- References to Schedule 4 substances in an advertisement for any therapeutic good (even if the substance is not contained in the advertised product) are prohibited under paragraph 42DL(1)(f) of the Act.
Checklist for a compliant advertisement
When advertising pain-relief products, there are a number of Act and Code provisions that require particular attention. A checklist to assist advertisers in developing compliant advertising, including examples of non-compliant advertising, is attached.
- For further information about advertising therapeutic goods:
- visit the TGA website
- email TGA.Advertising@tga.gov.au
- contact the Pharmacy Board or your State/Territory Health department.
- Further information on codeine and the decision to up-schedule is available from the Codeine Information Hub
Checklist for compliant pain-relief product advertising
The following provisions require particular attention when checking whether an advertisement for pain-relief products will comply with the Act and the Code in the context of codeine up-scheduling.
This is not an exhaustive list of requirements, nor does this checklist constitute legal advice. It is the advertiser's responsibility to ensure that a proposed advertisement complies with all applicable legislative requirements before release.
|Subsection 22(5) of the Act||
A pain-relief medicine must not be advertised for indications other than those included in the Australian Register of Therapeutic Goods (ARTG) for that medicine.
Example: a medicine registered for temporary relief of mild pain only cannot be advertised for relief of strong pain.
|Paragraph 42DL(1)(f) of the Act||
There should be no references to Schedule 3 (pharmacist-only) substances in an advertisement for a therapeutic good that are not also listed in Appendix H of the Poisons Standard.
This provision also prohibits the advertising of currently Schedule 3 (pharmacist-only) codeine-containing products for pain relief to consumers.
|Section 4(1)(b) of the Code||
All claims made in the advertisement for pain relief products are accurate and balanced.
Example: a claim that a therapeutic good provides the same relief as other strong pain medicines would need to be substantiated by a clinical trial.
|Section 4(2)(b) of the Code||
An advertisement for pain relief products must not be likely to lead to consumers self-diagnosing or inappropriately treating potentially serious diseases.
Example: an advertisement that encourages a consumer to treat their chronic pain with an over-the-counter medicine when they need a review by a health professional would contravene this requirement.
|Section 4(2)(c) of the Code:||
An advertisement for pain relief products must not mislead consumers.
Example: claims that overstate the relief that can be obtained from a product would mislead consumers.
|Section 4(2)(d) of the Code||
An advertisement for pain relief products must not exploit consumers' lack of knowledge or contain language which could bring about fear or distress.
Example: a message that consumers won't be able to access their codeine pain relief from 1 February 2018 is likely to cause fear and distress for consumers that rely on such medicines.
Example: a message that reports costs associated with obtaining a prescription medicine is also likely to exploit consumers and cause fear and distress.
|Section 4(2)(e)(ii) of the Code||
Pain relief products are not advertised in a way that is likely to lead a person to think harmful consequences may result from not using the therapeutic good.
Example: portraying the impact of pain on a person's life because they haven't taken the advertised medicine.
|Section 4(2)(f) of the Code||
An advertisement for pain relief products must not be likely to encourage inappropriate or excessive use.
Example: encouraging a consumer to persist with the use of an over-the-counter pain relief medicine when they need review by a health professional.
|Section 5(2) of the Code||
References to serious forms of diseases and conditions ('restricted representations') must be approved by the TGA before use in advertising. The TGA can only approve the use of a restricted representation if it is satisfied that it is accurate, balanced and not misleading.
Example: advertising a pain-relief product to consumers for osteoarthritis, rheumatoid arthritis or other conditions associated with chronic pain without TGA approval.
Retailers can check the TGA website or with product sponsors to see if there is an existing restricted representation approval.
|Section 4(5) of the Code||
Comparative advertisements must be accurate and not misleading. They must not imply that other therapeutic goods are harmful or ineffectual.
Example: advertising a pain-relief product that states or implies that codeine medicines are harmful.
|Section 6(3) of the Code||The advertisement must contain the mandatory warning statements prescribed under section 6(3) of the Code.|
|Section 7(1) of the Code||
For products containing certain ingredients (like paracetamol), the additional warning statements must be included in the advertisement:
For advertisements other than product labels and radio advertisements 15 seconds or less:
Use only as directed. Incorrect use could be harmful. Consult your healthcare professional if symptoms persist.
For radio advertisements 15 seconds or less:
Always read the label. Use only as directed by a healthcare professional