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TGA medicine labelling and packaging review
TGA medicine labelling and packaging review
Initial analysis of submissions and proposed next steps in the review process
The May 2012 Medicines Labelling and Packaging Review Consultation Paper was one of the first steps in addressing Recommendation 14 of the TGA Blueprint. As part of this recommendation, the TGA is committed to working with stakeholders to improve medicine labels and packaging to assist consumers and health practitioners to make informed decisions about the quality use of medicines.
In response to the consultation paper, 110 submissions were received from consumers, academics, healthcare professionals and industry. The diversity of stakeholders represented and the breadth of submissions received has provided valuable feedback on the issues being addressed by the review.
Overall there was support for the objectives of the review of labelling and packaging and the intentions of the recommendations in the consultation paper. In particular there was strong support for changes regarding active ingredient prominence, standardised medicine information presentation, dispensing label space and the creation of a committee to provide advice to the TGA on labelling and packaging issues. While the intent behind the recommendations for the remaining issues, including look-alike sound-alike names, look-alike packaging, look-alike branding, pack inserts, small containers and blister strips - were generally supported, there was significant opposition in some submissions to the proposed approach. Further discussion with stakeholders including consideration of possible alternatives is required to ensure the objectives are achieved.
Six consistent issues have been identified for further analysis and discussion with stakeholders. These are:
- The need to have some differences in the labelling requirements for different classes of medicine (prescription, over-the-counter and complementary);
- Evidence - the need, in subsequent analysis, to provide evidence that particular changes will improve medicine safety and the quality use of medicines;
- Greater clarity on which proposed options are to be mandated versus encouraged;
- Assessment of the cost of particular options, and ability of industry to implement them;
- Harmonisation of labelling plans with other jurisdictions where possible, including with New Zealand; and
- A commitment to undertake independent consumer testing of proposed options, followed by education and awareness programs once they are implemented.
However, there were consistently divergent views regarding the way to achieve the objectives of the recommendations between industry and consumer groups on some issues, such as prominence of active ingredient names and use of umbrella branding. It is proposed that these also be the subject of further discussion with stakeholders.
From analysis of the submissions a number of major issues have been identified and the TGA will conduct further consultation with stakeholders to determine appropriate regulatory solutions.
This paper outlines the major issues identified from the consultation submissions and provides details of the next steps to address these concerns.
Submissions from industry and some healthcare professional groups suggested strongly that a single set of requirements for medicines labelling is not appropriate for the different classes of medicines.
To address this concern, it is now proposed that labelling requirements will be specific to the class of medicine - prescription, over the counter (non-prescription registered) and listed (complementary) - and will reflect the level of risk associated with the product. Labelling requirements will consider the level of access and healthcare professional interaction associated with each class of medicine, for example a prescription only medicine or a product of self-selection in a pharmacy or supermarket. It is recognised that there are different information needs for consumers and healthcare professionals in these circumstances, and it is essential that this is reflected in regulatory requirements. For example, a medicines information panel (or similar information) may be more appropriate for an over the counter medicine than a prescription medicine. The large number of active ingredients in many complementary medicines may also require a different approach to ingredient prominence than prescription or OTC medicines.
Although TGA provided a list of studies of medicines labelling and packaging at Appendix 2 of the discussion paper, several submissions were concerned that that there was no evidence provided that the recommendations would adequately address the issues identified with labelling and packaging. To assist in the assessment of the evidence, a brief annotated bibliography has been prepared analysing the current shortcomings of labelling and packaging, as well as potential solutions to the identified issues. This bibliography is available at: Labelling and packaging practices: A summary of some of the evidence.
Where labelling and packaging options have been derived from practices adopted by overseas regulators, the TGA will report on work with those regulators to identify successes and failures of those regulatory approaches in improving the quality use of medicines.
Some submissions expressed concerns that there was insufficient time to conduct consumer testing of the proposals. TGA felt that it would have been premature to conduct such testing before the release of the discussion paper and receipt of initial feedback. However, prior to implementation of regulatory changes, independent consumer-testing of one or two proposed labelling and packaging options will be progressed and conducted in collaboration with stakeholders. Potential approaches to be used will be discussed at upcoming stakeholder workshops.
A number of the submissions raised concerns that the recommendations in the consultation paper were too prescriptive and inflexible. It was argued that the recommendations would only be suitable for specific packaging types and that for small containers and bottles, for example, the requirements would not be able to be implemented. Many of the submissions suggested the need for flexibility with regard to placement and information formatting to ensure compliance could be achieved. Industry submissions in particular requested greater clarity on which proposed options are to be mandated.
To ensure consistency in the application of the requirements for medicine labels, it is intended that this review will result in a legally binding Therapeutic Goods Order. However, it is recognised that some recommendations proposed for inclusion in Therapeutic Goods Orders could instead be supported with guidelines or industry codes to allow for some flexibility in how the recommendations are achieved.
The TGA will work with stakeholders to determine the best way to achieve the objectives of the review whilst ensuring that requirements are implementable and compliance can be achieved.
Since the commencement of this review, the governments of Australia and New Zealand have announced the intention to establish a joint Australian and New Zealand Therapeutic Products Agency. To reduce the impact on all stakeholders of revised labelling and packaging requirements, regulatory changes acceptable for both countries individually and as a joint agency will be specifically considered in the next steps of the review. New Zealand stakeholders were specifically invited to provide submissions on the May 2012 paper and going forward, they will be included in discussions and workshops as this reform progresses.
A number of overseas regulators have previously considered many of the issues being addressed by the review and have published guidelines and directives. In the context of a global pharmaceutical industry, and to reduce the possibility of creating uniquely Australian requirements for international labelling problems, the TGA, together with stakeholders, will investigate options for adopting and harmonising better practice requirements from overseas regulators. However, since labelling requirements are not fully harmonised between countries, compromises will be necessary.
Some industry submissions expressed concerns about the likely feasibility and cost of particular changes to labelling that were proposed. During the next phase, TGA will work closely with industry to obtain verifiable information on the costs of particular labelling changes, and discussions held on whether there are any alternative labelling and packaging options that could achieve the same intent for a much lower cost.
It is recognised that the "turnover" rates of particular packaging often differ – for example a prescription medicine from an innovator company may stay in similar packaging for over a decade, while modifications to OTC and complementary medicines are often made at much more frequent intervals. This will be factored into the analysis of cost for potential labelling change.
A range of other issues, often relevant to particular types of products, will be addressed in the specific discussion papers. The first paper will cover registered medicines, including prescription and OTC medicines, and will addresses:
- Prominence (Relative size) of active ingredient names
- Umbrella branding
- Small containers
- Look-alike / sound-alike names
- Look alike packaging
- Dispensing label space
- Blister strip labelling
- Medicine information box
In the following months, in conjunction with consultation on other planned reforms to complementary medicines regulation, a subsequent paper and consultation workshops will address labelling options for Listed (including Complementary) Medicines. While complementary medicines are lower in risk, labelling options will also need to complement and integrate with other proposed regulatory changes, as foreshadowed in the TGA Blueprint for Reform.
Need for education and awareness to support any changes
It is recognised that a number of factors contribute to medication errors, and that labelling and packaging is only one of them - albeit one that may be more readily addressed than some others that contribute to physician, nurse, pharmacist or patient error.
Any changes implemented by the TGA regarding medicine labelling will need to be a part of a comprehensive change program and will not be the panacea for all the identified problems. Improved health literacy within the community is an objective that will require commitment from all stakeholders, particularly those with a broader consumer focus.
The review process has highlighted that many of the risks associated with key issues for medicine labels and packaging may be reduced through improved understanding of medicine labels and the information provided.
Key areas for consumer education include active ingredient awareness, storage conditions for medicines, contraindications, dosage regimens and the maximum daily dose for medicines.
To address this concern, at stakeholder workshops we will discuss education and communication needs on labelling and packaging of medicines, and the roles of various stakeholders in the health system in providing consumer and professional education.
The overall aim of reviewing medicine labelling and packaging is to reduce the risk of errors by healthcare professionals and facilitate consumer access to information they need to:
- Make informed choices where they are self-managing minor conditions,
- Safely use a medicine that they have been prescribed by a healthcare practitioner for the treatment of a more serious condition.
It is proposed to, as a next step, focus on labelling requirements for registered prescription and non-prescription medicines. Separation of labelling and packaging reform for different classes of medicines will ensure that thorough consideration of the revised requirements and their impact can be undertaken, particularly for products at the interface of therapeutic and consumer products, such as sunscreens.
The initial recommendations will be refined to more specifically reflect the needs of registered prescription and OTC medicines, and options discussed in a separate paper In addition to this paper further information, including the annotated bibliography discussed above, will be circulated to major stakeholders and posted on the TGA website in the coming months.
It is proposed to initially work one-on-one over the next couple of months with representatives of the major industry, consumer and health care professional associations on the highly contended items relating to their areas of responsibility, and to discuss the proposed options in more detail with other parts of the Department, the Australian Commission on Quality and Safety in Healthcare and NPS.
With the options further refined and presumably with greater consensus having been achieved, workshops of the External Reference group (and as required, of broader groups with interests respectively in prescription, over the counter and complementary medicines) would be held after that time. One or two final proposed options would then be independently consumer tested in early 2013, ahead of proposing changes to the relevant Therapeutic Goods Order. Following this, the TGA will prepare a regulatory impact statement consistent with Government requirements for Best Practice Regulation. It is anticipated that together with the consultation submissions, further collaboration and discussion with stakeholders will provide adequate material to inform the regulatory decision making process.