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Regulation impact statement: General requirements for labels for medicines

Version 3.0, July 2016

10 August 2016

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Background

Regulation of medicine labelling in Australia

As part of the Department of Health, the TGA is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods.

Under the powers of the Therapeutic Goods Act 1989 (the Act), the TGA is responsible for establishing and enforcing requirements for the way medicines are labelled for commercial supply in Australia. Under the provisions of the Act, a number of standards have been created to assist in this regulatory function. These standards known, as Therapeutic Goods Orders, are registered on the Federal Register of Legislation and several are applicable to the labelling and packaging of medicines.[1] Proposed changes to a current Order, the Therapeutic Goods Order No. 69 - General requirements for labels for medicines (TGO 69) is the subject of this RIS. TGO 69 applies to both medicines supplied under a health practitioner's prescription and also those that are self-selected by consumers, without a prescription, from pharmacies, supermarkets or other retail outlets ('over-the-counter' medicines).

Current labelling requirements - TGO 69 and best practice guidelines

Medicines supplied in Australia must meet labelling requirements specified in TGO 69. Drafted over 16 years ago, TGO 69 mandates information that must be on labels and the format and placement in which it must be presented. Examples of information required by TGO 69 include the name of the medicine, the name of the active ingredient (e.g. paracetamol) and its strength or quantity, storage requirements, expiry date and the declaration of certain inert or inactive ingredients ('excipient' ingredients).

Clear and prominent labelling of active ingredients enables hospital and poisons centre staff to provide the most appropriate emergency advice and interventions in the event of an accidental or deliberate overdose, or incorrect use of a product. Declaration of active ingredients on the main labels of medicines, as required by TGO 69, seeks to minimise these incidents. However, the Order is now outdated and lags behind international labelling requirements and current labelling design research.

In some instances, Australian medicine labels must also include other information that is not required by TGO 69, such as that required under state or territory legislation or for commercial purposes. This includes label headings such as 'pharmacy medicine', 'pharmacist medicine' and 'prescription only medicine' required under the Standard for the Uniform Scheduling of Medicines and Poisons (the Poisons Standard), or bar codes and sponsors' logos. Additionally, some labels are applied after a medicine is in commercial supply; for example, dispensing labels attached to prescription medicines. TGA does not regulate the dispensing labels, nor any other user-applied labels, or implementation of the Poisons Standard as these are regulated under state and territory laws.

In addition to the mandated requirements of TGO 69, guidance documentation exists to outline best practice principles for the design of medicine labels. These guidelines aim to assist sponsors to design labels that enhance the ability of healthcare professionals and consumers to select the correct medicine, use it safely, and reduce medication errors. These include, for prescription medicines, Best practice guideline on prescription medicine labelling; and, for over-the-counter medicines, the Australian Regulatory Guidelines for Over-The-Counter Medicines, Australian Regulatory Guidelines for Sunscreens and the Australian Regulatory Guidelines for Complementary Medicines. However, recommendations in these guidance materials are not enforceable and the TGA relies on voluntary compliance. This means that best practice principles are inconsistently applied.

TGA medicines labelling review

There have been ongoing efforts by numerous organisations to improve the quality of the naming, labelling and packaging of medicines in Australia, including from:

  • medicines industry, including representative organisations
  • academic researchers
  • safety and quality organisations
  • consumer groups

Despite these efforts, concern about the contribution of naming, labelling and packaging practices to quality use of medicines continues to be voiced by both consumers and healthcare professionals.

In response to a recommendation in the 2010 Transparency Review[2] to work with stakeholders to improve labelling requirements of medicines, and in recognition of the ongoing safety concerns of medicines, in July 2011 the TGA commenced a systematic review of the regulatory framework that applied to the labelling of medicines.[3]

The objective of the review was to develop regulatory solutions that effectively addressed the consumer safety risks posed by the following issues:

  • information about the active ingredient(s) contained in the medicine is not always easy to find
  • use of the same brand name for a range of products with different active ingredients resulting in look-alike medicine branding (this is known as brand extension or trade name extension)
  • medicine names that look-alike and sound-alike that can lead to use of the incorrect medicine
  • medicine containers and packaging that look like that of another medicine
  • lack of a standardised format for information included on medicines labels and packaging
  • dispensing stickers that cover up important information
  • information provided on blister strips
  • information included on small containers
  • information provided in pack inserts

In February 2012 an External Reference Group, comprising industry, consumers, health professionals and government representatives, met to discuss labelling options. The overwhelming stakeholder view was that any changes to the current labelling standard should be mandatory and incorporated into a revised TGO, rather than implemented in a voluntary and inconsistent manner through best practice guidance.

Subsequently, public consultation was held in May 2012 to seek comments on recommendations to change the presentation of information on the labels and packages of medicines.[4] The TGA received 110 submissions from consumers, academics, healthcare professionals and industry.[5] Generally, 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 and dispensing label space.

In January 2013, the TGA published 'Labelling and packaging practices: A summary of some of the evidence'[6]. This report reviewed the published literature on the problems associated with the labelling of medicines and the subsequent health risk to consumers. Some of the issues identified include:

  • Lack of prominence of the active ingredient - leading to unintentional overdoses where a patient self-medicates with two products not realising they contain the same active ingredient[7,8,9,10]. This is a particular risk with active ingredients like paracetamol that can be found in a wide range of over-the-counter medicines and for which the difference between a therapeutically-effective dose (e.g. for osteoarthritis) and a dose which is potentially toxic to the liver is relatively small.
  • Lack of standardisation of the Medicine Information Panel for non-prescription medicines - leading to a lack of adherence to directions and inadequate dosing, both with self-administered or hospital/clinic administered medications, leading to poor treatment outcomes.[11]
  • Lack of comprehension of the language used on labels and poor readability of labels - leading to medication errors.[12,13]
  • Poor outcomes associated with taking a medicine, including complementary medicines, when they are contraindicated in combination with other medicines or for some conditions.[14]
  • Administration of the wrong medicine (particularly in hospital settings where staff are often fatigued and under pressure) because of difficulty in reading the labels, leading either to ineffective treatment or potentially the administration of dangerous medications not indicated for the circumstances.[15,16,17]

Footnotes

  1. Therapeutic Goods Administration (TGA), Diagram of the TGA labelling and packaging framework
  2. TGA reforms: A blueprint for TGA's future
  3. Therapeutic Goods Administration 2011, Labelling and Packaging Review
  4. Therapeutic Goods Administration 2012, TGA medicine labelling and packaging review Consultation
  5. Therapeutic Goods Administration 2012, TGA medicine labelling and packaging review
  6. Therapeutic Goods Administration 2013, Labelling and packaging practices: A summary of some of the evidence (January 2013)
  7. Sorensen, L, Stokes, J, Purdie, M, et al., 2005, 'Medication management at home: medication-related risk factors associated with poor health outcomes', Age and Ageing, vol. 34, no. 6, pp. 626-632.
  8. Graudins, L & Dooley, M 2010, 'Generic medicines literacy - minimising the potential for patient confusion', Medical Journal of Australia, vol. 193, no. 7, pp. 427.
  9. Carney, S, Gazarian, M, Denholm, J et al., 2011, 'What's in a name? Brand name confusion and generic medicines'. Medical Journal of Australia, vol. 195, no 11, pp. 650-651.
  10. Lalor, D 2011, 'Medicines Labelling'. Australian Prescriber, vol. 34, pp. 136-138.
  11. Wogalter, M & Vigilante, W 2003, 'Effects of label format on knowledge acquisition and perceived readability by younger and older adults'. Ergonomics, vol. 46, no 4, pp. 327-344.
  12. Medicines Australia Ltd 2011, Packaging and labelling of pharmaceuticals and consumer safety - A survey of the literature (pdf,243kb)
  13. Shrank, W, Avorn, J, Rolon, C, & Shekelle, P2007, 'Effect of content and format of prescription drug labels on readability, understanding and medication use: a systematic review', Ann Pharmacother, vol. 41, no. 5, pp. 783-801.
  14. Lalor, D 2011, 'Medicines Labelling'. Australian Prescriber, vol. 34, pp. 136-138.
  15. Weingart, S, Wilson, R, Gibberd, R & Harrison, B 2000, 'Epidemiology of medical error', BMJ vol. 320, no. 7237, pp.774-7.
  16. Morrow, D, Leirer, V, Andrassy, J, Hier, C and Menard, W, 1998, 'The influence of list format and category headers on age differences in understanding medication instructions'. Experimental Ageing Research, vol. 24, no.3, pp 231-256.
  17. Shrank, W, Avorn, J, Rolon, C, & Shekelle, P2007, 'Effect of content and format of prescription drug labels on readability, understanding and medication use: a systematic review', Ann Pharmacother, vol. 41, no. 5, pp. 783-801.

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