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Evaluating the feasibility of a new-to-market risk communication scheme

Summary of themes identified by participants at the stakeholder consultation workshops

1 August 2013

Introduction

The TGA hosted two workshops to discuss with stakeholders several proposals for improving the accessibility and quality of post market regulatory information. The workshops were held on Tuesday 28 May 2013 in Sydney and Wednesday 29 May in Melbourne.

The topics discussed included an evaluation of the feasibility of a new-to-market risk communication scheme for therapeutic goods. This work arose from a review conducted in 2010 of the way the TGA communicates its regulatory processes and decisions, with the aim of improving its transparency. The panel who conducted the review noted that there appeared to be a lack of public awareness of the uncertainties about the safety profiles of medicines early in their lifecycles, and felt that a risk communication scheme for new products could help to encourage public understanding of safety profiles. The TGA is currently evaluating the feasibility of implementing a new-to-market risk communication scheme, and will provide its evaluation to Government for consideration.

The aims of the workshop sessions about this proposal were to seek feedback to help determine how different stakeholder groups might value and use a new-to-market risk communication scheme, and to identify design aspects of a scheme likely to meet stakeholders needs. This document summarises the comments and themes that arose at the workshops in relation to a new-to-market risk communication scheme.

Question 1: Value of a scheme

Participants were asked to respond to the following questions.

  • Would a new-to-market risk communication scheme be of value to you? If so, how would you use it? If not, why not?
  • What might be the risks of a scheme?
  • Would you value and use a scheme for medicines differently from a scheme for medical devices?

There was general support for the idea of a new-to-market risk communication scheme for medicines.

From a consumer point of view, a scheme was seen as a way to promote public understanding of the risk-benefit balance for new medicines, the limitations of evidence considered for registration, and the fact that newer products are not necessarily better (or worse) than older products.

For health professionals, workshop participants considered that the benefits of a new-to-market risk communication scheme included promoting adverse event recognition and reporting, improve understanding of the limitations of the evidence for new products, and addressing the misconception of some health professionals that new products always provide an advantage over older products.

For industry, the value of a scheme was seen to be improving pharmacovigilance by increasing adverse event reporting, thereby supporting prompt detection of safety issues.

There was general support for the idea of promoting greater awareness of the limitations of evidence for, and encouraging adverse event reporting about, new medical devices. However, participants considered that a new-to-market risk communication scheme would have to operate differently for medicines and medical devices because of the broad range of different types of medical device and the way in which medical devices are regulated and used. Issues raised specifically in relation to medical devices are discussed on page 12.

The main risk of a new-to-market risk communication scheme identified by participants was misinterpretation of the meaning of the scheme. Concerns were raised that consumers and health professionals might interpret inclusion of a product in the scheme as meaning that the product was unsafe or should be avoided. Testing of messages with target audiences was considered to be important for avoiding misinterpretation.

Participants considered that a new-to-market risk communication scheme would be a useful trigger for reporting adverse events associated with products included in the scheme, but that the scheme would have little or no effect on reporting patterns if reporting was not promoted and made simpler and faster. Participants suggested incorporating reporting functions into clinical software and providing a 'single shopfront' on the TGA website for reporting adverse events associated with any therapeutic product. These suggestions will be considered as part of the development of mechanisms to improve adverse event reporting to the TGA.

Question 2: Which products to include

In the first part of this session, participants were asked to comment on how the decision should be made to include a product in a new-to-market risk communication scheme. In particular, they were asked to comment on:

  • whether the inclusion criteria should be completely non-discretionary, completely discretionary, or a combination of discretionary and non-discretionary criteria, and
  • how they would define 'new' for the purposes of a scheme.

In the second part of this session, participants were asked to comment on methods for removing products from a new-to-market risk communication scheme. In particular, they were asked to state their preference for removing products automatically after a certain time period, or conducting a review after a certain time to determine whether a product should be removed.

Inclusion

There was general support for inclusion in a scheme to be based on a combination of discretionary and non-discretionary criteria, although there was also some support for inclusion in a scheme to be completely discretionary. The key concern regarding inclusion criteria was that a scheme be targeted so that the number of products included in it was limited. Participants considered that if completely non-discretionary criteria were used, then the scheme would include a large number of products, and health professionals and consumers would become desensitised to the scheme's messages.

Participants considered that inclusion criteria for medicines should capture:

  • new active ingredients
  • new indications for 'old' medicines
  • new dose forms or routes of administration

but that there should be discretion for products to be excluded by the TGA if they were judged to not be new.

Including any product with a risk management plan (RMP) was considered to capture too many products in the scheme.

There was general agreement that overseas experience be considered when determining whether a product should be included in a scheme, as a product newly registered in Australia could have a history of use for the same indication in other countries.

A risk-based approach to considering products for inclusion was favoured by participants (for example, inclusion of prescription medicines but not over-the-counter medicines), although it was suggested that there be flexibility to include any new product judged to be associated with significant uncertainty in its risk-benefit profile.

There was a suggestion that there be flexibility for an older product or group of products to be included in the scheme if uncertainty about their safety profiles arose. An example of this was suggested to be the emergence of evidence for possible cardiovascular risk associated with non-steroidal anti-inflammatory drugs.

It was suggested that seasonal vaccines be specifically excluded from a scheme.

Removal

There was support for the removal of products to be based on a review of experience with the product, rather than automatic removal after a certain period, because exposure to and experience with different products would accumulate at different rates depending on their level of use. Participants commented that there should be a clear rationale for removing a product or retaining it in the scheme.

In discussions about the initial time period of inclusion for a product the following points were raised:

  • The time period for initial inclusion of a product should take into account the time it usually takes for new safety problems to emerge.
  • The potential for health professionals and consumers to become desensitised to the scheme's messages should be considered (eg if a single product remains on the scheme for a long time, or if many products are in the scheme at any one time).
  • Total exposure to the product (both in Australia and overseas) should be considered.
  • An 'exposure threshold' could be an alternative to a time period for inclusion.
  • If exposure is considered an important factor in determining whether a product should be removed from the scheme, then different arrangements should be applied to orphan drugs, otherwise they may remain in the scheme indefinitely.

Question 3: Communicating and promoting

Participants were asked to answer the following questions.

  • If a scheme was implemented, where could the symbol appear (for medicines and medical devices) so that it reached consumers and health professionals?
  • Where and how could the scheme be promoted and explained?

Communicating

Participants considered that the symbol should be visible to health professionals and consumers at as many points in the process of selecting and using a product as possible, so that it was most likely to be visible at points when the information was relevant and could be considered and discussed by health professionals and consumers. Places that were suggested for display of the symbol for medicines included:

  • prescribing software,
  • dispensing software,
  • pharmacy labels,
  • advertising and promotional materials,
  • product information (PI),
  • consumer medicines information (CMI),
  • health professional resources such as MIMS, Australian Medicines Handbook, Therapeutic Guidelines, clinical practice guidelines and information published by NPS Medicinewise, and
  • the Australian Register of Therapeutic Goods.

There was some discussion of the possibility of including the symbol on medicines packaging. Some participants supported including the symbol on packs, as an additional way to reach users with the schemes' messages. Other participants pointed out that consumers and health professionals would ideally have recognised and considered a product's inclusion in the scheme before the product was supplied to the consumer, and so inclusion of the symbol on packaging would add little and potentially increase the risk of consumer concern or confusion if the meaning of the symbol had not already been discussed by the consumer and health professional.

Another concern regarding the inclusion of the symbol on packaging related to logistical issues. For example, it was noted that (depending on stock turnover) stock might not be supplied to a consumer until several years after manufacture and packaging, but the product may have been removed from the scheme in the meantime. It was also noted that sponsors expect that under the Australia and New Zealand Therapeutic Products Agency, Australian and New Zealand packaging would be harmonised, in which case, an identical new-to-market risk communication scheme would need to operate in both countries if the symbol appeared on packaging.

There was discussion of the need to ensure that the symbol was removed promptly from sources in which it appeared once a product was removed from the scheme, and that this would require good communication between the TGA and other bodies involved in displaying the symbol.

It was suggested that the date a product was included in the scheme, and the date that its inclusion would be reviewed, should be publicly accessible, possibly by including this information in the PI and CMI.

It was suggested that when a product was removed from the scheme, the TGA communicate this fact to health professionals and consumers, and publish a summary of experience to date with the product.

Participants raised a number of challenges relating to placement of a symbol for medical devices.

Promoting

There was strong support for implementation of a scheme to be accompanied by targeted communications activities for consumers and health professionals explaining the purpose of the scheme, the meaning of the symbol and the background to the scheme (including the limitations of evidence collected before a therapeutic product is registered). Suggestions included that:

  • communications about the scheme be designed as an ongoing effort rather than a short-term publicity campaign,
  • a best-practice approach should be taken to development of a communications program for consumers to maximise its effectiveness,
  • educational activities, accredited for continuing professional development points, could be offered to health professionals,
  • health professional communications activities should include advice about responding to consumers' questions and concerns about the scheme,
  • the TGA work with other organisations (such as professional colleges and societies and consumer health organisations) to use existing information networks to publicise and explain the scheme,
  • the TGA generate a clear explanation of the scheme that could be disseminated by other organisations,
  • consideration be given to whether drug and therapeutics committees could assist in promoting the scheme,
  • information about the scheme be included in health professional training,
  • consideration be given to branding the scheme to improve recognition of it,
  • pharmacists be particularly encouraged to distribute CMI for products included in the scheme, and
  • the scheme be a topic for discussion at a National Medicines Symposium.

Question 4: Evaluating

Participants were asked to answer the following question:

'If a scheme was implemented, how could we measure its success?'

Participants agreed that if a new-to-market risk communication scheme was implemented, it should be evaluated.

It was noted that the TGA needed to understand clearly the aim of the scheme to be able to evaluate whether it had been successful.

It was suggested that an evaluation plan be developed that included process, impact and outcome measures.

Participants suggested the following evaluation measures:

  • effect of the scheme on the rate or pattern of adoption of new drugs,
  • self-reported prescribing behaviour for included vs excluded products,
  • effect of the scheme on self-reported adverse reaction reporting behaviour,
  • numbers of suspected adverse drug reactions reported for included products,
  • awareness of the scheme and understanding of messages,
  • implementation and effect of communications strategy, and
  • number of products included and excluded, adherence to inclusion criteria.

General design considerations

  • Harmonisation | Integration of scheme with existing registration and post-marketing processes
  • Harmonisation

    It was suggested that if a new-to-market risk communication scheme was implemented in Australia, it should be harmonised, as far as possible, with the 'additional monitoring scheme' recently introduced in the European Union. Ideally, both schemes would use the same symbol (an inverted black triangle) as this should reinforce understanding of the symbol. It was suggested that products included and the length of time for which they were initially included could also be the same in Australia and the EU as far as possible. It was noted, however, that 'harmonisation' could produce confusion if, for example, the same symbol was used in Australia as in the EU, but applied to different types of products.

    Integration of scheme with existing registration and post-marketing processes

    It was suggested that consideration of inclusion of a medicine in the scheme could be a topic for discussion at the presubmission planning stage, to give a sponsor as much notice as possible that a product was likely to be included. Sponsors could include in risk management plans a statement about whether they considered the product should be included in the scheme, with the final decision being made by the TGA as part of the registration process. A medicine could be considered for removal from the scheme as part of the TGA's review of Periodic Safety Update Reports (PSURs), with sponsors including in their PSURs justification for the product being removed from or remaining in the scheme.

    Considerations for medical devices

    There was general support for the idea of promoting greater awareness of the limitations of evidence for, and encouraging adverse event reporting about, new medical devices. However, participants considered that a new-to-market risk communication scheme would have to operate differently for medicines and medical devices because of the broad range of different types of medical device and the way in which medical devices are regulated and used.

    It was suggested that a new-to-market risk communication scheme could act as a trigger for 'informed consent' discussions to occur between health professionals and consumers about the risks and benefits of a particular medical device before use of the device. Participants considered that such discussions probably happened only rarely. It was also suggested that objective information for consumers about medical devices would be of value in supporting informed consent.

    Some participants considered that it would not be possible to design a feasible new-to-market risk communication scheme for medical devices, or that changes to the regulation of medical devices would be required in order for a scheme to operate effectively.

    Participants agreed that it was difficult to suggest straightforward criteria for including medical devices in a new-to-market risk communication scheme but that in general a risk-based approach could be taken, whereby devices associated with higher risk would generally be included (it was suggested, for example, that all implantable medical devices be included).

    It was noted that it is difficult to develop criteria to select medical devices that are truly novel because many new medical device entries on the ARTG represent modifications of older medical devices.

    Participants noted that there appeared to be few avenues through which it could be reliably communicated to health professionals and consumers that a product was included in a new-to-market risk communication scheme. It was noted that there was relatively limited availability of information about medical devices, compared with medicines, given that 'Instructions for use' for medical devices are not publicly accessible like PI for medicines, and that no equivalent of CMI exists for medical devices.

    The settings in which many medical devices are used were also considered to present challenges to communicating to health professionals and consumers that a medical device was included in a scheme. For example, if the symbol was printed on medical device product packaging, then for devices used in surgical settings it would probably not be seen by the surgeon at all, because the packaging would be removed and discarded by a nurse.

    In summary, while the concept of a new-to-market risk communication scheme for devices was generally supported, participants considered that such a scheme would be less feasible to implement than a scheme for medicines.

    List of participating organisations

    Sydney

    • Australasian Pharmaceutical Science Association
    • Australian Self Medication Industry
    • Australian Society of Plastic Surgeons
    • Cardiac Society of Australia and New Zealand
    • Complementary Healthcare Council of Australia
    • Consumers Health Forum
    • Generic Medicines Industry Association
    • Guildlink
    • IVD Australia
    • Laserase
    • Medical Technology Association of Australia
    • Medicines Australia
    • National Prescribing Service
    • New South Wales Therapeutic Advisory Group
    • Novartis Pharmaceuticals Australia Pty Ltd
    • Office of Health Protection - Department of Health and Ageing
    • Pharmaceutical Benefits Division - Department of Health and Ageing
    • Pharmacy Guild of Australia
    • Royal Australasian College of Surgeons
    • The Royal Australasian College of Physicians
    • The Royal Australian College of General Practitioners
    • University of Sydney
    • Western Australia Department of Health

    Melbourne

    • Australian and New Zealand College of Anaesthetists
    • Australian College of Nursing
    • Australian Dental Association
    • Australian Homoeopathic Association
    • Australian Self Medication Industry
    • CHOICE
    • Eastern Health
    • Generic Medicines Industry Association
    • Heart Foundation
    • Lung Foundation Australia
    • Medicines Australia
    • National Asthma Council Australia
    • Royal Australasian College of Surgeons
    • Royal Australian and New Zealand College of Psychiatrists
    • South Australian Department of Health
    • Therapeutic Guidelines Limited
    • The Royal Australasian College of Physicians
    • The Society of Hospital Pharmacists of Australia

    Version history

    Version Description of change Author Effective date
    V1.0 Original Publication Management and Co-ordination/Office of Product Review 10 July 2013

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