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TGA Transparency Review public meetings

21 March 2011

The Panel has been asked to report on:

  • opportunities to provide more information about products on the market;
  • how the public can improve its understanding of the ways new products are assessed and products on the market are monitored;
  • the timing for making information available about new products;
  • the type of information and how it is made public by comparable overseas regulators;
  • constraints (or barriers) to the release of further information, such as implications for public health and safety;
  • how the material can be published - e.g. use of the internet and other publication methods; and
  • opportunities for the public to access more information about the advertising of therapeutic goods.

In these meetings, the Panel were particularly interested in the types of information you thought the TGA should make available, and the ways you would like to receive that information. The meetings included the opportunity for participants to share views with all attendees on the Review, and for discussion in small groups chaired by a member of the Panel.

Public meetings details & presentation

The TGA Transparency Review Panel conducted the following public meetings:

  • Sydney - 23 February 2011
  • Melbourne - 1 March 2011
  • Perth - 4 March 2011

Presentation

How to access a pdf document

At each of the meetings the TGA provided a short presentation on the work of the TGA.

Presentation: Review to improve transparency of the Therapeutic Goods Administration - Public meetings - February and March 2011 (pdf,36kb)**

**This presentation paper is provided on the TGA's website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The papers are not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health and Ageing (of which the TGA is a division) advises that (a) the presentation papers should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation papers.**

Group discussion questions

During the meetings, attendees divided into groups of stakeholders and discussed questions relevant to their area of interest (consumer, health professionals, health media and industry).

Attendees were also able to make broader comments and if they wished, to forward further comments following the meeting. They were asked to provide those comments by no later than Friday, 11 March 2011.

Consumers

  • What type of information should TGA provide about medicines, supplements and devices.
  • How adequate is the information provided by the TGA on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices included on the Australian Register of Therapeutic Goods (ARTG).
  • How easy is it to access this information.
  • In what way should that information be provided to consumers - e.g. on the internet or other electronic media; through a doctor, pharmacist or health professional; in a brochure or handout about a specific medicine or a therapeutic device.
  • How should information provided by TGA best be updated and who should be responsible for this.
  • There is limited capacity for manufacturers of therapeutic goods to advertise their availability to the general public. The TGA has a role in ensuring that advertisements are truthful. Are you aware of seeing any advertisements for therapeutic goods (e.g. on TV, in magazines etc).
  • Do you know how to make a complaint about an advertisement for a therapeutic good? Have you ever done so; and if yes, comment on your experience with the process.
  • What other issues relevant to the interests of consumers and falling within the terms of reference should be considered by the review Panel.

Health professionals

  • How adequate is the information provided by the TGA on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices included on the Australian Register of Therapeutic Goods (ARTG).
  • Consider in particular the information provided in:
    • Australian Public Assessment Reports for prescription medicines;
    • Approved Product Information;
    • Consumer Medicine Information;
    • Public summary documents on the ARTG;
    • TGA Advisories and Medicines Safety Updates.
  • How easy is it to access this information.
  • Have you encountered problems in regard to the transparency of TGA processes and decision-making.
  • What can be done to make the advertising processes relating to therapeutic goods more transparent.
  • What other issues relevant to the interests of health professionals and falling within the terms of reference should be considered by the review Panel.

Producers and marketers of therapeutic goods

  • In what ways could TGA provide greater assistance in the evaluation and registration, listing or marketing processes.
  • Consider in particular:
    • the adequacy of guidelines; and
    • the provision of information relating to the making, withdrawal or refusal of applications (either to applicants or publicly or both).
  • What information additional to that presently made publicly available by TGA could be released without raising confidentiality issues.
  • Any issues that you have encountered in regard to the transparency of TGA processes and decision-making.
  • The scope and significance to your activities of commercial in confidence limitations on access to information.
  • What can be done to make the advertising processes relating to therapeutic goods more transparent.
  • What other issues relevant to the interests of producers and marketers and falling within the terms of reference should be considered by the Review Panel.

Media representatives

  • The timeliness, quality and utility of information provided in response to enquiries and/or Freedom of Information requests.
  • What are your information needs.
  • Are there ways the TGA could meet your needs more effectively, and if so, how.
  • What can be done to make the advertising processes relating to therapeutic goods more transparent.

Notes of the public meetings

Sydney - 23 February 2011

Notes compiled by the TGA Transparency Review Secretariat

The meeting was attended by 38 people representing therapeutic goods industry, consumer, health professional, media and regulatory consultant interests. The meeting divided into 6 discussion groups which addressed specific questions (see Attachment A) as well as giving participants an opportunity to raise other issues relating to transparency. Therapeutic goods industry representatives comprised four of the groups, while the other two focussed their comments predominately from a consumer and a health professional point of view.

The meeting was chaired by Professor Dennis Pearce, AO (chair of the Review Panel). It was attended by the following Panel members - Dr John Aloizos, AO; Professor Clifford Hughes; Dr Ken Harvey; Professor Andrew McLachlan; Ms Elizabeth de Somer; Mr Steven Scarff; and Ms Anne Trimmer.

Mr Stephen Dellar (TGA) gave a short presentation on the TGA. Ms Judi Sutton provided Secretariat services to the meeting.

There was a significant level of commonality across the issues raised by all of the groups.

Consultation

  • Needs to be greater consistency applied to TGA processes - criticism that guidelines and interpretations of them seem to vary during the assessment of an application, and that guidelines can be changed during the course of an assessment process. Also noted inconsistent interpretations by TGA delegates working in different areas of TGA.
  • Consultation needs to be improved - given chance to comment, publicise comments, propose actions and reasons, identify impact on stakeholders, allow further comment, then decision, then follow implementation timetable. Criticism that there are too many uncoordinated processes across TGA.

Communication

  • Improve communication - what is being considered, why it's considered and how it will be implemented; involve stakeholders in process and keep them up to date (too many consultations and reviews have not been actioned, and few explanations have been provided).
  • Suggestion of a periodic (e.g. every two years) report on "The state of the Australian therapeutic goods market' covering data (what was achieved and how), summary of changes made and the reasons, including to guidelines.
  • Suggestion that TGA develop and implement a broad communications strategy on its role.
  • Suggestion to establish an Australian Therapeutic Goods Council - would be advisory to the TGA with a membership composition similar to that of the transparency review Panel. Aim is to improve communication both ways between TGA and its key stakeholders. It would improve TGA's appreciation of stakeholder views.
  • Concern expressed that there is no obvious mechanism for TGA to consult with small companies which may not be members of an industry association.
  • View that TGA has a role in consumer education and that role should receive direct government funding.
  • Differentiation between high and low risk products is not well understood outside TGA & industry.
  • Suggestion that TGA needs its own media unit, funded directly by government.
  • Needs a Quality use of Medicines focus - how is information channelled to doctors, health professionals and consumers.
  • TGA does not use consumer and health professional newsletters, emails list and networks to spread information effectively.
  • Significance of interactivity of drugs needs to be recognised and appropriate information provided.

TGA structure and culture

  • Structural change within TGA is needed to strengthen the TGA's capacity to respond to change.
  • TGA needs to work, and be seen to work, with honesty and integrity to build greater confidence in the organisation - organisation has a 'duty of candour'.
  • TGA still operating in a silo fashion. Needs greater internal coordination to avoid different areas asking for the same information.
  • TGA organisation charts should show names and photos rather than 'positions' to address perception that it is a 'faceless organisation'.
  • Reviews and consultations should be brought to a conclusion and final outcomes published.

Application assessment & appeal process

  • Endorsement of the recent business process reforms to the prescription medicine assessment process and recommendation that these be adopted across all areas of the TGA. Reforms seen as being collaborative with industry and very positive.
  • Suggestion that an interactive communication process be adopted with the sponsor during the pathway from application to approval (as per European experience).
  • Suggestion that an 'application tracking system' be developed so sponsors can know the progress in assessment of their application.
  • Suggestion that companies be given the right of reply to concerns raised by advisory committees, rather than needing to wait for the appeal process, as these concerns can often be easily addressed.
  • Suggestion that overseas product approvals be taken into account in assessment processes.
  • Support for publications of 'refused' applications including the reason(s) for refusal.
  • Meeting did not support publication of 'withdrawn' applications as there can be multiple reasons for withdrawal.
  • Suggestion that TGA provide public access to its internal training documents as an information/education tool.
  • Suggestion that provision of evidence on efficacy needs to be appropriate to the product range and that a continuum should be developed for the assessment of risk across all products. Alternate view put that the current delineation is useful but not understood and that risk/benefit needs to be better communicated especially to consumers.
  • View that the public release of information on the outcome of product applications should be handled on a case-by-case basis as there are differences in the ways individuals product markets work.
  • The expertise of appeals committees was questioned - evaluators need to be well trained.

Guidelines

  • TGA Guidelines need to be consistent, and up-to-date, with effective consultation on proposed changes, new guidelines development and implementation plans.
  • There should be one set of guidelines for use by both TGA and industry which must be clearly, publicly available, user friendly and available in a range of formats.
  • Version control of guidelines is very important.
  • TGA advised that recent changes to the Freedom of Information Act mean that a widespread review of the guidelines used by TGA is timely.
  • Note that the TGA Industry Consultative Committee (TICC) is not an appropriate forum for consultation on changes to guidelines and guideline development.

TGA advisory committees

  • Suggestion that outcomes of TGA advisory committee deliberations should be publicly available (as in New Zealand) as they can provide guidance for future applications. However, publication should be done as part of a comprehensive communication strategy.
  • Meeting did not support publication of advisory committee agendas in advance of the meeting.
  • Suggestion that industry representatives be included on TGA advisory committees but noted that 'conflict of interest' issues would need to be carefully handled.

Advertising complaint process

  • Noted broad lack of understanding of TGA's role in the advertising complaint process, and lack of transparency about outcomes actioned by TGA.
  • Question whether advertising complaints processes are the same for medicines and devices.
  • Need for information on the range of sanctions available to the TGA, as well as on their imposition and monitoring.
  • Complaint resolution process needs simplification, especially the reporting of actions.
  • Suggestion that the 'false claims act' should be taken into account.

TGA information products

  • Support for AusPARs but questions raised about their pitch - who is their intended audience?
  • Suggestion to introduce the equivalent of an AusPAR for low-risk products.
  • Request for greater functionality in searching the Australian Register of Therapeutic Goods (ARTG) - Mr Dellar provided an outline of recent improvements to the search function (e.g. it is now possible to search for product additions/changes over certain periods of time and the introduction of the capacity to search by active ingredients) and to the overall redevelopment of the TGA website which is due for completion by the end of April 2011. Consumer interest in searching for new products was noted.
  • TGA is one source of information - there are others such as National Prescribing Service, Australian Medicines Handbook, Australian Prescriber.
  • TGA product information in Consumer Medical Information (CMI) and Product Information (PI) is important.
  • CMIs seemed too complex and sometimes over-emphasised uncommon side-effects. A useability study on CMIs should be undertaken.
  • Differences between AUST R and AUST L are not well understood, especially that low risk products are not assessed for efficacy. The level of evaluation made by TGA should be explicit for every product.
  • Concern that there are no CMIs or PIs for listed medicines or medical devices (although some sponsors provide useful information).
  • PIs and CMIs should be kept up to date.
  • Consumers seek comparative information on drugs, CMIs don't help with this.

Adverse drug reaction reporting

  • Confusion over the various ways to report Adverse Drug Reactions - e.g. to company, state/territory health departments, TGA, ACCC.
  • Quality and timeliness of reporting of Adverse Drug Reactions (ADR) are critical to health professionals; noted concern re doctors continuing to prescribe, even when a possible adverse drug reaction has been reported.
  • Adverse Drug Reaction reporting needs to be linked to morbidity and mortality data.
  • One suggestion was printing information about how to report ADRs on all CMIs.

Other issues

  • Jurisdictional differences in scheduling cause confusion.
  • Information on labels and packaging not well understood by consumers.
  • Similar sounding drug names should be prohibited by the TGA at the time of product evaluation.
  • Labelling of current drugs of similar names should consider Tallman lettering and other strategies to easily distinguish between products.

Melbourne - 1 March 2011

Notes compiled by the TGA Transparency Review Secretariat

The meeting was attended by 26 people representing the therapeutic goods industry, consumer, health professional, media and regulatory consultant interests.

The meeting was chaired by the Chair of the Transparency Review Panel, Professor Dennis Pearce, AO. The Transparency Review Panel was also represented by Panel members - Dr John Aloizos, AO; Ms Alison Marcus; Dr Ken Harvey; Mr Steven Scarff and Ms Anne Trimmer.

After introductions by Professor Pearce, Mr Stephen Dellar from the TGA gave a short presentation on the TGA before each panel member lead one of the focussed discussion groups. Each group addressed specific questions (see Attachment B) as well as providing participants the opportunity to raise other issues relating to transparency and the review.

At the end of the public meeting consumers requested that a draft summary of the consultations be made available on the consultation website.

There were common themes across the issues raised by the groups. The issues and suggestions raised at the meeting are summarised below under the key themes of consultation, communication, advertising, complaints, adverse drug reaction reporting and other issues.

Ms Judi Sutton and Ms Moya Smith provided Secretariat services to the meeting.

Consultation

  • TGA must be more transparent.
  • Proceed with regulation in the most transparent means.
  • TGA need to engage with companies that are not aligned with formalised industry organisations/associations. It is a challenge for them to provide input or comments.
  • Biologicals are a new area for TGA. The regulation of emerging areas requires input from industry to ensure there is a shared understanding of the framework.
  • Personal assistance may be necessary/should be available.

Communication

  • Currently the information available is generally inadequate, difficult to access, not always complete, inconsistent processes for different products.
  • The regulation of pharmaceuticals is well established however newer areas are more difficult to access simple assistance or information from within TGA. Stakeholders want more consistent information and advice. It was suggested the TGA consider a helpdesk for inquiries.
  • The balancing act of what should be made available - 3 stages:
    • Applications should not be made public,
    • Once a decision is made it should be published however rejections should be given a reason and recognise the sensitivities. Rejection - no harm in publication of a rejection with a reason (though there are still sensitivities). Australian Product Assessment Reports (AusPARs) can include a reason for rejection and are reviewed by industry before publication,
    • Product withdrawal - debate as to whether these should or should not be made public or provide a reason as there are many reasons a product is withdrawn from the market. The European Medicines Agency (EMA) publish withdrawals with a letter from the company, however it was noted that there is a lack of logic in not publicising an application but publicising a withdrawal.
  • The current TGA website is incomprehensible and impenetrable.
  • Web is most appropriate for bulk amount of information but needs to be supplemented through improved labels and printed information from professionals.
  • Simplified guidance e.g. the Pharmaceutical Benefits Scheme (PBS) website - where information provided is targeted to different groups. To accommodate a growing interest for more information the TGA needs to stratify information - broad for consumers with the capacity to drill down for further information which is more suited to professionals, sponsors. Links should also be provided to other useful sites e.g. National Prescribing Service (NPS).
  • Ease of access to information - TGA unable or unwilling to assist - printed information should be available for those who are unable to access the internet.
  • Discussion around how information can be made available through multiple access points (not just in writing), including:
    • the use of pictographs,
    • consumer information to be provided in a sensible format for people with disabilities,
    • consumer medicine information (CMI) needs to be user friendly, including side effects - although it was noted that these can sometimes frighten the consumer,
    • 'kiosks' in pharmacies to access further information (rather than CMIs).
  • More information would benefit all 3 sectors. The type of information needed include:
    • more about ingredients (e.g. nano materials),
    • sites and country of manufacture and sources of ingredients (for quality assurance),
    • access to evidence of approvals, including what was and wasn't considered in the assessment,
    • the approval process - availability of outcomes and reasons,
    • the suitability of information provided on the packaging is assessed by consumers (in a similar way to the EMA),
    • the distinction between AustR (Australian Registered) and AustL (Australian Listed) - evidence based medicine and non-evidence based medicine - is hard to find. It needs to be provided quite clearly on packaging, the website and must be available at the point of sale,
    • bioequivalence & safety,
    • suggestion of a traffic light system similar to the system proposed for food labelling.
  • Information fit for the purpose, tailor information to meet differing needs - no demarcation in the TGA - an emphasis on collaboration, need communicators and consumer health educators in TGA to interpret scientific information for consumers. Should also respond to media beatups.
  • Joint media/communication area within the TGA that would help scientists communicate in plain language to ensure the advice provided is accessible and allow a consumer voice.
  • There is a need to address the gap between TGA and end users - a need to reinterpret information into consumer information.
  • TGA's responsibility to update information (CMI) and Product Information (PI) - the complexity of when to update information was highlighted and stakeholders not knowing when the information has been updated.
  • Cost of Freedom of Information (FOI) requests and the completeness of information provided.
  • The efficacy of decisions - AustL and AustR - it is an issue of trust regarding the information that is provided to consumers at the point of sale e.g. If a pharmacy represents an AustL as a solution to a problem. There was general agreement that this was one area where the funds need to be provided to TGA but industry to do the necessary work.

Advertising

  • The complexity of the advertising complaint system - regarded as convoluted and unclear as there are numerous pathways, with many facets including the Australian Competition and Consumer Commission (ACCC). Participants had no idea of TGA advertising decisions and how effective the sanctions were. Should be a one stop shop. Participants suggested the TGA look toward the Food and Drug Administration (FDA).
  • Advertising accurate information for consumer choice however there was not support by all sectors for 'direct to the consumer' advertising.
  • TGA should have responsibility for advertising of S3 medicines - people are not aware of the restrictions - general information on S3 medicines should be available through the TGA including reasons for rescheduling where this has happened.

Complaints

  • TGA needs to be less defensive and more open. It should collaborate with other agencies.
  • The complaints process is complex, not transparent and unhelpful - it is not outcome focussed. A good example is the FDA which provides information on 'how to complain'.
  • Publicising how to complain about therapeutic goods should be advertised in the media and TGA should investigate how complaints can be best mediated in a straightforward consistent way.
  • It is unclear where consumers should go to complain and/or get redress regarding faulty devices.
  • There is concern that the Complaint Resolution Committee (CRP) was overloaded and under-resourced; this resulted in long delays in producing a complaint determination. In addition, the CRP (and also the TGA) appears to lack effective sanctions to deter repeat offences.

Adverse drug reaction reporting

  • Reporting of adverse drug reactions needs to be made easier.

Other issues

  • The name 'Therapeutic Goods Administration' is perceived by some as incomprehensible as the public may not understand that therapeutic goods encompassed medicines, medical devices, diagnostics and blood and tissue products all of which are in the scope of what the TGA regulates.
  • Devices must not be overlooked - consumers perceive the TGA as a regulator of drugs not devices. It is unclear what evaluations the TGA carries out to eliminate faulty products, nor where consumers could go to complain and/or get redress.
  • TGA is not collaborative - Industry versus consumer focus - concerns raised about 100% industry funding of TGA. There is a perception that the TGA is a captive of industry - question as to whether this compromised decisions.
  • TGA should not be solely industry funded. Performs (or should perform) functions for which industry cannot be expected to pay, eg. Education, updating information.
  • TGA needs to move from 'defensiveness' to 'openness'.
  • Concerns were raised regarding the review process - the timing for consultation and input is tight. Interested people and groups may not have been consulted or given sufficient opportunity to input.
  • Concern that Aboriginal and Torres Strait Islander people, people from non English speaking backgrounds, minority groups and community groups have been overlooked.

Perth - 4 March 2011

Notes compiled by the TGA Transparency Review Secretariat

The meeting was attended by 16 people representing consumer, health professional and therapeutic goods interests. The meeting divided into 3 discussion groups which addressed specific questions as well as giving participants an opportunity to raise other issues relating to transparency. Consumer representatives comprised two of the groups while the other group considered issues primarily from an industry perspective.

The meeting was chaired by Professor Dennis Pearce, AO (chair of the Review Panel) and attended by Ms Karen Carey, a member of the Review. Ms Judi Sutton (TGA) provided Secretariat services to the meeting and also provided an outline of the work of the TGA.

Consultation

  • TGA needs process to work with overseas and small business whose access to Australian markets is limited because of high fee structure.
  • Producers of new products (biologicals) need assistance to understand and meet registration requirements.

Communication

  • If people don't know the TGA exists then any activity relating to the TGA doesn't work e.g. accessing information from website, making reports of adverse incidents - so the TGA must raise its profile and educate consumers about:
    1. what the TGA does
    2. what processes it uses
    3. how consumers can interact with these processes.
  • Concern over lack of information for industry e.g. what applications are made, approved, withdrawn or refused; and that industry representatives on TGA committees are not allowed to talk about considerations to the industry they represent.
  • Much of the available information is too technical which makes it inappropriate for use by consumers, and even by health professionals.
  • Would prefer TGA could comment when media presents stories of new drugs so that consumers have realistic expectations of efficacy and timeframes for availability.
  • Concern that the 2010 seasonal influenza vaccine situation showed that TGA lacked the ability to effectively provide advice to consumers. When concerns are identified, public needs to be informed and TGA needs to take prompt action to address situation.
  • Reliance on website not satisfactory because many groups don't have access:
    1. rural and remote access to internet poor or non-existent
    2. 60% of people have a low level of health literacy
    3. People for whom English is a second language, including refugees, may be particularly disadvantaged by written material - importantly this also applies to labelling of medicines and CMIs.
  • Pharmacists & their assistants need to be trained to ask critical questions about over-the-counter and complementary medicines that people are taking with prescription drugs, and to provide CMI as a matter of course.
  • Public education needed for all groups on medicines safety (use by dates, dosages etc)
  • There should be a consumer summary version of AusPAR.
  • There should be an 'AusPAR' equivalent for medical devices.
  • Major problem with complementary medicines because people believe that being on the ARTG means the product is safe and effective because it has been assessed by the TGA. This leads to a false belief in both the product and the role of the TGA in keeping consumers safe.
  • People need to know what TGA assessment and approval actually means - what level of testing is actually conducted.
  • TGA should use every available method of disseminating information including those in the discussion questions but also mass media (magazines such as Veterans' Affairs, Centrelink and COTA publications, Have a Go newspapers etc), social media and social clubs (churches, cultural clubs, schools, shire councils).
  • Size of print in written material is a particular concern for seniors.
  • Consumers urge prompt reporting of changes in product status, especially recalls and warnings, so that health professionals and consumers are aware. This includes information on changes in overseas approval status - e.g. if TGA considers the product still to be safe in the Australian market, it needs to be able to explain why to health professionals and consumers, not just to the product sponsor.
  • Suggest publication of de-identified lists of problems detected on audits.

Advertising

  • There needs to be more stringent control over therapeutic claims e.g. ADHD, erectile dysfunction treatments, baldness, weight loss, nurofen for children. This needs to include features on programs like Today Tonight that create 'news' that is really advertising and which could be balanced by comment from TGA (if TGA would do this).
  • Media reports of a product which is not yet approved create problems for health professionals and raise consumer expectations. A media report should permit a relaxation of the rule that TGA does not confirm or deny it has received an application.

Complaints

  • Strong view that most consumers (and many doctors) wouldn't have any idea how to make a complaint, when to make one or who to make it to. Seen as a failure of TGA post-market surveillance which is used by TGA to demonstrate there are few problems.
  • Suggested that TGA does not support activities conducted by Medicines Australia and have not acted on complaints referred to them. In particular the TGA has taken no action in relation to complaints that pharmacists are covering key label information with their pharmacy label and using terms such as 'take as directed' which are inadequate to ensure safe use.
  • Complaints need to be made public, together with actions taken.

Adverse drug reaction reporting

  • Reporting of adverse events by clinicians should be compulsory.

Other issues

  • Cost recovery model doesn't allow the TGA to do the job that consumers believe and expect they do, particularly in relation to post marketing surveillance and investigations into adverse events.
  • Perception that 100% cost recovery from industry influences its regulatory decisions in favour of industry rather than the consumer.
  • TGA has too few staff to do the job consumers believe and expect they are doing e.g. reviewing/updating CMI and PI including for medical devices in which there appears to be a significant gap.
  • When deciding what information consumers need it should include all information that ensures 'safe use' of products. This should include information to facilitate decision-making prior to use, potential risks, complications and contraindications, complaints, what level of assessment it has undergone by the TGA, when it was first registered (i.e. is it new or been in use for years).
  • Need clear, unambiguous labelling - that isn't covered by a pharmacy label.
  • Health professionals seem to know very little about the TGA.
  • Consumer concern that health professionals, especially GPs may not have access to up-to-date information on which to base their recommendations.
  • The issue of the risk/benefit equation should be decided by individual patients and it is not the role of the TGA or health professionals to make a decision whether a product is 'safe enough'. Patients should be given clear information about the risks and benefits so that they can make a decision about whether or not the benefits outweigh the risks for their particular circumstances.
  • There is an increased need for information about medical devices because they cannot be ceased in the way that medications can be when a problem occurs. Further for devices there is no independent information broker like a pharmacist and so there is a clear role for the TGA. Consumers need good information prior to implant and they need to be made aware that some surgeons will only use specific devices for financial or training reasons rather than the best device for the patient.
  • There needs to be greater transparency around the requirements for maintenance of medical equipment, such as diathermy machines, because maintenance contracts are being given to people who are not the original manufacturer and may not have the knowledge required to adequately maintain equipment to ensure safety. This includes where hospital maintenance workers are conducting repairs of fragile and complex equipment.
  • Health professionals should be able to ascertain the stage in evaluation that an application has reached.

Perth - Meeting with WA Health staff, 4 March 2011

Attendees

  • Transparency review: Professors Pearce (Chair); Karen Carey (Review Panel member); Judi Sutton (Review Secretariat).
  • WA Health staff: Anna Gelavis (WA Pharmaceutical Services Branch); Joel Heeg (Snr Pharmacist, SCGH); Neil Keen (Chief Pharmacist, WA Pharmaceutical Services Branch); Audrey Koay (Snr Clinical Advisor, Office of the CMO); Maria Lau (Snr Pharmacist, RPH); Stephen Lim (Chief Pharmacist, Armadale Health Service); Helen Lovitt (Snr Pharmacist, Fremantle Hospital & Chair, WA Medication Safety Group); David Lyon (Executive Officer, WATAG); Karen Pedersen (Snr Project Officer, Office of the CMO); Elizabeth Rohwedder (Snr Project Manager, Health System Improvement Unit).

Summary of issues

  • Adequacy of TGA information in relation to shelf life of products - suggest inclusion in summary document on TGA website.
  • Timeliness of new device information - question whether it is possible to have advance information of new device approvals as technologies can develop relatively rapidly and advance information is useful to assist with service planning.
  • Useful to know PBAC agenda in advance - gives notice of products to be considered - would welcome similar for TGA committee agendas.
  • 'Off-label' use of drugs is controlled through hospital committees. Would welcome a system for TGA approvals of off-label use - similar to special access scheme and with no financial penalties for company i.e. this is usage in non-commercial quantities and company may have decided that commercial supply to Australia isn't viable, so haven't spent the money to have it approved for a different use or patient group e.g. children.
  • Suggestion to speak with Children's Hospitals Australasia as they have strong views on off-label usage.
  • Noted that with off-label use, the disadvantage for the consumer is that there are no information resources to aid decision making - consumers need to take the word of clinician as that is the only source of information.
  • Suggest off-label use should be supported especially where approval is given in other countries. Note companies may have clinical data but not safety data.

Comment on current TGA information provision

  • Concern re currency and adequacy of information in CMIs and PIs.
  • Support for development of AusPAR equivalent, CMIs and PIs for medical devices.
  • Would welcome access to clinical trial data - helps to define patient cohort who can benefit and, for devices, the need for credentialing and training of operators.
  • Patients need to understand how a device works vis-à-vis other treatment options.
  • Group noted that timing of the approval of a product is not connected to the timing of approval for reimbursements for its use which causes issues for clinicians and for patients who could benefit.
  • Questioned whether CMIs actually met consumer needs - are long, technical, and often out-of-date.
  • CMIs need to be updated when things change. For example, re its ARTG approval - e.g. a new indication or a 'boxed' warning; or when there is new research or adverse event data.
  • CMIs would be more useful if the same CMI was used for the same active ingredient, regardless of manufacturer - currently each manufacturer/sponsor has a different CMI.
  • Suggested need for consistency in PI formats - can vary from 1/2 to 10 pages; no consistency in level of information provided, seems to be at whim of company with little input from TGA.
  • Product recalls - always on Friday afternoons! Discussion of difficulty of providing timely information to many users, especially to clinicians, and whether this is a TGA or state health department issue. Noted that the National Coordinating Committee on Therapeutic Goods (NCCTG) is currently developing a national provision for the recall of drugs.
  • Note that the transparency of the reasons for a recall is not good.
  • The level of urgency of a recall needs to be identified.
  • Recalls - don't get information at the end of a recall process. There is no announcement that it is back on the market and that issues have been adequately/safely addressed.

Advertising

  • Discussion of 'advertorial' segments on news programs which present company information without qualifying information or comment on quality, safety and efficacy.
  • Some advertising in pharmacies may not contravene state laws, but does contravene commitments under TGA legislation.

Other issues

  • Generics - problems in similarities in pill sizes and colours across different dosages as well as in packaging similarities.
  • Problems often identified post-approval. Suggest a system where necessary changes to address safety issues can be approved without cost to company/sponsor. Council of Australian Therapeutic Advisory Groups (CATAG) has been advised that TGA can not require changes by the company.
  • Adverse Event Reporting - frequently clinicians report to company in 1st instance, or to state system (AIMS) to report to the state department rather than to TGA. Consider linking TGA reporting of adverse events into the AIMS and other state-based reporting systems.
  • Problem that adverse events caused by labelling and packaging problems often do not get reported, except to the company (who only have to report 'serious' events to the TGA).
  • Discussion of E-health potential, through linking into drug information as well as patient health information. Suggestion that companies need to be building systems now to be ready, including building in 'global trade identity' numbers (which have shelf life/expiry information encoded).
  • Generics - suggest using the generic name on packaging and labelling when generic versions of a drug are marketed. Currently they have different brand names and this causes problems/confusion for pharmacies and consumers.
  • Need to adopt naming conventions for combination drug products (UK has a generic name for each specific combination).
  • Bioequivalence - support more competition and rapid access than in Europe, as long as safety can be assured - pharmacovigilance must be assured (ref to UK system).
  • No post-market surveillance system is yet in evidence in Australia.
  • Market withdrawals - cause problems when sudden withdrawal of product and recall difficulties in finding alternatives. Discussion of lack of ability of TGA to 'guarantee' continuity of supply.
  • Compounding issues - support to retain systems in hospitals (especially for children), but noted safety issues for consumers as well as lack of transparency of outcomes.
  • As there is 3 hours time difference between Western Australia and Eastern states, especially for any TGA SAS enquiries, it is impossible for us to contact the office after 1pm, and we have to wait until the next day. Is there an afterhour service for any urgent queries we can attend to? Or if TGA can nominate someone based in WA to answer our questions after 1pm Monday to Friday?