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Management and communication of medicine shortages and discontinuations in Australia

Guidance for sponsors and other stakeholder bodies

1 May 2019

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Responding to a medicine shortage

The components of the response to a medicine shortage are detailed in Figure 1 and include:

  1. Sponsor is required to report to the TGA a known medicine shortage or anticipated medicine shortage of critical patient impact (based on the sponsor's self-assessment in accordance with Table 1) within 2 working days, and within 10 working days for all other shortages.
  2. The report (of an anticipated or current shortage or of a discontinuation) and its impact assessment are reviewed by the TGA to determine if the product contains an ingredient on the Medicines Watch List. Please note that, regardless of whether or not a medicine contains an ingredient that is on the Medicines Watch List, shortages with a critical patient impact are all treated in the same manner.
  3. If the medicine is on the Medicines Watch List, the shortage is automatically considered a critical impact shortage, there is no requirement for the quick touch review and a Medicines Shortages Action Group may be convened (see 4b below). This Group is supported by medical and pharmaceutical professional groups and State and Territory officials, where appropriate.
  4. If the ingredient is not on the Medicines Watch List, then the Medicine Shortages Section - following further input from the sponsor (if required) - undertakes a review using the assessment framework to confirm the impact level.

    An agreed patient impact rating will be determined and the notification will be processed as per Figure 1.

    1. Where assessed by the TGA as critical, the TGA may undertake a quick touch review within 3 working days. This review involves TGA representatives, including staff members with relevant expertise, such as medical officers, pharmacists and medicine shortages officers, as well as the impacted sponsor.

      These parties will undertake these discussions in confidence, through teleconference.

    2. Where the outcome of the impact assessment (refer Table 1 - Impact assessment framework) is critical patient impact, escalation may be required to a Medicines Shortages Action Group (refer to Figure 1 - Response to a reportable medicine shortage) which may comprise:
      • a representative from the relevant medical college(s)/specialist medical society
      • pharmacist organisation (Society of Hospital Pharmacists of Australia Specialty Practice Groups, and Pharmaceutical Society of Australia if the medicine is dispensed significantly in community pharmacy settings)
      • the TGA (and involving other areas of the Department of Health, for example the Chief Medical Officer / Office of Health Protection if the product shortage may have serious public health impacts or is part of the National Immunisation Program)
      • medicine sponsor who has the shortage.

      In consultation with the sponsor, a Medicines Shortages Action Group will prioritise use of any remaining stocks of the product in shortage and identify and communicate therapeutic alternatives for use during the period of the shortage.

      These parties will undertake these discussions in confidence.

    3. If assessed by Medicine Shortages Section as medium patient impact then a ‘quick touch review' may be conducted as required.

      We expect sponsors to provide a copy of the communication that has been/is to be sent to the relevant stakeholders. Publication of this information on the TGA website is not mandatory, but is strongly encouraged.

    4. If assessed by the TGA as low patient impact (for example, there is availability of an exact alternative), then communication from the sponsor to relevant healthcare providers only may be appropriate. Publication of information about the shortage on the TGA website is not mandatory, but is strongly encouraged.
  5. A Medicines Shortages Action Group may be convened for shortages assessed to be of critical patient impact or of medicines containing ingredients on the Medicines Watch List.
  6. Consultation with the sponsor will be undertaken for all medicine shortages notifications received. This will be to determine what steps, if any, the sponsor has already taken to alert health professionals and the public of the shortage. This may involve the TGA contacting other sponsors to gather information on supply status. This information will inform the action that will need to be taken. For low patient impact shortages all that may be required is the circulation of a letter advising of the nature of the shortage and the expected duration to be sent to wholesalers. For medium patient impact or critical patient impact shortages, this step will provide information for use in the next step.
  7. For medium and critical patient impact shortages, there may be a need for further engagement with the sponsor to circulate appropriate information. There may be the requirement for letters tailored to customers as well as health professionals and wholesalers.

    The sponsor may also be asked more in depth information about how they intend to handle the shortage and what steps have been, or are intended to be, taken.

    The TGA may then contact medical specialist colleges and other stakeholders directly to advise them of a shortage and draw their attention to the published information.

  8. The TGA would then coordinate separate activities with:
    • the sponsor
    • medical specialist colleges or societies
    • the Society of Hospital Pharmacists of Australia, the Pharmaceutical Society of Australia and/or the Pharmacy Guild of Australia
    • prospective section 19A applicants.

    This may be undertaken to mitigate the effects of the shortage and to promote awareness of the shortage. We will work individually with the sponsor(s) to identify suitable alternative overseas products and facilitate access under the Special Access Scheme or section 19A of the Act as needed. The TGA and the sponsor will coordinate communications to enable relevant stakeholders to receive timely and consistent advice on the details of the shortage and the management activities. Steps to mitigate the shortage may be published on the Medicine Shortages website as described below.

  9. The TGA will publish all medicine shortage notifications for critical impact shortages as soon as possible after receiving the initial information from the sponsor on a dedicated webpage for shortages of critical patient impact. Updates will be published as the investigation progresses and as solutions are identified.

    Shortages of a medium and low impact nature are handled in accordance with Table 3 - Activities by shortage impact level. Sponsors are encouraged to publish all shortage information as it will aid health professionals to improve awareness that alternatives may be required and make the appropriate changes to patient treatment.

  10. Further communication such as information provided by expert committees or medical specialist societies may be published if it assists in the management of the shortage. In these cases, the letters or decisions will be attached to the TGA shortage management action page which will be available on the Medicines Shortage Information Initiative website.

Figure 1 - Response to a reportable medicine shortage

Figure 1 - Response to a reportable medicine shortage

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