4.7 Quality use of medicines

Page last updated: September 2016

Information Requests

  • Describe activities to support QUM related to appropriate uptake of the proposed medicine (Subsection 4.7.1)
  • Describe any proposed postmarketing surveillance studies (Subsection 4.7.2)

4.7.1   Activities to support the quality use of medicines

QUM means deciding whether it is appropriate to use a medicine, determining which is the most appropriate medicine and then monitoring the safety and effectiveness of the medicine to ensure that the best possible results are achieved. Identify and discuss possible risks to achieving QUM, and offer solutions to mitigate the possibility of inappropriate or potentially harmful use of the proposed medicine. Where appropriate, present these discussions throughout the submission if the QUM issue is most relevant in a particular section.

Current or future sponsor activities to support QUM may include activities integrated with other QUM service providers. Discuss any of the following activities that are or will be implemented, and cross-reference the uncertainties from Section 4 they are addressing. Justify if any of the following activities are not required:

  • educational activities that help to identify patients eligible for treatment, and that are consistent with the proposed restriction (and avoid leakage outside the restriction or indication) and with the therapeutic conclusion in the submission
  • activities that ensure the population and circumstances of use in which the proposed medicine is to be used is consistent with the evidence presented in the submission
  • activities that minimise the sources of uncertainty identified in estimating uptake and overall usage patterns of the proposed medicine
  • activities that minimise misuse of the medicine in eligible patients (eg development and distribution of consumer medicine information, appropriate packaging, appropriate labelling)
  • any monitoring or evaluation of practices to ensure that QUM is being achieved
  • pathways that allow prescribers, patients or treating staff to report concerns about QUM
  • activities that may help to develop behaviours in patients, prescribers or the community that support QUM in general.

When discussing the proposed QUM activities, state when these will be implemented (approximately), and whether such activities will be available to all prescribers, hospitals and patients. Identify and describe any other risks to QUM and methods that are currently being, or are planned to be, used. These activities could reassure both the PBAC and the government that uncertainty about cost-effectiveness and usage within the requested restriction will be minimised.

The National Strategy for Quality Use of Medicines explains QUM in Australia.

4.7.2   Postmarketing surveillance study

Where the efficacy, safety or long-term safety of the medicine is uncertain, propose a postmarketing surveillance study, including the method of data capture, the outcomes of concern and how the results of the study will be communicated. Assess whether the interpretation of the results would be affected by the subsequent listing of another medicine in a similar population.