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Risk/Benefit Evaluation of NVP's

The Government has asked the Australian GP community to preside over the introduction of NVPs as a new unapproved medicine. This will start at significant scale from October 2021.

There are no obvious precedents in medicine for what is likely to prove a challenge for GPs, even while it represents a unique opportunity to utilise NVPs in treating one of the most intractable health problems of our times.

A clear picture on the safety and efficacy of NVPs is not available because the evidence around both has derived from:

  • Markets in which products are regulated as consumer goods;
  • Heterogeneous product typology, due to rapid innovation since the technology’s introduction, and little, if any, regulatory oversight in its early history; and
  • Regulatory contexts that differ between countries, with disagreements amongst the global research community as to what should even count as evidence [1].

In short, the literature does not provide a clear path towards satisfactory answers.

Nevertheless, there are fundamental areas in which consensus exists, which can guide judicious clinical decision making, ensuring a focus on patient safety.

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