Q（Question）

When a physician or pharmacist requests information on the switching dose from a competing product to one's own product, is it permissible to provide information from conference presentations that have not been published as papers?

A（MHLW answer）

Same as A4.

So what (meaning): Switching dose data from conference presentations is handled identically to A4: the provider must explicitly state that the source is unpublished and not peer-reviewed and that the evidence is not yet established.

So why (rationale): Switching dose information directly influences prescribing decisions, making explicit disclosure of evidence level especially important; A4's rules for unpublished conference presentations apply in full.

Commentary — background, application, practical notes

Switching dose information directly drives prescribing change decisions, which makes explicit disclosure of evidence level especially critical. Q8 applies A4, permitting the provision of switching dose data from unpublished conference presentations provided the provider clearly states that the data is unpublished, not peer-reviewed, and that the evidence is not yet established — while strictly maintaining that explanatory obligation.

A typical scenario is a physician who has been prescribing a competing product asking whether any conference data exists on the conversion dose when switching to the manufacturer's own product, since no published literature is available. If an abstract or presentation slides include results from a dose-conversion study, provision is permissible, but it must be accompanied by an explanation to the effect that 'this conversion ratio has not been peer-reviewed and does not represent a dosage approved through regulatory review; use within the dosage range stated in the package insert is the basis for any application.'

A common practical error is handing over conference data on conversion doses without explanation simply because 'the physician asked for it.' Errors in switching doses translate directly into patient overdose or treatment failure, so the risk of omitting a disclosure of evidence limitations is particularly high. When switching dose guidance based on conference data is given repeatedly to multiple physicians, there is also a risk that it qualifies as advertising activity, which would require assessment by the medical information function and prior internal review of the materials.