Q（Question）

Given that the guideline requires that information provision must not involve summarizing, omitting, or emphasizing content, what should a company bear in mind when a physician or pharmacist calls its medical information center requesting information on off-label drugs or unapproved dosage regimens?

A（MHLW answer）

In such situations, the company must take care to provide not only information on efficacy and dosage but also information on safety such as adverse events, ensuring that both efficacy and safety information are appropriately conveyed.

In particular, the company must not omit safety information merely because time is limited; in such cases, alternative methods of providing information should be considered.

Items requiring particular attention: (4), (6)

So what (meaning): Telephone responses must include safety information (adverse events, etc.) alongside efficacy data; omitting safety details due to time constraints violates the guideline, and another delivery method (e.g., follow-up in writing) must be arranged instead.

So why (rationale): The prohibition on summarizing, omitting, or emphasizing (items 4 and 6) applies regardless of the communication medium; limited call time does not justify omission.

Commentary — background, application, practical notes

Telephone calls to a company's medical information center are one of the most common channels through which healthcare professionals make requests for off-label information. This question examines how the guideline's prohibition on summarizing, omitting, or emphasizing content applies in an oral, time-limited telephone setting. The answer establishes two firm requirements: both efficacy and safety information must be conveyed, and safety information may not be omitted simply because the call is time-constrained.

The most prevalent risk in telephone responses occurs when a physician or pharmacist calls with a brief, focused question—such as whether a drug is effective for a specific off-label condition—and the company representative responds with only a quick overview of efficacy evidence, leaving out adverse event profiles or patient risk factors. This constitutes an omission that violates the guideline.

The practical response to time constraints is to proactively offer an alternative delivery mechanism: for instance, sending a written summary after the call or arranging a follow-up call with adequate time. Importantly, even when the caller presses for an immediate answer, the representative is not permitted to provide an incomplete response that omits safety information. The obligation to ensure completeness overrides the caller's preference for speed, and representatives must resist being drawn into delivering a truncated response by the pace of the conversation.