Q（Question）

Since it is difficult to record all verbal explanations in detail in business records, is it sufficient to record information such as the date and time, the name of the visited medical institution, the names of physicians and pharmacists, and the materials used?

A（MHLW answer）

As long as explanations are provided within the scope of promotional materials that have been reviewed and approved by the supervisory department, it is acceptable to record information such as the date and time, the name of the visited medical institution, the names of physicians and pharmacists, and the materials used. However, if explanations are provided on matters not described in the promotional materials, a specific record—including an overview of the exchange with the physician or pharmacist—is required.

So what (meaning): When an MR stays strictly within approved materials, a visit log (date, facility, counterpart, materials used) is sufficient. Any explanation going beyond the materials requires a concrete record of what was said and the substance of the exchange.

So why (rationale): Off-material explanations can only be verified through records; without them, the supervisory department cannot confirm whether inappropriate information was provided.

Commentary — background, application, practical notes

This Q&A on business records for verbal explanations establishes the important principle that the required standard of documentation varies with the nature of the information provided. A visit log is sufficient when the explanation stays within approved materials, but if the explanation goes beyond those materials, a summary of the content must also be recorded. This distinction is based on the recognition that explanations outside approved materials are precisely where inappropriate information provision is most likely to occur, and ensuring that monitoring can reach those situations requires the higher record standard.

A typical scenario is a physician asking about the latest clinical trial results or off-label efficacy data not covered in the materials. Even if the practitioner provides that information in the form of 'answering the physician's question,' as long as it has not been reviewed by the supervisory department, a specific summary of the content and the exchange must be entered in the business record. This record becomes the sole basis for subsequent monitoring to assess whether inappropriate information was provided.

A frequently observed practical error is a practitioner justifying an off-material explanation on the grounds that 'the physician asked for it' while not recording it. Even if the physician requested the information, failing to record the content of the off-material explanation does not meet this Q&A's requirement. The standard for 'overview of the exchange' means sufficient specificity for a subsequent reviewer to assess the propriety of the content—a record stating 'physician had a question, provided an answer' is inadequate; the content of the question, the information provided, and its sources must be specified.