Q&A Collection 3 — Full Text (1 questions)

Q（Question）

Is it permissible to include information on drug stability during simple suspension, crushing, and similar procedures in the Interview Form and provide it to healthcare professionals, when such procedures are performed at the discretion of clinical staff based on the patient's condition?

A（MHLW answer）

The MSA Guidelines permit marketing authorization holders to provide information on unapproved or off-label use when requested by healthcare professionals.

The Interview Form is created at the request of medical associations as an information resource for appropriate drug use, complementing the package insert and supplying information needed for dispensing.

Given the established clinical practice of performing simple suspension, crushing, and similar procedures at the discretion of medical staff for patients with dysphagia and pediatric patients, a marketing authorization holder's inclusion of stability data for such procedures in the Interview Form may be treated as a response to a healthcare professional's request under the Guidelines.

However, because such procedures fall outside approved indications, the entries must follow standardized common rules including explicit description of test methods. When excerpting such information for posting on a website, the content must be reproduced completely and without omission from the Interview Form.

So what (meaning): Stability data for simple suspension and crushing may be included in the Interview Form for dysphagia and pediatric use, but common documentation rules (e.g., explicit test methods) must be followed, and any web posting must reproduce the IF content in full.

So why (rationale): Because simple suspension and crushing are off-label procedures, they are legitimized by framing them as responses to healthcare professional requests, while rules on accuracy and consistency protect patients and ensure fair information provision.

Commentary — background, application, practical notes

Simple suspension and crushing are procedures outside the approved method of administration, which means they fall under the Guidelines' rule that information on off-label use may only be provided 'when requested by a healthcare professional.' However, the Interview Form (IF) is an official information resource created by marketing authorization holders at the request of medical associations to support dispensing decisions; including data in the IF can itself be characterised as a response to the collective request of the medical community. Under this reasoning, the act of including stability data in the IF and distributing it as part of routine information provision is treated as equivalent to a request-driven disclosure, keeping it within the Guidelines.

The most common real-world scenario involves pharmacists in facilities with tube-fed patients or paediatric wards consulting IF stability data — such as residual drug content after suspension or dissolution behaviour after crushing — and sharing this with prescribers. By pre-populating the IF with concrete test results (e.g., percentage of intact drug remaining in a thickened suspension after 30 minutes), manufacturers enable clinical teams to make informed decisions without delay. Proactively building and publishing this data in the IF provides more consistent and reliable support than answering ad hoc queries case by case.

A common compliance error arises when IF content is excerpted and posted to a company website. The Q&A requires that website postings reproduce the IF content 'completely and without omission'; selectively presenting only favourable values is not permitted. Equally, any entry must explicitly state the test method — suspension medium, temperature, time elapsed — in accordance with the common documentation rules. When website content diverges from the full IF entry, healthcare professionals risk interpreting data obtained under different conditions as if they were obtained under the same conditions, and that misunderstanding is precisely what the rule is designed to prevent.