The Adverse Drug Event Follow-Up Questionnaire (ADE FUQ) is designed to provide guidance to the EU/EEA regulatory medicines network on the appropriate use of Specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs) in routine pharmacovigilance activities, as outlined in the Good Pharmacovigilance Practices (GVP) module V, V.B.6.1.1.
In pharmacovigilance, the completeness of information in Individual Case Safety Reports (ICSRs) is crucial for accurate assessments. However, many initial reports often lack essential details needed to fully characterize the suspected adverse reactions (ARs). To resolve this, forms and questionnaires are used to gather additional information when initial reports are incomplete. These include both general follow-up questionnaires (FUQs) and Specific AR FUQs. The latter aims to obtain structured and detailed data directly from the reporter about a particular suspected adverse reaction, ensuring the information is standardized and comprehensive.
The Specific AR FUQ is a tool that facilitates the gathering of necessary and detailed information about suspected adverse reactions (ARs) that could impact the benefit-risk balance of a product or pose a public health concern. This questionnaire is used when initial reports lack crucial data that are essential for assessing the safety profile of the medicinal product.
Format of the Specific AR FUQThe format, content, and layout of Specific AR FUQs should align with the recommendations set forth in GVP Module V and GVP Module VI. These guidelines optimize the collection of additional information about a suspected adverse reaction that was not included in the original case report. To streamline this process, Specific AR FUQs should include:
- Concise content to ensure ease of understanding.
- Tick-box options where applicable to save time for the reporter.
- At least one free-text field to capture additional details or clarifications.
Specific AR FUQs should be provided to the reporter in their local language to ensure accurate and complete responses.
Requirements for a Specific AR FUQ- Preface: A brief explanation of the value of completing the Specific AR FUQ will help encourage reporters to provide additional information. For example: “You have received this questionnaire because you reported an adverse reaction to [name of medicinal product]. Please provide any additional details you can, as your input is valuable for the safety monitoring of this product.”
- AdministrativeSection: This section includes a privacy statement to ensure that the reporter’s personal data is protected in line with relevant data protection laws.
- BasicContent:
The questionnaire should capture essential details such as:
- Patient’s age and gender
- Medical history and concomitant medications
- Dates of drug intake and adverse reaction occurrence/resolution
- Outcome and actions taken with the medicinal product
- SpecificContent:
This section contains targeted questions designed to gather critical information for the characterization of the adverse reaction and/or assessment of causality between the adverse reaction and the medicinal product. The key areas to be addressed may include, but are not limited to:
- Context of Use: The exact therapeutic indication for which the medicinal product was used.
- Risk Factors: Factors that may contribute to the specific adverse reaction.
- Clinical/Biological Data: Including laboratory results (with reference values where relevant), histopathology, imaging data, or autopsy results in case of fatal outcomes.
- This data helps in confirming the suspected adverse reaction or excluding other possible causes.
Specific Adverse Reaction (AR) FUQs are vital for improving the quality and completeness of adverse reaction reports, supporting pharmacovigilance assessments, and ensuring ongoing safety evaluations of market products. By collecting crucial data, these questionnaires help identify risks, safeguard public health, and enhance the benefit-risk profile of medicines. At Masuu, we actively share ADE FUQs with reporters using specified tools to gather comprehensive safety data, followed by accurate follow case entry and timely submission in compliance with regulatory requirements. Please reach out for more details on our pharmacovigilance services.
