Standard Operating Procedure for Adverse Reaction Reporting for Transdermal Patches

1) Purpose

To establish procedures for identifying, documenting, reporting, and managing adverse reactions associated with the use of transdermal patches, ensuring compliance with regulatory requirements and timely communication of safety information.

2) Scope

This SOP applies to all personnel involved in pharmacovigilance, including medical affairs, regulatory affairs, quality assurance (QA), and healthcare professionals responsible for reporting adverse reactions related to transdermal patches.

3) Responsibilities

3.1 Pharmacovigilance Manager: Oversees the adverse reaction reporting process.
3.2 Medical Affairs: Assesses the medical significance and causality of reported adverse reactions.
3.3 Regulatory Affairs: Ensures compliance with regulatory reporting requirements.
3.4 Quality Assurance: Reviews adverse reaction reports for accuracy and completeness.
3.5 Healthcare Professionals: Report adverse reactions encountered during patient treatment with transdermal patches.

4) Procedure

4.1 Identification and Documentation:

4.1.1 Identify and document all adverse reactions associated with the use of transdermal patches reported by healthcare professionals or observed during clinical trials.

4.1.2 Document all relevant information, including patient demographics, medical history, concomitant medications, patch details, and details of the adverse reaction.