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.
4.2 Assessment and Causality:
4.2.1 Assess the severity and medical significance of reported adverse reactions.
4.2.2 Determine the likelihood of the adverse reaction being related to the use of transdermal patches (causality assessment).
4.3 Reporting to Regulatory Authorities:
4.3.1 Prepare and submit expedited (serious) and periodic (non-serious) adverse reaction reports to regulatory authorities as per regulatory requirements.
4.3.2 Ensure reports are submitted within specified timelines and in the required format (e.g., electronic submission).
4.4 Follow-Up and Communication:
4.4.1 Monitor and follow up on reported adverse reactions to gather additional information as needed.
4.4.2 Communicate relevant safety information to healthcare professionals, patients, and internal stakeholders as per regulatory requirements.
4.5 Record Keeping:
4.5.1 Maintain accurate and complete records of all adverse reaction reports and related communications.
4.5.2 Archive adverse reaction reports and supporting documentation for future reference and regulatory inspections.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QA: Quality Assurance
6) Documents, if any
Adverse Reaction Reports
Regulatory Submission Documents
Causality Assessment Reports
7) Reference, if any
ICH E2E: Pharmacovigilance Planning
EU Pharmacovigilance Legislation
FDA Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines
8) SOP Version
Version 1.0
