Why Triage Matters in Pharmacovigilance
Triage plays a vital role in ensuring pharmacovigilance teams can efficiently manage the increasing volume of adverse event reports. Without a structured triage process, serious cases may be overlooked or delayed, leading to compliance risks and potential harm to patients. A well-defined approach allows organizations to filter, prioritize, and process cases effectively, helping them stay ahead of regulatory requirements and ensure patient safety.
The Most Common Triage Mistakes
Misclassification of Cases
One of the most frequent errors in triage is incorrectly classifying an adverse event. Serious cases may be categorized as non-serious, delaying the required expedited reporting. On the other hand, misclassifying non-serious cases as serious can overwhelm the PV team with unnecessary urgency.
How to Avoid It: Establish clear, standardized triage criteria based on regulatory definitions. Continuous training and validation of triage teams can also help reduce classification errors.
Delays in Case Prioritization
Triage should be a rapid process, ensuring that serious cases are flagged and addressed immediately. Delays in prioritization can lead to missed regulatory deadlines and potential safety risks.
How to Avoid It: Implementing structured workflows and escalation mechanisms ensures that critical cases are handled first. Using predefined severity criteria can help speed up prioritization.
Incomplete or Inaccurate Case Data
Incomplete case data at the triage stage can lead to processing delays and incorrect assessments. Missing key details, such as patient demographics, event seriousness, or suspect drug information, can impact case classification and further processing.
How to Avoid It: Enforce robust data entry checks at the initial triage stage. Training staff to verify case completeness before proceeding can help prevent rework and reporting errors.
Failure to Identify Follow-Up Requirements
Some cases require additional follow-up to gather missing information. Failure to recognize these cases at the triage stage can result in incomplete reports being submitted, leading to regulatory queries or compliance risks.
How to Avoid It: Develop a clear follow-up assessment protocol at the triage level. Setting up alerts for missing critical fields can help ensure necessary follow-ups are identified early.
Over-Reliance on Manual Processes
Manual triage processes are prone to human errors, inconsistency, and inefficiencies. With increasing AE case volumes, relying solely on manual methods can cause bottlenecks and hinder compliance.
How to Avoid It: Leveraging automation in triage can improve accuracy, efficiency, and speed. Automated systems can assist in case classification, severity assessment, and prioritization, reducing the burden on PV teams.
An effective triage process is essential for maintaining pharmacovigilance compliance and ensuring patient safety. By addressing common triage mistakes—such as misclassification, delays, incomplete data, and reliance on manual processes—organizations can improve efficiency and regulatory adherence.
Investing in structured triage workflows, staff training, and automation can significantly enhance the accuracy and speed of AE case management, ultimately strengthening pharmacovigilance operations.
Ensuring accurate triage today means safer drugs and better compliance tomorrow.
