In this blog, we’ll explore:
- Understanding Case Triage in Pharmacovigilance
- The Significance of Triage in Pharmacovigilance
- Best Practices for Effective Case Triage in Pharmacovigilance
Table of Contents:
- Etymology of the word “Triage”
- Why Triaging is Important in Pharmacovigilance?
- What is Case Triage?
- How to triage the cases effectively?
- Triage sequence
- The Impact of Triage on Patient Safety
- Responsibilities of the process Triage
- Conclusion
- References
Overview
Triage is a critical step in determining the priority of tasks and ensuring that the most important and urgent tasks are addressed first. In general, all the process priority is essential.
Triage holds significant importance in all business processes. By prioritizing tasks and focusing on what is necessary, a business can be more efficient and effective in achieving its goals.
Etymology
Triage is the word derived from the french word in 1727, which means “picking out sorting” from the old french “trier” which means “to pick” influenced by the Latin word “tria”.
Significance of Triage in Pharmacovigilance
As discussed earlier, prioritisation is a very important thing to consider in all the way. Same here it is applicable in the field of pharmacovigilance.
Prioritization plays a crucial role in the field of pharmacovigilance, particularly at the beginning stage of case processing. It is essential to prioritize cases for submission to ensure that the most important and urgent cases are to handle first.
Triage in pharmacovigilance:
Triage plays pivotal role in pharmacovigilance case processing as it ensures a smooth regulatory submission process. It is a process of sorting and prioritising on the severity of the cases.
- To review, assess and prioritise the received safety information.
- To record the minimal information required.
- To quickly and reliably establish the case priority regarding expedited reporting requirements.
Under this step, the case processor prioritizes all the incoming reports as per the receipt date, seriousness, causality, and expectedness assessment in the triage step. Once the
cases are triaged, they can be processed as per the priority assigned to each case.
Triage applies to all the reported adverse events, special situations, and product complaints associated with Adverse Events from all type of cases.
“Triage is the art of making tough choices with compassion, prioritizing care based on need, and ensuring that every life receives the attention it deserves in the face of adversity.”
How to triage the cases effectively?
In case processing, effective triage is a crucial preliminary step that should give a careful consideration. By assessing and prioritizing cases, it can ensure that regulatory submissions are not affected.
There are some common aspects that should take note on,
- Seriousness of cases (Range from mild to life-threatening)
- Assessments of events (To learn more…)
- Based on the country of incidence (To learn more…)
- Considering any product-specific requirements
- Elevation of events
- Based on regulatory requirements
Specifically, the process of case triage often involves a two-step approach for effective prioritisation. They are:
- Preliminary triage
- Medical triage
Preliminary triage
- Determining case validity (To learn more…)
- Assessment of seriousness for each adverse event
- Identification of suspect company product (To learn more…)
- Assessment of causality and listedness (To learn more…)
- Case prioritisation as per regulatory guidelines
- Based on country of incidence (To learn more…)
Medical triage
This step is to perform by Medical reviewer.
- Assessment of seriousness of adverse events
- Determining the causality and listedness when combination of drugs involves
Triage Sequence
- Prioritizing Cases by Severity
- Addressing SUSAR Cases (To learn more…)
- Handling Other Serious Cases
- Managing Non-Serious Cases
- Adhering to Regulatory Deadlines
- Handling Cases According to Country-specific Criteria, e.g., Japan or US cases
- Product-specific Requirements
- Compliance with Regulatory Guidelines
The Impact of Triage on Patient Safety
In Triage, the correct assessment of Adverse event cases is crucial as it directly impacts regulatory submissions. Incorrect or missed assessments can lead to delays or improper submissions, which can negatively affect patient safety and devalue the drug in question.
Errors in triage, such as missed or incorrectly assessed serious events, can have severe consequences for the general population. If these cases are not properly monitored and submitted, they can still circulate in the market, putting patients at risk.
Responsibilities of the process Triage:
- To determine the validity of the case (View valid or invalid criteria of ICSR cases and processing)
- Assessment of seriousness of the events
- Identification of suspected drug (To learn more…)
- Assessment of causality and listedness
- Prioritization (To learn more…)
As per the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use E2A guideline, fatal or life-threatening unexpected ADRs should be notified to regulatory agencies within 7 days and all other serious, unexpected ADRs within 15 days.
According to the General Reporting Requirements of the Individual Case Safety Reports (European Medicines Agency), all serious ADRs should be notified within 15 days and all non-serious ADRs should be notified within 90 days.
Conclusion
As pharmacovigilance professionals, we have a responsibility to the society to ensure the safety of drugs. By focusing on compliance with regulations and being diligent in the triage of case processing, we can help pharmaceutical companies uphold their commitment to patient safety.
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