Things you should know about Signal Prioritization in the EU Signal Management Process in 5- minutes!
In today's article, the subject is relatively lesser-known step in the EU signal management process. Signal Prioritization is obscure but very important to understand at the same time. I call it obscure because you won't find all of the information below in one place. I scoured through some 8 sources to come up with all this.
The article covers concepts and definitions of signal prioritization, what actual and thematic parameters to consider while prioritizing signals, objectives, what actually WHO and MHRA do (methodologies), how actual prioritized signals look like and impact analysis of signal prioritization.
I hope you find this article useful and informative. Let's dive right in!
What is Signal Prioritization?
MAH performs signal prioritization to identify signals which may adversely impact:
1- Public health
2- Individual patients
3- BR balance of the product
• So things to remember about prioritization: Continuous, impact on public/patient health/BR balance and require urgent attention
Objectives of signal prioritization/ What MAHs should keep in mind:
1- Is the step that determines the timeline for signal assessment and recommendation of action
2- Issues derived from non-valid events that do not qualify as ICSRs
What MAH should keep in mind during signal prioritization:
Take a pause, see where you are NOW:
2- Being prepared to take action before process completion:
3- Be human, use nuance and be ready:
Signal Prioritization should be based on (actual/clinical parameters):
Signal prioritization: what points to consider (thematic):
2. Consequences of treatment discontinuation:
3. The evidence- strength and consistency:
4. Clinical (co-existence) context:
5. Public health impact:
6- Ongoing investigations with pending verdicts:
Signal Prioritization Methods:
1- WHO Method of signal prioritization
2- MHRA Method of signal prioritization
1- WHO method of signal prioritization:
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2. Unexpectedness
3. Strength of disproportionality score
4. The temporal displacement of disproportionality score
5. Age of the product
6. Signaling in multiple countries
7. Positive re-challenge
8. Existence of the signal term on a list of targeted terms
2- MHRA Method of signal Prioritization:
MHRA uses signal triage method.
• They analyze the immediate and high-risk signal attributes first
• These aspects drive formal evaluation
• While lower signal attributes are postponed for formal evaluation until a later time
- All in all, this triage is done using final priority score to triage and prioritize and to decide further action
What happens after getting final priority score at MHRA?
• The combination of this score is used in an undisclosed manner to categorize the signal into a final category of High, more information required, Low, or No action.
How the MHRA Signal Prioritization method derives the final priority score?
This final priority score is made of two scores:
2. Public Health score
Evidence score:
It is an algorithmic score based largely on:
2. Plausibility of causal relationship
3. Strength of the evidence provided
Public health score:
2. Anticipated health consequences
3. The reporting rate in relation to the level of drug exposure
What actual signal prioritization looks like with timelines:
Impact analysis for signal prioritization:
While analyzing impact of a signal during the process of prioritization, six points should be considered:
2. Is it reversible
3. Is it preventable
4. Strength of association
5. Likely to be a contraindication or W&P
6. Exposure – vulnerable patient population
So that is this quick article on Signal Priortization in the EU signal management process! I hope you found this article informative.
Please share your thoughts the comments section below!
Further reading:
You have read the article on signal priortization. Now compare and contrast with emerging safety issues in my article below!
Happy reading!!
Safety Operations and Management
1yMore focused approach for unlabeled events and new beneficial effects