From this blog, you will explore in detail into action items, covering:
- Definitions
- The role of action items in pharmacovigilance
- Approaches to managing action items in pharmacovigilance
Table of Contents:
- How We Define Action Items: Our Point of View
- Understanding Action items within Pharmacovigilance
- Identifying Action Items
- Key Takeaways
- Thoughts
- FAQ
Definition
Are action items error?
In a broader context, there’s a common misconception that action items equate to errors.
No, Action Items are not always linked to errors. Instead, they are a list of tasks that need to be done to reach a particular goal or desired result.
Action Items exist to give a straightforward plan that outlines the steps required to achieve a specific goal.
“Action items are the compass needles in the map of productivity, guiding us towards accomplishment. As we check off each task, we navigate the journey of progress, turning aspirations into achievements, and transforming plans into a tangible reality.”
Understanding Action items within Pharmacovigilance
In pharmacovigilance, case processors often come across the term “action items” during ICSR processing. Essentially, Action items are like requests for processors to take the right actions in addressing safety concerns or issues.
💡 Pro tip: Before taking care of action items, it’s important to grasp three factors: “Who,” “What,” and “When.”
As mentioned earlier, while action items don’t necessarily mean there’s an error, in case processing, they can be findings, suggestions that need attention or specific tasks to move the case forward to the next stage of the workflow.
Examples of Non-critical Action Items
Many action items are critical, but here I’ll define a few as non-critical, providing some examples below:
Suggestions:
- You might get action items to include extra details or send a follow-up query.
- In certain instances, some details might be overlooked or missed in the source (though not critical). In such cases, you may be requested to submit a query for clarification.
Justifications
- Sometimes, you might come across situations where you asked for explanations or need clarification if things are confusing.
Identifying Action Items
Action items, which are tasks that need attention, can originate from two common sources:
- Email Inboxes: Often raised during client case audits or quality checks.
- Returning Cases to Your Workflow: If you’ve been assigned any action items, cases will be routed back to your workflow accordingly.
- Inboxes at Clinical Databases: Generated through sophisticated systems available with clinical database.
Below is a screenshot example illustrating action items in the Argus Safety Database for reference:
Dealing action items in pharmacovigilance
- Start by checking the action items. Are they suggestions or pointing out errors?
- Examine your case based on the action items and see if they apply.
- If an action item indicates an error, figure out who is responsible.
- Talk to the MR if you disagree with or choose not to follow the action item.
- With help from the MR, send an email to the person who initiated it, asking questions to clear things up. (Merely carrying out action items without questioning or analyzing them is not a suitable approach)
- Follow the conventions; if necessary, fill out case correction forms.
- Complete the case correction form and attach it.
- It is essential to prioritize action items based on their importance and urgency to ensure that the most critical tasks are to complete first.
- Finally, send the case on its way after making all the needed corrections.
Common Slip-Ups in Performing Action Items
- Begin working on the case without looking at the to-do list (Action items).
- Sometimes forget on purpose or without realizing it.
- Remember that urgent tasks need to do right away.
- Skip doing it that are meant for people who are absent.
Typical Action Items in PV (Pharmacovigilance).
This could include:
- Further investigation into the reported adverse event.
- updating product labeling or instructions.
- Communicating safety information to healthcare professionals or patients.
- Raise an inquiry.
- Event and drug coding error.
- Errors in ICSR narratives are very common (To learn more…)
- Any important Medical data missing
Key takeaways:
- Not everything on the action item is an error.
- Just because something is on the action item doesn’t mean you have to do it.
- Seek the instructions and guidance from MR, before doing anything on the to-do list.
- Carefully examine the case and determine who is responsible.
- Stick to the company convention when working on the to-do list.
- Action items can enhance team to greater clarity and organised.
Closing thoughts
We hope this write-up provides you with an understanding of what action items are, especially focusing on how they are specifically managing within pharmacovigilance.
The goal of this blog is to bring clarity to the processes within pharmacovigilance.
Did I miss anything beyond what I’ve explained above? Please specify in the comments below, and feel free to share this message as much as possible.
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