Note: This blog is crafted solely from personal experience and may be subject to individual interpretation.
First and foremost, let’s consider the meaning of quality. Quality is not solely about production; it also entails ensuring sustainability over the long term.
In simple terms, we can define quality as the ability to maintain sustainability within the given cost constraints.
Quality in Pharmacovigilance
In pharmacovigilance, quality not measured by product delivery but by the effectiveness in delivering safety information to regulatory authorities and the World Health Organisation (WHO).
Quality in pharmacovigilance entails ensuring that all information is accurately coded, with no missing or extraneous or misleading data. In other words, it means capturing and coding safety information neither in excess nor in deficiency, but always in the correct manner.
“Quality is not an act; it is a habit.” – Aristotle
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Best practices to perform quality checks
Self-quality check
The associate conducts self-quality checks on cases before advancing them to the next workflow, ensuring completeness and accuracy, especially for Suspected Unexpected Serious Adverse Reactions or fatal cases.
Before going forward deeply in to know about the quality checks, If you’d like to explore the discussion in specific we discuss about quality upgrades. Firstly, explore simple hacks you can implement within case processing to improve quality. Secondly, delve into 10 common mistakes often overlooked in case processing.
Key steps include:
- Begin by giving priority to case selection.
- Note: The quality of case processing hangs on starting with the right prioritisation. Missing a submission can have a cascading impact on our overall quality and commitments in processing. Therefore, everything else takes a back seat to this critical aspect.
- Self-quality check for completeness and accuracy in important safety information.
- Drafting and updating queries for missing information with necessary attachments.
- Practice of doing a direct reference to the appropriate source yourself instead of seeking input from your colleague. (Aware: Since you are the coder, any errors ultimately fall on your responsibility. You cannot justify or shift blame for errors in your case onto someone else.)
- Focus and remain attentive when routing to the correct workflow.
- Share your knowledge with your team in case you encounter special instances and scenarios.
Quality Assessment(s) by the Quality Team
- Confirm the validation of cases, and the quality reviewer also assesses the medical significance of follow-up information.
- Verify the completeness of the case.
- The quality reviewer analyses whether the events coded and drugs have accurately coded with the most appropriate and relevant terms.
- Quality reviewer perform quality analysis of the case to ensure accurate and consistent data entry and processing from adverse event reports.
- Quality reviewer assesses event listedness , evaluates/confirms the seriousness assessment, and completes or modifies the narrative as necessary.
- Redirect the case to coder/processor when essential tasks need to be addressed.
- Ultimately, proceed to route the case to the next workflow, including medical assessment if required, or archive the case.
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For beginners seeking to enhance their processes with high-quality standards, feel free to download our ICSR Quality Checklist. It’s designed to support your journey and elevate your approach. Get your copy now!
Final note:
Quality assessment plays a pivotal role in the pharmacovigilance process, ensuring the precision of information submission. Therefore, the quality team must possess a comprehensive understanding of the entire process within this framework.
Is there anything you believe I may have overlooked in the aforementioned points?
Feel free to contribute any recommendations or suggestions in the comments below.
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