This blog covers:
- Analyzing Data for Data-Entry
- Coding of Reported Drugs and Adverse Events
Table of Contents:
- Introduction
- How to Analyze and What to Look for in the Given Data
- Coding of Drugs and Reported Medical conditions From The Given Data
- Conclusion
- References
Introduction
After triage and book-in the case into the database, the next step involves coding events and drugs. This process forms a crucial part of complete data entry.
So, what is complete data entry?
Complete data entry is a process requires the processor to enter all relevant details and data into the database, which is provided in the source.
This includes all the information such as reporter information, patient details, Patient medical history, suspected drug, events and so on.
Analyze the given data
Before proceeding with coding, it is crucial to identify the suspected drugs and adverse events.
- In many cases, patients may be prescribed multiple drugs, and in such situations, coders primarily focus their suspicion on our own product. However, if the report clearly indicates that our drug is not responsible for a specific event, the case should be deactivated upon confirmation.
- When analysing the medical history and events, it is essential to evaluate between the events and medical history of the patient. In Many instances that may cause a huge error. To learn more insights in to common errors that may possibly happen in data-entry.
- During follow-up cases, If you found out any errors made from previous versions through your source. Any mismatches with your current source. So you should correct the inaccuracies and ensure there are no delays.
“Pharmacovigilance processes primarily center on monitoring adverse events and their associated medications. Stay diligent and committed to safeguarding public health.”
Coding of Drugs and Events
The next step after analysing the data is to proceed with coding the events and drugs.
Coding of Suspected Drug(s)
Suspected drug:
A suspected drug is the medication associate with the Adverse Drug Reaction (ADR) as determine by the initial reporter. It is possible that there may be one or more drugs involved, based on the available information from the source.
Any remaining drugs considered as associated concomitant drugs.
The suspected drug(s) need to code using the company’s product dictionary for company drugs and the WHO Drug Dictionary (WHO DD) for non-company concomitant drugs.
📢 I suggest checking out our blog where we delve into the thorough assessment of suspected drugs and concomitant medications, and explore how concomitant drugs can become suspects themselves.
What is WHO-DD?
The WHO-DD is an international classification of medicines created by the WHO Program for International Drug Monitoring and managing by the Uppsala Monitoring Centre.
The associate will also add other information for the suspect drug which includes indication, therapy details, and action taken with the suspect drug in response to the event.
The case processor will identify and categorise the drugs provided by the primary reporter as either suspect, concomitant, or interacting. They will then code these drugs in the appropriate drug dictionaries configured in the company’s database.
Additionally, relevant information about the suspected drug, such as indication, therapy details, and any actions taken in response to the event, should also recorded.
Coding of Adverse Event(s)
In this step, the process of adverse events coding with using the Medical Dictionary for Regulatory Activities (MedDRA).
MedDRA is an internationally standardization of medical dictionary using for regulatory communication and evaluation of data relate to medicinal products for human use.
Keen to dive deeper into MedDRA? Explore our blog for an in-depth exploration.
The case processor can automatically code the event term (auto code) if an exact match exists in MedDRA. If an exact match is not available, the event term is to code manually which is more appropriate. The purpose is to ensure uniformity in language across countries, companies, and regulatory bodies.
Conclusion
From the above write-up, you can delve into the conditions required for analyzing the given data before importing it into the database. Furthermore, you might uncover nuances in the coding of drugs and patient medical conditions.
We encourage you to suggest or mention any specific topics for our upcoming articles.
Feel free to comment below if anything has been overlooked in this blog.
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