This blog features:

Definitions
Example scenarios that come in case processing
Coding conventions within case processing PV

Table of Contents:

Introduction
Drug Interactions Explained
Handling Cases of Drug Interactions
MedDRA Coding Conventions
Key Takeaways
Conclusion

Introduction

This is one of the special scenarios listed in pharmacovigilance case processing.

Drug interactions are a common problem during drug treatment. And so give rise to a large number of hospital admissions as a result of serious or even fatal adverse events.

This is one of the important scopes of pharmacovigilance.

📢 Recommendation: I recommend checking this out first before diving deeper if you wish to explore what are other special scenarios in pharmacovigilance.

Drug Interactions Explained

Drug-drug interactions can lead to partial or complete loss of treatment efficacy
Drug and food interactions
Possible interactions
Drug-drug interactions
Drug-food interactions
Drug-substance interactions
Loss of efficacy (LOE) may occur due to drug interactions that prevent the expected effect. (Learn more about LOE cases)

Causes of drug interactions

Rational use of medications can cause interactions
Drug interactions caused by polypharmacy and irrational uses
Food and drug interactions

Tracking Drug Interactions in Pharmacovigilance

To enhance the identification of potential interactions in safety data.
Limit the Level of Evidence (LOE) during administration.
Recognize that interactions between substances can occur within the body.
Identify the causes of polypharmacy.
Primarily drug interactions identified in post-market studies, rather than pre-marketing studies.

Handling Cases of Drug Interactions

Drug interactions are significant and must processed and validated. In the context of polypharmacy, there is a high chance of that events caused by drug interactions.

Can you make an inquiry?

Drug interactions are the reports taken only where the report clearly stated.

Yes, you can inquiry in-terms of uncertainty to get the information in Follow-Up (FU) reports.

For extra clarity, you may also approach internal medical support.

Example 1:

Patient drank cranberry juice which interacted with anticoagulant drug causing an INR increase.

Example 2:

After taking an antihistamine along with her prescription proton pump inhibitor, a 53-year-old woman developed vertigo

✍️ Note: Both examples appear to be related to drug interactions; however, one explicitly reports the interactions, while the other, looks related, lacks relevant details.

“Drug interactions are like hidden conversations between medications—sometimes they collaborate to enhance efficacy, but other times they clash and cause unexpected consequences. Understanding these interactions is crucial for safe and effective treatment.”

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MedDRA Coding Conventions

Drug interactions can involve various factors beyond just drug-drug interactions with:

Foods
Alcohol
Medical devices, &
Diseases

MedDRA provides a comprehensive Lowest Level Terms (LLTs) for each of these categories.

Always prefer specific in details. If the report clearly outlines the types of interactions that described.

Exploring MedDRA Terminology

Below are a few examples of LLTs related to drug interactions:

Drug – alcohol interaction
Drug – food interaction
Drug interaction
Drug interaction (NOS)
Drug interaction inhibition
Drug interaction potentiation
Drug-disease interaction
Drug-device interaction
Drug-drug pharmacodynamic interaction
Drug-drug pharmacokinetic interaction
Drug-genetic interaction

Key Takeaways

If you don’t find any evidence as referring the product specific documents. You should not consider any case as drug interactions.
Drug-interactions are more relevance with post-market studies, than in pre-marketing studies.
Always select MedDRA codes that matches the details provided, even if they fall under the same PT.

Conclusion

From this blog, you understood why drug interactions have a special interest in pharmacovigilance.

For Many this blog finds helpful, and gets awareness of handling the reports drug interactions.

It’s clear that drug interactions extend beyond just drug-drug interactions.

Please feel free to comment below if you have any extra valuable points to contribute.

Disclaimer: We write this blog based on our experience and extensive knowledge, supported by references. Please note that we are not responsible for the content on the referenced websites. If you come across any misinformation or misguidance or spelling mistakes, kindly inform us promptly.

╰┈➤ Drug Interactions: An Adverse Event