₊ ⊹ Patient Medical History and Adverse Events: An Analysis

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This blog highlights:

  1. Definitions of Medical History and Adverse Events
  2. Distinction Between These Two Terms
  3. Effectively Identifying Differences in Case Processing to Alleviate Confusion, Illustrated with Examples

Table of Contents:

  1. Introduction
  2. Medical History: An Overview
  3. Adverse Effects: An Overview
  4. Recognizing and Differentiating The Discrepancies b/w Them
  5. Quiz Time
  6. Thoughts

Introduction

Differing Medical history and Adverse event.

Many professionals may already be familiar with the distinction between these two terms.

However, let’s take a moment in this casual learning. The beginners, You will explore here the differences for those who may unclear about them.

Despite the complexity, there are confusions surrounding this topic, even among experienced individuals.

Medical History

Let me clarify.

In general, “history” refers to events from the past that have concluded.

Yet, in pharmacovigilance data analysis, medical history refers to events. That are past incidents and existing conditions.

That are historical conditions and current conditions.

It may not necessarily have reached to an end; they may still be ongoing or relevant from a past perspective.

It encompasses an investigation into the patient’s medical background:

  1. Prior surgical interventions
  2. Familial medical records
  3. Social background
  4. Ongoing conditions
  5. Social circumstances
  6. Historical medications
  7. Planned surgery

Adverse effects

In instances, where adverse events that are incidents occur following drug administration. That may be suspicion regarding their causality.

✍️ Note: In some cases, adverse events reported after the drug discontinued. In such cases, it is important to refer meticulously to the product-specific documents. This is to evaluate the temporal relationship requires consideration of the product’s half-life.

📢 Recommendations: I highly encourage exploring the detailed discussions on the distinctions between adverse reactions and adverse events and discussing about special situations in pharmacovigilance.

Recognizing and differentiating the discrepancies

An example of report:

“I’ve been prescribed medication (X) for (Y) due to certain symptoms. However, I’ve noticed that I’m experiencing more severe headaches than before since starting the medication. Additionally, I’ve been having several episodes of allergic reactions. Moreover, I’ve been dealing with acidity issues even before beginning the medication.”

From the report above, it’s evident that the patient is specifically mentioning three complications:

  1. Headaches
  2. Allergic reactions
  3. Acidity

Headaches: The patient reports experiencing headaches, which were present before medication but have worsened since starting the medication. Therefore, headaches are considered an adverse event due to exacerbation of the current condition. So it also a current condition.

Allergic reactions: The patient has experienced several episodes of allergic reactions, clearly indicating an adverse event.

Acidity: The patient reports having acidity since before taking the medication, indicating a pre-existing condition unrelated to the drug administration. Therefore, acidity is not considered an adverse event in this case. But it should be listed under patient current condition (Medical history).

Engage Your Mind: Take the Quiz:
Minimal Multiple Choice Quiz
Are ADR and AE synonymous?
  • Yes
  • No
  • Similar but not the same
Does the exacerbation of a condition constitute an adverse event?
  • Yes
  • No
Can a diagnosed indication for which a suspected drug is administered become an adverse event?
  • Yes
  • No
Does a product complaint become an adverse event?
  • Yes
  • No

Wrap up

From the above discussion, it cleared how straightforward the analysis, especially for beginners. We've aimed to simplify the process for easy comprehension. This guide serves as a valuable resource for differentiating and assessing case files.

If you believe we've missed anything crucial or have further insights, feel free to share your comments below. Your feedback is greatly appreciated.

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.



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Meet Bala, the founder of Drugvigil, a service provider specializing in pharmacovigilance. He’s not only an expert in this field, but also a passionate entrepreneur who enjoys creating new opportunities and helping others grow. Despite starting from scratch, he’s determined to develop his company from the ground up. If you’re interested in his work, be sure to show your support and share his message with others.




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One response to “₊ ⊹ Patient Medical History and Adverse Events: An Analysis”

  1. […] about distinguishing between a patient’s medical history and adverse events, we invite you to explore our comprehensive blog, which provides detailed explanations through Q&A sessions. and check out the blog that discusses key terms often referenced during causality assessments, […]

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