Disease Progression: A Special Case of Adverse Events

This blog covers the following topics:

1. Precise definition of disease progression
2. Standard conventions for capturing disease progression an event
3. MedDRA coding guidelines

Introduction

Diseases are a common part of daily life for everyone over here However, there are certain diseases and conditions that remain uncontrollable or even worsen over time.

As a pharmacovigilance professional, you are likely familiar with reports related to disease progression.

In this blog, we will explore the intricacies of disease progression an adverse event and how to effectively manage and document these reports.

Definition

Disease progression refers to the process by which a disease worsens or advances over time, often resulting in the deterioration of the patient’s health or the development of new symptoms.

In the context of pharmacovigilance, the definition remains the same. However, here, disease progression refers to the worsening or intensification of a specific condition, particularly related to the progression of the indication for the suspected drug being used.

Disease Progression: An Adverse Event

Disease progression is considered an event related to the indication of the case.

When a report includes information about disease progression, it is a valid report, though it represents a special case scenario of an adverse event.

For example, if the progression of malignant neoplasm is reported, and the indication for the case is malignant neoplasm, it is considered an adverse event.

However, in cases where an existing event is reported as having progressed, this refers to the outcome of that existing event rather than the initiation of a new adverse event.

Handling Disease Progression as an Adverse Event

Many professionals may confuse the scenarios of Loss of Efficacy (LOE) and disease progression, as both reports can seem similar. However, it is important to understand the distinction between them for accurate case processing.

1. LOE reports contain information indicating that the drug is ineffective. However, it should not be classified as LOE unless it is explicitly confirmed. At first glance, the information may appear to suggest LOE, but careful review and logical analysis are necessary to avoid premature conclusions.
2. In death reports where death linked to disease progression, the seriousness criterion in the Individual Case Safety Report (ICSR) should not be classified as “fatal“.
3. If an existing event is reported as having progressed, it indicates the outcome of that event at the time of the report, rather than representing a standalone event.

MedDRA Coding Conventions

When coding for disease progression, it’s important to note that there is no single strict code. Several options are available. To code disease progression accurately, you must identify the specific condition that has actually progressed. It’s not just a matter of labeling it as “progression” — other appropriate codes, such as “exacerbation,” may also be used.

1. Disease progression
2. Disease progression, NOS (Not Otherwise Specified)
3. Event-specific codes are also available for progression and exacerbations.

Many companies follow the practice of coding “disease progression” as a distinct part of the event, with the primary code reflecting the event that has actually progressed. In most cases, the indication will become the event.

Key Takeaways

Conclusion

This article has provided clarity on how to differentiate and handle LOE and disease progression as adverse events.

This content aims to provide a clarity in handling disease progression as an adverse event in case processing.

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