This blog features:
- Treatment drug explained
- Treatment drug vs other drugs involved
- Handling treatment drug in case processing
Table of Contents
Introduction
As we know, every condition in our body requires treatment for proper healing. However, it’s important to remember that all medications can cause side effects.
In the context of pharmacovigilance, defining treatment received is by the primary understanding from the source.
Every drug has the potential to produce some kind of effect, which could be either therapeutic or harmful.
In this blog, we’ll explore what treatment medications mean in pharmacovigilance and how they differ from other drugs that are also monitored in this field.
Treatment Received: Explained
In pharmacovigilance, “treatment received” in a case file refers to the treatment to mitigate an adverse event.
Generally from solicited reports, it is easier to find whether the patient received any treatment. While other reports need little review and understanding the case.
Here, “treatment” refers to any form of non-drug therapy, medication, or even medical techniques used to manage or mitigate the adverse event.
“Accurate handling of ‘treatment received’ in ICSR case processing is crucial for ensuring reliable data and proper causality assessments, ultimately guiding better patient safety outcomes.”
Treatment Drugs vs Other Types of Drugs
In pharmacovigilance, sources typically categorize drugs into three types:
- Suspected drug
- Concomitant drugs
- Treatment drugs
So, what differentiates a treatment drug from the other drugs involved?
A treatment drug (medication) recorded in a case file is defined by the following key points:
- Introduced only after the suspected drug is administered to the subject.
- Treated only after an adverse event occurs following the suspected drug’s use.
- Treatments are typically temporary, given specifically to address the adverse event.
- Treatments may also result in additional effects, which could be either beneficial or harmful.
- The outcome of the treatment is crucial in determining the causality of the case.
This distinction helps in evaluating the role of each drug in the adverse event and understanding its impact.
Conventions for Handling Reported Treatments
There are several important points to consider when defining treatments in the safety database:
- Assessing and differentiating reported drugs: Concomitant drugs and treatment drugs should be distinguished based on the following:
- The verbatim context provided.
- The date the drug was introduced.
- Treatment is not always a medication; it can also include procedures or other therapeutic methods.
- Treatment received should be selected for the specific event if a treatment drug was administered.
- In some cases, a treatment drug may become a co-suspect if it causes any effect, especially if the drug belongs to our company.
- Even if the treatment drug becomes a co-suspect, it should still be recorded as treatment received.
Coding Treatment Received in Cases
Treatment drugs should be coded using the WHODD system.
Is this applicable to our company’s product line?
- Yes, because when using our company’s core dictionary, the database automatically classifies the particular product as “suspected” and requires a causality assessment. Coding it incorrectly could lead to misleading submissions and incorrect data, which would not accurately reflect the cause of the event.
- Exclusions apply only when our company’s product is given as treatment and causes any additional effects.
- The decision to classify a treatment as a suspect is based on the temporal relationship of the case. Therefore, the conclusions of medical professionals are preferred.
- Many treatments cannot be coded under the product tab. Some companies prefer coding them under the MedDRA dictionary in the patient tab. Ensure that this step is never missed. Examples: Procedures
- If treatment cannot be coded anywhere else, select treatment received as “yes” and include the details in the narrative.
Note: Some companies prefer not to code treatments outside the product tab and instead only mention them in the narrative, providing an explanation of the treatment given.
Key Takeaways
Dechallenge and Rechallenge are not applicable if the treatment received.
Treatment received does not always refer to medication.
The Treatment received section should only be marked “yes” for the specific events.
Treatment drugs should always be coded using WHODD, even if they belong to our company’s product line.
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Conclusion
In this blog, you’ve gained a deeper understanding of the concept of “treatment received” and its related scenarios. Hopefully, it has provided clarity on any doubts you may have had. Moving forward, this information will guide you when handling cases.
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