Overdose and Under-dose: Adverse Event Analysis

This blog includes:

1. Definitions
2. Recognizing overdose and underdose as adverse events
3. MedDRA coding convention for these terms.

Introduction

This write-up explains about the reported adverse events that overdose and under-dose. It’s part of exploring adverse events, where we look at different things that can go wrong with medications.

Overdose and under-dose is one of the element which are listed under special scenarios in pharmacovigilance in regards with public safety.

Understanding Overdose and Under-dose

Overdose:

An overdose occurs when someone takes or is given more than the recommended amount of a medication or substance.

✍️ Note: The recommended dose is the dose of safe limit advised for use.

Under-dose:

Under-dose happens when someone takes or is given less than the recommended amount of a medication or substance.

✍️ Note: In the field of case processing, there are often more reported cases of prescribed under-dose compared to overdose.

Both the situations can possibly arise from:

1. Intentional use by the patient for desired effects.
2. Intentional prescription by the physician.
3. Unintentional errors or mistakes in dosage.

Importance of Recognizing Overdose/Under-dose as Adverse Events

1. Immediate Medical Attention: Overdose or under-dose incidents involving certain products, like medications, require urgent medical attention.
2. Reduced Effectiveness: Under-dosing can result in medications not being effective for the prescribed condition.
3. Risk of Treatment Failure: Such situations may increase the likelihood of treatment failure.
4. Potential Worsening of Condition: Failing to administer the correct dosage could lead to a worsening of the patient’s condition.

Coding Overdose/Under-dose with MedDRA

When coding overdose or under-dose cases using MedDRA, two scenarios are typically considered:

1. Off-Label Use: If the reported overdose or under-dose is due to a prescribed medication, it falls under off-label use.
2. Medication Error: If the reported events occur due to intentional or unintentional actions by the patient, they are categorized under medication errors.

Key takeaways

1. Both overdose and under-dose (lower dose) are considered events in pharmacovigilance.
2. Regulatory standards stipulate that simply reporting overdose or under-dose without any associated valid events renders the case invalid.
3. In spontaneous reports, special scenarios are assumed to be suspected by default unless explicitly stated otherwise.
4. Reports of overdose, abuse, off-label use, misuse, medication error or occupational exposure with no associated adverse reaction not necessarily be reported as ICSRs.

Conclusion

In conclusion, our sophisticated exploration of adverse events within pharmacovigilance underscores the critical importance of addressing overdose and under-dose occurrences.

Through meticulous analysis and comprehensive discussions, we have shed light on the intricate implications of these events for medication safety and efficacy.

Our insights serve as valuable resources for pharmacovigilance professionals seeking to enhance their understanding and approach to adverse event management. Should further clarification or additional information be desired.

We eagerly await your feedback to continue fostering an enriching dialogue in this vital field.

References:

1. EMA