This blog covers:
- Assessing medication errors coding scenarios during pharmacovigilance case processing.
- Key considerations before coding cases involving medication errors.
- Understanding how medication-error terms are grouped and structured in MedDRA, in accordance with WHO guidance.
Introduction
As a pharmacovigilance processor, it is often time confusions that to assess of cases included the scenarios that is relevant to medication errors.
Before assigning MedDRA codes to medication error reports, it is important to evaluate the available case information carefully. The presence or absence of clinical consequences, the circumstances surrounding the error, and the distinction between medication errors and product quality issues all influence the selection of appropriate MedDRA terms.
The following considerations should be reviewed before proceeding with coding.
1. Medication Errors with Clinical Consequences
When a medication error is reported with associated clinical consequences, it is important to capture both aspects of the event.
- Select an appropriate MedDRA term representing the medication error.
- Additionally, select the relevant term or terms describing the clinical consequences experienced by the patient.
This ensures that both the error itself and its resulting clinical effects are appropriately represented in the safety report.
2. Medication Errors Without Clinical Consequences
Medication errors do not necessarily result in patient harm or an adverse reaction. However, documenting these occurrences remains important for pharmacovigilance and medication safety monitoring.
Consider the following scenarios:
- Medication errors without clinical consequences are not adverse reactions. Nevertheless, the occurrence or potential occurrence of the medication error should be recorded.
- When the absence of an adverse effect is explicitly reported: It is acceptable to select the LLT No adverse effect.
- When the medication does not reach the patient: If the error is intercepted before the medication reaches the patient, it is acceptable to select the LLT Drug not taken in context of intercepted medication error.
Appropriate coding helps capture medication errors even when they do not result in actual patient harm.
3. Medication Errors in the Context of Labelled Interactions
Special consideration is required when a medication error is reported in the context of interactions described in the product information.
For example, product labelling may describe known effects associated with:
- Coadministration with specific medicinal products.
- Concomitant consumption of certain foods.
- Administration to patients with particular disease states.
In these situations, when the reported circumstances represent a medication error, an appropriate MedDRA medication error term should be selected to describe the type of interaction.
4. Do Not Infer Medication Errors Without Supporting Information
One important principle in MedDRA coding is to avoid making assumptions that are not supported by the information provided in the case report.
A medication error should not be inferred unless specific information indicates that an error has occurred.
For example, do not automatically conclude that an overdose, underdose or extra dose has occurred without supporting information in the report.
Coding decisions should always reflect the reported facts rather than assumptions made by the person performing the coding.
5. Product Quality Issues Versus Medication Errors
A product quality issue and a medication error are two different concepts and should be carefully distinguished before assigning MedDRA terms.
A product quality issue relates to a problem with the medicinal product itself, whereas a medication error concerns an error associated with the medication-use process.
Therefore, the available case information should be reviewed to determine the actual nature of the reported event before concluding which coding category is appropriate.
Grouping of Medication Error-Related Terms in MedDRA
MedDRA provides groupings of medication error-related terms that can support the identification, analysis and review of medication errors.
These groupings include:
1. Grouping according to WHO medication-use process categories
Medication error-related terms are grouped according to the following categories:
- Prescribing errors
- Dispensing errors
- Medicine preparation errors
- Administration errors
- Monitoring errors
2. Grouping according to the WHO Anatomical Therapeutic Chemical (ATC) Classification System
Medication error-related terms are also grouped according to the first level of the WHO Anatomical Therapeutic Chemical (ATC) classification system.
This provides an additional way to organise and analyse medication errors based on the anatomical or therapeutic classification of the medicinal products involved.
Conclusion
Medication error coding requires careful assessment of the reported circumstances, clinical consequences and available supporting information. Correctly distinguishing medication errors from adverse reactions and product quality issues is essential for consistent MedDRA coding.
Before assigning any term, always review the case narrative, identify whether an actual or potential medication error occurred, and ensure that the selected LLTs accurately represent the information reported.
