This blog features:
- What is occupational and accidental exposure
- Occupational exposure as special case scenario
- MedDRA coding conventions with examples
Table of Contents:
Introduction
In the context of pharmacovigilance, coding adverse events (AEs) is essential for the drug safety monitoring.
One particularly complex area involves exposure scenarios related to occupational and accidental incidents.
These cases need a nuanced approach to coding and reporting, as they may not always fit traditional adverse event categories.
This article will guide you through the definitions, coding conventions, and with examples.
Definitions
Accidental exposure
- Accidental exposure occurs when an individual is unintentionally exposed to a substance.
- This can include incidents such as a patient taking the wrong dose of a medication or a healthcare worker exposed to a drug (e.g., a needle-stick injury).
- Accidental exposure is commonly coded under Medication Error category within MedDRA. These cases are tracked to assess the safety profile of medicinal products and to prevent future occurrences.
- Accidental exposure is one of the most reported term and coded term with MedDRA under medication error concept.
“Special interest events require careful handling; neither should they be omitted nor processed incorrectly. Let’s ensure proper case management and accurate reporting with Drugvigil.”
Occupational exposure
Occupational exposure refers to the exposure to any agents during their occupation.
In healthcare settings, where healthcare professionals (HCPs) are often exposed to medicinal products or harmful chemicals.
For example, nurses, doctors, and laboratory technicians often exposes to medications, biological samples, or other substances is very common.
In pharmacovigilance, occupational exposure considered a special case, as it may involve both professional and non-professional contact with medicinal products.
In many regions, occupational exposure for healthcare workers could be of particular interest.
Acute and chronic
Occupational exposure encompasses the “chronic” or “acute” exposure to an agent (including therapeutic products) during the normal course of one’s occupation.
Acute and chronic is defined as based on accidental form of exposure that occurs in the context of one’s occupation.
MedDRA coding conventions
When reporting occupational or accidental exposure in pharmacovigilance, it’s essential to select the appropriate MedDRA terms.
The Lowest Level Term (LLT) should reflect the most accurate description of the exposure scenario, including any clinical consequences.
Below are examples of common exposure-related scenarios and how they should be coded:
| Reported | LLT Selected | Comment |
|---|---|---|
| Physical therapist developed a photosensitivity rash on hands after exposure to an NSAID-containing pain relief cream that she applied to a patient | Occupational exposure via skin contact with product, Photosensitive rash | |
| Pathologist chronically exposed to formaldehyde developed nasopharyngeal carcinoma | Occupational exposure to toxic agent, Nasopharyngeal carcinoma | Exposure to formaldehyde is a known risk factor for this type of malignancy |
| Nurse splashed injectable drug in her own eye resulting in excessive tearing | Accidental contact of product with eye, Excess tears | An alternative term – e.g., LLT Occupational exposure to product via eye – could be selected to replace LLT Accidental contact of product with eye, if applicable to regional requirements where acute exposures are considered to be occupational exposures |
Key Takeaways
Reports of occupationa exposure with no associated adverse reactions does not qualify for ICSR.
The omission of such terms in ICSR is necessary to include to be addressed as well in periodic safety update report, for example reported occupational exposure.
One of the core objective of pharmacovigilance is to preventing occupational exposure and its associated events.
Conclusion
Understanding and reporting accidental and occupational exposures is crucial in the field of pharmacovigilance.
By following proper coding conventions and recognizing the challenges, professionals can ensure that safety data is documented.
As you encounter cases of accidental or occupational exposure in your work, remember the importance of coding.
We encourage you to share any additional insights or experiences you may have related to occupational and accidental exposure reporting.
Your comments and feedback are valuable to us
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