This blog features:
- Understanding SOC Social Circumstances in MedDRA
- Purpose of this SOC
- Key Importance in MedDRA coding as a part of SOC
Introduction
We all know that MedDRA follows a hierarchical structure, with each level serving a specific purpose in organizing medical and regulatory terminology. At the top of this hierarchy is the System Organ Class (SOC) level, which currently consists of 27 SOCs, each covering a particular group of medical or related concepts.
Among these, SOC Social Circumstances stands out because it focuses not on diseases or adverse events themselves, but on the personal and social factors surrounding an individual. So, in this article, let’s take a closer look at SOC Social Circumstances, understand its unique characteristics, and explore how it differs from other SOCs in MedDRA.
What Is the Purpose of SOC Social Circumstances?
SOC Social Circumstances has some unique characteristics that set it apart from the other SOCs in MedDRA. Rather than focusing on diseases or adverse events, it brings together terms related to a person’s social situation, personal circumstances, and certain behaviours that may help provide additional context for a reported case.
Essentially, this SOC contains information about the person and their circumstances rather than the adverse event itself.
These factors may help reviewers understand the individual’s living conditions, disabilities, social difficulties, or other personal issues that could be relevant when evaluating a safety report.
For example, consider the following statement:
“The patient was confined to a wheelchair.”
This information describes the patient’s circumstances or functional limitations rather than a specific adverse reaction to a medicinal product. Depending on the intended concept and the MedDRA terminology, an appropriate term may be selected from SOC Social circumstances.
“Not every term in pharmacovigilance describes a disease or an adverse event. SOC Social Circumstances in MedDRA captures the personal and social context behind a case, reminding us that accurate coding begins with understanding what the information truly represents.”
Key Characteristics of SOC Social Circumstances
Three important characteristics distinguish this SOC from many other MedDRA SOCs.
Unlike SOCs that primarily classify medical conditions, diseases, or adverse events, this SOC focuses on personal and social factors that may provide additional context for an individual case safety report (ICSR).
A. One of the 27 SOCs in MedDRA
SOC Social circumstances is part of the standard MedDRA SOC hierarchy. It provides a dedicated classification for social and personal factors that may be relevant to the interpretation of reported medical information.
B. Single-axial structure
SOC Social circumstances is one of the three single-axial SOCs in MedDRA.
In the single-axial structure, terms belonging to this SOC are not linked to other SOCs through the usual multi-axial assignments. This differs from many medical concepts that may be represented in more than one SOC, depending on their clinical meaning.
C. Focus on the individual’s circumstances
The SOC captures information related to the person, including certain disabilities, social situations, legal issues, and circumstances involving abuse.
This distinction is important in pharmacovigilance because not every piece of information in a case narrative represents an adverse event. Some details describe the patient’s background or circumstances and may provide useful context for case assessment.
Important Conventions and Exceptions
MedDRA applies specific conventions within SOC Social circumstances to ensure that related concepts are classified consistently and remain distinguishable from similar medical or social concepts.
Many terms in SOC Social Circumstances may appear similar to terms found in other SOCs. Understanding the differences is essential to classify the reported information correctly and select the most appropriate Lowest Level Term (LLT) in MedDRA coding.
A. Social Circumstances Are Not Adverse Events Themselves
Social circumstances provide information about a person’s life, background, or personal situation rather than describing an adverse event directly.
Even when reported in an ICSR, these details help provide context about the patient.
For example, being confined to a wheelchair describes a person’s circumstances, not necessarily an adverse event.
B. Distinguishing victims from perpetrators of crimes or abuse
Within the relevant legal-issues hierarchy, MedDRA distinguishes between individuals who are victims of crimes and individuals who commit them.
The terminology also applies a specific convention to abuse-related concepts:
- The crime or action of abuse is represented at the Preferred Term (PT) level.
- The perpetrator of the crime or abuse is represented at the Lowest Level Term (LLT) level beneath the corresponding PT.
- Terms describing victims are qualified with the wording “victim of” at the PT level.
For example, PT Sexual abuse has LLT Sexual abuser in its terminology relationship.
This structure helps preserve the distinction between the act of abuse, the person responsible, and the person affected.
For accurate coding, users should consult the current licensed MedDRA terminology and select the term that best reflects the information documented in the source narrative.
C. Distinguishing disability from a medical disorder
Another important convention concerns blindness and deafness.
A disability and a medical disorder may describe related concepts, but they do not necessarily convey the same meaning in a case narrative.
For blindness, MedDRA distinguishes between:
- PT Sight disability, located in SOC Social circumstances, which represents blindness in the context of disability.
- PT Blindness, located in SOC Eye disorders and SOC Nervous system disorders, which represents blindness as a medical disorder.
The concept of deafness follows similar principles.
This distinction is particularly important when coding case narratives because the coder must identify whether the reported information describes a disability or a medical condition. The term should be selected according to the documented concept, not simply because two terms appear similar in ordinary language.
Why Is SOC Social Circumstances Important in Pharmacovigilance?
Understanding SOC Social circumstances helps pharmacovigilance professionals interpret case narratives more accurately and apply MedDRA terminology consistently.
Its practical importance includes:
1. Better contextual understanding
Social and personal information may provide additional context for understanding the patient and the circumstances surrounding a reported event.
2. More accurate MedDRA coding
Recognizing the difference between a social circumstance, a disability, and a medical disorder helps coders select terminology that reflects the source information.
3. Consistent classification
Understanding single-axial SOCs and their conventions reduces confusion when similar concepts appear in different parts of the MedDRA hierarchy.
4. Improved case review
Clear differentiation between the patient, the event, the perpetrator, and the victim can support more consistent case documentation and review.
It is important to remember that the presence of a social circumstance in a case does not, by itself, establish a causal relationship with an adverse event or a medicinal product.
Conclusion
SOC Social circumstances serves a distinct purpose within MedDRA by grouping personal and social factors that may provide context for an individual case. As one of the three single-axial SOCs, it follows a different assignment structure from the multi-axial SOCs used for many medical concepts.
Its conventions concerning substance use, abuse-related terminology, legal issues, and the distinction between disability and medical disorders demonstrate why understanding the MedDRA hierarchy is essential for accurate coding.
For pharmacovigilance professionals, the key principle is straightforward: code the documented concept accurately, distinguish personal circumstances from medical conditions, and always follow the applicable MedDRA hierarchy and coding conventions.
