This blog covers:
- The different types of reports handled in case processing
- How report type can vary depending on the reporter
- Special conventions or considerations based on the type of report
Table of Contents
Introduction
In this blog, we explore how report types can vary depending on the reporter, and conversely, how the reporter can often be inferred from the type of report submitted. While this isn’t a strict rule, it provides useful insights into how reports are typically classified and understood within case processing.
Reports vs. Reporters
You may wonder: How do report types vary based on who submits them?
The answer is—yes, report types often differ depending on the reporter. In many cases, you can identify the type of report simply by understanding who the reporter is. Let’s explore this further.
Who Are Reporters?
In pharmacovigilance, a reporter is the individual or source who first becomes aware of and documents an incident or adverse event related to a drug. They are the origin of the report and play a crucial role in case processing.
In fact, the reporter is one of the four essential criteria required for a valid Individual Case Safety Report (ICSR).
Reporters are characterized by key identifying details, such as:
- Qualification (e.g., physician, pharmacist, patient)
- Name or initials
- Contact details (e.g., organization, department, street, city, ZIP/postal code, country)
- Email or phone number
Example:
If you are a consumer who experiences an adverse event after taking a medication, and you report this incident through any available channel (e.g., health authority portal, email, or phone), you become the reporter. Your role and identity help classify the report, often as a spontaneous or consumer-submitted report.
Various type of reporters
Below mentioning are the few familiar and very common type of reporters:
- Patient or Consumer and their relatives (Who may aware og the incident)
- Physician
- Investigator
- Other HCPs
- Legal person eg: Lawyer
- Marketing authorization holder (MAH)
“In pharmacovigilance, the clarity between the report and the reporter is vital—one captures the data, the other gives it voice. Together, they drive the science of drug safety forward.”
Report Types and Their Relation to Reporter Categories
Report types can often be identified by considering who the reporter is. While this is not a strict rule, it serves as a helpful indicator when classifying reports.
- Patient or Consumer as Reporter:
Reports from patients or consumers are most commonly categorized as spontaneous reports or arise from patient-oriented programs. Consumers may include both healthcare professionals (HCPs) and non-HCPs. They may report adverse events directly to regulatory authorities or through their healthcare providers. - Physician / Healthcare Professional (HCP):
When physicians or other HCPs act as reporters, their reports are often associated with patient support programs, market research programs, literature cases, or follow-up reports to spontaneous cases. Physicians are often the preferred source of clinical information, especially when patients provide consent. This group includes general practitioners, specialists, and dentists. - Investigator:
Reports from investigators are typically linked to organized clinical studies, such as post-marketing surveillance (PMS) studies. In such contexts, investigators serve as the primary reporters. - Legal Representative / Lawyer:
These reports are referred to as legal cases. They usually involve ongoing legal investigations or are submitted by individuals authorized to act on behalf of the patient or study participant. - Other Healthcare Professionals (e.g., Pharmacists):
Pharmacists and other allied health professionals can contribute valuable information, particularly regarding concomitant medications or past medical history. They also play a crucial role in encouraging spontaneous reporting. - Marketing Authorization Holder (MAH):
MAHs are legally responsible for the safety monitoring of their products. They are required to report serious adverse drug reactions (ADRs) to regulatory bodies such as the JPC. Non-serious ADRs are typically compiled in Periodic Safety Update Reports (PSURs).
However, it’s important to note that during follow-up, especially in spontaneous reports, the reporter type and case classification may change.
| Reporter | Reports |
|---|---|
| Physician/Investigator | Any Solicited reports |
| Physician | Any unsolicited and solicited reports as a medium person mostly |
| Other HCP | Solicited and unsolicited reports |
| Consumer | Unsolicited reports (eg: Spontaneous reports) |
| MAH | Any |
| Legal person | Legal cases |
| Author | Literature reports |
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Conclusion
We hope this concise yet comprehensive overview has provided a unique perspective on identifying report types based on the reporter—an approach not commonly outlined in traditional pharmacovigilance discussions. While this method is applicable in most scenarios, there may be exceptions where it does not apply. Nonetheless, it offers a practical and insightful way to classify cases based on the reporter.
If you feel we’ve missed any important points, please let us know in the comments below. We also welcome your suggestions on topics you’d like us to cover in future posts.
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