Question 1

What is the Meaning of Spontaneous Reporting System?

Accepted Answer

A Spontaneous Reporting System collects voluntary reports of adverse events, including drug reactions and quality issues, from healthcare professionals and consumers. It serves as a crucial post-market tool for safety monitoring, gathering real-world data on medical product performance after public availability.

Question 2

What is the Context of Spontaneous Reporting System?

Accepted Answer

Within pharmacovigilance, this system is a core component of regulatory oversight for pharmaceuticals, devices, and vaccines. It continuously collects information from clinical and consumer experiences, extending safety assessment beyond controlled trials. This ongoing surveillance is vital for identifying safety concerns not apparent during initial product development.

Question 3

What is the Significance of Spontaneous Reporting System?

Accepted Answer

This system is critical for patient safety, acting as an early warning for unforeseen medical risks. It detects rare adverse events, new safety signals, and at-risk populations. Spontaneous reports directly inform regulatory actions, leading to label updates, safety alerts, or withdrawals, guiding clinical decisions and protecting well-being.

Question 4

What is the Mechanism of Spontaneous Reporting System?

Accepted Answer

The mechanism involves voluntary submission of individual case safety reports (ICSRs) to national regulatory authorities or manufacturers. These reports detail patient, product, observed adverse event, and reporter's causality assessment. Reports are coded, aggregated, and analyzed statistically to detect patterns or signals, indicating a potential causal link.

Question 5

What is the Application of Spontaneous Reporting System?

Accepted Answer

In clinical practice, the Spontaneous Reporting System provides essential real-world data complementing pre-market trial findings. Regulatory bodies use this data to assess the risk-benefit profile of approved medical products, informing post-market commitments and updates. Healthcare providers and patients contribute by reporting suspected adverse events, influencing ongoing safety evaluation.

Question 6

What is the Metric of Spontaneous Reporting System?

Accepted Answer

Effectiveness is assessed by the volume and quality of submitted individual case safety reports, along with timely identification of new or increased adverse event frequencies. Key metrics include report numbers per product and signal detection, which uses statistical algorithms to identify disproportionate reporting of specific adverse events.

Question 7

What is the Risk of Spontaneous Reporting System?

Accepted Answer

Despite its value, the Spontaneous Reporting System has inherent limitations, primarily significant underreporting, which can distort true incidence. Establishing definitive causality from individual, incomplete reports is challenging, potentially leading to false safety signals or delayed recognition of genuine risks. This system is prone to reporting bias, requiring careful interpretation and confirmation via robust studies.

Spontaneous Reporting System

Meaning

Context

Significance

Mechanism

Application

Metric

Risk

How Do Pharmacovigilance Systems Track PT-141 Cardiovascular Safety?