Lesson 10- PharmacovigiIlance Surveillance Methods

Question 1

What is spontaneous reporting?

Answer 1

Unsolicited ADR reports from healthcare professionals/consumers to regulatory bodies or companies, not part of organized studies.

Question 2

List advantages of spontaneous reporting.

Answer 2

• Covers all medicines/populations.
• Detects rare/serious ADRs.
• Cost-effective and easy to establish.
• Continuous monitoring throughout a drug’s lifecycle.

Question 3

What are disadvantages of spontaneous reporting?

Answer 3

• Underreporting and incomplete data.
• Reporting bias (focus on severe/acute ADRs).
• Cannot calculate incidence rates or detect delayed/high-background ADRs.

Question 4

When is spontaneous reporting most useful?

Answer 4

For identifying new safety signals post-marketing, especially rare or serious ADRs.

Question 5

What is stimulated reporting?

Answer 5

A method to encourage ADR reporting for new drugs or during limited periods (e.g., post-authorization phase).

Question 6

Give examples of stimulated reporting initiatives.

Answer 6

• Black triangle scheme (EU): Highlights new drugs under additional monitoring.
• Early Post-Phase Vigilance (EPPV) in Japan.

Question 7

What drugs are typically under additional monitoring?

Answer 7

New active substances, conditionally approved drugs, or those requiring post-marketing studies.

Question 8

What are limitations of stimulated reporting?

Answer 8

Selective/incomplete data, inability to estimate incidence rates.

Question 9

What is targeted spontaneous reporting?

Answer 9

Focused reporting on specific drugs or ADRs (e.g., treatment-threatening reactions requiring discontinuation).

Question 10

What is the objective of Targeted Spontaneous Reporting?

Answer 10

To estimate incidence of known ADRs for specific drugs in defined populations.

Question 11

Define active surveillance.

Answer 11

Proactive, systematic data collection (e.g., registries, sentinel sites) to detect/quantify ADRs.

Question 12

What are sentinel sites?

Answer 12

Institutions (e.g., hospitals) monitoring ADRs in a subset of the population to infer broader trends.
Limitations: Selection bias, small sample size, high cost.

Question 13

What is drug event monitoring?

Answer 13

Tracking patients via prescriptions/insurance claims, with follow-up surveys to prescribers/patients.
Limitations: Low response rates from physicians/patients.

Question 14

What are registries? Provide examples.

Answer 14

Databases tracking patients with specific exposures/conditions:
- Disease registries (e.g., cancer).
- Drug registries (e.g., biologics).
- Pregnancy exposure registries.

Question 15

What are comparative observational studies?

Answer 15

Studies comparing ADR rates between drug-exposed and unexposed groups (e.g., cohort studies).

Question 16

What are descriptive studies?

Answer 16

Studies summarizing ADR patterns without comparisons (e.g., case series).

Question 17

Compare spontaneous, stimulated, and targeted reporting.

Answer 17

*Method** | Medicines | Population | Reports |
|———————-|———————-|———————-|———————-|
| Spontaneous | All medicines | All exposed | All ADRs |
| Stimulated | New/specific drugs | All exposed | All ADRs |
| Targeted | Specific drugs | Defined cohort | Specific/all ADRs |

Question 18

When is active surveillance preferred?

Answer 18

To estimate ADR incidence, gather denominator data, or address specific safety concerns quickly.

Question 19

When are stimulated/targeted methods used?

Answer 19

For new drugs, conditional approvals, or known safety issues needing focused data.

Question 20

What does ICH E2E recommend for PV planning?

Answer 20

Selecting methods based on objectives (e.g., signal detection vs. risk quantification).

Question 21

What is a common limitation of registries?

Answer 21

Resource-intensive setup and maintenance.

Question 22

Why is underreporting a challenge in passive surveillance?

Answer 22

Relies on voluntary submissions, leading to incomplete data on ADR frequency.

Question 23

What are MAH responsibilities in PV?

Answer 23

Submit periodic safety reports (PSURs)
Maintain risk management plans (RMPs)
Respond to regulatory requests

Question 24

What might fall under “Others” in active surveillance methods?

Answer 24

Additional methods like:
- Patient surveys (direct feedback from patients on ADRs).
- Electronic Health Record (EHR) mining (automated analysis of EHRs to detect ADR patterns).
- Social media monitoring (tracking patient-reported outcomes on digital platforms).

Question 25

Define **comparative observational studies** with an example.

Answer 25

Studies comparing ADR rates between exposed and unexposed groups. - **Example:** Cohort study comparing cardiovascular risks in patients taking Drug A vs. placebo.

Question 26

What is the **purpose** of comparative observational studies?

Answer 26

To identify causal relationships and quantify risks (e.g., hazard ratios).

Question 27

Define **descriptive studies** with an example.

Answer 27

Studies summarizing ADR patterns without comparison groups. - **Example:** Case series documenting liver toxicity in 50 patients using Drug B.

Question 28

What is **primary use** of descriptive studies?

Answer 28

To generate hypotheses for further research or signal detection.

Question 29

How do **sentinel sites** differ from registries?

Answer 29

Sentinel sites focus on specific institutions (e.g., hospitals) for real-time monitoring, while registries track defined patient cohorts (e.g., disease-specific groups).

Question 30

What is **ICH E2E**’s role in PV planning?

Answer 30

Provides guidelines for selecting surveillance methods based on drug-specific risks (e.g., new biologics vs. established generics).