Lecture 6

Question 1

provide an example of an individual case safety report?

Answer 1

the spontaneous report, Literature report, Internet/Media, Observational, Clinical studies

Question 2

AKA core data-generating system of vigilance

Answer 2

Spontaneous ADR reporting

Question 3

Who reports spontaneous ADR?

Answer 3

Healthcare professionals
Patients or relatives
MAH: Marketing authorization holder

Question 4

who MUST report in spontaneous adr?

Answer 4

Marketing authorization holder

Question 5

what is the vigilance center in Egypt called?

Answer 5

National vigilance centre ( EPVC)

Question 6

where is uppsala monitoring centre found?

Answer 6

Sweden

Question 7

ICSR SUBMISSION ROUTE?

Answer 7

indirectly via marketing authorization holder ( Person responsible is called: Qualified person for vigilance (QPPV))
directly to the regulatory authority

Question 8

what is a disadvantage of spontaneous reporting?

Answer 8

Underreporting;
causes of underreporting:
-Lack of time or awareness
- Complexity of reporting & lack of accessibility 
- Poor feedback on reported cases
- Fear of litigation

Question 9

A drug safety awareness campaign to encourage patient reporting?

Answer 9

Take & Tell

Question 10

4 minimum essential components?

Answer 10

• An identifiable patient
• Suspected medicine
• An identifiable reporter
• suspected adverse reaction

Question 11

An ADR reporting form used by MAH?

Answer 11

CIOMs: Council for the international organization of medical sciences

Question 12

Reporting forms for each country:
US FDA?
UK?
EYPT?

Answer 12

MEDWATCH FORM- ISA
yellow card-UK
yellow card- EGY

Question 13

How to report ADR?

Answer 13

• Sending a hard copy
• via email
• through website
• electronic reporting
• hotline 15301

Question 14

What’s needed to validate a case?

Answer 14

• An identifiable patient
• Suspected drug
• suspected adverse drug reaction
• an identifiable reporter

Question 15

A medically confirmed report is submitted by?

Answer 15

HCP

Question 16

Case reporter details?

Answer 16

Spontaneous report: case reported by HCP

Literature report: Case reported through publication

Question 17

False signals AKA:

Answer 17

Duplicate reports

Question 18

An automatic algorithm for the detection of suspected duplicates

Answer 18

VigiMatch

Question 19

Processing a new case?

Answer 19

AKA; master case

Question 20

Assessment, classification and prioritization of the received reports
according to key regulatory, scientific and medical criteria

Answer 20

Triage

Question 21

Triage Assessment?

Answer 21

Assess:
Seriousness
Expectndness
Relatedness/Causality (WHO)
Literature

Question 22

Order of case serious reportability?

Answer 22

1)Serious Unexpected
Serious expected
non-serious unexpected
non-serious expected

Question 23

A system used in Marketing authorization holders?

Answer 23

Expedited ADR: As soon as possible & no later than 15 calendar days.

Question 24

Included in the PSURs & submitted as follows:

Answer 24

• Every 6 months for the first 2 yrs of its international marketing
• Annually for the subsequently 2yrs
• Every 3 yrs

Question 25

Complete data entry system:

Answer 25

Vigiflow

Question 26

_____A web-based individual case safety report management system specially designed for use by national Pharmacovigilance centers in the WHO program for international drug monitoring.

Answer 26

VigiFLOW

Question 27

Coding systems for: adverse events

Answer 27

Medical Dictionary For regulatory Activities (MedDRA) | WHO Adverse Reaction Terminology (WHOART)

Question 28

Coding system for DRUGS?

Answer 28

WHO DRUG DICTIONARY (WHO DD)

Question 29

The goal of coding systems?

Answer 29

Use the same language across countries, companies, and regulatory bodies.

Question 30

“The story of the entire case” aka: A summary of all the relevant clinical information of an adverse event. (i.e. Patient characteristics, therapy details, medical history, clinical course of events, diagnosis, outcome, lab evidence etc.)

Answer 30

Case narrative

Question 31

Key features of a narrative:

Answer 31

- Logical time “chronological” sequence (Medical story) - Completeness and comprehensiveness (Standalone) - Sufficient detail in a narrative - Conclusion

Question 32

Medical Review is done by?

Answer 32

Medical specialists Clinical Pharmacologists Pharmacists Epidemiologists

Question 33

Case Completion is made up of?

Answer 33

- Incorporation of any updates required by the review cycle - Generation of the final report and regulatory submission - Reporting ICSRs and aggregate report

Question 34

When is PSUR reported?

Answer 34

Post-Authorization: After a drug has been released in market

Question 35

When is DSUR reported?

Answer 35

``` periodic safety report of drugs under investigation (preauthorization) ```