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Vigilance > Lecture 6 > Flashcards

Lecture 6 Flashcards

1
Q

provide an example of an individual case safety report?

A

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

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2
Q

AKA core data-generating system of vigilance

A

Spontaneous ADR reporting

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3
Q

Who reports spontaneous ADR?

A

Healthcare professionals
Patients or relatives
MAH: Marketing authorization holder

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4
Q

who MUST report in spontaneous adr?

A

Marketing authorization holder

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5
Q

what is the vigilance center in Egypt called?

A

National vigilance centre ( EPVC)

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6
Q

where is uppsala monitoring centre found?

A

Sweden

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7
Q

ICSR SUBMISSION ROUTE?

A

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

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8
Q

what is a disadvantage of spontaneous reporting?

A 
Underreporting;
causes of underreporting:
-Lack of time or awareness
- Complexity of reporting & lack of accessibility 
- Poor feedback on reported cases
- Fear of litigation
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9
Q

A drug safety awareness campaign to encourage patient reporting?

A

Take & Tell

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10
Q

4 minimum essential components?

A
  • An identifiable patient
  • Suspected medicine
  • An identifiable reporter
  • suspected adverse reaction
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11
Q

An ADR reporting form used by MAH?

A

CIOMs: Council for the international organization of medical sciences

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12
Q

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

A

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

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13
Q

How to report ADR?

A
  • Sending a hard copy
  • via email
  • through website
  • electronic reporting
  • hotline 15301
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14
Q

What’s needed to validate a case?

A
  • An identifiable patient
  • Suspected drug
  • suspected adverse drug reaction
  • an identifiable reporter
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15
Q

A medically confirmed report is submitted by?

A

HCP

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16
Q

Case reporter details?

A

Spontaneous report: case reported by HCP

Literature report: Case reported through publication

17
Q

False signals AKA:

A

Duplicate reports

18
Q

An automatic algorithm for the detection of suspected duplicates

A

VigiMatch

19
Q

Processing a new case?

A

AKA; master case

20
Q

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

A

Triage

21
Q

Triage Assessment?

A 
Assess:
Seriousness
Expectndness
Relatedness/Causality (WHO)
Literature
22
Q

Order of case serious reportability?

A

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

23
Q

A system used in Marketing authorization holders?

A

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

24
Q

Included in the PSURs & submitted as follows:

A
  • Every 6 months for the first 2 yrs of its international marketing
  • Annually for the subsequently 2yrs
  • Every 3 yrs
25
Q

Complete data entry system:

A

Vigiflow

26
Q

_____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.

A

VigiFLOW

27
Q

Coding systems for: adverse events

A

Medical Dictionary For regulatory Activities (MedDRA)

WHO Adverse Reaction Terminology (WHOART)

28
Q

Coding system for DRUGS?

A

WHO DRUG DICTIONARY (WHO DD)

29
Q

The goal of coding systems?

A

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

30
Q

“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.)

A

Case narrative

31
Q

Key features of a narrative:

A
  • Logical time “chronological” sequence (Medical story)
  • Completeness and comprehensiveness (Standalone)
  • Sufficient detail in a narrative
  • Conclusion
32
Q

Medical Review is done by?

A

Medical specialists
Clinical Pharmacologists
Pharmacists
Epidemiologists

33
Q

Case Completion is made up of?

A
  • Incorporation of any updates required by the review cycle
  • Generation of the final report and regulatory submission
  • Reporting ICSRs and aggregate report
34
Q

When is PSUR reported?

A

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

35
Q

When is DSUR reported?

A 
periodic safety report of drugs
under investigation (preauthorization)

Vigilance (4 decks)

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