Lecture 6 Flashcards
provide an example of an individual case safety report?
the spontaneous report, Literature report, Internet/Media, Observational, Clinical studies
AKA core data-generating system of vigilance
Spontaneous ADR reporting
Who reports spontaneous ADR?
Healthcare professionals
Patients or relatives
MAH: Marketing authorization holder
who MUST report in spontaneous adr?
Marketing authorization holder
what is the vigilance center in Egypt called?
National vigilance centre ( EPVC)
where is uppsala monitoring centre found?
Sweden
ICSR SUBMISSION ROUTE?
indirectly via marketing authorization holder ( Person responsible is called: Qualified person for vigilance (QPPV))
directly to the regulatory authority
what is a disadvantage of spontaneous reporting?
Underreporting; causes of underreporting: -Lack of time or awareness - Complexity of reporting & lack of accessibility - Poor feedback on reported cases - Fear of litigation
A drug safety awareness campaign to encourage patient reporting?
Take & Tell
4 minimum essential components?
- An identifiable patient
- Suspected medicine
- An identifiable reporter
- suspected adverse reaction
An ADR reporting form used by MAH?
CIOMs: Council for the international organization of medical sciences
Reporting forms for each country:
US FDA?
UK?
EYPT?
MEDWATCH FORM- ISA
yellow card-UK
yellow card- EGY
How to report ADR?
- Sending a hard copy
- via email
- through website
- electronic reporting
- hotline 15301
What’s needed to validate a case?
- An identifiable patient
- Suspected drug
- suspected adverse drug reaction
- an identifiable reporter
A medically confirmed report is submitted by?
HCP
Case reporter details?
Spontaneous report: case reported by HCP
Literature report: Case reported through publication
False signals AKA:
Duplicate reports
An automatic algorithm for the detection of suspected duplicates
VigiMatch
Processing a new case?
AKA; master case
Assessment, classification and prioritization of the received reports
according to key regulatory, scientific and medical criteria
Triage
Triage Assessment?
Assess: Seriousness Expectndness Relatedness/Causality (WHO) Literature
Order of case serious reportability?
1)Serious Unexpected
Serious expected
non-serious unexpected
non-serious expected
A system used in Marketing authorization holders?
Expedited ADR: As soon as possible & no later than 15 calendar days.
Included in the PSURs & submitted as follows:
- Every 6 months for the first 2 yrs of its international marketing
- Annually for the subsequently 2yrs
- Every 3 yrs
Complete data entry system:
Vigiflow
_____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.
VigiFLOW
Coding systems for: adverse events
Medical Dictionary For regulatory Activities (MedDRA)
WHO Adverse Reaction Terminology (WHOART)
Coding system for DRUGS?
WHO DRUG DICTIONARY (WHO DD)
The goal of coding systems?
Use the same language across countries, companies, and regulatory bodies.
“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.)
Case narrative
Key features of a narrative:
- Logical time “chronological” sequence (Medical story)
- Completeness and comprehensiveness (Standalone)
- Sufficient detail in a narrative
- Conclusion
Medical Review is done by?
Medical specialists
Clinical Pharmacologists
Pharmacists
Epidemiologists
Case Completion is made up of?
- Incorporation of any updates required by the review cycle
- Generation of the final report and regulatory submission
- Reporting ICSRs and aggregate report
When is PSUR reported?
Post-Authorization: After a drug has been released in market
When is DSUR reported?
periodic safety report of drugs under investigation (preauthorization)
