Establishing a MedDRA Safety Surveillance Unit
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Transcript Establishing a MedDRA Safety Surveillance Unit
Establishing a MedDRA Safety
Surveillance Unit
Thanh Van T. Doan, RPh
PSI International Inc.
Working With MedDRA
The New Connaught Rooms
London, UK
17 September 1999
1
Background
• 1997 - PSI International Inc. tasked with the
challenge of conceiving, establishing, and
maintaining FDA’s Drug Safety Surveillance
Unit (DSS)
• Task includes:
Data entry
Utilizing MedDRA to code all adverse event
reports (AERs) received by FDA
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At present ….
Receive 4,500 - 5,000 AERs weekly
Process 1,000 AERs on a daily basis
Average turn around time - 3 days
To date ….
Over 350,000 AERs processed
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3
Issues
•Training
•High volume
•Timely processing
•Quality Assurance
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Issues
• Development of Standard Operating Procedures
(SOPs)
Workflow
Prioritization
Coding procedures — software
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Training
• Development of training manual — book
learning
Objective — uniformity and consistency
Introduction to structure & organization of
MedDRA
Introduction to “Principles of Coding”
Coding examples
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Training (2)
• “Buddy system” — real-time, hands-on training
Learn search strategies
Learn not memorize MedDRA
Reinforce Principles of Coding
Instant feedback
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Principles of Coding
• Development of coding principles in
conjunction with FDA
• ICH Guidelines for Good MedRA
Classification
• “Living” document - constantly evolving
Discussion of issues at monthly meetings
Revision of principle
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Quality
•Quality assurance process at 2 stages:
Data entry
- Ensure integrity of data
Coding
- Ensure uniform and consistent coding
- Ensure adherence to coding principles
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Quality (2)
•Feedback provided by :
Quality assurance (QA) team
FDA - Safety Evaluators (SE)
- Modifications to Principles of Coding
- Business rule changes
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MedDRA in action
Narrative: Information has been received from a 33 y.o.
female consumer who has taken Drug X for 30 days.
Approximately two weeks after initiating therapy, the
patient experienced a seizure. Hospital admission revealed
elevated liver enzymes. Drug was discontinued and
patient recovered.
Follow-up: Patient’s medical history includes hypertension
and seizures. On 30-Jan-99 she was admitted to the ER.
The following lab levels were observed: AST 651 unit/L,
ALT 800 unit/L, LDH 554 unit/L, Alk-P 986 unit/L, K +
3.3 mEq/L. All medications were discontinued. Patient
recovered without further complications.
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MedDRA in action (2)
PT
1. Convulsions NOS
Aggravated
2. Liver function tests
NOS abnormal
3. Hypokalemia
PT
1. Convulsions NOS
Aggravated
2. Hepatic function
abnormal
3. Blood potassium
decreased
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PT
1. Convulsions NOS
Aggravated
2. Aspartate
aminotransferase
increased
3. Alanine
aminotransferase
increased
4. Lactate dehydrogenase
increased
5. Alkaline phosphatase
increased
6. Hypokalemia
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MedDRA in action (3)
PT
LLT
1. Liver function tests
NOS abnormal
2. Hepatic function
abnormal NOS
Elevated liver enzyme
levels
LFT’s raised
Liver function tests
abnormal
SOC
Elevated liver enzymes Investigations
Raised LFT’s
Abnormal LFT’s
Abnormal liver function
tests
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Hepato-biliary disorders
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Legacy Data Conversion
•Points to consider:
Purpose - MedDRA-sizing vs.useful data
Level at which conversion will take place
Methodology
- Automation - use of an algorithm
- Manual
Result - QA
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Legacy Data Conversion (2)
Reported Term LLT
PT
Cerebrovascular Cerebrovascular Cerebrovascular
accident
accident
accident
CVA
CVA
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Haemorrhagic
Stroke
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Legacy Data Conversion (3)
Reported Term Linking Term
LLT
PT
Cerebrovascular Cerebrovascular Cerebrovascular Cerebrovascular
accident
accident
accident
accident
CVA
Stroke
Cerebrovascular Cerebrovascular Cerebrovascular
accident
accident
accident
Stroke
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Stroke
Cerebrovascular
accident
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Other Issues
• Level of reporting - PT v LLT
• Quarterly updates - Non-current terms
• Data retrieval - SSCs
• Software/ Coding tool
• Third parties - CROs, other pharmaceutical
companies
• Budgeting resources
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Take home message...
•MedDRA - comprehensive tool
•Training is a must
•Be PREPARED - SOPs
- Business rules
- Coding/classification guidelines
•Planned approach to conversion of legacy data
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Copy of presentation
will be made available:
at
www.MedDRAhelp.com
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