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
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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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4
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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