1 Establishing a MedDRA Safety Surveillance Unit Thanh Van T. Doan, RPh PSI International Inc. Working With MedDRA The New Connaught Rooms London, UK 17

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Establishing a MedDRA Safety Surveillance Unit

Thanh Van T. Doan, RPh

PSI International Inc.

Working With MedDRAThe New Connaught Rooms

London, UK17 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

PSI International Inc. All Rights Reserved 1999

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At present ….

Receive 4,500 - 5,000 AERs weeklyProcess 1,000 AERs on a daily basisAverage turn around time - 3 days

To date ….

Over 350,000 AERs processed


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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 PT PT1. Convulsions NOS

Aggravated2. Liver function tests

NOS abnormal3. Hypokalemia

1. Convulsions NOSAggravated

2. Hepatic functionabnormal

3. Blood potassiumdecreased

1. Convulsions NOSAggravated

2. Aspartateaminotransferaseincreased

3. Alanineaminotransferaseincreased

4. Lactate dehydrogenaseincreased

5. Alkaline phosphataseincreased

6. Hypokalemia

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MedDRA in action (3)


PT LLT SOC1. Liver function tests

NOS abnormal

2. Hepatic functionabnormal NOS

Elevated liver enzymes Raised LFT’s Abnormal LFT’s Abnormal liver function

tests

Elevated liver enzymelevels

LFT’s raised Liver function tests

abnormal

Investigations

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 accident



CVA CVAHaemorrhagic Stroke

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Legacy Data Conversion (3)


Reported Term Linking Term LLT PT





CVACerebrovascular accident



Stroke Stroke StrokeCerebrovascular 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 presentationwill be made available:

at

www.MedDRAhelp.com


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1 Establishing a MedDRA Safety Surveillance Unit Thanh Van T. Doan, RPh PSI International Inc. Working With MedDRA The New Connaught Rooms London, UK 17