Establishing a Med DRA Safety Surveillance Unit Thanh

Establishing a Med. DRA Safety Surveillance Unit Thanh Van T. Doan, RPh PSI International Inc. Working With Med. DRA 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: ØData entry ØUtilizing Med. DRA to code all adverse event reports (AERs) received by FDA PSI International Inc. All Rights Reserved 1999 2

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 PSI International Inc. All Rights Reserved 1999 3

Issues • Training • High volume • Timely processing • Quality Assurance PSI International

Issues • Development of Standard Operating Procedures (SOPs) ØWorkflow ØPrioritization ØCoding procedures — software

Training • Development of training manual — book learning Ø Objective — uniformity and consistency Ø Introduction to structure & organization of Med. DRA Ø Introduction to “Principles of Coding” Ø Coding examples PSI International Inc. All Rights Reserved 1999 6

Training (2) • “Buddy system” — real-time, hands-on training ØLearn search strategies ØLearn not memorize Med. DRA ØReinforce Principles of Coding ØInstant feedback PSI International Inc. All Rights Reserved 1999 7

Principles of Coding • Development of coding principles in conjunction with FDA • ICH Guidelines for Good Med. RA Classification • “Living” document - constantly evolving ØDiscussion of issues at monthly meetings ØRevision of principle PSI International Inc. All Rights Reserved 1999 8

Quality • Quality assurance process at 2 stages: Ø Data entry - Ensure integrity of data Ø Coding - Ensure uniform and consistent coding - Ensure adherence to coding principles PSI International Inc. All Rights Reserved 1999 9

Quality (2) • Feedback provided by : Ø Quality assurance (QA) team Ø FDA - Safety Evaluators (SE) - Modifications to Principles of Coding - Business rule changes PSI International Inc. All Rights Reserved 1999 10

Med. DRA 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 m. Eq/L. All medications were discontinued. Patient recovered without further complications. PSI International Inc. All Rights Reserved 1999 11

Med. DRA in action (2) PSI International Inc. All Rights Reserved 1999 12

Med. DRA in action (3) PSI International Inc. All Rights Reserved 1999 13

Legacy Data Conversion • Points to consider: ØPurpose - Med. DRA-sizing vs. useful data ØLevel at which conversion will take place ØMethodology - Automation - use of an algorithm - Manual ØResult - QA PSI International Inc. All Rights Reserved 1999 14

Legacy Data Conversion (2) PSI International Inc. All Rights Reserved 1999 15

Legacy Data Conversion (3) PSI International Inc. All Rights Reserved 1999 16

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 PSI International Inc. All Rights Reserved 1999 17

Take home message. . . • Med. DRA - comprehensive tool • Training is a must • Be PREPARED - SOPs - Business rules - Coding/classification guidelines • Planned approach to conversion of legacy data PSI International Inc. All Rights Reserved 1999 18