Update on the Adverse Event Management System and Electronic Data Interchange Bernadette Barton, Claire Larter, Iga Policinska and Warren Arndt Pharmacovigilance and Special Access Branch, Medicine Regulation Division, TGA Australian Pharmacovigilance Regulatory Requirements and Risk Management Plans Summit 27 March 2019
Session overview • Introduction • Current state • Looking to the future • Industry experiences • Panel discussion AEMS and EDI 1
What are AEMS and the EDI? : • Used by the TGA to collect, Adverse store and analyze adverse Event event data. M anagement • Replaced the former Adverse System Drug Reaction S ystem • Functionality which supports Electronic the system to system transfer Data of adverse event data. : Interchange • International format (E2B R2). 2 AEMS and EDI
Introduction to the AEMS team • Data entry team enter reports that have been received • Director - Claire Larter from: • Team - Health professionals – Consumers – Bernadette Barton – Health professional – Iga Policinsk – Sponsors • Data entry team - team of 5 data entry staff – State and Territory health officers Business support - Warren Arndt, Greg • • Subset of reports reviewed by health professional Knight, Daniel Tebbey – Prior to decision (accept/ reject) – Post-decision - data quality review AEMS and EDI 3
What do we do with reports? TGA Report • Signal Detection – Local: PSAB, Signal Investigation Unit – International: Data sent overnight to WHO (E2B R3 format) Transparency • – 90 day lag – Publication: Database of Adverse Event Notifications (DAEN) AEMS and EDI 4
Current state – reporting adverse events AEMS • EDI = Preferred method Online = 2 nd best • Email = 3 rd best • • Mail/fax = Last resort AEMS and EDI 5
Current reporting state Reports received from pharmaceutical industry Reports entered J ul-Aug 2018 Reports entered J an-Feb 2019 2% 2% 2% 25% EDI 37% Online 41% Email Other 71% 20% AEMS and EDI 6
How has the EDI been adopted? • 19 sponsors on board • 5 Sponsors in progress • >2200 new cases • >650 amendments AEMS and EDI 7
Why use the EDI? • Benefits to industry • Benefits to the TGA – International format – More comprehensive data received – E2B R2 – Efficient – Efficient – Data entry not duplicated – Reliable – Reliable – Well-supported on-boarding process AEMS and EDI 8
Alternatives to the EDI • Registered online is preferred - uses TBS credentials 8 • Emailed CIOM S preferable to mail/ fax • Information can be copied (improved accuracy) * • M ail and fax should only be used if there are no alternatives + • M ore time on data entry; less time on data quality AEMS and EDI 9
EDI-related process changes Attachments Duplicates • E2B R2 format doesn’t support • In AEM S, duplicates are assigned as embedded attachments ‘master’ or ‘duplicate’ • Indicate availability of attachments in • Y ou can help us identify duplicates by: report • Providing previous case identifiers • Provide if requested by TGA • For literature – provide citation in • Literature – critical to provide full A2.2 <literaturereference> citation in report AEMS and EDI 10
Looking to the future… • EDI uptake will decrease data entry for reports from pharmaceutical industry • This will increase capacity for: – Entering detailed information from: § consumer reports § health professionals reports § CIOMS received via other channels – Reviewing quality of the data set AEMS and EDI 11
Reviewing quality of the data set Current State Future State • Majority of effort is focused on entering cases • Increased focus on quality of data set • Review of data quality at case level • Periodic case line listings to look for common data quality issues • Risk-based review by health professional • Feedback will be provided to sponsors where • Coding may be corrected if reviewed deficiencies identified • Data quality checked mainly during signal • E.g. incomplete or inaccurate coding of reactions investigation • Aim is to improve quality of data set to improve signal detection AEMS and EDI 12
How are we reviewing data quality? For all input channels: • Medicine names – Should match ARTG/ ingredients list – Tradename in drug details preferred • Qlik analytics to visualise AEMS data – Data review by different characteristics § E.g. ingredient, product, reaction etc • Case line listings – ‘Death’ coded as an ADR – Disease progression – Procedures / treatments – No identified ADR AEMS and EDI 13
Feedback on data quality Individual sponsor feedback - Sponsors contacted when issues identified AE reporting FAQs - Identify common data quality issues and provide advice to all sponsors Updates to pharmacovigilance guidance - Consider clarifying reporting requirements in guidance AEMS and EDI 14
EDI enhancements • Improvements to internal notifications where unsuccessful processes occur in the gateway • Ability to resend E2B R2 ACK messages to our trading partners • New functionality to specify whether our trading partners would like to receive additional acknowledge letters via email • At present there are no set timeframes to move to E2B R3 AEMS and EDI
EDI outages If the gateway is unavailable for a period which affects the sender's ability to meet regulatory reporting timeframes, the sender should submit the ICH E2B(R2) case safety report to TGA within two TGA business days of the gateway becoming available. In reviewing regulatory reporting timeframe compliance the TGA will consider relevant periods of gateway unavailability. Users will be advised when the gateway is unavailable for scheduled maintenance. AEMS and EDI
Gilead Sciences - experience • Before EDI transmission, Gilead was submitting ICSRs as XM L files and pdf files via email to TGA. • In order to move to EDI transmission of ICSRs, Gilead requested the TGA clarification technical document – Gilead provided 10 test cases to TGA on 11 July 2018 – 15 July 2018 TGA was able to process the files but 2 files encountered an issue. The TGA system did not accept certain numeric values with more than 2 decimal places e.g. <patientweight>3.118</ patientweight> – Ther e was also an issue with the ACK message not including the DTD reference. Gilead were informed by TGA on 23 August 2018 that this issue was resolved. – 17 Sep 2018 TGA informed us that the decimal issue would be fixed in production in the week beginning 1 st October 2018. • TGA and Gilead were in close communication through the testing process • Gilead went live with E2B EDI submission to the TGA on 15 OCT 2018. – First case was submitted and acknowledged by TGA via email 17
Gilead Sciences - experience (cont) • Gilead are now successfully transmitting cases to TGA via E2B. • To date 110 E2B files have been transmitted (initial and follow up). • Acknowledgements are received back from the TGA in a timely manner and submissions have all been successful to date. • Gilead performs reconciliation activities and advised the TGA when a new case number was inadvertently provided for a previously submitted EDI case. The duplicate issue was investigated and resolved. • Benefit to Sponsors: Case submission centrally via electronic gateway ensures greater efficiency. 18
Panel discussion Getting on-board the EDI • TGA • Roche • AbbVie PSABSystems@health.gov.au ADR.Reports@health.gov.au AEMS and EDI 19
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