presentation: adverse event management system and ... · update on the adverse event management...
TRANSCRIPT
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,
store and analyze adverse event data.
• Replaced the former Adverse Drug Reaction System
Adverse Event
Management System
• Functionality which supports the system to system transfer of adverse event data.
• International format (E2B R2).
Electronic Data
Interchange
:
: AEMS and EDI 2
Introduction to the AEMS team ••
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Director - Claire Larter Team - Health professionals
Bernadette Barton Iga Policinsk
Data entry team - team of 5 data entry staff Business support - Warren Arndt, Greg Knight, Daniel Tebbey
Data entry team enter reports that have been received from:
Consumers Health professional Sponsors State and Territory health officers
•––
Subset of reports reviewed by health professional Prior to decision (accept/ reject) Post-decision - data quality review
AEMS and EDI 3
What do we do with reports? TGA Report •
– –
Signal DetectionLocal: PSAB, Signal Investigation UnitInternational: 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 methodOnline = 2nd bestEmail = 3rd bestMail/fax = Last resort
AEMS and EDI
5
Current reporting state
37%
20%
41%
2% Reports entered Jan-Feb 2019
Reports received from pharmaceutical industry
2%
25%
71%
2% Reports entered Jul-Aug 2018
EDIOnlineEmailOther
AEMS and EDI 6
How has the EDI been adopted? • • • •
19 sponsors on board5 Sponsors in progress>2200 new cases>650 amendments
AEMS and EDI 7
Why use the EDI? •
– – – – –
•Benefits to industry International formatE2B R2EfficientReliableWell-supported on-boarding process
Benefits to the TGA – – – –
More comprehensive data receivedEfficientData entry not duplicatedReliable
AEMS and EDI 8
Alternatives to the EDI
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• Registered online is preferred - uses TBS credentials
• Emailed CIOMS preferable to mail/fax • Information can be copied (improved accuracy)
• Mail and fax should only be used if there are no alternatives • More time on data entry; less time on data quality
AEMS and EDI 9
EDI-related process changes
Attachments
• E2B R2 format doesn’t support embedded attachments • Indicate availability of attachments in
report • Provide if requested by TGA
• Literature – critical to provide full citation in report
Duplicates
• In AEMS, duplicates are assigned as ‘master’ or ‘duplicate’
• You can help us identify duplicates by: • Providing previous case identifiers • For literature – provide citation in
A2.2 <literaturereference>
AEMS and EDI 10
Looking to the future…
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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 Future State ••
•
••
• Increased focus on quality of data set Periodic case line listings to look for common data quality issues Feedback will be provided to sponsors where deficiencies identified E.g. incomplete or inaccurate coding of reactions Aim is to improve quality of data set to improve signal detection
Current State Majority of effort is focused on entering cases
••••
Review of data quality at case level Risk-based review by health professional Coding may be corrected if reviewed Data quality checked mainly during signal investigation
AEMS and EDI 12
How are we reviewing data quality? For all input channels: •
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•–§
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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
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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 partnersNew functionality to specify whether our trading partners would like to receive additional acknowledge letters via emailAt present there are no set timeframes to move to E2B R3
AEMS and EDI
EDI outages
AEMS and EDI
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.
Gilead Sciences - experience
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Before EDI transmission, Gilead was submitting ICSRs as XML 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>There 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 1st 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
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Gilead Sciences - experience (cont)
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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.
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Panel discussion
[email protected] [email protected]
Getting on-board the EDI •••
TGA Roche AbbVie
AEMS and EDI 19
