Presentation: Adverse Event Management System and Electronic Data Interchange
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An update on the TGA Adverse Event Management System and Electronic Data Interchange
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Presentation: Adverse Event Management System and Electronic Data Interchange
- 1. 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
- 2. Session overview • Introduction • Current state • Looking to the future • Industry experiences • Panel discussion AEMS and EDI 1
- 3. 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
- 4. Introduction to the AEMS team • 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
- 5. 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
- 6. Current state – reporting adverse events AEMS • EDI = Preferred method • Online = 2nd best • Email = 3rd best • Mail/fax = Last resort AEMS and EDI 5
- 7. 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 EDI Online Email Other AEMS and EDI 6
- 8. How has the EDI been adopted? • 19 sponsors on board • 5 Sponsors in progress • >2200 new cases • >650 amendments AEMS and EDI 7
- 9. Why use the EDI? • Benefits to industry – International format – E2B R2 – Efficient – Reliable – Well-supported on-boarding process • Benefits to the TGA – More comprehensive data received – Efficient – Data entry not duplicated – Reliable AEMS and EDI 8
- 10. Alternatives to the EDI • 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
- 11. 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
- 12. 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
- 13. 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
- 14. 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
- 15. 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
- 16. 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
- 17. 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.
- 18. Gilead Sciences - experience • 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 17
- 19. 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
- 20. Panel discussion PSABSystems@health.gov.au ADR.Reports@health.gov.au Getting on-board the EDI • TGA • Roche • AbbVie AEMS and EDI 19
Editor's Notes
- Claire
- Claire
- Claire Worth distinguishing between business side support and our IT colleagues
- Claire - contribution to global PV. The TGA sends adverse event data nightly to WHO in the E2B R3 format. Previously monthly in an older format.
- Bernadette
- Bernadette Provide update on % via EDI in March
- Bernadette - Update stats prior to talk
- Bernadette Easier integration of follow-up information Structured data – supports signal detection
- Bernadette
- Bernadette
- As Bernadette mentioned there are a number of benefits to the EDI. I will briefly explain the importance of data quality within the EDI cases and provide an over view of the how we check data quality and how we wish to achieve this. The TGAs main focus is to decrease the amount of data entry allowing for better data quality; this is not only related to reports from industry but allows for more accurate review of cases from consumers and HCP. It also enables us to review the quality of the data at a higher level and improves signal detection.
- At present we focus on entering the data to allow for local signal detection through our ongoing monitoring strategies. We undertake a risk-based approach at the case level. We Use a subset of criteria….. cases are flagged and undergo review. These reviews are conducted by HCP – N, D, P. Throughout the review we may ask for further info, correct coding, or identify that no ADR has been identified. We further run a DPAR (Disproportionality Analysis Report) bi-monthly. And if a signal is detected by this method further review of cases is warranted. If a signal is detected through other avenues, such as the PRAC, FDA alert; investigation and more detailed review of cases will occur.
- We review our data in a number of ways, we use Qlik sense for our data analytics, now before I go on, I would like to stress the importance of submitting appropriate reports with the correct medical terminology. For best practice and consistency we require you to match the ARTG/ingredient list. Where possible if you have the trade name please submit this, this is our preference. Now back to Qlik data analytics. We review data by using different variables; we can review trends by searching ingredients, trade names, reactions etc. We further conduct CLLs exporting this in a tabular format allowing for in-depth identification of coding errors. Such coding errors may include: Death as an ADR – this is an outcome. Name of disease followed by disease progression. Using MedDRA to code this, it will code up to the Disease, therefore it will appear as if the drug is causing the disease it is indicated for. Hospitalisation Adverse event
- So what happens after we conduct and identify data quality issues? If we find discrepancies we will notify sponsors and request to change these. We are looking into putting together a FAQ in the future, after further review of cases. We also want to update the PV guidelines, The PV guidelines were written before the implementation of the EDI, therefore they are not necessarily applicable. I will stress we do not have a timeline for these updates. So now over to Warren for the more technical aspects.
- Notes: The TGA has been actively encouraging the adoption of the EDI functionality using the E2B R2 format. Many of you in room have probably been contacted by the system support team. We have been working closely with interested Sponsors in transitioning to the EDI. In a couple of slides we will share a case study. The EDI functionality has been in place for around 9 months. Like most new IT systems, there were a few teething issues that we had to work through. Our focus now is looking at ways of improving the overall experience. If you have any suggested improvements please share these with us. Your feedback is invaluable. On screen are some of the EDI enhancements we are planning on making: - Improving our internal monitoring and notifications to more easily identify unsuccessful exchanges - New functionality to be able to manually resend ACK messages - Being able to configure for each Sponsor whether they would like to opt out of receiving email acknowledgements in addition to the E2B R2 ACK message There are no set timeframes for when E2B R3 will be included in the EDI. Based off consultation during the project E2B R2 was the preferred EDI channel. AEMS has been designed with an E2B R3 data model. Cases received in E2B R2 are converted into E2B R3 using the ICH BFC guidelines. The design of AEMS will make it easier to include an E2B R3 channel in the future.
- Agreed approach for EDI outages – if EDI is unavailable it is not necessary to email a report unless advised to by the TGA – the normal process is to submit it via the EDI within 2 business days of the EDI functionality coming back on line. We send communications for scheduled maintenance to the nominated business and IT contacts that were provided during the EDI onboarding. If you encounter an unexpected issue in connecting with the service please contact us.
- TGA’s system and processes are intended to be quite similar to other regulators; though there are some subtle differences. Likewise we also see subtle differences from Sponsor to Sponsor. I will now step you through Gilead’s experience who were one of the early sponsors to go through the process. The end to end process took around 3 months. Along the way Gilead did encounter some issues which were investigated and able to be resolved through some IT adjustments. For example, feedback was provided that the ACK message should include a DTD reference. Consultation and testing was undertaken with the broader users to ensure the resolution would work for all our partners.
- For cases where the follow-up version has been submitted via EDI gateway, but the initial via e-mail, the TGA will assign a new case number to the EDI version.