Update on the Adverse Event Management System and Electronic Data - - PowerPoint PPT Presentation

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 S ystem

Adverse Event M anagement System

• Functionality which supports

the system to system transfer

• f adverse event data.
• International format (E2B R2).

Electronic Data Interchange

: :

AEMS and EDI 2

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

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 = 2nd best Email = 3rd best Mail/fax = Last resort

AEMS and EDI 5

Current reporting state

37% 20% 41% 2%

Reports entered J an-Feb 2019

Reports received from pharmaceutical industry

2% 25% 71% 2%

Reports entered J ul-Aug 2018

EDI Online Email Other

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

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

Alternatives to the EDI

8

* +

• Registered online is preferred - uses TBS credentials
• 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

• 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 AEM S, duplicates are assigned as

‘master’ or ‘duplicate’

• Y
• u 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…

• –

§ § § –

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:

• –

–

• –

§

• –

–

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

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

• –

–

–

–

• 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>

There was also an issue with the ACK message not including the DTD reference. Gilead were informed by TGA

• n 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

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

PSABSystems@health.gov.au ADR.Reports@health.gov.au

Getting on-board the EDI

• TGA

Roche AbbVie

AEMS and EDI 19