Post on 08-Aug-2020
Innovative Medicines InitiativeWEB-RADR 2
Webinar 1: technology and innovation
@WEBRADR #WEBRADR2020
David Lewis, Novartis
Phil Tregunno, MHRA
@WEBRADR #WEBRADR2020
Welcome
WEB-RADR
Vision
#WEBRADR2020
Aims of the webinar
• WEB-RADR 2 outputs and achievementsShare
• Future use of technologyInspire
• Further discussion and collaborationInitiate
Webinar 1: technology and innovation
Linda Härmark, LAREB
Kendal Harrison, MHRA
Speakers
Calvin Johnson, AbbVie
Mona Vestergaard Laursen, DKMA
Linda Härmark, LAREB
@WEBRADR #WEBRADR2020
Platform user needs and requirements
Vigilance Hub
Vigilance Hub
• Create reporting forms for the app or website, update to E2B-R3
• Report management
• Maintenance User management
• News
Kendal Harrison, MHRA
@WEBRADR #WEBRADR2020
Technology development
Vigilance Hub Vs App: what do they do
Hub configurations
drive the branding and features in
the App
Reports and users can be
reviewed in the Hub
Key functionality developments
Report configuration
Key functionality developments
News feeds
Key functionality developments
• R3 and will be mandated by June 2022
• Reporting forms can now be output in R3 format
ICH E2B R3 capabilities
Single Sign On
• Enables single log in to access multiple sites, which includes the WEB-RADR solution
Future enhancements
‘
Kendal Harrison, MHRA
@WEBRADR #WEBRADR2020
Mobile application overview
WEB-RADR Apps
Yellow Card, UK
14/07/2015
Lareb, Netherlands
29/01/2016HALMED, Croatia
18/05/2016
Burkina Faso
15/06/2017
Zambia
29/06/2017
Country onboarding
1. Get in touch with WHO and MHRA
2. Provide drug lists and configuration preferences
3. MHRA and the WHO Uppsala Monitoring Centre set you up
4. Country tests
5. Go Live!
6. Ongoing support provided, including video demos!
Med Safety App
Med Safety App
COVID-19 reporting
• Rapid development of a COVID-19 site based on WEB-RADR functionality
Calvin Johnson, AbbVie
@WEBRADR #WEBRADR2020
Industry case study: AbbVie e-PV mobile application
Disclaimer
The views expressed in this presentation are the views of the speaker and do not necessarily reflect the views, opinions or policies of AbbVie.
The Industry opportunity
IT systems link – limit manual data entry
Well-proven technology: mobile and desktop enabled
Collaboration Enhance reporter experience
AbbVie pilot approach
South Africa Affiliate
Users: 5 Patient Support Program Nurses
100 ICSRs (4 weeks)
Objectives:
• Technical feasibility
• User experience
• Efficiency measures
• Case comparisons vs. traditional methods
Our experience so far
• e-PV set-up: Flexi-XML format (not E2B)
• Balance of APP fields vs. reporter expectations
• Internal company standards for validation and information security
• Change management for Nurses
• Training on e-PV
• Overall user experience was very positive: “valuable for my role: is easy to access and faster to report”
• Some simplification of the fields were suggested
• Pilot results are under review
• Overall, data indicates at least comparable with traditional methods
• Important to outline approach early to align expectations
• Engage and educate legal teams early to support smooth contracting
Next steps and future opportunities
Assess e-PV and how this fits into AbbVie’s Global ICSR intake strategy
Benefit from future APP
enhancements
Enhance access to information
and significant news
Customize questions to enhance
data collection
Deployment to all reporters
PSP vendor experience
supporting multiple companies
Mona Vestergaard Laursen, DKMA
@WEBRADR #WEBRADR2020
Application Programming Interfaces within the Danish healthcare setting
Table of Contents1. The DKMA aims to improve pharmacovigilance
2. How the Danish health care it-setting looks like
3. The WEB-RADR API from a user perspective
4. Recommendation from a vendor
5. Going forward
Improving pharmacovigilance
• Through more than a decade of pharmacovigilance action plans the Danish Medicines Agency (DKMA) aims to strengthen and improve pharmacovigilance in Denmark
• In the current action plan the DKMA is focusing on several initiatives to
• increase the awareness of ADR reporting
• improve the quality of ADR reports
• improve the technical support to ADR reporting.
• Guided by a strong vision of being among Europe’s best in class, the DKMA aims to be an active European partner in pharmacovigilance and influence the European standard for pharmacovigilance
• WEB-RADR was the opportunity to gain valuable insight in future technical solutions and test the connectivity and feasibility in the Danish healthcare and pharmacovigilance systems
FMK-online
The Danish health care IT-setting
National Service Platform (NSP)
Dentist Home care GPHospital Pharmacy Other
Services
Shared medication
recordBirts
Report ADR(BIV proxy)
Deaths VaccinationsCPR number
Reference data - registries
Medicineprices
Organisations
Public and private it-systems
exam
ple
sexam
ple
s
Authority
• User
management
• Availability
• Security
• operational
stability
• 24/7 Service
Desk
NSP is the
infrastructure
that enables
national
registries and
services to be
used directly in
patient care.
FMK-online
The Danish health care IT-setting
The shared
medication record
online application
(FMK-online) was
used as a reference
EHR system.
FMK-ONLINE
National Service Platform (NSP)
Dentist Home care GPHospital Pharmacy Other
Services
SHARED MEDICATION
RECORDBirts
REPORT ADR (BIV proxy)
Deaths VaccinationsCPR number
Reference data and registries
Medicineprices
Organisations
Public and private it-systems
Authority
FMK-online
The exisating report
ADR service was
adapted to WEB-
RADR
How to submit ADR reports to WEB-RADR
• An internal test-client with a specially developed user interface for submitting ADR reports was developed in an existing EHR-system
• The functionality to submit ADR reports was added to a test module used only for internal testing purposes
• Information about patient and reporter and healthcare related data such as prescriptions and vaccines were already available to the user in the EHR-system
NSP NSPEHR test system
User perspective
Case overview
Report seriousness
Add short case summery
ADRs
Add ADRs
MedDRA look-up
Medicines
Add medicinefrom sharedmedicationrecord or manually
Medical history
Add diagnoses relevant to the case
Test and procedures
Add height and weight
Add relevant tests and procedures
Report an ADR easily
through your local it-
system…
…and use available
information in your EHR
system…
… and minimise the need
(and time) for manual
data entry…
… and increase data
quality in the ADR report
(and the quantity)
Subm
it A
DR
report
User interface (in Danish)
Vendor perspective
• Successful Proof of Content (PoC) implementation without major technical problems
• The key parts and most complex areas of API connectivity and compatibility with the existing Danish systems were prioritised in the PoC
• Important lessons learned about developer support and API documentation
— The overall experience was that the API documentation was not in a state ready for external developers at the time of the PoC project, and many hours were spend on error finding
— Ad hoc developer conferences were very effective in getting answers to important questions and missing information, but they took time to arrange and caused delays
• The agile approach and close collaboration between vendor and DKMA enabled a fast and flexible development and allowed technical issues to be escalated to the platform developers in a timely manner
Learnings
@WEBRADR #WEBRADR2020
Question and answer
Phil Tregunno, MHRA
@WEBRADR #WEBRADR2020
Concluding remarks
Next steps
@WEBRADR
Thank you for joining
Contact email: WEB-RADR@mhra.gov.uk
WEB-RADR website: https://web-radr.eu/
Webinar recording available on WEB-RADR website Events page:
https://web-radr.eu/events/
@WEBRADR
#WEBRADR2020
Innovative Medicines InitiativeWEB-RADR 2
Stakeholder-focused webinars
@WEBRADR #WEBRADR2020