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

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@WEBRADR #WEBRADR2020