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Use of mobile technologies and social media in pharmacovigilance WEB-RADR
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WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Jun 30, 2020

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Page 1: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Use of mobile technologies and social media in pharmacovigilance

WEB-RADR

Page 2: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Smartphones and mobile apps

•  1.75 billion smartphones in use worldwide

•  34.6 million in the UK

•  62% of UK adults have a smartphone

•  24% also have a tablet

•  1.3 million apps available for android users (1.2 million for iOS)

•  Around 6,000 health related apps

•  NHS has its own app store

Page 3: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Smartphones and mobile apps

•  2.6 billion smartphones in use worldwide

•  37.8 million in the UK

•  76% of UK adults have a smartphone

•  54% of households have a tablet

•  1.6 million apps available for android users (1.5 million for iOS)

•  Around 100,000 health related apps

•  NHS has its own app store

Page 4: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Social media

•  1.49 billion active Facebook users

•  1.3 billion on mobile devices

•  65% log on every day

•  35-54 largest age group

•  304 million active Twitter users

•  80% active on mobile

•  500 million tweets per day worldwide

Page 5: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

WEB-RADR Consortium

Page 6: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

High level aims and deliverables

•  Patient/ HCP needs analysis for mobile reporting and receipt of feedback during first year

•  Initial mobile app developed by April 2015; enhancement based on user feedback

throughout the project

•  Off the shelf package implementation guide and interface available by the end of the project

•  Novel techniques for identification of safety data and signal detection/ evaluation in social

media between throughout the project

•  Social media analysis platform for the whole pharmacovigilance community by project close

•  Surveillance and communications policies based on robust scientific evaluation of the tools

developed

App

Social media

Scientific impact evaluation & policy

Page 7: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Mobile Apps

•  UK App Launched in July by the Minister for Life Sciences

•  Uptake is free to users

•  Dutch and Croatian apps in development

•  Downloads: -  iOS: 1030

-  Android: 406 (as of 1st October 2015)

•  Reports: -  39 Received (as of 16th October 2015)

Page 8: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

User evaluation

•  Identifying barriers and facilitators for using mobile app -  To report ADRs

-  For accessing drug (safety) information

•  Segmenting target groups -  Patients: adolescents, orphan disease populations, elderly

-  Healthcare professionals

•  Targeted & differential app development

•  Validate in a range of settings -  Lab based

-  Clinical settings

-  Surveys

•  Comparison to patient notes

Page 9: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Feedback

Page 10: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Enhancement requests •  Unified login details •  Push notifications •  Enhancements to ADR details •  More news content •  Devices, Defects &

Counterfeits •  Additional Monitoring status •  All news option •  Minor tweaks

•  Barcode scanning

Page 11: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

What is the value of social media?

Massive volume of

discussion & patient-reported outcomes

Expectation that

someone is listening Unique stream

of intelligence that is not necessarily captured in other data sources

Not intended to supplant

traditional post-marketing

surveillance

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Page 12: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Social Media Monitoring Platform

•  Social media monitoring and analytics platform

•  Collects, aggregates, classifies and visualizes public content from social media platforms describing adverse drug events

•  Designed to support post-marketing drug safety surveillance

Page 13: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Data flow: Data acquisition

Social  Data  •  Public posts are

acquired from Facebook, Twitter and patient forums via Application Programming Interfaces (APIs), using medical product names as search terms.

Page 14: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Data flow: Filtering

•  An algorithm trained to recognize language that describes a possible adverse drug reaction classifies and filters the posts using a vernacular-to-regulatory dictionary.

Page 15: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Data flow: Curation

Social  Data  •  Human curation

further trains the classifier, improves symptom dictionary, ensures symptoms are attributed to appropriate product, and removes false positives.

Page 16: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Data flow: Dissemination

Social  Data   Filtering   Curation   Dashboard  •  Aggregate and

granular data are disseminated and visualized in an interactive, web-based dashboard.

Page 17: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Where are we now?

•  188 products identified: -  13 therapeutic areas

-  17 additional monitoring products

-  5 orphan drugs

-  15 biological medicines

•  Begun data collection: -  1,215,523 posts mentioning those products

-  1,189,534 removed using “spam” filters -  25,989 “meaningful mentions”

-  318 Proto-AEs

•  Initial dashboard developed

•  Gold standard reference set developed to enhance analytics

Page 18: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%
Page 19: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%
Page 20: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%
Page 21: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%
Page 22: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

What might we find?

•  Consortium keen for global applicability

•  Concordance with existing data?

•  What else can social media tell us -  Abuse?

-  Misuse?

-  Counterfeit?

•  Geo pharmacovigilance a possibility?

Page 23: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Scientific Impact evaluation

Essential Aim:

To determine whether novel media applications (apps and social media) add value to existing pharmacovigilance methodologies

•  Add information to the established safety profile of a medicine

•  Enable earlier detection of new signals

•  Reveal new patterns or trends in reporting

•  Provide a means for geo-pharmacovigilance

Page 24: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Communication

Desire

Response

•  Well understood that safety messages may not reach those need them in the timeframes desired -  Discussions with Healthcare professionals? -  Healthcare professional letters? -  Updates to product information? -  Online information?

•  Ability to put such messages directly in to the pockets of patients seems like a hugely powerful way to communication

•  Responsibility to test that messages to have the desired impact; impact of language used?

•  Need to assess the reaction of the public to receiving a response -  Via a mobile app?

-  Via Twitter?

-  Via Facebook?

•  Recommendations to be developed based on robust science, and relevant legal/ ethical considerations

Page 25: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

More Questions for Pharmacovigilance •  Who owns the data?

•  Legal and/or ethical responsibilities

•  Is consent needed?

•  What are the legal & ethical implications?

•  Do we listen only or intervene – when?

•  Health responsibility vs privacy

Page 26: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Summary

•  Traditional ADR reporting and signal management methods are changing

•  New technologies offer new possibilities

•  WEB-RADR seeks to investigate, develop tools and recommend policy

•  Watch this space……

Page 27: WEB-RADR - Pharmacovigilance...social media in pharmacovigilance WEB-RADR Smartphones and mobile apps • 1.75 billion smartphones in use worldwide • 34.6 million in the UK • 62%

Thank you. Questions? Email: [email protected]

[email protected]

Website: http://web-radr.eu

Twitter: @WEBRADR