WEB-RADR Use of mobile technologies and social media in - - PowerPoint PPT Presentation

Use of mobile technologies and social media in pharmacovigilance

WEB-RADR

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

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

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

WEB-RADR Consortium

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

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)

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

Feedback

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

What is the value of social media?

Massive volume of discussion & patient- reported

• utcomes

Expectatio n that someone is listening Unique stream

• f intelligence

that is not necessarily captured in

• ther data

sources Not intended to supplant traditional post-marketing surveillance 11

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

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.

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.

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.

Data flow: Dissemination

Social ¡Data ¡ Filtering ¡ Curation ¡ Dashboard ¡

• Aggregate and

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

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

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?

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

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
• f 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

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

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……

Thank you. Questions?

Email: Phil.Tregunno@mhra.gsi.gov.uk WEB-RADR@mhra.gsi.gov.uk Website: http://web-radr.eu Twitter: @WEBRADR