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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 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
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 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
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……