Harnessing Social Media for Pharmacovigilance...Harnessing Social Media Monitoring for Pharmacovigilance Laura Calao Jean Christophe Lahary LexisNexis –The Information Specialists

Harnessing Social Media Monitoring for Pharmacovigilance

Laura Calao Jean Christophe Lahary

2LexisNexis – The Information Specialists

1. Pharmacovigilance in a nutshell

2. Social media monitoring and

pharmacovigilance

• Why take an interest?

• What are the concrete benefits?

3. Social media monitoring – Best practices

4. Questions & answers

Agenda


What is pharmacovigilance?

• Improving the care given to patients and patient management

•Keeping patients safe while using medication and during medical and paramedical procedures

Patients

•Protecting the health and safety of communities in the use of medicationPublic health

•Taking part in an assessment of the benefits, harmfulness, effectiveness and risks of medicinesRisk assessment

•Promoting knowledge and medical training and encouraging communication intended for (and between) healthcare professions and the general public

Communication

“the science and activities

related to the detection,

assessment, understanding

and prevention of adverse

drug effects or any other

possible drug-related

problems”

--WHO


1995: Founding of the EMA

2004: Regulation 726/2004

2010: Directive 2010/84/EU

2012: New European directive with

regulation 1235/2010 and directive

2010/84/EU

2016: Work on the role of social media and

the Internet

1963: First pharmacovigilance centre founded at the

16th assembly of the WHO

1906: Founding of the FDA

1938: Federal Food, Drug and Cosmetic Act

1962: Kefauver-Harris amendment

1997: Erice declaration

2014: Draft of the directive on social media

A strict regulatory framework


Intense pressure from the media


Examples for pharmaceutical market exits


5% of feedback comes from the patients

A subject that remains complex

• Globalisation of production, distribution and consumptionGlobalisation

• Uncontrolled sale of drugsE-commerce

• Change in practices and uses within societySafety and openness

• Promoting good practices and sharing of information between stakeholdersEducation

• Control of interactions and surveillanceDeveloping generic products

• Disparity in pharmacovigilance practicesEmerging countries

• New vigilance directivesSocial media


Social media monitoringWhat for?

What are the benefits?


Content created every 60 seconds


The Internet has changed our relationship with health

44% 43% 42% 40% 37% 36% 36%

40% 38% 35% 37% 35% 34% 35%

Positive

Negative

Care receivedat hospital/ medicalfacility

Experiencewithmedication/ treatment

Health insurercustomerservice

Specificdoctor, nurse, healthcareprovider

Cost of healthinsurance

Coverage by health insurer

Cost of care ata hospital/ healthcare provider

*Consumers responding likely or very likely to share an experience using social mediaN = 1060Source: PwC HRI Social Media Consumer Survey, 2012

Likelihood of sharing positive and negative health experiences via social media*


• Better knowledge of product benefits and risks

• Improved strategies for risk evaluation

• Faster identification and communication of potential risks

• Optimised communication in the event of a crisis, incorrect

information about a product or detection of potential risks

• Better educating healthcare professionals and customers

• Improving relations between pharmaceutical companies,

laboratories and patient communities

PV and SMM: similar bases


Actual conversations about what is being said of a brand,

a competitor, or even a treatment area or a drug.

Indirect and unguided conversations. Unlike in a

conventional study, nobody guides the conversation. It is

spontaneous.

Millions of opinions can be heard in real time. The

quantity of information available and the speed at which the

information is accessed will never be possible in

conventional studies.

It is possible to detect weak signals and track opinion-

formers, critics and whistle-blowers

Benefits compared to “conventional” sources of information


Social media monitoringChallenges and good practices to

apply


Understanding the working of Social Media Monitoring

USUAL

CONVERSATIONSQuestions, histories, crises,

products, services, events,

campaigns, disasters, etc.

SOCIAL

MEDIATOOLS

SOCIAL MEDIA MONITORING (SMM)

DASHBOARDFLOW OF ACTIVITY & CONVERSATIONS

EXTRACTION OF

INFORMATIONDATA AGGREGATION

ENHANCEMENT &

STANDARDISATION


CollectionWhich data? Which sources?

ProcessingWhich

technologies? What enhancement?

Analysis Which know-how?

Key stages to control


Use good expertise


Do not get your

sources wrong,

because your

conclusions will be

incorrect as well.

Monitoring Twitter is

not enough...

Go beyond known SM

Rheumatoid

arthritis

Diabetes


Summary of good practices

Monitor your regulatory environment1Look out for whistle-blowers and weak signals2Do not stop at automatic analyses3Pay attention to methodologies4Use good expertise and train up your providers5

Thank you for your attention

Laura CalaoLexisNexis

[email protected]

Jean Christophe LaharyLexisNexis

[email protected]

Documents

Harnessing Social Media for Pharmacovigilance...Harnessing Social Media Monitoring for Pharmacovigilance Laura Calao Jean Christophe Lahary LexisNexis –The Information Specialists