Social Media & AER2nd Annual Pharma Customer Experience Management Summit

About me

Piotr Wrzosinski is a sociologist and digital marketing professional with +10 years of experience in highly competitive and regulated industries including Pharma,

Tobacco and Finance.

After 5 years at Roche in Basel he just moved to UK to join Janssen, a Johnson & Johnson Pharmaceutical Company.

Follow me @pwrzosin Read more at k-message.com

Disclaimer:The content of this presentation is intended to provide only general information and comment on the topic. Although an author made his best effort to ensure that the information presented isaccurate he cannot and do not guarantee that the information is either. Do not, under anycircumstances, rely on information from this presentation as legal advice.

The most frustrating part of the treatment experience

2ndposition

4 criteria for AER

IdentifiablePatient

IdentifiableReporter

SpecificMedication

AdverseEvent

Reporting rules

USA

• Postmarketing Safety Reporting Requirements for Drug and Biologic Products

• FAERS

EU

Pharmacovigilance guidelines in Vol. 9 of „The rules governing medicinal products in the European Union”

• http://www.adrreports.eu/

Occurence in Online Space

500

494

100

56

4

1

• 500 messages analysed

• 494 with identifiable patient

• 100 with specific medication

• 56 with identifiable reporter

• 4 messages with AE+patient+medication

• Only 1 message met all 4 criteriato be reported

Source: Nielsen, Melissa Davies, Listening to Consumers in a Highly Regulated Environment, August 2008

Occurence in Online Space

Of those only 1 in 7 have identifiable Name and Contact Info needed.

Only 0.3% of brand mentions actually discusses reportable AEs

Only 5% of brand mentions contains AE related keywords

Total number of reportable AEs averaged 3 per brand

For 30 days worth of data collected on 224 brands totaling over 257,000 posts

Source: Adverse Event Reporting in Social Media, Visible Technologies

Occurence in Online Space

A 2014 study, funded by the FDA and involving Epidemico

6.9 million Twitter posts

4,401 tweets that resembled an ADR.

High concordance between the data across organ classes with data held by the FDA

Source: Freifeld CC, Brownstein JS, Menone CM et al. Digital drug safety surveillance: monitoring pharmaceutical products in Twitter. Drug Safety 2014;37:343–350.

Regulators Activities

USA

• FDA’s Sources Sought Notice for Use of Social Media

EU

• EMA’s IMI WEB-RADR

• Demo

How to catch them?

Geo + language targeting for the

market AND

Brand name + variations AND

First person indication (I, me, we, my, our) AND

Relevant AE terms(headache, rash,

fever, pain, vomitting…)

Resulting list generated every 24 hrs, to be reviewed by Brand Team/Drug Safety Officer

Correcting Independent 3rd-Party Misinformation• The correction of misinformation is a voluntary activity • If a firm corrects misinformation in a truthful and non-misleading manner

per the guidance, FDA does not intend to object if appropriate corrective information does not satisfy otherwise applicable regulatory requirements regarding labeling or advertising (if any)

• Firms may contact the author of the misinformation and provide the information to author, request the misinformation be removed, or ask the author to allow comments to be posted

• Firms may contact the site administrator and request the misinformation be removed or allow comments to be posted

• Firms are not accountable if a third party declines to post corrective information or remove misinformation

• Firms may provide contact information for the firm (e.g. Medical Affairs)

Source: FDA’s Social Media Guidance Webinar – July 10, 2014

Outcome?

• Full regulatory compliance

• Better drug safety

• Improved treatment adherence

• Improved customer experience

Thank you!

Piotr Wrzosiński

@pwrzosin

http://www.k-message.com