© 2010 Creation Healthcare creation.co 1

Creation Healthcare Research

Reportable Adverse Events on the Worldwide Web

October 2010

PREVIEW EDITION: EXECUTIVE SUMMARY EXTRACT ONLY

This copy requires no license

© 2010 Creation Healthcare creation.co 2

Contributors

This report was produced thanks to contributions and long-distance collaboration from some of

Creation Healthcare’s international consultant team*.

Each consultant has knowledge of the regulatory intricacies of their local and surrounding area,

combined with an understanding of online trends and emerging social technologies. This unique

balance and international reach enables Creation Healthcare to deliver strategic recommendations

to the world’s largest global Pharmaceutical Companies

Alan Bowden Australia

Daniel Ghinn United Kingdom

Florence Suprin the Netherlands

Kathi Apostolidis Greece

Maria Öst Sweden

Paul Grant United Kingdom

Pedro L. González Spain

Sanjay Motivaras United Kingdom

Stevce Acevski Macedonia

*Creation Healthcare also has consultants in many other countries around the world.

©2010 Creation Healthcare. All rights reserved.

Cover image ©2008 Leigh Schindler - iStockPhoto

The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever

on the part of Creation Healthcare concerning the legal status of any country, territory, city or area or of its authorities, or concerning the

delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full

agreement.

The mention of specific companies or of certain manufacturers' products does not imply that they are endorsed or recommended by

Creation Healthcare in preference to others of a similar nature that are not mentioned. Brand or company names may be registered as

trademarks in one or more International territories, and are consequently shown without a ™or ® to avoid confusion.

Creation Healthcare does not warrant that the information contained in this publication is complete and correct and shall not be liable for

any damages incurred as a result of its use.

Creation Healthcare is the trading name of Creation Interactive Limited, a company registered in England. Registered number 3543711.

Registered office at Southcotte, Willington Street, Maidstone, Kent ME15 8ES, United Kingdom.

© 2010 Creation Healthcare creation.co 3

Contents 1. Foreword ......................................................................................................................................... 4

2. Executive summary ......................................................................................................................... 6

2.1. Key insights ............................................................................................................................. 6

2.2. Conclusion ............................................................................................................................... 7

3. Background ..................................................................................................................................... 8

3.1. Historical importance .............................................................................................................. 8

3.2. Definition ................................................................................................................................ 8

3.3. Guidelines for pharmaceutical reporting ................................................................................ 9

3.4. Impact of online conversation .............................................................................................. 10

3.5. Relevance for pharmaceutical companies ............................................................................ 10

4. Research ........................................................................................................................................ 11

4.1. About the study .................................................................................................................... 11

4.1.1. Rationale ....................................................................................................................... 11

4.1.2. Intent ............................................................................................................................. 11

4.1.3. Scope ............................................................................................................................. 12

4.1.4. Considerations .............................................................................................................. 13

4.2. Findings ................................................................................................................................. 14

4.2.1. Unfiltered drug ‘mentions’............................................................................................ 14

4.2.2. Channels and platforms for conversation ..................................................................... 20

4.2.3. Cardiovascular drug mentions online ........................................................................... 22

4.2.4. Other therapy areas ...................................................................................................... 32

5. What this means for healthcare engagement .............................................................................. 42

6. Further information ...................................................................................................................... 45

6.1. Methodology ......................................................................................................................... 45

6.2. Abbreviations ........................................................................................................................ 49

6.3. Regulatory reporting systems around the world .................................................................. 50

6.4. About Creation Healthcare ................................................................................................... 73

6.5. Global contacts ..................................................................................................................... 74

6.6. References ............................................................................................................................ 75

© 2010 Creation Healthcare creation.co 4

1. Foreword If you are a professional in pharmaceutical marketing and communications, or

in a medical role, you may relate to the dilemma faced by many in your shoes.

On the one hand, thanks to the Internet a wealth of information is readily

available about the experiences of individual patients taking medicines, which

could inform product development and potentially provide early warning of

product or patient safety concerns; on the other, for product marketers the

risk of creating a pharmacovigilance crisis if a high number of potentially

reportable adverse events are discovered.

Indeed, you may ask yourself, “In the increasingly-unpredictable world of the

Internet, who would dare engage in conversations with patients online?”

But is the Internet really such an unpredictable environment? What if it were possible to predict the

relative likelihood of discovering potentially reportable adverse events between conversations

taking place in different territories, or in different languages? What if the likelihood of discovering a

potentially reportable adverse event could be compared between therapy areas, or even between

individual drugs? For a single product, could it be possible to identify where in the world the greatest

likelihood of discovering a potentially reportable adverse event online is? Amongst social media

channels like Twitter or blogs, what if it were possible to even know which channels would be most

likely to reveal a potentially reportable adverse event for a particular product?

The document you are about to read demonstrates that all this is possible. And in setting out to

determine whether it was possible to compare countries, languages, platforms, therapy areas and

individual drugs, a wealth of additional insights have been discovered.

I believe that this report, the product of a research team of nine specialists based in seven countries,

is the most comprehensive study carried out to date into drug side effects mentioned by Internet

users. Until now, nobody has carried out such a proactive and detailed study.

This report does not answer all the questions. In fact, it raises some very important new questions.

But what I hope it does do is to move the conversation on, from the avoidance of social media and

two-way digital engagement because of perceived pharmacovigilance risks, to a better-informed

discussion about the role of social media in pharmaceutical and medical communications and

marketing.

I hope that in reading this report, you will be as inspired as I have been by the insights it reveals. And

I hope these insights equip you to embrace the potential of emerging channels in your

communications, marketing or medical information strategies.

Daniel Ghinn

Director of Digital Engagement & Co-Founder, Creation Healthcare

© 2010 Creation Healthcare creation.co 5

The rapidly evolving face of Internet communication is impacting the

pharmaceutical and healthcare industry in unforeseen ways. This dynamic

environment is in a permanent state of flux; presenting opportunities for

innovation, and yet uncovering challenges to established models for

communication within regulatory guidelines.

One of the most cited barriers to two-way engagement is the threat of

unprecedented demands and resource requirements upon pharmacovigilance

and regulatory teams caused by reports of adverse effects.

Enthusiasts and advocates for social media in healthcare have championed the

case for engagement and dismissed these challenges; yet very little published work attempts to

quantify the variations which do occur internationally, by language, and by therapy area for which

the targeted communication is planned.

Rather than speculate, Creation Healthcare has sought to better understand these variations

through this research project; so as to provide informed consultancy services to our global clients

who are embracing ‘healthcare engagement in a digital world’.

I truly hope that within this document there are thought ‘triggers’ and key concepts which will help

you in your real-world role; that this report may unlock new perspectives on how to engage with the

empowered people of this new age, as we all seek information about one of our most valuable

personal assets – our health and wellness.

Paul R. Grant

Head of Strategy Implementation, Creation Healthcare

© 2010 Creation Healthcare creation.co 6

2. Executive summary Creation Healthcare is a global, research-led healthcare engagement strategy consultancy with a

team of experts in 15 countries providing local insights to shape strategies worldwide.

The company is committed to understanding the differences between cultures, languages, and

countries, so that the consultant team can be better equipped to help clients to develop long-lasting

local and global strategies.

During August and September 2010, nine members of Creation Healthcare’s consultant team

collaborated to better understand the relative volumes and differences in the way that drugs and

their active ingredients are discussed on the Worldwide Web. Studying a single week of ‘online

discussion’ from July 2010, the team looked at ten major therapy areas, at five major branded

products in the biggest therapy area (by sales revenue), and then created a detailed analysis of the

number one product (by sales revenue) including generic and localized names for that product.

In particular, the research was focused on discovering key insights about a subset of information

that contained a brand name or active ingredient, plus a ‘side effect’, and also contained language

which might indicate a personal experience from the author. These so-called ‘potentially reportable

adverse events’ were the basis of comparative analysis, indicating possible variations and trends

which can affect “Reportable Adverse Events on the Worldwide Web”.

2.1. Key insights

Within the context of the research scope:

‘Spam’ placed on websites, commenting facilities, forums, and in social media accounts for

more than 80% of all mentions of brands

Without significant news events inflating results, there are less than 1000 brand or

ingredient mentions in a week throughout the entire world

The top Cardiovascular drug has an average of 165 mentions per day across the entire world

– including brand names, name derivatives, and active ingredients

Where identifiable the majority of online drug mentions (81%) are in English

Micro blogs and websites tend to be more reactive to news items than other conversational

channels including Forums, Blogs, and Social Networks

Generic or localized versions of a product name have numerous additional names which can

make monitoring more complex

A relatively low volume of mentions for one territory may in fact produce a high volume for

the other territory, due to the particular idiosyncrasies of each

Across five cardiovascular drugs, the number of side effects mentions ranges from 15%

through to 47% of the total mentions

For a top-selling cardiovascular drug, approximately 3.5% of all mentions internationally may

contain a potentially reportable adverse event

Less than 3.5% of all mentions for the top-selling cardiovascular drug would actually contain

all elements to create an adverse event report

Side effects mentions versus the number of brand/active ingredient name mentions for ten

therapy areas, varies between 14-42%.

© 2010 Creation Healthcare creation.co 7

Conversations most likely to produce a potentially reportable adverse event will be generally

found in a forum or message board

Communities have a high concentration of results which contain mentions of side effects

The level of intimacy for a platform is often a precursor for the depth of personal

information that may be shared about an individual

Twitter tends to have superficial conversation which rarely contains enough of the requisites

for a reportable adverse event

Micro blogging channels can contain all of the requisites of a reportable adverse event, if

monitored with a full historical ‘lifestream’ context

An individual and identifiable ‘lifestream’ can contain evidence of adverse events – even if

not all within the same post, comment, or blog entry

Whether a social media conversation is likely to contain a reportable adverse event depends

on the therapy area and the context

Any two-way engagement through online channels should consider the expected volume of

conversation for that therapy area

There are variations in the prevalence of potentially reportable adverse events online by

therapy, platform, country, and language.

Within a therapy area there are variations in the prevalence of potentially reportable

adverse events online by brand name, by active ingredient, and language

A strategy which works well in one country or language could potentially have the opposite

effect in another

It is advisable to allocate resources based on the predicted volume of conversation – not the

volume of reports received

Social media monitoring tools and techniques are always improving and are being constantly

adjusted in response to the rapidly changing online landscape.

Pharmaceutical Companies can likewise embrace these landscape changes continuously and

wholeheartedly, seeking to know about and understand the online conversations that relate to their

products and brands.

With continued efforts from the World Health Organization and countries around the world,

together with advances in technology, it may soon be possible to improve and standardize systems

for reporting adverse events – embracing the rise of the ‘empowered patient’ as a participant in this

process.

Such efforts can only be beneficial for human health, for Pharmaceutical Companies through

improved efficiency, and for increasing the quality of information provision and healthcare

engagement online.

© 2010 Creation Healthcare creation.co 8

FULL Research & Insights Report NOW AVAILABLE Featuring additional insights launched at DigiPharm

Conference 2010, plus detailed data analysis.

In the full 75-page Research and Insights Report

you will discover:

• What kind of social media conversations are

likely to result in reportable adverse events?

• Are there variations in the prevalence of

reportable adverse events online by therapeutic

area, platform, country or language?

• How can pharmaceutical companies choose the

most effective digital engagement channels to

suit their approach to handling reportable

adverse events?

An extensive international study of potentially reportable

adverse event mentions amongst ten major therapy areas:

Anaemia • Arthritis • Asthma • Breast Cancer • Cardiovascular • Deep Vein Thrombosis •

Gastrointestinal • Mental Health • Osteoporosis • Type II Diabetes

Including the most comprehensive published analysis of social media brand mentions worldwide in

cardiovascular medicine that exists to date.

To purchase a copy of Reportable Adverse Events on the Worldwide Web Special Research and

Insights Report, or discuss its implications for you, contact:

Daniel Ghinn

+44 (0)207 849 3167

daniel.ghinn@creationhealthcare.com