1. ONE Safety Patient Engagement – Website Enhancement Opportunity
June 2018
Beverly Harrison, Sr. Director and Head, Patient Support, GMO

2. Background and Objective of The Website Analysis
Company websites are a key communication channel for delivery of information to patients
Company websites could be used to educate patients about safety related topics, as well as to encourage patient AE reporting in an efficient and user friendly manner
Objective of the survey and analysis:
To survey what patient directed safety education and AE related information is available on biopharma company websites
To begin to reveal potential best practices

3. Website Analysis Approach
Company Selection:
The top 20 biopharma companies, as defined by 2017 global revenue, were selected to be surveyed
Method:
Patient AE reporting information and safety education pages were identified through Google searches with select key words and the company name (e.g. “Janssen side effect”, “Janssen patient safety”, “Janssen adverse events”)
Google searches were conducted from a US location
Company websites were also navigated from the links that emerged in the search results
Notes:
Global and US company webpages were analyzed, potentially introducing a US bias into the analysis
This analysis did not include how companies may list safety or AE information on product specific websites for patients
The relative ease of finding information on company websites was not a part of the analysis (this is an analysis of if the information exists or not, and what information is included)

4. Dedicated webpages with information for patient to report adverse event are common
17 of 20 companies surveyed have instructions for patients on how to report AEs on their websites
Roche, Biogen, and AbbVie do not have any publicly posted information about patients reporting AEs to the company
11 companies have dedicated AE reporting pages
Some include educational information on why AEs may occur, the importance of reporting, and how the company uses the information
Some of the companies make clear efforts to use patient friendly language
Some companies have interactive ‘portals’ that enable patients to enter information in a potentially easy-to-use, step wise manner
5 companies do this through their general ‘contact us’ page (including Janssen)
For many of these ‘contact us’ pages, the info for patient AE reporting is not easily identifiable (a sentence or 2 among paragraphs of text), and generally use more technical, less patient friendly language.
1 company (Merck) has patient AE reporting info on both a dedicated page, and on its contact-us page

5. Multiple companies have general patient safety education webpages
9 of 20 companies have a dedicated safety education webpage (or set of linked webpages)
All 9 companies explain the steps that they take in the development process, and in post marketing with PV, to evaluate and then track the safety of their products
8 companies include information about the dangers of counterfeit products, or link to pages on this topic
5 companies make apparent efforts to describe safety concepts in patient friendly language (laymen terms)
5 companies provide patient AE reporting information, or link to their dedicated AE reporting page from their safety education page

6. Detailed Findings and Examples

7. (1/2) Patient AE Reporting Information Website Survey
Company
Any contact info/ instructions for patient reporting AEs?
Through general ‘contact us’ page?
Through dedicated AE reporting web-page?
Modes of contact
Other Notes
Janssen
Yes
Yes (link) No
Phone
Also have downloadable .pdf with global contact info and s in addition to phone number
Pfizer
Links to Medicine Safety page, and has MedWatch info
Roche
N/A
Instruct patients to contact personal physician (link)
Merck
Also directs patients to product pages
Sanofi
Instructs to contact HCP, gives FDA MedWatch info, and Sanofi, with description of information to provide
BMS
Also have link to a global site that provides #s for Ex-us countries to report side effects
Bayer
Online portal
Explains what side effects/PV is, and then links to a portal to fill out select information in a step-by-step approach
GSK
, Phone
Describes how GSK takes seriously, and how use data. Lists the information to provide.
Novartis
Online portal,
Explains what a side effect is, and why you should report side effects.
Amgen
Describes what AEs are, gives MedWatch information in addition to phone #, and recommends what information to report

8. (2/2) Patient AE Reporting Information Website Survey
Company
Any contact info/ instructions for patient reporting AEs?
Through general ‘contact us’?
Through dedicated web-page?
Modes of contact
Other Notes
Shire
Yes
Yes (link) No
Not necessarily patient or HCP direct – just states ‘to report suspected side effects’ on corporate contact page
Biogen
N/A
Instructs patients to call your doctors, and/or to report to the FDA (link).
Gilead
Phone
Nothing more than provides a number to call to ‘report an adverse event’
Celgene
Online form, , Phone, mail
The most comprehensive out of any company in terms of number of available channels to report an AE
Novo Nordisk
Online form, Phone
Includes definition of side effect, and why you should report.
Eli Lilly
Provides both Lilly phone number and FDA MedWatch info
Teva
Online Form
General corporate contact page has form, in which AE reporting is an option to choose
AbbVie
No apparent information for Patient AE reporting
Astra - Zeneca
Online form
Boehringer Ingleheim

9. AE Reporting Page Examples1
Sanofi-Genzyme: Example of relative simplicity
Brief note encouraging patients/HCPs to report
Explains what a side effect/AE is
Gives steps to take if you are a patient that believes you are experiencing a side effect (first contact HCP)
Provides FDA MedWatch info as one avenue to report
Provides contact info for Sanofi-Genzyme with an overview of what information will be requested
Bayer: Advanced portal that may enhance user experience and intake efficiency
Explains why side effects may occur
Why capturing side effects post-approval is important
Ties together the importance of PV for Bayer and various stakeholders including patients
Relatively advanced intake portal for reported AEs 2

10. Sanofi-Genzyme Reporting Page (link)1
Sanofi-Genzyme Reporting Page (link)
Why collect side information
Explanation of what side effects/ AEs are
Instructions for contacting, and what may happen afterwards
Information to have ready when contacting about side effect/AE

11. Bayer Reporting Page (link) Portal (link)2
Bayer Reporting Page (link) Portal (link)
What side effects are, and why collect side effects/ AEs
Why important to Bayer, importance of stakeholder collaboration
Portal that takes you through in a stepwise manner to provide side effect information

12. (1/2) General Patient Safety Education Information Survey (non-product specific)
Company
Patient Safety Education Page(s)
Layman description of safety concepts
Education on steps the company takes/ activities performed for patient safety
Information about counterfeits on safety education page or linked
AE reporting info, or link to AE reporting pg?
Notes
Janssen No
Pfizer
Yes (link)
Yes
Also has information on disposing of unused medicines, and sharps disposal.
Roche
Roche has a significant amount of patient safety information – but notably does not encourage patients to report AEs
Merck
Lots of info, but relatively technical and not written in a very patient friendly manner. Provides AE reporting info directly.,
Sanofi
Some info on AE reporting page, but don’t consider to be at the same level as others
BMS
Bayer
Clean and interactive knowledge tour of the benefits and risk of drugs.
GSK
Novartis
Amgen
Lots of info, but relatively technical and not written in a very patient friendly manner.

13. (2/2) General Patient Safety Education Information Survey (non-product specific)
Company
Patient Safety Education Page(s)
Layman description of safety concepts
Education on steps the company takes/ activities performed for patient safety
Information about counterfeits on safety education page or linked
AE reporting info, or link to AE reporting pg?
Notes
Shire No
Biogen
Gilead
Do have counterfeiting information on website
Celgene
Novo Nordisk
Yes (link)
Yes
Eli Lilly
Teva
AbbVie
Astra - Zeneca
Don’t have webpage, but do have patient safety information in a downloadable PDF.
Boehringer Ingleheim

14. Patient Safety Education Website Examples1
Pfizer: A comprehensive patient safety education site
The pages breaks the information into sections. Topics include:
The patient role in drug safety (e.g. shared decision making)
Concept of benefit/risks
The steps taken to analyze drug safety in different phases of its life
The different stakeholders in safety
Information on how to dispose of unused medicines, sharps, and counterfeits
Bayer: A ‘knowledge tour’ educates patients about the benefits and risk of drugs
The knowledge tour covers B/R drug development. Topics include:
Overall concept of B/R, and the B/R of drugs are determined
Tips for patients for how to interpret the PI
How to react to statistics quoted about drugs by the media (‘risk literacy’
Warnings about changing doses/ splitting pills with out discussing with HCP/Pharmacist
What to do if you experience a side effect
Counterfeits 2

15. Pfizer Patient Safety Education Website (link)1
Pfizer Patient Safety Education Website (link)
Education information segmented into categories
Links to other topics and AE reporting pg.

16. Bayer’s home page to explain benefit-risk (link)2
Bayer’s home page to explain benefit-risk (link)
Bayer has multiple resources on its website, including an interactive ‘knowledge tour’, and a patient oriented series of PV education videos on YouTube. Video topics include:
What is PV?
How does PV work?
PV – You can help to improve patient safety
Bayer YouTube Videos
Bayer is an example of a peer who is actively positioning patients as partners with their safety activities

17. Bayer Patient Knowledge Tour About B/R (link)2
Bayer Patient Knowledge Tour About B/R (link)
Bayer’s ‘Knowledge Tour’ goes through various B/R related topics from the patient perspective, and is interactive through videos, downloadable education brochures, and ‘quizzes’