Impact of Social Media adverse event reporting

Impact of social media on adverse event reporting

Example: Potential Copaxone AE cases on patientslikeme

By SiljaChouquet
Owner and managing director of whydot

Basel, April 21st, 2009

-1-

Capturing AEs via online communities will help to
increase patient safety
Patientlikeme rationale for reporting AEs
Definition of Adverse Event (AE)
“Patients like you are becoming more and
An adverse event is any undesirable
experience associated with the use of a more influential in their treatment decisions. No
medical product in a patient. The event is longer are you simply consumers of
serious and should be reported when the pharmaceuticals and medical products, you
patient outcome is: are customers. In this emerging world, you
•Death have become better educated about your
•Life-Threatening treatment options, the risk and benefits of
•Hospitalization (initial or prolonged) different treatments, and your overall quality of
•Disability health. Now you have the opportunity to tell
•Congenital Anomaly. the FDA if you’ve had an adverse event.”
•Requires Intervention to Prevent
Permanent Impairment or Damage David S. Williams III
Founding Executive, Marketing and Business
Development
Patientslikeme
• FDA estimates that AEs are currently under reported with only 10% of serious and
2-4% of non-serious AEs getting captured
 Is the systematic reporting of AEs via online communities going to improve
the amount and quality of cases reported?
Source: www.fda.gov,, http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/
whydotpharma presentation – www.whydotpharma.com
-2-

Copaxone number one MS treatment on patientslikeme

Top 5 prescription drugs in patientslikeme MS community
n= number of patients

Copaxone 2129

Baclofen 1413

Gabapentin 903

Avonex 820

Provigil 757

0 500 1000 1500 2000 2500

 Therefore, used Copaxone as example to analyze impact on number
and type of potential AEs

Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/

Majority of Copaxone AE cases in FDA database
have been reported by patients
Example
63% of AE cases Copaxone
are
# of Copaxone cases reported in FDA database by …
currentlyreported
by patients N= 2854
2000 1788

1500
# of Cases

822
1000

500
110
100 89
38 12 4
3
0
Representative

Professional

Study
Literature

User Facility
Distributor

Other
Consumer

Foreign
Company

Health

Source: fdablecopaxone AE report


Currently patients report mainly via pharma and HCPs

HCPs

HCPsreport AEs on
a voluntary* basis
to the appropriate
source, most often
regulatory responsibility for
Patient the manufacturer.
ensuring the safety of all
marketed medical products.
Patient experiences
adverse event
(AEs)

Pharma
Source:http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und *Note: AE reporting by an individual Healthcare
professional is voluntary, except for specified vaccines **as well as distributors of FDA approved pharmaceuticals (drugs and
biologics) and medical devices, plus pharmaceutical packers and device user facilities
5

Patientslikeme opens up a new “AE reporting channel”
for patients
Will FDA require
pharma to
collaboratewith site on
AE reporting?

How
HCPs
willphysiciansreact to
patients
reportingAEs?

Patient Pharma
Patient experiences
adverse event (AEs)

helps patients submit treatment-
related AEs directly to the FDA
through their site.
Source: http://blog.patientslikeme.com/2009/04/15/patientslikeme-offers-adverse-event-reporting-for-ms-patients/
6

Patientslikeme has more patients on Copaxone
than the product’s label data
Number of patients on Copaxone Example
(glatiramer acetate) Copaxone

2129
Patientslikeme 1601 528

Discont’d
Currently treated

Label 900

0 500 1000 1500 2000 2500
• AEs in Copaxone label based on data from 900 patients, but 2129
patientslikeme members have taken the product
 Will the data captured in patientslikeme impact the current label?
Source: http://www.patientslikeme.com/multiple-sclerosis/treatments/show/823-copaxone, Copaxonelable,
http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und

Potentially, reporting via patientslikeme could
increase AE cases by up to 23% for Copaxone
Number of Copaxone (glatiramer acetate) AE cases Example
Copaxone
4000
3521
3500
484-667* potential
additional AE cases=
3000
17-23%* increase
2500

Patientslikeme
2000
Moderate SE on treatment
1500 2854
Severe SE on treatment
1000
Discontinuation due to sever SE
500

0 Current FDA database
Number of Adverse events

 How is a sudden 23% increase of AE cases going to be perceived by FDA?
http://www.fda.gov/medwatch/articles/medcont/postrep.htm#und *Note: not sure whether discontinued patients were counted in
side-effect analysis

A potential 7% increase of cases could come from
patients thatdiscontinuedtreatment due to severeSEs
Example
Copaxone
2129

•Currently, 2854 CopaxonerelatedAEs have been reported to FDA
•36% or 198 of Copaxone patients on patientslikemediscontinued due to
severesideeffects, representing a potential 7% increase in reportable AEs

Another 16% increase of AEs could come from severe
and moderate side-effects reported by patients
Example
Copaxone

Side effects captured by patients in
patientslikeme community
• 22% of Copaxonepatientslikeme
members report severe or
moderate side-effects
• If severe side-effects can be seen
as a proxy for serious AEs, while
moderate side-effects can be taken
as a proxy for non-serious AEs

•Please note that only 299 out of 2129 patients on Copaxone within patientslikeme
community chose to disclose details about their side effects, percentages were
then applied to entire Copaxonepatientlikeme population

10

Open questions on impact

• Under reporting: Actual increase in AE cases reported dependent on
transformation rate of severe and moderate side-effects to a reported AE.
How many AE cases will patients report, especially the non-serious ones?

• Biases: patientlikeme population might not be representative of total patient
population
Are inherent biases in patientlikeme population (ie. Age, educational level
etc.) likely to skew the AE reported?

• Clinical impact: new AE cases reported might reveal new or more reactions
than currently captured
Will increase of AE cases have an impact on Copaxone current label?
Are patients going to report reactions currently not part of label?
Are they going to report more on certain reactions vs. others?


What does this mean for pharma?

• For right now, only one social media online community is reporting AEs, but
many more will follow, if patientslikeme pilot is successful
Set up social media monitoring now to find out about side-effects and
AEs discussed online

• If large number of online communities start to report AEs, FDA might turn to
Pharma to
• check AEs for accuracy and quality as it done for HCPs reported events
• evaluate impact and need for follow up studies

Be proactive and start setting up processes to deal with FDA request
Get data on how many of your patients are active in online
communities and what the potential impact could be
Talk to online communities and FDA about potential implications of
patient-driven AE reporting

Contact

SiljaChouquet
Owner and managing director of whydot GmbH
Bloggerwhydotpharma

E-mail: siljachouquet@whydot.net


Impact of Social Media adverse event reporting

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Impact of Social Media adverse event reporting