Handling of Safety

Information from Social Media

 RESPONSIBILITY

• Drug Safety Associate shall be responsible to

ensure the collection and follow-up with the team
who is handling social media accounts for the
MAH regularly and to communicate the safety
information (ADR related information irrespective
of valid, invalid, missing information etc.).
• Designated Pharmacovigilance (PV) associate
shall be responsible for the assessment of safety
information received.
 Collection of Data

• Designated team who is handling MAH social media accounts

will monitor social media accounts on weekly basis and
whenever safety information reported,
• information will be forwarded to the ICSR (Individual Case
Safety Reports) team over e-mail xxxxxx.
• Whenever Pharmacovigilance team receives the safety information,
designated drug safety associate will assess the data for validity
• Designate PV associate responsible for triage, collect this
information to proceed further i.e., for duplicate search and book-in
the case as per MAH SOP.
 Handling of data

• Any suspected adverse reactions from the

internet and digital media should be handled
as “spontaneous reports”.
 Country of incidence (COI):

• If the country of incidence is available in the

information posted by the user, by default it
should be captured. If the COI is missing, the
country where the information was collected
and reviewed (India) should be captured as
COI for processing in the Safety database.
  Initial Receipt Date (IRD):

• In case of valid cases, initial receipt date (IRD)

is the date when the information is posted on
any of the MAH owned social media platforms
will be considered as IRD.
    Reporter Information

•  If reporter details are available in the information posted by

the user,   consider that information as primary reporter,
capturing the reporter type as applicable (Ex: If reporter is a
doctor capture “Physician”, etc.) and consider user (who
posted the information) as secondary reporter capturing the
reporter type as “Other”.
• If reporter details are not available in the information posted by
the user, consider the user (who posted the information) itself
as primary reporter capturing reporter type as “Other” or
consumer (If specifically known).
    Source documents

• For valid cases, consider corresponding screenshots as source

documents and attach those in additional information tab of
respective cases.
    Follow up

• In case of any incomplete/additional information

required, initial contact with the reporter to be performed within
two working days from the date of the receipt of the AE. In the
absence of any response received, first follow-up shall be
made within two weeks after the initial communication (1st
follow up). A further follow-ups shall be done within another
two weeks. In case no further information is needed or no
response received then follow-up activity shall be considered
as closed.
     Frequency of screening

• The designated MAH social media team will screen the social media
websites weekly once & the same to be informed to PV team,
accordingly.
     MAH Social Media Accounts

Sr No            Social Media Name

1 Facebook

2 Twitter

3 Linkedin

4 You tube

5 Instagram
     Compliance

• Monthly reconciliation of social media cases will

be checked in the first week of every month and
document accordingly.
 Reference

• GVP - Module VI    - Collection, management

and submission of reports of   suspected
adverse reactions to medicinal products
• Pharmacovigilance guidance document for
MAHs of Pharmaceutical products module 2 -
Collection, processing & reporting of ICSR