This is an overview of the Literatures in Pharmacovigilance. This presentation might helpful for the beginners in literature stream. this is not a detailed explanation of the literature case processing,

1. Overview of Literature in
Pharmacovigilance
Ch Satya NK M Pharmacy
Drug Safety Specialist II

2. The medical literature is a significant source of information for the monitoring of the safety profile and of the risk-
benefit balance of medicinal products, particularly in relation to the detection of new safety signals or emerging safety
issues.
How Where
Why
• Widely used reference databases e.g. Medline,
Excerpta Medica or Embase
• No less frequently than once a week.
Relevant published abstracts, case reports,
Letter to editors, abstratcs from meetings and
draft manuscripts, should be reviewed and
assessed.

3. Manual Search
When to start & stop
• Search would start from the date of submission of the application for the authorization.
• Searches should be conducted for all products with a marketing authorization, irrespective of commercial status.
• In case of product withdrawals from the market, literature search will continue till the last batch expiry date of the
marketed drug.
Search construction
Manual
Metformina and adverse events
Metformin
Metformin and adverse drug reactions
Automatic
Mail alerts weekly/daily

4. Validation criteria
Patient
Event
Reporter
Drug
Causality

5. • where ownership of the suspected medicinal product by the marketing authorization holder can be excluded on the basis of
the medicinal product name, active substance name, pharmaceutical form, batch number or route of administration.
• which originates in a country where a company holds a marketing authorization but has never commercialized the medicinal
product.
• which is based on an analysis from a competent authority database within the EU. However, the submission requirements
remain for those ICSRs which are based on the analysis from a competent authority database outside the EU.
• which refers to data from publicly available databases (e.g. poison control centres) and where the cases are presented in
aggregate tables or line listings. The submission requirement remains for valid cases described individually.
• which presents the results from post-authorisation studies, meta-analyses, or literature reviews.
• which describes suspected adverse reactions in a group of patients with a designated medicinal product and the patients
cannot be identified individually for creating valid ICSRs.
Validation criteria as per EMA

6. Validation criteria as per US FDA
• Reports of serious, unexpected adverse experiences described in the scientific literature should be submitted for
products that have the same active moiety.
• The above statement is an applicable event if the excipient, dosage forms, strengths, routes of administration, and
indications vary.
• All the expedited cases from the USA and foreign origin, need to be submitted.

7. Basic concepts
Day zero The day 0 is the day when an organization received literature article with minimum information
eligible for reporting The article received on 01-Jan-2022 as a abstract, which is not having any causality. Then for
the same article FTA received on 04-Jan-2022, which is meeting all the required criteria. Hence, we will consider
the date 04-Jan-2022 as IRD.
Primary Reporter A person will be mentioned as corresponding author, he/ she will be the point of contact
for any clarifications of queries on the information provided in literature article. In the absence of the
corresponding author, primary author will be the primary reporter
Country of incidence generally, author country will be consider as case country, unless it was clearly
mentioned in the report.

8. Journal Name
Citation
Type of
the report
Authors
Corresponding
Authors
Tittle
Different sections of the article

9. Literature search using standard databases like
PUBMED, Springer or any other database
Validate the article
Patient, Event, Reporter, Drug, Causality
Valid for ICSR
Invalid for ICSR
Need FTA or Translation
to validate
Process the case & submit
English article or FTA
Kee the record with the
proper invalid reason
*FTA- Full text article
Basic workflow
revalidation
Yes
No

10. References
1. GVP Module VI – Collection, management and submission of reports of suspected adverse reactions to medicinal
products (Rev 2)
2. Guidance for Industry Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines

11. THANK YOU
Note
This presentation is intended to give you an overview of the literatures in PV.
If you feel something needs to be added or something needs to be corrected
please mail me @ chandalurisatya@gmail.com