Literature
screening
General:
The
scientific and 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. Marketing authorisation holders are
therefore expected to maintain awareness of possible publications through a
systematic literature review of widely used reference databases (e.g. Medline,
Excerpta Medica or Embase) no less frequently than once a week.
MAH
should review the literature search results to identify both individual cases
which may qualify for expedited reporting and also safety studies which are
relevant to the safety profile of the medicinal product and need to be
discussed as part of the continuous review of safety data and should also be
included in the next PSUR.
Market
Authorization Holders:
During
implementation of new EU pharmacovigilance legislation by the EMA published on
the EMA website, the monitoring of selected medical literature for certain
active substances suppose to start in July 2012. Further information on the
start of this activity supposed to be communicated in 2013. The stakeholders
were consulted in due time on guidance for the conduct of the literature
monitoring activities. Until further notice MAHs should continue to report
cases they have identified from the literature.
1.
The process, including but not limited to how the search is done, the
database(s) used, and the periodicity of those searches describing the search
in the literature should be written in a procedure.
2.
Searches, on the marketed drug and active pharmaceutical ingredients, in
published literature should be performed on a regular basis.
3.
ADRs found during literature searches should be classified according to their
seriousness and expectedness. These assessments should be retained and be well
documented.
4.
ADR reports from the scientific and medical literature must be reported to
relevant Competent authorities as per the interim arrangements and GVP module
6.
5.
Results of the literature searches should be documented.
Process
Model of Literature Search for Drug Safety:
1.
Identify the drug.
2.
Check for alternate names of the drug. Using Micromedex, type in the drug name.
From the Integrated Index, click on Summary Documents and under Drug
Information, click on links that might say “List of Drugdex Tradename Products”
or “List of Martindale Tradename Products”. Martindale is especially good for
foreign drug names.
3.
Define the research setting and population in which the drug will be used.
4.
Consult reference or tertiary sources as a starting point. Tertiary sources are
usually summaries of available information in an understandable format
(reference sourcebooks, textbooks).
5.
Consult secondary sources for comprehensiveness and quality assurance.
Secondary sources are databases that index or abstract the primary literature
(bibliographies, reviews, indexing and abstracting services). Primary sources
are patents, conference papers, case reports, journal articles, correspondence,
and theses.
6.
Choose the most appropriate sources of evidence of safety/adverse effects.
7.
Create bibliography.
Specific
requirement from Netherlands MEB:
The
MEB and the Health Care Inspectorate do not define or list what publications
should be covered by local literature searches since this depends on the type
of product and its indication(s) for use (as well as on the geographic area).
It is not possible to produce one list of local literature that covers all
scenarios and products. A significant percentage of relevant articles that
appear in medical and scientific publications would be included in standard
global literature search databases e.g. Medline and Embase. In addition, there
are relevant local publications that are not included in Medline or Embase.
‘Standard’ local medical publications (for the Netherlands these include for
example Pharmaceutisch Weekblad, NtvG, Geneesmiddelenbulletin, Medisch Contact)
should always be included in your literature search strategy. Depending on the
product (e.g. herbal) and/or indication (e.g cardiovascular), other local
publications might be relevant as well. You are therefore advised to document
your rationale for ensuring that relevant local literature is included in your
literature surveillance strategy
Below
list of countries are few exceptions of reporting ICSRs:
UK
MHRA--- updates a spread sheet with list of literature reports that received.
Every MAH should review the spread sheet prior to submitting any ICSR to MHRA.
Italy----
Do not require to receive non-serious ICSRs published in literature
