SOP for Surveillance of Scientific and Medical Literature

PURPOSE

The scope of this SOP is routine surveillance of scientific and medical literature in accordance with applicable laws to detect adverse event case reports and other relevant drug safety information. This SOP begins with the establishment of search parameters and ends with the receipt of an article or abstract and finally reviewing for AE/PQC.

RESPONSIBILITY

The Qualified Person for Pharmacovigilance/Deputy QPPV shall be responsible for the surveillance of scientific and medical literature and further processing adverse events identified therein. As for any potential Safety Signal identified, the QPPV/Deputy QPPV shall process the event as per the SOP on Signal Detection and Risk Management.

No change in this SOP may be made without authority.

Introduction

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 signal or emerging safety issue.

Medical literature include;

Published abstracts or articles in medical/scientific journals
Unpublished manuscript involving case reports.
Important safety findings or clinical studies including posters, letters to the editors and associated communication from scientific meetings.

XYZ Industries the shall monitor scientific and medical literature and to report individual cases of suspected adverse reactions for medicinal products, for which it holds a Marketing Authorisation.

XYZ Industries Limited shall perform a:

Global literature search, through a systematic literature review of widely used reference databases (e.g., East Africa Medical Journal, Journal of infectious diseases and immunity, International journal of medicine and medical sciences).
Local literature search, in local journals in countries where the medicinal product has a Marketing Authorization.

The literature review includes literature on the benefit/risk profile of the product and not just individual cases of suspected adverse reactions (also referred to as individual case safety reports (ICSRs)). It shall also identify any emerging safety issues (ESI).

PROCEDURE

Consideration in identifying inclusion or exclusion of relevant databases;
The QPPV/Deputy QPPV shall on a monthly basis assess the available databases and the list of registered products plus those under registration for literature search. The following shall be used as a selection criterion to include a new data base or exclude an existing data base.

Accessibility: The data base should be readily accessible.
Coverage: The coverage of the database should be well defined i.e. global database or local database.
Focus/therapeutic area: The data base should be oriented towards a particular discipline or therapeutic area that XYZ Industries has a marketing authorization.
Overlap: The data base should not overlap with available databases being monitored by the QPPV/Deputy QPPV.
Updated list of registered products and those undergoing registration.