Reply To: Literature review guidance

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#8047

Dear PIPA Member,

Thank you for posting your question regarding literature reviews.

Firstly, I would always recommend that the first source of information should be GVP VI – Collection, management and submission of reports of suspected adverse reactions to medicinal products (https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-good-pharmacovigilance-practices-gvp-module-vi-collection-management-submission-reports_en.pdf)

Regarding your question, which article is relevant and which is not? In literature remember, not only are you searching for Individual Case Safety Report (ICSRs), the review should also be used as a basis for collating articles for signal detection purposes including the Periodic Safety Update Report (PSUR).

In terms of relevance, you are looking for the below key criteria when assessing whether an article contains a valid ICSR, remember this acronym <u>PREP</u>:

  • Patient
  • Reporter
  • Event
  • Product

The lack of any of the four elements means that the case is considered incomplete and does not qualify for submission as ICSR however, this should still be recorded.

You are also searching for special situation reports which are of relevance also, these include:

  • Use of a medicinal product during pregnancy or breastfeeding
  • Use of a medicinal product in a paediatric or elderly population
  • Reports of overdose, abuse, misuse, medication error or occupational exposure
  • Lack of therapeutic efficacy
  • Off-label use

Please also refer to the UK Guidelines on Standards for Pharmacovigilance Departments – Post Marketing (Revised 2018).

As I am unsure what processes and systems you already have in place in your company, your company should have procedures in place to record and collate literature articles. These can be in the form of off the shelf literature recording systems (depending on the number of products you are reviewing as these can be quite costly) or spreadsheets. The spreadsheet should detail:

  • Title of the article/abstract
  • Author information
  • Country
  • Publication date
  • Valid / Invalid
  • Reason for validity / invalidity
  • Whether the full article needed to be requested
  • Who quality checked the article for relevance
  • Valid for ICSR submission
  • Valid for the PSUR
  • Valid for signal detection

Please note, the above list is an example and is not an exhaustive list.

The articles should be reviewed once weekly at a minimum from widely used systematic databases such as; PubMed/Embase etc.

There should be more than 1 person trained to search and review literature articles and relevant training should be recorded in the persons training record.

Please do refer to GVP VI as this module contains much more guidance regarding literature search, review and validation.

I do hope this answers your responses however, please do feel free to contact us for further information & guidance.

Kindest regards