The Increasing PV Obligations of Scientific Literature

Scientific literature is a significant source of information for the monitoring of the safety profile of medicinal products, particularly in relation to the detection of new safety signals or emerging safety issues.

With global regulations constantly shifting and with the level of scientific literature progressively increasing, pharmacovigilance teams are under continued pressure to create literature strategies that are both comprehensive and flexible. Therefore, establishing the right process from the outset is fundamental to ensure that compliance deliverables are met.

5 points to consider when developing a literature review process:

1. Where to look for scientific literature?

The type of medicinal product (drug, medical device) should determine what type of database to use however, most well-known databases such as Medline or Embase cover most scientific and medical journals.

2. How to develop a scientific literature strategy?

Author abstracts are not always consistent in the choice of words relating to pharmacovigilance concepts thus, applying a search strategy will help to eliminate background noise, giving focus to scientific publications that are most relevant to pharmacovigilance. It is important to know your product and what you are trying to achieve; the highest recall for a search would be to enter the medicinal product name and active substance name (in all their variants) only. In practice, additional text can be added to increase precision. It is always good practice to retain a record of the search construction, the database used and the date the search was run.

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3. Creating a scientific literature process

Following a decision on the type of database to be used and the search strategy,  consideration should be given to the details of the literature process such as;

  • the screening process,
  • implementing quality review checks to ensure that the primary reviewer is identifying the relevant articles,
  • storage systems such as repositories,
  • methods for the ordering of full articles, and
  • the management of translations.

Once a process has been established it should be clearly outlined in an SOP.

4. Carrying out a testing phase

Initial testing should be conducted to check that relevant records are not omitted. Term selection should be relevant to the database used and the subject of the search and/or medicinal product. Recorded confirmation that the search results have been tested will assist in demonstrating that there is a systematic approach to collecting information about suspected adverse reactions from literature sources.

5. Are your staff trained appropriately?

It is expected that the person reviewing the results of a search is trained to identify articles of relevance. A common issue in selecting relevant articles from the results of a search is that often this process is conducted for the purposes of identification of ICSRs only. Whereas the review should also be used for collating articles of safety information, for example, to support PSURs.

Having an appropriately trained team will mitigate the risk of missing important information.

As literature is the one of the largest sources available for the collection of safety information it is crucial that careful planning is allotted to the development of an adequate process.

If you would like to speak to us about issues relating to scientific literature or seek our advice then call us on 00353 52 61 76706, email us: info@acornregulatory.com or complete the form below and we will get back to you.

About the author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
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