The scientific and medical literature is an important source of information for the safety profile of medicinal products, especially in the detection of new safety signals or emerging safety issues (ESI).
What is the Difference Between Global and Local (non-indexed) Literature Screening?
Global literature screening is an activity that needs to be performed regularly in large biomedical databases that include the majority of scientific and medical journals. Articles retrieved during global literature searches can be written in any language.
Local Literature Screening (LLS) is performed by screening the journals which are not included in biomedical databases used during global literature screening. Those journals are considered non-indexed literature. Some countries have specialized local databases that help shorten the process of journal selection.
How to be compliant?
To stay compliant with different regulatory requirements worldwide, it is necessary to perform global, and in some countries local, biomedical literature screening to identify Individual Case Safety Reports (ICSRs) and any information that could impact the benefit-risk profile of the product, which includes new safety signals for emerging safety issues. The PrimeVigilance Global Literature Monitoring Team of more than 40 medical professionals and life-science experts currently screens over 750 unique INNs, and that number is constantly increasing. Our process is tracked and documented at every step to ensure quality and compliance with worldwide regulations. Leveraging the PrimeVigilance Global Literature Monitoring Service delivers costs benefits through our scale of operation and allows you to focus on other areas of your core business.
Global Literature Monitoring Team can help you with:
Selecting global biomedical databases to be used during Global Literature Screening (e.g., Medline, PubMed, Embase)
Developing unique search strategies which will be used for every single medicinal product
Systematically monitoring these databases for publications worldwide
Agreeing on the frequency of the searches
Record keeping – retaining the results from literature searches for an appropriate period.
Understanding and complying with the time deadlines that apply to Individual Case Safety Reports from Literature Screening.
Avoiding duplicate reporting of ICSRs from literature
Also, PrimeVigilance offers services of Local literature screening that includes:
Selecting relevant local (non-indexed) journals per country where the product is authorized (or propose local database if applicable)
Regular monitoring of selected sources and documenting the process
Maintaining records of regular local literature screening
Insights on regulatory requirements for screening of local literature (LLS)
Monitoring of Scientific and Medical Literature
PrimeVigilance operates a comprehensive Worldwide Pharmacovigilance Literature Screening Service as part of the company’s suite of drug safety services. Features include:
Conducting the searches via validated biomedical databases e.g. Medline, Embase
Review and initial assessment of abstracts and full-text articles for identification of potential ICSRs
Review and initial assessment of abstracts and full-text articles for identification of new safety signals (signal detection) or emerging safety issues for inclusion in various aggregate reports (e.g. PSUR) with focus on:
Pregnancy outcomes (including termination) with no adverse outcomes
Use in the pediatric population
Use in the elderly population
Compassionate supply named patient use
Lack of efficacy
Change in frequency of adverse drug reaction
Asymptomatic overdose, abuse, or misuse
Medication error where no adverse events occurred
Falsified medicinal product
Important non-clinical and clinical safety results.
Your service may be extended to full or part service, including:
Entry of identified cases into a validated safety database
Full medical review of ICSRs
Regulatory reporting of ICSRs
Signal Detection and Benefit-Risk analysis
Medical Assessment of safety issues
Why Choose PrimeVigilance For Pharmacovigilance Literature Screening Service?
The requirement to proactively screen the published medical and scientific literature as part of a pharmacovigilance system can be challenging, time-consuming, and resource-intensive. Search strategies are common during regulatory authority inspections, and the identification of ICSRs and safety information can be complex and challenging to evaluate.
The benefits of contracting PrimeVigilance to perform Global and Local Literature Screening are our experience and knowledge. PrimeVigilance has a dedicated team with over seven years of experience in literature monitoring adverse drug reactions for patient safety.
Our team will comprehensively manage literature screening requirements together with the support of PV Physicians – medical reviewers, specialized in literature screening, helping to identify important signals and provide benefit-risk comments on each literature reference.
In addition, PrimeVigilance utilizes an existing international network to establish screening of the local, non-indexed medical and scientific literature. Literature searches can be performed for purposes of signal evaluation or for identifying safety concerns for inclusion in PSUR.
References Guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report 21CFR314.80 Postmarketing reporting of adverse drug experiences