Importance of literature screening
08 Jul 2018
Screening literature is not only a mandatory requirement for marketing authorisation holders (MAH) but it is also the major and important source of information related to drugs. Literature also provides more up to date information regarding the safety and efficacy of the drugs worldwide.
Literatures can be screen through any large international databases (e.g. Embase, Medline, PubMed) which covers a wide range of medical and scientific journals. MAH can refer one or more databases depending on the nature of molecules they hold and purpose of the literature screening. Important local journals published in countries in local language can also provide vital information regarding the drug and its safety.
Screening of literature includes collection, review, selection, documentation and archiving of literatures retrieved from global literature database or local scientific journals.
The aim of literature screening is to identify Individual case Reports (ICSR) and/or any new significant information from safety and efficacy studies (clinical, non-clinical and epidemiological) which is not covered by the current product labelling, and/or any variation from the known safety information on the product label by increase in the frequency of an already known adverse reaction or change in severity or specificity of an event or any safety information which is not consistent with the product label.
Literature articles which provide this new significant information related to safety and efficacy of the drugs forms the important part of a Aggregate report preparation and also provide the vital information to detect a new signal.
A search strategy needs to be defined to retrieve the relevant articles from the literature database. A search strategy can be kept broad including only drug names and synonyms to get the maximum articles for the drug from the literature database or it can be specific covering drug name and case reports or any special situation.
Selection of literature articles:
- Each literature article shall be reviewed for identification of ICSRs and other safety concerns. An article can be selected as an ICSR if it has four valid elements, like at least an identifiable reporter, an identifiable patient; at least one suspected adverse event and at least one suspect medicinal product/suspected substance.
- Selection of articles for ICSRs shall be based on the above point and the possibility that the event may be attributed with use of the suspected medicinal product. This may not always be apparent in the authors’ text but should be judged while reviewing the article. At least one causal relationship of drug with event should be indicated by author.
- After selecting the literature article as an ICSR attempt should be made to get the full article for the complete evaluation of case report.
- If the information from the full article is still not clear then author can be contacted to get the required information for the complete evaluation of the case report.
Selection of other relevant articles containing important safety information:
Any data which is not an ICSR, but contains significant new safety information from safety or efficacy studies (clinical, non-clinical and epidemiological) that is not already covered by the current product labelling shall be selected as an article of special interest.
Following are the few examples:
- Major safety findings from a newly completed non-clinical study, non-interventional post-authorisation study or of a clinical trial.
- Signal of a possible teratogen effect or of significant hazard to public health
- Safety issues arising from the signal of a possible teratogen effect, signal management activity or emerging from a new ICSR, and which impact on the risk-benefit balance of the medicinal product and/or have implications for public health
- Safety issues due to misinformation in the product information
- Marketing authorization withdrawal, non-renewal, revocation or suspension outside the EU for safety-related reasons
- Urgent safety restrictions or any Regulatory alerts (worldwide) have been reported
During routine literature review positive or negative findings shall be collected for the following, if relevant:
- Pregnancy outcomes (including termination) with no adverse events, drug/food interactions, lack of efficacy, asymptomatic overdose, abuse or misuse, medication error (no adverse events), occupational exposure, withdrawal symptoms, suspected transmission of an infectious agent via a medicinal product, use in the pediatric, elderly or organ-impaired populations, compassionate or named patient use, near misses, important non-clinical safety results, off-label use, class effects.
- Literature articles describing the use of a drug in special populations, including the use in pediatric, elderly or organ impaired patients should be selected as an article of Interest if the information in the article is not consistent with the product label. Any article containing potentially interesting information that occurred during off-label use should also be selected as an article of Interest.