Literature Safety Monitoring

Learn about the literature search and review process in Pharmacovigilance.
www.pubmed.gov
Search String:
DRUG NAME AND ('adverse drug reaction'/exp OR 'adverse drug reaction' OR 'drug overdose'/exp OR 'drug overdose' OR 'drug misuse'/exp OR 'drug misuse' OR 'drug abuse' OR 'substance abuse'/exp OR 'substance abuse' OR 'pregnancy'/exp OR 'pregnancy' OR 'drug efficacy'/exp OR 'drug efficacy' OR 'drug withdrawal'/exp OR 'drug withdrawal' OR 'drug tolerance'/exp OR 'drug tolerance' OR 'medication error'/exp OR 'medication error' OR 'death'/exp OR 'death' OR 'drug interaction'/exp OR 'drug interaction' OR 'carcinogenicity'/exp OR 'carcinogenicity' OR 'off label drug use'/exp OR 'off label drug use' OR 'occupational exposure'/exp OR 'occupational exposure' OR 'toxicity'/exp OR 'intoxication' OR 'drug contraindication'/exp OR 'drug contraindication' OR 'congenital disorder'/exp OR 'congenital disorder' OR 'drug treatment failure'/exp OR 'drug treatment failure' OR 'lactation'/exp OR 'lactation' OR 'case report'/exp OR 'case report' OR 'environmental exposure'/exp OR 'environmental exposure' OR 'treatment contraindication'/exp OR 'treatment contraindication')

[@chessgold8768]

great and very instructive sir.. thanks a lot..

[@avbviswanath]

Thanks for the videos, new scope of learning

[@anupreetkang3475]

Thanks so much for a detailed video on lit screening for ICSRs. Don't we consider a related/possible causality for a literature article to be valid along with the 4 min criteria?

[@VigiServeAcademy]

Yes, you can consider Author's causality

[@mudassirsheikh3970]

Thanks for your efforts and conviniance

[@Sanket_2202]

Thank you so much sir. It would really help in my interviews😃.

[@Praveenkumarvarungowda85]

Wonderful explanation of Literature screening... Thank you😊

[@YogeshJadhav-qm2zb]

Amazing video. So much of learning👍

[@jenisharon1076]

It was very informative sir.. Thank u so much..

[@riajuli3]

Very useful Thanks.

[@nitinpawar9182]

Need to understand the process for literature review for the product marketed in INDIA.
We are doing literature review through 2 website Indian Pharmacology and Dermatology sites

[@VigiServeAcademy]

There is no point if these are indexed journals. Look for grey literature or journals published by various organizations (e.g., colleges)

[@ksravanthi-ge3bg]

Thank you sir....

[@SandeepSingh-ci5cf]

Really Great lesson for Literature Triage, However This was only for ICSR, could you kindly make a lecture on the process of Literature Triage process for aggregate/PSUR.
Explain 10 Criteria points for PSUR triage.

[@VigiServeAcademy]

Thanks, Sandeep. Yes, we will consider this in the future.

[@0602ify]

For drugs that are on clinical trails, how do we do literature search? Using comparator drugs and what do we look for?

[@VigiServeAcademy]

You can even look for emerging safety issues with the class of drugs

[@ravitejasambu8533]

As per the USFDA guidelines we search with only the active ingredient irrespective of drug dose, dosage form and strength of the drug as you have covered only regarding the EU guidelines is it true sir

[@VigiServeAcademy]

yes, we have primarily covered the EU/EEA or the GVP VI guideline. The FDA guidelines (the document that talks about this briefly is still in draft) are not very clear in this regard and hence companies prefer a conservative approach.

[@prakash-xb8ck]

Very good session

[@parimalavaskula3706]

Can we have that ppt link for better understanding

[@VigiServeAcademy]

Unfortunately we cannot do that as per our organisation policy