Adverse Event Received Date vs. Adverse Event Onset Date (aka Event start date) vs. Case Received Date Many companies uses Oracle Argus version 8.1.2 do not enter Adverse Event Received date because the date entered for initial/follow-up is the date of AE onset. Details… (cont)
Individual Case Safety Reports (ICSRs) Every country has representative who reports Medicines’ side effects to World Health Organizations (WHO). Each side effect related “a drug” (aka Primary Suspect Drug) must be reported to WHO. Valid ISCR: A Case created in the Safety system that includes the following four (4) minimum data elements: 1. Product…
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Empirica Signal and Topics – What’s new in version 8.1.0.2 (difference between version 7.3.2 and 8.1.0.2) How to add Comment (aka Outcome) and Detail Comment (aka Disposition) under “Signal” tab?
Regression-Adjusted GPS Algorithm (RGPS) vs. Multi-item Gamma Poisson Shrinker (MGPS) RIR, ROR, MGPS, etc methods do not adjust for the effects of polypharmacy—patients taking multiple drugs at the same time, and that drugs for the same indication will show up in the same patient reports, creating confounding issues and other potential statistical biases. Hence, RGPS comes in.…
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Where to download JADER data? http://www.info.pmda.go.jp/fukusayoudb/CsvDownload.jsp Food and Drug Administration (FDA) vs. Pharmaceuticals and Medical Devices Agency (PMDA) Food and Drug Administration (FDA) Pharmaceuticals and Medical Devices Agency (PMDA) United States of America Japan CIOMS Started accepting electronic study data (estudy data) submissions, beginning October 2016 Since 1962 3.5 year transitional period
What is Pharmacovigilance aka Drug Safety? Yeah, that is not in the dictionary. Pharmacovigilance (PV) means, Medicine(s) to watch out. Per World Health Organization, it is “The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.” Why do Pharmaceutical companies do that ? As…
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FDA’s Adverse Event Reporting System (FAERS) Public Website https://fis.fda.gov/hub/ offers dashboard by Product Report Statistics Demographic Reaction Cases Listings For Vaccines, VAERS click here The Vaccine Adverse Event Reporting System (VAERS) About (cdc.gov)
European database of suspected adverse drug reaction reports Go to http://www.adrreports.eu/ Select language link. (Example for English: http://www.adrreports.eu/en/index.html) Select a Product or Substance (for example Viagra) The following screenshots shows list of ISCR received for all products ! (yes.. you heard me!) Cumulative list of Individual Cases (for All products till 30APR2017) Number of individual…
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FDA Adverse Event Reporting System (FAERS) FAERS is a database that contains information on adverse event and medication error reports submitted to FDA. It contains over 9 million reports of adverse events from 1969 to the present. How did FDA collected this data? Reporting of adverse events and medication errors by healthcare professionals and consumers…
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What is DILI? “Drug-induced”……liver damage. Liver is body’s waste collector. Waste from the medicine you consume would go to the Liver. What DILI would Cause: In the United States, drug-induced liver injury (DILI) is the most common cause of acute liver failure. It can occur due to ingestion of any therapeutic drug, herbal product, or…
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