Safety Information From Spontaneous and Literature Adverse Reaction Reports: A Comparison

Therapeutic Innovation & Regulatory Science
Janine KloseAxel Nolting

Abstract

Marketing authorization holders should report adverse drug reactions (ADRs) derived from spontaneous case reports and literature for their medicinal products to competent authorities. Yet the difference in quality of data from both sources has never been analyzed. To this end, YES Pharmaceutical Development Services in cooperation with the German Medicines Manufacturers Association has conducted an analysis examining more than 25,100 spontaneous and literature cases that occurred between 2007 and 2008. Reporting rates of ADRs for specific drug substances (DSs), expectedness, and the system organ class (SOC) referred to were examined. It was found that the distribution of ADRs to specific SOCs differs between both groups for selected DSs. For more than 37% of the DSs being evaluated, a difference of 10% or more regarding reporting rates of unexpected ADRs was observed between both groups. These findings underline the substantial importance of regular literature reviews in addition to the spontaneous reporting system for a sufficient safety assessment of medicinal products.

References

Sep 20, 1997·British Journal of Clinical Pharmacology·F HaramburuY Moride
May 19, 2005·Journal of Cataract and Refractive Surgery·David F Chang, John R Campbell
Jul 29, 2005·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Frantz ThiessardBernard Bégaud
May 16, 2006·Pharmacoepidemiology and Drug Safety·Pascale Olivier, Jean-Louis Montastruc
May 2, 2007·Pharmacoepidemiology and Drug Safety·William N KellyUNKNOWN International Society of Pharmacovigilance
Jul 3, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Manfred Hauben
Sep 18, 2007·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Antoine ParienteNicholas Moore
Sep 11, 2009·British Journal of Clinical Pharmacology·Neda TavassoliUNKNOWN French Association of Regional Pharmacovigilance Centres
Aug 13, 2010·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Piero Impicciatore, Massimiliano Mucci
Jun 17, 2011·International Journal of Clinical Pharmacy·Eva KopečnáJana Mladá

❮ Previous
Next ❯

Citations

May 28, 2020·Wiener klinische Wochenschrift·Bartlomiej OchyraAdam Przybylkowski
Jun 5, 2014·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Helena PontesVictoria Rollason

❮ Previous
Next ❯

Software Mentioned

SPSS Statistics
mySQL
Vigilit

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.