The determination of whether an ADR is or is not expected is not an exact science; there are many grey areas. A decision in many instances will have to be based on clinical evaluation of inadequate case information. Evaluation of expectedness will probably remain subject to high variability between assessors. …
As per regulatory authorities an adverse reaction will be unexpected unless it is mentioned in the appropriate reference safety information (RSI) document(s) for the drug. The purpose of RSI is, of course, not limited to the determination of expectedness. Apart from adverse events RSI document also contain the information about …
Gestational diabetes mellitus (GDM) is a type of diabetes that can develop during pregnancy in women who don’t already have diabetes. Gestational diabetes is affecting around 1 in 7 pregnancies worldwide, and can be associated with adverse outcomes for both mothers and babies. Causes: Gestational diabetes occurs when your body …
There are two principal criteria that control the priority for documenting, validating, evaluating and regulatory-reporting of ADR cases: seriousness and expectedness. The concept of expectedness refers to events that may or may not have previously been observed and documented. It does not refer to what might be anticipated (expected in …
Methotrexate is authorised for two different groups of indications, each with a different administration schedule: treatment of certain types of cancer of the breast, skin, head and neck, or lung for which the dosing frequency depends on the regimen and can involve daily administration of methotrexate; treatment of inflammatory diseases …
Once the adverse event report or case is received to safety team, the case is triaged and reviewed and the medically most important or “primary event” is chosen. The case will be sent for data entry. The received report will be reviewed and the terms which require coding with MedDRA …
To perform coding of individual cases for data entry, training in MedDRA is needed. MedDRA coding will be easy for people with a medical background as the knowledge on medical terminology is important for coding. Each person who handle safety reporting must be trained in MedDRA which will be taken …
Eszopiclone (Lunesta), zaleplon (Sonata), and zolpidem (Ambien, Ambien CR, Edluar, Intermezzo, Zolpimist) are some prescription medicines which are used to treat insomnia in adults who have difficulty falling asleep or staying asleep. FDA advised that with these medicines there were serious injuries including sleepwalking, sleep driving, and engaging in other …
On 15 Aug 2019, Pfizer issued the voluntarily recalling of migraine headache medicine RELPAX® (eletriptan hydrobromide) 40 mg tablets, lots AR5407 and CD4565, to the Patient level. Pfizer initiated this recall because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia. …
MedDRA (Medical Dictionary for Regulatory Activities) coding is a critical requirement in pharmacovigilance. MedDRA coding is a skill and in many cases medical judgments have to be made about how to code. So everyone should be trained in coding and up to date on the MSSO guidelines (https://www.meddra.org/training-materials). MedDRA Definition: …
