Table of Contents
What is a suspect drug?
A suspect drug is the drug associated with the ADR as determined by the initial reporter.[7] The associate needs to code the company drugs in company product dictionary and the noncompany drugs in the WHO Drug Dictionary (WHO DD).
What is considered a concomitant medication?
Concomitant medications (a.k.a., con-meds) are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation. Con-meds may be used by study subjects for the same indication as the study or for other indications.
What are con meds?
Concomitant medications (con-meds) are any prescription or over-the-counter drugs and. supplements taken in addition to an investigational therapy by a study subject. Many study protocols require capturing con-med usage into subject’s study record.
What does concomitant use mean?
: accompanying especially in a subordinate or incidental way. concomitant. noun. con·com·i·tant | \ kən-ˈkä-mə-tənt , kän- \ Definition of concomitant (Entry 2 of 2)
What is pharmacovigilance case?
In pharmacovigilance, case processing is the fundamental activity that provides data for the analysis of adverse effects that allows to detect new safety concerns and to periodically assess the benefit to risk ratio associated with the use of a pharmaceutical product.
When should a drug be classified as concomitant?
Concomitant drugs in medicine This designation is used when medicinal drugs are given either at the same time or almost at the same time. This is often the case in medicine.
What is a concomitant procedure?
The Many Definitions of Concomitant Surgery. The topic of multiple surgical procedures occurring at the same time and attended to by the same surgeon has become of greater societal and clinical interest in the past one to two years partly because of publications by the Spotlight Team from the Boston Globe (1).
What is the difference between drug safety and Pharmacovigilance?
Both refer to the same function – of gathering and reporting adverse drug reactions. The main difference between ‘Drug Safety’ and ‘Pharmacovigilance’ lies in the value of the data generated. One’s reactive, the other proactive. The Pharmacovigilance model takes drug safety to another level.
What is Pharmacovigilance commonly called?
Pharmacovigilance (PV, or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.
What is a concomitant disease?
Concomitant means occurring during the same time period. It usually refers to secondary symptoms that occur with a main symptom.
What is a concomitant drug?
A concomitant drug is a drug which the patient is using at the time of the adverse event in question. A concomitant drug won’t have any relation with the adverse event.
What is the difference between a suspect product and concomitant product?
A suspect product is one which is thought to have caused the adverse drug reactions or an side effect to patient and concomitant product is one which patient is consuming for some other concuurent medical condition. For official definitions from pharmacovigilance point of view suggest to check ICH or GVP guidelines.
Does concomitant drug abuse lead to more deaths?
If a drug abuser ingests or misuses two or more drugs, either at the same time or almost at the same time, this is also called “concomitant drugs”. Whether concomitant drug abuse leads to an increased number of deaths was scientifically analysed in Sheffield, UK.
What are concomitant drugs and how do they affect kidney function?
Often, they monitor the kidney function and the hydration status of their patients during the imaging procedure, especially whenever a concomitant drug (that is harmful to the kidney) is being used. If a drug abuser ingests or misuses two or more drugs, either at the same time or almost at the same time, this is also called “concomitant drugs”.