The field of Pharmacovigilance is developing quickly and its improvement is having huge effects in restorative sciences and pharmaceuticals.
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March Learn how and when to remove this template message Pharmacovigilance has its own unique terminology that is important to understand.
Most of the following terms are used Drug safety this article and are peculiar to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well. Adverse drug reaction is a side effect non intended reaction to the drug occurring with a drug Drug safety a positive direct causal relationship between the event and the drug is thought, or has been proven, to exist.
Adverse event AE is a side effect occurring with a drug. By definition, the causal relationship between the AE and the drug is unknown. Causal relationship is said to exist when a drug is thought to have caused or contributed to the occurrence of an adverse drug reaction.
The design of a clinical trial will depend on the drug and the phase of its development. Control group is a group or cohort of individual patients that is used as a standard of comparison within a clinical trial.
The control group may be taking a placebo where no active drug is given or where a different active drug is given as a comparator.
Dechallenge and rechallenge refer to a drug being stopped and restarted in a patient, respectively. A positive rechallenge has occurred when the adverse event re-occurs after the drug is restarted. Dechallenge and rechallenge play an important role in determining whether a causal relationship between an event and a drug exists.
Effectiveness is the extent to which a drug works under real world circumstances, i. Efficacy is the extent to which a drug works under ideal circumstances, i. Event refers to an adverse event AE. Harm is the nature and extent of the actual damage that could be or has been caused.
Implied causality refers to spontaneously reported AE cases where the causality is always presumed to be positive unless the reporter states otherwise. Life-threatening refers to an adverse event that places a patient at the immediate risk of death.
Phase refers to the four phases of clinical research and development: There are also intermediate phases designated by an "a" or "b", e.
Risk is the probability of harm being caused, usually expressed as a percent or ratio of the treated population. Risk factor is an attribute of a patient that may predispose, or increase the risk, of that patient developing an event that may or may not be drug-related.
For instance, obesity is considered a risk factor for a number of different diseases and, potentially, ADRs. Others would be high blood pressure, diabetes, possessing a specific mutated gene, for example, mutations in the BRCA1 and BRCA2 genes increase propensity to develop breast cancer.
Signal is a new safety finding within safety data that requires further investigation. There are three categories of signals: Temporal relationship is said to exist when an adverse event occurs when a patient is taking a given drug. Although a temporal relationship is absolutely necessary in order to establish a causal relationship between the drug and the AE, a temporal relationship does not necessarily in and of itself prove that the event was caused by the drug.
Triage refers to the process of placing a potential adverse event report into one of three categories:Pharmacovigilance has its own unique terminology that is important to understand.
Most of the following terms are used within this article and are peculiar to drug safety, although some are used by other disciplines within the pharmaceutical sciences as well. Jun 05, · Ensuring the safety of food and drugs is a key government responsibility. But today’s products originate in farms and factories all over the world, through manufacturing and supply chains that can involve growers, processing plants, suppliers, brokers, packagers, and distributors.
The ACR Hotline is intended to provide a succinct, balanced, timely, evidence-based review of novel information relevant to rheumatologists and allied rheumatology professionals before it is readily available from other sources, such as peer-reviewed literature.
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In the U.S., the government's Food and Drug Administration (FDA) must approve any drug before it can be sold. This is true whether it's a prescription or an over-the-counter drug. Drug safety systems (DSSs) play an important role in monitoring suspected adverse drug reactions. Requiring maintenance and adherence to a range of regulations, such systems can be very costly.