Importance of Pharmacovigilance
Some of the terms used in drug safety may vary in the way the terminologies are interpreted and used. For example:
Adverse drug reaction
In pre-approval of clinical drug experience with a new drug or its uses, specifically since the therapeutic dose(s) may not be established, all unintended and deleterious drug responses associated with any dose must be considered. as an adverse drug reaction.
adverse event
An adverse event or AE can be any unintended and unfavorable sign, including abnormal laboratory finding, symptom or illness temporarily related to the use of the drug, whether or not it is considered associated with the drug.
Benefits
Evaluation of the favorable or beneficial and unfavorable results of undertaking a particular course of action, medicinal action can contribute to the final evaluation of the advantages of drugs.
causal relationship
Causal relationship or assessment is the method of assigning the probability of causation to a suspended adverse drug reaction.
clinical trial
A clinical trial or study is research on human subjects for the purpose of verifying or discovering the pharmacology, clinical or pharmacodynamics of an investigational product or to identify any of the adverse reactions of the investigational product.
control group
Control group or cohort studies typically identify and compare exposed patients with unexposed patients or with patients who receive a different exposure from drug use.
Challenge and Re-challenge
Withdrawal refers to the discontinuation of the drug generally after the adverse event or at the end of the planned treatment. Rechallenge refers to the resumption of a similar drug after its use has been discontinued, usually due to an adverse event.
Effectiveness
Drug efficacy examines trends in disease events over time in various geographic locations and then correlates these with trends in putative exposures, such as drug utilization rates.
Efficiency
Efficacy has to do with the conduct, design, and safety and reporting of clinical trials of the drug. It also covers new types of drugs derived from biotechnological procedures.
Event
It is considered vital while testing the effect of the new drug on the market that all events occur after its use is reported to clinics.
to damage
The use of drugs in the Pharmacovigilance sector is tested before being released to the market so that users do not suffer any harm, however if users experience any harm they should discontinue use and inform the clinic.
implicit causation
Implied causality refers to spontaneously reported adverse events, even where causation is always presumed positive unless event reports indicate otherwise.
Individual case study report
The individual case study report in Pharmacovigilance is part of the adverse event report. Includes serious and unlisted events believed to be associated with the individual’s use of the drug.
life in danger
Life-threatening refers to the adverse event or AE that places the patient at instantaneous risk of death due to the use of the new drug.
Phase
The drugs introduced by the company are tested on humans on the basis of phases or tier, where the effect of the drug after its intake on the patient is examined.
Sign
Signal detection or SD includes a range of many techniques to detect drug effects in the patient.
temporary relationship
Temporal relationship is defined as abnormal liver or kidney function tests based on the date they are initially detected in patients.
Classification
Triage in Pharmacovigilance refers to the chronological order in which drug treatment is given to patients or victims.
What is clear about Pharmacovigilance is that it will continue to be the influential party in the development of new drugs and therapies for many years to come.
