Sunday, April 19, 2009

Risk management, pharmacoepidemiology, and pharmacovigilence

Risk Management:
Risk management is the overall and continuing process of minimizing risks throughout a product's lifecycle to optimize its benefit/risk balance. Risk information emerges continuously throughout a product's lifecycle, during both the investigation and marketing phases through both labeled and off-label uses. FDA considers risk management to be a continuous process of (1) learning about and interpreting a product's benefits and risks, (2) designing and implementing interventions to minimize a product's risks, (3) evaluating interventions in light of new knowledge that is acquired over time, and (4) revising interventions when appropriate.

pharmacoepidemiology is the study of the utilization and effects of drugs in large numbers of patients. It can be viewed as an epidemiological discipline with particular focus on drugs.The process of identifying and responding to safety issues about drugs.

Pharmacovigilance (PVG):
Pharmacovigilance is generally regarded as all postapproval scientific and data gathering activities relating to the detection, assessment, understanding, and prevention of adverse events or any other product-related problems. This includes the use of pharmacoepidemiologic studies.

Patient registry:
The term "registry" as used in pharmacovigilance and pharmacoepidemiology is often given different meanings. For the purpose of this concept paper, we are defining a registry as a systematic collection of defined events or product exposures in a defined patient population for a defined period of time. Through the creation of registries, a sponsor can monitor for safety signals identified from spontaneous case reports, literature reports, or other sources, and evaluate factors that affect the risk of adverse outcomes, such as dose, timing of exposure, or other patient characteristics.

REMS: Risk Evaluation and Mitigation Strategy

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage a known or potential serious risk associated with a drug or biological product. A REMS will be required if FDA finds that a REMS is necessary to ensure that the benefits of the drug or biological product outweigh the risks of the product, and FDA notifies the sponsor. A REMS can include a Medication Guide, Patient Package Insert, a communication plan, elements to assure safe use, and an implementation system, and must include a timetable for assessment of the REMS. Some drug and biological products that previously were approved/licensed with risk minimization action plans (RiskMAPs) will now be deemed to have REMS.

For more information, see FDA's website about FDAAA.

also, the following website may be useful:

1 comment:

Symposier said...

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