Drug Safety

Drug Safety is the pharmacological science focused on the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. Drug safety is also referred to as pharmacovigilance.

Overview

Drug safety involves the study of the side effects or adverse reactions caused by drugs. It is a key component of pharmacology, the study of how drugs interact with the body. Drug safety is concerned with the potential harm that drugs can cause, and the ways in which this harm can be prevented or managed.

Drug Safety Monitoring

Monitoring the safety of drugs is a complex process. It begins with the preclinical testing of new drugs and continues throughout the drug's entire market life. This process is designed to detect any potential adverse effects that may not have been apparent in the initial clinical trials.

Adverse Drug Reactions

An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug. ADRs can range from minor side effects to life-threatening conditions.

Risk Management in Drug Safety

Risk management in drug safety involves identifying, assessing, and minimizing the risk of adverse effects while maximizing the therapeutic benefits of the drug. This can involve a variety of strategies, including changes to the drug's labeling or packaging, additional post-marketing surveillance studies, or even withdrawal of the drug from the market in extreme cases.

Post-Marketing Surveillance

Post-marketing surveillance is the practice of monitoring the safety of a pharmaceutical drug or medical device after it has been released on the market. This surveillance is designed to identify any adverse events that may be associated with the drug's use in the general population.

See Also

• Pharmacology
• Adverse drug reaction
• Post-marketing surveillance

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