Changes in the US Drug Safety System

How the US drug safety system should be changed.

READING A RECENT NEWSPAPER MIGHT REMIND ONE of the above quote. One of the questions the nation is currently confronted with is what should be done to address the safety of drugs. In this Commentary, the current system of drug safety monitoring will be described and the limitations of the current system will be highlighted. A potential solution will then be proposed that will require legislatio...

The US Food and Drug Administration’s drug safety recommendations and long-acting beta2-agonist dispensing pattern changes in adult asthma patients: 2003–2012

BACKGROUND Emerging safety issues associated with long-acting beta2-agonist (LABA) have led to multiple regulatory activities by the US Food and Drug Administration (FDA) since 2003, including Drug Safety Communications (DSCs) in 2010. These DSCs had three specific recommendations for the safe use of LABA products in adult asthma treatment. METHODS We examined the initiation of LABA-containin...

System changes to improve patient safety.

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Report calls for overhaul of US food safety system.

[Establishment and effect of the drug safety management monitoring system].

Early detection and early treatment of adverse drug reactions have recently become more important. It is natural that physicians should treat adverse drug reactions carefully, but it is also important to establish a system for their early systematic detection and treatment. Therefore, by comparing current data with that preserved in our clinical laboratory's data management registry and identif...