Definition, Documentation, Labelling and Medical Records

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Definition

Documentation

Labelling

Medical Records

Sentinel Events Should Result In A Blameless Society — Not Make The Employee The Scapegoat

The Happy PharmD

OCTOBER 26, 2022

These documents focused on why the sentinel event occurred. In this particular case, the physician folded the medication order when he placed it in the nurse’s bin. The nurse transcribed the medication order on the patient’s (nurse’s) record system. Both the label and the product had to match the order before the product.

Hospitals

Hospitals Labelling Medical Records Documentation

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

The FDA Law Blog

OCTOBER 2, 2023

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended the definition to make clear that substantial evidence could also be demonstrated by “one adequate and well-controlled clinical investigation and confirmatory evidence.” objective clinical outcomes in the context of detailed medical record collection).

FDA

FDA Documentation Labelling Medical Records

Pharmacy Technician Pulse

Sentinel Events Should Result In A Blameless Society — Not Make The Employee The Scapegoat

Long-Awaited Guidance on FDAMA 115: Confirmatory Evidence Finally Has Its Moment (to be Crossed Off the FDA’s Guidance To-Do List)

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