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How to Successfully Employ External Comparator Arm Studies Using Real World Data

pharmaphorum

Therefore, to help contextualise study findings, external comparator arms (ECAs) can be employed, which compile data from external sources, such as patient registries and other medical records. However, methodological considerations must be undertaken to ensure the best conduct and minimise potential biases in ECA study designs.

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Hospital pharmacist-led re-evaluation of medication errors: a pilot study

Hospital Pharmacy Europe

The incidence of medication errors varies greatly among published studies, not only due to the lack of a clear definition, 1,2 but also because of different factors such as the healthcare setting, differing levels of automation (e.g. 3–5 Medication errors are often documented in national or local electronic incident reporting systems.

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What conditions qualify for disability benefits?

The Checkup by Singlecare

The SSA offers two types of Social Security disability benefits for those who meet the agency’s strict definition of “disabled.” This means you must develop a severe medical ailment on the list of disabling conditions and then meet other criteria for each type of benefit. Where do you go to start the process?

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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

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 62
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Sentinel Events Should Result In A Blameless Society — Not Make The Employee The Scapegoat

The Happy PharmD

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. Blaming Employees For Sentinel Events. I was momentarily stunned.