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Exam (elaborations)

BCPS - Policy, Practice, Regulatory Issues 100% ACCURATE

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JCo requirements for a hospital formulary - ANSWER criteria must include inidcations, effectiveness, interactions, potential for errors and abuse, ADE's sentinel event advisories, populations, other risks, costs DUE - ANSWER Process used to assess the appropriateness of drug therapy by evaluatin...

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  • September 26, 2024
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  • 2024/2025
  • Exam (elaborations)
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  • BCPS
  • BCPS
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BCPS - Policy, Practice, Regulatory Issues
100% ACCURATE

JCo requirements for a hospital formulary - ANSWER criteria must include
inidcations, effectiveness, interactions, potential for errors and abuse, ADE's
sentinel event advisories, populations, other risks, costs


DUE - ANSWER Process used to assess the appropriateness of drug therapy by
evaluating data on drug use
in a given health care environment compared with predetermined criteria and
standards


MUE - ANSWER Performance improvement method that focus on improving
patient outcomes by preventing actual or potential medication related problems


Medication error - ANSWER error occurring anywhere in the process


ADE - ANSWER injury from medication use. May or may not be d/t error


ADR - ANSWER Injury not caused by error, nonpreventable


Patient safety and quality improvement act of 2005 (Patient Safety Act) - ANSWER
authorized patient safety organizations (PSO)
encourage voluntary reporting

, Who created Patient Safety Organization Privacy Protection Center? - ANSWER
AHRQ - ensures events are non-identifiable


ADE reporting - ANSWER Report to FDA Adverse Event Reporting System


Medwatch form FDA 3500 - ANSWER healthcare professionals report serious
adverse event or product issue with FDA regulated drug, biologic, device or
supplement - voluntary


Medwatch form FDA 3500A - ANSWER Industry following IND and biologic
regulations or facilities (hospital, nursing home) - mandatory


BPCI - ANSWER biologics price competition innovation act 2009
Provision of ACA to streamline approval of biosimlars


Sunshine Act - ANSWER have to report stuff given to you by drug reps/companies


Safe and Secure Drug Disposal Act of 2010 - ANSWER Rules for pt and LTCF
disposal of controls


The FDA Safety and Innovation Act of 2012 - ANSWER amends Food, Drug,
Cosmetic act
life saving drug mfgr must report to DHHS before ceasing production
drug shortage lists, etc

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