BCPS - Policy, Practice, Regulatory Issues 100% ACCURATE
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Course
BCPS
Institution
BCPS
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...
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
, 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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