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WTI Extern FDA/ISMP

WTI Extern FDA Pregnancy & ISMP Med. Error Categories

CategoryMeaning
FDA Category A Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).
FDA Category B Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
FDA Category C Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA Category D There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
FDA Category N FDA has not classified the drug.
FDA Category X Studies in animals/humans have shown fetal abnormalities and/or evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, & the risks involved in use in pregnant women clearly outweigh potential benefits
ISMP Category A Circumstances or events that have the capacity to cause error
ISMP Category B An error occurred but did not reach the patient
ISMP Category C An error occurred that reached the patient but did not cause patient harm
ISMP Category D An error occurred that reached the patient and required monitoring to confirm that it resulted in no harm to the patient and /or required intervention to preclude harm
ISMP Category E An error occurred that may have contributed to or resulted in temporary harm to the patient and required intervention
ISMP Category F An error occurred that may have contributed to or resulted in temporary harm to the patient and required initial or prolonged hospitalization
ISMP Category G An error occurred that may have contributed to or resulted in permanent harm patient harm
ISMP Category H An error occurred that required intervention necessary to sustain life
ISMP Category I An error occurred that may have contributed to or resulted in the patient's death
Created by: lrhamyWTI
 

 



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