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Initial Build

Status
colourGreen
titledone
SE 1/31

Staff Review

Status
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titledone
Suzanne Wood

Approval Status

Status
in progress
colourYellowGreen
titleapproved
8/30/2022

Additional Support Review

Status
colourBlue
titleReady for Add. Support Review

Comms Approval

Description

Determination of the type of medication or other substance event.

Info

The system uses an algorithm to determine the appropriate medication or other substance event type. The algorithm was developed in consultation with practicing pharmacists and is comprised of a series of questions. Some questions may appear more than once in the online form if the participant indicates that more than one medication or substance is involved in the event.

To apply a single event type to each adverse event report, the algorithm organizes event types in a hierarchy. This hierarchy helps to reduce the time needed to complete a report by limiting the number of questions.

On-Screen Instructions

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Field Type

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Top
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Responses

Table of Contents
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excludeDescription|On-Screen Instructions|Field Type|Responses|Response Codes|OPSC Staff Notes|History|Guide for Use|Additional Support

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Adverse_reaction
Adverse_reaction
Adverse reaction not due to allergy or known contraindication

Patient death or serious injury associated with being given a medication or other substance (at normal dosage during normal use) for which an adverse reaction occurred that was not due to an allergy or known contraindication.

Includes

  • Anticholinergic reaction syndrome as a result of medication administration

  • Severe hypotensive event as a result of medication administration

  • Other reactions that cannot be classified as an allergic reaction

Excludes

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Allergic_reaction
Allergic_reaction
Allergic reaction due to unknown allergy

Patient death or serious injury associated with being given a medication or other substance for which an unanticipated allergic reaction occurred either in the facility or at home and reported to facility.

Includes

  • An inappropriate immune response, such as a rash or hives, as a result of medication administration

  • Anaphylaxis as a result of medication administration

Excludes

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Brand_substitution
Brand_substitution
Brand substitution

Patient death or serious injury associated with a brand substitution.

Includes

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No additional guidance excerpt
No additional guidance excerpt

Excludes

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and space = currentSpace ( ) and title ~ "Was the substitution therapeutically"

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Drug_interaction
Drug_interaction
Drug interaction

Patient death or serious injury associated with an unanticipated drug interaction.

Includes

  • Ordered medications interacting with recreational drugs

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Expired
Expired
Expired medication or other substance

Patient death or serious injury associated with being given a medication or other substance whose expiration date has passed.

Includes

  • Giving medications or other substances whose expiration date has passed

Excludes

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No additional guidance excerpt
No additional guidance excerpt

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Generic_substitution
Generic_substitution
Generic substitution

Patient death or serious injury associated with a generic substitution

Includes

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No additional guidance excerpt
No additional guidance excerpt

Excludes

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and space = currentSpace ( ) and title ~ "Was the substitution therapeutically"

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Incorrect_directions
Incorrect_directions
Incorrect directions

Patient death or serious injury associated with patient receiving incorrect directions for taking or applying medications.

Includes

  • Directions that correspond to the written prescription if the directions are incorrect

  • Medications taken according to incorrect directions (i.e. directions to cut extended release tablet, or swallow chewable tablet)

Excludes

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and space = currentSpace ( ) and parent = "2179990176"

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Incorrect_dosage_form
Incorrect_dosage_form
Incorrect dosage form

Patient death or serious injury associated with being given a medication or other substance in the incorrect dosage form.

Includes

  • Sustained release instead of immediate release

  • Giving tablet instead of liquid form

Excludes

Include Page
No additional guidance excerpt
No additional guidance excerpt

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and ancestor = "2179858963" and space = currentSpace ( )

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Incorrect_dose
Incorrect_dose
Incorrect dose

Patient death or serious injury associated with being given a medication or other substance in the incorrect dose (i.e., too much or too little).

Includes

  • Giving too much or too little of a medication or other substance at once

  • Overdose

  • Underdose

  • Extra dose

  • An error in compounding, mixing, etc. may result in incorrect dose

Excludes

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and ancestor = "2180186452" and space = currentSpace ( )

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Incorrect_medication
Incorrect_medication
Incorrect medication or substance

Patient death or serious injury associated with being given a medication or other substance that was not ordered for them, or was intended for another patient.

Includes

  • Medication or other substance that was not ordered for patient

  • An error in compounding, mixing, etc. may result in giving an incorrect medication or substance

Excludes

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Labeling
Labeling
Incorrect or incomplete labeling

Patient death or serious injury associated with being given a medication or other substance with incorrect or incomplete labeling.

Includes

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No additional guidance excerpt
No additional guidance excerpt

Excludes

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Incorrect_patient
Incorrect_patient
Incorrect patient

Patient death or serious injury associated with medication being given to the wrong patient.

Includes

  • Prescription, over-the-counter, compounded preparations

Excludes

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No additional guidance excerpt
No additional guidance excerpt

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Incorrect_quantity
Incorrect_quantity
Incorrect quantity, amount or size

Patient death or serious injury associated with being given a medication or other substance in the incorrect quantity, amount or size

Includes

  • 100 tablets dispensed instead of 10

Excludes

Include Page
No additional guidance excerpt
No additional guidance excerpt

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and ancestor = "2179858971" and space = currentSpace ( )

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Incorrect_route
Incorrect_route
Incorrect route

Patient death or serious injury associated with being given a medication or other substance through the incorrect route of administration.

Includes

  • Giving a suppository instead of tablet

Excludes

Include Page
No additional guidance excerpt
No additional guidance excerpt

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and ancestor = "2180186475" and space = currentSpace ( )

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Incorrect_strength
Incorrect_strength
Incorrect strength or concentration

Patient death or serious injury associated with being given a medication or other substance in the incorrect strength or concentration.

Includes

  • Concentrations that are too high or  too low

  • Patient is given an “unmixed” antibiotic that was supposed to mixed with another substance

  • Patches applied that are the wrong concentration (e.g., Fentanyl patch 25mgm instead of 50mgm)

  • An error in compounding, mixing, etc. may result in incorrect strength or concentration

Excludes

Include Page
No additional guidance excerpt
No additional guidance excerpt

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and ancestor = "2180775951" and space = currentSpace ( )

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Contraindicated
Contraindicated
Medication or other substance contraindicated (includes documented allergies and sensitivities)

Patient death or serious injury associated with being given a medication or other substance they should not have been given for a known, documented reason.

Includes

  • Patient given a medication or other substance, or a prescription for a medication or other substance, they should not have been given for a documented reason regardless of result

  • Drug-drug contraindication

  • Drug-food contraindication

  • Drug-disease contraindication

  • Drug-clinical condition contraindication

Excludes

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No additional guidance excerpt
No additional guidance excerpt

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Omitted
Omitted
Medication or other substance omitted

Patient death or serious injury associated with not being given a medication or other substance that they should have received.

Includes

  • Prescribed medication not given for any reason, including incomplete medication reconciliation or failure to process/enter medication reconciliation form

Excludes

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Taken_incorrectly
Taken_incorrectly
Medication taken incorrectly

Patient death or serious injury associated with a medication or other substance being incorrectly taken by the patient

Includes

  • Incorrect patient/family action (e.g., self-administration error)

  • Directions that were accurate, but misunderstood or forgotten by patient

Excludes

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Counseling_omitted
Counseling_omitted
Patient counseling omitted

Patient death or serious injury associated with not providing counseling during a patient encounter.

Includes

  • Failure to warn of serious side effects requiring immediate notification of a health care professional

Excludes

Include Page
No additional guidance excerpt
No additional guidance excerpt

Event-Type Specific Questions

Filter by label (Content by label)
showLabelsfalse
sorttitle
showSpacefalse
reversetrue
cqllabel = "pharmacy" AND label != "staffonly" and ancestor = "2181038196" and space = currentSpace ( )

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Other
Other
Other (please describe)

Patient death or serious injury associated with being given a medication or other substance not otherwise included in the above categories.

Includes

  • Incorrect hard copy of prescription sent home with patient

  • Incorrect preparation, including inappropriate cutting of tablets, error in compounding, mixing, etc.

  • Contaminated medications

  • Hypoglycemia is considered a harm resulting from a medication event

Excludes

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No additional guidance excerpt
No additional guidance excerpt

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Guide for Use

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History

Start Date

2013

End Date

n/a

Change History

n/a

Field Name

med_event