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Description
Determination of the type of medication or other substance event.
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To streamline the process of determining the appropriate medication or other substance event type, the Commission, in consultation with practicing pharmacists, has created an algorithmcomprised of a series of questions. In this document, references to “algorithm” mean the full series of questions that are used to determine the appropriate event type. For ease of use, the questions in this data dictionary appear alphabetically. 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. Due to the algorithm’s complexity, we are currently developing a comprehensive, easy-to-understand flowchart to help users visualize the series of questions in the order in which they would appear. The flowchart is coming soon! To apply a single event type to each adverse event report, the algorithm organizes event types in a hierarchy in the Commission’s. This hierarchy helps to reduce the time needed to complete a report by limiting the number of questions. Table 1 provides an overview of the event type hierarchy used by the algorithm. |
On-Screen Instructions
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Field Type
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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 ordered for him or her, or was intended for another patient.
Includes
Medications intended for another patient; medication or other substance that was not ordered for patient
Excludes
Wrong graft tissue (submit as a “Surgical or other invasive procedure” event)
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
Metabolic reactions
Other reactions that cannot be classified as an allergic reaction
Excludes
Unanticipated allergic reactions (submit as “Allergic reaction”)
Documented allergies or sensitivities (submit as “Medication or other substance contraindicated”)
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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
Allergic reactions due to documented allergies (select “Medication or substance contraindicated”)
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Brand substitution
Patient death or serious injury associated with a brand substitution.
Includes
Excludes
Generic substitutions (select “Generic substitution”)
Contaminated medications (select “Other medication or substance event”)
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Patient death or serious injury associated with an unanticipated drug interaction.
Includes
Ordered medications interacting with recreational drugs
Excludes
Drug interactions due to contraindications (select “Medication or substance contraindicated”)
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Patient death or serious injury associated with being given a medication or other substance through the incorrect route of administrationwhose expiration date has passed.
Includes
Injection of medication or substance given instead of medication or substance being used for irrigation
Giving IM dose titrated through IV
Suspension medication given through PICC instead of PEG
Giving a suppository instead of tablet
Giving a patch instead of an IV
Excludes
Giving medications or other substances whose expiration date has passed
Excludes
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Patient death or serious injury associated with a generic substitution
Includes
Excludes
Brand substitutions (select “Brand substitution”)
Contaminated medications (select “Other medication or substance event”)
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directions
Patient death or serious injury associated with being given a medication or other substance in the incorrect dosage formpatient receiving incorrect directions for taking or applying medications.
Includes
Sustained release instead of immediate release; giving tablet instead of liquid form
Excludes
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
Directions that were accurate, but misunderstood or forgotten by patient (select “Medication taken incorrectly”)
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dosage form
Patient death or serious injury associated with being given a medication or other substance in the incorrect strength/concentrationdosage form.
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)Sustained release instead of immediate release; giving tablet instead of liquid form
Excludes
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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
Omitted medication (submit as “Medication or substance omitted”)
Incorrectly discontinued medication (submit as “Medication or substance discontinued”)
IV medications given at an incorrect rate (submit as “Incorrect rate
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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
Medications intended for another patient (select “Incorrect patient”)
Medication not appropriate to the patient’s clinical situation (e.g., giving a patient with a drug resistant infection a drug in the family to which the infection is resistant) (select “Medication or other substance contraindicated”)
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Patient death or serious injury associated with being given a medication or other substance with incorrect or incomplete labeling.
Includes
Excludes
Incorrect patient name on label (select “Incorrect patient”)
Incorrect directions on label (select “Incorrect directions”)
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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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Patient death or serious injury associated with being given a medication or other substance in the incorrect quantity, amount or size
Includes
Giving 100 instead of 10 oxycontin
Excludes
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Patient death or serious injury associated with being given a medication or other substance whose expiration date has passedthrough the incorrect route of administration.
Includes
Giving medications or other substances whose expiration date has passedUsing expired bone matrix admixture in a procedurea suppository instead of tablet
Excludes
Labeling
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strength
Patient death or serious injury associated with being given a medication or other substance with incorrect or incomplete labelingin the incorrect strength/concentration.
Includes
Medication hung and infused but not labeled or documented
Excludes
Mislabeled blood products (submit as “Blood or blood product”)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
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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
Drug procedure contraindication
Excludes
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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 at intake or discharge and failure to process/enter medication reconciliation form
Giving epidural medication through a disconnected line; ordering a medication late that is not administered to the patient
Excludes
Medications that have been incorrectly discontinued (submit as “Medication or substance discontinued”)
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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 post-discharge.
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
Allergic reactions due to documented allergies (choose “Medication or substance contraindicatedbeing 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
Medications taken according to incorrect directions (select “Incorrect directions”)
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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
Metabolic reactions
Other reactions that cannot be classified as an allergic reaction
Excludes
Unanticipated allergic reactions (submit as “Allergic reaction”)
Documented allergies or sensitivities (submit as “Medication or other substance contraindicated”)
Oversedation (submit as “Oversedation”)
Patient death or serious injury associated with an unanticipated drug interaction.
Includes
Ordered medications in hospital interacting with recreational drugs
Excludes
Drug interactions due to contraindications
Patient death or serious injury associated with one or more medications that result in a level of sedation greater than the desired therapeutic level of sedation.
Includes
Oversedation associated with medications after the patient has left the PACU
Excludes
Oversedation associated with anesthesia during the operative period and prior to discharge from the PACU (submit as “Anesthesia”)
Incorrect directions
text
Includes
Excludes
Patient counseling omitted
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Includes
Excludes
Incorrect quantity, amount or size
text
Includes
Excludes
Medication taken incorrectly
text
Includes
Excludes
Generic substitution
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Includes
Excludes
Brand substitution
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Includes
Excludes
not providing counseling during a patient encounter.
Includes
Failure to warn of serious side effects requiring immediate notification of a health care professional
Excludes
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Patient death or serious injury associated with being given a medication or other substance not otherwise included in the above categories.
Includes
Placing epidural needle in subarachnoid space instead of epidural space
Patient non-compliant with medication discontinuation instructions prior to surgery
Incorrect Incorrect hard copy of prescription sent home with patientTranscription error on discharge medication schedule
Incorrect preparation, including inappropriate cutting of tablets, error in compounding, mixing, etc.
Contaminated medications
Excludes
Incorrect patient/family action (e.g. self-administration error)
Excludes
Invasive incorrect site medication administration (submit as “Surgical or other invasive procedure event (wrong site)(select “Medication taken incorrectly”)
Guide for Use
In keeping with NQF, hypoglycemia is considered a harm resulting from a medication event.
How do I classify my medication-related adverse event?
Adverse events involving medication have several possible classifications. If the patient has a known, documented allergy or sensitivity, the event is Medication or substance contraindicated. If the patient has an allergic reaction but no known, documented allergy or sensitivity, the event is an Allergic reaction due to unknown allergy. If the patient has a reaction other than an allergic reaction and no known, documented allergy or sensitivity, the event is an Adverse reaction not due to allergy or known contraindication. Please note: Medication or substance contraindicated can also refer to clinical contraindications (e.g., pregnancy is a contraindication for the administration of tetracycline).
Example A) Patient with known penicillin allergy given dicloxacillin suffers no reaction
Medication or substance contraindicatedExample B) Patient with no known allergies given a medication and suffers hives and mild throat swelling
Allergic reaction due to unknown allergyExample C) Patient with no known allergies given a medication and has a severe hypotensive event
Adverse reaction not due to allergy or known contraindication
History
Start Date | Summer 2013 |
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End Date | n/a |
Change History | n/a |