Type of medication or other substance event (Pharmacy)
- Sydney Edlund
- Norris Mei
- Suzanne Wood
Description
Determination of the type of medication or other substance event.
Pharmacies participating in PSRP are committed to reporting—only in situations where a patient receives or has control of the medication:
Any unanticipated, usually preventable event that is not related to the natural course of the patient's illness or underlying condition, and that resulted in temporary or permanent physical patient harm or posed a risk for patient harm
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
Field Type
Responses
- 1 Adverse reaction not due to allergy or known contraindication
- 2 Allergic reaction due to unknown allergy
- 3 Brand substitution
- 4 Drug interaction
- 5 Expired medication or other substance
- 6 Generic substitution
- 7 Incorrect directions
- 8 Incorrect dosage form
- 9 Incorrect dose
- 10 Incorrect medication or substance
- 11 Incorrect or incomplete labeling
- 12 Incorrect patient
- 13 Incorrect quantity, amount or size
- 14 Incorrect route
- 15 Incorrect strength or concentration
- 16 Medication or other substance contraindicated (includes documented allergies and sensitivities)
- 17 Medication or other substance omitted
- 18 Medication taken incorrectly
- 19 Patient counseling omitted
- 20 Other (please describe)
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
Unanticipated allergic reactions (see Allergic reaction)
Documented allergies or sensitivities (see Medication or other substance contraindicated (includes documented allergies and sensitivities))
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
Allergic reactions due to documented allergies (see Medication or substance contraindicated (includes documented allergies and sensitivities))
Brand substitution
Patient death or serious injury associated with a brand substitution.
Includes
Excludes
Generic substitutions (see Generic substitution)
Contaminated medications (see Other medication or substance event)
Event-Type Specific Questions |
Drug interaction
Patient death or serious injury associated with an unanticipated drug interaction.
Includes
Ordered medications interacting with recreational drugs
Excludes
Drug interactions due to contraindications (see Medication or substance contraindicated (includes documented allergies and sensitivities))
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
Generic substitution
Patient death or serious injury associated with a generic substitution
Includes
Excludes
Brand substitutions (see Brand substitution)
Contaminated medications (see Other medication or substance event)
Event-Type Specific Questions |
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
Directions that were accurate, but misunderstood or forgotten by patient (see Medication taken incorrectly)
Event-Type Specific Questions |
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
Event-Type Specific Questions |
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
Omitted medication (see Medication or substance omitted)
Event-Type Specific Questions |
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
Medications intended for another patient (see 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) (see Medication or other substance contraindicated (includes documented allergies and sensitivities))
Incorrect or incomplete labeling
Patient death or serious injury associated with being given a medication or other substance with incorrect or incomplete labeling.
Includes
Excludes
Incorrect patient name (see Incorrect patient)
Incorrect directions (see Incorrect directions)
Incorrect patient
Patient death or serious injury associated with medication being given to the wrong patient.
Includes
Prescription, over-the-counter, compounded preparations
Excludes
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
Event-Type Specific Questions |
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
Event-Type Specific Questions |
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
Event-Type Specific Questions |
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
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
Medications that have been incorrectly discontinued (see Medication or substance discontinued)
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
Medications taken according to incorrect directions (see Incorrect directions)
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
Event-Type Specific Questions |
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
Guide for Use
History
Start Date | 2013 |
|---|---|
End Date | n/a |
Change History | n/a |
Field Name | med_event |
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