Pharmacoeconomics and Safe Medication Use

vi.

Category F: An error occurred that may have contributed to or resulted in temporary harm to

the patient and required initial or prolonged hospitalization

vii.

Category G: An error occurred that may have contributed to or resulted in permanent patient

harm

viii.

Category H: An error occurred that required intervention necessary to sustain life

ix.

Category I: An error occurred that may have contributed to or resulted in the patient’s death

Medication errors are defined by The Joint Commission as a sentinel event that includes events such

as those that cause severe temporary harm (requiring intervention), permanent harm, or death (e.g.,

potentially category E, categories F–I).

Reporting Program)

A confidential and voluntary system, investigated by ISMP staff and then reported to the FDA’s

MedWatch program and product vendors

ii.

A separate reporting method is used for vaccines, specifically the ISMP Vaccine Errors

Reporting Program. Vaccine medication error reports provide an option to submit the vaccine’s

manufacturer name, dosage, lot number, expiration date, and National Drug Code.

iii.

Consumers may also report medication errors through ISMP.

iv.

Medication errors may be reported directly to the FDA by the MedWatch system. The FDA’s

MedWatch allows ADE and medication error reporting.

Adverse drug events

Injuries resulting from use of a drug, which include harm caused by the drug (ADRs and overdoses)

and harm from use of the drug, including dose changes and discontinuations of drug therapy

Overall, ADE is the broader term used to describe any harmful event associated with a medication,

including inappropriate use such as an overdose, whereas ADR is used when an adverse response,

including harm, occurs with normal use of the medication.

Preventable ADEs

A preventable ADE occurs when a breach of standard professional behavior, practice, or technique

was identified or when necessary precautions were not taken, or when the event was preventable by

modifying behavior, practice, technique, or care.

Results from any medication error that reaches the patient and causes harm

ii.

About 30%–50% of all ADEs are preventable.

iii.

Drug interactions account for 3%–5% of all preventable in-hospital ADRs (drug interactions

are discussed further in section IV, Drug Interaction Surveillance and Prevention).

Examples of preventable ADEs

Carbamazepine prescribed for an Asian patient with bipolar disorder without testing for the

HLA-B*1502 allele; in turn, the patient develops carbamazepine-induced toxic epidermal

necrolysis

ii.

Heparin administered without the use of weight-based dosing, causing a supratherapeutic

partial thromboplastin time and an intracranial hemorrhage

iii.

Phenytoin mixed accidentally with dextrose rather than normal saline, causing precipitation

and lack of drug potency and leading to a patient developing withdrawal seizures and status

epilepticus

Nonpreventable ADEs

ADEs not associated with a medication error and are unintended reactions without known mitigation

strategies resulting in patient harm (a patient with a bleed despite appropriate dosing, administration,

and monitoring of the anticoagulant)