Pharmacoeconomics and Safe Medication Use

The ADE committee should

Designate which ADEs are preventable, explain why they are preventable, and determine possible

preventive measures

Determine which ADEs will be reported to the FDA or the manufacturer

Report the data regarding who is detecting ADEs and who reports, documents, and manages the

ADEs

Benchmark the hospital’s ADEs against itself in previous years and compare them with the data from

other hospitals published in the biomedical literature. Total ADE data can be reported according to

the following:

Total number of ADEs

ii.

ADEs per admission

iii.

ADEs per patient

iv.

ADEs per patient-days

ADEs per doses dispensed

vi.

ADEs per doses administered

1. Mild ADR or ADE: Results in heightened need for patient monitoring with or without a change in vital

signs, but no ultimate patient harm, or any adverse event that results in the need for increased laboratory

monitoring

2. Moderate ADR or ADE: Results in the need for aggressive intervention with antidotes or increased length

of hospital stay (e.g., severe hypotension [e.g., BP < 90/50 mm Hg], bleeding necessitating transfusions)

3. Severe ADR or ADE: Results in harm to the patient, prolonged hospitalization, transfer to a higher level

of care, permanent organ damage (e.g., irreversible hepatotoxicity or renal failure), or death with probable

ADE causality nomogram score

Box 1. Definitions for the Degree of ADR or ADE Severitya

aOther ADE severity scales are available.

ADE = adverse drug event; ADR = adverse drug reaction; BP = blood pressure.

The ADE committee should meet monthly, bimonthly, or quarterly, depending on the number of reports

and actionable items that need review.

ADE data can be reported by a specialty unit or service (e.g., emergency medicine, ICU).

ADE data can ensure that appropriate preventive measures are developed for that specialty unit.

A proactive method to reduce the incidence of ADEs is a failure mode and effects analysis (FMEA),

which is a proactive, structured method to identify potential failure points within a system that may

lead to an ADE.

If an ADE has occurred, performance of a root cause analysis, which is a structured method

to determine why an ADE occurred (i.e., retroactive), can help identify methods to prevent the

recurrence of the ADE in the future.

ADR and ADE data should be reported as mild, moderate, or severe. Many scales are available in the

literature. Definitions for each should be established. Box 1 provides an example.