Pharmacoeconomics and Safe Medication Use

Brand name

Generic name

Manufacturer

Therapeutic classification

FDA status: Prescription, nonprescription, or con-

trolled substance

Look-alike sound-alike names with any other FDA

label-approved medications

Look-alike sound-alike names with any other FDA

label-approved medications on the formulary

Date of FDA label approval

FDA rank (priority or standard)

FDA label-approved indication

Unlabeled indications

Potential unlabeled uses

Similar agents not on the formulary

Similar agents on the formulary

How the drug can be used when applied to available

national guidelines

How the drug can be used when applied to hospital

guidelines, protocols, or pathways

Dosage form

Dosage strength

Mechanism of action

Absorption

Distribution

Metabolism

Excretion

Common ADRs or ADEs

Significant or life-threatening ADRs or ADEs

Boxed warnings, including Risk Evaluation and

Mitigation Strategies

Precautions

Contraindications

Drug-drug interactions

Drug-food interactions

Drug-laboratory test interactions

IV incompatibilities

IV compatibilities

Pregnancy category

Use during breastfeeding

Dosage regimen recommendations

Dosage regimen recommendations for special pop-

ulations such as children, older adults, persons

with renal and hepatic impairment, and persons

undergoing dialysis

Routes of administration and/or limitations

Any special administration techniques (prescriber

certification, smart pump limitations)

Preparations available

Storage and stability considerations

Any availability concerns (specialty pharmacy

restrictions)

Critical review of pertinent clinical trials with

salient critique and conclusions

Critical review of comparison trials with similar or

alternative agents

Cost analysis including annual projected costs and

reimbursement

Economic evaluations

Pharmacoeconomic analyses available

Budget impact analysis specific to the institution

Reimbursement from third-party payers

Are there any severe medication errors or sentinel

events with this agent?

Does this medication need to be stored under spe-

cific circumstances to avoid medication errors or

mix-ups?

Does this medication require tall man lettering

labeling or precautionary or high-risk labeling to

avoid potential medication errors or mix-ups?

Is the manufacturer-provided labeling considered

clear and safe for dispensing?

Is an abuse potential associated with the use of this

medication?

Patient education requirements

Will this agent replace an existing agent, and should

a formulary deletion take place?

Reason why or why not this medication should be

included in the formulary Recommendation for

addition to the formulary

References

Box 3. Elements of a Drug Evaluation Monograph

ADE = adverse drug event; ADR = adverse drug reaction; IV = intravenous(ly).

stronger levels of evidence guiding decisions regarding whether to add to the formulary.

Prospective double-blind randomized controlled trials should have greater weight than retrospective

cohort and case-control studies, though it is important to critique all types of studies regarding limitations

to understand the strength of a study.

Case reports should be used only when no other evidence is available.