Pharmacoeconomics and Safe Medication Use

pharmacoeconomics.

Drug evaluations should contain references to evidence, and opinion statements should be clearly noted.

Internal prescribing data may also be used in formulary decisions, such as

Quantity of drug used over a specified time

ADR data

Medication error data

detect ADEs (especially more long-term effects), it is prudent to observe safety profiles of new drugs before

considering addition to the formulary, if possible. For example, some drugs may cause life-threatening

toxicity such as hepatic failure at a rate of 1:20,000 patients, thus requiring more than 100,000 postmarketing

patient exposures before generating a signal of toxicity.

such as the following:

Restriction to specific patient population meeting use criteria (e.g., level of monitoring, other therapies

tried)

Restriction to specific providers

appropriate CDS such as dosing and recommended monitoring, as well as information on formulary

restrictions.

Education of formulary additions is critical for appropriate use, including appropriate indications and

monitoring.

recommendations to manage limited supply.

evaluation or reviews of use (including compliance with institutional guidelines), cost, safety, and efficacy

should be made, preferably within 3–6 months and again in 1 year. The goal is to determine the effectiveness

of the drug. Effectiveness is the use of a drug in the real-world setting outside a randomized controlled trial

and differs from the efficacy reviewed before adding the drug to the formulary. Examples of approvals that

may require quicker reevaluation (e.g., 3 months) are those with very limited efficacy data, concern for lack

of compliance with formulary restrictions, high risk of safety events, or medications with a very high cost.

important change in prescribing information, when a landmark trial or publication affects the drug’s use, or

when new FDA label-approved agents are available within the drug class. Medication assessments typically

prompt updates and modifications to the drug’s current use.