Prescribing Off-Label Drugs

Here we will look at off-label use and medication use evaluation (MUE), with an explanation of how MUE improves the overall quality of pharmaceutical care services. Off-label drugs are drugs not specifically approved by governing authorities such as FDA.

Off-Label Use Includes the Use of Pharmaceuticals

• Outside specified populations
• For different diseases or disease stages of diseases
• By different routes of administration
• With dosing or dosing schedule changes
• With changes to chronology or sequence of use

Before considering off-label use, carefully evaluate all supporting evidence and the risk-benefit ratio, especially when FDA-approved alternatives are available.

Guide for Off-Label Use

• Provide strong supporting published evidence patient safety should be the primary consideration.
• PTC should establish protocols guiding frequently used off-label drugs.
• The ultimate responsibility resides with the prescriber. They should be familiar with the evidence regarding off-label use and the local protocols related to the agent.
• When necessary, they must consult an appropriately knowledgeable pharmacist.
• Evidence for off-label use should be comprehensive and balanced. A proper review should be conducted.

Medication use evaluation (MUE), the systematic evaluation of medication use, utilising standard observational quality-improvement methods. It is a quality-improvement activity, but it can also be considered as a formulary system management technique.

MUE can simply be data collection, to guide decision-making. However, it can be used to measure the effect of interventions. MUE activities can focus on any dimension of the medication-use process from acquisition to patient monitoring.

A systematic plan to monitor, evaluate, and improve medication use should be developed. MUE should be a part of the organization’s overall quality-improvement programme to examine the effect of medication-use policy decisions, informing decision-makers of possible flaws.

All steps of the medication-use process should be evaluated over time. PTC should be involved in the MUE process. Concurrent evaluation is usually preferred over retrospective methods.

Medications recently added to the formulary are good candidates for review. A review should occur 6–12 months after their addition to the formulary. High-cost, high-use and problem-prone medications are also good candidates.

Policies should be integrated directly into the therapeutic decision-making processes to guide healthcare professionals communicate information.

Automation provides new methods of formulary management. Computerised prescriber order entry implements and facilitates compliance with the drug therapy guidelines.

Share and learn:

Does your hospital apply MUE?

In what scenario would you dispense off-label drugs?