Adverse Drug Event (ADE)

An undesirable and unintended occurrence related to the use of a drug, including side effects, medication errors, allergic reactions, and any harm resulting from the use of a pharmaceutical product.

 

Pharmacovigilance

The science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.

 

Medication Error

Inaccuracies or mistakes in the prescribing, dispensing, or administration of a medication that may lead to patient harm. This can include dosage errors, wrong medication, or incorrect administration routes.

 

Drug Interaction

The effect of one drug on the effectiveness or toxicity of another when they are administered together. Interactions can enhance or diminish the therapeutic effects, leading to unexpected consequences.

 

Polypharmacy

The simultaneous use of multiple medications by a patient increases the risk of adverse drug interactions and complicates the management of potential side effects.

 

Allergic Reaction

An exaggerated immune response to a drug often results in symptoms such as rash, itching, swelling, or, in severe cases, anaphylaxis. It is crucial for healthcare providers to identify and manage allergies to prevent adverse outcomes.

 

Black Box Warning

The strongest safety warning that the U.S. Food and Drug Administration (FDA) can issue for a prescription drug. It is designed to call attention to serious or life-threatening risks associated with the drug.

 

Therapeutic Index

The ratio of the dose of a drug that causes a therapeutic effect to the dose that causes toxicity. A narrow therapeutic index indicates a smaller margin of safety and a higher risk of adverse effects.

 

Off-label Use

The use of a medication for a purpose other than what it was originally approved for by regulatory authorities. This practice may increase the risk of adverse events due to limited evidence supporting safety and efficacy in these alternative uses.

 

Incidence and Prevalence

The frequency (incidence) and total number (prevalence) of adverse drug events within a specific population and time frame. Monitoring these statistics helps in identifying trends and implementing preventive measures.

 

Risk-Benefit Ratio

The comparison between the potential benefits of a drug and the risks of adverse events. Healthcare professionals weigh these factors to make informed decisions about the appropriateness of a particular treatment for an individual patient.

 

Medication Reconciliation

The process of creating and maintaining an accurate list of a patient’s current medications and comparing it with the healthcare provider’s prescription during care transitions to avoid errors and adverse events.