Pharmacovigilance
B.Pharmacy
Unit I
There are several terminologies related to adverse medication events, some of which include:
1.Adverse Drug Reaction (ADR): This is an unintended and harmful response to a medication, which occurs at doses normally used for treatment or prevention. ADRs can range from mild to severe and may require medical intervention.2.Medication Error: This occurs when a mistake is made during the prescribing, dispensing, or administration of a medication, which can lead to harm to the patient. Medication errors can occur due to various reasons, including incorrect dosage, incorrect route of administration, or incorrect medication.
3.Adverse Event (AE): This is any undesirable experience associated with the use of a medication, which may or may not be related to the medication. AEs can include side effects, drug interactions, and medication errors.
4.Serious Adverse Event (SAE): This is an adverse event that results in hospitalization, disability, or death, or is life-threatening or requires intervention to prevent harm.
5.Adverse Drug Event (ADE): This is a broader term that includes both ADRs and medication errors. ADEs can occur at any point in the medication use process, from prescribing to administration.
6.Drug Toxicity: This is the harmful effect of a medication due to excessive doses or prolonged use, leading to organ damage or failure.
7.Drug-Drug Interaction: This occurs when the effects of one medication are altered by another medication, leading to adverse effects or reduced efficacy.
8.Drug-Disease Interaction: This occurs when a medication exacerbates or interacts with an underlying medical condition, leading to adverse effects or reduced efficacy.
9.Off-Label Use: This refers to the use of a medication for a purpose not approved by regulatory authorities, which may increase the risk of adverse events.
10.Black Box Warning: This is the strongest warning issued by regulatory authorities for medications, indicating that the medication carries a significant risk of serious or life-threatening adverse effects.