ADRs Flashcards
(24 cards)
What is an ADR?
Noxious, unintended response at normal drug doses for prophylaxis, diagnosis, treatment, excluding therapeutic failures, overdose, abuse, and errors.
List the three classifications of ADRs.
- By Onset
- By Severity
- By Type
What are the onset classifications of ADRs?
- Acute: Within 60 minutes
- Sub-acute: 1-24 hours
- Latent: More than 2 days
How are ADRs classified by severity?
- Mild: No change in therapy required
- Moderate: Requires change in therapy, hospitalization
- Severe: Life-threatening, disabling
- FDA Serious ADR: Includes death, life-threatening events, hospitalization, disability, congenital anomalies
What characterizes Type A ADRs?
Augmented predictable effects, common, usually mild, high morbidity, low mortality
Provide an example of a Type A ADR.
Propranolol causing heart block or anticholinergics causing dry mouth.
What characterizes Type B ADRs?
Non-dose related, unpredictable, rare, high morbidity, high mortality, idiosyncratic or hypersensitivity reactions
Provide an example of a Type B ADR.
Chloramphenicol causing aplastic anemia.
What characterizes Type C ADRs?
Chronic, dose- and time-related, variable severity, moderate to severe
Provide an example of a Type C ADR.
Tardive dyskinesia with neuroleptics.
What characterizes Type D ADRs?
Delayed onset, dose-independent, often serious, risk-benefit balance matters
Provide an example of a Type D ADR.
Lymphomas from immunosuppressants.
What characterizes Type E ADRs?
Related to drug withdrawal, uncommon, variable severity
Provide an example of a Type E ADR.
Opiate withdrawal syndrome.
What characterizes Type F ADRs?
Unexpected treatment failure, often caused by drug interaction, variable severity
Provide an example of a Type F ADR.
Oral contraceptives with enzyme inducers leading to reduced efficacy.
Define pharmacodynamic interactions.
Direct or indirect drug interactions at common targets or different organ sites.
Define pharmacokinetic interactions.
- A: Change in rate/extent of absorption
- D: Protein binding displacements
- M: Altered metabolism of co-administered drugs
- E: Competition between drugs for transport
What are risk factors for ADRs?
- Age: Higher risk in children & elderly
- Polypharmacy: More medications increase risk
- Comorbidities: Multiple diseases increase susceptibility
- Genetic predispositions, prior history of ADRs, end-organ dysfunction
List common causes of ADRs.
- Antibiotics
- Anticoagulants
- Hypoglycemics
- Antihypertensives
- NSAIDs/Analgesics
- Diagnostic agents
- Cardiovascular drugs
- CNS drugs
- Antineoplastics
What are the subjective and objective ways to detect ADRs?
- Subjective: Patient complaints
- Objective: Physical exam, lab tests
What should be reported as an ADR?
Significant, unusual, or unanticipated ADRs, especially involving high-risk drugs.
What are the management steps for ADRs?
- Discontinue offending drug if possible
- Administer treatment: Atropine, naloxone, corticosteroids as needed
- Supportive care: Hydration, analgesics
- Rechallenge/desensitization in specific cases
What are the components of an ADR report?
- Product name and manufacturer
- Patient demographics
- Description of adverse event and outcome
- Dose, frequency, and method
- Confounding variables
