ADRs Flashcards
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
