ADRs

Question 1

What is an ADR?

Answer 1

Noxious, unintended response at normal drug doses for prophylaxis, diagnosis, treatment, excluding therapeutic failures, overdose, abuse, and errors.

Question 2

List the three classifications of ADRs.

Answer 2

• By Onset
• By Severity
• By Type

Question 3

What are the onset classifications of ADRs?

Answer 3

• Acute: Within 60 minutes
• Sub-acute: 1-24 hours
• Latent: More than 2 days

Question 4

How are ADRs classified by severity?

Answer 4

• 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

Question 5

What characterizes Type A ADRs?

Answer 5

Augmented predictable effects, common, usually mild, high morbidity, low mortality

Question 6

Provide an example of a Type A ADR.

Answer 6

Propranolol causing heart block or anticholinergics causing dry mouth.

Question 7

What characterizes Type B ADRs?

Answer 7

Non-dose related, unpredictable, rare, high morbidity, high mortality, idiosyncratic or hypersensitivity reactions

Question 8

Provide an example of a Type B ADR.

Answer 8

Chloramphenicol causing aplastic anemia.

Question 9

What characterizes Type C ADRs?

Answer 9

Chronic, dose- and time-related, variable severity, moderate to severe

Question 10

Provide an example of a Type C ADR.

Answer 10

Tardive dyskinesia with neuroleptics.

Question 11

What characterizes Type D ADRs?

Answer 11

Delayed onset, dose-independent, often serious, risk-benefit balance matters

Question 12

Provide an example of a Type D ADR.

Answer 12

Lymphomas from immunosuppressants.

Question 13

What characterizes Type E ADRs?

Answer 13

Related to drug withdrawal, uncommon, variable severity

Question 14

Provide an example of a Type E ADR.

Answer 14

Opiate withdrawal syndrome.

Question 15

What characterizes Type F ADRs?

Answer 15

Unexpected treatment failure, often caused by drug interaction, variable severity

Question 16

Provide an example of a Type F ADR.

Answer 16

Oral contraceptives with enzyme inducers leading to reduced efficacy.

Question 17

Define pharmacodynamic interactions.

Answer 17

Direct or indirect drug interactions at common targets or different organ sites.

Question 18

Define pharmacokinetic interactions.

Answer 18

• A: Change in rate/extent of absorption
• D: Protein binding displacements
• M: Altered metabolism of co-administered drugs
• E: Competition between drugs for transport

Question 19

What are risk factors for ADRs?

Answer 19

• 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

Question 20

List common causes of ADRs.

Answer 20

• Antibiotics
• Anticoagulants
• Hypoglycemics
• Antihypertensives
• NSAIDs/Analgesics
• Diagnostic agents
• Cardiovascular drugs
• CNS drugs
• Antineoplastics

Question 21

What are the subjective and objective ways to detect ADRs?

Answer 21

• Subjective: Patient complaints
• Objective: Physical exam, lab tests

Question 22

What should be reported as an ADR?

Answer 22

Significant, unusual, or unanticipated ADRs, especially involving high-risk drugs.

Question 23

What are the management steps for ADRs?

Answer 23

• Discontinue offending drug if possible
• Administer treatment: Atropine, naloxone, corticosteroids as needed
• Supportive care: Hydration, analgesics
• Rechallenge/desensitization in specific cases

Question 24

What are the components of an ADR report?

Answer 24

• Product name and manufacturer
• Patient demographics
• Description of adverse event and outcome
• Dose, frequency, and method
• Confounding variables