[DISPENSING] Adverse Drug Reactions

a. Pharmacovigilance

Science of detection, assessment, understanding, and prevention of adverse effects (AE) of medical drugs after they have been licensed for use, especially in order to identify and evaluate previously reported adverse drug reactions (ADR).

a. Pharmacovigilance
b. Pharmacoepidemiology
c. Pharmacoeconomics
d. Pharmacogenomics

a. Very common

[FREQUENCY]

> 10%

a. Very common

b. Common

c. Uncommon

d. Rare

e. Very rare

b. Common

[FREQUENCY]

1-10%

a. Very common

b. Common

c. Uncommon

d. Rare

e. Very rare

c. Uncommon

[FREQUENCY]

0.1-1%

a. Very common

b. Common

c. Uncommon

d. Rare

e. Very rare

d. Rare

[FREQUENCY]

0.01-0.1%

a. Very common

b. Common

c. Uncommon

d. Rare

e. Very rare

e. Very rare

[FREQUENCY]

< 0.01%

a. Very common

b. Common

c. Uncommon

d. Rare

e. Very rare

a. Acute

[ONSET]

1h upon exposure

a. Acute

b. Subacute

c. Latent

b. Subacute

[ONSET]

Within 24h upon exposure

a. Acute

b. Subacute

c. Latent

c. Latent

[ONSET]

2 days or more upon exposure

a. Acute

b. Subacute

c. Latent

• Type A (Augmented)

• Type B (Bizarre)

• Type C (Continuous/Cumulative)

• Type D (Delayed)

Types of ADRs [4]

a. Type A (Augmented)

[TYPES OF ADRs]

• Extension of drug MOAs

• Common

• Predictable

• Dose-dependent

• Reproducible

• Can result from concomitant disease states and drug interactions

• Discovered even before the drug is marketed

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

a. Type A (Augmented)

[TYPES OF ADRs]

Extension of drug MOAs

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

a. Type A (Augmented)

[TYPES OF ADRs]

• Common

• Predictable

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

a. Type A (Augmented)

[TYPES OF ADRs]

Dose - dependent

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

a. Type A (Augmented)

[TYPES OF ADRs]

Reproducible

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

a. Type A (Augmented)

[TYPES OF ADRs]

Can result from concomitant disease states and drug interactions.

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

a. Extension effect

[TYPES OF ADRs]

Related to the pharmacological activity of the drug

a. Extension effect

b. Side effect

b. Hypoglycemia

[Type A ADRs - Extension Effect]

Extension effect of oral sulfonylureas.

a. Tachycardia
b. Hypoglycemia
c. Bleeding
d. Sedation

c. Tachycardia

[Type A ADRs - Extension Effect]

Extension effect of Albuterol.

a. Hypoglycemia
b. Diarrhea
c. Tachycardia
d. Alopecia

c. Sedation

[Type A ADRs - Extension Effect]

Extension effect of CNS depressants.

a. Bleeding
b. Hypokalemia
c. Sedation
d. Serotonin syndrome

d. Bleeding

[Type A ADRs - Extension Effect]

Extension effect of anticoagulants.

a. Diarrhea
b. Alopecia
c. Hypoglycemia
d. Bleeding

b. Diarrhea (disturbance of normal flora)

[Type A ADRs - Extension Effect]

Extension effect of antibiotics

a. Tachycardia
b. Diarrhea
c. Sedation
d. Hypokalemia

a. Serotonin syndrome (increased serotonin levels = fever, confusion, nausea and vomiting).

[Type A ADRs - Extension Effect]

Extension effect of SSRIs

a. Serotonin syndrome
b. Hypoglycemia
c. Alopecia
d. Hyponatremia

b. Fever, confusion, nausea and vomiting

[Type A ADRs - Extension Effect]

Extension effect of SSRIs is serotonin syndrome characterized by:

a. Hypoglycemia and tachycardia
b. Fever, confusion, nausea and vomiting
c. Bleeding and alopecia
d. Sedation and hypokalemia

c. Alopecia

[Type A ADRs - Extension Effect]

Extension effect of anticancer drugs.

a. Diarrhea
b. Bleeding
c. Alopecia
d. Tachycardia

c. Both a and b

• Hypokalemia

• Hyponatremia

[Type A ADRs - Extension Effect]

Extension effect of loop diuretics.

a. Hypokalemia
b. Hyponatremia
c. Both a and b
d. Serotonin syndrome

b. Side effect

Not related to the pharmacological activity of the drug

a. Extension effect

b. Side effect

b. Constipation

[Type A ADRs - Side Effect]

Side effect of opiates.

a. Cough
b. Constipation
c. Headache
d. Sedation

c. Cough

[Type A ADRs - Side Effect]

Side effect of ACE inhibitors (ACEI).

a. Hirsutism
b. Constipation
c. Cough
d. Vasodilation

c. Hirsutism (increased hair on parts of the body)

[Type A ADRs - Side Effect]

Side effect of Minoxidil.

a. Headache
b. Sedation
c. Hirsutism
d. Cough

b. Sedation

[Type A ADRs - Side Effect]

Side effect of antihistamines.

a. Constipation
b. Sedation
c. Headache
d. Vasodilation

d. Headache

[Type A ADRs - Side Effect]

Side effect of nitroglycerin (NTG).

a. Cough
b. Hirsutism
c. Constipation
d. Headache

c. Vasodilation

[Type A ADRs - Side Effect]

Side effect of nitrates.

a. Sedation
b. Headache
c. Vasodilation
d. Constipation

b. Type B (Bizarre)

[TYPES OF ADRs]

• Unrelated to MOA

• Idiosyncratic reaction

• Uncommon

• Unpredictable

• Dose-independent

• Not reproducible

• May be influenced by genetic and environmental factors

• Frequently not discovered until after a drug is marketed

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]
Unrelated to mechanism of action (MOA).

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]

Idiosyncratic reaction

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]

Uncommon and Unpredictable

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]

Dose-independent

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]

Not reproducible

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Continuous/Cumulative)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]

May be influenced by genetic and environmental factors

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Chronic)

d. Type D (Delayed)

b. Type B (Bizarre)

[TYPES OF ADRs]

Frequently not discovered until after a drug is marketed.

a. Type A (Augmented)

b. Type B (Bizarre)

c. Type C (Chronic)

d. Type D (Delayed)

a. Idiosyncrasy

[TYPES OF ADRs]

Generally determined reactions.

a. Idiosyncrasy
b. Allergy
c. Tolerance
d. Tachyphylaxis

a. Neuroleptic malignant syndrome (fever, muscle rigidity, confusion)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of Antipsychotic agents:

a. Neuroleptic malignant syndrome
b. Hemolytic anemia
c. Stevens-Johnson Syndrome
d. Red Man Syndrome

• Fever

• Muscle rigidity

• Confusion

[Type B ADRs - Idiosyncracy]

Neuroleptic malignant syndrome is characterized by:

a. Fever, muscle rigidity, confusion
b. Hypotension, flushing
c. Hemolytic anemia
d. Blistering of skin

b. Hemolytic anemia

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of G6PD Deficiency + antimalarials / sulfa drugs.

a. Neuroleptic malignant syndrome
b. Hemolytic anemia
c. Stevens-Johnson Syndrome
d. Red Man Syndrome

c. Stevens-Johnson Syndrome (SJS)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from anticonvulsants, NSAIDs, penicillin, sulfonamides involving <30% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

c. <30%

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from anticonvulsants, NSAIDs, penicillin, sulfonamides involving _______ % of the body.

a. ≥80%
b. <10%
c. <30%
d. ≥50%

c. Stevens-Johnson Syndrome (SJS)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of Anticonvulsants involving <30% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

c. Stevens-Johnson Syndrome (SJS)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of NSAIDs involving <30% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

c. Stevens-Johnson Syndrome (SJS)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of Penicillin involving <30% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

c. Stevens-Johnson Syndrome (SJS)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of Sulfonamides involving <30% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

a. Toxic Epidermal Necrosis (TEN)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from anticonvulsants, barbiturates, hydantoins, penicillin, sulfonamides involving ≥80% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

a. Toxic Epidermal Necrosis (TEN)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from Anticonvulsants involving ≥80% of the body.
a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

a. Toxic Epidermal Necrosis (TEN)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from Barbiturates involving ≥80% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

a. Toxic Epidermal Necrosis (TEN)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from Hydantoins involving ≥80% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

a. Toxic Epidermal Necrosis (TEN)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from Penicillins involving ≥80% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

a. Toxic Epidermal Necrosis (TEN)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction from Sulfonamides involving ≥80% of the body.

a. Toxic Epidermal Necrosis (TEN)
b. Red Man Syndrome
c. Stevens-Johnson Syndrome (SJS)
d. Hemolytic anemia

d. Red Man Syndrome (pseudoallergic reaction)

[Type B ADRs - Idiosyncracy]

Idiosyncratic reaction of Vancomycin.

a. Neuroleptic malignant syndrome
b. Hemolytic anemia
c. Stevens-Johnson Syndrome
d. Red Man Syndrome (pseudoallergic reaction; symptoms: hypotension, flushing; treatment: Diphenhydramine)

b. Hypotension and flushing

[Type B ADRs - Idiosyncracy]

Vancomycin causes Red Man Syndrome (pseudoallergic reaction) with symptoms of:

a. Fever and muscle rigidity
b. Hypotension and flushing
c. Hemolytic anemia
d. Blistering of skin

b. Diphenhydramine

[Type B ADRs - Idiosyncracy]

Vancomycin causes Red Man Syndrome (pseudoallergic reaction) with symptoms of hypotension and flushing; treatment is ______

a. Epinephrine
b. Diphenhydramine
c. Corticosteroids
d. Albuterol

b. Hypersensitivity reactions

Immune responses to environmental antigens resulting in symptomatic reactions upon secondary exposure to the same antigen, commonly referred to as allergens.

a. Idiosyncrasy

b. Hypersensitivity reactions

c. Dose-dependent reactions

d. Type A ADRs

b. Allergens

[HYPERSENSITIVITY REACTIONS]

Hypersensitivity reactions are immune responses to environmental antigens resulting in symptomatic reactions upon secondary exposure to the same antigen, commonly referred to as _______

a. Antibodies
b. Allergens
c. Histamines
d. Cytokines

• IgG

• IgA

• IgM

• IgD

• IgE

📌Mnemonic: “GAMDE”

[IMMUNOGLOBULINS]

Immunoglobulins include ______ [5]

a. IgG

[IMMUNOGLOBULINS]

Can traverse placenta

a. IgG

b. IgA

c. IgM

d. IgD

e. IgE

b. IgA

[IMMUNOGLOBULINS]
Present in bodily secretions

a. IgG

b. IgA

c. IgM

d. IgD

e. IgE

c. IgM

[IMMUNOGLOBULINS]
First to respond in infection (malaki, mauuna)

a. IgG

b. IgA

c. IgM

d. IgD

e. IgE

d. IgD

[IMMUNOGLOBULINS]
Presents itself with β cells

a. IgG

b. IgA

c. IgM

d. IgD

e. IgE

e. IgE

[IMMUNOGLOBULINS]
Allergic reactions

a. IgG

b. IgA

c. IgM

d. IgD

e. IgE

• IgG

• IgD

• IgE

[IMMUNOGLOBULINS]

Immunoglobulins Monomers [3]

IgA

[IMMUNOGLOBULINS]

Immunoglobulins Dimer

IgM

[IMMUNOGLOBULINS]

Immunoglobulins Pentamer

a. Monomer

[IMMUNOGLOBULINS]

IgG

a. Monomer

b. Dimer

c. Pentamer

b. Dimer

[IMMUNOGLOBULINS]

IgA

a. Monomer

b. Dimer

c. Pentamer

c. Pentamer

[IMMUNOGLOBULINS]

IgM

a. Monomer

b. Dimer

c. Pentamer

a. Monomer

[IMMUNOGLOBULINS]

IgD

a. Monomer

b. Dimer

c. Pentamer

a. Monomer

[IMMUNOGLOBULINS]

IgE

a. Monomer

b. Dimer

c. Pentamer

a. Type I

[BIZARRE ADRs]

IgE-mediated

a. Type I

b. Type II

c. Type III

d. Type IV

a. Type I

[BIZARRE ADRs]

Anaphylactic reaction

a. Type I

b. Type II

c. Type III

d. Type IV

b. Type II

[BIZARRE ADRs]

IgG/IgM-mediated

a. Type I

b. Type II

c. Type III

d. Type IV

b. Type II

[BIZARRE ADRs]

Cytotoxic reaction

a. Type I

b. Type II

c. Type III

d. Type IV

c. Type III

[BIZARRE ADRs]

IgG-mediated

a. Type I

b. Type II

c. Type III

d. Type IV

c. Type III

[BIZARRE ADRs]

Immune complex reaction

a. Type I

b. Type II

c. Type III

d. Type IV

d. Type IV

[BIZARRE ADRs]

T cell-mediated

a. Type I

b. Type II

c. Type III

d. Type IV

d. Type IV

[BIZARRE ADRs]

Delayed reaction

a. Type I

b. Type II

c. Type III

d. Type IV

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Penicillin allergy is an example of which type of hypersensitivity reaction?

a. Type I (Immediate / Anaphylactic immune response)

b. Type II (Cytotoxic reactions)

c. Type III (Immune complex mediated hypersensitivity)

d. Type IV (Cell mediated / Delayed)

b. Type II (Cytotoxic reactions)

[BIZARRE ADRs]

Methyldopa and chloramphenicol-induced blood dyscrasias are examples of which type of hypersensitivity reaction?

a. Type I (Immediate / Anaphylactic immune response)

b. Type II (Cytotoxic reactions)

c. Type III (Immune complex mediated hypersensitivity)

d. Type IV (Cell mediated / Delayed)

c. Type III (Immune complex mediated hypersensitivity)

[BIZARRE ADRs]

HIPS (Hydralazine, Isoniazid, Procainamide, Sulfonamides) cause multi-system involvement in which type of hypersensitivity reaction?

a. Type I (Immediate / Anaphylactic immune response)

b. Type II (Cytotoxic reactions)

c. Type III (Immune complex mediated hypersensitivity)

d. Type IV (Cell mediated / Delayed)

d. Type IV (Cell mediated / Delayed)

[BIZARRE ADRs]

Dermatitis

Example: Urushiol , Tuberculin skin test

a. Type I (Immediate / Anaphylactic immune response)

b. Type II (Cytotoxic reactions)

c. Type III (Immune complex mediated hypersensitivity)

d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Most common category of allergic rxn

a. Type I (Immediate / Anaphylactic immune response)

b. Type II (Cytotoxic reactions)

c. Type III (Immune complex mediated hypersensitivity)

d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Occurs after antigen binds to IgE found on the surface of mast cells

a. Type I (Immediate / Anaphylactic immune response)

b. Type II (Cytotoxic reactions)

c. Type III (Immune complex mediated hypersensitivity)

d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Immediate/anaphylactic immune response

a. Type I (IgE-mediated)
b. Type II (IgG/IgM-mediated)
c. Type III (IgG-mediated)
d. Type IV (T cell-mediated)

• Anaphylaxis

• Hay fever

• Asthma

• Urticaria (hives)

[BIZARRE ADRs]

Examples of Type I (Immediate/anaphylactic immune response) [4]

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Anaphylaxis

a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Hay fever
a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Asthma

a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Urticaria (hives)

a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)

• Penicillins

• Cephalosporins

• Dextran

• Barium

[BIZARRE ADRs]

Drugs that cause Type I (Immediate/anaphylactic immune response) [4]

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Penicillins

a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Cephalosporins

a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)

a. Type I (Immediate / Anaphylactic immune response)

[BIZARRE ADRs]

Dextran

a. Type I (Immediate / Anaphylactic immune response)
b. Type II (Cytotoxic reactions)
c. Type III (Immune complex mediated hypersensitivity)
d. Type IV (Cell mediated / Delayed)