IPS1- Part 9- Adverse Drug Reaction

Proverbs 16:3

A

An injury resulting from the use of a drug. It includes both preventable (human errors, such as medication errors) and unpreventable (ADR) reaction

a. Adverse drug event

b. Adverse drug reaction

c. Unfortunate event

d. Drug interaction

B

Response to a drug that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis or therapy

a. Adverse drug event

b. Adverse drug reaction

c. Unfortunate event

d. Drug interaction

A

ADR is a case type of ADE

a. True

b. False

C

Expected and known effect of a drug that is NOT the intended therapeutic outcome

a. Adverse drug event

b. Adverse drug reaction

c. Side effect

d. Drug interaction

C

An ADR mediated by immune response

a. Adverse drug event

b. Adverse drug reaction

c. Allergy

d. Drug interaction

A

I. Augmented

II. Dose dependent, predictable, most common (75%)

III. Avoidable

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

A

Extension effect or side effect

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

A

Causes hypoglycemia

a. Sulfonylureas (OHA)

b. Furosemide (Loop Diuretics)

c. Antihistamine

d. Opioid analgesic

B

Cause loss of electrolytes

a. Sulfonylureas (OHA)

b. Furosemide (Loop Diuretics)

c. Antihistamine

d. Opioid analgesic

A

Causes sedation

a. Antihistamine

b. Nitroglycerin

c. ACE inhibitors

d. Opioid analgesic

C

Causes cough

a. Antihistamine

b. Nitroglycerin

c. ACE inhibitors

d. Opioid analgesic

B

Cause headache

a. Antihistamine

b. Nitroglycerin

c. ACE inhibitors

d. Opioid analgesic

D

Cause constipation

a. Antihistamine

b. Nitroglycerin

c. ACE inhibitors

d. Opioid analgesic

A

Causes GI irritation

a. NSAIDS

b. Minoxidil

c. Antineoplastic

d. Statins

B

Causes hypertrichosis

a. NSAIDS

b. Minoxidil

c. Antineoplastic

d. Statins

C

Causes alopecia

a. NSAIDS

b. Minoxidil

c. Antineoplastic

d. Statins

D

Causes rhabdomyolysis

a. NSAIDS

b. Minoxidil

c. Antineoplastic

d. Statins

B

I. Bizarre

II. Uncommon, not dose related

III. Non-predictable (not pharmacologically related)

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

Bizarre ADR

Idiosyncratic reaction

Hypersensitivity Reaction (Immunoglobulins)

Idiosyncratic reaction

Genetically determined

A

The following can lead to what type of bizarre ADR?

Antipsychotic agents

Vancomycin

Sulfonamides, Phenytoin, Carbamazepine

Antimalarial

a. Idiosyncratic

b. Immunologic

A

Can cause malignant hyperthermia

a. Antipsychotic agents

b. Vancomycin

c. Sulfonamides, Phenytoin, Carbamazepine

d. Antimalarial and sulfonamides

B

Can cause Red Man Syndrome

a. Antipsychotic agents

b. Vancomycin

c. Sulfonamides, Phenytoin, Carbamazepine

d. Antimalarial and sulfonamides

C

Can cause SJS

a. Antipsychotic agents

b. Vancomycin

c. Sulfonamides, Phenytoin, Carbamazepine

d. Antimalarial and sulfonamides

D

Can cause hemolytic anemia

a. Antipsychotic agents

b. Vancomycin

c. Sulfonamides, Phenytoin, Carbamazepine

d. Antimalarial and sulfonamides

Immunologic reactions or hypersensitivity

Immune responses to environmental antigens resulting in symptomatic reaction upon secondary exposure to the same antigen more commonly referred to as allergy

A

Immediate or anaphylactic immune response

IgE mediated

Most common type of allergic reaction

a. Type I

b. Type II

c. Type III

d. Type IV

A

Anaphylaxis from penicillins, hay fever, asthma (NSAID + aspirins), urticaria

a. Type I

b. Type II

c. Type III

d. Type IV

Treatment for anaphylaxis

Antihistamines

Epinephrine

Cromolyn sodium

Steroids

Cromolyn sodium

Mast cell stabilizers

Steroids

Help antihistamines or other medications to effect faster

B

I. Cytotoxic reactions

II. Mediated by IgG and IgM

III. Blood dyscrasias: hemolytic anemia, aplastic anemia, thrombocytopenia

a. Type I

b. Type II

c. Type III

d. Type IV

A

Can cause aplastic anemia

a. Chloramphenicol

b. Methyldopa

c. Aspirin/Ibuprofen

B

Can cause hemolytic anemia

a. Chloramphenicol

b. Methyldopa

c. Aspirin/Ibuprofen

C

Can cause Immune Thrombocytopenia (ITP)

a. Chloramphenicol

b. Methyldopa

c. Aspirin/Ibuprofen

C

I. Complex Hypersensitivity (IgG, IgM)

II. IgG and IgM mediated

III. Occurs when there is accumulation of immune complexes

a. Type I

b. Type II

c. Type III

d. Type IV

C

I. Drug induced serum sickness

II. Farmer's lung: Inflammation of alveoli

III. SLE or Systemic Lupus Erythematosus

IV. HIPPS

a. Type I

b. Type II

c. Type III

d. Type IV

D

I. Delayed or cell mediated

II. T-cell mediated

a. Type I

b. Type II

c. Type III

d. Type IV

D

Tuberculin skin test

Poison Ivy

Tissue or organ rejection

a. Type I

b. Type II

c. Type III

d. Type IV

D

Mycobacterium Tuberculosis - cause Mantoux reaction Atopic dermatitis

Tuberculosis

Pneumonitis

Granulomatosis with polyangiitis

a. Type I

b. Type II

c. Type III

d. Type IV

C

Addiction

Dependence

Tolerance

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

C

I. Continuous

II. Uncommon, dose and time related

III. Result from cumulative dose (repeated) of the drug

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

A

Person takes the drug compulsively despite potential harm and desire to stop

a. Addiction

b. Dependence

c. Tolerance

Marijuana

causes retardation

Cocaine

causes hole in the nose

B

Without the drug, the patient experience withdrawal effects

a. Addiction

b. Dependence

c. Tolerance

B

Benzodiazepines, caffeine, steroids can cause

a. Addiction

b. Dependence

c. Tolerance

d. Tachyphylaxis

C

Loss of response to the drug

a. Addiction

b. Dependence

c. Tolerance

d. Tachyphylaxis

C

Nicotine for smoking cessation (patch, gum, spray)

a. Addiction

b. Dependence

c. Tolerance

d. Tachyphylaxis

D

I. Delayed

II. Rare and usually dose related

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

D

Carcinogenicity and teratogenicity

a. ADR Type A

b. ADR Type B

c. ADR Type C

d. ADR Type D

Teratogenicity

Ability to cause fetal or congenital malformations. Risk is highest during the first trimester of the pregnancy.

A

Antineoplastic

Aromatic hydrocarbons

Heterocyclic amines

Aflatoxins

Nitrosamines

Diethylstilbesterol

Asbestos and hydrocarbons

a. carcinogenic

b. teratogenic

C

Causes vaginal adenocarcinoma and breast cancer

a. Aflatoxins

b. Nitrosamines

c. Diethylstilbesterol

d. Asbestos and hydrocarbons

B

Vitamin A Derivatives

Phenytoin

Valproic acid/Carbamazepine

ACEIs

Thalidomide

Lithium

Methimazole

Warfarin

Antineoplastic

Alcohol

Streptomycin

Tetracycline

Estrogen and Androgen

a. carcinogenic

b. teratogenic

A

Can cause heart and brain abnormality

a. Vitamin A Derivatives (isotretinoin, tretinoin, etretinate)

b. Phenytoin

c. Valproic acid/Carbamazepine

d. ACEIs

e. Thalidomide

B

Can cause fetal hydantoin syndrome or craniofacial defect

a. Vitamin A Derivatives

b. Phenytoin

c. Valproic acid/Carbamazepine

d. ACEIs

e. Thalidomide

C

Can cause neural tube defects which can be prevented by vitamin B9

a. Vitamin A Derivatives

b. Phenytoin

c. Valproic acid/Carbamazepine

d. ACEIs

e. Thalidomide

D

Can cause renal dysgenesis

a. Vitamin A Derivatives

b. Phenytoin

c. Valproic acid/Carbamazepine

d. ACEIs

e. Thalidomide

E

Can cause phocomelia.

a. Vitamin A Derivatives

b. Phenytoin

c. Valproic acid/Carbamazepine

d. ACEIs

e. Thalidomide

Antileprosy

Current use of thalidomide

A

Can cause Ebstein's anomaly which is a problem in tricuspid valve

a. Lithium

b. Methimazole

c. Warfarin

d. Antineoplastic

B

Causes aplasia cutis or the absence of epidermis (1st trimester)

a. Lithium

b. Methimazole

c. Warfarin

d. Antineoplastic

C

Can cause nasal hypoplasia and depressed nasal bridge (1st trimester)

a. Lithium

b. Methimazole

c. Warfarin

d. Antineoplastic

D

Embryocidal

a. Lithium

b. Methimazole

c. Warfarin

d. Antineoplastic

A

Fetal alcohol syndrome

a. Alcohol

b. Streptomycin

c. Tetracycline

d. Estrogen and Androgen

B

Can cause 8th nerve defect

a. Alcohol

b. Streptomycin

c. Tetracycline

d. Estrogen and Androgen

C

Can cause mottling and defects of teeth adn altered bone growth

a. Alcohol

b. Streptomycin

c. Tetracycline

d. Estrogen and Androgen

D

May cause serious genital tract malformation

a. Alcohol

b. Streptomycin

c. Tetracycline

d. Estrogen and Androgen

A

I. Controlled studies of pregnant women show no risk in first trimester

II. No evidence of risk to fetus

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

A

Levothyroxine

Folic acid

Magnesium sulfate

Liothyronine

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

B

Animal studies show no risk, there are no adequate studies in pregnant women, unconfirmed in humans

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

B

Metformin

Hydrochlorothiazide

Amoxicillin

Pantoprazole (PIP)

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

C

I. Animal studies have shown adverse effects

II. No adequate well controlled studies in human, caution is advised

III. Benefits may outweigh risks

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

C

Tramadol

Gabapentin

Amlodipine

Prednisone

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

D

I. Evidence of risk to human fetus

II. Benefits may outweigh risks in serious conditions

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

D

Lisinopril

Alprazolam

Losartan

Clonazepam

Lorazepam

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

E

I. Positive evidence of human fetal risk

II. Risk outweighs benefits

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

E

Statins: Atorvastatin, Simvastatin

Methotrexate

Finasteride

Warfarin

a. Category A

b. Category B

c. Category C

d. Category D

e. Category X

A

I. End of use

II. Uncommon

III. Withdrawal symptoms

a. ADR Category E

b. ADR Category F

c. ADR Category G

d. ADR Category H

A

I. Opiate withdrawal

II. Clonidine

III. Steroids

IV. Oxymetazoline

a. ADR Category E

b. ADR Category F

c. ADR Category G

d. ADR Category H

B

can cause rebound hypertension

a. Opiate withdrawal

b. Clonidine

c. Steroids

d. Oxymetazoline

C

can cause adrenal insufficiency (Addison's disease)

a. Opiate withdrawal

b. Clonidine

c. Steroids

d. Oxymetazoline

D

can cause rhinitis medicamentosa (rebound congestion)

a. Opiate withdrawal

b. Clonidine

c. Steroids

d. Oxymetazoline

B

I. Failure of therapy

II. Common

III. Can be dose related

a. ADR Category E

b. ADR Category F

c. ADR Category G

d. ADR Category H

B

Lack of efficacy

Poor patient compliance

Counterfeit drugs

Drug interactions

Antimicrobial resistance

Inappropriate use/wrong route of administration

Underdosing

Manufacturing errors/toxic excipients

Expired drugs

a. ADR Category E

b. ADR Category F

c. ADR Category G

d. ADR Category H

D

Repeated administration decrease effectiveness

a. Addiction

b. Dependence

c. Tolerance

d. Tachyphylaxis