ADR

Question 1

What are adverse drug reactions (ADRs)?

Answer 1

Any response to drug which is noxious or unintended and occurs at doses used for prophylaxis, diagnosis or therapy.

ADRs are significant in clinical practice as they can lead to serious health issues.

Question 2

What is drug toxicity?

Answer 2

Toxic effects seen with overdose.

Question 3

What are the two main types of ADRs?

Answer 3

Type A (Augmented) and Type B (Bizarre).

Question 4

Describe Type A ADRs.

Answer 4

Related to dose, common, predictable, and reversible upon reducing dose.

Question 5

Give an example of a Type A ADR.

Answer 5

Hypoglycemia from insulin.

Question 6

Describe Type B ADRs.

Answer 6

Unrelated to pharmacological action, uncommon, unpredictable, and often irreversible.

Question 7

What is an example of a Type B ADR?

Answer 7

Anaphylaxis from penicillin.

Question 8

How are ADRs categorized according to severity?

Answer 8

1. Minor 2. Moderate 3. Severe 4. Lethal.

Question 9

What are side effects in the context of ADRs?

Answer 9

Effects that can be on-target or off-target.

Question 10

What is pharmacovigilance?

Answer 10

The science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Question 11

What are the clinical consequences of ADRs?

Answer 11

Drug-related hospital admission, prolongation of hospital stay, and emergency department visits.

Question 12

What are the economical consequences of ADRs?

Answer 12

Management of ADRs may cost up to 30.1 billion dollars annually in the USA.

Question 13

What are the mechanisms of adverse effects?

Answer 13

1. Toxin-induced cell damage and cell death 2. Immunological mechanisms 3. Mutagenesis and carcinogenicity 4. Teratogenesis and drug-induced fetal damage.

Question 14

Define teratogenesis.

Answer 14

Production of gross structural malformations during fetal development.

Question 15

What is off-label drug use?

Answer 15

Prescribing marketed drugs for an indication that has never been approved by the FDA.

Question 16

Provide an example of off-label drug use for Bupropion.

Answer 16

Smoking cessation.

Question 17

Fill in the blank: Pharmacovigilance aims at identifying drug safety signals as early as possible to minimize potential clinical and _______.

Answer 17

economic consequences of ADRs.

Question 18

True or False: Type A ADRs are always reversible.

Answer 18

False.

Question 19

What are the common consequences of Type B ADRs?

Answer 19

Immuno-allergic reactions, metabolic intolerance, and idiosyncratic effects.

Question 20

What is the impact of ADRs on hospital admissions in the USA?

Answer 20

ADRs account for 4.2-30% of hospital admissions.

Question 21

What is an example of an immunological mechanism of ADR?

Answer 21

Anaphylactic shock from penicillin.

Question 22

What type of hypersensitivity is associated with allergic liver damage?

Answer 22

Type II and III hypersensitivity.

Question 23

What is the role of DNA repair in carcinogenesis?

Answer 23

It acts as a protective mechanism against mutations.

Question 24

List the stages of fetal development affected by teratogenic drugs.

Answer 24

• Blastocyte formation
• Organogenesis
• Histogenesis and function maturation.

Question 25

What is the consequence of administering folate during pregnancy?

Answer 25

It reduces the frequency of both spontaneous and drug-induced malformations.

Question 26

Name a drug used off-label for chronic insomnia.

Answer 26

Quetiapine.

Question 27

Fill in the blank: The economic impact of ADRs in the USA may cost up to _______ annually.

Answer 27

30.1 billion dollars.