Adverse Drug Reactions and Interactions

Question 1

Define Side Effect

Answer 1

Involves the unintended effects when a drug is given at normal doses

Question 2

Define Adverse Event

Answer 2

Dose not imply a known or suspicion of a causal relationship between drug exposure and an event

Question 3

Define Adverse Drug Reaction

Answer 3

Involves the suspicion of a causal relationship between drug exposure and the occurrence

Question 4

What are misconceptions about adverse drug reactions?

Answer 4

1. All serious ADRs are documented by the time a drug is marketed
2. It is difficult to determine if a drug is responsible
3. Should only be reported if one is certain of cause and effect
4. One reported case is not significant

Question 5

Define Signal Event

Answer 5

Reported information on a possible causal relationship between an adverse event and a drug. If serious, triggers a regulatory investigation

Question 6

What are some examples of high-risk drugs that are more likely to cause ADRs?

Answer 6

Drugs with narrow therapeutic windows:
- Digoxin
- Theophylline
- Heparin
CYP450 Polymorphisms
-Warfarin
-Codeine
- Antidepressants
Medications requiring monitoring
- opioids

Question 7

Characteristics of Type A Drug Reactions

Answer 7

1. Pharmacological Properties:
   - Defects in drug manufacturing
   - Changes in PK properties
   - PD: difference in target organ sensitivity
2. Dose Dependent
3. Often Predictable & Preventable
4. Usually mild

Question 8

Characteristics of Type B Drug Reactions

Answer 8

1. Allergic or Idiosyncratic effects
2. Not dose Depending
3. Three U’s
   - Unexpected
   - Unpredictable
   - Unavoidable

Question 9

What is a Type I Reaction?

Answer 9

Immediate Hypersensitivity

Question 10

What Immunoglobulin is involved in Type I Reactions?

Answer 10

IgE

Question 11

How is a Type I Reaction treated?

Answer 11

Prednisone and Epinephrine

Question 12

What are some examples of Type I Reactions?

Answer 12

Asthma, Hives, Food, Eczema

Question 13

What is a Type II Reactions?

Answer 13

Cytotoxic; Reaction time is minutes to hours

Question 14

What immunoglobulin is involved in Type II Reactions?

Answer 14

IgG / IgM

Question 15

What are some examples of Type II Reactions?

Answer 15

Autoimmune hemolytic anemia, drug induced immune thrombocytopenia, hemolytic disease of a newborn, Goodpasture syndrome

Question 16

What is a Type III Reaction?

Answer 16

Immune complex hypersensitivity

Question 17

How long does is take for Type III symptoms to form?

Answer 17

Take longer time. Symptoms appears 3 weeks after drug is ceased.

Question 18

What are some examples of Type III Reactions?

Answer 18

Lupus, RA

Question 19

What is a Type IV Reaction?

Answer 19

Delayed hypersensitivity

Question 20

How long does it take for Type IV symptoms to form?

Answer 20

24-72 hours

Question 21

What immunoglobulin is involved in Type III Reactions?

Answer 21

IgG

Question 22

What immunoglobulin is involved in Type IV Reactions?

Answer 22

Memory CD4 cells

Question 23

What are some examples of Type IV Reactions?

Answer 23

Poison Ivy, Nickel Allergy, TB Test

Question 24

What are Category A medications in the PLLR?

Answer 24

Medications that have a remote risk of fetal harm

Question 25

What are some examples of Category A medicaitons?

Answer 25

Folic Acid; Levothyroxine; Doxylamine; Vitamins (A, B12, C, D, E etc.) Nystatin (vaginal)

Question 26

What are Category B medications?

Answer 26

Medications that have a slightly more risk than A drugs or animal studies do not show a risk but controlled studies in women has failed to show a risk

Question 27

What are some examples of Category B medications?

Answer 27

Acetaminophen; Ondansetron; Metformin; Nitrofurantoin; Loratadine; Montelukast; Cetirizine; Diphenhydramine

Question 28

What are Category C Medications in the PLLR?

Answer 28

Medications that have a greater risk than B or no studies have been done on animals or women.

Question 29

What are some examples of Category C medications?

Answer 29

Albuterol, Sertraline (Zoloft), Fluoroquinolones, Sulfonamides, Lithium, Opioids (codeine, morphine, meperidine), Pseudoephedrine, Ibuprofen, other NSAIDs.

Question 30

What are Category D Medications in the PLLR?

Answer 30

Medications with proven risk of fetal harm. Studies in women show proof of fetal damage, but the potential benefits may be acceptable

Question 31

What are some examples of Category D medications?

Answer 31

Paroxetine (Paxil), Phenytoin (Dilantin), ACE-Inhibitors

Question 32

What are Category X medications in the PLLR?

Answer 32

Proven risk of fetal harm. Studies in women and animals show definite risk of fetal abnormality

Question 33

What are examples of Category X medications?

Answer 33

Isotretinoin (Accutane), Warfarin, Methotrexate

Question 34

Define PK DDIs

Answer 34

Frequently caused marked shifts in serum drug concentration and alter clinical response. Influences ADME of a drug.

Question 35

Define PD DDIs

Answer 35

Frequently associated with synergism, antagonism, or altered transport across the cell membrane, and the effect organ systems and/or receptor sites. Affect interaction at receptors

Question 36

High Risk Populations for DDIs

Answer 36

Elderly patients Critical Care Patients Patients with complications surgical patients (Only infants in critical care)

Question 37

Define synergistic

Answer 37

combined drug effects produce a response greater than the combination of the two drugs

Question 38

Define addtiive

Answer 38

combined drug effects produce a reaction that is equal to the combination fo the drugs (also called summative)

Question 39

Define Potentiation

Answer 39

one drug increases the effect of the other

Question 40

Define antagonist

Answer 40

one medication counteracts the effect of another drug