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OTC Theraputics > Exam 1 > Flashcards

Exam 1 Flashcards

OTC drug requirements, Drug references, Nutrients

1
Q

What are the 2 routes for marketing nonprescription drug products?

A

OTC Monograph and NDA

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2
Q

What is the act that regulates dietary supplements?

A

1994 Dietary Supplement Health and Education Act (DSHEA)

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3
Q

What is the act that required proof of safety pre-approval?

A

Federal Food, Drug, and Cosmetic Act of 1938 (FDCA)

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4
Q

What is the amendment that required efficacy pre-approval?

A

Kefauver-Harris Amendment of 1962

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5
Q

What are the 7 defining criteria for serious adverse events?

A
  1. Death
  2. Life-threatening
  3. Hospitalization (initial or prolonged)
  4. Disability or permanent damage
  5. Congenital anomaly/ birth defect
  6. Intervention required to prevent permanent impairment or damage
  7. Other serious medical events

DIOHC on the DL

diiiiiooooohccccc on the down low

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6
Q

What is the definition of dietary supplements?

A

Dietary supplements include vitamins, minerals, herbs, botanicals, and amino acids.

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7
Q

What are the general FDA criteria for a drug to be considered for nonprescription status?

A
  1. Drug can be used by consumer guided by the product label such that the consumer can self-diagnose, self-treat, and self-manage
  2. No health care provider is needed for safe and effective use of the drug
  3. Low potential for abuse and misuse
  4. Adequate labelling
  5. Safety margin
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8
Q

What does GRASE mean?

A

Generally recognized as safe and effective

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9
Q

What were the key provisions of the DSHEA act?

A
  1. Dietary supplements are distinct from food and drugs
  2. No requirement for proof of safety and efficacy
  3. Allowed to make “structure and function” claims
  4. FDA bears burden of proof for unsafe
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10
Q

What are characteristics of a monograph for nonprescription drugs?

A
  1. No premarket approval
  2. Public
  3. Applies to all products with the ingredient
  4. User fees under the CARES act
  5. 18-month exclusivity
  6. Good manufacturing practices apply
  7. No clinical development required
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11
Q

What are the characteristics of a New Drug Approval (NDA) for nonprescription drugs?

A
  1. Premarket approval
  2. Confidential
  3. Drug product specific
  4. Potential for market exclusivity
  5. Application filling fees
  6. Good manufacturing practices apply
  7. Clinical development required
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12
Q

What are the requirements for the drugs fact label (DFL) on nonprescription drugs?

A
  1. “Drug fact” title
  2. Active ingredients
  3. Purpose
  4. Uses
  5. Warnings (Do not use, Ask doctor before use, ask doctor or pharmacist before use, stop use and ask doctor)
  6. Directions for use
  7. Other information
  8. Inactive ingredients (ABC order)
  9. Questions and comments (optional)
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13
Q

What amendment provided a statutory basis of 2 classes of drugs (prescription and nonprescription)?

A

Durham-Humphrey Amendment of 1951

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14
Q

What are the 3 classes of drug recalls?

A

Class 1- reasonable probability for serious adverse health consequences.

Class 2- may cause temporary or medically reversible adverse health consequences. The probability of serious adverse health consequences is remote.

Class 3- not likely to cause adverse health consequences but does violate FDA labeling or manufacturing laws.

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15
Q

Who regulates OTC advertising?

A

Federal Trade Commission (FTC)
Advertising must be truthful and not misleading

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16
Q

Who regulates OTC drugs?

A

FDA

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17
Q

What route needs to be taken to switch a drug from prescription to nonprescription status?

A

An NDA needs to be filled out. It can be an NDA supplement which is an abbreviated NDA.

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18
Q

What is the packaging requirement for OTC drugs?

A

OTC drugs require tamper-evident packaging

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19
Q

What is the process for adding, changing, or removing GRASE conditions from an OTC monograph?

A

The new CARE act allows this process to be an administrative order process that can be initiated by the FDA or the industry. It can be expedited to address safety issues.

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20
Q

Who regulates dietary supplements?

A

FDA Center for Food Safety and Applied Nutrition as food

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21
Q

What reference is availablle to find medication related issues in the geriatric population?

A

Geriatric Lexi-drug

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22
Q

What sections are required in labeling related to pregnancy and lactation?

A

Sections no longer include the pregnancy categories. Labelling is required to have 3 narrative sections.

  1. Pregnancy
  2. Lactation
  3. Females and Males of Reproductive Potential
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23
Q

T or F: Labeling for OTC medicines are not required to comply with the Pregnancy and Lactation Labeling Rule.

A

True

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24
Q

What is included in the pregnancy section of OTCs?

A

Pregnancy- information on risk summary, clinical considerations, and data.
Information for the pregnancy exposure registry for drug is included

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25
Q

What is included in the lactation section of OTCs?

A

Lactation- information about using the drug while breastfeeding including the amount in the breastmilk and potential effects on the infant.

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26
Q

What is included in the Females and Males of Reproductive Potential section on OTCs?

A

Females and Male Reproductive Potential- NEW subsection. Information including pregnancy testing, contraceptive methods, and information about infertility.

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27
Q

What are the universal principles for medication selection in pregnancy?

A
  1. Try non-drug routes if possible
  2. Try to avoid any drug in the 1st trimester
  3. Older drugs have more pregnancy data
  4. Decrease fetal drug exposure
  5. OTCs should only be used if the benefit to mother outweighs the risk to the fetus or nursing infant
    (Is the drug therapy necessary? Is the safest drug being used? Can the dose be adjusted to minimize exposure to fetus/infant? Is a different route of administration safer?
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28
Q

Microcytic anemia treatment?

A

Iron

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29
Q

Macrocytic anemia treatment (megaloblastic anemia)?

A

B12 and Folate

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30
Q

How much of your grains from MyPlate should be whole grains?

A

1/2

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31
Q

What is the maximum dose of calcium per dose?

A

500mg- anymore than that will not be absorbed

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32
Q

Does calcium have a UL?

A

Yes, 2,500mg. Too much calcium can cause kidney stones

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33
Q

What are the recommendations for OTC drug use during lactation?

A
  1. Advise using non-pharmacologic first
  2. If drugs cannot be avoided then use the lowest dose for the shortest amount of time
  3. Avoid nursing during peak drug concentration
  4. Dose after feeding or take medications before the infant’s longest sleep period
  5. Use alternative feedings for 1-2 feedings after the dose
  6. Avoid recommending combination products
  7. Counsel about potential side effects to infant
  8. Remember that some medications can reduce milk supply
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34
Q

What are the characteristics of drug transfer during lactaction?

A
  1. Maternal blood levels- a higher dose means a higher transfer
  2. Plasma protein binding- more protein bound means a lower amount transferred
  3. Lipid soluble- more lipophilic means higher transfer
  4. Molecular weight- the bigger the drug the lower the transfer
  5. Half-life- a shorter half-life means less transfer
  6. Ionization- breast milk is more acid than plasma so weak base drugs can be transferred
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35
Q

What are the different gestational ages?

A

First trimester- 1-12 weeks
Second trimester- 13-27 weeks
Third trimester- 28-40 weeks

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36
Q

What is the age range for a neonate?

A

0-27 days

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37
Q

What is the age range for an infant/toddler?

A

28 days- 23 months

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38
Q

What is the age range for children?

A

2-11 years

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39
Q

What is the age range for adolescents?

A

12-18 years

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40
Q

What are the drug administration guidelines for toddlers?

A
  1. Allow toddler to choose position to take medication
  2. Disguides medication with small amount of drink or food
  3. Do not refer to as candy
  4. Use simple commands in the toddler’s word to obtain cooperation
  5. Allow toddler to decide which medication to take first if more than one
  6. provide verbal and tactile responses to promote cooperation
  7. Allow toddler to become familiar with oral dosing device
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41
Q

What are the OTC drug considerations for older adults?

A
  1. Polypharmacy
  2. Lifestyle behavior changes
  3. Burdensome self-care tasks like managing conditions
  4. High prevelance of functional limitations
  5. Affected self-care ability
  6. Frequent physician visits with many prescribers
  7. Frequent pharmacy visits
  8. Financial costs
  9. Changes in cognition
  10. Decreased visual acuity
  11. Behavorial health issues
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42
Q

What are the age-related changes in pharmacokinetics in older adults?

A
  1. Decreased GIT secretions, motility, surface area, and blood flow
  2. Increased pH of stomach
  3. Decreased total body water and muscle mass
  4. Increased body fat
  5. Decreased hepatic blood flow, enzyme activity, and renal function
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43
Q

What are the 5 exclusions for self-treatment?

A
  1. Symptoms are beyond the scope of self-treatment
  2. Patient specific factors preclude treatment with OTCs
  3. Patient health status or history precludes self-treatment
  4. OTC not indicated for the disorder
  5. Previous treatment with OTC was ineffective after adequate trial
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44
Q

What are the 5 components of the pharmacist patient care process (PPCP)?

A
  1. Collect
  2. Assess
  3. Plan
  4. Implementation
  5. Follow-up: monitor and evaluate
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45
Q

What is QUest-SCHOLAR?

A

This is the way that patient in community pharmacy should have information collected in order to advise appropriate medications.

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46
Q

What does SCHOLAR stand for?

A

S- Symptoms
C- Characteristics
H- History
O- onset
L- location
A- aggravating factors
R- remitting factors

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47
Q

What does the QU stand for in QUest?

A

Quickly and accurately assess the patient

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48
Q

What does the E stand for in QUest?

A

Establish the patient is an appropriate candidate for self-care

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49
Q

What does the S stand for in QUest?

A

Suggest appropriate self-care strategies

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50
Q

What does the T stand for in QUest?

A

Talk with patient

How the drug works, administration, side effects and what to expect from the treatment

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51
Q

What are resources that can be used regarding lactation and drugs?

A

Lactmed, Brigg’s, Lexicomp, Micromedex, and Clinical pharmacology

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52
Q

What are the resources that can be used regarding pregnancy and lactation and drugs?

A

Brigg’s, Lexicomp, micromedex, and clinical pharmacology

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53
Q

What are the administrations guidelines for infants?

A
  1. Use a calibrated dropper or syringe
  2. If dropped is used, squirt into side of cheek
  3. Do not put medication into formula
  4. Support infant’s head while holding the lap
  5. Give small amounts to prevent choking
  6. Allowed to crush non-enteric-coated tablets into a powder and sprinkle into food
  7. Provide comfort while giving medications.
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54
Q

What are the nutrients for concern for vegans and vegetarians?

A

Protein, essential fatty acids, iron, iodine, vitamin D, and vitamin B12

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55
Q

What are the nutrient concerns for the elderly?

A

Vitamin D, Vitamin B12, Potassium, and Calcium

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56
Q

What are the micronutrients of concern for the US population as a whole?

A

Calcium, potassium, iron, and
vitamin D

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57
Q

What are ultra-processed foods?

A

Ultra-processed foods go beyond the incorporation of salt, sugar, and fat to include artificial colors and flavors, emulsifiers, and artificial sweeteners that promote shelf stability, preserve and enhance texture, and increase palatability.

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58
Q

What are processed foods?

A

Processed foods have added salt, sugar, and/or fat and are derived from natural or minimally processed foods.

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59
Q

What are minimally processed foods?

A

Minimally processed food have been changed physically by being slightly altered so they can be easily stored, prepared, and eaten.

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60
Q

What are unprocessed foods?

A

Unprocessed foods are foods in their natural state and are free of added ingredients.

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61
Q

What are refined foods?

A

Refined means that the food has been processed and their nutrition has been modified.

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62
Q

What is enrichment?

A

Enrichment is the process of adding nutrients back to foods that were lost during processing. (ie; bread, flour, pasta, rice)

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63
Q

What is fortification?

A

Fortification is the process of adding extra nutrients to food or adding nutrients that are not normally there. (ie; orange juice, milk, tofu)

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64
Q

What are essential nutrients?

A

Essential nutrients are nutrients that the body cannot make. Includes carbs, proteins, fats, minerals, vitamins, and water.

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65
Q

What is a micronutrient?

A

Micronutrients are vitamins and minerals that the body needs in small amounts.

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66
Q

What is a macronutrient?

A

Macronutrients include carbohydrates, proteins, and fats that are required in large amounts from the diet.

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67
Q

What is vitamin D2?

A

Vitamin D2 is known as ergocalciferol. It comes from ergosterols, plant sterols, and yeast.

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68
Q

What is vitamin D3?

A

Vitamin D3 is known as cholecalciferol. It is synthesized in the skin by 7-dehydrocholesterol which is a cholesterol precursor.

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69
Q

Where is vitamin D2 sourced in vitamin D2 supplements?

A

Vitamin D2 in supplements is made by irradiating ergosterol from yeast.

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70
Q

Where is vitamin D3 sourced in vitamin D3 supplements?

A

Vitamin D3 in supplements is made by irradiating 7-dehydrocholesterol from lanolin.

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71
Q

Both vitamin D2 and D3 are effective at raising _____________ levels.

A

Vitamin D

72
Q

At high doses, vitamin D3 seems to be almost _________ as potent compared to vitamin D2.

A

Twice

73
Q

Meta-analysis of fracture studies suggest that ____________ is more effective for reducing fracture risk.

A

Cholecalciferol (Vitamin D3)

74
Q

What are the disease and conditions associated with the malabsorption of fat-soluble vitamins?

A

Celiac disease, cystic fibrosis, bariatric surgery aftermath, and short bowel syndrome

75
Q

What are the different compounds that interact with calcium?

A

Iron, zinc, and magnesium
Corticosteroids
Aluminum-containing antacids, phosphates, and cholestyramine
Histamine-2 Receptor Antagonist (H2RAs), and PPIs
Levothyroxine
Tetracyclines and fluroquinolones
Phenytoin, carbamazepine, and phenobarbital

76
Q

How do calcium and minerals like iron, zinc, and magnesium interact?

A

High calcium intake inhibits the absorption of minerals like iron, zinc, and magnesium. The clinical recommendation is to separate calcium and iron, zinc, and magnesium dosing by 2 hours.

77
Q

How does calcium interact with corticosteroids?

A

Corticosteroids inhibit calcium absorption from the gut leading to increased bone fractures and risk for osteoporosis. The clinical recommendation is to take calcium supplementation if on corticosteroids.

78
Q

What is the interaction between calcium and aluminum-containing antacids, phosphates, and cholestyramine?

A

These compounds decrease calcium absorption. The clinical recommendation is to separate dosing by 2 hours.

79
Q

What is the interaction between calcium and H2RAs and PPIs?

A

H2RAs and PPIs decrease the absorption of calcium carbonate at it requires an acidic environment to be absorbed and these drugs decrease the acidity of the stomach. The clinical recommendation is calcium citrate supplementation if taking these medications.

80
Q

What are the different types of calcium?

A

Calcium Carbonate
Calcium Citrate
Calcium Lactate
Calcium Gluconate

81
Q

Is it better to take calcium with food or on an empty stomach?

A

It is better to take calcium supplements with food to improve absorption.

82
Q

Which form of calcium is best absorbed in the elderly population and those on anti-ulcer medications?

A

Calcium Citrate

83
Q

What is the interaction between calcium and levothyroxine?

A

Calcium reduces the drug absorption of levothyroxine. The clinical recommendation is to separate dosing by 4 hours.

84
Q

What is the interaction between calcium and tetracyclines and fluoroquinolones?

A

Calcium decreases the absorption of these antibiotics. The clinical recommendation is to separate dosing by 2 hours before the ingestion of the antibiotic or 6 hours after taking the antibiotic.

85
Q

What is the interaction between calcium and phenytoin, carbamazepine, and phenobarbital?

A

These drugs decrease calcium absorption by increasing the metabolism of vitamin D. The clinical recommendation is to supplement vitamin D and calcium.

86
Q

What are the different compounds that interact with iron?

A

Antacids, tetracyclines and fluoroquinolones, and levothyroxine.

87
Q

What is the interaction between iron and antacids?

A

Antacids decrease iron solubility and absorption. The clinical recommendation is to separate dosing by 2 hours.

88
Q

What is the interaction between iron and tetracyclines and fluroquinolones?

A

Together the antibiotic and iron absorption is decreased. If concurrent administration is medically necessary then take antibiotic 2 hours before or 6 hours after taking iron.

89
Q

What is the interaction between iron and levothyroxine?

A

Iron decreased absorption of levothyroxine. The clinical recommendation is to separate dosing by 4 hours.

90
Q

What are the vitamins and minerals important for children?

A

Vitamin D and Iron

91
Q

What are some foods that are high in potassium?

A

Bananas, beet greens, juices (carrot, prune, pomegranate), milk, oranges and orange juice, potatoes and sweet potatoes, spinach, tomates, white beans, yogurt, etc.

92
Q

What are foods high in vitamin K?

A

Green leafy vegetables like broccoli, kale, spinach, turnip greens, collards, etc.

93
Q

What are foods high in vitamin D?

A

Eggs, fish, fish liver oil, fortified cereals, fortified dairy products, fortified margarine, fortified orange juice, fortified soy beverages, etc.

94
Q

What is true about fish oil?

A

Fish oil may prevent heart disease

95
Q

What are foods high in calcium?

A

Almond, rice, coconut, and hemp milks, canned seafood with bones, dairy products, fortified cereals and juices, fortified soy beverages, green vegetables, tofu made with calcium sulfate, etc.

96
Q

What are foods high in iron?

A

Beans, peas, dark green vegetables, meats, poultry, prunes, raisins, seafoods, whole grains, enriched and fortified cereals and breads.

97
Q

Which vitamin may improve immune function?

A

Vitamin C

98
Q

Which mineral may boost immune function?

A

Zinc

99
Q

Which mineral may decrease nausea and vomiting in pregnancy?

A

Vitamin B6

100
Q

Which vitamin K type is found in food?

A

Phytonadione

101
Q

What vitamin is involved in clotting factors?

A

Vitamin K

102
Q

Which vitamin decreases the effects of warfarin?

A

Vitamin K

103
Q

What are the common drugs that can cause B12 deficiency?

A

Metformin, PPIs, and Histamine 2 Receptor Antagonists (H2RAs)

104
Q

What are factors that can cause nutritional deficiencies?

A

**Substance abuse, poverty, eating disorders, dementia, and restrictive diets.
Consumption of energy-dense but nutrient-poor foods.
Poor dentition, swallowing, and xerostomia.
Loss of taste, smell, and sight perception.
Decreased absorption due to cystic fibrosis, short bowel syndrome, Roux-en-Y gastric, gastric hypochlorhydria, chronic diarrhea.
Not able to buy or prepare meals due to tremor, fatigue, or arthritic pain.
Anorexia
Lack of knowledge about nutrition
Increased losses due to hemodialysis therapy.
Inadequate synthesis of nutrients.
Abnormal metabolism due to alcoholism, genetic polymorphisms.
Increased metabolic requirements due to severe injury, infection, trauma, pregnancy, or prolonged physical exercise.
Medications affecting judgement, coordination, memory, appetite, nutrient absorption, gastric pH, and GIT function.

105
Q

What is the vitamin that helps to strengthen nails and hair?

A

Biotin

106
Q

Regarding MyPlate, how much of the plate should be healthy proteins?

A

1/4

107
Q

Regarding MyPlate, what portion of the plate should be fruits and veggies?

A

1/2

108
Q

What illustrates the 5 food groups that are the building blocks for a healthy diet?

A

MyPlate

109
Q

What are the 3 forms of iron?

A

Iron Sulfate
Iron Fumarate
Iron Gluconate

110
Q

What type of iron contains the lowest amount of elemental iron?

A

Iron Gluconate (12%)

111
Q

What type of iron contains the highest amount of elemental iron?

A

Iron Fumarate (33%)

112
Q

What are the most common micronutrient deficiencies in the US population?

A

Calcium, iron, potassium, and vitamin D

113
Q

Which calcium product type is best absorbed regardless of stomach pH?

A

Calcium citrate (Citracal)

114
Q

What are the key things that should be mentioned when counseling on iron?

A

Iron is best to take on an empty stomach to improve absorption but it can be taken with food if upset stomach and nausea develops. Iron supplementation can result in constipation, dark stools, and a metallic taste in mouth.

115
Q

What are the key things that should be mentioned when counseling on calcium?

A

Calcium should be taken with food for better absorption. Do not take more than 500mg at a time.

116
Q

What is the calcium requirements for men younger than 71 years old?

A

1,000 mg/day

117
Q

What is the calcium requirement for women older than 50 years?

A

1,200mg/day

118
Q

What is the calcium requirement for women younger than 50 years?

A

1000mg/day women ages 19-50

119
Q

What are the micronutrient needs during pregnancy?

A

Iron, Calcium, Folic acid, Vitamin D, Omega-3 FA, and Iodine

120
Q

What are the effects of Niacin?

A

Niacin lowers cholesterol, specifically triglycerides.

121
Q

What is the difference between folic acid and folate?

A

Folate is the naturally occuring version in foods while folic acid is the synthetic version.

122
Q

Why is folate important to take during pregnancy?

A

Folate aids in spinal cord developments and prevent megaloblastic anemia.

123
Q

Deficiency of ____________ can cause neuropathy and macrocytic anemia.

A

Vitamin B12

124
Q

What is vitamin K important in?

A

Clotting factor synthesis

125
Q

What is vitamin E important in?

A

Antioxidant

126
Q

What is vitamin D important in?

A

Bone health

127
Q

What is vitamin A important in?

A

Eye health

128
Q

What is the definition of UL?

A

Upper Tolerable Limit.
There is evidence guiding this number.

129
Q

What is the definition of RDA?

A

Recommended Dietary Allowance

130
Q

What is the definition of EAR?

A

Estimated Average Requirement. Intake of nutrients that is estimated to meet the needs of half of a specific gender group and life stage.

131
Q

What is the definition of AI?

A

Adequate Intake. The average amount of nutrients a healthy population consumes daily.

132
Q

What is the definition of DRI?

A

Dietary Reference Intake. A set of scientifically developed reference values for nutrients.

133
Q

What are the fat-soluble vitamins?

A

K, A, D, and E

134
Q

What is the likely effect of cannabidiol?

A

Prescription cannabidiol products that are FDA approved have a likely effect on epilepsy. It is unclear if other formulations will treat epilepsy.

135
Q

What are the 6 common ailments that garlic can aid?

A

Atherosclerosis, diabetes, hyperlipidemia, hypertension, NAFLD, and periodontitis

136
Q

What is the drug interaction between glucosamine and chondroitin with antiplatelets and anticoagulants?

A

If used together, they may increase bleeding risk.

137
Q

What is the major use of glucosamine?

A

Arthritis

138
Q

What is the major use of saw palmetto?

A

Saw palmetto may help urinary symptoms associated with an enlarged prostate.

139
Q

What is the common use of milk thistle?

A

Diabetes, improving glycemic control, and liver disease

140
Q

What is the common use of tumeric?

A

Osteoarthritis and antiinflammatory

141
Q

What does homeopathy mean?

A

Homeopathy is a type of alternative medicine that uses highly diluted substances to treat a variety of conditions. “Like treats like”. 6C would be for local ailments while 30C would be for whole body symptoms.

142
Q

What is the official compendium for homeopathy?

A

Homeopathic Pharmacopoeia of the United States (HPUS)

143
Q

How is homeopathy regulated?

A

Homeopathic medicines have been regulated as drugs since 1938. The FDA regulates the manufacturing and distribution of homeopathic medications.

144
Q

T or F: There are FDA-approved homeopathic products that have been evaluated for safety and efficacy.

A

False. There has been no homeopathic drugs evaluated for safety and efficacy by the FDA.

145
Q

What are the drug interactions with Asian Ginseng?

A

Induce CYP3A4 decreasing effectiveness of calcium channel blockers, chemotherapy, HIV agents, antihypertensives and statins, and some antidepressants.

146
Q

What are the drug interactions with Ginkgo?

A

Inhibits platelet aggregation and can increase risk of bleeding with other antiplatelet and anticoagulant drugs.

147
Q

What are the common uses of ginseng?

A

Cognitive function

148
Q

What are the common uses of ginkgo?

A

Anxiety and Dementia

149
Q

What are the serious adverse effects of Kava?

A

Liver toxicity

150
Q

What is the definition of integrative medicine?

A

Integrative medicine combines conventional appraoches with natural approaches in a coordinated and purposeful way.

151
Q

What is the definition of alternative medicine?

A

A range of medical therapies that are not regarded as orthodox by the medical profession, such as herbalism, homeopathy, and acupuncture.
**Use of natural products in place of conventional medicine. **

152
Q

What is the definition of complementary medicine?

A

Complementary medicine uses natural medicine in additional to conventional medicine.

153
Q

What are the side effects of fish oil?

A

Upset stomach, burping, fishy taste in mouth, potential for seafood allergy, and prolonged bleeding at high doses.

154
Q

What is the dietary supplement that contains mevinolin that is also the active ingredient in lovastatin?

A

Red yeast rice

155
Q

How do you counsel consumers on dietary supplements?

A
  1. Caution against use in elderly, children , pregnancy and lactation, and those with liver and kidney disease
  2. Purchase products with a seal of quality or acquired through a quality assurance program (USP or NSF) OR content claim assessed by CosumerLab.com
  3. Purchase from large and reputable companies
  4. Once a dietary supplement has been selected, continue to use the same brand and formulation
  5. Know the dietary supplement you are using and tell you healthcare provider
  6. Report an adverse effect of the dietary supplement to your healthcare provider
156
Q

What is the definition of dietary supplements?

A

Dietary supplements includes vitamins, minerals, herbs, other botanicals, and amino acids.

157
Q

What are the claims on dietary supplements that require FDA approval?

A

Health claim and nutrition claim require FDA approval but structure-function claim does not require FDA approval.

158
Q

What are some sources of omega-3 fatty acids ALA?

A

Vegetable oils like soy and canola, flaxseed, walnuts, and other nuts.

159
Q

What is the drug interaction with St. John’s Wort?

A

St. John’s Wort is a CYP enzyme inducer therefore there is many potential interactions. Includes serotonin syndrome if used with SSRIs

160
Q

What is the common use of St. John’s Wort?

A

Depression

161
Q

What is the common use of Kava?

A

Anxiety

162
Q

What is the common use of Feverfew?

A

Migraine

163
Q

What is the common use of red yeast rice?

A

It has a similar mechanism of action as lovastatin and it used for cholesterol.

164
Q

What are drug interactions with omega-3 fatty acids?

A

Omega-3 FA may increase the bleeding risk when used with anticoagulants and antiplatelets.

165
Q

What are the common uses of omega-3 fatty acids?

A

Heart health, lowers triglycerides, and heart failure

166
Q

What are common sources of omega-3 fatty acids liks DHA and EPA?

A

Salmon, herring, and tuna.

167
Q

What is the common use of glucosamine/chondroitin?

A

Osteoarthritis

168
Q

What is the interaction between coenzyme Q10 and warfarin?

A

Coenzyme Q is structurally similar to vitamin K and it may reduce the effects of warfarin.

169
Q

What are the common uses of coenzyme Q10?

A

It it typically used for Coenzyme Q10 deficiencies and mitochondrial myopathies. It is also used for statin induced myopathy, preventing heart problems after surgery, and preventing migraines.

170
Q

Dietary supplements may make ________ and ____________ claims.

A

Structure
Function

(Without FDA approval)

171
Q

What are some reliable resources for information regarding dietary supplements?

A

NatMed Pro
NIH Office of Dietary Supplements
National Center for Complementary and Integrative Health
Lexicomp

172
Q

What are the 3 quality assurance programs that ensure that the dietary supplement product contains the ingredient listed on the label, in the declared potency and amounts, does not have contaminants, and is made under good manufacturing practices?

A

USP Verified Mark
Consumer Lab
NSF

173
Q

What act requires that manufacturers, packers, and distributors report serious adverse events to the FDA based on information received by the public?

A

Dietary Supplement and Nonprescription Drug Consumer Protection Act

174
Q

What act allowed the FDA to regulate dietary supplements under the purview of the center for food safety and applied nutrition?

A

Dietary Supplement Health and Education Act of 1994 (DSHEA)

175
Q

If generalized ailment, use a more _________ concentration

A

Dilute like 30C

176
Q

If a specific ailment, use a more _____________ solution.

A

Concentrated like 6C

OTC Theraputics (2 decks)

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