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Human Disease and Therapeutics > Final Study Guide: Drug Development and OTC's > Flashcards

Final Study Guide: Drug Development and OTC's Flashcards

1
Q

Why was the Pure Food and Drug act put into place in 1906 and what did it accomplish?

A
  • To deal with addiction problem of popular drugs.

- It required manufacturers to list ingredients

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2
Q

Why was the Modified Food, Drug and Cosmetic Act put into place in 1938 and what did it accomplish?

A
  • Mass poisoning of individuals taking sulfa drugs containing Diethylene Glycol.
  • Drugs must be demonstrated safe
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3
Q

What was the Durham-Humphrey Amendment and what did it accomplish?

A
  • There were many new drugs including OTC’s.

- It made the distinction between OTC’s and Rx.

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4
Q

What were the reasons set forth at the time of the Durham-Humphrey amendment for prescription drugs?

A

1) Addiction
2) Toxicity
3) Serious Disease

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5
Q

What was the Kefauver-Harris amendment for, and what did it accomplish?

A
  • Thalidomide was causing Phocomelia (Flipper Limbs)

- It established that EFFICACY and Safety are musts

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6
Q

What are some important things that the FDA regulates?

A
  • Foods (Dietary Supplements)
  • Drugs
  • Tobacco Products
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7
Q

What are the stages of Pre-clinical Research and Development?

A

1) Initial Synthesis
2) In Vitro Testing
3) Animal Testing

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8
Q

What are the goals of initial synthesis?

A

Solubility
Specificity
Toxicity

*they make hundreds of thousands of variants of the drug during this process.

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9
Q

What is needed before Animal Testing can begin?

A

IACUC approval

*Institutional Animal Care and Use Committee

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10
Q

What are the animals generally used in animal testing and what are they trying to measure?

A
  • 2-3 species of rat or mouse

- Side effects and dose

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11
Q

After the stages of testing are complete, what is the next step in development?

A
  • Make an Investigational New Drug Designation (IND)

* Essential first communication with the FDA

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12
Q

If the FDA gives the go ahead after IND, how many phases of clinical testing must then take place?

A

3

Phases I, II, and III

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13
Q

What happens during Phase I clinical testing?

A
  • Group of small # of healthy volunteers
  • Non-blind study
  • 70% of drugs don’t pass this phase

Goal= establish safety, learn about dose, report data to FDA

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14
Q

What happens during Phase II of clinical testing?

A
  • Clinical Pharmacology Phase
  • Double-blind study w/ Placebo controls
  • Small Group of individuals with illness
  • 30% Pass to phase III

Goal = Efficacy and safety

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15
Q

What happens during Phase III of clinical testing?

A
  • Extended Clinical Phase
  • Thousands of individuals
  • Double-blind study w/ Placebo controls
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16
Q

If a drug passes all of the clinical phases what is the next step?

A

New Drug Application (NDA)

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17
Q

What is done after the NDA and is many times considered “Phase 4”?

A

Marketing

*includes a period of continued assessment for Side Effects

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18
Q

What are possible exceptions to the full length development process?

A

-Fast-track: Streamline a drug that is needed for urgent situations.

  • Orphan Drug Act: Drugs for Rare conditions
    • Tax Breaks
    • Longer patents
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19
Q

As far as exclusive rights are concerned, what does Proprietary mean?

A

The Company that owns the patent.

They are the only ones that can make the drug.

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20
Q

As far as exclusive rights are concerned, what does Generic mean?

A

Market for the Patent

Anyone approved can make the drug

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21
Q

As far as exclusive rights are concerned, what does Generic Substitution mean?

A

“Dispense as Written”

The formulation may be slightly off in a substitute, though most are very close.

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22
Q

When were there first committees to regulate OTC’s?

A

1970’s

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23
Q

What is the definition of a Category I OTC?

A
  • Safe and effective for indicated purpose

* most OTC’s

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24
Q

What is the definition of a Category II OTC?

A

-Not Safe and/or Not Effective
or
-Inappropriate Indication

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25
Q

What is the definition of a Category III OTC?

A
  • Formerly Category I but a problem emerged

* insufficient data

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26
Q

What are the 3 requirements for switching a Rx to an OTC?

A
  • Safe (Side effects not a major problem)
  • Marketed for 3 years
  • Widely used as Rx
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27
Q

What is the FDA policy for Herbal Medicines/Dietary Supplements?

A

Herbal products are treated as “foods”

*This includes Vitamins, Minerals, and Herbs

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28
Q

Are the regulations for Rx and OTC’s the same?

A

No, they are very different.

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29
Q

What is a Label Regulation with Herbal/dietary supplements?

A

Must list ingredients

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30
Q

T or F, A healthcare provider can prescribe a medication for a purpose other than the indication approved by the FDA.

A

True

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31
Q

Companies must include what in the supplemental facts?

A
  • The part of the plant from which a dietary ingredient is derived.
  • Serving Size
  • Servings per Container
32
Q

What also must be listed when they are present in measurable amounts?

A 
Total calories
Calories from Fat
Total Fat
Saturated Fat
Cholesterol
Sodium
Total Carbs
Dietary Fiber
Sugars
Protein
Vitamins A&C
Calcium
Iron
33
Q

What types of drugs are used to treat Congestion?

A

Vasoconstrictors

Sympathomimetics

34
Q

What are some examples of Decongestants?

A

Oxymetazoline (Afrin, Dristan)
Phenylephrine (Neosynephrine)
Pseudophedrine (Restricted Sales)

35
Q

What are the effects of a systemic Decongestant?

A
  • Longer lasting
  • Increased HR
  • Increased BP
36
Q

What are the effects of a topical Decongestant (Nasal Spray)?

A
  • Faster acting
  • Rebound Congestion
  • Harder to control dosing
    • Higher risk of overdose
37
Q

What is the cause of Rinorrhea and what type of drug treats it?

A
  • Caused by mucus draining to clear irritants

- Antihistamines (H1)

38
Q

What are some of the characteristics of Antihistamines (H1)

A
  • Work for allergies
  • Anticholinergic properties
    • Dry secretions (minor effect)
  • Drowsiness
39
Q

What are examples of antihistamines?

A
  • Diphenhydramine (Benadryl) - Drowsiness
  • Chlorpheniramine (Chlor-Trimeton) - Less Drowsiness
  • Clemastine (Tavist Allergy) - Less Drowsiness
  • Loratidine (Claritin) - Least Drowsiness
40
Q

What are the two types of coughs?

A
  • Non-productive
    • Smokers response to irritation
  • Productive
    • Moving Mucus

*Want to encourage a productive cough

41
Q

What are some examples of Antitussives?

A
  • Codeine (Schedule V in Utah)
  • Dextromethorphan (Robotussin DM) *less abuse
  • Diphenhydramine (Antihistamine)
42
Q

What are examples of Expectorants?

A
  • Guaifenesin (Mucinex)
  • Demucents
  • Water/Humidification
43
Q

What does Guaifenesin (Mucinex) do along with water and Humidification?

A

Increase Productive Cough

44
Q

What do Demucents do?

A

Sooth/Coat the throat

45
Q

Is zinc useful in preventing/fighting a cold?

A

Maybe if taken within 24 hours of onset.

*Nasal may result in permanent damage to sense of smell

46
Q

How does Mentholated Cream (Vicks) relive nasal congestion?

A

Strong menthol odor tricks brain to make it feel like you are breathing through an unclogged nose.

  • Unsafe for children under 2
  • Only on neck and chest if under age 6
  • Camphor poisoning in toddlers
47
Q

What does Menthol do?

A
  • Provides short term relief of minor sore throat or minor mouth/throat irritation.
  • Antipruritic to reduce itching
  • Reduce throat and sinus irritation in smokers
  • Bad breath
48
Q

What are 3 antivirals discussed in this lecture?

A

Oseltamivir (Tamiflu) - Not OTC
Zanamivir (Relenza) - Not OTC
Docosanol (Abreva) - Cold Sores

49
Q

What is Phenol (Chloraseptic)

A

Oral - anesthetic/analgesic

*contraindicated if allergic to local anesthetics (Benzocaine)

50
Q

Characteristics of Aspirin (acetylsalicylic acid)…

A
  • GI irritation
  • Cox 1 and 2 inhibitor (Analgesic)
  • Antipyretic
  • Anti-inflammatory
  • DON’T give to Children (Especially with Flu Symptoms)
51
Q

Characteristics of Acetaminophen…

A
  • NOT Antiinflammatory
  • Don’t take with Alcohol (Liver damage)
  • Doesn’t cause GI irritation
  • Overdose = liver failure and death
52
Q

Characteristics of Ibuprofen…

A
  • Similar to Aspirin
  • More Cox-2
  • No cause of Reyes Syndrome

*Don’t mix with aspirin

53
Q

What is special about Naproxen?

A

Long Lasting salicylate

54
Q

What are examples of Xanthines and what do they do?

A
  • Caffeine
  • Theobromine (Chocolate)
  • Theophilline

*These are adenosine antagonists

55
Q

What are effects of Caffeine (Vivarin) on CNS?

A
  • Increase Alertness
  • Increase Concentration
  • Increase Flow of thoughts
56
Q

What are effects of Caffeine (Vivarin) on GI and Kidneys?

A

GI = Increased Gastric Secretions

Kidneys = Mild Diuretic -Decreases bloating from menstruation (*Pamabrom)

57
Q

What are characteristics of Caffeine (Vivarin) on CV system?

A

Minor constriction of cerebral vessels

58
Q

What are forms of Nicotine treatments and what are their side effects?

A

Patches, Lozenges, Gums to treat tobacco dependence

*Dizziness, Headaches, Nausea, Diarrhea, redness and swelling at patch site.

59
Q

What is Diphenhydramine?

A

An antihistamine sleep aid

60
Q

What is Doxylamine?

A

An antihistamine sleep aid

61
Q

What is miconazole?

A

An anti fungal for thrush, and vaginal infections

62
Q

What is Neosporin/Polysporin?

A

Antibiotic for first-aid

*preventive on minor abrasions

63
Q

What is Hydrocortisone?

A

Anti-inflammatory, anti-itching for…

  • dermal lesions
  • eczema
  • insect bites
  • poison ivy
64
Q

What is Capsaicin?

A

Pain relief topical ointment

TRPV channels

65
Q

What is Scopolamine?

A

An anticholinergic used for motion sickness

66
Q

What is Dimenhydrinate?

A

An anticholinergic used for motion sickness

*dry mouth, constipation, blurred vision, reduced urination

67
Q

What is Minoxidil?

A

(Rogaine) for hair growth

-Vasodilator- Causes rapid heart beat

68
Q

What is used to treat Hemorrhoids?

A

Phenylephrine - Vasoconstriction

69
Q

What is the active ingredient in Marijuana?

A

Anandamide - Endogenous ligand that is a natural neurotransmitter

70
Q

What does Marijuana cause as a side effect?

A

amotivation syndrome -Loose sense of ambition

71
Q

What systems does Marijuana activate?

A
  • Cannabinoid Receptors
  • Bronchodilator-causes reflex increase in heart contractions
  • Vasodilator
  • Tolerance and dependence
  • Many cannabinoid agonists developed for street drugs (Spice)
72
Q

What is the legal status of Marijuana?

A
  • Schedule 1 Federal Laws

- Variable according to state laws

73
Q

What is Marinol (Dronabinol)?

A

FDA approved cannabinoid agonist that…

  • increases appetite
  • anti-nausea
  • CB1 agonist
  • Synthetic THC/Prescription
74
Q

What are the proposed THC/Marijuana uses?

A
  • anti-nausea
  • increased appetite
  • glaucoma (reduce intraocular pressure)
  • chronic pain
75
Q

What is CBD (cannabidiol)?

A

analog promoted as anti seizure .

*Not as addictive as THC

76
Q

What is Rimonabant?

A

Approved in Europe but later withdrawn

  • CB1 antagonist
  • Used to treat obesity by reducing apetite
77
Q

What is characteristic of Spice Products?

A
  • Contain cannabinoid agonists/antagonists and other drugs
  • Originally legal, but has now been outlawed.

*these cannabinoid ingredients are now schedule I

Human Disease and Therapeutics (24 decks)

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