Final Study Guide: Drug Development and OTC's Flashcards Preview

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Flashcards in Final Study Guide: Drug Development and OTC's Deck (77):
1

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

-To deal with addiction problem of popular drugs.

-It required manufacturers to list ingredients

2

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

-Mass poisoning of individuals taking sulfa drugs containing Diethylene Glycol.

-Drugs must be demonstrated safe

3

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

-There were many new drugs including OTC's.

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

4

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

1) Addiction
2) Toxicity
3) Serious Disease

5

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

-Thalidomide was causing Phocomelia (Flipper Limbs)

-It established that EFFICACY and Safety are musts

6

What are some important things that the FDA regulates?

-Foods (Dietary Supplements)
-Drugs
-Tobacco Products

7

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

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

8

What are the goals of initial synthesis?

Solubility
Specificity
Toxicity

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

9

What is needed before Animal Testing can begin?

IACUC approval

*Institutional Animal Care and Use Committee

10

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

-2-3 species of rat or mouse
-Side effects and dose

11

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

- Make an Investigational New Drug Designation (IND)

*Essential first communication with the FDA

12

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

3
Phases I, II, and III

13

What happens during Phase I clinical testing?

-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

14

What happens during Phase II of clinical testing?

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

Goal = Efficacy and safety

15

What happens during Phase III of clinical testing?

-Extended Clinical Phase
-Thousands of individuals
-Double-blind study w/ Placebo controls

16

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

New Drug Application (NDA)

17

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

Marketing

*includes a period of continued assessment for Side Effects

18

What are possible exceptions to the full length development process?

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

-Orphan Drug Act: Drugs for Rare conditions
- Tax Breaks
- Longer patents

19

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

The Company that owns the patent.
They are the only ones that can make the drug.

20

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

Market for the Patent
Anyone approved can make the drug

21

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

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

22

When were there first committees to regulate OTC's?

1970's

23

What is the definition of a Category I OTC?

-Safe and effective for indicated purpose

*most OTC's

24

What is the definition of a Category II OTC?

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

25

What is the definition of a Category III OTC?

-Formerly Category I but a problem emerged

*insufficient data

26

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

-Safe (Side effects not a major problem)
-Marketed for 3 years
-Widely used as Rx

27

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

Herbal products are treated as "foods"

*This includes Vitamins, Minerals, and Herbs

28

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

No, they are very different.

29

What is a Label Regulation with Herbal/dietary supplements?

Must list ingredients

30

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

True

31

Companies must include what in the supplemental facts?

-The part of the plant from which a dietary ingredient is derived.
-Serving Size
-Servings per Container

32

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

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

33

What types of drugs are used to treat Congestion?

Vasoconstrictors
Sympathomimetics

34

What are some examples of Decongestants?

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

35

What are the effects of a systemic Decongestant?

-Longer lasting
-Increased HR
-Increased BP

36

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

-Faster acting
-Rebound Congestion
-Harder to control dosing
-Higher risk of overdose

37

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

-Caused by mucus draining to clear irritants
-Antihistamines (H1)

38

What are some of the characteristics of Antihistamines (H1)

-Work for allergies
-Anticholinergic properties
- Dry secretions (minor effect)
-Drowsiness

39

What are examples of antihistamines?

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

40

What are the two types of coughs?

-Non-productive
-Smokers response to irritation

-Productive
-Moving Mucus

*Want to encourage a productive cough

41

What are some examples of Antitussives?

-Codeine (Schedule V in Utah)
-Dextromethorphan (Robotussin DM) *less abuse
-Diphenhydramine (Antihistamine)

42

What are examples of Expectorants?

-Guaifenesin (Mucinex)
-Demucents
-Water/Humidification

43

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

Increase Productive Cough

44

What do Demucents do?

Sooth/Coat the throat

45

Is zinc useful in preventing/fighting a cold?

Maybe if taken within 24 hours of onset.

*Nasal may result in permanent damage to sense of smell

46

How does Mentholated Cream (Vicks) relive nasal congestion?

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

What does Menthol do?

-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

What are 3 antivirals discussed in this lecture?

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

49

What is Phenol (Chloraseptic)

Oral - anesthetic/analgesic

*contraindicated if allergic to local anesthetics (Benzocaine)

50

Characteristics of Aspirin (acetylsalicylic acid)...

-GI irritation
-Cox 1 and 2 inhibitor (Analgesic)
-Antipyretic
-Anti-inflammatory
-DON'T give to Children (Especially with Flu Symptoms)

51

Characteristics of Acetaminophen...

-NOT Antiinflammatory
-Don't take with Alcohol (Liver damage)
-Doesn't cause GI irritation
*Overdose = liver failure and death

52

Characteristics of Ibuprofen...

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

*Don't mix with aspirin

53

What is special about Naproxen?

Long Lasting salicylate

54

What are examples of Xanthines and what do they do?

-Caffeine
-Theobromine (Chocolate)
- Theophilline

*These are adenosine antagonists

55

What are effects of Caffeine (Vivarin) on CNS?

-Increase Alertness
-Increase Concentration
-Increase Flow of thoughts

56

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

GI = Increased Gastric Secretions

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

57

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

Minor constriction of cerebral vessels

58

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

Patches, Lozenges, Gums to treat tobacco dependence

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

59

What is Diphenhydramine?

An antihistamine sleep aid

60

What is Doxylamine?

An antihistamine sleep aid

61

What is miconazole?

An anti fungal for thrush, and vaginal infections

62

What is Neosporin/Polysporin?

Antibiotic for first-aid
*preventive on minor abrasions

63

What is Hydrocortisone?

Anti-inflammatory, anti-itching for...
-dermal lesions
-eczema
-insect bites
-poison ivy

64

What is Capsaicin?

Pain relief topical ointment
TRPV channels

65

What is Scopolamine?

An anticholinergic used for motion sickness

66

What is Dimenhydrinate?

An anticholinergic used for motion sickness

*dry mouth, constipation, blurred vision, reduced urination

67

What is Minoxidil?

(Rogaine) for hair growth
-Vasodilator- Causes rapid heart beat

68

What is used to treat Hemorrhoids?

Phenylephrine - Vasoconstriction

69

What is the active ingredient in Marijuana?

Anandamide - Endogenous ligand that is a natural neurotransmitter

70

What does Marijuana cause as a side effect?

amotivation syndrome -Loose sense of ambition

71

What systems does Marijuana activate?

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

72

What is the legal status of Marijuana?

-Schedule 1 Federal Laws
-Variable according to state laws

73

What is Marinol (Dronabinol)?

FDA approved cannabinoid agonist that...
-increases appetite
-anti-nausea
-CB1 agonist
-Synthetic THC/Prescription

74

What are the proposed THC/Marijuana uses?

-anti-nausea
-increased appetite
-glaucoma (reduce intraocular pressure)
-chronic pain

75

What is CBD (cannabidiol)?

analog promoted as anti seizure .

*Not as addictive as THC

76

What is Rimonabant?

Approved in Europe but later withdrawn
-CB1 antagonist
-Used to treat obesity by reducing apetite

77

What is characteristic of Spice Products?

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

*these cannabinoid ingredients are now schedule I