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