Final Study Guide: Drug Development and OTC's Flashcards
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
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
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.
What were the reasons set forth at the time of the Durham-Humphrey amendment for prescription drugs?
1) Addiction
2) Toxicity
3) Serious Disease
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
What are some important things that the FDA regulates?
- Foods (Dietary Supplements)
- Drugs
- Tobacco Products
What are the stages of Pre-clinical Research and Development?
1) Initial Synthesis
2) In Vitro Testing
3) Animal Testing
What are the goals of initial synthesis?
Solubility
Specificity
Toxicity
*they make hundreds of thousands of variants of the drug during this process.
What is needed before Animal Testing can begin?
IACUC approval
*Institutional Animal Care and Use Committee
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
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
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
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
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
What happens during Phase III of clinical testing?
- Extended Clinical Phase
- Thousands of individuals
- Double-blind study w/ Placebo controls
If a drug passes all of the clinical phases what is the next step?
New Drug Application (NDA)
What is done after the NDA and is many times considered “Phase 4”?
Marketing
*includes a period of continued assessment for Side Effects
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
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.
As far as exclusive rights are concerned, what does Generic mean?
Market for the Patent
Anyone approved can make the drug
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.
When were there first committees to regulate OTC’s?
1970’s
What is the definition of a Category I OTC?
- Safe and effective for indicated purpose
* most OTC’s
What is the definition of a Category II OTC?
-Not Safe and/or Not Effective
or
-Inappropriate Indication
What is the definition of a Category III OTC?
- Formerly Category I but a problem emerged
* insufficient data
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
What is the FDA policy for Herbal Medicines/Dietary Supplements?
Herbal products are treated as “foods”
*This includes Vitamins, Minerals, and Herbs
Are the regulations for Rx and OTC’s the same?
No, they are very different.
What is a Label Regulation with Herbal/dietary supplements?
Must list ingredients
T or F, A healthcare provider can prescribe a medication for a purpose other than the indication approved by the FDA.
True
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
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
What types of drugs are used to treat Congestion?
Vasoconstrictors
Sympathomimetics
What are some examples of Decongestants?
Oxymetazoline (Afrin, Dristan)
Phenylephrine (Neosynephrine)
Pseudophedrine (Restricted Sales)
What are the effects of a systemic Decongestant?
- Longer lasting
- Increased HR
- Increased BP
What are the effects of a topical Decongestant (Nasal Spray)?
- Faster acting
- Rebound Congestion
- Harder to control dosing
- Higher risk of overdose
What is the cause of Rinorrhea and what type of drug treats it?
- Caused by mucus draining to clear irritants
- Antihistamines (H1)
What are some of the characteristics of Antihistamines (H1)
- Work for allergies
- Anticholinergic properties
- Dry secretions (minor effect)
- Drowsiness
What are examples of antihistamines?
- Diphenhydramine (Benadryl) - Drowsiness
- Chlorpheniramine (Chlor-Trimeton) - Less Drowsiness
- Clemastine (Tavist Allergy) - Less Drowsiness
- Loratidine (Claritin) - Least Drowsiness
What are the two types of coughs?
- Non-productive
- Smokers response to irritation
- Productive
- Moving Mucus
*Want to encourage a productive cough
What are some examples of Antitussives?
- Codeine (Schedule V in Utah)
- Dextromethorphan (Robotussin DM) *less abuse
- Diphenhydramine (Antihistamine)
What are examples of Expectorants?
- Guaifenesin (Mucinex)
- Demucents
- Water/Humidification
What does Guaifenesin (Mucinex) do along with water and Humidification?
Increase Productive Cough
What do Demucents do?
Sooth/Coat the throat
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
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
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
What are 3 antivirals discussed in this lecture?
Oseltamivir (Tamiflu) - Not OTC
Zanamivir (Relenza) - Not OTC
Docosanol (Abreva) - Cold Sores
What is Phenol (Chloraseptic)
Oral - anesthetic/analgesic
*contraindicated if allergic to local anesthetics (Benzocaine)
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)
Characteristics of Acetaminophen…
- NOT Antiinflammatory
- Don’t take with Alcohol (Liver damage)
- Doesn’t cause GI irritation
- Overdose = liver failure and death
Characteristics of Ibuprofen…
- Similar to Aspirin
- More Cox-2
- No cause of Reyes Syndrome
*Don’t mix with aspirin
What is special about Naproxen?
Long Lasting salicylate
What are examples of Xanthines and what do they do?
- Caffeine
- Theobromine (Chocolate)
- Theophilline
*These are adenosine antagonists
What are effects of Caffeine (Vivarin) on CNS?
- Increase Alertness
- Increase Concentration
- Increase Flow of thoughts
What are effects of Caffeine (Vivarin) on GI and Kidneys?
GI = Increased Gastric Secretions
Kidneys = Mild Diuretic -Decreases bloating from menstruation (*Pamabrom)
What are characteristics of Caffeine (Vivarin) on CV system?
Minor constriction of cerebral vessels
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.
What is Diphenhydramine?
An antihistamine sleep aid
What is Doxylamine?
An antihistamine sleep aid
What is miconazole?
An anti fungal for thrush, and vaginal infections
What is Neosporin/Polysporin?
Antibiotic for first-aid
*preventive on minor abrasions
What is Hydrocortisone?
Anti-inflammatory, anti-itching for…
- dermal lesions
- eczema
- insect bites
- poison ivy
What is Capsaicin?
Pain relief topical ointment
TRPV channels
What is Scopolamine?
An anticholinergic used for motion sickness
What is Dimenhydrinate?
An anticholinergic used for motion sickness
*dry mouth, constipation, blurred vision, reduced urination
What is Minoxidil?
(Rogaine) for hair growth
-Vasodilator- Causes rapid heart beat
What is used to treat Hemorrhoids?
Phenylephrine - Vasoconstriction
What is the active ingredient in Marijuana?
Anandamide - Endogenous ligand that is a natural neurotransmitter
What does Marijuana cause as a side effect?
amotivation syndrome -Loose sense of ambition
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)
What is the legal status of Marijuana?
- Schedule 1 Federal Laws
- Variable according to state laws
What is Marinol (Dronabinol)?
FDA approved cannabinoid agonist that…
- increases appetite
- anti-nausea
- CB1 agonist
- Synthetic THC/Prescription
What are the proposed THC/Marijuana uses?
- anti-nausea
- increased appetite
- glaucoma (reduce intraocular pressure)
- chronic pain
What is CBD (cannabidiol)?
analog promoted as anti seizure .
*Not as addictive as THC
What is Rimonabant?
Approved in Europe but later withdrawn
- CB1 antagonist
- Used to treat obesity by reducing apetite
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
