Week 1 - Intro to Self Care

Question 1

What is self-care?

Answer 1

The diagnosis, treatment, and prevention of one’s own illness without having professional expertise

Question 2

What are the classifications of self-care?

Answer 2

1. Healthy lifestyle behaviors
2. Medical behaviors for treating symptoms
3. Behaviors that relate to improving quality of life and daily living in individuals with disabling limitations

Question 3

What regulates OTC drug advertising?

Answer 3

Federal Trade Commission

Question 4

What regulates prescription drug advertising?

Answer 4

FDA

Question 5

What is charged toy congress to oversee the approval of OTC medicines and devices?

Answer 5

FDA

Question 6

What is the arm of the FDA that carries out the evaluations?

Answer 6

Center of Drug Evaluation Research

Question 7

What is the role of CDER?

Answer 7

1. Evaluate all new drugs
2. Ensures that the drugs already on the market
3. Oversees ads
4. Provide info to consumers
5. Ensures that OTCs are properly labeled
6. Review benefits vs risk of OTC

Question 8

What law required a NDA for proof of safety on all new drugs

Answer 8

Food Drug and Cosmetic Act

Question 9

What law split Rx drugs from OTC drugs from controlled substances?

Answer 9

Durham-Humphrey Amendment

Question 10

What law requires proof of effectiveness for Rx and OTC drugs marketed after 1938?

Answer 10

Kefauver-Harris Amendments

Question 11

What law required FDA approval of all medical devices?

Answer 11

Medical Device Amendments

Question 12

What is the purpose for NDAs?

Answer 12

1. Sponsors submit applications that must be approved before the product can be markets
2. FDA reviews the safety and effectiveness of the product
3. Clinical studies required
4. Approved label is unique to the drug

Question 13

What are the types of NDAs

Answer 13

1. RX-to OTC switches
2. Fullswitch (NDA supplement)
3. Partial switch (new NDA)
4. Direct
5. Direct to OTC
6. Rx

Question 14

What is an OTC monograph?

Answer 14

1. Set of marketing requirements that make the product Generally Recognized as Safe and Effective
2. A recipe book for marketing requirements for an OTC drug

Question 15

Who reviews the safety and effectiveness of the ingredients in an OTC monograph?

Answer 15

FDA

Question 16

What are the requirements of an OTC product label?

Answer 16

1. Approved use of product
2. Detailed instructions on safe and effective use
3. Cautions or warnings to those at risk
4. Contact info for reporting side effects

Question 17

What are the characteristics of OTC medication?

Answer 17

1. Benefits outweigh risk
2. Safe and effective
3. Low misuse and sbuse potential
4. Condition to be treated is self-diagnosable
5. Don’t require health care practitioner for safe and appropriate use
6. Can be adequately labeled

Question 18

What must the customers be able to do regarding OTC medication?

Answer 18

1. Self-diagnose
2. Self-treat
3. Self-manage
4. Self-help

Question 19

What are the risks of self-treatment?

Answer 19

1. Drug-drug or drug-disease interactiosn
2. Overuse or misuse
3. Incorrect diagnosis
4. Misinterpretation of drug facts
5. Patient confusion

Question 20

What is a nutraceutical?

Answer 20

Product intended to supplement the diet that bears or contains:
1. Vitamins, minerals, amino acid
2. Herbs or botanicals
3. Dietary substance
4. Concentrate or combination
5. Constituent or combination

Question 21

What law permitted the use of therapeutic claims made about vits/mins

Answer 21

Nutrition labeling and education act

Question 22

What law had FDA take action to remove products from the market that were misbranded or adulterated?

Answer 22

Dietary supplement health and education act

Question 23

Who regulates the finished dietary supplement products and ingredients?

Answer 23

FDA

Question 24

Who enforces laws outlawing unfair or deceptive acts or practices?

Answer 24

Federal Trade Commission (FTC)

Question 25

What are the common-sense proportions of FTC?

Answer 25

1. Advertising must be truthful and not misleading 2. Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims

Question 26

What is the USP?

Answer 26

Sets official standards for dietary supplements

Question 27

What is the approval process of a drug?

Answer 27

1. No premarket approval 2. No evaluation for safety and efficacy 3. Manufacture is responsible for safety eval 4. FDA determines drug is unsafe once product is markets 5. If drug contains new ingredient manufacturers submit a statement ingredient is safe

Question 28

What does it mean to be safe?

Answer 28

No significant risk of illness

Question 29

What does the DSHEA require?

Answer 29

1. Detailed direction for use 2. Specific warnings 3. SIde effects 4. Contraindications 5. Does not reach the level of labeling for OTC products 6. Warning, side effects, and contraindications are absent

Question 30

What should an OTC label include?

Answer 30

1. Name of ingredients 2. Quantity of ingredient 3. Total weight 4. Identify of part of plant derived from 5. Dietary supplement if necessary

Question 31

What is the required statement for supplements?

Answer 31

This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, curve, or prevent any disease

Question 32

What are some FDA approved health claims?

Answer 32

1. FOlic acid and neural tube pregnancies 2. Calcium and osteoporosis 3. Sodium and hypertension 4. Fruit and vegetables and cancer 5. Dietary lipids and cancer 6/ Saturated fat and cholesterol and coronary artery disease

Question 33

What are the requirement of prescription medicine?

Answer 33

1. New drugs an unsafe till proven safe 2. Intended to diagnose, treat, and cure

Question 34

What are the requirement of OTC medicine?

Answer 34

1. New drugs an unsafe till proven safe 2. Intended to diagnose, treat, and cure 3. Self-diagnose, treat, and mange

Question 35

What are the requirement of dietary supplements?

Answer 35

1.New products are unsafe till proven safe 2. New ingredients don't need clinical trials 3. Supplement the diet not to treat or diagnose

Question 36

What is the duty of a pharmacist?

Answer 36

1. Fore-see-ability 2. Duty to warn 3. Duty to inquire

Question 37

What is the role of pharmacists?

Answer 37

1. Helping patients with selection of appropriate drug 2. Choose quality OTC to be sold in pharmacy 3. Provide balance to info 4. Review risks 5. Provide direction

Question 38

What is the guide to making a recommendation?

Answer 38

1. Confirm dose 2. Check interactions 3. Suggest monitoring 4. Document specifics

Question 39

What is the guide to making a D/S recommendation?

Answer 39

1. Source of supplements 2. Type of supplement 3. Dose and frequency 4. Reason patient is taking supplement 5. Confirm dose 6. Check interactions 7. Suggest monitoring 8. Document specifics