Week 1: Intro to Self-Care

Question 1

Define self care

Answer 1

• independent act of preventing, diagnosing, and treating one’s illnesses WITHOUT seeking professional advice
• sold without prescription
• is preventive or sickness self care

Question 2

Differentiate between preventive self-care vs sickness self care.

Answer 2

preventive:
- no need for self-diagnose
- you take an OTC to prevent the illness from happening

sickness self care:

• self diagnose
• is limited to mild illness or short term management
• recommends to contact health care provider if conditions do not improve

Question 3

Identify the highest number of commercial products available in the market for preventive and sickness self-care

Answer 3

Majority of products are preventive care.

Preventive care: over 20,000 products, majority containing vitamins and dietary supplements

Sickness care: over 5,000 products, majority containing cold and allergy medication

Question 4

List the contributing factors that have led to an increase in demand for self-care

Answer 4

1. growth of aging population
2. restricted access to prescribers
3. increasing cost of health care
4. high proportion of underinsured or uninsured
5. fast, easy, economical, convenient

Question 5

Describe the principles of effective health care communication

Answer 5

1. verbal and non-verbal communication
2. active listening
3. effective questioning
4. patient confidentiality
5. assess knowledge gap
6. layman’s language
7. acknowledge cultural differences

Question 6

Differentiate between open and close-ended questions

Answer 6

open ended questions fully understand the patient’s chief complaint: “What are your symptoms?”

close ended questions keep the conversation focused: “How often do you floss?”

Question 7

List the steps involved in the process of patient evaluation

Answer 7

1. information gathering
   - SCHOLAR (symptom, characteristics/course, history of symptoms, onset, location, aggravating factors, relieving factors)
2. patient assessment
3. care plan development
4. patient education

Question 8

What are the potential effects of prescription drugs transitioning to OTC shelves?

Answer 8

Benefits: unnecessary doctor visits, logical step-care, better access

Risks (should be prevented by pharmacists actively involved in patient’s well being): inaccurate self-diagnosis, redistribution of health care costs, delay in needed medical care, improper use of products

Question 9

List items/topics to be discussed with a patient during counseling

Answer 9

• reason for self treatment
• description of the treatment (name, how it works, what to expect)
• appropriate usage (dose, frequency, route, duration of therapy, storage)
• precautions
• adverse effects and how to manage them
• how to follow up

Question 10

list the steps involved in the drug approval process

Answer 10

1. Drug developed and animals tested
2. IND Application (Investigational New Drug) submitted to FDA
3. Phase 1 (20-80 healthy individuals - tests safety)
4. Phase 2 (100’s of unhealthy individuals - tests effectiveness)
5. Phase 3 (1000’s of individuals to gather more information)
6. Review meeting
7. NDA application (New drug application including all animal+human data, etc)

8 -9. Application reviewed (FDA has 60 days to decide to file the NDA)

10. Drug labeling
11. Facility Inspection
12. Phase 4 (after FDA approval, post marketing monitoring stage begins)

Question 11

There are a number of __a__ volunteers used in phase 1 of the drug approval process.

This phase emphasizes __b__.

The goal is to determine __c__.

Answer 11

a. 20-80 healthy
b. safety
c. the most frequent side effects; how the drug is metabolized and excreted

Question 12

There are a number of __a__ volunteers used in phase 2 of the drug approval process.

This phase emphasizes __b__.

The goal is to obtain __c__.

Answer 12

a. 100’s
b. effectiveness
c. data on whether the drug works in people who have the disease/condition (also studies short-term side effects)

Question 13

There are a number of __a__ volunteers used in phase 3 of the drug approval process.

These studies gather more information about __b__.

Answer 13

a. 1000’s
b. safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs

Question 14

Once FDA approves a drug, the post-marketing monitoring stage begins. Phase 4 of the drug approval process includes the role of the FDA’s post-marketing safety system to ____.

Answer 14

Detect serious unexpected adverse events and take definitive action when needed.

The sponsor (typically the manufacturer) is required to submit periodic safety updates to FDA.

Question 15

Identify the different types of NDA’s

Answer 15

Abbreviated NDA (ANDA)

• when there is an Rx to OTC switch
• when a Brand becomes Generic

New NDA
- direct to OTC

NDA deviation
- OTC monograph deviation

Question 16

Lecture Objective: Recognize the elements required in OTC drug labeling and packaging:

Labeling is to assure CLEAR communication to consumers about a product. FDA has required a standardized content and format for labeling non-Rx drugs known as _____.

Answer 16

Drug Facts box

contains:

• active ingredients
• uses
• warnings
• drug interactions
• side effects
• directions
• storage
• inactive ingredients

Question 17

Identify products that require a drug-facts label

Answer 17

Drug (example: Ibuprofen) requires drug facts label

Cosmetic (example: shampoo) does not require drug facts label

Drug-cosemetic (example: antidandruff shampoo) requires drug facts label

Question 18

Identify the role of FDA

Answer 18

• regulated Rx and non-Rx drugs

excludes dietary supplements

Question 19

Identify the role of FTC

Answer 19

• regulates OTC drug advertisement

- language is approved by FDA for use in product labeling must match language used to advertise

Question 20

Identify the role of DSHEA

Answer 20

• regulates dietary supplements

- is FDA regulated by having authority to withdraw dangerous products and address false and misleading claims

Question 21

Describe the purpose of drug recalls.

Answer 21

to remove the product from the market because of potential risk to the public

Question 22

Class ____ drug recall is dangerous or defective and could cause serious health problems or death

Answer 22

1

Question 23

Class ____ drug recall might cause temporary health problems or pose only a slight threat of a serious nature

Answer 23

2

Question 24

Class ____ drug recall is unlikely to cause any adverse health reactions but violate FDA labeling or manufacturing

Answer 24

3

Question 25

What is the purpose of using pregnancy category on pharmaceuticals?

Answer 25

to classify risk of fetal injury due to pharmaceuticals if used by the mother during pregnancy

Question 26

The ____ is a “Cook Book” for marketing an OTC drug and lists recipes for category of drugs that are referred to as GRASE (Generally Recognized As Safe and Effective).

Answer 26

OTC drug monograph

Question 27

Human studies have failed to demonstrate a risk to the fetus in the 1st trimester of pregnancy. There is no evidence of risk in later trimesters.

This represents pregnancy category ____.

Answer 27

A

safe

Question 28

Animal production studies have failed to demonstrate a risk to the fetus and there are no adequate and well controlled studies in pregnant women.

This represents pregnancy category ____.

Answer 28

B

safe

Question 29

Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well controlled studies in humans. Potential benefits may warrant use of the drug in pregnant women, despite potential risks.

This represents pregnancy category ____.

Answer 29

C

benefits > adverse effect

Question 30

There is positive evidence of human fetal risk based on experience and studies in humans. Potential benefits may warrant use of the drug in pregnant women despite potential risks.

This represents pregnancy category ____.

Answer 30

D

safety of mother > child

Question 31

Studies in animals or humans have demonstrated fetal abnormalities. There is positive evidence of human fetal risks. The risks involved use of the drug in pregnant women clearly outweigh potential benefits.

Answer 31

X

not safe