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Self Care > Exam 1 > Flashcards

Exam 1 Flashcards

1
Q

What is self care?

A

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

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2
Q

Who initiates self care?

A

Individuals themselves

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3
Q

Who can reccommend self care to patients?

A

Health care providers

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4
Q

What can self care be classified as?

A

Healthy lifestyle behaviors
Medical bhaviors for treating symptoms
Behaviors for improving quality of life and daily living with disabling limitations

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5
Q

What is essential for self care?

A

Use of over the counter nonprescription medications, complientary medicines, and medical devices

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6
Q

Who regulates the OTC drug advertising?

A

The Federal trade commission FTC

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7
Q

Who regulates prescription drug advertising?

A

FDA

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8
Q

How many OTC products are there?

A

Over 100,000

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9
Q

What is the FDA charged to oversee?

A

The approval of OTC medicines and devices

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10
Q

What branch of the FDA carries out approval of OTC medicines and evaluations?

A

Center of Drug Evaluation and Research (CDER)

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11
Q

What is the role of CDER?

A

Evaluates all new drugs
Ensures that the drugs already on the market continue to meet standards
Oversees ads appropriateness
Provides information to consumers and HCP on appropriate and safe use of the OTCs
Ensure proper labels
Review benefits vs risk of OTC to make sure the benefits outweigh the risk

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12
Q

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

A

Food Drug and Cosmetic Act (FDCA)

1938

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13
Q

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

A

Durham-Humphrey Amendment

1951

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14
Q

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

A

Kefauver-Harris Amendments of 1962

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15
Q

What law required FDA approval of all medical devices?

A

Medical device amendments of 1976

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16
Q

What must be labeled on controlled drugs because of the Durham-Humphrey Amendment?

A

Caution: Federal law prohibits dispensing without prescription

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17
Q

How many regulatory systems are their for OTC products?

A

2

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18
Q

What are the two OTC regulation pathways?

A

NDA Process
OTC Monograph process

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19
Q

Which OTC regulation pathways does not require pre-market approval?

A

OTC Monograph Process

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20
Q

Which OTC regulation pathways is drug product specific and not active ingredient specific?

A

NDA Process

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21
Q

What regulatory pathway for OTCs has no user fees, no marketing exclusivity, and no mandatory timelines?

A

OTC Monograph Process

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22
Q

What OTC Regulation pathway has confidential filing?

A

NDA process

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23
Q

What are the types of NDAs?

A

Rx to OTC switches
Full switch
Partial switch
Direct
Direct to to OTC
Rx

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24
Q

What is GRASE?

A

Generally recognized as safe and effective

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25
Q

What is an OTC Monograph?

A

Recipe book for marketing requirements for an OTC drug

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26
Q

What is required on an OTC label?

A

Approved uses and products
Detailed instructions on safe and effective use
Cautions or warnings to those at greatest risk when taking the medication
Must provide contact information so patients can report side effects

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27
Q

What are the characteristics of OTC Medication?

A

Their benefits outweigh their risks
Safe and efficacious
Low misuse and abuse potential
Condition to be treated is self diagnosable
Does not require a health care practitioner for safe and appropriate use
They can be adequately labeled

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28
Q

What must the consumer be able to do with otc medication?

A

Self diagnose
Self treat
Self manage
Self help

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29
Q

What are the risks of self treatments?

A

Drug drug interactions
Some still can be misused
Incorrect diagnosis of the self care condition
Misinterpretation of drug fact labels
Patient confusion caused by combinationproducts and brand lines extensions

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30
Q

What is another name for dietary supplement?

A

Nutraceuticals

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31
Q

What is a nutraceutical?

A

A product intended to supplement the diet that bears or contains these ingredients

vitamin, mineral, or amino acid
Herb or other botanical
Dietary substance
Concentrate, metabolite
Constiuent or combination

32
Q

What law permitted use of therapeutic claims made about vitamins

A

Nutritional Labeling and education act

1990

33
Q

What law made it where the FDA can take action to remove products from the market?

A

1994 Dietary Supplement Health and Education Act

34
Q

Who regulates both finished dietary supplement products and dietary ingredients?

A

FDA

35
Q

What does DSHEA do?

A

FDA regulates dietary supplements under a different set of regulations than those convering conventional foods and drug products

36
Q

Who enforces laws outlawing unfair or deceptive acts or practices/

A

FTC

37
Q

What ate the two common sense propositions for OTC from ftc?

A

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

38
Q

What does the USP do?

A

Sets official standards for dietary supplements

If they carry a USP mark then it has been independtly tested and verified ingredients, potency, and manufacturing process

39
Q

Are dietary supplements approved premarket?

A

No and there is no evaluation for safety and efficacy at this point

40
Q

What does DSHEA require?

A

Detailed directions for use
Specific warnings
Side effects
Contraindications
Does not reach the level of labeling for OTC products

41
Q

What must be on a label for dietary supplements?

A

Name of each ingredients
Quantity of each ingredient
Total weight of all ingredients
Identify part of plant
Term Dietary Supplements

42
Q

What is the require statement for Dietary supplements?

A

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

43
Q

What does folic acid relate to?

A

Pregnancy

44
Q

What does calcium relate to?

A

Osteoporosis

45
Q

What is sodium related to?

A

Hypertension

46
Q

What are fruits and vegetables and dietary lipidsrelated to?

A

Cancer

47
Q

What are the duties of a pharmacist?

A

Fore see ability
Duty to warn
Duty to inquire

Must make reccomendation with best intentions and outcomes in mind

48
Q

How can a pharmacist help patients with selection of appropriate drug?

A

Assess patient’s symptoms
Screen for drug interactions
Educate patients
Refer if necessary

49
Q

What are the guides for making reccomendations?

A

Confirm dose
Check interactions
Suggest monitoring
Document specifics

50
Q

What is the Quest/SCHOLAR Method?

A

Method to quickly collect information and assess patients requesting self care advice

Structured
More complete counseling
Gain rapport

51
Q

What does QuEST stand for?

A

Quickly and accurately assess the patient
Establish that the patient is an appropriate candidate for self care
Suggest appropriate self care strategies
Talk with the patient

52
Q

How do you quickly and accurately gather objective information?

A

MAC
Ask about Medications (Rx/OTC/herbal)
Ask about drug Allergies
Ask about Coexisting health conditions

53
Q

How do you quickly and accurately assess the patient through subjective information?

A

SCHOLAR
Symptoms
Characteristics
History
Onset
Location
Aggravating factors
Remitting factors

54
Q

How do you establish that the patient is an appropriate candidate for self care?

A

Make sure they dont have severe symptoms
No symptoms that persist or return repeatedly
No self treating to avoid medical care

55
Q

What should you suggest for appropriate self care strategies?

A

Medication and general care measures

56
Q

What should you talk to the patient about?

A

About medication actions
Dosing and administration
Adverse effects
Follow up

57
Q

At which stage of quest do you determine a recommendation?

A

Establish that the patient is an appropriate candidate for self care

58
Q

What are the 5 aspects of Patient centered care?

A

Collect
Assess
Plan
Implement
Follow up - Monitor and evaluate

59
Q

What should you collect from the patient?

A

Chief complaint
History of present illness
Past medical history
Medication history
Allergies

MAC
SCHOLAR

60
Q

What does MAC do?

A

Checks for interactions

61
Q

What should you ask in the history portion of scholar?

A

What has been done so far?
Has this happened in the past?
What was done then to help?

62
Q

How should you find the onset of symptoms?

A

When did it start?

63
Q

How should you find out about aggrevating factors?

A

What makes it worse?

64
Q

How do you find out about the remitting factors?

A

What makes it better?

65
Q

What health statuses would preclude them from self care?

A

Pregnancy
Below 2 years old
Below 12 years old depending on medication

66
Q

What should be done in the plan portion?

A

Suggest appropriate self care strategies
Medication
General care measures
Refering to healthcare provider

67
Q

How should you implement the plan?

A

Talk with the patient
Confirm dose frequency and administration
Discuss possible adverrse reactions
Suggest monitoring

What to do if symptoms worsen
How to manage adverse reaction/ when to seek help
How long to treat before seeking further intervention
When they should expect to see results

68
Q

How should you implement the plan?

A

Talk with the patient
Confirm dose frequency and administration
Discuss possible adverrse reactions
Suggest monitoring

What to do if symptoms worsen
How to manage adverse reaction/ when to seek help
How long to treat before seeking further intervention
When they should expect to see results

69
Q

What should you avoid during patient counseling?

A

Avoid leading questions
Avoid distractions

70
Q

What should you do during patient counseling?

A

Use open ended questions
Closed ended to clarify
Use active listening
Empathize with patient

71
Q

What special population consumes 33% of all otcs?

A

Geriatric patients

72
Q

Which special population would have alteration in absorption, distribution, metabolism, and elimination?

A

Geriatric patients

73
Q

What special population should you calculate the appropriate weight based dose?

A

Pediatric patients above 2 years old

74
Q

How should you show the correct dose to the child’s parent?

A

Mark the dose on a dosing device for the parent or caregiver

75
Q

Why would most OTC products direct pregnant and breastfeeding women to ask health professional before use?

A

Most medications cross the placenta or transfer to breast milk

76
Q

What must you identify in pregnant patients?

A

Which trimester of pregnancy

Self Care (3 decks)

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