Week 1: Intro to Self-Care Flashcards
Define self care
- independent act of preventing, diagnosing, and treating one’s illnesses WITHOUT seeking professional advice
- sold without prescription
- is preventive or sickness self care
Differentiate between preventive self-care vs sickness self care.
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
Identify the highest number of commercial products available in the market for preventive and sickness self-care
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
List the contributing factors that have led to an increase in demand for self-care
- growth of aging population
- restricted access to prescribers
- increasing cost of health care
- high proportion of underinsured or uninsured
- fast, easy, economical, convenient
Describe the principles of effective health care communication
- verbal and non-verbal communication
- active listening
- effective questioning
- patient confidentiality
- assess knowledge gap
- layman’s language
- acknowledge cultural differences
Differentiate between open and close-ended questions
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?”
List the steps involved in the process of patient evaluation
- information gathering
- SCHOLAR (symptom, characteristics/course, history of symptoms, onset, location, aggravating factors, relieving factors) - patient assessment
- care plan development
- patient education
What are the potential effects of prescription drugs transitioning to OTC shelves?
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
List items/topics to be discussed with a patient during counseling
- 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
list the steps involved in the drug approval process
- Drug developed and animals tested
- IND Application (Investigational New Drug) submitted to FDA
- Phase 1 (20-80 healthy individuals - tests safety)
- Phase 2 (100’s of unhealthy individuals - tests effectiveness)
- Phase 3 (1000’s of individuals to gather more information)
- Review meeting
- 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)
- Drug labeling
- Facility Inspection
- Phase 4 (after FDA approval, post marketing monitoring stage begins)
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__.
a. 20-80 healthy
b. safety
c. the most frequent side effects; how the drug is metabolized and excreted
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__.
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)
There are a number of __a__ volunteers used in phase 3 of the drug approval process.
These studies gather more information about __b__.
a. 1000’s
b. safety and effectiveness, study different populations and different dosages, and uses the drug in combination with other drugs
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 ____.
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.
Identify the different types of NDA’s
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
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 _____.
Drug Facts box
contains:
- active ingredients
- uses
- warnings
- drug interactions
- side effects
- directions
- storage
- inactive ingredients
Identify products that require a drug-facts label
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
Identify the role of FDA
- regulated Rx and non-Rx drugs
excludes dietary supplements
Identify the role of FTC
- regulates OTC drug advertisement
- language is approved by FDA for use in product labeling must match language used to advertise
Identify the role of DSHEA
- regulates dietary supplements
- is FDA regulated by having authority to withdraw dangerous products and address false and misleading claims
Describe the purpose of drug recalls.
to remove the product from the market because of potential risk to the public
Class ____ drug recall is dangerous or defective and could cause serious health problems or death
1
Class ____ drug recall might cause temporary health problems or pose only a slight threat of a serious nature
2
Class ____ drug recall is unlikely to cause any adverse health reactions but violate FDA labeling or manufacturing
3
What is the purpose of using pregnancy category on pharmaceuticals?
to classify risk of fetal injury due to pharmaceuticals if used by the mother during pregnancy
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).
OTC drug monograph
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 ____.
A
safe
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 ____.
B
safe
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 ____.
C
benefits > adverse effect
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 ____.
D
safety of mother > child
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.
X
not safe
