PPD Level 2 Quiz 1

How does the FDA define a drug?

- recognized by an official pharmacopoeia or formulary

- intended for use in the diagnosis, cure, mitigation, treatment, orprevention of disease

- intended to affect the structure or any function of the body(other than food)

- intended for use as a component of a medicine but not a deviceor a component, part or accessory of a device

What is a biologic drug?

a large molecule produced from livingmaterial such as microorganisms, plant cells, or animal cells

What are the key steps in the drug development and approval process? In what order do they takeplace?

1. Researchers focus on discovering targets (receptors, enzymes, etc.), testing compounds, and refining promising desired drug activity

2. Researchers confirm biological activity and safety of the drug before human use through preclinical in vitro studies (isolatedcells/tissues) and in vivo studies (animals)

3. Study sponsors submit an FDA Investigational New Drug (IND) application to request permission to administer the drug to humans

4. Clinical trials are conducted with humans in three phases to evaluate safety, ideal dosing, and efficacy of the treatment in the target population

5. Study sponsors compile all preclinical and clinical data in an FDA New Drug Application (NDA) submission to request approval for sale of the product in the United States

6. The FDA approves the product under a proprietary (brand) name with around 7-13 years of patent protection

7. Drug monitoring continues through additional clinical trials to provide post-marketing surveillance on long-term safety and effectiveness

8. Drug companies submit Abbreviated New Drug Applications (ANDA) to the FDA that demonstrate bioequivalence of generic products to be sold when the brand patent expires

brand

initial drug with patent upon initial development

generic

medication with the exact same active ingredient as the brand-name drug, is taken the same way and offers the same effect. They do not need to contain the same inactive ingredients as the name-brand product and they can only be sold after the brand-name drug's patent expires.

reference product

'brand name' biologic drug

biosimilars

'generic' biologic drug

orphan drug

An FDA designation for a medication intended to diagnose, treat, or prevent a rare condition that affects less than 200,000 people in the United States. Special incentives for development are provided.

Emergency Use Authorization (EUA)

FDA authority to allow unapproved medical products (or the unapproved use of approved products) in an emergency for serious or life-threatening conditions caused by chemical, biological, radiological,or nuclear threats when certain criteria are met, including there are no adequate, available alternatives

characteristics of a fixed mindset

"i'm either good at something or i'm not" "i want to avoid making mistakes" "i'll never be that smart" "this is good enough"

characteristics of a growth mindset

"mistakes help me learn" "feedback is valuable" "is this my best work?" "i improve with practice"

What are the 3 key skills that underlie effective time management?

awareness, arrangement, adaptation

What are examples of strategies to build time awareness?

-Identify when your energy and focus are at their peak and schedule the most difficult or least desirable things for that time.

-Time yourself when you do new tasks to see how much time they actually take and make a note for future planning

-"Futurecast"- When you are deciding what to do, think about how what you are doing will help or hurt you in the future

What are examples of strategies to build time arrangement?

the apps, create a plan, treat the day like a workday, fill in the blank spaces of the weekly schedule, if interrupted or if time runs out, "remember where you parked"

What are examples of strategies to build time adaptation?

If interruptions derail your focus, find a good hiding spot (Medical Library, Sherrod Library, Building 60), signal to others that you are in focus mode (put on headphones, sit with your back to the door, use a study carrell), use apps that block notifications or turn them off, set a specific amount of time to study create a plan with a beginning and an end

Which of the 3 key skills of time management do apps typically address?

time arrangement

Of the 3 key time management skills, which one has the most impact on procrastination?

awareness

What are the 6 domains of wellbeing that we track in PPD?

social, emotional, career, financial, community, physical

emotional wellbeing

ability to handle life's stresses and adapt to change and difficult times

career wellbeing

Considering what you do on a daily basis to be fulfilling and meaningful

financial wellbeing

feeling secure in your ability to meet current and future financial needs

physical wellbeing

Having good health and enough energy to get things done daily

social wellbeing

Having supportive relationships and love in your life

community wellbeing

Liking where you live, feeling safe, and having pride in your community

What are possible benefits of a healthcare provider having a high level of wellbeing?

-Functional teams

-Improved patient-provider relationships

-Better care outcomes

- Less patient mortality

- Career/life fulfillment

What are possible risks of a healthcare provider having a low level of wellbeing?

- Burnout & distress

- More medical errors

- High job turnover

- More substance use

- More suicide & suicidal ideation

acute

Rapid onset or sudden change in condition that lasts for a short amount of time

chronic

Long-standing, progressive condition that is continuous and/or recurring

inpatient

Overnight stays for:

• Urgent or severe acute needs

• Intensive monitoring

• Pts unsafe/unreadyto go home

outpatient

Temporary visits for:

• Preventive care

• Chronic disease management

• Minor acute care needs

ambulatory care

▪AKA Primary Care

▪Based in healthcare clinics

▪May see patients alone or in joint visits with other providers

institution

▪includes hospitals and other inpatient settings (long-term care, rehab, etc.)

▪Pharmacy services may be centralized, decentralized, or a mix of both

▪Variety of clinical and dispensing roles

private insurance

about 2/3 of population, employment-based, direct purchase or ACA marketplace, TRICARE (military)

Medicaid

jointly funded by state and federal governments for individuals, families, and children with limited income and resources

Medicare

administered by the federal government, generally for people 65 and older or those with a qualifying disability

self-pay

anyone left without insurance coverage, responsible for costs out of pocketq

clinical pharmacy

Clinical pharmacy is a health science discipline in which pharmacists provide patient care that optimizes medication therapy and promotes health and disease prevention

What information is required at minimum for a prescription order to be valid?

date of issue, name of patient, name of medication, strength and dosage form of medication, quantity of medication, directions for medication, number of refills, prescriber name, prescriber address, prescriber phone number, prescriber signature (if written)

What additional information must be on a prescription for a controlled substance?

DEA number of prescriber, address of patient

What are the limits on refills and prescription expiration dates for controlled and non-controlled medications in Tennessee?

legend: no max refill, 1 year expired

C1: N/A

C2: 0 refills, no expired (1 year typically honored)

C3: 5 refills, 6 months expired

C4: 5 refills, 6 months expired

C5: no max refill, 1 year expired

What are the standard components of medication administration instructions that are typically included on prescription labels?

[Verb] [quantity] [dosing unit] [route] [time(s) per day] [optional extra directions]