FIPA 2

What were the roles of the pharmacist during the apothecary era?

compounded, responsible for ensuring product purity, provided patients medical advice

What was the role of the pharmacist during the dispensing era?

were not allowed to discuss therapeutic effects or composition of a prescription with a patient

Durham-Humphrey amendment passed

What was the role of the pharmacist during the clinical era?

pharmacists promoted to role of therapeutic advisor

What was the intent of the Durham Humphrey act?

distinguished between prescription and OTC drugs

reduced role of pharmacist to dispenser of drugs

Describe factors that have helped shift community pharmacist’s roles from being product focused to patient focused.

robotics/technology

mail order pharmacy

prescription drug insurance programs

increased roles of pharm techs

emergence of new prescription medications

Give examples of responsible provision of drug therapy

indication, efficacy, safety, adherence

What are some outcomes a pharmacist can focus on with pharmaceutical care?

cure of a disease

elimination or reduction of a patient’s symptoms

slowing of a disease process

preventing a disease or symptoms (vaccines)

What are some examples of medication therapy management activities that pharmacists can provide?

counseling

making a med treatment plan

performing health assessments

med review

What year was the PharmD degree mandated as the entry level degree?

1992

Define transitions of care

the movement of a patient from one setting of care to another

Define medication reconciliation

process of avoiding inconsistencies across transitions in care by reviewing the patient’s complete medication regimen at the time of admission, transfer, and discharge and comparing the medications the patient is currently taking to the new ones being prescribed

What is a collaborative practice agreement?

voluntary written agreement between a physician and pharmacist that allows pharmacist to do drug therapy management

What are some examples of barriers to pharmacists’ expanding roles

recognition and acceptance from stakeholders in healthcare system and patients

lack of reimbursement for patient care services

resistance within pharmacy profession

Who makes the most from a prescription drug?

pharmaceutical company

Who makes the least from a prescription drug?

wholesaler

What percentage of our health care costs are spent on pharmaceuticals?

10%

What is the formula for the average gross margin a pharmacy makes on prescription medications?

price (how much the drug is for the patient) of drug- cost (how much the drug is when pharmacy buys it) of drug

How much of a pharmacy’s revenue come from dispensing prescriptions?

92% for independents, 75% for chains

Do pharmacies have more negotiating power with wholesalers and manufacturers on brand-name or generic drugs?

generic

What is a pharmacy co-op/buying group?

when several pharmacies get together to negotiate with wholesaler or manufacturer for better prices

Do pharmacies make more money on generic or brand name prescriptions?

generic

How many prescriptions does a pharmacy have to fill per day to break even?

250

How much does it cost a pharmacy to fill a precsription?

10-12 dollars

What percent of patients pay cash for their prescriptions?

10 percent

Do pharmacies make more money from cash prescriptions or ones paid by insurance companies?

cash

Do pharmaceutical manufacturers price their products based on how much it costs to make the drug?

no

What are the 2 biggest problems community pharmacies face?

insurance (below cost reimbursement)

cash flow (money going out faster than going in)

How long does it take for a drug to become approved after discovery?

12-15 years

Who makes the recommendation for the NDA?

advisory committee but FDA doesn’t have to follow it

What is the concern with biosimilars?

immunogenicity and exact copy

What did the Pure Food and Drug Act do?

prohibited the interstate commerce of adulterated (not pure) food and drugs

What was the intent of the Shirley Amendments?

prohibited false and misleading claims for drug products

What was the intent of the federal food, drug and cosmetic act?

scientific proof of safety before a drug could be marketed

What was the intent of the Harris-Kefauver Amendments?

scientific proof of efficacy

What was the intent of the Orphan Drug Act?

gave economic and tax incentives for manufacturers to develop drugs for rare disease

What was the intent of the Drug Price Competition and Patient Restoration Act?

created the ANDA for generic drugs

gave brand drugs additional patent protection which gave generics an easier way to market

What was the intent of the Prescription Drug Marketing Act?

cannot reimport drugs from other countries

regulates who hospitals can sell to

restricted distribution of drug samples

What is the focus of phase I of the clinical trials?

safety in humans

How many subjects are in phase I trials?

100 or less

What is done during phase I trials?

PK and PD are examined

designed to help researchers determine what the safe dosing range is

What is the focus of phase II clinical trials?

safety and efficacy in a small group of patients

How many subjects are in phase II clinical trials?

100-500

What happens during phase II clinical trials?

patients in the study receiving the drug are compared with patients receiving a different treatment or different drug that is considered the standard of care for the disease

What is the focus of phase III clinical trials?

to generate significant data about the safety, efficacy, and benefit-risk relationship of the drug

How many patients are enrolled in phase III trials?

1,000-5,000

Which of the phases of clinical trials are the longest and most expensive?

Phase III

What is the focus of stage 4 trials?

to find rare side effects that didn’t show up in clinical trials

this occurs after drug is already on the market

What is the abbreviated new drug application (ANDA)?

the application to get a generic version of an already approved brand name drug that is much shorter than the process for the brand name because the manufacturer can rely on the existing safety information of the brand drug

For a generic drug to be approved it must demonstrate bioequivalence. Explain what this means.

the generic drug must have the same rate and extent of absorption of the brand name drug so that the patient gets the same amount of drug in the same way

How long does approval/development take for a generic drug?

1-3 years

How much does it cost to develop a generic drug?

1-5 million

Who is eligible for Medicare?

those 65 and older

those that are any age but disabled

beneficiary of spouse who paid into Medicare for at least 10 years

What is covered under Part A of medicare?

covers inpatient hospital stay, psychiatric, skilled nursing facility stay, home health, and hospice care

What is covered under Part B of medicare?

AKA medical insurance

outpatient services such as physician visits, X-ray and lab visits, durable medical equipment, preventive services, drugs that cannot be self-administered

What is Medicare Part C?

this is a private insurance plan approved by Medicare known as Medicare Advantage

includes both Parts A and B coverage and sometimes part D

What is covered under medicare part d?

prescription drugs

Which parts of Medicare are mandatory?

Part A

Which parts of Medicare are optional?

Parts B, C, and D

How do patients enroll in Medicare Part A?

if you’re already receiving social security you are automatically enrolled

if not receiving social security you can manually enroll

What is original medicare?

consists of parts A and B

What can you add on to original medicare?

part d and secondary insurance such as MedSup

What does Medicare Part C include?

parts a and b coverage and most have part d coverage as well

most include dental, vision, and hearing services

Is the provider network for Medicare Part C sometimes limited?

yes

Why would a person get supplemental insurance if they have original Medciare?

because original medicare is only meant to cover 80% of a patient’s costs

What is the eligibility window for Part D?

3 months before you turn 65- 3 months after you turn 65 (7 months total)

What happens if you enroll after the eligibility window?

you will have a higher premium when you do enroll

you will have 1% of the national base premium added for each month you don’t enroll if you don’t have credible coverage or if you qualify for LIS

Is Part D mandatory or optional?

optional

Who approves Part D plans?

Medicare/CMS

Who is the primary payer for Part D?

the private insurance company that administers the plan

Does Part D use patient cost-sharing and formularies?

yes

What happens in the deductible phase of the 2026 standard benefit?

patient pays 100 percent of drug costs until they meet their deductible ($615)

What happens in the initial coverage phase of the 2026 standard benefit?

patient pays 25 percent of drug costs (co-insurance)

What happens in the catastrophic phase of the 2026 standard benefit?

the patient pays 0 percent of drug costs because they have reached their out of pocket limit ($2100)

What is the purpose of LIS?

helps people with limited income and resources to afford prescription drugs

decreases deductible and copayments

reduces premiums to zero or almost zero

allows someone to join medicare outside the enrollment window and won’t get the late penalty fee

What are the criteria for a patient to qualify for MTM services through their Part D plan?

1)must have a chronic condition

2)must be taking at least 2-8 or more maintenance, Part D covered medications

3)must meet an annual threshold of spending on Part D prescription drugs

Can a patient without LIS switch plans outside the enrollment window?

generally no unless they have a qualifying condition or life circumstance and then they can be granted a special enrollment period

If a patient receives a special enrollment period and decides to switch plans, when will this new plan start?

first day of the month after enrollment

If a patient misses the initial enrollment period (7 months) for parts a or b, when can they try to enroll in the future?

general enrollment (January 1-March 31) or through a special enrollment period

When is Medicare Advantage open enrollment?

Jan 1-Mar 31

What aspects of the ACA help to improve patient access to healthcare?

medicaid expansion

individual mandates that require people to have health insurance (later eliminated)

employer requirements to offer affordable health insurance to eligible employees

Have all states expanded Medicaid due to the ACA?

no

With the passage of the ACA, do all Americans have health insurance?

no

What are examples of how the ACA has affected private health insurance?

covers preventive healthcare with no patient cost sharing

allows children to stay on parent’s healthcare plan until 26

prohibits cancelling coverage

prohibits pre-existing condition exclusions and discrimination based on health status

prohibits lifetime money caps on insurance coverage

How is the ACA financed?

What is a health insurance exchange?

a website where individuals and small business or families can shop for health insurance

What are essential health benefits package?

a set of 10 categories of healthcare services that ACA compliant marketplace plans must cover

What are the different tiers of health plans?

bronze, silver, gold, platinum

Which plan has the highest premium/lowest deductible?

platinum

Which plan has the lowest premium/highest deductible?

bronze

What are ACOs?

group of healthcare providers that work together to coordinate a patient’s care and held accountable for the quality and cost of that care

Do providers share risk and/or cost savings for not meeting quality benchmarks?

yes