411 Exam 2

What is an independent pharmacy?

A pharmacy owned by individual pharmacist or small group of HCP

Between chain pharmacies and independent pharmacies, who has more negotiating power for discounts from wholesalers?

Chain pharmacies

What are the advantages of owning an independent pharmacy?

Greater flexibility in division making, patient care, adapting to community specific needs

Independent pharmacies are key access points for what communities?

Rural, 65+, low income, poor, and ethnic communities

What are the advantages of owning a chain pharmacy?

Can share data between many locations, longer hours of operation, standardization of products sold, good negotiation power, and able to buy in bulk

What is a limitation to chain pharmacies?

The corporate structure limits its independence and flexibility

What is a dispensing fee?

The fixed dollar amount paid to pharmacy for each prescription dispensed

Where and between who is the dispensing fee negotaited?

Negotiated between the PBM and the pharmacy in the participating pharmacy agreement

Between the pharmacy and the PBM, who wants a higher dispensing fee?

The pharmacy wants the higher dispensing fee

What are the categories of hospitals based on services provided?

Community, psychiatric, and non-community

What would be examples of a non-community hospital?

Prison hospitals and school infirmaries

What are the categories of hospitals based on length of stay?

Short term: <30 days

Long term: >30 days

How are hospitals categorized based on levels of care?

Primary, secondary, tertiary, quaternary

How are hospitals categorized based on ownership?

Non-profit, for-profit, state and local gov, federal gov

What is the role of the director of pharmacy?

Management and leadership: oversee personnel and budget

• Justify and develop job descriptions to hire new staff

• Manage drug budget

• Evaluate policy and procedures

• Implement new programs

• Ensure regulatory compliance

What is the role of a pharmacy technician?

• Perform drug distribution: unit dose medications, prepare sterile products, restock

• Limited patient care activities

  • Medication history

  • Test claims for medication prior to discharge

  • Screen for vaccines and nicotine replacement therapies while inpatient

What does a staff pharmacist do?

Focus on distributive functions

What is the role of the attending physician?

A hospitalist, surgeon, or specialist physician who leads the physician team in the diagnosis, treatment, and care plan of patients

What is the role of medical residents and interns?

What is an intern?

A fully licensed doctor in first year of residency training after graduating from medical school

What is a resident?

A fully licensed doctor in second year of residency training after graduating from medical school

What does an occupational therapist do?

Assess people’s ability to do daily activities like eating dressing, grooming, bathing, toileting, cooking

What does a physical therapist do?

• Evaluate/treat people who have difficulty w/ function

• Assess strength, endurance and coordination and design exercise programs to help people function better physically

What does a respiratory therapist do?

• Treat conditions of lungs and breathing

• Involved in care of intubated patients on ventilators, or patients with other difficulties breathing

What does a speech and language pathologist do?

Work with patients who struggle swallowing or speaking

What does a dietician do?

Determine dietary needs appropriate for a disease state/condition

Explain the basic pharmacy workflow when insurance is not involved

Pharmacy receives prescription —> data entered into system —> first pharmacist checks accuracy and does DUR —> prescription is prepared —> 2nd pharmacist verifies the final product —> product is dispensed and sold

What are the limitations of a dispensing software system?

• Does not communicate to EHR or to each other

• Accuracy depends on data you enter

What is the purpose and function of a pharmacy dispensing software system?

Manage complex pharmacy workflow

• Keep records and maintain profiles

• Communicate claim info to PBM and insurers

• Create/print labels and patient handouts

• Track inventory and products

• Internal checks/alerts for allergies/interactions

Describe the payer adjudication process

Patient insurance info collected and stored —> Prescription claim data electronically sent to payer —> Claim is processed —> pharmacy is informed of the claim status —> drug is dispensed

What happens when a claim is covered?

The drug is covered, and the pharmacy is informed of the patient cost-share amount. Filing process continues

what happens when a claim is denied?

Resolve the reason for rejection and resubmit claim. If can’t be resolved sell prescription for cash prices. 

What are some reasons for third party payer retraction of claims?

• Missing/invalid patient plan information

• Prior authorization needed

• Out of network pharmacy

• DUR rejection 

• Quantity limits

Who performs DUR?

Pharmacists, PBMs, or payers

What is the purpose of a DUR?

Ensures appropriate, safe, and effective drug use

What does DUR stand for?

Drug Utilization Review

What is a retrospective DUR?

DUR done after dispensing the drug. Educates prescribers/pharmacies on medication use patterns

what is a prospective DUR?

DUR done prior to/at the time of dispensing the drug

Ensure appropriateness by informing the pharmacist of potential problems

What does a clinical pharmacist do?

Patient care services, order verification, rounding with medical team, admission/discharge education

How do drugs move through the channel of distribution?

Manufacturer —> wholesaler —> pharmacy —> patient

What needs to be submitted to the FDA prior to starting Phase I clinical trails?

Investigation New Drug (IND) application

What is done during Phase I clinical trials?

Determine how the drug works, the dosing, and the toxicities

What is done during Phase II clinical trials?

Determine the drug safety and effectiveness

What is done during Phase III clinical trials?

Determine the drug safety and effectiveness via randomized controlled trials

What is done during Phase IV clinical trials?

Monitor for potential adverse reactions and other problems after market approval

Before what trial is an New Drug Application (NDA) submitted?

Before Phase IV

What is a New Drugs Application (NDA)

Shows the results of Phase I - III clinical trials

How long is the exclusivity period of a patent?

20 years

When are patents for a drug filed?

Soon after its discovery and MOA

Describe the generic drug approval process

Abbreviated process - safety and effectiveness already proved

Abbreviated NDA - proof of bioequivalence, bioavailability, and pharmacokinetic/dynamic properties to ensure the same or similar to reference product

Who do manufacturers sell drugs to?

Wholesalers

What are wholesalers?

Purchase, store, and distribute drug products

How do wholesalers ensure integrity of the drug distribution system?

Using drug pedigrees to track each sale of the drug through the system; prevents adultered or counterfeit drugs from entering the system

What is the list price of a drug?

• The estimated average price of a drug

• The price before discounts and rebates

• Publicly disclosed

What is the net price of a drug?

• The actual price paid for a drug

• Price paid by wholesaler after discounts and rebates

• Not publicly disclosed

• Less than or equal to list price

What is another name for the list price?

Wholesale acquisition cost (WAC)

Who sets the list price or WAC?

The manufacturer

What is another name for the net price?

Average manufacturer price (AMP)

What is the price range wholesalers pay for brand drugs from the maufacturers?

WAC - (2-5%)

Do generics or brand drugs get higher discounts and why

Generics because they are more profitable

Who do pharmacies purchase drugs from?

Wholesalers

What is the average wholesale price (AWP)?

The list price for the wholesaler to pharmacy transaction; publicly disclosed

How do wholesalers make profit?

Sell the drug to pharmacies at a price higher than the AMP they bought it for

Explain the flow of money through the channel of distribution

Manufacturer sets WAC; Wholesaler buys for AMP; Wholesaler sets AWP higher than AMP; Pharmacy buys at AAC

How can smaller pharmacies gain purchasing power?

Group purchasing organizations (GPOs)

What is the actual acquisition cost (AAC)

The price the pharmacy pays to the wholesaler

Is there a large difference between the AMP and AAC prices?

No. Emphasizes the need for efficiency in wholesalers

What is the usual and customary price (U&C) of a drug?

The cash price a patient without insurance pays

How is the U&C price determined?

drug ingredient cost + cost of dispensing (COD) + profit

What is the drug ingredient cost?

What the pharmacy pays for drugs (AAC)

What is the cost of dispensing?

Costs other than the drug itself

What is the purpose of a hospital drug formulary?

Limit the drugs they stock to reduce variety and decrease costs

What is a central pharmacist?

Pharmacists performing clinical pharmacy services or patient care services

• Located in main/central pharmacy

• Call/message prescribers with recommendations

• Lower cost and more efficient

What is a decentral pharmacist?

Pharmacists located on patient care units who participate in face-to-face rounds

• More accessible to prescribers

• Easier/faster to interact w/ patients

• Increased job satisfaction across health care team

Who approves changes to the hospital formulary or conditions/criteria to use medications?

Pharmacy & Therapeutics (P&T) Committee

Describe the centralized drug distribution model

Medications are distributed from the pharmacy to the patient care units based on patient-specific orders; cartfill process

Describe the decentralized drug distribution model

Commonly used medications are stocked in the patient care unit, typically within an automated dispensing cabinet (ADC)

What is the cartfill process?

Carts used to distribute medications to patient care units. Each patient has a drawer on the cart with scheduled medication doses

What happens when a patient needs a medication not included in the cartfill process?

the medication is filled independently and delivered to the patient care area via a technician or pneumatic tube system

What are the advantages of a centralized medication distribution model?

• High degree of control over inventory and medication access

• Lower cost (fewer staff, smaller/fewer ADCs, reduced inventory)

• No bottlenecks at standard medication administration times

What are the advantages of a decentralized medication distribution model?

• Faster medication turnaround time

• Reduced waste of medications in transit

• More opportunities to interact with health care team (satellite pharmacies)

What are emergency carts or crash carts?

Contain medications that may be needed in an emergency or code scenario readily available in the cart stored on patient care units

Explain what happens when a patient is admitted

• EHR profile is created/updated

• Demographic, contact, and insurance info is verified

• Perform medication reconciliation

• Screen for medication related needs

What is an order set?

Groups of orders organized by disease state, admission type, etc.

How are hospital orders different from community pharmacy prescriptions?

More attention to timing and dispensing location

Describe the components of “preparing” a medication

• Compound sterile pharmaceuticals

• Repackage multi-dose products into unit-dose

• Reconstitute oral suspensions; draw up oral syringes

• Splitting tablets

• Preparing radiopharmaceuticals

Why is medication preparation in the hospital setting important?

• Medications come in stock bottles

• Prefer to send only dose(s) needed to minimize waste

What are the components of dispensing in the hospital setting?

• Selecting the correct product based on the pick-list/patient-specific order

• Labeling the product based on the patient-specific order

• Delivering the product to the correct location

• Removing the correct product from ADC for patient care

By what means are orders dispensed?

• ADC on patient care unit

• Delivery from central pharmacy

• Patient-specific medication drawer 

Who primarily performs the administration of a drug?

Nursing staff

What is barcode medication administration (BCMA)?

Creates entry in the Medication Administration Record (MAR) of the EHR that documents drug, dose and time administered

What is the pharmacist role in drug administration?

• Develop/revise guidelines on drug administration

• Manage IV smart pump drug library

• Maintain EHR drug-specific instructions

• Address compatibility and administration method issues

What is a transition of care

Actions designed to ensure the coordination and continuity of healthcare as patients transfer between different locations

What coordination happens during care transitions?

• Comprehensive planning of care

• Involvement of healthcare providers who are well informed about the patient’s goals, status, and preferences

• Logistical arrangements

• Coordination between healthcare providers, patient, and family/caregiver education

What are barriers to medication management in care transition?

• Financial/staff resources

• Electronic transfer of patient data

• Developing partnerships

• Communication across levels of care and groups

What are facilitators of medication management in care transition?

• Multidisciplinary support & collaboration

• Integration of pharmacy into care transition team

• Justification of resources

• Electronic transfer of patient data between in/outpatient

• Strong partnership network

What is fee-for-service reimbursement?

A retrospective, transaction-based payment; Contracts negotiate charge allowance for payment for services

What are the issues with fee-for-service reimbursement?

• Individual payment for each covered service

• No incentive to decrease utilization or costs

• provider-induced demand - use more services unless reimbursement is below cost 

• No penalty for duplicate service or waste

What is a charge allowance?

What the insurance will agree to reimburse for each procedure, service, or good that is provided during admission

What is per diem reimbursement?

A prospective payment reimbursement method with a flat rate per day regardless of actual cost; Used by Medicare for skilled nursing facilities, home health, and hospice