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US Healthcare Exam 2 > Drug Use Slides (Industry, Drug Use Issues) > Flashcards

Drug Use Slides (Industry, Drug Use Issues) Flashcards

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1
Q

SLIDE 8 AND AFTER ON THE DRUG USE SLIDES

A
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2
Q

MUA

A

Medically Underserved Areas

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3
Q

What is a MUA?

A

The Department of Health & Human Services’ Health Resources
Services Administration (HRSA) designates communities with unmet
health care need as Medically Underserved Areas (MUAs)

Ex: Too few primary care providers, high infant mortality, high poverty, and a significant elderly population.

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4
Q

MUPs

A

Medically Underserved Populations

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5
Q

What is a MUP?

A

HRSA designates populations with unmet healthcare needs.

Criteria: Similar factors as MUAs, but with a focus on specific population groups sharing common characteristics.

Ex: Low-Income Neighborhood

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6
Q

HPSAs

A

Health Professional Shortage Areas

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7
Q

What is an HPSA?

A

Designated areas with shortages of primary medical care, dental, or mental health providers.

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8
Q

BPS

A

Board of Pharmacy Specialties

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9
Q

What specialities are recognized by the BPS?

A
  • Ambulatory Care
  • Cardiology Pharmacy
  • Compounded Sterile Preparations Pharmacy
  • Critical Care Pharmacy
  • Geriatric Pharmacy
  • Infectious Diseases Pharmacy
  • Nuclear Pharmacy
  • Nutrition Support Pharmacy
  • Oncology Pharmacy
  • Pediatric Pharmacy
  • Pharmacotherapy
  • Psychiatric Pharmacy
  • Solid Organ Transplantation Pharma
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10
Q

What are the main components of the pharmacy supply chain?

A

Drug manufacturers: Produce and sell medications to wholesalers.

Drug wholesalers: Distribute medications from manufacturers to pharmacies.

Pharmacies: Dispense medications to patients.

Pharmacy benefits managers (PBMs): Negotiate drug prices with manufacturers on behalf of insurers and employers.

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11
Q

Drug manufacturers

A

Produce and sell medications to wholesalers. They are responsible for developing new drugs, conducting clinical trials, and obtaining FDA approval.

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12
Q

Drug wholesalers:

A

Distribute medications from manufacturers to pharmacies. They store and transport medications, and they also provide services such as inventory management and order fulfillment.

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13
Q

Pharmacies

A

Dispense medications to patients. Pharmacists are responsible for verifying prescriptions, counseling patients on medication use, and providing other healthcare services.

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14
Q

Pharmacy benefits managers (PBMs)

A

egotiate drug prices with manufacturers on behalf of insurers and employers. They also manage prescription drug plans, including setting formularies and processing claims.

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15
Q

How does the payment flow work in the pharmacy supply chain?

A

Consumers pay their premiums to their employers or health insurers.

Employers or health insurers pay negotiated payments to PBMs.

PBMs pay negotiated payments to drug manufacturers.

Drug manufacturers pay rebates to PBMs.

PBMs may pass some of the rebates on to consumers in the form of lower copays or deductibles.

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16
Q

What are some of the challenges facing the pharmacy supply chain?

A

Rising drug prices: The cost of prescription drugs has been rising steadily for many years. This is a major challenge for consumers, insurers, and employers.

Drug shortages: Drug shortages can occur when there is a disruption in the supply chain. This can be caused by a variety of factors, such as manufacturing problems, and quality control issues

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17
Q

Payment flow (Supply Chain)

A

The patient pays their copayment to the pharmacy.

The pharmacy submits a claim to the patient’s insurance company.

The insurance company pays the pharmacy a negotiated reimbursement rate.

The pharmacy pays the wholesaler for the medication.

The wholesaler pays the manufacturer for the medication.

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18
Q

Rebate flow:

A

The manufacturer pays a rebate to the pharmacy benefits manager (PBM) based on the volume of medications dispensed by the pharmacy.

The PBM may share a portion of the rebate with the insurance company.

The insurance company may pass some of the rebate savings on to the patient in the form of lower copays or deductibles.

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19
Q

Product flow:

A

The manufacturer ships medications to the wholesaler.

The wholesaler ships medications to the pharmacy.

The pharmacy dispenses medications to the patient.

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20
Q

example of how the payment flow, rebate flow & product flow work together

A

A patient with a prescription for a brand-name medication goes to the pharmacy to fill it.

The patient pays their copayment, which is $20.

The pharmacy submits a claim to the patient’s insurance company, which is Anthem.

Anthem pays the pharmacy a negotiated reimbursement rate of $80.

The pharmacy pays the wholesaler $60 for the medication.

The wholesaler pays the manufacturer $50 for the medication.

The manufacturer pays a rebate of $10 to the PBM, CVS Caremark.

CVS Caremark shares $5 of the rebate with Anthem.

Anthem passes some of the rebate savings on to the patient in the form of a lower copayment. The patient’s copayment on the next refill of the medication is only $15. may not always happen

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21
Q

Why does this rebate system work?

A

PBMs play a crucial role in managing formularies for insurance plans. Manufacturers may offer rebates to PBMs to ensure that their medications are included in the formulary, increasing access for patients and driving sales volume.

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22
Q

What are the biggest three wholesalers of meds in the US?

A

AmerisourceBergen, Cardinal Health, and McKesson.

These three companies control over 90% of the wholesale drug distribution market in the United States.

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23
Q

Why are wholesalers in pharmacy necessary?

A

Convenience: Wholesalers offer a wide range of medications and other products, which can save pharmacies time and money.

Expertise: Wholesalers have the expertise to help pharmacies manage their inventory and ensure that they have the medications they need when they need them.

Credit: Wholesalers can offer credit to pharmacies, which can help them to manage their cash flow.

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24
Q

What is a PBM?

A

A pharmacy benefit manager (PBM) is a third-party company that helps oversee and run prescription drug programs for various groups, including commercial health plans, self-insured employer plans, Medicare Part D plans, the Federal Employees Health Benefits Program, and state government employee plans.

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25
Q

Responsibility of PBMS

A

PBMs are primarily responsible for developing and maintaining formularies, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims.

PBMs also negotiate drug prices with manufacturers on behalf of insurers and employers. Also manages prescription drug plans, including setting formularies and processing claims.

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26
Q

Major PBMs in the US?

A

Caremark (CVS Health) / Aetna:
Express Scripts
OptumRx (UnitedHealth):
Humana Pharmacy Solutions:
MedImpact Healthcare Systems
Prime Therapeutics
All other PBMs + cash pay

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27
Q

PBM Roles

Section name

A
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28
Q

PBMS- Maintain Formularies:

A

PBMs maintain formularies, which are lists of covered medications for their clients.

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29
Q

PBMS- Pharmacy Network Management:

A

PBMs work with pharmacy networks, process claims, and offer reimbursement services.

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30
Q

Cost Determination:

A

PBMs set copays, coinsurance, and determine out-of-pocket costs for prescription medications.

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31
Q

PBMs: Negotiate Rebates and Discounts:

A

use their purchasing power to negotiate rebates and discounts from drug manufacturers.

32
Q

Cost-Cutting Strategies that PBMs use:

A

PBMs help cut drug costs through strategies such as mail order and home delivery of medications, creating networks of cost-effective pharmacies, encouraging the use of generics and affordable brand medications, managing high-cost specialty medications, and reducing waste while improving adherence.

33
Q

Additional Services:

A

PBMs engage in compliance building, Utilization Management (UM), disease management (DM), and Drug Utilization Review (DUR) programs.

34
Q

AWP

A

Average wholesale price (AWP)

35
Q

What is an AWP?

A

the average price paid by a retailer to buy a drug from the wholesaler.

36
Q

Historical Use of AWP:

A

The AWP benchmark has been employed for over four decades to determine pricing and reimbursement of prescription drugs for third parties, including government and private payers.

37
Q

Limitations of AWP:

A

The AWP is not a true representation of actual market prices for generic or brand drug products and is typically inflated by about 20 percent.

38
Q

AWP vs”List Price”:

A

The key point of the comparison is that the AWP is often not what is actually paid by entities such as pharmacies, insurers, or consumers. The actual transaction price can be lower due to negotiations between various players in the pharmaceutical supply chain.

39
Q

What do Managed Care Pharmacists do?

A

Ensure patient safety
* Conduct drug utilization review (DUR)
* Serve on pharmacy and therapeutics (P&T) committees
* Design and run Medication Therapy Management (MTM) programs
* Develop quality assurance programs
* Create programs to detect fraud, waste, and abuse of medications
* Design drug benefit plans
* Help clients evaluate and improve their pharmacy benefit

40
Q

Patient Safety: Managed Care Pharmacists

A

Managed care pharmacists ensure patient safety by overseeing medication-related processes.

41
Q

Drug Utilization Review (DUR): Managed Care Pharmacists

A

Managed care pharmacists conduct drug utilization reviews to assess the appropriateness and effectiveness of medications.

42
Q

Pharmacy and Therapeutics (P&T) Committees: Managed Care Pharmacists

A

They serve on pharmacy and therapeutics committees, contributing to decisions on formulary management and medication selection.

43
Q

Medication Therapy Management (MTM) Programs: Managed Care Pharmacists

A

Managed care pharmacists design and run Medication Therapy Management programs to optimize patient outcomes.

44
Q

Managed Care Pharmacists:
Quality Assurance Programs:

A

They develop quality assurance programs to ensure the high standards of pharmaceutical care.

45
Q

Managed Care Pharmacists: Drug Benefit Plan Design:

A

They design drug benefit plans, contributing to the development of effective and efficient coverage.

46
Q

Managed Care Pharmacists:
Pharmacy Benefit Evaluation

A

Managed care pharmacists assist clients in evaluating and improving their pharmacy benefit programs.

47
Q

Formulary

A

A formulary is a list of prescription medications approved by a health insurer or pharmacy benefit manager for coverage under a specific health insurance plan. It categorizes drugs into tiers, indicating coverage and cost-sharing levels for patients. Formularies aim to promote cost-effective and clinically appropriate medication use.

48
Q

Formulary Tiers

A

Tier 1: Generics

This tier includes generic medications, which are typically lower-cost alternatives to brand-name drugs.

Tier 2: Preferred
The preferred tier includes brand-name medications that are considered the preferred or recommended choices within a therapeutic class.

Tier 3: Non-Preferred

Non-preferred drugs are brand-name medications that are not on the preferred tier. They are still covered but may have higher patient cost-sharing.

Tier 4: Specialty

The specialty tier includes high-cost specialty medications, often used to treat complex or rare conditions.

49
Q

DUR

A

Drug Utilization Review

50
Q

What is a DUR?

A

DUR is a structured and ongoing review of prescribing, dispensing, and medication use to ensure proper decision-making and positive patient outcomes.

51
Q

Prospective DUR

A

This type of review occurs in advance, often at the point of prescribing or before medication is dispensed to the patient. Pharmacists or automated systems check the prescribed medication against predetermined criteria to ensure its appropriateness, safety, and adherence to guidelines.

52
Q

Concurrent DUR

A

This type of review occurs in real-time or near real-time as patients receive and continue their medications. It involves regular assessment of prescription and medication data to ensure appropriateness, safety, and adherence throughout the treatment.

53
Q

Retrospective DURs:

A

This type of review occurs after the medication has been dispensed and the patient has undergone the treatment. It looks back at historical data to assess the appropriateness, safety, and effectiveness of the drug therapy.

54
Q

Phases of Drug Development

A

Potential Candidates
Preclinical Testing
Phase I Clinical Trial
Phase II Clinical Trial
Phase III Clinical Trial
FDA Approval
Approved Drug

55
Q

Potential Candidates:

A

Scientists identify potential drug candidates through research and discovery.

56
Q

Preclinical Testing:

A

Promising compounds undergo laboratory and animal testing to assess safety, efficacy, and potential side effects.

57
Q

Phase I Clinical Trial:

A

Small group testing in humans to evaluate safety, dosage, and initial efficacy.

58
Q

Phase II Clinical Trial:

A

Expanded testing with a larger group to further assess effectiveness and side effects.

59
Q

Phase III Clinical Trial:

A

Large-scale testing involving diverse populations to confirm efficacy, monitor side effects, and compare to existing treatments.

60
Q

FDA Approval:

A

Researchers submit a New Drug Application (NDA) to regulatory authorities, providing comprehensive data from clinical trials.

61
Q

Approved Drug:

A

Regulatory agencies review the NDA, and upon satisfaction with safety and efficacy, grant approval for the drug to enter the market.

62
Q

How much does it cost to develop a drug?

A

estimated total cost at $2.6 billion. This breakdown includes approximately $1.4 billion in average out-of-pocket costs and $1.2 billion in time costs.

Time costs refer to the economic value of the time invested in the lengthy drug development process.

THOUSAND percent will be asked he loves this question

63
Q

NDC Codes

A

The NDC, or National Drug Code, is a unique 10-digit or 11-digit, 3-segment
number, and a universal product identifier for human drugs in the United States.

64
Q

3 segments of an NDC code

A

the labeler, the product, and the
commercial package size.

65
Q

Labeler:

A

The first set of numbers identifies the labeler, such as the drug manufacturer, repackager, or distributor.

66
Q

Product Code

A

The second set identifies specific drug details like strength, dosage form (e.g., capsule, tablet, liquid), and formulation for a specific labeler.

67
Q

Package Code:

A

The third set identifies package sizes and types.

68
Q

What is the purpose of an NDC?

A

The NDC provides a standardized method for identifying and cataloging drugs, facilitating accurate tracking and management in the healthcare system.

69
Q

Drug Approval Process:

A

Overview of the regulatory steps a drug must pass to gain FDA approval, ensuring safety and efficacy.

70
Q

RCT and Clinical Trial Phases

A

Randomized Controlled Trials (RCTs) are crucial in drug development, and clinical trial phases (I-IV) determine safety and effectiveness.

71
Q

Post-marketing Surveillance:

A

Ongoing monitoring after a drug is on the market to identify and assess potential safety issues.

72
Q

Orange Book:

A

A publication listing approved drug products with therapeutic equivalence evaluations.

73
Q

NDC Code Database:

A

National Drug Code, a unique identifier for drugs in the U.S., used for tracking and cataloging.

74
Q

Drugs@FDA:

A

Online database providing information on FDA-approved drugs.

75
Q

MedWatch:

A

FDA’s safety information and adverse event reporting program for healthcare professionals and the public.

US Healthcare Exam 2 (8 decks)

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