US Health Care: Block 1

What are the paths that can be taken after Pharmacy School?

What are the paths that can be taken after Pharmacy School?

1. Straight to work

2. Residency

3. fellowship

4. Additional Degree

What are the 4 regulatory Bodies?

1. United States Food and Drug Administration (FDA)

2. Drug Enforcement Agency (DEA)

3. National Association of Boards of Pharmacy (NABP)

4. North Carolina Board of Pharmacy (NCBOP)

What is FDA’s Role?

1. Protection of Public Health

2. New Drug Approval Process

3. Manufacturing standards

4. Post-Marketing Surveillance

5. Compound Pharmacy

6. Drug Importation

7. Label and Advertising

8. Oversee Laws

   1. Federal Pharmacy Laws

9. Shortages and Recalls

Explain The FDA’s PRE-CLINICAL Drug Approval Process

Drug is developed and tested on small animals similar to humans so a IND application and Patent can be completed

Explain Phase one of FDA’s CLINICAL Drug Approval Process

20-80 people, all healthy to see for adverse affects

Explain Phase two of FDA’s CLINICAL Drug Approval Process

100’s of people, used to determine dosing

Explain Phase three of FDA’s CLINICAL Drug Approval Process

1000’s of people, Only tested on people with the disease state

What must happen in order for FDA to give approval during the NDA Review?

1. Application Reviewed (60 days)

2. Drug Labeling

3. Facility Inspection

What happens during Post Marketing with the FDA?

The drug is monitored continually nationwide in order to assess for adverse events

What is the DEA’s Regulatory role?

Controlled Substance Laws

What is the NCBOP’s role?

1. Laws and Rules Directly related to the practice of pharmacy

   1. Inspections

   2. Disciplinary actions

2. Licensing Requires

   1. Creates MPJE

3. Pharmacy Permits

What is the NABP’s Role?

• Naplex Exam

  • Creates and Administers

• MPJE

  • Administers

• Continuing Education

  • Helps Track

• US Pharmacopeia (USP)

What was USP-795 for?

Non-Sterile Compounding

What was USP-797 for?

Sterile Compounding

What was USP-800 for?

Hazardous Drugs

What are the 3 pharmacy associations?

1. American Pharmacist Association (APhA)

2. America Society of Health-System Pharmacist (ASHP)

3. American College of Clinical Pharmacy (ACCP)

What Pharmacy association has the largest outreach?

American Pharmacist Association (APhA)

What Pharmacy association has the smallest outreach?

American College of Clinical Pharmacy (ACCP)

What is the NCAP?

• North Carolina Association of Pharmacy

• Focus on advocacy and advancing pharmacist role in state

• State-wide “reach”

What is Pharmacology?

• How Drugs Work

  • How they treat a condition

  • How they affect your body

  • How they interact with other medications

What is Drug Knowledge?

• “All things Drugs”

  • Patient Councling

  • Side effects

  • Dosage Forms/strengths

  • Color/Shape/Taste(?)

  • Reimbursement

  • Drug Cost

What is Pharmacotherapy?

• How to use these drugs to treat ___ condition

  • Guideline recommended therapy

  • Drug research expert

  • Safe Use of Drugs