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2 > Lecture 20 > Flashcards

Lecture 20 Flashcards

1
Q

What are examples of therapeutic goods?

A
  • band-aids
  • Panadol
  • Injection
  • Vitamins
  • Immune boosters
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2
Q

Define therapeutic goods

A

Any product used in healthcare to:
- treat/prevent/diagnose a
disease/aliment/defect/injury

  • Influence/inhibit/modify a physiological
    process
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3
Q

What are excluded therapeutic goods?

A
  • those that technically meet the definition but declared by law not be be

e.g.
o Hair bleaches/dye/colourants
o Dental bleaches/whiteners
o Blood alcohol measurement devices

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4
Q

Examples of therapeutic goods gone wrong

A
  • Thalidomide
  • Vioxx
  • Porcine Small Intestine Submucosa
  • Metal on metal hip replacements
  • poly implant protheses breast implants
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5
Q

Thalidomine

A

Drug for morning sickness that inhibited angiogenesis = lost limbs

  • Fetus limbs not develops
  • 1990s used as a potent antio-angiogenesis drug
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6
Q

Vioxx

A

$4.85bn legal claims

  • Anti-inflammatory drug for rheumatoid arthritis
  • Increases risk of CVD
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7
Q

Porcine Small Intestine Submucosa (SIS)

A
  • Johnson & Johnson product
  • Not acellular collagenous matrix
  • contains porcine DNA
  • possible implications in human implantation
  • used for repair of rotator cuff tendon tear
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8
Q

What is the Aus Federal department responsible for in the health care system?

A
  • health financing
  • disease control & major health programs
  • therapeutic goods regulation
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9
Q

What is the Aus State & Territory department responsible for in the health care system?

A
  • Pharmacy regulation
  • Hospitals
  • Health services
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10
Q

What is the Aus Local/Municipality department responsible for in the health care system?

A
  • Health inspectors
  • Water quality
  • Sanitation
  • Food premises inspections
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11
Q

What are the 4 core pillars of therapeutic goods regulation?

A
  1. Quality
  2. Safety
  3. Efficacy
  4. Cost - effectiveness, reimbursement
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12
Q

What are the three major categories of therapeutic goods?

A
  1. Medicine
  2. Medical Devices
  3. Biologicals
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13
Q

Medicine

A
  • used on humans
  • generally pharmaceutical, immunological, chemical or metabolic effect on body
  • over counter mild analgesics
  • antibiotics
  • blood & blood components
  • vaccines
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14
Q

Medical Devices

A
  • Used on humans
  • Therapeutic benefits
  • Generally have a physical benefit
  • Wheelchair
  • Pacemaker
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15
Q

Biologicals

A
  • Used on humans
  • Therapeutic benefits
  • Made from or contain processed/manipulated human tissue
  • Processed/maipulated cell therapy products
  • Genetically modifies human cell and tissue products
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16
Q

What biotherapeutic products are excluded from regulation as therapeutic goods?

A
  • fresh viable human organs
  • fresh human hematopoietic progenitor cells
  • autologous human tissue/cells
  • unmanipulated reproductive tissues

2 (21 decks)

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