Final > Canada's Vaccine Safety Systems (Book ch. 9) Flashcards

1
Q

Describe the events of the “Cutter Incident”.

A

Cutter Labs produced a defective polio vaccine responsible for infecting >300,000 people with the virus. Talk about irresponsible…

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2
Q

What is the purpose of clinical trials?

A

To test the safety and efficiency of a new drug.

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3
Q

What occurs during phase 1 clinical trials?

A

1st human trials. A small # of healthy adults are tested.

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4
Q

What occurs during phase 2 clinical trials?

A

Increased # of participants, randomized samples, determine dose schedule.

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5
Q

What occurs during phase 3 clinical trials?

A

Many participants. Demonstrate efficacy of drug on randomized samples. Final safety trials before drug release.

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6
Q

What occurs during phase 4 clinical trials?

A

Post-marketing surveillance of consumers for rare drug effects.

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7
Q

What event spurred the need for the pharmacovigilance system?

A

the Thalidomide incident resulting in a bunch of kids missing limbs and stuff.

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8
Q

What is the purpose of pharmacovigilance?

A

Monitor product safety after market authorization.

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9
Q

What are the 4 main laws which must be adhered to when producing vaccines?

A
  1. Review documents from clinical and non-clinical experiments
  2. On-site evaluation of drug production
  3. Independent testing of at least 3 lots
  4. Compliance with Good Manufacturing Practices (GMP)
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10
Q

During a phase 4 trial, what is meant by passive monitoring?

A

Individuals report adverse affects to point of care.

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11
Q

During a phase 4 trial, what is meant by active monitoring?

A

Hospital-based. Monitoring of secondary vaccine effects on inpatients by healthcare staff.

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12
Q

What is a “safety signal” with regards to vaccine delivery?

A

An undesirable secondary effect of a vaccine which would be detected and addressed. Ex: paralysis from polio vaccine, meningitis from mumps vaccine.

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