Final > Canada's Vaccine Safety Systems (Book ch. 9) Flashcards
Describe the events of the “Cutter Incident”.
Cutter Labs produced a defective polio vaccine responsible for infecting >300,000 people with the virus. Talk about irresponsible…
What is the purpose of clinical trials?
To test the safety and efficiency of a new drug.
What occurs during phase 1 clinical trials?
1st human trials. A small # of healthy adults are tested.
What occurs during phase 2 clinical trials?
Increased # of participants, randomized samples, determine dose schedule.
What occurs during phase 3 clinical trials?
Many participants. Demonstrate efficacy of drug on randomized samples. Final safety trials before drug release.
What occurs during phase 4 clinical trials?
Post-marketing surveillance of consumers for rare drug effects.
What event spurred the need for the pharmacovigilance system?
the Thalidomide incident resulting in a bunch of kids missing limbs and stuff.
What is the purpose of pharmacovigilance?
Monitor product safety after market authorization.
What are the 4 main laws which must be adhered to when producing vaccines?
- Review documents from clinical and non-clinical experiments
- On-site evaluation of drug production
- Independent testing of at least 3 lots
- Compliance with Good Manufacturing Practices (GMP)
During a phase 4 trial, what is meant by passive monitoring?
Individuals report adverse affects to point of care.
During a phase 4 trial, what is meant by active monitoring?
Hospital-based. Monitoring of secondary vaccine effects on inpatients by healthcare staff.
What is a “safety signal” with regards to vaccine delivery?
An undesirable secondary effect of a vaccine which would be detected and addressed. Ex: paralysis from polio vaccine, meningitis from mumps vaccine.
