Intro to Case Flashcards
1
Q
What is the title of Case 1
A
Outbreak of fungal meningitis in patients who had received steroid injections
2
Q
Describe what occurred in case 1
A
- source of outbreak was traced to 3 lots of preservative free methylprednisolone acetate
- lots were recalled but more than 13000 people had been exposed
- hundreds of meningitis cases and 76 deaths were reported
- methylprednisolone lots were shown to be contaminated mainly with black moulds and several bacteria
3
Q
what went wrong in case 1?
A
- failure to sterilise products for the minimum amount of time necessary to ensure sterility
- shipment of orders without final results of sterility tests
- several hazards in manufacturers clean rooms
- eg. sterile hoods not properly cleaned - environmental sampling always detected contamination in the air or on surfaces of clean rooms
4
Q
What was the outcome in case 1?
A
- US federal prosecutors charged more than a dozen employees at NECC
- owner/head pharmacist and supervisory pharmacist were arrested and charged with acts of 2nd degree murder
5
Q
what is the title of case 2
A
Outbreak of Bacillus cereus septicaemia in babies who had received Total parenteral nutrition
6
Q
describe what happened in case 2
A
- affected babies were in neonatal intensive care units at a small number of hospitals in england
- cases were linked with a number of batches of parenteral nutrition manufactured by ITH Pharma limited
- Bacillus cereus is found widely in the environment in dust, soil and vegetation and produces endospores
- ITH Pharma recalled specific batches of liquid phase parenteral nutrition from specific hospitals
- 22 cases linked to blood poisoning and 3 babies died
7
Q
what was the outcome in case 2
A
- investigations suggested that the source of bacillus cereus infection was contamination of intravenous liquid products during a single day of production
- MRHA believed it was an isolated incident and appropriate immediate actions were taken by manufacturer to avoid reoccurance
