Medicines Safety Flashcards
Side effects: VERY Common definition?
1 in 10
Side effects: common definition?
1 in 100 to 1 in 10
Side effects: Uncommon definition?
1 in 1000 to 1 in 100
Side effects: Rare definition?
1 in 10,000 to 1 in 1000
Side effects: Very rare definition?
Less than 1 in 10,000 experience this
Class 1 MHRA defective medicines alert: requires action within?
24 hours
Immediate recall: because the product poses a serious or life threatening risk to health
Class 2 MHRA defective medicines alert: requires action within?
48 hours
the defect could harm the patient but is not life threatening
Class 3 MHRA defective medicines alert: requires action within?
5 days
the defect is unlikely to harm patients and is being carried out for reasons other than patient safety.
Class 4 MHRA defective medicines alert: requires action within?
Means caution in use only
indicates that the product poses no threat to patient safety
By law, manufacturers must report to the MHRA any important defects in both medicines and medical devices. What can Warnings/ Alerts be issued about?
Defective medicines
problems with devices
side effects associated with medicines and blood and blood products.
What does the black triangle mean?
Means this drug is recently on the market- so it prompts people that all ADR’s need to be reported with these drugs.
Usually kept for 5 years
Endocrine disorders Anaphylaxis Jaudine Heamorrhage Renal impairment Eye disorders fertility effects
Are all examples of what?
‘Serious’ reactions that must be reported to MHRA in all circumstances.
Any pro-longed hospitalisation, disabling, fatal, teratogenicity all must be reported.
Do all ADR’s in children have to be reported?
The BNF states they do!! ALL of them
What is Steven Johnsons Syndrome? What could cause it?
Severe hypersensitivity reaction:
Ulcers and other lesions begin to appear in the mucous membranes, almost always in the mouth and lips, but also in the genital and anal regions. Rash usually appears all over the body bar the scalp.
Drugs causing it examples: a lot of the anti-epileptics
Lamotrigine (most common!)
Phenytoin
Carbamazepine
What could cause brown staining of the teeth?
Most common cause: Chlorhexidine mouthwash
Iron salts
Intrinsic staining: tetracyclines (usually only in children)