Use of Medicines Flashcards
1
Q
What is the MHRA?
A
Medicine and Healthcare Products Regulatory Agency
Ensures human medicines meet acceptable standards on safety, quality and efficacy
Product
- clinical trial authorisation
- product licence; market authorisation
Company
- company licences; manufacturing and wholesale dealer
2
Q
Describe pharmacovigilence
A
Process involving detection, assessment, understanding and prevention of ADRs
Provides continual assessment of risks and benefits of each drug resulting in best drug therapy for the patient
3
Q
What is the Yellow Card Scheme?
A
main method of post-marketing surveillance of ADRs in UK
Collects info on suspected problems involving
- side effects
- medical device adverse incidents
- defective medicines
- counterfeit or fake medicines or devices
- safety concerns e.g. e-cigs
4
Q
What is a black triangle drug?
A
A drug/vaccine which is still under intense surveillance
5
Q
What are the classifications of medicines?
A
Prescription only
OTC; pharmacy and general sales list
