Clinical Pharmacology- Regulation, Induction and Monitoring of medicine Flashcards
What is the role of the Commission on Human Medicine?
- Advises Ministers on matters relating to human medicinal products
- Advises Licensing Authority (LA)
- Considers representations by an applicant or MA holder
- Promotes collection and investigation of information relating to adverse Drug Reactions to human medicines.
What is the role of the MHRA?
- Post-marketing surveillance – ADRs and incidents
- Assessment & Authorisation of medicinal products for sale in UK
- Devices
- Quality control
- Internet sales & counterfeiting
- Clinical Trials regulation
- Statutory controls
- Promotion of safe use
- Manage British Pharmacopoeia & Clinical Practice Research Database
Why is pharmacovigilance needed?
to see how many times ADR’s occur in the population
Who was the Scottish Medical Consortium (SMC) established by?
The Scottish Government in 2001
What is the principal remit of the Scottish Medical Consortium (SMC)?
To make decisions on the cost effectiveness of new/existing pharmaceutical products in respect of their use in NHS Scotland
Who is part of the Scottish Medical Consortium (SMC)?
- Pharmacists
- Health economists
- Pharma representatives
- Lay representatives
- Physicians
- NHS management
What are the advantages of the Scottish Medical Consortium (SMC)?
- Comprehensive assessment
- Rapid response
- Uniformity within Scotland
- Minimise “post code prescribing”
- Education
What are the problems with the Scottish Medical Consortium (SMC)?
- Pharmaceutical freedom
* Funding
How long is the assessment process at the time of launch?
3 months
What is the problem with very expensive drugs?
Political overtones
What is disinvestment?
Recommended removal from Grampian joint formulary
When would disinvestment occur?
evidence for
superior efficacy/safety/kinetics now available for alternative product
evidence from major outcome studies now favour an alternative product
evidence of superior cost/benefit now available for an alternative product
evidence that this product is of limited clinical effectiveness
