clinical pharmacology: drug regulation Flashcards
how do drug prices generally change with time?
drugs under patent: expensive
drugs become generic: cheaper
what needs to be known about all new drugs being considered for general population?
- does it work
- therapeutic dosage
- toxic dosage
- safe
- necessary
regulation of new drugs in the UK is done by?
Commission on Human Medicines (CHM)
what are some roles of the CHM?
advises ministers on the safety, efficacy and quality of medicinal products
what is CHM part of?
Medicines & Healthcare Products Regulatory Agency (MHRA) which is an executive agency of the department of health (DoH)
What are some roles of MHRA?
regulates medicines, medical devices and blood components for transfusion in the UK
why is pharmacovigilance needed?
sample size required to detect adverse events
how do you calculate if an adverse effect is significant?
what is the european equivalent of the Food and Drug Administration (FDA) in the US?
Committee for Medicinal Products for Human Use (CHMP)
- Quality
- Safety
- Efficacy
what is a major factor for the government in what drugs doctors should use?
cost-effectiveness
who decides what drugs doctors should be prescribing by considering cost-effectiveness?
Scottish Medicines Consortium (SMC)
advantages and disadvantages of SCM?
advantages
- comprehensive assessment
- rapid response
- uniformity within Scotland
- education
disadvantages
- pharmaceutical freedom
- funding
what are the possible outcomes after a company submits a drug to the SMC?
- approved for use
- approved for restricted use
- not recommended
- clinical effectiveness not convincing
- cost-effectiveness not demonstrated
- no submission by manufacturer
who considers applications for use of expensive drugs?
Patient Access Schemes Assessment Group (PASAG):
once a drug is approved by SMC, who needs to approve it for local use?
Area Drugs and Therapeutics Committees (ADTCs)
