Drug Regulation Flashcards
How do drug prices generally change with time?
Drugs when under patent are expensive, but when they become generic once the patent expires they should become cheaper
Issue in US, pharmaceutical companies bought all companies making the generic drug and hiked price up
Where is drug advertising legal, and what are some advantages and disadvantages?
Only countries this can be done directly to consumers is US and New Zealand:
- Advantages
- Empowers patient
- Disease education
- Prompts patient to seek timely medical advice
- Disadvantages
- Consumers think it increases price
- Reduces authority of the doctor
- Inflates demand for new/expensive drugs
- Off patient use
What needs to be known about all new drugs being considered for general population?
- Does it work
- What dose is therapeutic
- What dose is toxic
- Is it safe
- Is it necessary
Regulation of new drugs in the UK is done by?
- Commission on Human Medicines (CHM)
- Advices ministers on matters relating to medicine
- Advices licensing authority (LA)
- Considers representation by an applicant or MA holder
- Promotes collection and investigation of information relating to adverse drug reactions
What does CHM stand for?
Commission on Human Medicines
What are some roles of the CHM?
- Advices ministers on matters relating to medicine
- Advices licensing authority (LA)
- Considers representation by an applicant or MA holder
- Promotes collection and investigation of information relating to adverse drug reactions
What is CHM part of?
CHM is part of the Medicines & Healthcare Products Regulatory Agency (MHRA) which is an executive agency of the department of health (DoH)
What are some roles of MHRA?
- Post marketing surveillance
- ARDs and incidents
- Assessment and authorisation of medicinal products for sale in UK
- Devices
- Quality control
- Internet sales and counterfeiting
- Clinical trial regulation
- Statutory control
- Promotion of safe use
Why is pharmacovigilance needed?
Pharmacovigilance is needed as frequency of ADR may be less than the sample population for research so not be detected:
- Yellow card scheme is used, where ADRs are reported by doctors and the public
- New drugs indicated by black triangles
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 does CHMP stand for?
Committee for Medicinal Products for Human Use
Do drugs with a license from CHMP need to apple for another in the UK?
No
What is a major factor for the government in what drugs doctors should use?
Cost-effectiveness
In the UK, who decides what drugs doctors should be prescribing by considering cost-effectiveness?
- In Scotland, Scottish Medicines Consortium (SMC) decides
- Has representation from all area drugs and therapeutics committees
- Pharmacists
- Health economists
- Pharma representatives
- Lay representatives
- Physicians
- NHS management
- Has representation from all area drugs and therapeutics committees