Drug Regulation

Question 1

How do drug prices generally change with time?

Answer 1

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

Question 2

Where is drug advertising legal, and what are some advantages and disadvantages?

Answer 2

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

Question 3

What needs to be known about all new drugs being considered for general population?

Answer 3

• Does it work
• What dose is therapeutic
• What dose is toxic
• Is it safe
• Is it necessary

Question 4

Regulation of new drugs in the UK is done by?

Answer 4

• 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

Question 5

What does CHM stand for?

Answer 5

Commission on Human Medicines

Question 6

What are some roles of the CHM?

Answer 6

• 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

Question 7

What is CHM part of?

Answer 7

CHM is part of the Medicines & Healthcare Products Regulatory Agency (MHRA) which is an executive agency of the department of health (DoH)

Question 8

What are some roles of MHRA?

Answer 8

• 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

Question 9

Why is pharmacovigilance needed?

Answer 9

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

Question 10

How do you calculate if an adverse effect is significant?

Answer 10

Question 11

What is the european equivalent of the Food and Drug Administration (FDA) in the US?

Answer 11

• Committee for Medicinal Products for Human Use (CHMP)
  
  • Quality
  • Safety
  • Efficacy

Question 12

WHat does CHMP stand for?

Answer 12

Committee for Medicinal Products for Human Use

Question 13

Do drugs with a license from CHMP need to apple for another in the UK?

Answer 13

No

Question 14

What is a major factor for the government in what drugs doctors should use?

Answer 14

Cost-effectiveness

Question 15

In the UK, who decides what drugs doctors should be prescribing by considering cost-effectiveness?

Answer 15

• 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

Question 16

What does SMC stand for?

Answer 16

Scottish Medicines Consortium

Question 17

What are some advantages and disadvantages of SCM?

Answer 17

• Advantages
  
  • Comprehensive assessment
  • Rapid response
  • Uniformity within Scotland
  • Education
• Disadvantages
  
  • Pharmaceutical freedom
  • Funding

Question 18

What are the possible outcomes after a company submits a drug to the SMC?

Answer 18

• Approved for use
• Approved for restricted use
• Not recommended
  
  • Clinical effectiveness not convincing
  • Cost-effectiveness not demonstrated
  • No submission by manufacturer

Question 19

Who considers applications for use of expensive drugs?

Answer 19

For expensive drugs, look at by Patient Access Schemes Assessment Group (PASAG):

• Remit is to advice on acceptability of Patient Access Schemes within NHS Scotland
• Convened by Secretary of State for Health and reports to SMC

Question 20

What are the prescribing budgets for NHS Scotland and the UK NHS?

Question 21

Once a drug is approved by SMA, who needs to approve it for local use?

Answer 21

Area Drugs and Therapeutics Committees (ADTCs)

Question 22

What does ADTCs stand for?

Answer 22

Area Drugs and Therapeutic Committees

Question 23

What are roles of ADTCs?

Answer 23

• Takes local preference into account
• Development of regional formularies
• Implementation of SMC advice, NICE appraisals and SIGN guidance
• Dealing with drugs not on SMC agenda
• Dealing with unlicensed products
• Antibiotic policies

Question 24

What is disinvestment and why might it be done?

Answer 24

Disinvestment is removal from Grampian Joint Formulary, may be done because:

• Evidence for superior efficacy/safety/kinetics now available
• Evidence now favours another product
• Evidence for better cost/efficacy now available
• Evidence product of limited clinical effectiveness