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Flashcards in Drug Regulation Deck (24)
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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?



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



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


What does SMC stand for?

Scottish Medicines Consortium


What are some 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?

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


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


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

Area Drugs and Therapeutics Committees (ADTCs)


What does ADTCs stand for?

Area Drugs and Therapeutic Committees


What are roles of ADTCs?

  • 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


What is disinvestment and why might it be done?

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