3.4 Wholesaling

• What is the primary requirement for anyone trading medicines other than to a patient?

     a) Registration with the MHRA

     b) Holding a Wholesale Distribution Authorisation (WDA)

     c) Compliance with NHS guidelines

     d) Obtaining a Home Office CD licence

  Holding a Wholesale Distribution Authorisation (WDA)
• Which standards must a wholesaler comply with to trade medicines?

     a) Good Manufacturing Practice (GMP)

     b) Good Clinical Practice (GCP)

     c) Good Distribution Practice (GDP)

     d) Good Laboratory Practice (GLP)

  Good Distribution Practice (GDP)
• Who should be named on the wholesale license as the Responsible Person?

     a) Pharmacist in Charge

     b) CEO of the company

     c) Responsible Pharmacist

     d) Experienced 'Responsible Person'

  Experienced 'Responsible Person'
• Which pharmacies are exempted from holding a WDA for supplying stock to another pharmacy within the same legal entity?

     a) All pharmacies

     b) Pharmacies in rural areas

     c) Pharmacies not trading CDs

     d) Pharmacies holding a WDA

  Pharmacies holding a WDA
• What conditions must be met for registered pharmacies and hospitals to supply small quantities of medicines without a WDA?

     a) Occasional basis, large quantities, for profit basis

     b) Occasional basis, small quantities, not for profit basis

     c) Regular basis, small quantities, not for profit basis

     d) Regular basis, large quantities, for profit basis

  Occasional basis, small quantities, not for profit basis
• If a pharmacy holds a WDA, what must be ensured for a pharmacy supplied with medicines for wholesaling?

     a) Named on the WDA

     b) Holding a Home Office CD licence

     c) Registered with the MHRA

     d) Compliant with NHS standards

  Named on the WDA
• What is likely required if a pharmacy needs a WDA(H) and supplies Controlled Drugs (CDs)?

     a) MHRA registration

     b) WDA(V) application

     c) Home Office CD licence

     d) General Pharmaceutical Council (GPhC) approval

  Home Office CD licence
• According to the regulations, who can receive medicines by wholesale?

     a) Anyone with a medical degree

     b) Persons and organisations as listed in Schedule 22 of the Human Medicines Regulations 2012

     c) Only pharmacists

     d) Only NHS Trusts

  Persons and organisations as listed in Schedule 22 of the Human Medicines Regulations 2012
• What is the minimum duration to retain records of POM supply?

     a) 6 months

     b) 1 year

     c) 2 years

     d) 5 years

  2 years
• What information must be included in the POM register for each supply?

      a) Name and quantity of medicine only

      b) Date, name, quantity, formulation, strength, and purpose of supply

      c) Date and quantity of medicine only

      d) Date, name, and quantity of medicine only

  Date, name, quantity, formulation, strength, and purpose of supply
• What does the Home Office CD licence regulate?

      a) Distribution of Controlled Drugs

      b) Wholesale Distribution of Medicines

      c) Manufacturing of Medicines

      d) Import and Export of Medicines

  Distribution of Controlled Drugs
• How can NHS hospitals manage medicine shortages?

      a) By implementing Serious Shortage Protocols (SSPs)

      b) By limiting the sale of medicines to pharmacies

      c) By stockpiling medicines

      d) By following Best Practice Standards

  By following Best Practice Standards
• What is the purpose of SSPs in England, Wales, and Northern Ireland?

      a) To prevent medicine export

      b) To manage medicine shortages

      c) To regulate pharmacy licensing

      d) To promote generic medicines

  To manage medicine shortages
• Where can one find a list of persons and organisations who can be supplied with medicines by wholesale?

      a) On the pharmacy's website

      b) In the local newspaper

      c) In Schedule 22 of the Human Medicines Regulations 2012

      d) In the GP's office

  In Schedule 22 of the Human Medicines Regulations 2012
• Which document sets out the key legal and ethical obligations on trading medicines?

      a) NHS Guidelines

      b) RPS Handbook

      c) Trading Medicines for Human Use: Shortages and Supply Chain Obligations

      d) BNF (British National Formulary)

  Trading Medicines for Human Use: Shortages and Supply Chain Obligations
• In which settings do the requirements to hold WDA(H) and Home Office CD licences apply?

      a) Only in NHS hospitals

      b) Only in community pharmacies

      c) In all settings where medicines are distributed

      d) In hospitals and private clinics

  In all settings where medicines are distributed
• What is the purpose of the Medicines and Healthcare products Regulatory Agency (MHRA)?

      a) To regulate the sale of prescription-only medicines

      b) To monitor medicine shortages

      c) To regulate the safety and quality of medicines in the UK

      d) To promote generic medicines

  To regulate the safety and quality of medicines in the UK