Medicine Composition and Interactions Quiz
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Questions and Answers

What distinguishes a biosimilar medicine from a generic medicine?

  • Molecular structure (correct)
  • Originator medicine
  • Therapeutic equivalence
  • Patent expiration
  • Who has the authority to decide whether to prescribe a biosimilar or originator biological medicine?

  • Patient
  • EMA
  • Pharmacist
  • Clinician (correct)
  • Why is automatic substitution of brands not appropriate for biological medicines?

  • To avoid black triangle status
  • Due to different molecular structures
  • To prevent inadvertent switching (correct)
  • Because of patent expiration
  • What must be demonstrated or extrapolated for a biosimilar medicine to be licensed for all indications of the originator biological medicine?

    <p>Therapeutic equivalence</p> Signup and view all the answers

    What status are biosimilar medicines subject to at the time of initial authorization?

    <p>(A) Black triangle status</p> Signup and view all the answers

    In what way does a biosimilar medicine differ from a generic medicine?

    <p>Molecular structure</p> Signup and view all the answers

    Why should the brand name specified on a prescription for biological medicines be dispensed as specified?

    <p>To prevent inadvertent switching</p> Signup and view all the answers

    Who makes the final decision on whether to prescribe a biosimilar or the originator biological medicine?

    <p>Clinician</p> Signup and view all the answers

    In patients with severe lactose intolerance, what should be considered before prescribing a medicine?

    <p>The lactose content in the medicine</p> Signup and view all the answers

    For patients requiring long-term or regular medication, why should the sodium content of medicines be considered?

    <p>To avoid cardiovascular events</p> Signup and view all the answers

    What information is provided in the product literature for medicines with more than 1 mmol sodium per dose?

    <p>Sodium content</p> Signup and view all the answers

    Which patient population is particularly at risk when medicines contain high levels of sodium as an excipient?

    <p>Patients with renal failure</p> Signup and view all the answers

    Why might slow metabolizers of a substance need special consideration when taking certain medications?

    <p>Greater potential for drug interactions</p> Signup and view all the answers

    What potential risk is associated with effervescent, dispersible, or soluble formulations of medicines?

    <p>Cardiovascular events</p> Signup and view all the answers

    Why is it important to determine the amount of lactose in medicines for patients with severe lactose intolerance?

    <p>To avoid problems caused by the lactose content</p> Signup and view all the answers

    What is the concern with inventing non-proprietary titles for prescribing generically?

    <p>It can lead to confusion, especially for compound and modified-release preparations</p> Signup and view all the answers

    Where are the non-proprietary titles used in the book sourced from?

    <p>European Pharmacopoeia, British Pharmacopoeia, or British Pharmaceutical Codex 1973</p> Signup and view all the answers

    What must preparations comply with when using non-proprietary titles from certain publications?

    <p>Standard in the appropriate publication</p> Signup and view all the answers

    When are names followed by the symbol ® typically applied?

    <p>To products supplied by the owners of the trademarks</p> Signup and view all the answers

    What do the doses, indications, cautions, and side-effects in the BNF reflect?

    <p>Those in manufacturers' data sheets or Summaries of Product Characteristics (SPCs)</p> Signup and view all the answers

    What does the BNF generally exclude when it comes to proprietary medicines?

    <p>Medicines not supported by a valid Summary of Product Characteristics</p> Signup and view all the answers

    What documents do the BNF entries generally mirror?

    <p>Marketing authorisations (formerly known as Product Licences)</p> Signup and view all the answers

    Which publication's guidelines influence the content of the BNF?

    <p>Manufacturers' data sheets or Summaries of Product Characteristics (SPCs)</p> Signup and view all the answers

    What percentage of the WHO recommended maximum daily dietary intake of sodium for an adult is approximately 17 mmol sodium?

    <p>20%</p> Signup and view all the answers

    When is a medicine considered to have a high sodium content due to its sodium quantity?

    <p>When it contains more than 17 mmol sodium</p> Signup and view all the answers

    When should a product be dispensed extemporaneously?

    <p>Only when other products are not available</p> Signup and view all the answers

    What does the BP direction that a preparation must be freshly prepared mean?

    <p>It must not be prepared more than 24 hours before use</p> Signup and view all the answers

    What happens if a preparation is stored for longer than about 4 weeks at 15–25° C?

    <p>It becomes less effective</p> Signup and view all the answers

    When the term 'water' is used without qualification, what does it mean?

    <p>Purified or potable water suitable for consumption</p> Signup and view all the answers

    If potable water is unsuitable for a particular preparation, which type of water should be used according to the text?

    <p>'Water for injections'</p> Signup and view all the answers

    'Water for injections' should be used if which condition is met?

    <p>'Purified water' is unavailable</p> Signup and view all the answers

    What should patients do if they are taking drugs for medical reasons and want to drive?

    <p>Carry suitable evidence that the drug was prescribed and taken correctly.</p> Signup and view all the answers

    Why is it important for patients to carry evidence of their prescription when driving?

    <p>To prove that the drug was prescribed for a medical reason.</p> Signup and view all the answers

    What information is advised to be carried by patients when driving and taking medication?

    <p>Repeat prescription form or medicine's patient information leaflet.</p> Signup and view all the answers

    In the context of the BNF, what does inclusion of certain drugs signify?

    <p>The drugs are protected by Letters Patent.</p> Signup and view all the answers

    Why should particular attention be given when handling chemical or biological materials?

    <p>To prevent allergic reactions.</p> Signup and view all the answers

    What types of substances should be handled with caution due to their irritant or potent nature?

    <p>Corticosteroids, some antimicrobials, phenothiazines, and many cytotoxics.</p> Signup and view all the answers

    Why should contact with the skin and inhalation of dust be avoided when handling certain substances?

    <p>To prevent accidental ingestion.</p> Signup and view all the answers

    Why are certain drugs included in the BNF despite patent rights protection?

    <p>To enable medical professionals to access necessary information.</p> Signup and view all the answers

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