39 Questions
What distinguishes a biosimilar medicine from a generic medicine?
Molecular structure
Who has the authority to decide whether to prescribe a biosimilar or originator biological medicine?
Clinician
Why is automatic substitution of brands not appropriate for biological medicines?
To prevent inadvertent switching
What must be demonstrated or extrapolated for a biosimilar medicine to be licensed for all indications of the originator biological medicine?
Therapeutic equivalence
What status are biosimilar medicines subject to at the time of initial authorization?
(A) Black triangle status
In what way does a biosimilar medicine differ from a generic medicine?
Molecular structure
Why should the brand name specified on a prescription for biological medicines be dispensed as specified?
To prevent inadvertent switching
Who makes the final decision on whether to prescribe a biosimilar or the originator biological medicine?
Clinician
In patients with severe lactose intolerance, what should be considered before prescribing a medicine?
The lactose content in the medicine
For patients requiring long-term or regular medication, why should the sodium content of medicines be considered?
To avoid cardiovascular events
What information is provided in the product literature for medicines with more than 1 mmol sodium per dose?
Sodium content
Which patient population is particularly at risk when medicines contain high levels of sodium as an excipient?
Patients with renal failure
Why might slow metabolizers of a substance need special consideration when taking certain medications?
Greater potential for drug interactions
What potential risk is associated with effervescent, dispersible, or soluble formulations of medicines?
Cardiovascular events
Why is it important to determine the amount of lactose in medicines for patients with severe lactose intolerance?
To avoid problems caused by the lactose content
What is the concern with inventing non-proprietary titles for prescribing generically?
It can lead to confusion, especially for compound and modified-release preparations
Where are the non-proprietary titles used in the book sourced from?
European Pharmacopoeia, British Pharmacopoeia, or British Pharmaceutical Codex 1973
What must preparations comply with when using non-proprietary titles from certain publications?
Standard in the appropriate publication
When are names followed by the symbol ® typically applied?
To products supplied by the owners of the trademarks
What do the doses, indications, cautions, and side-effects in the BNF reflect?
Those in manufacturers' data sheets or Summaries of Product Characteristics (SPCs)
What does the BNF generally exclude when it comes to proprietary medicines?
Medicines not supported by a valid Summary of Product Characteristics
What documents do the BNF entries generally mirror?
Marketing authorisations (formerly known as Product Licences)
Which publication's guidelines influence the content of the BNF?
Manufacturers' data sheets or Summaries of Product Characteristics (SPCs)
What percentage of the WHO recommended maximum daily dietary intake of sodium for an adult is approximately 17 mmol sodium?
20%
When is a medicine considered to have a high sodium content due to its sodium quantity?
When it contains more than 17 mmol sodium
When should a product be dispensed extemporaneously?
Only when other products are not available
What does the BP direction that a preparation must be freshly prepared mean?
It must not be prepared more than 24 hours before use
What happens if a preparation is stored for longer than about 4 weeks at 15–25° C?
It becomes less effective
When the term 'water' is used without qualification, what does it mean?
Purified or potable water suitable for consumption
If potable water is unsuitable for a particular preparation, which type of water should be used according to the text?
'Water for injections'
'Water for injections' should be used if which condition is met?
'Purified water' is unavailable
What should patients do if they are taking drugs for medical reasons and want to drive?
Carry suitable evidence that the drug was prescribed and taken correctly.
Why is it important for patients to carry evidence of their prescription when driving?
To prove that the drug was prescribed for a medical reason.
What information is advised to be carried by patients when driving and taking medication?
Repeat prescription form or medicine's patient information leaflet.
In the context of the BNF, what does inclusion of certain drugs signify?
The drugs are protected by Letters Patent.
Why should particular attention be given when handling chemical or biological materials?
To prevent allergic reactions.
What types of substances should be handled with caution due to their irritant or potent nature?
Corticosteroids, some antimicrobials, phenothiazines, and many cytotoxics.
Why should contact with the skin and inhalation of dust be avoided when handling certain substances?
To prevent accidental ingestion.
Why are certain drugs included in the BNF despite patent rights protection?
To enable medical professionals to access necessary information.
Test your knowledge on medication composition and interactions. Learn about lactose content in medicines, interactions with substances like disulfiram and metronidazole, and considerations for patients with renal failure, neonates, and lactose intolerance.
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