Podcast
Questions and Answers
What distinguishes a biosimilar medicine from a generic medicine?
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?
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?
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?
What must be demonstrated or extrapolated for a biosimilar medicine to be licensed for all indications of the originator biological medicine?
What status are biosimilar medicines subject to at the time of initial authorization?
What status are biosimilar medicines subject to at the time of initial authorization?
In what way does a biosimilar medicine differ from a generic medicine?
In what way does a biosimilar medicine differ from a generic medicine?
Why should the brand name specified on a prescription for biological medicines be dispensed as specified?
Why should the brand name specified on a prescription for biological medicines be dispensed as specified?
Who makes the final decision on whether to prescribe a biosimilar or the originator biological medicine?
Who makes the final decision on whether to prescribe a biosimilar or the originator biological medicine?
In patients with severe lactose intolerance, what should be considered before prescribing a medicine?
In patients with severe lactose intolerance, what should be considered before prescribing a medicine?
For patients requiring long-term or regular medication, why should the sodium content of medicines be considered?
For patients requiring long-term or regular medication, why should the sodium content of medicines be considered?
What information is provided in the product literature for medicines with more than 1 mmol sodium per dose?
What information is provided in the product literature for medicines with more than 1 mmol sodium per dose?
Which patient population is particularly at risk when medicines contain high levels of sodium as an excipient?
Which patient population is particularly at risk when medicines contain high levels of sodium as an excipient?
Why might slow metabolizers of a substance need special consideration when taking certain medications?
Why might slow metabolizers of a substance need special consideration when taking certain medications?
What potential risk is associated with effervescent, dispersible, or soluble formulations of medicines?
What potential risk is associated with effervescent, dispersible, or soluble formulations of medicines?
Why is it important to determine the amount of lactose in medicines for patients with severe lactose intolerance?
Why is it important to determine the amount of lactose in medicines for patients with severe lactose intolerance?
What is the concern with inventing non-proprietary titles for prescribing generically?
What is the concern with inventing non-proprietary titles for prescribing generically?
Where are the non-proprietary titles used in the book sourced from?
Where are the non-proprietary titles used in the book sourced from?
What must preparations comply with when using non-proprietary titles from certain publications?
What must preparations comply with when using non-proprietary titles from certain publications?
When are names followed by the symbol ® typically applied?
When are names followed by the symbol ® typically applied?
What do the doses, indications, cautions, and side-effects in the BNF reflect?
What do the doses, indications, cautions, and side-effects in the BNF reflect?
What does the BNF generally exclude when it comes to proprietary medicines?
What does the BNF generally exclude when it comes to proprietary medicines?
What documents do the BNF entries generally mirror?
What documents do the BNF entries generally mirror?
Which publication's guidelines influence the content of the BNF?
Which publication's guidelines influence the content of the BNF?
What percentage of the WHO recommended maximum daily dietary intake of sodium for an adult is approximately 17 mmol sodium?
What percentage of the WHO recommended maximum daily dietary intake of sodium for an adult is approximately 17 mmol sodium?
When is a medicine considered to have a high sodium content due to its sodium quantity?
When is a medicine considered to have a high sodium content due to its sodium quantity?
When should a product be dispensed extemporaneously?
When should a product be dispensed extemporaneously?
What does the BP direction that a preparation must be freshly prepared mean?
What does the BP direction that a preparation must be freshly prepared mean?
What happens if a preparation is stored for longer than about 4 weeks at 15–25° C?
What happens if a preparation is stored for longer than about 4 weeks at 15–25° C?
When the term 'water' is used without qualification, what does it mean?
When the term 'water' is used without qualification, what does it mean?
If potable water is unsuitable for a particular preparation, which type of water should be used according to the text?
If potable water is unsuitable for a particular preparation, which type of water should be used according to the text?
'Water for injections' should be used if which condition is met?
'Water for injections' should be used if which condition is met?
What should patients do if they are taking drugs for medical reasons and want to drive?
What should patients do if they are taking drugs for medical reasons and want to drive?
Why is it important for patients to carry evidence of their prescription when driving?
Why is it important for patients to carry evidence of their prescription when driving?
What information is advised to be carried by patients when driving and taking medication?
What information is advised to be carried by patients when driving and taking medication?
In the context of the BNF, what does inclusion of certain drugs signify?
In the context of the BNF, what does inclusion of certain drugs signify?
Why should particular attention be given when handling chemical or biological materials?
Why should particular attention be given when handling chemical or biological materials?
What types of substances should be handled with caution due to their irritant or potent nature?
What types of substances should be handled with caution due to their irritant or potent nature?
Why should contact with the skin and inhalation of dust be avoided when handling certain substances?
Why should contact with the skin and inhalation of dust be avoided when handling certain substances?
Why are certain drugs included in the BNF despite patent rights protection?
Why are certain drugs included in the BNF despite patent rights protection?
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