labelling and PILs Flashcards
what has regulations on labelling and packaging?
HMR 2012
Does labelling or packaging have more specific requirements?
labelling
What must all packaging for licenced products have?
prominent label with ingredients
space for dispensing label (if POM)
info in Braille
regulations for excipients in labelling
list of excipients with known effects
but if eye preparation, injection or topical all excipients must be listed
another name for MA number
PL
additional requirements for POM and P meds
capital P or POM in rectangle containing no other matter
What should ‘Immediate medical advice should be sought in the event of an overdose, even if you feel well’ say if there’s no PIL given?
‘… because of risk of delayed, serious liver damage’
additional label on codeine/dihydrocodeine products on front of pack
‘Can cause addiction. For 3 days use only’
What does not need to legally be on label of dispensed med product?
quantity (but good practice)
legal or good practice to have BNF cautionary/advisory labels on label of dispensed medicinal product?
good practice
What is needed for pharmacy to assemble pre-packaged meds?
assembly licence
What are Chemists’ Nostrums?
Medicinal products prepared in a registered pharmacy for retail sale from that pharmacy only, which are not advertised
What classification are Chemists’ Nostrums meds?
P meds
advantages of PILs?
info to patients/carers
patients informed/increase adherence
helps pharmacists with counselling
disadvantages of PILs?
worry patients with side effects/cautions
not relate to the indication
generic manufacturers may contain different info
