Labelling Medicines Flashcards
What are the standards for labelling?
must be:
- in English
- legible
- indelible
- clear
- comprehensible
What are the requirements of a label?
name of the patient
name and address of the supplying pharmacy
telephone number of the supplying pharmacy
date of dispensing
directions for use
precautions relating to the use of the medicine
keep out of the reach and sight of children
- legal requirement on all labels
Why is labelling needed?
to make sure the patient receives sufficient information and advice to enable the safe and effective use of the prescribed medicine
What can pharmacists amend when making a label?
directions for use
name of the medicine
precautions relating to the use of the medicine
What are auxiliary labels? What are examples?
extra information to help the patient
- e.g. storage or usage
for external use only
- topical preparations
store in the fridge
not to be taken
shake the bottle
What are the labelling requirements for assembled (pre-packed) medicines?
pre-packed = breaking of bulk into smaller quantities
the name of the medicinal product the ingredients the quantity special handling or storage requirements the expiry date the batch reference e.g. BN or LOT
must be labelled with regular requirements when dispensing
What is Chemist’s Nostrum?
medicinal products prepared in a registered pharmacy for retail sale from that pharmacy which are not advertised
- preparation and the sale or supply must be carried out by or under the supervision of a pharmacist
What are the labelling requirements for Chemist’s Nostrum?
name of the product pharmaceutical form quantitative particulars quantity directions for use handling and storage requirements expiry date keep out of the reach and sight of children
where appropriate the words “Warning. Do not exceed the stated dose” - in a rectangle
- e.g. where a POM was an ingredient but incorporated in such a way as to exempt it from POM control
the name and address of the supplier
the letter P in a rectangle
What are the labelling requirements for relevant medicinal products?
the brand name and its common (generic) name
the active ingredient of the product stated expressed quantitatively and qualitatively per dosage unit or form of administration
the pharmaceutical form
the contents by weight, volume or number of doses
a list of excipients with a recognised action
for injections, topical or eye products - all excipients
the method and route of administration
store out of the reach of children
special warnings
expiry date
storage precautions
special disposal precautions for waste
the name of the holder of the marketing authorisation MA
the address of the MA holder
MA number
batch reference
if non-POM- instructions on the use of the product
if a POM, these letters must be in capitals within a rectangle
What are the labelling requirements for non-relevant medicinal products?
a batch number should be included if the preparation has been prepared extemporaneously
an expiry date should be indicated if the preparation has been prepared extemporaneously or the shelf life has been shortened
- e.g. diluted preparation.
also needed if the preparation is sterile
- e.g. eye drops
When must a patient information leaflet be supplied?
each time a relevant medicinal product is supplied, a Patient Information Leaflet (PIL) must also be supplied
- each time a pharmacist makes a supply or sells a medicinal product
even when products are used ‘off-label’ a PIL should be included
PILs are not required for hospital dispensed products for inpatients
- should be held in the pharmacy or on the ward so that it can be provided to the patient or prescriber on his/her request
for outpatients a PIL should be provided in each case
