Labelling Flashcards
What is a label?
The thing on the container and/or package which identifies the product
What needs to be labelled?
The primary container and the secondary package- some containers have special exemptions
Why is labelling important?
Patients need information to help them use their medicines safely and effectively, and information given on the label can help with this
A third of reported medication incidents may be due to packaging and labelling
Offences
A person is guilty of an offence if they sell or supply the product, knowing or having reasonable cause to believe-
That a package or package leaflet relating to the medicinal product does not comply with the applicable requirements, or
That the product is not accompanied by a package leaflet when one is required
A person who is guilty of an offence under the regulations is liable to:
A fine not exceeding the statutory maximum (£5000), or
To a fine, to imprisonment for a term not exceeding two years, or both
Manufacturing labels
Written by the manufacturer, read by the public, patient and/or pharmacist, both the container and the package (where provided) need to be labelled
Manufacturing label contains:
Name of the product, name of the drugs, strength, amount of drug per dose unit, total content, excipients, pharmaceutical form, method of administration, route of administration, instructions for use if not POM, intended for use by babies/children/adults, name and address of MA holder, MA number, keep out of reach and sight of children, P/POM, batch number, expiry date, any necessary warnings, storage requirements, disposal requirements
A list of excipients:
For injectable, topical and eye preparations, all excipients must be listed; for all other medicines, any excipients known to have a recognised action or effect must be listed
Instructions for use
Unless otherwise directed often added
Expiry date (month and year)
Exp and use by- for use up to and until the last day of the specified month; use before- for use until the first day of the specified month
Unlicensed medicines
Licensed medicines are made by a licensed manufacturer and the product itself is licensed, so has a MA number
Unlicensed medicines do not have a MA number and can be made either by a manufacturer who holds a manufacturing specials license, or under the supervision of a pharmacist
Labelling requirements for blister packs
Name, strength and form of product, name of drug, expiry date and batch number, for babies/ children/ adults, MA name
Labelling requirements for small containers
Name, strength and form of product, name of drug, expiry date and batch number, for babies/ children/ adults, method and route of administration, MAH name of space allows
Labels for medicines on prescription
Legally required- name of patient, name of medicine, name and address of supplying pharmacy, directions for use, date of dispensing, any necessary precautions
usually added- total content, pharmaceutical form, keep out of the reach and sight of children, strength (unless only one exists)
Potential problems
Bad package/ container design, errors in application, incorrect wording, unclear printing, incomprehensible wording, misinterpreted wording
