Labelling and PILs Flashcards
What is primary packaging?
Packaging which is in contact with the medicinal product.
What is secondary packaging?
Packaging which includes primary packaging.
All packaging for licensed products must have what?
- Labelling with ingredients
- Space for dispensing label
- Information in Braille (dots on packaging for visually impaired individuals)
What are the 4 characteristics of a label?
- Legible
- Comprehensible (understandable)
- Indelible
- In English or in English and one or more other language(s)
What are the labelling requirements?
- Name of product
- Generic name
- Active ingredients and strength
- Pharmaceutical form
- List of excipients
- Route of administration
- Special warnings
- Warnings particular to the product
- Expiry date
- Special storage conditions
- Special precautions for disposal
- Marketing Authorisation’s name and address
- Marketing Authorisations number (PL number)
- Batch reference
- Self administration? required instructions for use
Which medicine classification requires the name in a rectangle box on packaging?
- P
- POM
Why must a patient seek immediate medical advice if they have overdosed on paracetamol and feel well?
Can lead to serious liver damage. Early detection -> reversible.
What is stated as a warning on a codeine/dyhydrocodeine label?
- Can cause addiction
- For three days use only
True or False: Labelling requirements must be followed when you have a package of dispensed medicinal product.
False. The product is put into another brown bottle or white box so it is not required.
True or False: Quantity is a legal requirement on a label for a dispensed medicinal product.
False - it is good practice
What information is required on the label of a dispensed medicinal product?
- Patient name
- Name and address of pharmacy
- Date of dispensing
- Name of product
- Directions for use
- Precautions relating to product
Are BNF cautionary and advisory labels a legal requirement or good practice?
Good practice
When should a syringe be provided?
When the dose volume is <5ml.
Does a label need to state to take a certain dose ‘using the syringe provided’, if a syringe is provided?
It is good practice to do so.
What must a label contain for an assembled (pre-packed) medicine?
- Name of medicine
- Strength
- Quantity
- Special handling/storage requirements
- Expiry date
- Batch reference -> BN or Lot no.
True or False: There should always be a PIL with a product when selling or supplying to a person.
Yes as it is a legal requirement.
What are some advantages of a PIL?
- Provide info
- Encourage patients to be informed -> More adherence
- Help in patient counselling
What are some disadvantages of PIL?
- Worry patients (e.g. side effects) -> stop medication
- Might not relate to indication (unlicensed use)
- Different manufacturers -> slightly different information
Give 2 examples of Child Safety Regulations for the packaging of product?
- Tablets in blister packs
- Liquids in a bottle with click-loc tops
When may medicines not be given in a CRC?
- In original packaging
- Patient can’t open CRC (arthritis)
- Patient requests not to have CRC (Valid reason)
- No suitable CRC exists
- Patients requests 7-day compliance aid
What is a ‘Chemists’ Nostrum’?
Medicinal product prepared in pharmacy for sale in that pharmacy only.
-> Not advertised
True or False: For a Chemists’ Nostrum, any medicine classification as an ingredient can be added.
False, only P or GSL.
Chemists’ Nostrums are legally classified as what?
P medicines.
