L10 Packaging Flashcards
What legislation governs the packaging and labelling of medicines in the UK?
The Human Medicines Regulations 2012.
What must all labelling of containers and packages be according to HMR?
Legible, comprehensible, indelible, and provided in English.
Who must approve packaging and labelling before marketing a medicine?
The MHRA (Medicines and Healthcare products Regulatory Agency).
What must the ‘UK Only’ label comply with starting January 2025?
Clearly legible text, at least 7-point font, in line with MHRA and Article 5 of EU Regulation 2023/1182.
What is Tallman lettering and when is it used?
It emphasizes differences in similar drug names (e.g.,CEPhalosporins) to reduce errors.
Name three items that must be on a dispensing label.
Patient name, supplier name & address, date supplied.
What extra labelling must paracetamol products have?
Warnings about overdose risks and advice not to take other paracetamol products simultaneously.
What warning must appear on OTC codeine and dihydrocodeine packs?
“Can cause addiction, for three days only.”
Which of the following is NOT a requirement for medicine packaging under HMR 2012?
A) Legible labelling
B) English language only
C) Made of recyclable materials
D) Indelible labelling
Answer: C) Made of recyclable materials
From January 2025, packaging for UK medicines must:
A) Be bilingual in English and Welsh
B) Carry a ‘UK Only’ label
C) Have a hologram for security
D) Display the Brexit logo
Answer: B) Carry a ‘UK Only’ labe
What is an excipient?
A) The main active ingredient in a drug
B) An inactive constituent added for a specific purpose
C) A preservative used in vaccines
D) A type of antimicrobial agent
Answer: B) An inactive constituent added for a specific purpose
Which of the following is NOT true about good labelling practice?
A) Use trailing zeros (e.g., 2.50mg)
B) Use positive administration instructions
C) Spell out “micrograms”
D) Use colour to differentiate products
Answer: A) Use trailing zeros (e.g., 2.50mg)
Which statement is TRUE about patient information leaflets (PILs)?
A) They are optional for medicines dispensed on prescription.
B) They must match the SmPC (Summary of Product Characteristics).
C) They should contain promotional material.
D) They are only needed for injectables.
Answer: B) They must match the SmPC.
What is a legal requirement for paracetamol packaging for children under 12 years?
A) Dosage to be in teaspoons
B) Warning not to give any other paracetamol-containing products
C) Maximum pack size of 100 tablets
D) Display a liver icon on packaging
Answer: B) Warning not to give any other paracetamol-containing products
Which symbol indicates a batch number on pharmaceutical labelling?
A) Exp
B) BN
C) Rx
D) SmPC
Answer: B) BN
Which of the following is a labelling requirement for Schedule 2 Controlled Drugs?
A) Include the wording “Controlled Drug – Store securely”
B) Omit the patient’s full name for confidentiality
C) Dispense in clear, unsealed packaging
D) Only label if the quantity is less than 5 doses
Answer: A) Include the wording “Controlled Drug – Store securely”
When labelling a dispensed Schedule 2 or 3 controlled drug, which item must be clearly included on the label?
A) The prescriber’s home address
B) The total quantity (both in words and figures)
C) The manufacturer’s signature
D) The prescription issue time (to the minute)
Answer: B) The total quantity (both in words and figures)
(Note: Words + figures are mandatory on the prescription, but not always on the label — just testing that awareness.)
For a dispensed Schedule 2 CD (e.g., morphine), which additional consideration is important for the packaging?
A) Pack must be tamper-evident or sealed properly.
B) Pack must contain a personal letter from the pharmacist.
C) Pack must be stored at room temperature without restriction.
D) Pack must be labelled with ‘This product may cause constipation’.
Answer: A) Pack must be tamper-evident or sealed properly.
How long is a controlled drug prescription valid after it is issued?
28 days from the date on the prescription.
Are cautionary labels (CALs) important for CDs?
Yes — many CDs require labels like “Warning: This medicine may cause drowsiness. If affected do not drive or operate machinery.”
