Packaging & Labelling

Question 1

Packaging & leaflets

Answer 1

It is an offence for anyone other than the MA holder to:
- Sell (or offer to sell)
- Supply (or offer to supply)
A medicine (human) which:
- does not comply with the packaging legislation
- without a leaflet
Offenders:
- fine
- conviction
- imprisonment

Question 2

Public law

Answer 2

• Applies to everyone e.g criminal, constitutional, administrative law.

Question 2

By law

Answer 2

• you have to supply a leaflet when dispensing meds
• manufacturer has to fulfil certain requirements for the manufacturing packaging

Question 2

What does the HMR legislation say?

Answer 2

All labelling of containers & packages must be:
- Legible, comprehensible & indelible
- provided in English
Package:
- enclosure for one or more containers
Container:
- inner receptacle which actually contains the medicine
- Could be a bottle or pack

Question 3

Labelling Requirements MA Holders (1-5)
For the outer packaging

Answer 3

1. Name (& brand name) of medicinal product (must also be in Braille)
2. Strength & pharmaceutical form
3. Whether intended for babies, children or adults (where appropriate)- if it is just for adults you don’t need to write anything
4. Active substance common name
   (for up to 3 active substances)
5. Qualitative & quantitative expression of the
   active substance (common name) per
   dosage unit or for a given volume or weight

Question 4

Labelling Requirements MA Holders (6-11)
For the outer packaging

Answer 4

6. Pharmaceutical form & contents by weight, volume or number of doses
7. The method of administration
8. Where appropriate, space for the prescribed dose to be indicated (i.e., POMs require space for a dispensing label)
9. A warning that the product must be stored out of the reach & sight of children
10. Any applicable special warnings
11. Any applicable storage precautions

Question 5

Labelling Requirements MA Holders (12-17)
For the outer packaging

Answer 5

12. Expiry date (month and year)
13. Manufacturer’s batch number (lot no.)
14. Name & address of MA holder
15. Marketing Authorisation number (Product licence no.= PL number)
16. Legal category if P or POM and if not a POM, instructions for use
17. Any special disposal precautions

Question 6

Labelling Requirements
MA Holders (18)

Answer 6

• 18. A list of ( for certain products)
      A) all excipients for injectable, topical or eye products
      B) in any other case, excipients with a recognised
      action or effect (i.e. anything active or colourings should be listed as s/ may be allergic to them, lactose allergy, peanut oil).
      Excipient:
• “a constituent of a medicine other than the active
  substance, added in the formulation for a specific
  purpose… Most …are…inactive, some…have a
  known action … must be declared…” EMA, 2021

Question 7

Best Design Practice for Safety
MHRA Guidance for MA Holders

Answer 7

• Packaging & labelling must be approved by
  MHRA (includes changes) before marketed (for patient safety)
• Labelling can contribute to medication error
• Critical information together (same field of view)
• Full name on 3 non-opposing faces (at least)
• Generic cephalosporins Tallman lettering = Certain letters are highlighted or in bold to make it clear as to what exactly you are picking. Highlights differences in the name & helps things stand out.

Question 8

Best Design Practice for Safety
MHRA Guidance for MA Holders

Answer 8

• manufacturers must express different strengths of the same drug in the same manner using the same units (e.g., 250mg, 500mg, 750mg, 1000mg and NOT 1g)
• No trailing zeros (e.g., 2.5mg and NOT 2.50mg) as they may be misread
• ‘micrograms’ is spelt out in full (not abbreviated) so that it isn’t misread
• Positive administration instructions only = For INTRATHECAL use ONLY = Clearer & more easily processed
• Consider colour to ensure accurate identification & selection

Question 9

Con of similar designs

Answer 9

• s/ manufacturers use the same design across all their products & in busy settings one may not be able to easily distinct which is which
• errors can be made

Question 10

Labelling Requirements
MA Holders

Answer 10

• Legislation allows symbols, diagrams, pictures or additional information:
• In line with summary of product characteristics (SmPC) = Has to be in w/ the licensed use of that drug)
• NOT promotional
• Fewer requirements for blister packs & small containers= Have to have expiry date & batch number
• Specific additional requirements for Traditional Herbal Remedies, homeopathic products & radiopharmaceuticals
• Different requirements for ‘special’ medicines, ingredients, contract manufacture, assembly & clinical trials (Special meds = Meds made specifically for a patient aren’t licensed)
• Additional requirements for paracetamol products
• Additional requirements for codeine & dihydrocodeine products

Question 11

Labelling Requirements
Paracetamol Products

Answer 11

The following words MUST appear on the package
- ‘Contains paracetamol’ unless already stated in product name
- ‘Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor’ adjacent to dose directions
- If intended for over 12-year-olds ‘Do not take anything else containing paracetamol while taking this medicine. Talk to a doctor at once if you take too much of this medicine, even if you feel well’ (not e/o feels unwell)
- Either the leaflet or the packaging must include the explanation ‘This is because too much paracetamol can cause delayed, seriousliver damage’

Question 12

Why does paracetamol have labelling requirements?

Answer 12

• Paracetamol untreated can result in irreversible
  hepatotoxicity & death
• Legislation change 1998
• Pack size sales restrictions
• From 100 tablets (pharmacy) & 24 tablets (non-
  pharmacy)
• To 32 tablets (pharmacy) & 16 tablets (non-
  pharmacy)

Question 13

Labelling Requirements
Paracetamol Products

Answer 13

The following words MUST appear on the package
- If intended for under 12-year-olds ‘Do not give anything
else containing paracetamol while giving this
medicine. Talk to a doctor at once if your child takes
too much of this medicine, even if they seem well’ = The same warning just rephrased for the caregiver
- Either the leaflet or the packaging must include the
explanation ‘This is because too much paracetamol can
cause delayed, serious liver damage’

Question 14

Labelling Requirements
Codeine & Dihydrocodeine Products

Answer 14

Over-the-counter (P & GSL) packs MUST
include the following warning on the front
- ‘Can cause addiction, (only take) for three days only’
- Max. pack size of 32 tablets

Question 15

Patient Information Leaflet Requirements

Answer 15

• must be included unless all required information is on the packaging
• Requirement also applies to products dispensed in accordance with a prescription
• Publicly available by MHRA = MHRA approves them
• In accordance with the SmPC= Summary of product characteristics
• Patient education & safety

Question 16

Leaflet Requirements
MA Holders

Answer 16

• Name of medicinal product
• Strength & pharmaceutical form
• Whether intended for babies, children or adults (where appropriate)
• Active substance common name (for up to 3 active substances)
• Drug pharmaco-therapeutic group or type of activity (lay language)= What type of drug is this
• Therapeutic indications= What the drug is for

Question 17

Leaflet Requirements
MA Holders

Answer 17

A list of
− Contraindications (e.g., pregnancy, breastfeeding)= Who can not take the drug
− Precautions= Who needs to use it w/ caution
− Interactions (medicines and other substances)
− Special warnings (e.g., possible effects on the ability to drive & operate machinery) Drowsy
- Instructions for use (e.g., dose, route, frequency etc)
- Adverse reactions (i.e., ALL known side-effects in W/ most common first)

Question 18

Leaflet Requirements
MA Holders

Answer 18

• Reference to expiry date, storage requirements, active ingredients & excipients, name & address of MA holder, name & address of manufacturer
• Information on adverse event reporting = Side effects reporting
• Date last revised
  Additional requirements for:
  − Paracetamol, codeine & dihydrocodeine products (warnings)
  − Radiopharmaceuticals

Question 19

Legal Requirements of Dispensing Labels (1-3)

Answer 19

• Medicines dispensed in accordance with a prescription MUST be labelled
• Outer package or container
  Label MUST include the following:
  1. Patient name
  2. Name & Address of supplier = e.g Supplying pharmacy
  3. Date supplied

Question 20

Legal Requirements of Dispensing Labels (4)

Answer 20

Label MUST include the following:
4. Pharmacist professional judgement is
allowed for the following (substitute for similar
alternative if prescription not appropriate)
- Product name (include quantity, product
name/form, strength where appropriate)
- Directions for use
- Precautions relating to product use
(e.g., ‘For external use only’ on a cream)
Optimise dispensing labels for patient safety

Question 21

Dispensing Labels
Good Practice & Guidance
These are not legal requirements but good practice

Answer 21

• Keep out of reach & sight of children’
  ▪ Dispense & Check boxes for operator(s) initials=
  − Governance procedures
  − Dispense against prescription (operator 1)
  − Check labelled product against prescription (operator 2)
  ▪ Cautionary & Advisory Labels=
  − aka CALs, auxiliary labels
  − 30 CALs listed in the British National Formulary (BNF)
• If you don’t include CAL s you must have a good reason as to why = For patient safety

Question 22

Dispensing Labels
Good Practice & Guidance

Answer 22

• Patient full name (not just initials) & title
  (distinguishes between family members)
• Good labelling practice for directions (see
  practical 03)= Directions for use
• Outer package vs container (a container need
  not be labelled if it is in a package which is labelled BUT
  consider whether outer package will be discarded e.g.,
  inhalers, creams)