Labelling and Presentation of Medicines

Question 1

Standard labelling particulars for Medicinal Products

Answer 1

1. The name of the medicinal product.
2. The strength and pharmaceutical form of the product.
3. Where appropriate, whether the product is intended for babies, children or adults.
4. Where the product contains up to three active substances, the common name of each active substance.
5. A statement of the active substances in the product, expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names.
6. The pharmaceutical form and the contents by weight, by volume or by number of doses of the product.
7. A list of—
   (a)where the product is injectable or is a topical or eye preparation, all excipients; or
   (b)in any other case, those excipients known to have a recognized action or effect and included in the guidance
8. The method of administration of the product and if necessary the route of administration.
9. Where appropriate, space for the prescribed dose to be indicated.
10. A warning that the product must be stored out of the reach and sight of children.
11. Any special warning applicable to the product.
12. The product’s expiry date (month and year), in clear terms.
13. Any special storage precautions relating to the product.
14. Any special precautions relating to the disposal of an unused product or part of a product, or waste derived from the product, and reference to any appropriate collection system in place.
15. The name and address of the holder of the marketing authorisation or traditional herbal registration relating to the product and, where applicable, the name of the holder’s representative.
16. The number of the marketing authorisation or traditional herbal registration for placing the medicinal product on the market.
17. The manufacturer’s batch number.
18. In the case of a product that is not a prescription only medicine, instructions for use.
    18A. In the case of a medicinal product, other than a radiopharmaceutical, that is required by Article 54a of the 2001 Directive to bear safety features—
    (a) a unique identifier which complies with the technical specifications set out in Chapter II of Commission Regulation 2016/161; and
    (b) an anti-tampering device allowing verification of whether the packaging of the medicinal product has been tampered with.

Question 2

Human Medicines Regulations 2012 simplified previous legislation
-Labelling of OTC medicines

Answer 2

Removed all previous general warnings for OTC medicines except paracetamol
Warnings now specifically provided for as part of Marketing Authorisation on a product-specific basis

Question 3

Paracetamol warnings

Answer 3

Unless the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging
“Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”
must appear adjacent to either the directions for use or the recommended dosage

Question 4

Paracetamol Warnings - Adults

Answer 4

“Do not take anything else containing paracetamol while taking this medicine”
and (a) if a package leaflet accompanies the product
“Talk to a doctor at once if you take too much of this medicine, even if you feel well”;
or (b) if no package leaflet accompanies the product or the package leaflet does not include those words
“Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage”

Question 5

Paracetamol Warnings - Children

Answer 5

“Do not give anything else containing paracetamol while giving this medicine”
and (a) if a package leaflet used
“Talk to a doctor at once if your child takes too much of this medicine, even if they seem well”;
or (b) if no package leaflet accompanies the product or the package leaflet does not include those words
“Talk to a doctor at once if your child takes too much of this medicine, even if they seem well. This is because too much paracetamol can cause delayed, serious liver damage”.

Question 6

Packaging of medicines dispensed on prescription (Rx) must legally be labelled with the following:

Answer 6

Name of patient
Name + address of person who sells or supplies (i.e. pharmacy)
Date of supply
Name of the product
Directions for use e.g. take one tablet three times a day.
Precautions relating to the use of the product (includes BNF warning labels.. Appendix 3 of BNF).
(medicines optimisation rules apply to 4,5,6)
Labels to be computer-generated unless emergency when handwritten labels permitted

Question 7

Labelling of containers for dispensed medicines

Answer 7

Keep out of sight and reach of children” –legal requirement.
“Use this medicine only on your skin” (where applicable) (Royal Pharmaceutical Society guidelines)
“Shake well before use” for suspensions.
Legally – label outer container only, but
National Patient Safety Agency (NPSA) advised to label actual container ( i.e. inhaler or tube of cream)
BNF states- for steroid creams, tube must be labelled.
Therefore, you must label actual container (tube, inhaler, etc.)

Question 8

Cautionary labels

Answer 8

For external use only (legally required)
e.g. topical dermatological products
Not to be taken (by mouth)
Used where for external use only could confuse patients, i.e. where products are not taken by mouth, but could be perceived as “internal” by patients
e.g. suppositories, ear drops

Question 9

Expiry dates and storage instructions

Answer 9

Expiry date on dispensing label not needed except for vet Rx.
Sterile preserved eye drops / ointment
4 weeks after first opening
Certain specific products
Follow manufacturer’s guidance
Extemporaneously-dispensed products
Follow establishment policy
See SL32114 (Preparing for professional practice 3) unit guidance (MPharm3)
Recently prepared (BP)
4 week expiry- quote date
Freshly prepared (BP)
1 or 2 week expiry- quote date
Consider storage instructions
e.g. “Store in a cool dry place”

Question 10

Wording on label:

Answer 10

Use active verbs:
E.g. “ take” and not “to be taken”
“ Apply” and not “to be applied”
More easily understood and remembered.
Use words and not numbers in dosing (except 5ml)
Take One tablet Three times a day.
Separate two numbers with dosage form
Take One Three times a day (potential for error with patient)
Take One tablet Three times a day.