Best practice guidance on the labelling and packaging of medicines Flashcards
Common factors affecting all users of medicines may be summarised under three headings:
- Information: Certain items of information are vital for the safe use of the medicine.
- Format: The information must be presented in a legible manner that is easily understood by all those involved in the supply and use of the medicine.
- Style: There is potential for confusion between both similarity in drug names and similarity in medicines packaging. Medication errors occur due to many factors.
Labelling must contain all elements required by Regulation 257 and Schedule 24 of the HMRs. Nevertheless, certain items of information are deemed critical for the safe use of the medicine. These items are:
- name of the medicine
- expression of strength (where relevant)
- route of administration
- posology
warnings
Pack and label - critical information
hese critical items of information should be located together on the pack and appear in the same field of view where practicable. These items should not be broken up by additional information, logos or background texts or graphics.
* For medicines available on prescription it is likely that these pieces of information will appear together on the front face of the labelling.
* In the over-the-counter sector due to the difference in pack design it is usual for this to appear together on the back of the pack.
* The information hierarchy is important. Critical information as described here should be located more prominently than information of lesser importance. Prominence is influenced by text size and style but is also impacted by other factors such as the colour used, the space on the pack and any other graphic elements included in the design.
Pack and label - name of medicine
- The name that is registered in the summary of product characteristics (SmPC) must be used on all packaging components. The name is defined as comprising the name, strength and pharmaceutical form of the medicine.
- The name registered in the SmPC may not be abbreviated for inclusion on the labelling and should be selected with this in mind.
- Braille Regulation 259 of the HMRs requires the name of the medicine to be shown on the packaging in Braille.
- The full name of the medicine should appear on at least three non-opposing faces of the pack to aid accurate identification of the drug. Where this is employed the end-face of the pack, the side face and the front face should include the full name of the product.
- The full pharmaceutical form, employing standard terms, must appear in section 3 of the SmPC.
- Where the medicine contains up to three active ingredients, Paragraph 4 of Part 1 of Schedule 24 to the HMRs requires that the common names of these active ingredients should immediately follow the name of the medicine on the pack, unless these are part of the name.
Pack and label - strength
- It may be necessary in some cases to express the strength as quantity per unit volume and also as the total quantity per total volume.
- Reference to the total quantity per total volume should be highlighted. This is particularly important for injectable products and other medicines available in solution or suspension.
- For safety reasons it is important that ‘micrograms’ is spelled out in full and not abbreviated.
In cases where this cannot be accommodated on a small label (e.g. vial label), the abbreviation mcg rather than μg should be used.
Pack and label - Route of administration
- This should be as registered in the SmPC only. Positive messages should be used; for example “give by …” and only standard abbreviations will be acceptable.
- Non-standard routes of administration should be spelt out in full to avoid confusion.
- Some routes of administration will be unfamiliar to patients and may need careful explanation. This is particularly important when medicines are made available for self-selection.
However, use of the standard terms will be considered acceptable for those medicines that will have a dispensing label applied
Pack and label - Posology
- This will be necessary only when the product is intended for self-medication.
- In general, posology will not appear on medicines that are intended to be supplied on prescription.
- Posology remains a legal requirement for products marketed for over-the-counter sale.
Medicines that are supplied on prescription would have the posology added at the time of dispensing.
Pack and label - warnings
- It is not the purpose of this section to include all the warnings registered in section 4 of the SmPC in the critical field.
- Only those warnings, specifically required by the terms of the marketing authorisation to be stated on the labelling, will form part of the critical labelling.
- Many medicines will not need the addition of any warnings on the front of the pack.
- As a result of the consolidation of the Medicines Act, with the exception of medicines containing paracetamol, the new legislation no longer requires any warnings to be applied by means of a legal obligation.
Pack and label - indications
Medicines available on prescription only (POM) do not need to make reference to the approved indications. Over-the-counter medicines, however, which are either pharmacy only [P] or general sales list [GSL] category must, in line with Paragraph 18 of Part 1 of Schedule 24 to the HMRs, include the registered indications as part of the critical information set so that patients are easily able to ascertain whether the product is suitable for them.
Pack and label - general guidance
The critical information should appear in as large a font as possible to maximise legibility, on at least one face of the presentation. It should not be broken up or separated by non-critical information. The critical information (see 4.1 above) should appear in the order stated.
Innovative pack design that may incorporate the judicious use of colour is to be encouraged to ensure accurate identification of the medicine.
In line with Paragraph 9 of Part 1 of Schedule 24 to the HMRs the labelling of packs intended for supply against a prescription should include space for the placement of the dispensing label. It is recommended that this should be a blank white space in which there is no text of any kind, to aid legibility of the dispensing label.
Only positive statements should appear on medicines labelling to avoid ambiguity of the message. For example, “For intravenous use only”. Negative statements such as “Not for intravenous use” should not be used.
Undertaking a user test to ensure the maximum clarity of the critical information is desirable and recognised as best practice. Although user testing is not part of the legal provisions many companies choose to test packs when considering introducing a corporate redesign.
Pack and label - small containers
Where the full labelling requirements cannot be legibly applied to a container, Regulation 257 of the HMRs alongside Part 3 of Schedule 24 permits a lesser information set to be applied. . The criteria for small container status would normally be considered to apply to containers with a nominal volume of 10mls or less. However, other factors may need to be considered such as the amount of information which needs to appear on the label and the font size necessary to achieve legibility of the information.
For traceability purposes it is recommended that the following additional information should appear on the labelling of small containers where space allows:
* PL number
* The MA holder’s name. This may be replaced by the company logo where the MAH name is an integral part of it, but the use of a logo should not be at the expense of other critical information and it should be of a small size relative to the rest of the text. Where space is at a premium, the inclusion of the MA holder’s name will not be mandatory.
Pack and label - blister packs
Where a blister or strip pack is enclosed in a container which meets the full labelling requirements set out in Regulation 257 of and Part 2 of Schedule 24 to of the HMRs a lesser information set applies to the blister or strip packs.
Where practicable:
* name and strength of the product should appear over each blister pocket or be oriented centrally across the pack.
* Batch number and expiry date to the end of the blister strip. If technically possible this could be applied to both ends of each strip.
In addition, blister foils should be printed to ensure maximum legibility of the statutory information using a sufficiently large font.
Colour for the text and the font style, should be chosen carefully as the legibility of the text on the foil is already impaired due to the nature of the material. Where possible, non-reflective material or coloured foils should be considered to enhance the readability of the information presented and the correct identification of the medicine.
Calendar packs are only appropriate for tablets or capsules that are taken as a single dose once (or twice) daily. The packs must be supplied in multiples of 7 and all blister pockets must be labelled with the days of the week.
Pack and label - INCLUSION OF NON-STATUTORY INFORMATION IN LINE WITH REGULATION 261 OF THE HMRs
Regulation 261 of the HMRs permits the inclusion on the label and in the patient information leaflet (PIL) of symbols and pictograms which are intended to clarify information presented in addition to being compatible with the Summary of Product Characteristics (SmPC), useful for the patient and importantly, not promotional.
Quick Response (QR) codes
QR codes may be included on packaging provided they are subordinate in prominence and placement to the statutory information. In addition, such a code must link to information which is compliant with Regulation 261 of the HMRs. It must therefore be:
* compatible with the SmPC
* useful for the patient
* non-promotional.
An applicant intending to include a QR code on the labelling or in the patient information leaflet for a particular product must make an application to the Patient Information Quality Unit in the usual manner.
QR codes should not be confused with 2D barcodes which are added to labelling at the time of packaging to enable batch number, expiry date and other product specific details to be recorded on the labelling.
E-mail addresses An email address may be included as a means of contacting the marketing authorisation holder and in circumstances where a patient information leaflet is not separately available this may appear on the labelling.
