The primary purpose of medicines labelling and packaging is the clear identification of the medicine and the conditions for its safe use. The safe use of all medicines depends on users reading the labelling and packaging carefully and accurately and being able to understand and act on the information presented.
Medication errors occur due to many factors. “Building a Safer NHS for Patients” published in April 2001, which implemented “Organisation With A Memory”, identified such factors as training, communication, storage, and supervision. Problems with labelling have also been associated with a high percentage of errors. Within the current regulatory framework there is the potential for improving the layout of medicines labelling to aid clarity. This can assist health professionals and patients/carers to select the correct medicine and use it safely, thereby helping to minimise medication errors.
Here we expand a set of principles which have been agreed by the Committee on Safety of Medicines and to support a move to more self-regulation by the pharmaceutical industry of changes to labelling and packaging of medicines. When the guidance is applied, it will help to ensure that the critical information necessary for the safe use of the medicine is legible, easily accessible and that users of medicines are assisted in assimilating this information so that confusion and error are minimised. In preparing this guidance, it is acknowledged that different users of medicines require and use information differently.
Name of the 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. A number of different scenarios exist and for which different advice is provided.
For a bespoke product name (for example, Bloggo Cold and Flu Relief 300mg tablets), this must be reflected on all packaging components where the name is required to appear. Where a generic medicine has a company name included as part of the name registered in section 1 of the SmPC the full colour mock-ups should not include reference to the company name for reasons related to safe selection of the product. Regulation 259 of the HMRs requires the name of the medicine to be shown on the packaging in Braille. The name selected should be chosen carefully to ensure that what is set out for sighted patients is also communicated in Braille to blind and partially sighted patients.
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. This is particularly applicable to carton presentations for medicines available on prescription but can be relevant on all medicines. 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.
However, an abbreviated pharmaceutical form may be used on the label in the interests of clarity for the patient. The full pharmaceutical form, employing standard terms, must appear in section 3 of the SmPC. Where the medicine contains up to three active ingredients, it is required 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. There should be no intervening text of any kind. The recommended International Non-proprietary Name (rINN) should be used, or the usual common name where no rINN exists.
Where the common name(s) appears after the brand name, these should be given due prominence. Generally, this will be determined by the relative size of the text, but other factors may be relevant such as colour of text, the font used and any other graphic elements on the pack. If a “Co-” name is used for the medicine, this should be registered in the SmPC and appear on the labelling as part of the name.
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. Where it is not possible to employ a blank space, use of a colour that will not interfere with the readability of the dispensing label should be considered for any text over which the dispensing label will be applied. In the UK, the space required is 35mm x 70mm usually. This consideration need not apply to products intended for over-the-counter sale directly to the patient. 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.
Small Containers and Extended Content Labels
Extended content or booklet labels can help with the information required on labels. 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.
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. Inclusion of a QR code on the label or in the PIL cannot be achieved by means of a notification since the application must include, as part of the dossier, a detailed account of the information to which this code links. Information which would be deemed acceptable would be likely to include patient support materials such as additional disease related information and life-style information.
Medicines for which such support materials are considered appropriate would usually be for long term medical conditions and/or medicines where additional support was required as part of the licensed indication. Many such medicines already make reference to additional support in the PIL and it may be appropriate in these cases to include a QR code in addition to other signposting to such support materials. 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.
Labelling of Over-the-Counter Medicines
Non-statutory information is frequently used in the labelling for medicines available over-the-counter. The Proprietary Association of Great Britain administers a Code of Practice on Pack Design which sets out MHRA policy in this area and examples of best practice. Non-statutory information must be subordinate in placement and prominence to the statutory information. As a general rule this would mean that any such statements are smaller than the declaration of the common name(s) on the front of the pack.
For medicines supplied over-the-counter for self-selection, the use of this provision can be useful. While the critical health information panel must be the primary place for people to locate and understand the information, they need to use the product safely, the rest of the pack is also important. While OTC medicines have a good safety profile, they are not suitable for everyone.
Pregnant women in particular should be advised not to take medicines without professional advice. Other groups of the population such as diabetics and parents of children find it useful if the label includes information which is relevant to them which helps them choose the appropriate product. Where such statements are made on a pack, evidence must be provided to support the statement.
Statements relating to side effects and safety
Within some therapeutic categories there are differences in the side effect or interaction profiles, and it helps people to choose the appropriate products if this is highlighted on the pack. No medicine is absolutely safe. To the consumer ‘safe’ means that there are no side effects or interactions. Even if the SmPC has ‘no known side effects’ packaging information should not imply that the product is completely safe.
Non-Drowsy – this statement may be used on products in a range where some contain ingredients which cause drowsiness, to help people identify or avoid products which may affect their driving. It may not be used to artificially distinguish between products where this is not an issue for the ingredients commonly available in a category. Any reference to drowsiness or sleepiness in the side effects section of the SmPC would preclude use of this statement.
Statements linking safety with natural ingredients – may not be made unless supported by the SmPC as described above.
Once new packaging components have been approved by the MHRA these must be introduced into packed stock being certified for release to the market by the Qualified Person within three to six months, unless
MAHs have been advised of the need for earlier introduction of the new components for safety reasons. The Qualified Person should not certify a medicinal product for release to the market if the packaging components, at the time of certification, have not been updated within three to six months following approval.
In closing, we at Labelservice have provided many types of medical labels including for the NHS during covid. If you need new or additional medical or pharmaceutical labels of any type and need help in design, compliance and production then please get in touch today.
