Labels, patient information leaflets and packaging for medicines

 

Information on how a medicine should be used is provided to doctors and pharmacists in the Summary of Product Characteristics (SPC). Information to patients or consumers is provided on the label and, more recently, by patient information leaflets (PILs) - unless all the necessary information can be included on the label. All medicines in the UK have labels and/or PILs approved in line with Title V of Council Directive 2001/83/EC.

• The Unit assesses labels and PILs provided by the pharmaceutical industry for compliance with the Regulations (Directive 2001/83/EC) After assessment, and approval by the Unit, the pharmaceutical companies must use the labels and PILs in the packaging of their medicines. For further information,  please see Legislation and guidelines.
• The Unit assesses supplementary 'health educational' material that can be obtained by patients prescribed a particular medicine. For example, videos, magazines and literature sent out when the patient enrols in a 'patient club'. All health education material must be strictly non-promotional and we liaise closely with the Advertising Unit for this work. 
• The Unit responds to correspondence from members of the public received by Members of Parliament, the Health Minister and Secretary of State for Health regarding patient information and advises as appropriate.

Medicines can be obtained in three ways: 

• From a retail outlet such as a supermarket with no input from a health professional at the point of sale. 
• From a pharmacy, where the product can only be sold under the supervision of a pharmacist who will advise the patient on how to use the medicine. 
• On prescription, following consultation with a doctor and the pharmacist at the point of dispensing.
  

The provision of good quality patient information is intended to supplement and not replace the advice given to patients by health professionals.   Every patient should be given a patient information leaflet with each medicine regardless of whether these are purchased over the counter, supplied on prescription or administered by a health professional.

For patients that purchase their medication from retail outlets, patient information represents the only advice the patients receive on how to take their medicine safely and effectively.

Patient information must be written in clear and understandable terms.  New requirements have recently been introduced requiring those responsible for the writing of statutory patient information leaflets to make sure that these have been drawn up to take into account the needs and views of patients.   Presentation of information in terms of print size, colour and layout is an important factor in overall 'readability'. 

Guidance on this has been produced by the MHRA and published in “Always Read the Leaflet – getting the best information with every medicine”. (602Kb) This publication also includes details of how to comply with the new requirements concerning “user testing” – taking account of patients views. 

For details of the Guideline on the readability of the label and package leaflet of medicinal products for human use, published by the European Commission, please see the Legislation and guidelines section.

Reminder – update to labelling to comply with Article 54(a), 54(e) and 56(a)

UK legislation was amended in 2004 to implement the new medicines labelling provisions in Title V of Council Directive 2001/83/EC [as amended]. The relevant statutory instrument is The Medicines (Marketing Authorisations etc) Amendment Regulations 2005 number 2759 [SI 2005/2759]. The legislation provided a transitional period for the labelling of medicines which were the subject of a granted marketing authorisation at the time the regulations came into force on 30 October 2005. This transitional period ends on 30 October 2010 by which time the necessary applications must have been approved to bring the marketing authorisations into compliance. The new requirements for labelling under the articles cited above are as follows: Following the brand name of the medicine (where one has been registered) the packaging must include reference to the common name(s) of the active substances in the formulation (where up to three active substances are present in the formulation). The common name(s) must be prominently displayed on the packaging. Space for the prescribed dose to be indicated – in the UK this is in the form of space for a dispensing label to be indicated on the outer packaging. Such space should be 35mm by 70mm in size. Although not required by the legislation, best practice suggests that the space should be marked on the pack and appear on a face where the name of the medicine is displayed. The name registered in section 1 of the summary of product characteristics must be displayed in Braille on the packaging. Detailed guidance on how to apply for these changes and the criteria which apply are available from the labels, patient information leaflets and packaging section of the MHRA website. Action required Where the necessary changes have not already been implemented, marketing authorisation holders must submit applications by 1 August 2010 to ensure compliance by 30 October 2010. Further information is available from patient.information@mhra.gsi.gov.uk or by telephoning Mrs Jan MacDonald on 020 3080 6267.

Labelling
Clear labelling is crucial for the safe use of all medicines and its primary purpose is for the clear and unambiguous identification of the product and the conditions for safe use.  Similarity in packaging is known to contribute to medication error and MHRA has published guidance for those involved in the design and layout of labelling to help improve the way in which labelling information is presented both to health care professionals and patients.  This guidance applies to medicines available on prescription and also over the counter.

'Best Practice Guidance on labelling and packaging of medicines' (226Kb)

Name differentiation designs for generic cephalosporin products - added 10 November 2009
Similarity in drug names is known to cause errors in drug prescription and selection. Recent medication errors have been reported concerning the mis-selection of generic cephalosporin products resulting in patients receiving the wrong product.

The MHRA and the National Patient Safety Agency have reviewed the errors and have agreed a labelling design mechanism which will help pharmacy staff more easily identify the correct medicine. To reduce the likelihood of errors occurring in the dispensing environment, use of Tallman lettering or other means of picking out key portions of the drug name will be required on the labelling of all medicines in this class.

Tallman lettering involves the use of capital letters (or the use of different coloured text) to highlight some unique aspect of the drug name. The particular string of letters to be highlighted in the cephalosporin range is set out below.

Applications for new or revised labelling for any medicine in this drug class submitted to assessment areas in the MHRA will be expected to comply with these provisions with immediate effect.

cefaCLOR
cefADROxil
cefALEXin
ceFIXime
cefoTAXime
cefPODOXime
cefRADine
cefTAZIDime
cefTRIAXone
cefUROXime

For further information please email Patient Information Quality Unit, patient.information@mhra.gsi.gov.uk

Guidance on patient information leaflets
Extensive advice and guidance on writing patient information leaflets (PILs) is available in Always read the leaflet (602Kb).

Specific guidance has been developed for writing PILs as follows:

Can you read the leaflet? A guideline on the usability of the patient information leaflet for medicinal products for human use (154Kb)

MHRA guidance on the development of artwork in relation to medicines containing codeine and dihydrocodeine (34Kb) - added 16 October 2009

Guidance on communication of risk in patient information leaflets (121Kb)

Glossary of medical terms in lay language (69Kb)

Signposting from the Patient Information Leaflet to additional sources of information and other services (69Kb)

Guidance on information in the PIL to address areas of potential misuse or abuse of over-the-counter (OTC) antihistamine sleep aid and laxative medicines (35Kb)

For comprehensive guidance on user testing, please see the User testing of patient information leaflets page. Additional guidance is available on our frequently asked questions page.

Contact for further information
The Unit responds to and investigates enquiries and complaints regarding patient information reported by members of the public and the pharmaceutical industry. Enquiries and complaints should be made in writing and sent to:

The Patient Information Quality Unit
MHRA
151 Buckingham Palace Road
London
SW1W 9SZ

Email patient.information@mhra.gsi.gov.uk