john Gill technology header image

Braille Labelling of Medicines: Meeting Directive 2004/27/EC

Dr. John Gill
September 2004, revised May 2005


A new European Directive places obligations on the marketing holder of medicinal products for human use concerning the provision of braille labels and on the availability of information leaflets in alternative formats (see Appendix 1). The implementation date is 30th October 2005.

The European Commission has issued Guidance concerning the braille requirements for labelling and the package leaflet. This guidance states that the directive only applies to medicinal products approved after 30th October 2005.

The Directive does not specify in which "alternative formats" information leaflets should be provided. In the UK, the braille readership is between ten and twenty thousand people, but about a hundred times as many would benefit from large print. Another format is audio (usually on compact cassette) or an electronic text file (possibly on the web). For details of alternative formats see www.tiresias.org/guidelines/alternative_formats.htm

However the end users need to know how to obtain these information leaflets in alternative formats. One solution would be for there to be a single freephone number to request leaflets irrespective of the pharmaceutical supplier. This number would need to be widely advertised by appropriate means (not just a visual poster in pharmacies).

For the user, the key items on the label are product name, dosage and expiry date. Since some medicines are made up in the pharmacy, there needs to be some facility for adding the required labelling at this point.

 

Braille

Braille characters consist of one to six embossed dots which can have 64 different configurations. There are various standards for the spacing of the dots (see www.tiresias.org/reports/braille_cell.htm); most braille producers in the UK use the Standard American dimensions rather than the English Interpoint dimensions. The EC Guidance recommends the use of Marburg Medium braille cell size.

Most braille books and magazines employ a contracted braille code (known as Grade 2); the use of particular contractions can depend on pronunciation and meaning. However there are computer programs (see www.tiresias.org/equipment/eb25.htm) to convert text to contracted braille.

It is possible to use uncontracted braille (Grade1) but even this is not a straight character to character transformation. For instance, numbers are represented by the first ten letters of the alphabet preceded by a braille numeral sign. The EC Guidance recommends uncontracted braille should be used except for small volume packaging.

A significant problem with braille is the lack of redundancy in the system. This means that a single damaged dot can completely change the meaning. For instance, if one dot was damaged in "£75" it would become "large". This has implications for braille medicine labels since a change in meaning could have serious consequences for the user.

Braille is usually produced by embossing dots on long-fibre paper. To lessen the risk of dots becoming damaged, the traditional approach has been to spray the back of the paper with shellac. An alternative is to emboss the braille on plastic sheets but most computer-controlled braille embossers (see www.tiresias.org/equipment/eb4.htm) output on paper not plastic. If plastic is used, the 'feel' can be improved by calendering the plastic sheets prior to embossing. A variety of labelling systems are on the market (see www.tiresias.org/equipment/labelling_intro.htm) but many of these are designed for individual use.

If there is a risk that the braille could become detached from the medicine container, it would be highly desirable to include an ink-print version of, at least, the product name on the braille label. Otherwise staff, who have no knowledge of braille, could issue an incorrect braille label with possible serious consequences.

It is not clear from the Directive as to whether the braille should be on the outer packaging (eg on the carton which contains a bottle of medicine) or on the innermost packaging or on both. The EC Guidance specifies that it should be on the outer/secondary packaging.

If the braille is embossed over printed text, it is likely to reduce the legibility of the text. If this happens then the addition of the braille maybe a significant disadvantage to the majority of visually impaired users.

The packaging of braille is an important factor in preserving its readability. The usual method is to package the braille between two sheets of stiff cardboard. However a page of braille can be rolled and then protected with an outer wrapping. The essential aspect is to test the system of packaging in the actual supply chain.

It may be possible to contract out the production of material in alternative formats (for a list of UK braille producers, see Appendix 2). An alternative would be for the pharmaceutical companies to form their own production unit.

Liability

If a blind patient blames the braille label for taking the wrong medicine or an incorrect dosage, there is the potential for litigation. Therefore responsibilities should be clearly defined before the introduction of any new labelling system.

If you have any comments on this brief paper, please contact:
Dr John Gill OBE FIEE
RNIB
105 Judd Street
London WC1H 9NE
Tel: 020 7391 2244
Email: john.gill@rnib.org.uk


Appendix 1. The Regulations


The Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use should be implemented by 30th October 2005. The relevant parts of these directives are:

Article 56a of 2004/27/EC

'The name of the medicinal product, as referred to in Article 54, point (a) must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients' organisations in formats appropriate for the blind and partially-sighted.'

Article 54 of 2001/83/EC

The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging:

  1. the name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product;
  2. a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names;
  3. the pharmaceutical form and the contents by weight, by volume or by number of doses of the product;
  4. list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated;
  5. the method and, if necessary, the route of administration;
  6. a special warning that the medicinal product must be stored out of reach of children;
  7. a special warning, if this is necessary for the medicinal product;
  8. the expiry date in clear terms (month/year);
  9. special storage precautions, if any;
  10. special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate;
  11. the name and address of the holder of the authorization for placing the medicinal product on the market;
  12. the number of the authorization for placing the medicinal product on the market;
  13. the manufacturer's batch number;
  14. in the case of self-medication, instructions on the use of the medicinal products.

Article 55

  1. The particulars laid down in Articles 54 and 62 shall appear on immediate packagings other than those referred to in paragraphs 2 and 3.
  2. The following particulars at least shall appear on immediate packagings which take the form of blister packs and are placed in an outer packaging that complies with the requirements laid down in Articles 54 and 62.
    • the name of the medicinal product as laid down in Article 54 (a),
    • the name of the holder of the authorization for placing the product on the market,
    • the expiry date,
    • the batch number.
  3. The following particulars at least shall appear on small immediate packaging units on which the particulars laid down in Articles 54 and 62 cannot be displayed:
    • the name of the medicinal product and, if necessary, the strength and the route of administration,
    • the method of administration,
    • the expiry date,
    • the batch number,
    • the contents by weight, by volume or by unit.

Article 56

The particulars referred to in Articles 54, 55 and 62 shall be easily legible, clearly comprehensible and indelible.


Appendix 2. UK Braille Producers & Transcription Services


A2i Transcription Services
139a Whiteladies Road, Clifton, Bristol BS8 2NR
Tel: 0117 973 6013
Contact: Susie Fisher
Email: info@a2i.co.uk
Web: www.a2i.co.uk
Last updated: 10/08/2006

AIRS (Access to Information & Reading Services)
Central Library, Prince Consort Road, Gateshead NE8 4LN
Tel: 0191 433 8450
Fax: 0191 477 7852
Contact name: Janice Holmes
Email: airs@gateshead.gov.uk
Website: www.gateshead.gov.uk/airs
Last updated: 10/08/2006

Adept Transcription Ltd
6 Leck House, Lake Street, Leighton Buzzard, Bedfordshire LU7 1TQ
Tel: 01525 373964
Fax: 01525 850030
Email: transcription@adept-uk.org
Web: www.adept-uk.org
Last updated: 30/03/2007

All Formats
Queen Alexandra College, 49 Court Oak Road, Harborne, Birmingham B17 9TG
Tel: 0121 428 5018
Fax: 0121 428 5048
Contact: Paul Hopkins, Transcriptions Manager
Email: allformats@qac.ac.uk
Web: www.allformats.org.uk
Last updated: 26/04/2006

Audio Exchange Ltd
Tubwell Business Park, Maynards Green, Heathfield, East Sussex TN21 0BY
Tel: 0870 242 3343
Contact name: Tricia Williams
Email: info@audioexchange.co.uk
Website: www.audioexchange.co.uk
Last updated: 26/04/2006

Bayfield Media Ltd
11-15 Betterton Street, London WC2 9BP
Tel: 07879 652686
Contact name: Alexander Bayfield
Email: info@bayfieldmedia.com
Last updated: 26/04/2006

Blind Spot (UK) Ltd
Ballast House, Ballast Quay Road, Fingringhoe, Colchester, Essex CO5 7DB
Tel: 01206 728689
Contact name: Stephen Bourne
Email: blind.spot@virgin.net
Last updated: 26/04/2006

Braille Guild
182 Featherstone Lane, Featherstone, West Yorkshire WF7 6AD
Tel: 01977 792583
Contact name: May Nock
Last updated: 26/04/2006

Braille-Trans Services
The Lodge Bungalow, High Street, Baldock, Herts SG7 6BL
Tel: 01462 892365
Contact name: Ruth Bishop
Last updated: 26/04/2006

Braille Transcan
15 Lindley Street, Castlefields, Shrewsbury SY1 2JZ
Tel: 01743 350926
Contact name: John G Smith
Email: brltranscan@castlefields6.fsnet.co.uk
Website: www.brltranscan.fsnet.co.uk
Last updated: 10/08/2006

Braille Transcription UK Ltd
PO Box 2386, Newcastle under Lyme ST5 8XB
Tel: 01782 563383
Fax: 01782 870716
Contact: Philip Anderson
Email: enquiries@brailletranscriptionuk.co.uk
Web: www.brailletranscriptionuk.co.uk
Last updated: 26/04/2006

Braille Translations
9 Wadham Gardens, Greenford, Middlesex UB6 0BP
Tel: 08000 190 946 (voice); 07903 996 533 (mobile)
Fax: 0808 208 9588
Contact: Ghow Ratnaraja
Email: ghow@brailletranslations.co.uk
Web: www.brailletranslations.co.uk
Last updated: 26/04/2006

CVC - Braille Bureau
Social Services, Nottinghamshire County Council, County Hall, West Bridgford, Nottingham, NG2 7QP
Tel: 0115 977 3157
Contact names: Ivan Rockley, Manager CVC; Darren Beniston, Lisa Cheung, Alison Hall - Braille Bureau Services Operators
Email: ivan.rockley@nottscc.gov.uk; darren.beniston@nottscc.gov.uk; lisa.cheung@nottscc.gov.uk; alison.hall@nottscc.gov.uk
Last updated: 26/04/2006

Computer Room Services
77 Exeter Close, Stevenage, Herts SG1 4PW
Tel: 01438 742286
Fax: 01438 759589
Contact: Steve Nutt
Email: steve@comproom.co.uk
Web: www.comproom.co.uk
Last updated: 26/04/2006

Derbyshire Coalition for Inclusive Living (DCIL)
Park Road, Ripley, Derbyshire DE5 3EF
Tel: 01773 740246
Contact name: Debbie Newton
Email: debbie@dcil.org.uk
Website: www.dcil.org.uk
Last updated: 26/04/2006

Disability Resource Team
2nd Floor, 6 Park Road, Teddington, Middlesex TW11 0AA
Tel: 020 8943 0022
Contact name: Maurice Press
Email: info@disabilityresourceteam.com
Website: www.disabilityresourceteam.com
Last updated: 10/08/2006

ECom Communications
152 High Street, Uckfield, East Sussex TN22 1AT
Tel: 01825 765999
Fax: 01825 766999
Contact: Cindy Duchesne
Email: info@e-comcommunications.co.uk
Web: www.e-comcommunications.co.uk
Last updated: 26/04/2006

Fieldsman Trails Ltd
Fron Deg, Clayton Road, Mold, Flintshire CH7 1SU
Tel: 01352 756202
Contact name: Colin Antwis
Email: fieldsman@fieldsmantrails.com
Website: www.fieldsmantrails.com
Last updated: 26/04/2006

Inside Out Trust
(Facilitates transcription services in HM Prisons)
Hilton House, 55-57a High Street, Hurstpierpoint, West Sussex BN6 9TT
Tel: 01273 833050
Contact name: Chrissie Dimitri-Cooper
Email: info@iotrust.plus.com
Website: www.inside-out.org.uk
Last updated: 26/04/2006

Judith Furse
23 Masefield Avenue, Swinson, Wilts SN2 7HT
Tel: 01793 644346
Contact name: Judith Furse
Email: jf@23masefield.freeserve.co.uk
Last updated: 26/04/2006

Keighley & District Association for the Blind
1 Albert Street, Keighley, West Yorkshire, BD21 2AT
Tel: 01535 602354
Contact name: Antony Horner
Email: antony@keighleyblind.org
Web: www.keighleyblind.org
Last updated: 26/04/2006

Leeds Braille Group
27 Nook Road, Scholes, Leeds LS15 4AX
Tel: 0113 273 4283
Contact name: Mrs Margaret Taylor
Email: aormondroyd@hotmail.com
Last updated: 26/04/2006

Leeds City Council
Braille and Large Print Services, Shire View, 72 Headingley Lane, Headingley, Leeds LS6 2DJ
Tel: 0113 214 4540
Contact name: John Britten, Michael Cooper
Email: braille.unit@leeds.gov.uk
Last updated: 26/04/2006

The Lin Berwick Braille Transcription Service
Blaketon, 4 Chaucer Road, Sudbury, Suffolk CO10 1LN
Tel: 01787 882111
Contact name: Dr Lin Berwick MBE
Email: lin@lberwick.fsnet.co.uk
Last updated: 26/04/2006

MagRay Document Services
178 Castle Road, Northolt, Middlesex UB5 4SG
Tel: 020 8864 7208
Fax: 020 8933 5740
Contact name: Ray Dawson
Email: info@magray.co.uk
Web: www.magray.co.uk
Last updated: 26/04/2006

Master Transcriptions
MT Studios on the Common, The Pantiles, Tunbridge Wells, Kent TN2 5TE
Tel: 01892 516157
Fax: 01892 544796
Contact name: Daniela Bayfield
Email: mastrans@argonet.co.uk
Web: www.mastertranscriptions.co.uk
Last updated: 26/04/2006

National Library for the Blind
Far Cromwell Road, Bredbury, Stockport SK6 2SG
Tel: 0161 355 2000
Fax: 0161 355 2098
Email: enquiries@nlbuk.org
Web: www.nlbuk.org
Last updated: 26/04/2006

The Oxfordshire Association for the Blind
9 Newtec Place, Magdalen Road, Oxford, OX4 1RE
Tel: 01865 725595
Fax: 01865 725596
Contact name: John Lynch
Email: development@oxeyes.org.uk
Website: www.oxeyes.org.uk
Last updated: 26/04/2006

PIA
Victoria Street, Cwmbran, NP44 3YT
Tel: 0870 321 6450
Fax: 0870 321 6451
Contact: Debra Budd
Email: db@pia.co.uk
Web: www.pia.co.uk
Last updated: 26/04/2006

Playback Service for the Blind
17 Gullane Street, Glasgow G11 6AH
Tel: 0141 334 2983
Contact: John Green
Email: playback@btinternet.com
Web: www.play-back.com
Last updated: 10/08/2006

RNIB & Univeristy of Leeds Transcription Centre
The Social Sciences Building, The University of Leeds, Leeds LS2 9JT
Tel: 0113 343 3928/9
Contact: Vibi Rothnie, AIO Supervisor
Email: leedstrans@rnib.org.uk
Last updated: 10/08/2006

RNIB Central Transcription Services
PO Box 173, Peterborough PE2 6WS
Tel: 01733 375000
Contact: Sarah-Jane Parrott, Senior Manager, Business Liaison Team
Email: businesslink@rnib.org.uk
Web: www.rnib.org.uk
Last updated: 10/08/2006

RNIB Cymru
Trident Court, East Moors Road, Cardiff CF24 5TD
Tel: 029 2045 0440
Contact: Nia Morgan
Email: nia.morgan@rnib.org.uk; cymraeg@rnib.org.uk
Web: www.rnib.org.uk
Last updated: 10/08/2006

RNIB Scotland Transcription Centre
17 Gullane Street, Partick, Glasgow G11 6AH
Tel: 0141 337 2955
Contact: Kim Walker / Margaret Hay
Email: glasgowtrans@rnib.org.uk
Web: www.rnib.org.uk
Last updated: 10/08/2006

RNIB Transcription Centre Northwest
67 High Street, Tarporley, Cheshire CW6 0DP
Tel: 01829 732115
Fax: 01829 732408
Contact: Judith Watts
Email: tarporley@rnib.org.uk
Web: www.rnib.org.uk
Last updated: 10/08/2006

RNIB Transcription Centre Southwest
2 Whiteoaks Court, David’s Lane, Ivybridge, Devon PL21 0DW
Tel: 01752 690092
Contact: Gill Cowsill
Email: ivytcsw@rnib.org.uk
Web: www.rnib.org.uk
Last updated: 10/08/2006

St. Vincent's School for Blind Children
Yew Tree Lane, West Derby, Liverpool L12 9HN
Tel: 0151 228 9968
Fax: 0151 230 5070
Email: office@stvin.com
Web: www.stvin.com
Last updated: 26/04/2006

Scottish Braille Press
Craigmillar Park, Edinburgh EH16 5NB
Tel: 0131 662 4445
Fax: 0131 662 1968
Contact: Stewart Connell or J. Donaldson, General Manager
Email: info.sbp@royalblind.org
Web: www.royalblind.org/sbp
Last updated: 10/08/2006

Julie Smethurst
79 Duncan Road, Crookes, Sheffield S10 1SN
Tel: 0114 268 5405
Contact name: Julie Smethurst
Email: email@juliesmethurst.fsnet.co.uk
Last updated: 26/04/2006

Sound Talking
National Recording Centre, Unit 1A Browning Road, Heathfield, East Sussex TN21 8DB
Tel: 01435 862737
Contact name: Thelma Hamilton
Email: talk@soundtalking.co.uk
Website: www.soundtalking.co.uk
Last updated: 26/04/2006

Techno-Vision Systems Ltd
76 Bunting Road Industrial Estate, Northampton NN2 6EE
Tel: 01604 792777
Fax: 01604 792726
Contact: George Bell
Email: info@techno-vision.co.uk
Web: www.techno-vision.co.uk
Last updated: 26/04/2006

Transmedia Link Limited
Oxford House, 15-17 Mount Ephraim Road, Tunbridge Wells, Kent TN1 1EN
Tel: 0870 2410 772
Contact name: Morrison Ellis, General Manager
Email: info@transmedialink.co.uk
Website: www.transmedialink.co.uk
Last updated: 26/04/2006

VIPER Services
Huddersfield Library, Princess Alexandra Walk, Huddersfield HD1 2SU
Tel: 01484 221955
Contact name: Elaine Curran
Email: hudlib.viperser@kirklees.gov.uk
Web: www.kirklees.gov.uk/community/libraries/whatservice/viper.shtml
Last updated: 26/04/2006

Vis-Ability
Central Library, Walker Place, Rotherham, South Yorkshire S65 1JH
Tel: 01709 373658
Contact name: Helen Bollington
Email: helen.bollington@rotherham.gov.uk
Last updated: 26/04/2006

Vision Support Trading Ltd
Beech House, Park West, Sealand Road, Chester CH1 4RJ
Tel: 01244 651900
Fax: 01244 651909
Contact name: Duncan Tranter, Business Development Manager
Email: marketing@vstrading.co.uk
Web: www.vstrading.co.uk
Last updated: 10/08/2006

Voluntary Transcribers' Group
8 Segbourne Road, Rubery, Birmingham B45 9SX
Tel: 0121 453 4268
Contact name: Wynne Batchelor
Email: braille@vtg.org.uk
Website: www.vtg.org.uk
Last updated: 26/04/2006

X L Braille Limited
3 King Dicks Lane, St George, Bristol BS5 8HN
Tel: 0117 955 7992
Contact name: Jenni Fortescue
Email: jenni@xlbraille.co.uk
Last updated: 10/08/2006

 



John Gill Technology Limited Footer
John Gill Technology Limited Footer