Labelling of medicines
Poster on the FIP Congress Dublin
Seminar for legemiddelkomiteer, arrangert av Statens legemiddelverk, i Oslo
Poster on FIP Congress in Lisbon
Patient packs vs dispensing from bulk. Symposium at the FIP congress in Lisbon
Pharmacy based systems for patient packs in Europe Presentation by me
Logistics and Patient Safety Implications in Dispensing from Bulk - Jeannie Kim Lee
Bulk dispensing in Africa - Alexander Dodoo
Presentation given at Lundbeck Denmark
Poster on FIP Congress in Basel
A guide to labelling and packaging of injectable medicines.
Link pdf-file From the National Patient Safety Agency in UK. May 2008
Presentasjon på Fagdag i forbindelse med årsmøte i Norske Sykehusfarmasøyters forening.
Poster presented at FIP, Beijing 2-8th September 2007.
Tvillingpreparater er en uting.
Presentation on Pharmaceutical Packaging & Labelling Congress 2007 arranged by Visiongain, London 29th May 2007 (13,5Megabyte)
Comment on Pedea - an extreme multinational package - put on this website
Innlegg av Stein Lyftingsmo ved temadag i Stockholm 24. november 2005 arrangert av Läkemedelsakademin
Läkemedelsförpakningar - design, säkerhet och marknadsaspekter (13,2 Megabyte)
Information design for patient safety Link pdf-file by designer Thea Swayne gives guidance on the design of prescription medicine packs— including blister packs and all types of secondary packaging. The book is the result of a collaboration by the National Patient Safety Agency, the Helen Hamlyn Research Centre and the Royal College of Art in UK.
Presentation FIP congress Cairo September 2005
September 2005 Identical tablets and company - but different names and information. Presentation held by Stein Lyftingsmo, FIP congress in Cairo September 2005.
September 2005 FIP Cairo 2005. Taiwan poster presented by Sherry F Chao about dispensing labels for medicines. Very good, especially on the background that in our Labeling Survey 1999, we were informed that a very small proportion of prescription medicines were dispensed through pharmacies (this poster is from Taipei Veterans General Hospital)
July 2005 The Helen Hamlyn Research Centre in London, UK has two very interesting projects:
Thea Swayne: Packaging and labelling for patient safety.
Jonathan West: Reducing medication errors with pharmaceutical packaging.
At last. I have been hoping for years for such initiatives.
July 2005 The British MRHA has published a report:
The report can be seen as a step forward in the development of 'making information more suitable for patients' which aim to enable people to use medicines correctly.
July 2005 Draft guidelines for Achieveing Harmonised Patient Information. From Mutual Recognition Facilitation Group MFRG. MFRG is a cooperational group of the medicinal authorities in the European Union, Norway, Iceland and Lichenstein. The draft will probably become EU regulations. It emphasises performance testing, and also suggests that testing in English is sufficient.
July 2005 With the proposed formation of a joint Australia - New Zealand agency for the regulation of therapeutic products, to commence operation by 1 July 2006, it was agreed by the responsible Ministers that a single, harmonised standard for medicine labels be established.
June 2005 The Food and Drug Administration in US has issued a draft Guidance on Useful Written Consumer Medication Information (CMI, which is the same as PIL, Patient Information Leaflet).
The document is already outdated by 20 years. FDA state that CMIs should be useful, but provide no criteria for this and nothing about performance testing.
In Australia David Sless at Communication Research Institute of Australia has developed criteria and methods for making useful CMIs. They have been available for ten years.
Any ideas how to make FDA realise their anachronism?
June 2005 Performance testing of Patient Information Leaflets, PILs. At last someone is following in the footsteps of David Sless and Communication Research Institutute of Australia.
Theo Raynor is leading a University of Leeds spin-out company, LUTO, which has been set up to provide a patient information leaflet (PIL) testing service to the pharmaceutical industry. The company was developed in response to regulations making user testing of PILs mandatory. The regulations come into force in the UK on 1 July and in other EU member states on 31 October.
May 2005 Karel van der Warde's comments on template for package leaflet as stated in EU Directive 2004/27/EC put on this website. Further comments to this is wanted.
May 2005 New page on use of colour.
February 2005 Food and Drug Administration in USA, FDA is announcing a public hearing on Use of Color on Pharmaceutical Product Labels, Labeling and Packaging (notice the American spelling). Link and Announcing document.
December 2004 Patients with visual impairment are not able to read the instructions on their bottle of eye drops. This has now been scientifically documented. I feel it difficult not to get sarcastic about the superiority of evidence based medicine over common sense. But I welcome the focus this may create on the need of giving priority to the most important elements of information.
October 2004 Cheer list established on this website. Pharmaceutical manufacturers publishing good labelling initiatives will be honoured.
October 2004 The National Consumer Council in UK has released Health Literacy Report
in August 2004
October 2004 Link to site listing research on pictograms put on this website.
October 2004 David Sless and Alex Tyers
This publication is probably a historic event, describing real user testing in developing the label.
October 2004 FIP congress New Orleans. Presentation about pictograms put on this website.
October 2004 David Sless: Designing Public Documents.
International Design Journal + Documents Design 12(1), 24-35
After half a year with no labelling news, I am back on the track. For a while there will be a mix of old and new news.
April 2004 Communication Research Institute of Australia issued October 2003 Code of practice for developing usable labels for non-prescription medicines
March 2004 After four years of litigation, parallel importers Medihealth and Dowelhurst have won their ongoing battle with GlaxoSmithKline, Boehringer Ingelheim and Eli Lilly over how pharmaceutical PIs can be repackaged for the UK market. Yahoo Finance Reuters
March 2004 The MHRA in UK has published guidelines on naming products in umbrella sectors.
February 2004 FDA Rule Requires Bar Codes on Drugs and Blood
February 2004 The report Design for patient safety was issued by the Departement of Health and the Design Council in UK.
February 2004 Frank Phillipin: small print: improving visual pack information for older consumers.
Case study added under Presentations and publications
February 2004 Building a safer NHS for patients Improving Medication Safety.
A report by the Chief Pharmaceutical Officer (United Kingdom)
February 2004 Shape of words. Labelline revised
January 2004 How to give a cat a pill. Pill line added
January 2004 Picture of tablets on package. Labelline added
January 2004 Colour differentiation. Labelline added
January 2004 Same tablet and company different name. Labelline added
January 2004 Report from Health information Design Forum in Coventry UK December 2003
January 2004 Labelling of male-female. Labelline added
Great news! 11 December 2003 a Forum was arranged in Coventry University, UK, which hopefully made the basis for a Health Information Design Network.
December 2003 Shape of words. Labelline added
December 2003 The word Labelling. Additional comment added.
November 2003 klowrul hIdrate. Labelline added
September 2003 Strength indication of nasal pump spray put on this website.
September 2003 Tall Letter Writing ('Tall Man' letters) of generic cepALOSPOrine names put on this website.
June 2003 The Committee on Safety of Medicines (CSM) in UK on their meeting 26 June established a Working Group on Patient Information Leaflets. The terms of reference for the working group is at page 3 in the Summary from the CSM meeting.
June 2003 Theo Raynor gets grant to compare medicine information (PILs) in UK, USA and Australia.
March 2003 MCA issues Best Practice Guidance on the Labelling and Packaging of Medicines
December 2002 Bob Calverts presentation 'Background and present situation on MLX275 from MCA', at
Vision in Business conference, London December 2002, put on this website.
September 2002 Move to phase out British Approved Names (BANs) before the end of 2005.
September 2002 Therapeutic Goods Administration in Australia has issued a consultation paper on labelling of non-prescription medicines (April 2002)
September 2002 Parallel importers can repack medicines without breaching trademark rights. Judgement from European Court of Justice C-433/00.
September 2002 Presentations from FIP congress in Nice put on this website.
June 2002 Two package inserts in one package?