Can't read, won't read

Drugs are at their most effective when taken in accordance with the manufacturer's instructions. But if the information is not readily accessible to patients, the consequences could be downright dangerous

Compared with the time and money spent on developing pharmaceuticals, the effort put into making sure they are taken correctly by the people for whom they were intended seems to be something of an afterthought. It is estimated that in the UK alone one person in every five has difficulty in reading the information accompanying their medication, and according to a recent report by the Royal National Institute for the Blind (RNIB), this means that more than two million people with sight problems are being put at risk. And the proportion rises to two in five among the over-75s.

The report, A Bitter Pill, says that vital information on medicines, including dosage details or warnings of possible side effects, is being poorly presented or printed in a tiny typeface. Although many blind people devise ways of coping with the difficulties this poses – including asking other family members to monitor their medication and keeping different pills in different parts of the house – the RNIB says that these methods are unsatisfactory as they undermine people's independence and put them in danger of taking the wrong dose or even the wrong medicine.

It cites case studies of eye drops being confused with superglue, fast-release and slow-release diabetes medications being taken at the wrong times, and side-effects from anti-inflammatory drugs occurring because the patient information leaflet was printed in tiny type on very thin paper.

The organisation is calling on the pharmaceutical industry to ensure that all patient information leaflets are made available in a range of formats accessible to the blind or partially sighted, such as large print, tape and Braille. All packaging should carry the name of the medicine, the dosage and a customer care line number in Braille and large print.

voluntary initiatives

Present UK disability discrimination law is flawed, the report says, as it does not require manufacturers to provide accessible information. The RNIB is therefore calling on the government to consider pharmaceutical information separately from other manufactured goods.

'There have been some positive, voluntary initiatives from the pharmaceutical industry, such as moves by Eli Lilly to improve its information and packaging,' said RNIB campaigns officer Helen Dearman, 'but these encouraging examples are, sadly, too rare.'

The organisation is setting up a Working Group on Accessible Pharmaceutical Information to address the issues affecting manufacturers and users of pharmaceutical products. It will involve key stakeholder representatives from the pharmaceutical industry, pharmacists and patients. The RNIB has called on the UK government to support the initiative.

Under the EU Directive 92/27/EEC, patient information leaflets must conform to strict rules about what information must be provided and in what order it must appear. The RNIB wants the directive to be amended to include improved, enforceable guidelines on readability and patient testing. Legibility is covered in a Commission guideline issued in 1999, but this has no legal basis and is flawed in several ways, the organisation believes.

lack of awareness

It has put forward 10 recommendations in the report for the pharmaceutical industry and the UK government to ensure that patient information leaflets and other information is readily accessible to those with sight difficulties.

'For far too long blind and partially sighted people have been put at risk because they cannot read the information on medicines,' said Dearman. 'This must be addressed by both the pharmaceutical industry and the government if we are to prevent the accidents that are waiting to happen.'

But it is not just those who are visually impaired who are at risk from a failure to heed the information on pharmaceutical packaging. A survey carried out recently by Markem Systems, the Salford-based supplier of marking and coding solutions, revealed a dangerous lack of awareness about the information coded onto the packaging of otc medicines.

tragic consequences

According to Markem, the bathroom cabinet is potentially one of the most dangerous places in the home, because people have little or no idea whether its contents are safe to use. The survey showed that 91% of the 1,000 householders polled did not know how long they could keep a packet of paracetamol tablets before they passed their expiry date. And nearly one in three were not even aware that such information actually exists on the packaging. The company fears that such ignorance could have tragic consequences and is calling for greater consumer education about the content of information on otc products as a matter of urgency.

'The findings are alarming because pharmaceutical manufacturers do put expiry coding onto their products, but clearly the public doesn't know to look for this information,' commented Simon Chidgey general manager of Markem. 'I'm sure there are householders up and down the country who have no idea whether the creams, medicines and tablets in the bathroom cabinets are fit for use – and this is very worrying.'

Markem believes part of the problem lies with the coding methods used by some pharmaceutical manufacturers. More specifically, it argues, issues of clarity and consistency need addressing. For example, some manufacturers are not embracing new technologies and still rely on tried and trusted embossing techniques, which can produce coding information that is not always that easy to read on some types on packaging.

While the theory of embossing – a permanent mark that is not erasable by ink abrasion – may be a good one, says Chidgey, it is not a realistic coding system for meeting the demands of the 21st century. 'This is particularly true at a time when there are calls for greater traceability for many consumable products; information coded onto packaging is an integral part of any audit trail and therefore needs to be clear and easy to read,' he said.

The manual date set-up raises issues of mistakes due to transcription errors, miscalculated offset dates and other human errors. With on-line coders, this data can be sourced automatically and directly from the factory system, for enhanced coding integrity.

Also embossed codes are generally difficult to see with the naked eye at the best of times, and the quality of printing can deteriorate when the embossing characters, either steel or brass, become worn, Chidgey pointed out. There are a number of digital coding technologies currently available that are suitable, but the emergence of lasers may be of particular interest to pharmaceutical manufacturers, he believes.

Markem's SmartLase, for example, was developed specifically for applications such as the pharmaceutical industry, where there is a particular requirement for high levels of permanent print from compact coders. Its lens can be adjusted through 90° and it can be fitted easily – either horizontally or vertically – onto cartoning and labelling lines. It can be networked so it is operated automatically, away from the factory floor.

There also appears to be a lack of consistency concerning where on the pack manufacturers actually place their coded information. Chidgey pointed out that public awareness of coded information on otc medicines lags far behind shoppers' understanding of the equivalent 'use by' information on food packaging. He added: 'Previous research conducted by Markem showed that shoppers have a much better understanding of where to look on food packaging to find coded 'use by' information. And interestingly, this is becoming one of the key factors influencing the buying decision.'

The optimum location really depends on the pack type, the product involved and its usage, Chidgey suggests. Laser coding, for example, offers a quality which is good enough to give significantly improved visibility, even on the traditional end of carton position favoured particularly by otc brand owners. However, the quality of laser coding would not disgrace the front of pack position, which gives the consumer maximum expiry date awareness.

Bar codes keep industry on track

Strict codes of practice in the pharmaceutical world make it imperative that those involved in the production and marketing of medication have the capacity to trace every bottle, box and container from source to point of consumption. The ubiquitous bar code goes a long way towards ensuring total traceability from the minute any pack leaves the production line, and many manufacturers use this tried and trusted technology for their security labelling. A leading global pharmaceutical manufacturer recently turned to Logopak International to supply print and apply bar code labelling machinery to apply health industry bar codes and human readable information to a range of packaged products coming off the production lines at its state-of-the-art plant in Plymouth. The latest installation consists of two systems that are capable of real-time label application onto packaged products as they leave case-sealing equipment at speeds of up to 12/min. One challenge was that the new print and apply labellers had to be fitted into a confined space on the output leg of a sealer conveyor unit. Logopak's technicians therefore manufactured the machines to take up the smallest possible floor space. Logopak's UK general manager Wilson Clark says: The end result is a 901T and a V90 measuring just 300 x 270mm and – another stipulation from the customer – the standard Logopak control keyboard installed in a special operator box close to where the workforce performs all its main duties." T +44 1904 692333
F +44 1904 690728
wclark@logopak.net

Taking the ALS tube

An alternative to direct printing on tubes is offered by Advanced Labelling Systems, of Thame in the UK. Its latest range of ALS-T-Series tube labellers is suitable for the application of partial or complete wraparound labels to metal and plastic tubes and is said to offer greater flexibility, increased production throughput and the ability to print relatively small quantities. As a result, both cycle times and tube inventories are significantly reduced, the company says. T +44 1844 213177
F +44 1844 217188
sales@als-eu.com

Self-cleaning case coder takes ink jet to a new level

Interactive Coding Equipment (ICE) has launched what it believes is the first fully self-maintaining case coder, providing a high-resolution, indelible on-line coding alternative to printed labels and pre-printed outer cases. Existing high-resolution ink jet systems are vulnerable to the effects of dust and vibration in factory environments, resulting in variable and often unacceptable print quality and necessitating regular maintenance. The ICE Infineon's novel automatic self-cleaning system operates every time the machine is asked to print, ensuring that the print heads remain immune to dust and debris. The 180 dpi print heads have 500 addressable jets for clear and accurate reproduction of barcodes, company logos and time and date fields directly onto outer case packaging. Print area is 70 x 400mm for each of up to four print heads at a maximum print speed of 33m/min. A central ink management system allows up to four heads to be operated per machine. Ink replacement is by a sealed ink bottle, a clean and simple process with no need to stop the line. T +44 115 9677705
F +44 115 9677706
info@uk.interactivecoding.com

Pharmaceutical electronic records and signatures secure with PrisyMedica

PrisyMedica, the latest software program from MAP80 Systems, has been introduced to help companies in the pharmaceutical and medical fields meet the requirements of 21 CFR Part 11 regarding electronic records and electronic signatures. One requirement of 21 CFR Part 11 is that labelling software needs to store securely a complete record of each label design and its individual version history. There also needs to be a system for the control and use of a two-component electronic signature. Labelling terminals are required to use time elapsing passwords and an electronic signature for each individual print run. Furthermore, the software needs to link an electronic signature with its appropriate record and provide a full production log. Labelling software on its own cannot achieve 21 CFR Part 11 compliance. This is possible only through the use of the correct software in conjunction with appropriate hardware and operating system. At present only Windows NT or Windows 2000 provide a suitable operating environment in terms of security and remote data storage, says MAP80 Systems, and the introduction of PrisyMedica was a natural progression from the launch of Prisym2000. T +44 118 973 1800
F +44 118 973 1900

AstraZeneca first in line for NV2 labelling system

AstraZeneca in Destelbergen in Belgium is the first customer for the NV2 labelling system from UK-based Newman Labelling Systems. It is being used to label an extensive range of pharmaceutical products, packed in various sizes of plastic tubs, glass vials and aluminium aerosols. The machine features a wide range of options, including unlabelled container detection and auto-reject with verification. The installation also includes an Allen hot foil coder and conveyor extensions for infeed and outfeed. We recently transferred our packaging operations from contract packers to our own on-site facility at Destelbergen and required a system that could label a wide variety of container styles and sizes with minimum change parts," said Birk Vanderweeen, AZ production manager. The labeller also needed to be fully validated in compliance with current GMP guidelines." AZ is now understood to have ordered a second machine. T +44 20 8440 0044
F +44 20 8449 2890
sales@newman.co.uk

Coding onto cartons

Thermo Allen Coding recently won an order to supply a vacuum carton coder to Abbott Laboratories, based in Queenborough in the UK, for the printing of variable batch information onto crash-lock cartons. The fully automatic machine was designed for ultra-accurate print positioning at high speeds onto a wide range of flat cartons, cards or wallets. The unit has a maximum output of 180 cartons/minute in sizes from 10x50mm to 400x300mm. As well as standard format product the unit can also handle highly complex shapes. Product is fed via a rapid dispense magazine onto vacuum belts and positioned accurately under the printhead. The simplicity of loading the magazine allows for rapid product changes to be made, the company says, while digital indicators help to achieve repeatable positioning of product on the belts. To meet demanding hygiene standards, the machine is manufactured from stainless steel and anodised aluminium and has sealed bearings throughout. T +44 1707 379500
F +44 1707 320225
allen@thermoallen-coding.co.uk

Pharmaceutical sector seen as a key market for labelling

Labelling products and services company Sato UK has selected the pharmaceutical sector as one of its key markets. Based in Harwich, the company conforms to the Pharmaceutical Supplier Code of Practice and manufactures printed self-adhesive labels, for use both as primary labels – on vials, for example – and as secondary labels for cartons. Many of the labels contain bar codes or pharmacodes. Sato also supplies complete systems for labelling outers, cartons, trays and pallets using a choice of electronic printers, ranging from small stand-alone models to more sophisticated machines that can be integrated into existing production and distribution systems. To supply this sector we have developed a long-standing and close working relationship with pharmaceutical companies," explained marketing manager Dave Webb. We offer 100% checking of all pharmaceutical labels. A supplier has to be totally committed and willing to undergo the rigorous quality and service checks all pharmaceutical businesses will impose." T +44 800 614105
F +44 1255 252840
enquiries@satouk.com