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Pharmaceutical Manufacturing and Packing Sourcer

On the Same Page


Is it time to re-think patient information leaflets? Considerations for readability guidelines are encouraging labelling companies to revise their approach to the way essential information is presented to product users. The revised EU guidelines on the readability of labelling and package leaflets for medicinal products are just one example of the rapidly changing regulatory landscape in which pharmaceutical companies operate (1). By viewing change in a different light, companies can become more proactive in their patient messaging.

The guidelines have had a significant impact on artwork and production departments striving to increase efficiency in a global marketplace. One major factor is the type size increase – since 1st February 2011, the minimum type size increased to 9pt “as measured in font Times New Roman, which should not be narrowed and should have a space between lines of at least 3mm.” Dr Beate Schaper from the Labelling, Artwork and Operations Support department of Pfizer Pharma, Germany, researched evolving trends in patient information and legislation. She measured the effects of the type size increase and a practical exercise proved that for each point size increase, the patient information leaflet (PIL) grows by about 25 per cent. So, if the point size is enlarged from 6pt to 8pt, the leaflet size may increase by 50 per cent.

This has further implications, as cartons may need to increase in size to accommodate bigger leaflets, and extra stabilising materials may be required. In addition, inserting machines may not be able to cope with larger leaflets or operate within the new parameters. Therefore special solutions are required, such as prefolded leaflets, out-serts and so on. Also, larger pack sizes and increased materials require more pallet space and lead to higher costs for transportation and warehousing. The effects are felt throughout the supply chain.

Increased Information Requirements

When Schaper studied leaflet trends between 2000 and 2009, she discovered that there was also an increase in the amount of information required due to national legislation and pharmacovigilance procedures. By 2009, the leaflet increased to 157 per cent of its original text size in 2000. The changes were incremental, with the number of artwork updates required depending on the type of product. For example, centralised, authorised products covering new active substances required more than two artwork updates a year on average, whereas well-established medical substances, such as generic products, averaged less than one artwork update a year.

Managing these changes efficiently and accurately is key to the effective running of the packaging operations department and affects the entire supply chain. By developing strategies to deal with future as well as current changes (such as anticipating additional space requirements), operations managers can gain a greater degree of control over the process, rather than continuously reacting to imposed change.

EU guidelines now also require clear separation of languages for multilingual PILs. Using separate PILs for each language or reducing the number of languages per PIL can overcome this. However, there are then decisions to be made on country groupings (as small countries may require smaller batch sizes), hand or machine packaging and batching of variations. Agreeing a regulatory strategy in advance and tightening up production processes can give businesses greater control and pay dividends later.

Change Management

An effective change management strategy is crucial in this rapidly evolving regulatory environment. End-to-end visibility of changes and the ability to take a snapshot at any point, as well as see a clear overview of the entire labelling artwork process, all contribute to better change management. Combined with simple, standardised but fl exible processes, which are supported by workfl ow tracking and documentation, this approach can remove some of the headaches caused by new regulations.

The combination of micromanagement and high-level coordination ensure that attention to detail is maintained, while being aware of the bigger picture of productivity and effi ciency. For example, networking teams at regional, local and plant levels with a focus on precise and timely communication, and clearly defined roles and responsibilities, are all crucial factors in the effective management of change.

The revised EU readability guidelines provide an opportunity to re-think patient leafl ets. Rather than just making small adjustments to conform to revised regulations, additional aims can be achieved.

Patient-Friendly PILs

A Pfizer project, initiated in 2006 in collaboration with patient organisations in Germany, focused on the design of PILs and aimed to improve patient understanding and compliance with medication use. Schaper reported on the seven key factors that would make the PIL more patient-friendly, which included:

  • Readable font – aspects included font size, font type and weight of paper
  • Comprehensible language – well written and fl uent text that assumed no existing medical knowledge and was written in short sentences
  • Clear information about the disease and action of drug, including the benefi ts of compliant use
  • Structured layout – including an index and consistent layout so the patient can navigate information, spaces between paragraphs, colourful and high contrast layout
  • Use of pictograms and photos to enhance visual awareness
  • Use of information boxes to guide the patient to important sections, tips and application methods
  • Listing patient organisations or other support groups help to reduce the isolation caused by the disease.

Streamlining the Artwork Management Process

Using clearly defi ned parameters for PILs not only has the potential to improve compliance with medication use and a better patient experience; it could also streamline the artwork management process while aiding regulatory compliance.

Forward-thinking pharmaceutical companies are now turning to templatedriven automated artwork generation solutions, which enable the effi cient management of messaging, translations and artwork generation to ensure brand consistency and compliance. Dynamic, rule-based templates are set up to meet all the design criteria – such as layout structure, font sizes, colours, branding and regulatory information. These templates are then automatically populated with content from a central database (or asset repository), which includes product descriptions, images, brand logos, regulatory statements, warnings, and so on. The templates are then used to automatically generate print-ready artwork for labelling and packaging materials.

Requirements for Different Patient Groups

Once PILs and packaging materials have been developed for general use, they can be adapted for specific patient groups (such as partially-sighted patients). Using a template-based artwork generation solution, this is a straightforward process. It simply involves creating a new dynamic template to the required design (for example with larger font sizes, high contrast text, and so on), then pulling the content directly from the master database, ensuring consistency and compliance.

Some countries (such as the UK, Sweden and Germany) now have internet portals which provide leaflets in formats for people who are partiallysighted and blind. These are accessible to the public or patient organisations. In the UK, the Royal National Institute of Blind People (RNIB) has a medical leaflet line which patients can call to request PILs in large/clear print, Braille or on audio CD. In addition, patients are able to listen to the content of a PIL over the phone.

Managing Translations

When content in different languages is added to the mix, it results in a further layer of complexity. Deciding on different combinations of languages to be grouped together on a PIL or package can be a time-consuming and costly process, adding unwanted and  unnecessary delays. This is another opportunity for template-based artwork generation solutions to prove their worth. Approved content in any language can be easily obtained from the master database and fed directly into the artwork templates. It is then easy to determine how the text will fit and if the ideal language combinations will actually work.

Gaining Greater Control

Streamlining artwork management and production processes can give pharmaceutical companies greater control. They also gain the opportunity to re-think how product information is displayed and interpreted – and to enhance understanding and compliance from the patient. By planning ahead and anticipating further changes (as far as possible), companies can save themselves headaches in the future.


Being one step ahead of the regulators may seem a radical approach for the risk-averse pharmaceutical industry, but by introducing innovative technology that can manage the entire labelling and packaging process, providing transparency and efficiency, regulatory changes can be managed with ease.

By moving from document management to structured content management – where fragments of content and individual elements form the master database – pharmaceutical companies become agile and empowered to adapt to any changes, whether self-initiated or imposed by regulators.

Once these steps are in place, providing patient information in other formats becomes a real possibility. PILs could be provided at different levels, tailoring them more closely to the patient’s needs, or separating patient and physician information. Other delivery methods could be considered, such as print on demand by pharmacies or by electronic transfer. Of course, there will be new regulations to ensure that the patient receives their information, but making it more accessible will be advantageous to both the patient and the manufacturer. New technologies enable pharmaceutical companies to view change positively, rather than as a costly burden.

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Neil Gleghorn is CEO of Kallik, artwork management solution provider for the packaging sector. Before establishing Kallik in 2001, Neil spent his career working in the printing, design and related software industry. His experience spans a wide range of roles within the sector, giving him the foresight to deliver software solutions that drive efficiencies right across the artwork management process.
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