The revised EU guidelines on the readability of the labelling and package leaflet of medicinal products are just one example of the rapidly changing regulatory landscape in which pharmaceutical companies operate. By viewing change differently, companies can become more proactive in their patient messaging.
The revised EU guidelines have had a significant impact on artwork and production departments striving to increase efficiency in a global marketplace. One of the major factors is the type size increase – since 1 Feb 2011 the minimum type size increased to 9 points “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 Labelling, Artwork and Operations Support in 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 about 25%. So, if the point size is enlarged from 6pt to 8pt, the leaflet size may increase by 50%.
This has further implications as cartons may need to increase in size to accommodate the 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, including technology are required, like prefolded leaflets, out serts, etc. 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 Dr. Schaper studied leaflet trends between 2000 and 2009, she discovered there was also an increase in the amount of information required due to other national legislation and pharmacovigilance procedures. By 2009 the leaflet increased to 157% of its original text size in 2000. The changes were incremental, with the number of artwork updates required dependent 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 like 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 impacts on the entire supply chain. By developing strategies to deal with future changes as well as current ones (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.
The revised EU guidelines also require clear separation of languages for multi-lingual 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 taken on country groupings (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.
An effective change management strategy is crucial in this rapidly changing regulatory environment. End to end visibility of changes, 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 flexible processes, which are supported by workflow tracking and documentation, these 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 seeing the bigger picture of productivity and efficiency. For example, networking teams at regional, local and plant level with a focus on precise and timely communication with clearly defined roles and responsibilities are all crucial factors in managing change effectively.
The revised EU readability guidelines provide an opportunity to re-think patient leaflets. Rather than just making small adjustments to conform to revised regulations, you can achieve additional aims.
A Pfizer project together with patient organisations in Germany was initiated in 2006 and focussed on the design of PILs and aimed to improve patient understanding and compliance with medication use. Dr. Beate Schaper reported on the seven key factors in making the PIL more patient-friendly.
- Readable font – aspects included font size, font type and weight of paper
- Comprehensible language – well written and fluent text that assumed no existing medical knowledge and written in short sentences
- Clear information about the disease and action of drug including the benefits of compliant use
- Structured layout – including an index and consistent layout so the patient knows where to find the 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 defined parameters for PILs, not only has the potential to improve compliance with medication use and a better patient experience, it also has the potential to streamline the artwork management process while aiding regulatory compliance.
Forward-thinking pharmaceutical companies are now turning to template-driven Automated Artwork Generation Solutions. They enable the efficient 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, etc. 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 just involves creating a new dynamic template to the required design (for example with larger font sizes, high contrast text, etc.) then pulling the content directly from the master database, ensuring consistency and compliance.
Some countries (such as UK, Sweden and Germany) now have internet portals which provide leaflets in formats for partially-sighted patients and blind people. These are accessible to the public or patient organisations. Also in the UK, the Royal National Institute for 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, there is a Leaflet Line which enables patients to listen to the content of a PIL over the phone.
When content in different languages is added to the mix, it results in another layer of complexity. Working out 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 leveraged 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
By streamlining their artwork management and production processes, pharmaceutical companies can also gain greater control. It gives them the opportunity to re-think how their 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) then they 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 are 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 is a real possibility. It could be provided at different levels, tailoring it 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 digital/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.