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U s e r - f r i e n d l y p h a r m a c e u t i c a l p a c k a g e s : e a s y - t o - o p e n, e a s y - t o - r e a d Raija-Liisa Heiniö Senior Scientist, PhD VTT Technical Research Centre of Finland P.O. Box 1000 (Tietotie 2, Espoo) 02044 VTT, Finland raija-liisa.heinio@vtt.fi Tiivistelmä: K ä y t t ä j ä y s t ä v ä l l i s e t lääkepa k ka u k s e t: helppoja avata ja lu k e a Hyvin suunniteltu lääkepakkaus parantaa potilas- ja työskentelyturvallisuutta, mutta huonosti suunniteltu lääkepakkaus saattaa koitua kohtalokkaaksi potilaalle. Erityisesti vanhemmille, usein sairaille henkilöille on tärkeää, että pakkaus on suunniteltu siten, että se on helppo avata, lääke on helppo annostella ja käyttöohjeet ovat helposti luettavissa. Pakkaussuunnittelun tulee perustua tuotteen käyttäjän tarpeisiin. Pahimmassa tapauksessa potilas tai terveydenhoitaja valitsee erehdyksessä väärän lääkkeen, annostelee sen väärin tai ei saa pakkausta lainkaan auki. VTT:n koordinoimassa Helppokäyttöinen lääkepakkaus (HELP) -projektissa lääkepakkausten useiden erityyppisten avausmekanismien käytettävyyttä ja toimivuutta tutkittiin potilailla ja terveydenhoitohenkilökunnalla. Tutkimuksessa ideoitiin myös käyttäjäystävällisiä lääkepakkauksia. Lisäksi hankkeessa kehitettiin tutkimusmenetelmät pakkausten helpon avattavuuden ja pakkausten ja pakkausselosteiden helpon luettavuuden määrittämiseksi. Nämä helppo avata - ja helppo lukea -menetelmät ovat nyt teollisuuden käytettävissä niin lääkepakkausten tuotekehityksessä kuin lääkepakkausten käytettävyyden arvioinnissakin. Tämän artikkelin tarkoituksena on kuvata VTT:llä kehitettyjä lääkepakkausten käytettävyyden avattavuuden ja luettavuuden tutkimiseen soveltuvia testimenetelmiä. Lääkkeiden helppokäyttöisyys auttaa estämään virheiden syntymistä lääkityksessä ja parantaa potilasturvallisuutta. Avainsanat: pakkaus, avattavuus, luettavuus, käytettävyys Key words: package, openability, readability, usability Introduction: Are pharmaceutical packages designed for patients and other users? Safety aspects of pharmaceutical packages are regulated by the European Union (Directive 2001/ 83/EC, Regulation (EC) No 726/2004), including packaging and labelling of pharmaceuticals, and the content and structure of the package leaflet. However, challenges for consumers with functional limitations, such as reduced hand function and vision, as well as for all of us arise how to open the package easily, and how to see all instructions written with small font on several languages on the package or package leaflet. Thus, there existed a real need to study the current state of the usability of pharmaceutical packages, and to develop methods for evaluating that. Only the pharmaceuticals used can heal. It is a necessity both for consumers and health - 97 - D O S I S V O L. 3 0 n : o 2 / 2 0 1 4

a b Fig. 1. a. Pharmaceutical packages must be easy to open and the given instructions must be easy to read. 1. b. Medicine packaging concepts design at Lahti Institute of Design by students (from above and left to right) Antti Ojala, Hokkanen, Anna Engblom, and (from below left to right) Esko Pyyluoma, August Salo, Anu Nokua and Joona Louhi. care workers to be able to easily open the pharmaceutical packages and to be able to read and understand the given instructions (Banfi et al. 2005) (Fig. 1). Many people suffer from chronic conditions and diseases resulting in, e.g., poor grip and pinch strength, reduced joint range of motion and poor vision. After the age of 50, a majority of men and women also suffer from presbyopia, and consequently have difficulties in reading small text. Little by little middle-aged and older consumers and workers become disabled with respect to daily activities and also in the use of pharmaceutical packages (Raivio 2009). By the design and ergonomics of medication rooms error reduction and performance improvement in medication preparation can be reached (Straucher et al. 2005). Easy to use packages are a great competitive advantage for a pharmaceutical company, if their packages are easy and safe to use and if the risk for mistakes in medication is minimal (Anselmi 2005). Standardisation work and research around easiness to open and read packages Several tests to evaluate the easiness of opening packages have been developed in Europe and worldwide (Antvorskov et al. 2008, Heiniö et al. 2008, European Committee for Standardization CEN 2011). However, the procedures vary, making the standardisation work challenging both in Europe (European Committee for Standardization, CEN) and internationally (International Organization for Standardization, ISO). It is a clear necessity to screen the suitability of the different test methods measuring the easiness to open packages, and in that way to make it easier to choose the proper test method. Challenges to open easily a package raise from its opening mechanism s properties (e.g., visibility, clarity, taking and keeping the grip, need of strength) and the package itself (e.g., keeping the grip, breaking down). As an information provider the package is very practical because it brings the information near to the end-user. However, the information will not reach the user if the instructions are impossible to read or understand. Readable text is a prerequisite for understanding. It is essential to differentiate between findability (text can be detected), readability (text can be read), and understanding (content of text can be understood, comprehension). Prerequisites for comprehension are findability and readable text (Rusko et al. 2012). Keeping this interdependency in mind, it becomes clear that in order to achieve understandable text, it is worthwhile to investigate readability. This study focused on developing test methods for evaluating the readability. Comprehension of information has been widely studied by van der Waarde (van D O S I S V O L. 3 0 n : o 2 / 2 0 1 4-98 -

der Waarde 2008). The size and readability of the text are remarkable factors, and they most probably cause everyday challenges to the users, especially among elderly people. This is valid also to the opening instructions. The problems in reading may be caused by several factors: e.g., because of the chosen font type and size, colour contrasts, amount of information and intelligibility of the text (Rusko et al. 2012). VTT has a long experience both in developing test methods to assess the easiness to open packages and to evaluate the easiness to read text (Kiesvaara and Kivikataja 1988, Rusko 2003). In the Nordic Easyopenpack Project (Scientific background for the basis of an international standard for easy-to-open packages) financed by NICe (Nordic Innovation Center, Report No. NT614) critical factors influencing the easiness to open packages were determined. The laddering technique commonly used in consumer tests was used in generating the sensory attributes for testing the easiness to open packages. The descriptive profiling method for evaluating the easiness to open packages established in the Easyopenpack Project was developed further by VTT. The method was validated, the sensory panel trained, and the criteria for the sensory attributes were set. The Finnish Rheumatism Association grants the Easy to open label for packages based on this validated sensory profiling method (VTT-5631-09). Some food and pharmaceutical packages have already got the Easy to open label. The descriptive profiling method is suitable also for product development while designing novel, easy to open packages. The HELP Project (Easy to Use Pharmaceutical Packaging 2010 2013; the acronym is based on Project s Finnish title) involved developing testing methods to facilitate packaging design, and comparing different types of pharmaceutical packaging. The objectives of the research project were to define what makes a pharmaceutical package easy to open and what makes the instructions easy to read. In the HELP project the most critical factors for consumers and health care workers in using of pharmaceutical packages were systematically screened, and packaging design and prototyping were conducted as student works. Foremost, tools to produce user-friendly pharmaceutical packages that are easy to open with easy to read instructions were developed. The results of the research aim to help companies to design user-friendly pharmaceutical packages, and to guide the standardisation work of userfriendly packages for its part. The background for this research was formerly introduced in Dosis (Heiniö 2011). The project was implemented jointly by VTT, the Gerontology Research Centre of the University of Jyväskylä, and the Finnish Institute of Occupational Health. The students of the Institute of Design and Fine Arts at Lahti University of Applied Sciences generated novel, easy-to-open design solutions for pharmaceutical packaging. Other participants in the project included two pharmaceutical companies, Santen Oy and Abbvie Oy, and the graphical industry player Jaakkoo-Taara Oy. The three advisors of the HELP project were from Pharma Industry Finland, the Finnish Rheumatism Association, and the Association of Packaging Technology and Research. The project was funded by the Finnish Funding Agency for Technology and Innovation Tekes. This article focuses describing the development of test methods for evaluating the easiness to open pharmaceutical packages and easiness to read the information on packages and leaflets. The methods are based on sensory assessment. Descriptions of the easy-to-open and easy-to read test methods developed in the HELP project are given in the following chapters. Openability of pharmaceutical packaging: test methods There are no official requirements or legislation for assessing the easiness to open pharmaceutical packages or packages in general. However, the technical specification of European Committee for Standardization CEN/TS 15945:2011 determines criteria and suggestion of test methods for evaluating the easiness of opening consumer packaging, but it is only a recommendation. The sensory easy-to-open method developed by VTT is mentioned in this CEN specification. The general test method for studying the openability of packages was developed in an earlier Nordic Easyopenpack project (Heiniö et al. 2008). This method was applied in the current research project for testing the openability of pharmaceutical packages. Easy-to-open test method (VTT-5631-09) (Heiniö and Ström 2009, Heiniö et al. 2010, Heiniö 2011) is intended for studying the easiness to - 99 - D O S I S V O L. 3 0 n : o 2 / 2 0 1 4

open packages with various types of opening mechanisms (Table 1). The sensory test method was developed by first applying the laddering technique where elderly consumers described easy and difficult factors in opening packages. The sensory profile of the most critical opening attributes was generated based on this consumer study. The trained sensory panel evaluated the openability of eight model packages by using the developed descriptive profiling. Finally, the acceptance criteria for each sensory attribute were set by rheumatic consumers who evaluated the openability of the same model packages. In the end, the test method was validated aiming to show its reliability (Heiniö 2009). In the method a trained sensory expert panel evaluates the easiness to open the sample packages in two replicate sessions. The trained panel (n = 10) assesses by visual and tactile evaluation the intensities of the sensory attributes of the descriptive profile by using a linear intensity scale of 0 10 anchored in both ends. The package samples are served to the assessors coded and in random order. Easiness to open the packages is described also verbally. For easy opening the scores must be over 8 for all attributes, except for strength needed to open the package, for which the limit is 3 or below on the scale 0 10. A package fails, if one of the criteria is under the specified limit. In opening a package the most critical factors for the opening mechanism are visibility, getting and keeping the grip from the opening mechanism, clarity of the opening manner, strength needed to open the package and breakage of the opening mechanism. Important factors for openability are also keeping the grip from the package, breakage of the package and product staying inside the package after opening. Readability of pharmaceutical packaging: test methods Table 1. The descriptors used in the easy-toopen sensory profiling method (VTT-5631-09) Opening mechanism 1 Visibility of the opening mechanism 2 Clarity of the opening manner 3 Getting the grip from the opening mechanism 4 Keeping the grip from the opening mechanism 5 Strength needed to open the package 6 Breakage of the opening mechanism Package 7 Keeping the grip from the package 8 Breakage of the package 9 Product staying inside the package after opening Overall assessment 10 Easiness to open the package The visual design of packaging and package leaflet are guided and controlled by European Union (EU) guidelines (Directive 2001/83/EC, European Commission, 2009: Guideline on the readability of the labelling and packaging leaflet of medicinal products for human use). It determines strictly about the readability of the packaging and package leaflet of medicinal products. EU guidelines does not necessitate that the intended use of a self-care/non-prescription pharmaceutical product is labelled on the package but only on the package leaflet. In Finland Finnish Medicines Agency FIMEA necessitates that the intended use of a self-care/non-prescription pharmaceutical product is labelled on the package, but the intended use of a prescription medi cine shall not be printed on the package (Finnish Medicines Agency 2013). In addition to these guidelines, the technical report of CEN (CEN/TR 15753:2008) gives information about package leaflets for medicinal products. The quality of package leaflets in EU has been studied particularly by Raynor s research group at the University of Leeds, UK (Brooke et al. 2013, Raynor 2013, Hamrosi et al. 2014). D O S I S V O L. 3 0 n : o 2 / 2 0 1 4-100 -

For evaluating the visual design of information, it is essential to differentiate findability, readability, understanding and application (Näsänen 2007, van der Waarde 2008). Information needs to be found first and visually interpreted after that. If a text can be read, it is readable for the reader but this does not mean that the information is understood (van der Waarde 2008, Rusko et al. 2012). Findability (text can be detected) and readability (text can be read) of the text are prerequisites for understanding (content of text can be understood) and comprehension of the message (van der Waarde 2008). This interdependency verifies that in order to achieve understandable text, it is worthwhile to investigate readability. In the HELP project research on the readability of pharmaceutical packages included literature reviews, technical measurements, international cooperation and development of a readability test (Heiniö et al. 2013). Easy-to-read test method was developed in the HELP project in a corresponding way as the easy-to-open test method (Heiniö et al. 2013). The method is intended for studying the easiness to read the information on pharmaceutical packages or package leaflets. Also this test method is validated (Heiniö et al. 2013). In the easy-toread method the trained sensory expert panel evaluates the easiness to read the information on the sample packages or package leaflets in two replicate sessions. The trained panel (n = 10) assesses by visual evaluation the intensities of the sensory attributes of the descriptive profile by using a linear intensity scale of 0 10 anchored in both ends (Table 2). The package/ leaflet samples are served to the assessors coded and in a random order. Easiness to read the information on the samples is described also verbally. For easy to read the scores must be 7 or above for all package attributes. For all package leaflet attributes the scores must be 8 or above, except for font size, text compactness and transparency of paper, for which the limit is 7 or above on the scale 0 10. A package/leaflet fails, if one of the criteria does not reach the specified limit. Concerning the readability, font size and type, layout the text, including text separation, compactness and visibility of essential information and best before date, contrast, language differentiation, clarity of pictures and symbols, reflectivity of the surface material of the Table 2. The descriptors used in the easy-to-read sensory profiling method for pharmaceutical packages Typeface 1 Type size 2 Clarity of the typeface (font type) Layout of the text 3 Text separation 4 Compactness of text 5 Visibility of essential information 6 Visibility of the best before date Colours 7 Contrast between the text and the background Language 8 Differentiating languages Pictures and symbols 9 Clarity of the pictures and symbols Packaging material 10 Reflectivity of the surface material Overall assessment 11 Easiness to read The descriptors used in the easy-to-read sensory profiling method for package leaflets Typeface 1 Type size 2 Clarity of the font type/ typeface Layout of the text 3 Text separation 4 Column width 5 Compactness of text 6 Visibility of essential information Colours 7 Contrast between the text and the background Language 8 Differentiating languages Pictures and symbols 9 Clarity of the pictures and symbols Leaflet 10 Shape of the leaflet 11 Transparency of the leaflet Overall assessment 12 Easiness to read - 101 - D O S I S V O L. 3 0 n : o 2 / 2 0 1 4

package. For the leaflet column width, and shape and transparency of the leaflet are also crucial for the easiness to read the information. Technical measurements on readability: test methods The development of the readability test method included also technical measurements of sample packages and leaflets (Heiniö et al. 2013). These measurements covered variables related to type size, text layout, contrast, print though (for leaflets) and gloss (for packages). If measured contrast between the font and the background is large enough, contrast does not affect reading. If contrast is too small evaluated easiness of reading is strongly disturbed. In addition to these above mentioned parameters, new parameters were introduced: information coverage analysis, text transfer analysis and text information density analysis. The results of the technical measurements showed that also the amount and content of the text should be optimised. A case study: Openability and readability of packages for painkillers Openability of packages, readability of information on packages/package leaflets and their technical measurements were studied from eight commonly used painkiller pharmaceuticals in Finland (Heiniö et al. 2013). The sample packages from different manufacturers were blister plates packed to a carton box. Readability of packages and package leaflets were evaluated by the sensory panel. In technical measurements the measured variables were font height, font width and distances between letters, words and lines. In the packaging analysis it was found that font size evaluated in sensory profiling was related to measured font x-height (Heiniö et al. 2013). In the package leaflet analysis it was found that sensory font size was related to measured font x-height, sensory compactness of text was related to measured distance between lines, and sensory easiness of reading was related to measured font x-height. Font clarity, text compactness, and language and text separation were the most important sensory attributes, and font width and font line weight the key technical factors related to the easiness to read the text. Font clarity, text compactness, contrast, column width, font size and language and text separation were the most important sensory attributes, and font line, font width, distance of lines and letters the key technical factors related to easiness to read the text on the leaflets. Conclusions In the HELP project the usability of package opening mechanisms was examined, and solutions to support their improvement in opening and readability of user instructions for package were developed. The research was focused on studying what makes a pharmaceutical package easy to open and what makes the instructions easy to read. The openability studies of the packages and the readability studies of the packages and package leaflets were performed by the trained sensory panel. The evaluation panel of the Finnish Rheumatism Association recognizes the label easy-to-open for packages based on the validated sensory profiling method (VTT-5631-09) (Suomen Reumaliiton ETU-projekti) (Fig. 2). Negotiations on offering the easy-to-read test method as a service are on-going. Figure 2. The evaluation panel of the Finnish Rheumatism Association recognises the label easy-to-open for packages based on the validated sensory profiling method (VTT-5631-09). D O S I S V O L. 3 0 n : o 2 / 2 0 1 4-102 -

An easy opening of a pharmaceutical packaging can be achieved through, e.g., a simple opening mechanism, by getting a good grip from the package, and by using minimal force in opening. For easy readability font clarity, text compactness and language, and text separation clarity are the most critical features. For the leaflet column width, leaflet shape and transparency are also crucial for the easiness to read the information. The results of the technical measurements showed that the amount and content of the text are not well balanced in pharmaceutical packages. The text is often placed on a rather small area and the package surface is not optimally utilised. Thus, the area of the text and package surface should be optimised. When designing packaging graphics, measured values can be used as designing tools for visual quality and even predicting the final easiness of reading. The easy-to-open and easy-to-read test methods developed at VTT show the critical factors in opening of packages and reading the instructions on pharmaceutical packages. They help in developing and designing packages with enhanced usability, and thus, may bring competitive advantage to commercial package solutions. The organisations participated in the HELP Project hope that the drafting of EU legislation would be developed by taking better into account the user needs in regulations concerning markings on pharmaceutical packaging and their openability. New methods combined with user-oriented packaging design are major steps towards user-friendlier and safer pharmaceutical packaging. Summary Well-designed pharmaceutical packaging improves patient and work safety, but poorly designed pharmaceutical packaging can be fatal to the patient. Especially for elderly people, often weakened by an illness, it is important that the packaging is designed in a way that makes it easy to open, easy to administer the drug, and easy to read the user instructions. Packaging design must be based on the needs of product users. In a worst case, the patient or nurse selects a wrong drug, administers the drug incorrectly, or cannot open the packaging at all. In Easy-To-Use Pharmaceutical Packaging (HELP) Project, coordinated by VTT Technical Research Centre of Finland (VTT), the usability and functionality of various package opening mechanisms were studied by patients and health-care workers, and novel ideas for user-friendly pharmaceutical packages were designed. Furthermore, test methods for evaluating the easiness to open the packaging and easiness to read the instructions were developed. These easy-to-open and easy-to-read test methods are now available to be used in package design development and in evaluating the usability of packages for industrial purposes. The aim of this paper was to describe the test methods suitable for studying the usability openability and readability of pharmaceutical packages. The test methods were developed at VTT. Easy usability of pharmaceuticals aids in preventing errors in medication and improving patient safety. Key words: package, package leaflet, openability, readability, usability Raija-Liisa Heiniö Senior Scientist, PhD VTT Technical Research Centre of Finland - 103 - D O S I S V O L. 3 0 n : o 2 / 2 0 1 4

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