Research database

This Research Database has been developed by HCPC Europe to create an overview of the available research in the field of patient-friendly and adherence packaging. The database is for all members of HCPC Europe. Members can register as a user to get access to the database. Is your organisation not a member yet? Then please register your organisation as a member or contact our Executive Director Ger Standhardt for more information.


Verpackungstechnologische Einflussfaktoren auf leichtes Öffnen und sichere Handhabung von Verbraucherverpackungen

Die vorliegende Arbeit soll sich hauptsächlich mit den Einflüssen der Verpackungsgestaltung auf die erforderliche Öffnungskraft, möglichen weiteren Faktoren wie Motorik und Kognition und die daraus resultierende Verbraucherzufriedenheit beschäftigen. Daraus soll die Bedeutung dieser Einflussfaktoren erstmals in einer der Lebenswirklichkeit von Verbrauchern angelehnten Situation für das Verständnis der Verpackungskonzeption ermittelt werden. Die Kenntnis der Zusammenhänge im Vergleich mit instrumentellen Untersuchungsmethoden eröffnet die Möglichkeit, mit Hilfe der erhaltenen Daten leichtes Öffnen und sichere Handhabung gezielt hinsichtlich bestimmter Merkmale planbar vorherzusagen und zu optimieren.

From the English summary that starts on page 118:
The studies comprise examination of various commercial packages based on target group testing according to CEN/TS 15945. The choice of packages based on the priorities of the BAGSO studies and suspected barriers during opening. The results of the test steps effectiveness and efficiency of the opening procedure and the evaluation of consumers’ satisfaction with the opening procedure  were decisive for the assessment as easy-to-open package. The tests took place under standardized conditions, which were modelled on the situation at domestic kitchen tables. The target group  comprised random samples of people who represent a wide range of life experiences and life situations. With participant’s approval hand movements during opening procedures were documented using videotapes in order to understand and recognize patterns. Instrumental measurements of selected packaging types acted as reference to investigate the required opening force and to detect a possible correlation with the results of the target group testing. The comparison of both methods showed that the required opening force or the applicable force to the packages correlated not primarily with the results of target group tests, they had only minor importance for the consumers ́ satisfaction with the opening procedure. A study of blister packages led to a surprising result: the packages affording greater applied force when opened were evaluated significantly better in target group study than a n equivalent package, which needed less opening force. Similar packages, which required the same maximum force to open, have been rated significantly different in target group testing.


Usability of tabs in semi-rigid packaging

The ability to easily peel the lid of a container is a critical issue for semi-rigid packages used to protect and deliver a myriad of products including medical devices, foods, and beverages. An in-depth search of the scientific literature revealed very little information and several gaps about the fundamentals of peelable semi-rigid packaging opening. Therefore this research had the following objectives: (i) to perform a thorough literature review on packaging usability with special focus on semi-rigid packaging, (ii) to describe the relationship between peel angle and peel force, (iii) to evaluate peel direction during real package opening, and (iv) to evaluate the relationship between tab size and grip choice. A wide range of research methods were used to achieve these objectives including kinetics (the study of forces), kinematics (the study of motions), anthropometrics, computer simulations, package testing, and observational techniques.First, a theoretical framework for human-package interactions (H-PIM) was created and used to assess the gaps in the research literature relating to packaging usability studies. Second, an affordance-based design method was created and illustrated with a packaging example with tabs. Third, experimental peel force measurements for two seal geometries were collected varying peel angle every 15° intervals. Experimental data (force vs. angle) for both conditions followed a U-shaped pattern with minimum values at peel angle 45°. Classical mechanics was then used to derive an equation in which peel force is a function of peel angle. Two approaches were taken to fit the data to this equation: linearization and nonlinear regression. Fourth, a method was developed to calculate seal strength for a given semi-rigid packaging system and a mathematical algorithm was designed to calculate peel forces. Results show that the proposed mathematical model for peeling semi-rigid packaging can predict experimental values very well.Fifth, a motion capture system was used to measure peel angles (α) and peel direction angles (β) during an opening task under two experimental setups (i.e., unrestrained and restrained). Mean peel angle measurements fell within the theoretical optimal peel angle range (α=45°±15°). The initial peel direction angle measured during the unrestrained opening condition (βi=48°) approximated the theoretical angle of β=45° confirming that most participants pulled the tab in this direction during the initial stages of the opening task. Finally, an observational study revealed grip preferences based on tab size. For initial grip of larger tabs, participants tended to use lateral pinch more than pulp pinch or chuck pinch. During pulling, lateral grip was preferred by participants regardless of tab size. Participants’ postural preferences were found to be correlated with ways of opening a specific tray design. This research provides theoretical frameworks, mathematical models, methodologies, and findings that help the design and development of more usable peelable semi-rigid packaging. Many of the conclusions and design guidelines also apply to flexible packaging.

 


The pursuit of user-friendly medicines: older people in the hot seat

This thesis addresses the user-friendliness of medicines. Using medicines is a complex process during which many difficulties can be experienced, for instance with the opening of packaging, the breakability of tablets or the administration of eye drops. Such practical problems can lead to incorrect use of medicines and consequently into deterioration of medical conditions or to adverse effects ranging from bothersome complaints to serious reactions including disability or (re)admissions to hospital. We took the usability of medicines for older people as a starting point for our studies. Aging comes with an increased prevalence of functional decline, e.g. with regard to decreased vision, hearing, manual dexterity and hand-grip strength. Consequently, aging can affect patients’ ability to adequately use medicines. Besides, older people are the largest user group of medicines. Taking the capabilities of the aging population into account during the development of medicines will help older people to use their medicines independently. First, we investigated the practical problems that older people experience with the daily use of their medication through telephone questionnaires and interviews. These two studies provide insight in the variety of problems that older people may experience with the use of their medicines and their strategies to overcome the usability issues. In addition, the potential clinical consequences of the problems and solutions were determined. We then focussed on the suitability of the design of medicines for use by older people. We investigated the design features of medicines that caused the previously identified use problems among older patients, and the functionality of the score mark on tablets for dividing tablets in equal doses. At last, approaches to prevent usability problems with medicines are explored. This includes overcoming problems with the swallowing of tablets and with the subdivision of tablets. In addition, it was investigated to what extent pharmacy technicians identify problems with opening medicine packaging and how they assist patients in resolving these problems. This thesis demonstrates that the user-friendliness of medicines can be approved significantly. This requires a multifaceted approach; not only medicine developers can contribute to the better use of medicines, also regulatory agencies, health care providers, health insurers and patients themselves should be committed to contribute to this. We recommend that medicines developers evaluate the usability of medicines for the intended user population during product development. Concomitantly, we advise regulators to encourage medicine developers to conduct usability studies and assess the outcomes of such studies as part of the marketing authorisation application. In addition, collecting and sharing post-marketing reports on usability problems with medicines could significantly contribute to the prevention of similar problems with other products. As patients are not forthcoming about problems with the use of their medicines, health care providers should encourage patients to report their usability problems and address these problems as part of counselling. Health care insurance companies can play a role in preventing usability problems with medicines by taking the usability of a medicine into account when selecting preferred suppliers.


Toward inclusive pharmaceutical packaging: An innovation and design process perspective

Pharmaceutical packaging has an increasing importance in aging societies, where
people depend on medicines for their own care and well-being. Previous research shows that pharmaceutical packaging is a source of uncertainties, confusion, and daily struggles. The challenges experienced by users are extensive; the pharmaceutical industry needs to respond with packaging innovation. To address these complex challenges, more research is necessary on packaging that fulfills user needs and capabilities. This research purpose is to investigate innovation and design processes for pharmaceutical packaging, as well as to stimulate the uptake of inclusive design toward pharmaceutical packaging that meets society’s needs.


Toward inclusive pharmaceutical packaging: An innovation and design process perspective

Pharmaceutical packaging has an increasing importance in aging societies, where people depend on medicines for their own care and well-being. Previous research shows that pharmaceutical packaging is a source of uncertainties, confusion, and daily struggles. The challenges experienced by users are extensive; the pharmaceutical industry needs to respond with packaging innovation. To address these complex challenges, more research is necessary on packaging that fulfills user needs and capabilities.

This research purpose is to investigate innovation and design processes for pharmaceutical packaging, as well as to stimulate the uptake of inclusive design toward pharmaceutical packaging that meets society’s needs. The research is interdisciplinary with a qualitative, explorative approach based on three studies and five appended papers.

The first study explored state-of-art pharmaceutical packaging use by older patients. Physical constraints regarding packaging design features and the need to support medication management were identified. Subsequent studies were based on empirical investigations.

The second study investigated packaging innovation drivers based on a customer-supplier relationship case study of a brand-owner drug manufacturer, and a packaging supplier.

The third study expanded those findings, through an interview study with stakeholders (top management, mid-management, and specialists) with experience in pharmaceutical packaging innovation and design processes. As argued and shown in the empirical investigations, pharmaceutical packaging innovation is mainly driven by technology and legislation which reinforce standard and incremental packaging design. Furthermore, there are multiple stakeholders’ needs to be balanced.

Findings in this research suggest that if packaging design is to be user-centered and inclusive, stakeholders should be actively involved to broaden the spectrum of driving forces that lead packaging innovation and open up new business opportunities. The empirical studies also revealed different levels and modes of user involvement in pharmaceutical packaging design.

Overall, the research expands the rather technological focus of packaging toward the exploration of industry processes, opening the way for further studies on inclusive design and social aspects of pharmaceutical packaging innovation and design, being the collaboration and involvement of users in these processes also of great interest. Packaging practitioners can benefit from the results obtained to benchmark their own processes. Policy makers and health care providers can reflect about the dilemmas of innovating pharmaceutical packaging that is inclusive and user-centered, and can use the empirical evidence from this research to strengthen and pave the way for new regulations and guidelines. Future agendas may be leveraged from research to other spheres of society, increasing dialog about inclusively designed pharmaceutical packaging and better patient care.