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.
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• The study presents a theoretical framework of packaging innovation drivers.
• Technology and legislation drive contemporary pharmaceutical packaging innovation.
• There are limited logistics, marketing, and sustainability drivers of pharmaceutical packaging innovation.
• External driving forces are proposed to pull innovation toward patient-centered packaging solutions.
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.
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.
Ascertaining barriers for compliance: policies for safe, effective and cost-effective use if medicines in Europe01/02/2012/ABC Group/Scientific Research
Meta analyses of research on compliance issues
One of the most pressing challenges facing the pharmaceutical industry today is patient compliance – how to ensure the patient takes the right medicine at the right time in the right way. Studies show that patient adherence (the extent to which a patient takes a medicine as prescribed) usually starts well but then falls away strongly over time, a worrying trend seen across almost all therapeutic areas. After 12–18 months, adherence rates may drop to around 30%, even for disease areas with very low survival rates.
The impact of poor medication adherence is serious and costly to both patients and the healthcare system. Consequences include medical complications, disease progression, hospitalizations, impaired quality of life and or even death. With approximately 50% of patients not taking their medications as prescribed across diseases and health conditions, moving the needle even a little toward better adherence can make a big difference.
This paper aims to show how pharmaceutical packaging can have a significant impact on patient compliance and how the introduction of patient-friendly packs really can lead to improved adherence rates.