Abstract
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
... read more
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.
show less