We are the experts: people with asthma talk about their medicine information needs

Abstract

People with chronic illness are being encouraged to become more involved in their care. For this, they need to be well informed about their medicines, and more written medicines information is becoming available. However, there is little data about its effectiveness and impact. This study examined the patient perspective of medicines information through focus groups of people with asthma. Most participants actively sought medicines information from a variety of professional and lay sources. There were some positive experiences but many examples of partial or total information failure. Individualised information was valued and medicine leaflets were generally seen as less helpful than face-to-face advice. Some felt strongly that patients with long experience should be involved in the development of medicine information leaflets. We conclude that medicine information leaflets do not currently meet the needs of users and that people who take medicines should be involved in their development and testing.

Introduction

There is an international trend to increase people’s involvement in their health care. In the United Kingdom, it is a major goal of the National Plan for the National Health Service [1], which promotes the provision of individualised information. Medicines are the most common healthcare intervention, making information about medicines an important part of this empowerment process.

Verbal information should be the mainstay of such provision, but increasingly it needs to be complemented by written information [2].This is due to the increasing volume of information and the lack of time available to health professionals [3]. Important benefits of written information are that it is available for later reference by the patient when the need arises, and that it is also accessible by the patient’s family and other carers. Studies have shown that patients prefer to have a combination of verbal and written medicines information [2].

Regulations appeared in the 1990s across the developed world, governing the provision of written medicines information for patients. In the European Union (EU), comprehensive leaflets for patients are now mandatory, and all medicine packs should contain a leaflet as a package insert [4]. These leaflets are produced by the manufacturer, but the content is closely defined by the regulations. They are required to contain all of the information provided to professionals in the Summary of Product Characteristics, but in a form understandable to the patient [5]. The leaflets are much more detailed than those previously supplied to patients in the UK. Guidelines were introduced in 1998 by the European Commission to improve the readability of these leaflets [6].

Initiatives have also been introduced in the USA and Australasia [7]. In the USA, most medicines are covered by a voluntary agreement, with leaflets developed by the private sector [8]. They are computer-generated in the pharmacy, at the time a prescription is dispensed, and are smaller and less detailed than their European counterparts. The US Food and Drugs Administration (FDA) have set a target that by 2006, 95% of patients will receive such a leaflet with the first supply of their medicine. Their content and quality are not regulated, but an Action Plan commissioned by the Department of Health and Human Services recommended a number of criteria, which included aspects of content and design [9]. In contrast, for some medicines in the US, a recent law mandates the provision of a leaflet, with every supply. This applies to a very small number of medicines designated as having particular risks. In these cases, a detailed leaflet, written by the manufacturer and approved by the FDA, must be supplied as a package insert [10].

In Australia, as in Europe, legislation requires that all new medicines be accompanied by a leaflet. The regulations here are the result of a collaboration of professionals, government, industry and patients [11]. They are evidence based, drawing on the expertise of the Australian Communications Research Institute who produced guidelines for the writing and testing of the leaflets [12]. As in Europe, the leaflets are produced by the manufacturers according to the regulations. The authorities in New Zealand have adopted a similar process.

There is no evidence that the European initiative was introduced with any close reference to patients’ needs. Our initial work suggests that, in the UK, the leaflets are not read by most people [13] and other work has suggested that, as currently provided, they do not meet patient need [14]. The aim of this study was to provide an understanding of the experiences of people with a chronic illness of medicines information. Specifically, we wanted their views on the current leaflet provision, following implementation of the EU Directive.