Abstract
Introduction: Medicines information leaflets help equip patients to be in control of their own healthcare, and support the safe and effective use of medicines. Leaflet design and content can influence patients’ willingness to read them; poor examples can cause confusion and anxiety. A leaflet may be the only information patients receive due to consultation time constraints and patient preference. The New Zealand pharmacy council code of ethics and the HDC code of rights require patients be fully informed; ineffective leaflets may result in ethical requirements not being fulfilled. This study’s aim was to provide an up-to-date review of the literature to determine patients’ requirements for design and content of medicine information leaflets.
Methods: Embase, Medline, Scopus, and Web of Science were searched from 2008-2015, followed by bibliography and citation searching. A data extraction form was used to synthesise qualitative data from the selected studies. A comprehensive list of recommendations for leaflet content was developed. Government recommendations for leaflet design from Europe, New Zealand, UK, and USA were compared with outcomes from studies in the review.
Results: 19 studies from seven countries met inclusion criteria. Existing medicines information leaflets do not meet patients’ needs and appear ineffective. Current leaflets lack required information and may contain unessential material, affecting patients’ perception and willingness to read it. The acceptable length of leaflets varies; tailoring of leaflets to individuals requirements is necessary. Application of good design principles improve readability, comprehension, and ability to locate information. Variation was found in the recommendations from health regulatory bodies and the literature.
Discussion: Medicine information leaflets must be well designed and meet patients’ information needs. Types and quantity of information required differs between patients. Automated information tailoring to patients’ requirements (e.g. by indication, age, sex) might generate effective leaflets. In New Zealand there is little regulatory guidance given to those creating medicine information leaflets. The design principles identified here can be used as a template.
Conclusions: Many medicines information leaflets do not meet patients’ needs and will not be used. Leaflet design affects patients’ understanding and ability to find information and must be optimised according to good design principles. Leaflets should clearly explain patients’ benefits and risks and avoid the inclusion of irrelevant information for individuals. Ideally, information should be tailored to each patient.
Lessons learned: Current practice of passively giving pre-printed leaflets is outdated and ineffective. The ability to use automated programs for leaflet tailoring would be a desirable innovation. New Zealand needs stronger guidance on the use of good design principles for those creating medicine information leaflets.
Limitations: Authors of the original studies could not be contacted to provide more detailed information. Studies examined intended adherence, not actual adherence. The search focus was patient information leaflets, not how patients’ want information presented and design information was gathered from the studies identified.
Suggestions for further research: Evaluation of medicine information leaflets available in New Zealand and investigation of patient use and opinion; differing requirements for over-the-counter and prescription-only medicines. Additionally, whether images would improve leaflet effectiveness.