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Objectives (1) Present deprescribing experiences of patients living with frailty, their informal carers and healthcare professionals; (2) interpret whether their experiences are reflective of person-centred/collaborative care; (3) complement our findings with existing evidence to present a model for person-centred deprescribing for patients living with frailty, based on a previous collaborative care model. Methods Qualitative design in English primary care (general practice). Semi-structured interviews were undertaken immediately post-deprescribing and 5/6 weeks later with nine patients aged 65+ living with frailty and three informal carers of patients living with frailty. Fourteen primary care professionals with experience in deprescribing were also interviewed. In total, 38 interviews were conducted. A two-staged approach to data analysis was undertaken. Key findings Three themes were developed: attitudes, beliefs and understanding of medicines management and responsibility; attributes of a collaborative, person-centred deprescribing consultation; organisational factors to support person-centred deprescribing. Based on these findings and complementary to existing evidence, we offer a model for person-centred deprescribing for patients living with frailty. Conclusions Previous models of deprescribing for patients living with frailty while, of value, do not consider the contextual factors that govern the implementation and success of models in practice. In this paper, we propose a novel person-centred model for deprescribing for people living with frailty, based on our own empirical findings, and the wider evidence base.

In older people living with frailty, polypharmacy can lead to preventable harm like adverse drug reactions and hospitalization. Deprescribing is a strategy to reduce problematic polypharmacy. All stakeholders should be actively involved in developing a person-centred deprescribing process that involves shared decision-making.To co-design an intervention, supported by a logic model, to increase the engagement of older people living with frailty in the process of deprescribing.Experience-based co-design is an approach to service improvement, which uses service users and providers to identify problems and design solutions. This was used to create a person-centred intervention with the potential to improve the quality and outcomes of the deprescribing process. A 'trigger film' showing older people talking about their healthcare experiences was created and facilitated discussions about current problems in the deprescribing process. Problems were then prioritized and appropriate solutions were developed. The review located the solutions in the context of current processes and procedures. An ideal care pathway and a complex intervention to deliver better care were developed.Older people living with frailty, their informal carers and professionals living and/or working in West Yorkshire, England, UK. Deprescribing was considered in the context of primary care.The current deprescribing process differed from an ideal pathway. A complex intervention containing seven elements was required to move towards the ideal pathway. Three of these elements were prototyped and four still need development. The complex intervention responded to priorities about (a) clarity for older people about what was happening at all stages in the deprescribing process and (b) the quality of one-to-one consultations.Priorities for improving the current deprescribing process were successfully identified. Solutions were developed and structured as a complex intervention. Further work is underway to (a) complete the prototyping of the intervention and (b) conduct feasibility testing.Older people living with frailty (and their informal carers) have made a central contribution, as collaborators, to ensure that a complex intervention has the greatest possible potential to enhance the experience of deprescribing medicines.

Background Dispensed prescription medicine labels (prescription labels) are important information sources supporting safe and appropriate medicines use. Objective To develop and user test patient-centred prescription label formats. Methods Five stages: developing 12 labels for four fictitious medicines of varying dosage forms; diagnostic user testing of labels (Round 1) with 40 consumers (each testing three labels); iterative label revision, and development of Round 2 labels (n = 7); user testing of labels (Round 2) with 20 consumers (each testing four labels); labelling recommendations. Evaluated labels stated the active ingredient and brand name, using various design features (eg upper case and bold). Dosing was expressed differently across labels: frequency of doses/day, approximate times of day (eg morning), explicit times (eg 7 to 9 AM), and/or explicit dosing interval. Participants' ability to find and understand medicines information and plan a dosing schedule were assessed. Results Participants demonstrated satisfactory ability to find and understand the dosage for all label formats. Excluding active ingredient and dosing schedule, 14/19 labels (8/12 in Round 1; 6/7 in Round 2) met industry standard on performance. Participants' ability to correctly identify the active ingredient varied, with clear medicine name sign-posting enabling all participants evaluating these labels to find and understand the active ingredient. When planning a dosing schedule, doses were correctly spaced if the label stated a dosing interval, or frequency of doses/day. Two-thirds planned appropriate dosing schedules using a dosing table. Conclusions Effective prescription label formatting and sign-posting of active ingredient improved communication of information on labels, potentially supporting safe medicines use. Patient and public involvement Consumers actively contributed to the development of dispensed prescription medicine labels. Feedback from consumers following the first round was incorporated in revisions of the labels for the next round. Patient and public involvement in this study was critical to the development of readable and understandable dispensed prescription medicine labels.

Background\ud \ud Experience‐based co‐design (EBCD) brings patients and staff together to co‐design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service.\ud \ud \ud \ud Methods\ud \ud The primary aim was to assess the feasibility and acceptability of conducting research‐initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adaptations: (a) working across primary and secondary care sectors, (b) working on multiple sites and (c) incorporating theory‐informed analysis.\ud \ud \ud \ud Results\ud \ud We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups—followed by a single joint patient‐staff event, where four priority areas for co‐design were agreed. This event was driven by theory‐informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co‐design groups met over 2‐3 months to design prototype tools. A second joint event was held (not usually undertaken in single‐site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial.\ud \ud \ud \ud Conclusions\ud \ud EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co‐designed an intervention which directly reflected patient priorities.

ObjectiveTo explore the barriers/facilitators to deprescribing in primary care in England from the perspectives of clinicians, patients living with frailty who reside at home, and their informal carers, drawing on the Theoretical Domains Framework to identify behavioural components associated with barriers/facilitators of the process.DesignExploratory qualitative study.SettingGeneral practice (primary care) in England.Participants9 patients aged 65+ living with frailty who attended a consultation to reduce or stop a medicine/s. 3 informal carers of patients living with frailty. 14 primary care clinicians including general practitioners, practice pharmacists and advanced nurse practitioners.MethodsQualitative semistructured interviews took place with patients living with frailty, their informal carers and clinicians. Patients (n=9) and informal carers (n=3) were interviewed two times: immediately after deprescribing and 5/6 weeks later. Clinicians (n=14) were interviewed once. In total, 38 interviews were undertaken. Framework analysis was applied to manage and analyse the data.Results6 themes associated with facilitators and barriers to deprescribing were generated, respectively, with each supported by between two and three subthemes. Identified facilitators of deprescribing with patients living with frailty included shared decision-making, gradual introduction of the topic, clear communication of the topic to the patient and multidisciplinary working. Identified barriers of deprescribing included consultation constraints, patients' fear of negative consequences and inaccessible terminology and information.ConclusionsThis paper offers timely insight into the barriers and facilitators to deprescribing for patients living with frailty within the context of primary care in England. As deprescribing continues to grow in national and international significance, it is important that future deprescribing interventions acknowledge the current barriers and facilitators and their associated behavioural components experienced by clinicians, patients living with frailty and their informal carers to improve the safety and effectiveness of the process.

Background Experience-Based Co-Design (EBCD) is a participatory design method which was originally developed and is still primarily used as a healthcare quality improvement tool. Traditionally, EBCD has been sited within single services or settings and has yielded improvements grounded in the experiences of those delivering and receiving care. Method In this article we present how EBCD can be adapted to develop complex interventions, underpinned by theory, to be tested more widely within the healthcare system as part of a multi-phase, multi-site research study. We begin with an outline of co-design and the stages of EBCD. We then provide an overview of how EBCD can be assimilated into an intervention development and evaluation study, giving examples of the adaptations and research tools and methods that can be deployed. We also suggest how to appraise the resulting intervention so it is realistic and tractable in multiple sites. We describe how EBCD can be combined with different behaviour change theories and methods for intervention development and finally, we make suggestions about the skills needed for successful intervention development using EBCD. Conclusion EBCD has been recognised as being a collaborative approach to improving healthcare services that puts patients and healthcare staff at the heart of initiatives and potential changes. We have demonstrated how EBCD can be integrated into a research project and how existing research approaches can be assimilated into EBCD stages. We have also suggested where behaviour change theories can be used to better understand intervention change mechanisms.

Background: Printed participant information about randomised controlled trials is often long, technical and difficult to navigate. Improving information materials is possible through optimisation and user-testing, and may impact on participant understanding and rates of recruitment. Methods: A study within a trial (SWAT) was undertaken within the CASPER trial. Potential CASPER participants were randomised to receive either the standard trial information or revised information that had been optimised through information design and user testing. Results: A total of 11,531 patients were randomised in the SWAT. Rates of recruitment to the CASPER trial were 2.0% in the optimised information group and 1.9% in the standard information group (odds ratio 1.027; 95% CI 0.79 to 1.33; p=0.202). Conclusions: Participant information that had been optimised through information design and user testing did not result in any change to rate of recruitment to the host trial. Registration: ISRCTN ID ISRCTN02202951; registered on 3 June 2009.

This research was conducted in collaboration with the University of Leeds School of Healthcare. Open Access article Service users rely upon pharmacy staff to provide advice on prescription medicines. The purpose of this study was to compare the prevalence of advice-giving in pharmacies located across different areas within an inner-city population. A questionnaire was administered with service users outside 29 community pharmacies in an English Midlands city between February and July 2014. The primary outcome measure was the percentage who had received information or advice when collecting a prescription medicine. A total of 1206 service users took part, of whom 49.1% were female and 50.9% were of minority ethnicity (48.8% white British). The age ranges were: 17–30 years (21.0%), 31–60 years (55.0%) and 61–80+ years (24.1%). Sixty-nine per cent of participants had collected a prescription for themselves, and the proportions of new and repeat prescriptions were 22.1% and 77.6% respectively. A subset of 141 participants had requested advice, of whom 94% confirmed that they had received it. Overall, 28.6% of 1065 participants received unsolicited information or advice. The overall prevalence of unsolicited advice-giving varied per pharmacy from 14% to 63% and for new and repeat prescriptions was 41.9% and 25.5% respectively (p < .001, new vs repeat). In areas of greater deprivation, a higher proportion of service users of minority ethnicity received unsolicited repeat prescription advice, compared to that of white British (33.0% vs 17.3% respectively; p < .001). Thus, the low incidence and contrasting patterns of prescription advice-giving suggests that the training and expertise of pharmacy staff may not always be used effectively within the UK NHS. Therefore, the current challenge is how community pharmacies can work in partnership with colleagues across the wider healthcare system when optimising the use of medicines and reducing health inequalities. The research performed here provides new insights reflecting the low prevalence of advice-giving and potential inequity associated with delivery of this pharmacy service.

Background In 2011 there was a strengthening of European Union (EU) legislation on the licencing of herbal products which, in the UK, resulted in the introduction of the Traditional Herbal Registration (THR) scheme. This scheme sets out standards for the safety and quality of herbal medicines and includes the provision of information to the customer on the safe use of the product. The aim of this study is to replicate a survey undertaken in 2011, prior to the implementation of the THR scheme, and evaluate the impact of this scheme on the information provided with herbal products bought over-the-counter. Methods We undertook a survey on 5 herbal products commonly available over-the-counter (St John’s wort, echinacea, Ginkgo biloba, Asian ginseng, garlic). The information was searched for key safety messages identified by the National Center for Complementary and Integrative Health (NCCIH). We also explored the presence of risk of harm information. Results We recorded a rise in the number of products registered with the THR scheme (37% in 2016 compared to 7% in 2011). We also identified a reduction in the number of products that did not contain key safety information (75% in 2011 compared to 20% of products obtained in 2016). Risk of harm information was only communicated in products containing a PIL. We identified more products containing frequency of risk of harm information but this was not statistically significant. Conclusion The introduction of the THR scheme appears to be associated with an increase in the provision of information about key safety messages on the safe use of herbal products. However, it is important to note that at least half of the products on the market that are not included in the THR scheme do not contain any information about their safe use; this includes information about precautions, interactions and side effects. The use of NCCIH herbal monographs replicated the methods used in the previous study; we recognise that the use of a different resource might effect the appraisal of the information provided. We also acknowledge that surveying presence of information does not assure that the latter is effectively communicated to patients, for which a close textual analysis would be required. While it is promising that more information is available after the introduction of the THR scheme, the public needs to be informed about ways to optimise safe use of all herbal products.

Background: In the European Union (EU), all medicines are mandated to be provided with a patient information leaflet (PIL). Many patients express concerns about the length and complexity of some PILs, and this can be a disincentive for patients to read the PILS. In order to address this, the UK’s regulatory body (Medicine and Healthcare products Regulatory Agency [MHRA]) suggested leaflets might include a headline section—information presented prominently at the beginning of a leaflet that summarizes key safety messages about a drug. Objective: To explore the extent to which readers used a headline section in a PIL, using a form of diagnostic testing called user-testing, which examines how readers find and understand key information. Methods: The study used a cross-sectional design to user-test a PIL with a headline section in a target sample of 20 participants. Participants were provided with an exemplar PIL, and the performance of the PIL was evaluated by a questionnaire and semistructured interview. Results: The results showed that a headline section was used just over one-third of the time (39%); 90% of participants used the headline section to find information when they initially began the user-test. The qualitative findings suggested that the participants valued the presence of the headline section. Conclusion: The research suggests there does not appear to be any negative impact from including a headline section in a PIL, and it is a technique that is highly valued by the consumers of medicines information.

One of the roles of the Summary of Product Characteristics (SmPC) is to provide information for health professionals. The objective of this work was to understand the effectiveness of the SmPC document in communicating essential information to prescribers. The process of user testing, widely used to test information for patients, was applied. First, 30 general practitioners were involved in the testing of the SmPC for Lariam, an antimalarial drug. As user testing is an iterative process, 15 points of information in the original SmPC were tested in 3 rounds of 10 participants. The document was revised between rounds according to the results; good practice in information writing and design was used. Next, the SmPC for CellCept, an immunosuppressant, was tested in 20 senior hospital doctors. Again, the document was revised between rounds, according to the results, with revisions also taking account of findings from the Lariam testing related to the general structure of SmPCs. Of the 15 points of information tested, for the original Lariam SmPC, 6 points of information met the target of 90% to find, and 90% of those to understand, whereas for the final version of the CellCept SmPC, 11 points of information met this target. Qualitative comments showed that in their current format, SmPCs are of low perceived value to prescribers and are not central to the clinicians' prescribing behavior. Current content and presentation of SmPCs, while meeting regulatory approval standards, contribute little to the safe and effective use of medication in practice. Key recommendations include revising and simplifying the heading structure and making the headings more visible, adding a "Key Information" summary at the start, using simpler language, and adding bullet points for listings.

Objective: To apply “user testing” to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary—a new European requirement.\ud \ud \ud \ud Methods: “User testing” (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version.\ud \ud \ud \ud Results: In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants’ symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable.\ud \ud \ud \ud Conclusions: Applying “user testing” resulted in a largely health-literate summary suitable for people across a range of backgrounds.

This paper presents a review of the literature, including government legislations, policies, guidelines, and recommendations available in the European Union, the United States of America, and Australia pertaining to the availability, development, and distribution of written medicine information (WMI) for prescription medicines. The online databases searched were Embase, International Pharmaceutical Abstracts, Medline, and PubMed, together with Google as the Internet search engine. The design and content of WMI documents have similarities and differences across all the 3 geographical regions. All the 3 regions have legislations in place to evaluate and regulate WMI documents for health care professionals (HCPs) and, to some degree, for patients; however, the degree of regulation varies between the 3 regions. The regulations around the content and information design of WMI impacts how well the WMI performs and consequently influences patients’ knowledge and medication-taking behavior. Legislation in certain areas could be seen as more beneficial and can be implemented across the 3 regions. Furthermore, the required legislation on the evaluation of the content of WMIs can be seen in some areas to be more stringent and comprehensive, which when taken onboard across the 3 regions can be valuable when creating WMIs for both patients and HCPs.

Limited research has evaluated the consumer usability of written information available with similar over-the-counter (OTC) products in different countries. This study evaluated the usability of labels and leaflets for Australian and UK OTC diclofenac products and explored consumer perspectives on their design, content, usability, and potential improvements. Australian and UK OTC diclofenac products were selected for user testing. Demographically matched groups of Australian and UK consumers were recruited to user test each label and leaflet set to determine whether 9 salient clinical messages could be found and understood. Consumer perspectives on the tested label and leaflet were explored using semi-structured interviews as part of user testing. Forty consumers user tested the Voltaren Rapid 25 (Australia) and Voltarol Pain-eze Extra Strength 25-mg tablets (UK) information (10 participants per brand per country). Dosage, maximum daily dose, and contraindications information was found and understood by most (≥9/10 per group), except the Voltaren dosage which was misunderstood by 4/20. However, 12/20 could not locate the maximum duration of continuous use in the Voltaren leaflet. Participants had difficulty determining that another nonsteroidal anti-inflammatory drug could not be used with diclofenac (7/20 and 9/20 understood this in the Voltaren and Voltarol groups, respectively). Suggested label and leaflet improvements included increased font size, bolding/highlighting, and color. When evaluated in both countries, not all key clinical information was effectively communicated by information accompanying Australian and UK diclofenac products. Improvements in how information is communicated are needed.

Background Over-the-counter (OTC) labels help support safe medication use by consumers. In 2012, the Australian Therapeutic Goods Administration (TGA) released a consultation paper proposing OTC label standardization to improve label quality via implementation of the Medicine Information Box (MIB) label. However, consumer opinions of the MIB and standardization of OTC labelling remain unexplored. Objective To explore consumer perspectives of OTC label standardization and the proposed MIB. Design Mock MIB labels were developed by the research team, guided by the TGA consultation paper, and used as interview stimulus material. Participants and setting Semi-structured interviews were conducted with 38 Australian and 39 UK adult participants. Participant perspectives on OTC label standardization, opinions on the MIB and perceived improvements were explored. All interviews were audio-recorded with permission, transcribed verbatim, and the content thematically analysed. Results Participants expressed a range of opinions towards OTC label standardization, from welcoming standardization to concern that important details may be overlooked. The MIB was generally positively received due to its perceived good information design and ease of navigation. Participants requested reordering of information-specifically, for the active ingredient to be moved to a less prominent position. Suggested improvements centred on content and design changes, for example colour, pictograms, bolding. Conclusions Participants felt positively towards OTC label standardization and saw the MIB as a feasible standardized format to implement for OTC labels. Although they appreciated its good information design, they felt further improvements to its content and design are required to enhance its quality and usability.

Patients’ perceptions of side effect risks are important influences on their medicine-taking behaviour. A previous survey of Patient Information Leaflets (PILs) showed considerable variation in the terms used to communicate risks. Our objective was to assess the methods used to describe risk of side effects in recent PILs and to compare them with PILs sampled in 2006. We sampled PILs for the 50 most frequently dispensed medicines in England and Wales in 2012 and PILs for the 50 most recently licensed medicines. We assessed the use of risk frequency terms or numbers, and the use of the risk format recommended by the European Medicines Agency (EMA). A majority (76 %) of PILs for the most frequently dispensed medicines included a risk frequency descriptor, with 66 % using the recommended format. No difference was seen between PILs for branded and generic medicines. All 50 PILs for the most recently licensed medicines used the EU recommended risk format. PILs from the 2012 sample were much more likely than those from the 2006 sample to include risk descriptors and to use a consistent approach. The increased use and consistency of risk descriptors in PILs should benefit patients, particularly those using multiple medicines produced by different market authorisation holders. A need remains for further research evaluating the risk format recommended by the EMA. There is also a need for research evaluating spoken information and other sources of printed risk information about medicines that is available to patients.

Introduction Patient information leaflets (PILs) are required with all licensed medicines throughout the European Union (EU) and they must include information about all side effects and their likelihood. This has led to criticism of a lack of balance, with little information included about potential benefits. Recent European Medicines Agency guidance proposed the inclusion of benefit information, and this study examined the current prevalence and type of such information in PILs in the EU. Methods A survey and content analysis of the English translation of PILs in the EUwas carried out. Random quota sampling was used on the most frequently dispensed (n = 50) and newly licensed medicines (n = 50) in 2011/2. Leaflets were searched for benefit information meeting predefined criteria, and data synthesised and categorised into 10 categories. Results Eighty-five (85%) leaflets described how the medicine works, with 45 providing information about the rationale for treatment (more commonly for newly licensed (32/50) than most commonly dispensed medicines (13/50; P < 0.001). Nearly half (47) did not describe whether the medicine was curative, symptomatic or preventative. The terms used to communicate uncertainty were imprecise (such as ‘may help’). None communicated numerical benefit information. Conclusion Current PILs do not appropriately communicate information about benefit. At the basic level, around a half did not include information about treatment rationale or whether the treatment was to treat symptoms, curative or preventative. However, for true informed decision making, patients need quantitative information about benefits and none of the leaflets provided this.

BackgroundOutpatient parenteral antimicrobial therapy (OPAT) is widely used in most developed countries, providing considerable opportunities for improved cost savings. However, it is implemented only partially in the UK, using a variety of service models.ObjectivesThe aims of this research were to (1) establish the extent of OPAT service models in England and identify their development; (2) evaluate patients’ preferences for different OPAT service delivery models; (3) assess the cost-effectiveness of different OPAT service delivery models; and (4) convene a consensus panel to consider our evidence and make recommendations.MethodsThis mixed-methods study included seven centres providing OPAT using four main service models: (1) hospital outpatient (HO) attendance; (2) specialist nurse (SN) visiting at home; (3) general nurse (GN) visiting at home; and (4) self-administration (SA) or carer administration. Health-care providers were surveyed and interviewed to explore the implementation of OPAT services in England. OPAT patients were interviewed to determine key service attributes to develop a discrete choice experiment (DCE). This was used to perform a quantitative analysis of their preferences and attitudes. Anonymised OPAT case data were used to model cost-effectiveness with both Markov and simulation modelling methods. An expert panel reviewed the evidence and made recommendations for future service provision and further research.ResultsThe systematic review revealed limited robust literature but suggested that HO is least effective and SN is most effective. Qualitative study participants felt that different models of care were suited to different types of patient and they also identified key service attributes. The DCE indicated that type of service was the most important factor, with SN being strongly preferred to HO and SA. Preferences were influenced by attitudes to health care. The results from both Markov and simulation models suggest that a SN model is the optimal service for short treatment courses (up to 7 days). Net monetary benefit (NMB) values for HO, GN and SN services were £2493, £2547 and £2655, respectively. For longer treatment, SA appears to be optimal, although SNs provide slightly higher benefits at increased cost. NMB values for HO, GN, SN and SA services were £8240, £9550, £10,388 and £10,644, respectively. The simulation model provided useful information for planning OPAT services. The expert panel requested more guidance for service providers and commissioners. Overall, they agreed that mixed service models were preferable.LimitationsRecruitment to the qualitative study was suboptimal in the very elderly and ethnic minorities, so the preferences of patients from these groups might not be represented. The study recruited from Yorkshire, so the findings may not be applicable nationally.ConclusionsThe quantitative preference analysis and economic modelling favoured a SN model, although there are differences between sociodemographic groups. SA provides cost savings for long-term treatment but is not appropriate for all.Future workFurther research is necessary to replicate our results in other regions and populations and to evaluate mixed service models. The simulation modelling and DCE methods used here may be applicable in other health-care settings.FundingThe National Institute for Health Research Health Service and Delivery Research programme.

Background Providing written medicine information to consumers enables them to make informed decisions about their medicines, playing an important role in educating and improving health literacy. In Australia, standardized written medicine information called Consumer Medicine Information (CMI) is available for medicines as package inserts, computer prints, or leaflets. Consumers want and read CMI, but may not always ask for it. General practitioners (GPs) and pharmacists are an important source of written medicine information, yet may not always provide CMI in their practice. Objective To examine and compare the awareness, use and provision of CMI by consumers, pharmacists and general practitioners (GPs). Methods Based on previous studies, structured questionnaires were developed and administered to a national sample of consumers (phone survey); community pharmacists and GPs (postal surveys) about utilization of CMI. Descriptive, comparative and logistic regression analyses were conducted. Results The respondents comprised of 349 pharmacists, 181 GPs and 1000 consumers. Two-thirds of consumers, nearly all (99%) pharmacists and 90% of GPs were aware of CMI. About 88% of consumers reported receiving CMI as a package insert, however most pharmacists (99%) and GPs (56%) reported providing computer-generated CMI. GPs' and pharmacists' main reason for providing CMI was on patient request. Reasons for not providing were predominantly because consumers were already taking the medicine, concerns regarding difficulty understanding the information, or potential non-adherence. Of the 691 consumers reportedly reading CMI, 35% indicated concerns after reading. Factors associated with reading included gender, type of CMI received and frequency of provision. Conclusion Consumers want and read information about their medicines, especially when received from their GP or pharmacist. Healthcare professionals report usually discussing CMI when providing it to patients, although continued improvements in dissemination rates are desirable. Regular use of CMI remains a challenge, and ongoing strategies to promote CMI use are necessary to improve uptake of CMI in Australia.

BACKGROUND: Consumer Medicine Information (CMI) is a brand-specific and standardized source of written medicine information available in Australia for all prescription medicines. Side-effect information is poorly presented in CMI and may not adequately address consumer information needs. OBJECTIVE: To explore consumer opinions on (i) the presentation of side-effect information in existing Australian CMI leaflets and alternative study-designed CMIs and (ii) side-effect risk information and its impact on treatment decision making. DESIGN: Fuzzy trace, affect heuristic, frequency hypothesis and cognitive-experiential theories were applied when revising existing CMI side-effects sections. Together with good information design, functional linguistics and medicine information expertise, alternative ramipril and clopidogrel CMI versions were proposed. Focus groups were then conducted to address the study objectives. PARTICIPANTS AND SETTING: Three focus groups (n = 18) were conducted in Sydney, Australia. Mean consumer age was 58 years (range 50-65 years), with equal number of males and females. RESULTS: All consumers preferred the alternative CMIs developed as part of the study, with unequivocal preference for the side-effects presented in a simple tabular format, as it allowed quick and easy access to information. Consumer misunderstandings reflected literacy and numeracy issues inherent in consumer risk appraisal. Many preferred no numerical information and a large proportion preferred natural frequencies. CONCLUSIONS: One single method of risk presentation in CMI is unable to cater for all consumers. Consumer misunderstandings are indicative of possible health literacy and numeracy factors that influence consumer risk appraisal, which should be explored further.

Background Written medicine information is an important aspect of patient education, increasing patient knowledge and satisfaction. It can play an important role in promoting education, communication, and improving health literacy. In Australia, standardized, comprehensive written medicine information is available for all medicines. Patients' want such written information, however they report it is generally not supplied or there is limited interaction between healthcare professionals and patients when provided. Objective A qualitative study was conducted to explore the opinions and attitudes of healthcare professionals toward the use of written medicine information in practice. Method The study involved focus groups with 32 general practitioners (4 groups), 29 community pharmacists (4 groups) and 7 hospital pharmacists (1 group) in Sydney and rural New South Wales. All discussions were transcribed verbatim and analyzed using thematic content analysis. Findings Across the groups, professionals were aware of patients' needs for medicine information, but provision to patients in practice appeared the exception rather than the rule. Common reasons for non-provision were lack of time, possible creation of patient anxiety, low literacy, and perceived length and complexity of the information. Many desired more balanced information for patients on both benefits and risks. Most felt current materials were not useful information-sharing tools; some perceived that it undermined their relationship with patients. Improvement strategies proposed included increased consultation times and improved quality of the information. Conclusion Participants were ambivalent about supplying written medicine information to their patients and concerned about its impact on the patient-provider relationship. This contributed to limited provision, despite the information being available for all medicines. A tailored approach to meet individual patient information preferences, together with efforts to support professionals as facilitators of information may increase written medicine information utilization as an information-sharing tool to improve health literacy and patient engagement.

Objectives To explore Australian and UK consumers’ receipt and use of spoken and written medicine information and examine the role of leaflets for consumers of over-the-counter (OTC) medicines. Methods Semistructured interviews were conducted with 37 Australian and 39 UK consumers to explore information received with their most recent OTC medicine purchase, and how information was used at different times post-purchase. Interviews were audio-recorded, transcribed verbatim and thematically analysed. Key findings Similarities were evident between the key themes identified from Australian and UK consumers’ experiences. Consumers infrequently sought spoken information and reported that pharmacy staff provided minimal spoken information for OTC medicines. Leaflets were not always received or wanted and had a less salient role as an information source for repeat OTC purchases. Consumers tended not to read OTC labels or leaflets. Product familiarity led to consumers tending not to seek information on labels or leaflets. When labels were consulted, directions for use were commonly read. However, OTC medicine information in general was infrequently revisited. Conclusions As familiarity is not an infallible proxy for safe and effective medication use, strategies to promote the value and use of these OTC medicine information sources are important and needed. Minimal spoken information provision coupled with limited written information use may adversely impact medication safety in self-management.

Objective: To explore the impact of providing additional information about the potential benefits of simvastatin in a patient leaflet on attitudes and beliefs. Design: Interview-based study using a generic qualitative approach and framework analysis. Participants: 21 participants receiving a prescription for simvastatin were recruited from a General practitioner (GP) practice (from a total of 120). 8 participants were female; the age range was 55-92. Intervention: Participants were provided with leaflets showing one of 3 types of additional benefit information: (1) textual statement (2) number needed to treat (NNT) or (3) natural frequency. Semi-structured interviews explored patient’s attitudes and beliefs. Results: A descriptive narrative of preferences for format suggested patients prefer textual as opposed to numerical benefit information. Significant barriers to the acceptance of numerical benefit information included difficulty in understanding the numbers. Patients over-estimated the benefits of statins and expressed surprise at the numerical information. Conclusions: Textual information was preferred but numerical information, in particular in the form of a natural frequency, may help patients make judgements about their medicines. NNTs were found to be very difficult to understand. This raises the prospect that some patients might reject medicines because of disappointment with the perceived low benefits of their medicines. The self-reported impact on behaviour appeared minimal with reports of intentions to ‘do what the doctor tells me’. Further research is needed to explore the impact of such statements on people who are yet to be prescribed a statin.

Background In recent years, the Australian Therapeutic Goods Administration (TGA) has proposed implementing a standardized over-the-counter (OTC) medicine label. However, there were mixed consumer opinions regarding a label proposed in 2012 and limited evidence demonstrating the usability of the revised (2014) format. Objective To develop and examine the usability of alternative OTC medicine label formats for standardization, and explore consumer perspectives on the labels. Materials and methods Four alternative labels were developed for the exemplar medicine diclofenac. One was based on the Medicine Information label proposed by the TGA (‘Medicine Information’), one was based on the U.S. Drug Facts label (‘Drug Facts’), and two were based on suggestions proposed by consumers in the earlier needs analysis phase of this research (referred to as the ‘Medicine Facts’ and ‘Consumer Desires’ label formats). Five cohorts of 10 participants were recruited. Each cohort was assigned to user test one of the alternative labels or an existing label for a proprietary diclofenac product (which acted as a comparator) for diagnostic purposes. Each participant then provided feedback on all 5 labels. Each interview consisted of the administration of a user testing questionnaire, measuring consumers' ability to find and understand key points of information, and a semi-structured interview exploring consumer perspectives. Results Overall, all 4 alternative label formats supported consumers' ability to find and understand key points. The existing comparator label was the poorer label with respect to participants' ability to find and understand key points. Factors such as perceived usability, color, design, content, and/or content ordering impacted consumer preferences. The ‘Consumer Desires’ or ‘Drug Facts’ label formats were most often preferred by consumers for use as the standardized OTC label over the TGA proposed format. Conclusions All alternative label formats demonstrated satisfactory usability and could be considered for use in OTC label standardization. User testing of OTC labels and consumer feedback received as part of the testing process can assist in the refinement of OTC labeling to ensure that implemented policies are evidence-based.

Background User testing evaluates written medicine information (WMI) usability by examining participants' ability to find and understand information. It can also be an effective method to determine how consumers say they will act on information on an over-the-counter (OTC) label. Objective To examine consumers' proposed behaviors regarding dosage and storage as a measure of a medicine label's usability and consumers' functional health literacy. Material and methods User testing of 5 diclofenac OTC labels (by 50 subjects; 10 per label) measured consumers' ability to find and understand key points of information using a 13-item questionnaire. Consumers were required to elaborate on their behavior in regard to 2 additional questions: 1) when they would take diclofenac if they had constant back pain from 8 am (dosage-related) and; 2) where they would store it in their home (storage-related). Responses were transcribed verbatim, and coded by 2 pharmacists. Results Appropriate dosing for constant back pain was reported by 29 consumers. However, dosing intervals shorter than the specified 8 h were often reported ( n = 19), due to adjusting intervals to accommodate up to the maximum of 8 tablets in 24 h, desire for pain relief, and/or pragmatic dosing (e.g. around bedtime). Only 29 consumers stated completely appropriate storage location examples (e.g. medicine cabinet). Conclusions Consumers may act inappropriately on OTC label information about dosage and/or storage, which could potentially adversely impact medication use. User testing can contribute to the development of high quality WMI and help identify where label wordings are inappropriate for the health literacy levels of consumers.

Background: There is a substantial body of evidence that prescribing for care home residents is suboptimal and requires improvement. Consequently, there is a need to identify effective interventions to optimise prescribing and resident outcomes in this context. Objectives: The objective of the review was to determine the effect of interventions to optimise prescribing for older people living in care homes. Search methods: We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL), The Cochrane Library (Issue 11, 2012); Cochrane Database of Systematic Reviews, The Cochrane Library (Issue 11, 2012); MEDLINE OvidSP (1980 on); EMBASE, OvidSP (1980 on); Ageline, EBSCO (1966 on); CINAHL, EBSCO (1980 on); International Pharmaceutical Abstracts, OvidSP (1980 on); PsycINFO, OvidSP (1980 on); conference proceedings in Web of Science, Conference Proceedings Citation Index - SSH & Science, ISI Web of Knowledge (1990 on); grey literature sources and trial registries; and contacted authors of relevant studies. We also reviewed the references lists of included studies and related reviews (search period November 2012). Selection criteria: We included randomised controlled trials evaluating interventions aimed at optimising prescribing for older people (aged 65 years or older) living in institutionalised care facilities. Studies were included if they measured one or more of the following primary outcomes, adverse drug events; hospital admissions;mortality; or secondary outcomes, quality of life (using validated instrument); medication-related problems; medication appropriateness (using validated instrument); medicine costs. Data collection and analysis: Two authors independently screened titles and abstracts, assessed studies for eligibility, assessed risk of bias and extracted data. A narrative summary of results was presented. Main results: The eight included studies involved 7653 residents in 262 (range 1 to 85) care homes in six countries. Six studies were cluster-randomised controlled trials and two studies were patient-randomised controlled trials. The interventions evaluated were diverse and often multifaceted. Medication review was a component of seven studies, three studies involved multidisciplinary case-conferencing, two studies involved an educational element for care home staff and one study evaluated the use of clinical decision support technology. Due to heterogeneity, results were not combined in a meta-analysis. There was no evidence of an effect of the interventions on any of the primary outcomes of the review (adverse drug events, hospital admissions and mortality). No studies measured quality of life. There was evidence that the interventions led to the identification and resolution of medication-related problems. There was evidence from two studies that medication appropriateness was improved. The evidence for an effect on medicine costs was equivocal. Authors' conclusions: Robust conclusions could not be drawn from the evidence due to variability in design, interventions, outcomes and results. The interventions implemented in the studies in this review led to the identification and resolution of medication-related problems, however evidence of an effect on resident-related outcomes was not found. There is a need for high-quality cluster-randomised controlled trials testing clinical decision support systems and multidisciplinary interventions that measure well-defined, important resident-related outcomes.

To use performance-based user-testing to evaluate the effectiveness of balance appointment patient information leaflets (PILs) in conveying important information.The study used a sequential groups design. Twenty participants were asked to find and demonstrate understanding of 11 key points of information contained within two NHS leaflets, A and B (10 participants each), through individual structured-interviews. Participants' views of the leaflets were explored through a short semi-structured interview. Following analysis, a revised leaflet was developed and tested on a further 20 participants.40 participants (25F/15M, aged 46-72) with no experience of balance problems or balance assessment appointments.Participants exhibited difficulties with finding and/or understanding 5/11 and 6/11 points of information within leaflets A and B, respectively. Five out of eleven points of the revised leaflet also posed problems. Ten out of eleven points were understood by90% of participants testing the revised leaflet compared with 6/11 points for leaflets A and B.Some balance appointment PILs contain information which is difficult to find and/or understand for some readers. PILs should be evaluated prior to use using performance-based methods, since poor information provision may lead to increased patient anxiety and appointment non-attendance, cancellation, or postponement.

Objectives To explore consumers' beliefs and preferences for benefit information in medicine leaflets and examine their understanding and reaction to treatment benefits. Methods Forty-five participants were recruited to eight focus groups, run concurrently in Australia (23 participants in four groups) and the UK (22 participants in four groups). Participants were provided with amended leaflets based on the medicine clopidogrel, containing textual and numerical benefit information presented using numbers needed to treat (NNT). A topic guide which explored use of leaflets, preferences and opinions was used to direct discussion. Focus group discussions were recorded, transcribed verbatim and content analysed using adapted cross-case study analysis. Key findings The consensus was that the inclusion of benefit information was a positive factor. Many participants felt that textual benefit information offered an incentive to take a medicine, although some Australian participants had concerns that included benefit information could create anxiety. The presentation of numerical benefit information provoked strong feelings of disbelief and shock. Participants were surprised that so few people would benefit. Some participants struggled to understand and interpret the NNT and others found it difficult to comprehend the magnitude of the benefit information, instead operating on initial and often crude assumptions of what the data meant. In both countries the provision of numerical benefit information appeared to shake participants' faith in drug treatments. Participants were concerned about how this might affect the ‘less-informed’ patient. However, in the UK, participants stated that their adherence to treatment was also reinforced by their doctor's advice. Conclusions Participants wanted to receive information about the benefits of their medicines. However, they may misinterpret the numerical information provided.

Background UK policy expects health professionals to involve patients in decisions about their care (including medicines use) and, at the same time, to follow prescribing guidelines. The compatibility of these approaches is unclear. Aim To explore the relationship between prescribing guidelines and patient-partnership by exploring the attitudes of patients, GPs and primary care trust (PCT) prescribing advisors. Design and setting A mixed-methods study using qualitative, semi-structured interviews followed by a quantitative, questionnaire survey in primary care in Northern England. Method Interviews were conducted with 14 patients taking a statin or a proton pump inhibitor, eight GPs and two prescribing advisors. A multi-variate sampling strategy was used. Qualitative findings were analysed using framework analysis. Questionnaires based on themes derived from the interviews were distributed to 533 patients and 305 GPs of whom 286 (54%) and 142 (43%) responded. Results Areas of tension between guidelines and patient partnership were identified, including potential damage to trust in the doctor and reduced patient choice, through the introduction of the policy maker as a third stakeholder in prescribing decisions. Other areas of tension related to applying single condition guidelines to patients with multiple illnesses, competition for doctors9 time and the perception of cost containment. Many GPs coped with these tensions by adopting a flexible approach or prioritising the doctor–patient relationship over guidelines. Conclusion Rigidly applied guidelines can limit patient choice and may damage the doctor–patient relationship. GPs need flexibility in order to optimise the implementation of prescribing guidelines, while responding to individuals9 needs and preferences.

Purpose This study aimed to explore peoples’ needs and expectations of written medicines information (WMI), and to determine the barriers and facilitators experienced or perceived in the context of WMI provision and use. Methods We conducted eight focus groups with 62 participants over 6 weeks in late 2008 in New South Wales, Australia. Using a semi-structured topic schedule and examples of WMI from Australia and other English-speaking countries as a guide, we explored themes relevant to WMI, including participant experiences, attitudes, beliefs and expectations. Findings Our findings suggest less than half had previously received WMI, with many unaware of its availability. Many, but not all, wanted WMI to supplement the spoken information they received but not to replace it, and it was predominantly used to facilitate informed choice, ascertain medicine suitability and review instructions. The current leaflets were considered technical and long, and a summary leaflet in addition to comprehensive information was favoured. Accurate side-effect information was the most important element that participants desired. The most common barriers to effective WMI use were time constraints and patient confidence, with participants citing empowerment, time and health-care professional (HCP)–patient relationships as important facilitators. Conclusion The findings provide insight and understanding of peoples needs and expectations, and clarify issues associated with use and non-use of WMI. Challenges include addressing the barriers, especially of time and HCP attitudes to drive changes to workplace practices, and learning from the facilitating factors to encourage awareness and accessibility to WMI as a tool to empower patients.

Objective To investigate the relationship between numeracy and the accuracy of side effect risk estimation following the presentation of information about a medicine via the Cancer Research UK (CR-UK) patient information website. Methods 591 website users were presented with information in different formats about the risks of side effects from taking tamoxifen. Participants estimated the risk of each side effect, provided other subjective ratings about the information and completed a numeracy task. Results Regardless of presentation format, numeracy was correlated with the accuracy of three side effect risk estimates. People with cancer and tamoxifen users showed stronger correlations for all side effect estimates. In addition, numeracy was positively related to the perceived influence of the information on the decision to take the medicine and was negatively related to ratings of satisfaction with the information. Conclusion People with a lower numeracy level make larger errors in interpreting medicines side effect risk information. Practice implications Pharmacists, other health professionals and patient information websites should ensure they provide clear explanations of risk, particularly to people with low numeracy, and assess their understanding of those explanations. Future research into risk communication should take account of numeracy level, to investigate the impact of different formats.

Background: Low adherence of older people to multiple medicine regimens is of widespread concern, and multi-compartment compliance aids are frequently supplied to older people in an attempt to improve their ability to take all their medicines at home. However, the evidence base for the use of such aids is very limited, and there is some evidence that they are used inappropriately. Objective: We aimed to determine how the attitudes and beliefs of older people and healthcare professionals impacted on the use of multi-compartment compliance aids by older people living at home. Method: This was a qualitative study using grounded theory. Semi-structured interviews were conducted with 15 older people (mean age 82 [range 72–92] years) living independently in the community and receiving primary healthcare from two health service organizations in a large northern UK city. We then interviewed 17 healthcare professionals working in primary, secondary or intermediate care and involved in the provision of multi-compartment compliance aids. Results: Maintaining independence and remaining in control was important for all the older people interviewed, and professionals supported the view that this influenced patients’ attitudes towards using their aid. Some patients saw the aids as helping to maintain independence, others as casting doubt on their independence. The aids were often issued without discussion with the patient. The patients largely agreed that the aids did not help with memory problems and that the decision to issue an aid could be seen as paternalistic. A minority of patients had difficulties using the aids. Conclusions: Careful multi-disciplinary assessment of older people is required before a compliance aid is provided. The views of the older person must be considered and respected. Further research is required to produce an evidence base for the use of such aids in this group of people.

INTRODUCTION: Older people in care homes are at increased risk of medication errors and adverse drug events. The effect of formulation on administration errors is not known, that is whether the medicine is a tablet or capsule, liquid or device such as an inhaler. Also, the impact on administration errors of monitored dosage systems (MDS), commonly used in UK care homes to dispense tablets and capsules, is not known. This study investigated the influence of formulation and MDS on administration errors. METHODS: Administration errors were identified by pharmacists (using validated definitions) observing two drug rounds of residents randomly selected from a purposive sample of UK nursing and residential homes. Errors were classified and analysed by formulation and medicine delivery system. RESULTS: The odds of administration errors by formulation, when compared with tablets and capsules in MDS, were: liquids 4.31 (95% CI 2.02 to 9.21; p = 0.0002); topicals/transdermals/injections 19.61 (95% CI 6.90 to 55.73; p < 0.0001); inhalers 33.58 (95% CI 12.51 to 90.19; p < 0.0001). The odds of administration errors for tablets and capsules not in MDS were double those that were dispensed in MDS (adjusted OR 2.14, 95% CI 1.02 to 4.51; p = 0.04). CONCLUSIONS: Inhalers and liquid medicines were associated with significantly increased odds of administration errors. Training of staff in safe administration of these formulations needs implementing. Although there was some evidence that MDS reduced the odds of an administration error, the use of MDS impacts on other aspects of medicines management. Because of this, and as the primary topic of our study was not MDS, a prospective trial specifically designed to evaluate the overall impact of MDS on medicine management in care homes is needed.

Research of websites with information about medicines has not previously taken sufficient account of the design aspects that may affect user’s interacting with the site. This explanatory study combined four concurrent usability methods (user testing, think aloud protocol, observation, and tracking the participant’s online actions), with a sequential interview to examine five websites. Site design and content were found to obstruct participants’ attempts to locate specific information on the web pages. Draft evidence-based design recommendations were derived which, if implemented, could improve the usability of the websites and the readability of their content. Combining concurrent and sequential methods is probably a novel approach for mixed methods and provides a good base on which future mixed methods could be based.

Background: Consumer Medicine Information (CMI) forms an important basis for the dissemination of medicines information worldwide. Methods: This article presents an overview of the design and development of Australian CMI, and discusses ‘user-testing’ as an iterative, formative process for CMI design. Findings: In Australia, legislation and templates guide the creation of CMI by pharmaceutical manufacturers using principles of written health information design, giving consideration to both content and structure. Following these principles to the letter, however, does not always assure the creation of a useable document. A suggested method to gauge the usability of CMI is ‘user-testing’. The process, based on observing individuals using the CMI to answer specific questions, aims to identify areas of weakness in the document allowing targeted improvement. Each question identifies whether (a) the individual can find the relevant information and (b) they can understand it. It is an iterative process designed to be performed repeatedly until it results in a highly-useable CMI. Crucially, the revisions of this information between rounds of testing need to be based on principles of good writing and information design. Other methods of analysing CMI do not actively engage the target audience while simultaneously testing the usability of both content and structure. Although developed in Australia, user testing is not routinely performed on Australian CMI. This is despite the fact that user testing is a legal requirement for leaflets for all new medicines across the European Union (EU). Conclusions: Given CMI’s role in empowering patients with information, it follows that every attempt should be made to ensure that they are consumer friendly and usable. There is a strong argument that user testing should be employed in writing medicine information.

Background High rates of long-term antidepressant prescribing have been identified in the older population. Aims To explore the attitudes of older patients and their GPs to taking long-term antidepressant therapy, and their accounts of the influences on long-term antidepressant use. Design of study Qualitative study using in-depth semi-structured interviews. Setting One primary care trust in North Bradford. Method Thirty-six patients aged ≥75 years and 10 GPs were interviewed. Patients were sampled to ensure diversity in age, sex, antidepressant type, and home circumstances. Results Participants perceived significant benefits and expressed little apprehension about taking long-term antidepressants, despite being aware of the psychological and social factors involved in onset and persistence of depression. Barriers to discontinuation were identified following four themes: pessimism about the course and curability of depression; negative expectations and experiences of ageing; medicine discontinuation perceived by patients as a threat to stability; and passive (therapeutic momentum) and active (therapeutic maintenance) decisions to accept the continuing need for medication. Conclusion There is concern at a public health level about high rates of long-term antidepressant prescribing, but no evidence was found of a drive for change either from the patients or the doctors interviewed. Any apprehension was more than balanced by attitudes and behaviours supporting continuation. These findings will need to be incorporated into the planning of interventions aimed at reducing long-term antidepressant prescribing in older people.

Background: All licensed medicines in the European Union must be provided with a Patient Information Leaflet that includes a list of all known side effects. Among patients who read the leaflet, the side effects section is the most often read. A UK government regulatory publication recommends providing medicine side effect risk information in a combined format, using verbal descriptors accompanied by numerical information. Objectives: This study, with users of an existing popular patient information website, investigates the effectiveness of presenting medicine side effect risk information in different forms. Design: Participants were randomly allocated to one of the three formats for representing risk information (verbal descriptors, e.g. ‘common’; absolute frequencies, e.g. ‘less than 1 in 10 people’; and a combination of verbal descriptors and frequency bands, e.g. ‘common (affects less than 1 in 10 people)’. Methods: Participants (n= 187) were recruited from users of the Cancer Research UK patient information website. They were asked to imagine that they had to take a cancer treatment (tamoxifen), estimate the risks of four side effects occurring, and complete Likert scales relating to their satisfaction with the information supplied and perceived likelihood of various outcomes. Results: Those in the absolute frequency format demonstrated greater accuracy in estimating the likelihood of having two of four side effects than the other two formats. They were also more accurate at estimating the likelihood of themselves or the average person having any side effect from taking tamoxifen. Participants in the absolute frequency format rated the risk to health from tamoxifen as lower than those in the other two formats, were more satisfied with the information they received than those in the verbal format, and felt there would be less impact of the information on tamoxifen use than those in the combined format. Conclusions: These findings fail to confirm that the recommended use of combined descriptors for medicine side effects is unequivocally superior to absolute frequency alone. They also add weight to the growing body of research highlighting the deficiencies in using verbal descriptors for conveying side effect risk, and the strength of using absolute frequency descriptors.

To revise and improve an existing scale to measure health practitioners' attitudes to partnership in medicine taking and to ascertain the views of medical students, nursing students and pre-registration pharmacists on concordance. The traditional model of the practitioner-patient interaction incorporates a practitioner-centred approach, focusing on the disease rather than the patient. The philosophy of 'concordance' (or 'partnership in medicine-taking') puts the patient at the centre of the interaction, with the patient interacting reciprocally with the practitioner. The Leeds Attitude to Concordance (LATCon) scale was developed in 2001 to assess practitioners' and patients' attitudes to concordance. However, thinking on concordance has developed since then and the present study aimed to revise the scale to ensure that it reflected current thinking and also to increase its reliability and validity. A pool of potential items was developed and sent to three subject experts for opinion. An attitudinal Likert scale of 31 items was developed. Its completion was followed by statistical item reduction to 20 items. The shorter scale was completed by the same participants 4-6 weeks later. The study was set in a university in the UK. Participants were 183 medical students, nursing students, and pre-registration pharmacists. The study derived a 20 item scale, including five negatively-worded items, with good levels of internal and test-retest reliability. Factor analysis suggested five main factors. A statistically significant difference in attitudes was found between student nurses and medical students, and student nurses and pre-registration pharmacists, with student nurses being more in agreement with the concordant approach. Overall, participants were in agreement with the concordant approach to medicine taking. The UK National Health Service advocates partnership in medical care and is encouraging both practitioners and patients to work to introduce this. There is increased awareness of the patients' perspective by practitioners, but its impact on their practice remains unclear. Education and skills teaching must continue for the benefits of a concordant approach to be seen. The LATCon scale could play a useful role in education and training, and in research assessing the movement towards the new approach.

Background: Effective written consumer medicines information is essential to support safe and effective medicine taking, but the wording and layout of currently provided materials do not meet patients' needs. Objective: To identify principles from the wider discipline of information design for use by health professionals when developing or assessing written drug information for patients. Methods: Six experts in information design nominated texts on best practice in information design applicable to consumer medicines information. A content analysis identified key principles that were tabulated to bring out key themes. Results: Six texts that met the Inclusion criteria, were Identified, and content analysis indentified 4 themes: words, type, lines, and layout. Within these main themes, there were 24 subthemes. Selected principles relating to these subthemes were: use short familiar words, short sentences, and short headings that stand out from the text; use a conversational tone of voice, addressing the reader as “you”; use a large type size while retaining sufficient white space; use bullet points to organize lists; use unjustified text (ragged right) and bold, lower-case text for emphasis. Pictures or graphics do not necessarily improve a document. Conclusions: Applying the good information design principles identified to written consumer medicines information could support health professionals when developing and assessing drug information for patients.

Aim The identification of medication-monitoring errors requires a validated definition. This paper describes the development and validation of a definition which includes criteria for specific medicines to determine whether a medication-monitoring error has occurred in the care home setting. Setting Criteria were developed for older people (aged 65 years or older) living in care homes. Methods Criteria were developed by two clinical pharmacists using published guidelines. The criteria were divided into those relating to initiation of therapy and maintenance monitoring. The study steering group, made up of clinical pharmacists, a general practitioner (GP) and pharmacy academics, then reviewed the criteria and a consensus was achieved. The criteria were then reviewed by a sample of 21 GPs and 11 clinical pharmacists. The threshold for acceptance for each criterion was set at 70% by agreement of all participants. Key findings The definition of a medication-monitoring error was accepted as ‘when a prescribed medicine is not monitored in the way which would be considered acceptable in routine general practice. It includes the absence of tests being carried out at the frequency listed in the criteria for each medicine, with tolerance of +50%’. Seventy per cent agreement was reached on all criteria for the initiation of therapy, except warfarin (69%), and on all criteria for maintenance monitoring, except penicillamine (63%) and potassium (63%). Conclusions To our knowledge, this is the first study to define a medication-monitoring error, and to determine and validate specific criteria to identify such errors in older people living in care homes.

Aims and MethodTo determine the prescribing patterns for antipsychotics in care homes for the elderly, a cross-sectional study was carried out using data from the intervention group of a randomised controlled trial of medication review in care homes.ResultsOf 331 residents studied, 67 (20%) were prescribed an antipsychotic (70% atypical); 57 of these (85%) did not have a diagnosis of a psychotic disorder. The antipsychotic prescribing rate was 32% (46 out of 146) for those with dementia and 10% (17 out of 174) for those without dementia. A quarter (82 out of 331) had received a medication review by the general practitioner in the preceding 12 months.Clinical ImplicationsOne-fifth of residents were prescribed an antipsychotic with little evidence of review. Systems should ensure residents' treatment is reviewed regularly.

Objectives To describe the rate and nature of pharmacist interventions following clinical medication review of elderly people living in care homes. Setting Care home residents aged 65+ years, prescribed at least one repeat medication, living in nursing, residential and mixed care homes for older people in Leeds, UK. Method Analysis of data from care home residents receiving clinical medication review in the intervention arm of a randomised controlled trial. Intervention outcomes for each medicine were evaluated for each resident. Key findings Three-hundred and thirty-one residents were randomised to receive a clinical medication review and 315 (95%) were reviewed by the study pharmacist; 256 (77%) residents had at least one recommendation made to the general practitioner. For the 2280 medicines prescribed, there were 672 medicine-related interventions: medicines for cardiovascular system (167 (25%)), nutrition and blood (121 (18%)), central nervous system (113 (17%)) and gastrointestinal conditions (86 (13%)) accounted for 487 (73%) of medicine-related interventions. There were 75 non-medicine-related interventions. The most common interventions were ‘technical’ (225 (30%)), ‘test to monitor medicine’ (161 (22%)), ‘stop drug’ (100 (13%)), ‘test to monitor conditions' (75 (10%)), ‘start drug’ (76 (10%)), ‘alter dose’ (40 (5%)) and ‘switch drug’ (37 (5%)). Recommendations to stop a medicine were most common for CNS drugs (32 (32%)). The most common medicine to be recommended to be started was calcium and vitamin D (45 (59%)). Following a recommendation to test to monitor a medicine, 23 (14%) medicines required a change. Conclusions This study has demonstrated that clinical medication review by a pharmacist can identify medicine problems in approximately 80% of care home residents, requiring intervention in 1 in 4 of their prescribed medications.

Introduction Outpatient parenteral antimicrobial therapy (OPAT) is used to treat a wide range of infections, and is common practice in countries such as the USA and Australia. In the UK, national guidelines (standards of care) for OPAT services have been developed to act as a benchmark for clinical monitoring and quality. However, the availability of OPAT services in the UK is still patchy and until quite recently was available only in specialist centres. Over time, National Health Service (NHS) Trusts have developed OPAT services in response to local needs, which has resulted in different service configurations and models of care. However, there has been no robust examination comparing the cost-effectiveness of each service type, or any systematic examination of patient preferences for services on which to base any business case decision. Methods and analysis The study will use a mixed methods approach, to evaluate patient preferences for and the cost-effectiveness of OPAT service models. The study includes seven NHS Trusts located in four counties. There are five inter-related work packages: a systematic review of the published research on the safety, efficacy and cost-effectiveness of intravenous antibiotic delivery services; a qualitative study to explore existing OPAT services and perceived barriers to future development; an economic model to estimate the comparative value of four different community intravenous antibiotic services; a discrete choice experiment to assess patient preferences for services, and an expert panel to agree which service models may constitute the optimal service model(s) of community intravenous antibiotics delivery. Ethics and dissemination The study has been approved by the NRES Committee, South West—Frenchay using the Proportionate Review Service (ref 13/SW/0060). The results of the study will be disseminated at national and international conferences, and in international journals.

Objective: to measure the impact of pharmacist-conducted clinical medication review with elderly care home residents. Design: randomised controlled trial of clinical medication review by a pharmacist against usual care. Setting: sixty-five care homes for the elderly in Leeds, UK. Participants: a total of 661 residents aged 65+ years on one or more medicines. Intervention: clinical medication review by a pharmacist with patient and clinical records. Recommendations to general practitioner for approval and implementation. Control patients received usual general practitioner care. Main outcome measures: primary: number of changes in medication per participant. Secondary: number and cost of repeat medicines per participant; medication review rate; mortality, falls, hospital admissions, general practitioner consultations, Barthel index, Standardised Mini-Mental State Examination (SMMSE). Results: the pharmacist reviewed 315/331 (95.2%) patients in 6 months. A total of 62/330 (18.8%) control patients were reviewed by their general practitioner. The mean number of drug changes per patient were 3.1 for intervention and 2.4 for control group (P < 0.0001). There were respectively 0.8 and 1.3 falls per patient (P < 0.0001). There was no significant difference for GP consultations per patient (means 2.9 and 2.8 in 6 months, P = 0.5), hospitalisations (means 0.2 and 0.3, P = 0.11), deaths (51/331 and 48/330, P = 0.81), Barthel score (9.8 and 9.3, P = 0.06), SMMSE score (13.9 and 13.8, P = 0.62), number and cost of drugs per patient (6.7 and 6.9, P = 0.5) (£42.24 and £42.94 per 28 days). A total of 75.6% (565/747) of pharmacist recommendations were accepted by the general practitioner; and 76.6% (433/565) of accepted recommendations were implemented. Conclusions: general practitioners do not review most care home patients’ medication. A clinical pharmacist can review them and make recommendations that are usually accepted. This leads to substantial change in patients’ medication regimens without change in drug costs. There is a reduction in the number of falls. There is no significant change in consultations, hospitalisation, mortality, SMMSE or Barthel scores.