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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.

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.

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 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 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.

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.

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.

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.

Increasing evidence suggests that implementation intentions are effective in moving people towards achieving health behaviour goals. However, the type of health behaviours for which they work best is unclear. Furthermore, implementation intentions appear to be less effective when studied in clinical rather than student populations. This prospective study tested implementation intentions with a complex, repeated health behaviour in a patient sample. A total of 120 cardiac patients in the UK were asked to increase their daily fruit and vegetable consumption by two portions and to maintain this over 3 months. Participants were randomly assigned to three groups (control, Theory of Planned Behaviour (TPB) questionnaire, TPB questionnaire+implementation intention) and telephoned at 7, 28 and 90 days follow-up to record daily consumption (24-h recall measure); 94 participants completed the study. Daily fruit and vegetable consumption increased from 2.88 portions (SD=1.67) at recruitment to 4.28 portions (SD=2.25) at 90 days. A 4×3 (time by group) mixed design ANCOVA was computed with daily fruit and vegetable consumption at recruitment entered as a covariate. This revealed a significant time effect (F (3, 270)=29.79, p 0.001 ) ( η 2 = 0.25 ) but non-significant group (F (2, 90)=0.32, p = 0.73 ) ( η 2 = 0.07 ) and time by group effects (F (6, 270)=0.48, p = 0.82 ) ( η 2 = 0.01 ) . There was also a significant main effect of the covariate (F (1, 90)=48.51, p 0.001 ) ( η 2 = 0.35 ) and a significant time by covariate effect (F (3, 270)=12.14, p 0.001 ) ( η 2 = 0.12 ) . Substantial increases in fruit and vegetable consumption were achieved particularly by participants who were eating low levels at recruitment. Consumption was not improved by implementation intentions. These findings are discussed in the context of the targeted health behaviour and sample.

Objective: To determine whether the use of verbal descriptors suggested by the European Union (EU) such as "common" (1–10% frequency) and "rare" (0.01–0.1%) effectively conveys the level of risk of side effects to people taking a medicine. Design: Randomised controlled study with unconcealed allocation. Participants: 120 adults taking simvastatin or atorvastatin after cardiac surgery or myocardial infarction. Setting: Cardiac rehabilitation clinics at two hospitals in Leeds, UK. Intervention: A written statement about one of the side effects of the medicine (either constipation or pancreatitis). Within each side effect condition half the patients were given the information in verbal form and half in numerical form (for constipation, "common" or 2.5%; for pancreatitis, "rare" or 0.04%). Main outcome measure: The estimated likelihood of the side effect occurring. Other outcome measures related to the perceived severity of the side effect, its risk to health, and its effect on decisions about whether to take the medicine. Results: The mean likelihood estimate given for the constipation side effect was 34.2% in the verbal group and 8.1% in the numerical group; for pancreatitis it was 18% in the verbal group and 2.1% in the numerical group. The verbal descriptors were associated with more negative perceptions of the medicine than their equivalent numerical descriptors. Conclusions: Patients want and need understandable information about medicines and their risks and benefits. This is essential if they are to become partners in medicine taking. The use of verbal descriptors to improve the level of information about side effect risk leads to overestimation of the level of harm and may lead patients to make inappropriate decisions about whether or not they take the medicine.

Aims To determine whether a medicine review and education programme influences the compliance and knowledge of older people in general practice. Methods Older people taking at least three medicines were randomly allocated to a control or intervention group. Both groups received three visits from a clinical pharmacist: Visit 1: Assessment and patients' medicines rationalized in intervention group. Visit 2: Intervention group given medicines education. Visit 3: Knowledge and compliance in both groups assessed by structured questionnaire Results Compliance in the intervention group was 91.3%, compared with 79.5% in the control group (P

There have been widespread changes in society and the roles of professionals. This change is also reflected in health care, where there is now acceptance of the need to involve patients in decision making. In prescribing specifically, the concordance agenda was developed alongside these initiatives to encourage improved medication taking and reduce wastage. However the extent to which these partnerships are delivered in practice remains unclear. This paper explores some of the issues to be considered when preparing patients and professionals for partnership and summarizes the limited evidence of barriers to, and benefits of, this approach. Firstly patients must be given the confidence, skills and knowledge to be partners. They need information about medicines, provided in ways known to be acceptable to them. Likewise professionals may need new skills to be partners. They need to understand the patient agenda and may need training and support to change the ways in which they consult with patients. There are also practical issues such as the perceived increase in time taken when consulting in partnership mode, room layout, computer interfaces and record keeping. Health care professionals other than doctors are also expected to behave in partnership mode, whether this is as prescribers in their own right or in supporting the prescribing of others. Whilst much has been claimed for the benefit of partnership approaches, hard evidence is limited. However whilst there is still much more to understand there will be no going back to the paternalistic model of the mid 20th century.

Background The participant information sheet (PIS) provided to potential trial participants is a critical part of the process of valid consent. However, there is long-standing concern that these lengthy and complex documents are not fit-for-purpose. This has been supported recently through the application of a performance-based approach to testing and improving readability called user testing. This method is now widely used to improve patient medicine leaflets - determining whether people can find and understand key facts. This study applied for the first time a controlled design to determine whether a PIS developed through user testing had improved readability over the original, using a sheet from a UK trial in acute myeloid leukemia (AML16). Methods In the first phase the performance of the original PIS was tested on people in the target group for the trial. There were three rounds of testing including 50 people in total - with the information revised according to its performance after each of the first 2 rounds. In the second phase, the revised PIS was compared with the original in a parallel groups randomised controlled trial (RCT) A total of 123 participants were recruited and randomly allocated to read one version of the PIS to find and show understanding of 21 key facts. Results The first, developmental phase produced a revised PIS significantly altered in its wording and layout. In the second, trial phase 66% of participants who read the revised PIS were able to show understanding of all aspects of the trial, compared with 15% of those reading the original version (Odds Ratio 11.2; Chi-square = 31.5 p < .001). When asked to state a preference, 87.1% participants chose the revised PIS (Sign test p < .001). Conclusions The original PIS for the AML16 trial may not have enabled valid consent. Combining performance-based user testing with expertise in writing for patients and information design led to a significantly improved and preferred information sheet. User testing is an efficient method for indicating strengths and weaknesses in trial information, and Research Ethics Committees and Institutional Review Boards should consider requesting such testing, to ensure that PIS are fit-for-purpose.

Background: There has been an increasing drive from consumers for more information to be available about their medicines. However, the layout and presentation of such written information is variable, and the poor format and design discourages people from reading the documents. Objective: To identify, collate, and evaluate different formats of written medicine information (WMI). Methods: Three researchers evaluated 157 samples of WMI for 10 prescription and 3 over-the-counter medicines from 6 English-speaking countries compared with the United States Keystone Consensus Criterion 8 (USKCC8) and the Ten Key Principles (TKP) of Consumer Medicine Information. Readability was measured using Flesch-Kincaid Grade Level (FKGL) and Fog tests. Compliance (%) with the criteria was computed and examined using the median test. Results: Overall median compliance with USKCC8 was 70%, and 74% to TKP. New Zealand leaflets achieved the highest compliance with USKCC8 (83%, Interquartile range (IQR) 70–89%), with US leaflets the lowest (55%. IQR 45–70%). Australian and New Zealand leaflets showed the highest compliance with TKP (90%, IQR 80–100% and 87–97%, respectively), while UK leaflets demonstrated the lowest (60%, IQR 52–71%). Overall median reading grades for the leaflets were 10 (Flesch-Kincaid Grade Level) and 11 (Fog). Conclusions: Compliance with USKCC8 and TKP varied greatly between countries, with readability grades exceeding the recommended range. International examples of WMI show wide variation in compliance with guidelines on recommended format and presentation. These examples of WMI require high literacy to read. Future WMI development should use more recommended formats and increase comprehensibility.

OBJECTIVE--To investigate whether a reminder chart improved patients' compliance with their drug regimen after discharge from hospital. DESIGN--Patients were randomly allocated to one of four groups. Two groups received the reminder chart: one also received routine counselling from a nurse and the other received structured counselling from a pharmacist, which included an explanation of the reminder chart. The other two groups received only counseling, either from a nurse or from a pharmacist. Patients were visited about 10 days later: they were questioned about their drug regimen, and their compliance was measured by tablet counting. SETTING--The pharmacy in a district general hospital and patients' homes. PATIENTS--197 patients being discharged from hospital who were regularly taking two or more drugs. INTERVENTION--An individualised reminder chart, which listed each person's medicines and when they were to be taken and was automatically generated by a medicine labelling computer. MAIN OUTCOME MEASURES--Patient's compliance with and knowledge of their drug regimen. MAIN RESULTS--Of the patients who received the reminder chart, 83% (95% confidence interval 74% to 90%) correctly described their dose regimen compared with 47% (37% to 58%) of those without the chart (p < 0.001). The mean compliance score was 86% (81% to 91%) in both groups not given the reminder chart; 91% (87% to 94%) in the group given the chart without an explanation; and 95% (93% to 98%) in the group given the chart and an explanation. A mean compliance score of > 85% was achieved by 63% (53% to 73%) of patients without a reminder chart and by 86% (78% to 93%) of those receiving the chart (p < 0.001). CONCLUSIONS--An automatically generated reminder chart is a practical and cost effective aid to compliance.

Objective: To determine whether a pharmacist can effectively review repeat prescriptions through consultations with elderly patients in general practice. Design: Randomised controlled trial of clinical medication review by a pharmacist against normal general practice review. Setting: Four general practices. Participants: 1188 patients aged 65 or over who were receiving at least one repeat prescription and living in the community. Intervention: Patients were invited to a consultation at which the pharmacist reviewed their medical conditions and current treatment. Main outcome measures: Number of changes to repeat prescriptions over one year, drug costs, and use of healthcare services. Results: 590 (97%) patients in the intervention group were reviewed compared with 233 (44%) in the control group. Patients seen by the pharmacist were more likely to have changes made to their repeat prescriptions (mean number of changes per patient 2.2 v 1.9; difference=0.31, 95% confidence interval 0.06 to 0.57; P=0.02). Monthly drug costs rose in both groups over the year, but the rise was less in the intervention group (mean difference £4.72 per 28 days, −£7.04 to -£2.41); equivalent to £61 per patient a year. Intervention patients had a smaller rise in the number of drugs prescribed (0.2 v 0.4; mean difference −0.2, −0.4 to −0.1). There was no evidence that review of treatment by the pharmacist affected practice consultation rates, outpatient consultations, hospital admissions, or death rate. Conclusions: A clinical pharmacist can conduct effective consultations with elderly patients in general practice to review their drugs. Such review results in significant changes in patients9 drugs and saves more than the cost of the intervention without affecting the workload of general practitioners. What is already known on this topic Review of patients on long term drug treatment is important but is done inadequately Evidence from the United States shows that pharmacists can improve patient care by reviewing drug treatment What this study adds Consultations with a clinical pharmacist are an effective method of reviewing the drug treatment of older patients Review by a pharmacist results in more drug changes and lower prescribing costs than normal care plus a much higher review rate Use of healthcare services by patients is not increased

Background: Herbal products obtained over the counter are commonly used in Europe, North America and Australia.\ud Although there is concern about a lack of information provided to consumers to allow the safe use of these products,\ud there has been no published research to confirm these fears. In this study, we evaluated written information provided\ud with commonly used herbal products in the UK in advance of a European Union Directive issued in April 2011 that\ud tightened regulations for some herbal products, including requirements to provide safety information.\ud Methods: Five commonly used herbal products were purchased from pharmacies, health food shops and\ud supermarkets: St John’s wort, Asian ginseng, echinacea, garlic and ginkgo. Written information provided with the\ud products (on the package or on a leaflet contained in the package) was evaluated for inclusion of each of the key\ud safety messages included in the monographs of the US National Center for Complementary and Alternative\ud Medicine. Specifically, we looked for information on precautions (such as Asian ginseng not being suitable for\ud people with diabetes), interactions with conventional medicines (such as St John’s wort with the contraceptive pill\ud and warfarin) and side effects (such as ginkgo and allergic reactions).\ud Results: Our analysis showed that, overall, 51 (75%) of 68 products contained none of the key safety messages.\ud This included 4 of 12 St John’s wort products, 12 of 12 ginkgo products, 6 of 7 Asian ginseng products, 20 of 21\ud garlic products and 9 of 13 echinacea products. The two products purchased that are registered under the new\ud European Union regulations (for St John’s wort) contained at least 85% of the safety messages.\ud Conclusions: Most of the herbal medicine products studied did not provide key safety information which\ud consumers need for their safe use. The new European Union legislation should ensure that St John’s wort and\ud echinacea products will include the previously missing information in due course. The legislation does not apply to\ud existing stock. Depending on therapeutic claims made by manufacturers, garlic, ginkgo and Asian ginseng products\ud may not be covered by the legislation and can continue to be bought without the safety information. Also,\ud consumers will still be able to buy products over the internet from locations outside European Union jurisdiction.\ud Potential purchasers need to know, in both the short term and the long term, how to purchase herbal products\ud which provide the information they need for the safe use of these products.