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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.

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 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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

Objectives To describe the nature and rate of interventions made by a pharmacist conducting clinical medication reviews in general practice. Method Patients, randomly allocated to the intervention group, in a randomised controlled trial of 1,188 patients, were invited to a pharmacist-conducted medication review clinic at their general practice. Patients were seen over one year from June 1, 1999, to May 31, 2000. In the consultation an assessment was made of the patient, their clinical conditions and medication. Consultation outcomes for each patient and intervention outcomes for each medicine were evaluated. Setting Patients were recruited from four randomly selected general practices in Leeds, UK. Patients were eligible if aged 65 years or over and on at least one repeat medicine. Key findings Consultations were held with 590 patients in the intervention group (97 per cent). A recommendation for change was made in 44 per cent (258/591) of consultations. The most common outcome was a change in medication: 29 per cent of consultations (170/591). Doctor referral occurred for 28 patients (5 per cent) and nurse referral for 25 (4 per cent). Study patients were recorded as taking 2,927 repeat medications (mode of two per patient). Interventions were made for 21 per cent of medications (603). Clinically related interventions accounted for 71 per cent (430/603). Recommendations were spread evenly across therapy groups. At the study end, 90 per cent (433/484) of recommendations remained implemented. Conclusion A pharmacist who clinically reviewed elderly patients, their conditions and their medications, intervened in nearly half the patients. The pharmacist was able to implement most interventions without referring the patient to a doctor or nurse.

Background: Written medicine information can play an important role in educating consumers about their medicines. In Australia, standardised, comprehensive written information known as Consumer Medicine Information (CMI) is available for all prescription medicines. CMI is reportedly under-utilised by general practitioners (GPs) and community pharmacists in consultations, despite consumer desire for medicine information. This study aimed to determine consumers', GPs' and community pharmacists' preferences for CMI provision and identify barriers and facilitators to its use. Method. Structured questionnaires were developed and administered to a national sample of Australian consumers (phone survey), community pharmacists and GPs (postal surveys) surrounding utilisation of CMI. Descriptive and comparative analyses were conducted. Results: Half of consumers surveyed wanted to receive CMI for their prescription medicine, with spoken information preferable to written medicine information for many consumers and healthcare professionals. GPs and pharmacists remained a preferred source of medicine information for consumers, although package inserts were appealing to many among all three cohorts. Overall pharmacists were the preferred provider of CMI primarily due to their medicine expertise, accessibility and perceived availability. GPs preferred CMI dissemination through both the GP and pharmacist. Some consumers preferred GPs as the provider of medicines information because of their knowledge of the patients' medicines and/or medical history, regularity of seeing the patient and good relationship with the patient. Common barriers to CMI provision cited included: time constraints, CMI length and perceptions that patients are not interested in receiving CMI. Facilitators to enhance provision included: strategies to increase consumer awareness, longer consultation times and counseling appointments, and improvements to pharmacy software technology and workflow. Conclusion: Medicine information is important to consumers, whether as spoken, written or a combination of both. A tailored approach is needed to ascertain individual patient preference for delivery and scope of medicine information desired so that appropriate information is provided. The barriers of time and perceived attitudes of healthcare practitioners present challenges which may be overcome through changes to workplace practices, adoption of identified facilitators, and education about the positive benefits of CMI as a tool to engage and empower patients.

Background Over-the-counter medicines must be supplied with appropriate, user-friendly medicine information to satisfactorily support consumer self-management and safe use. Product labels and written medicine information leaflets are highly accessible over-the-counter medicine information sources for consumers. Factors such as comprehensibility and design underpin the usefulness of over-the-counter labels and leaflets and should be further examined to better inform future optimisation strategies. Aim of the review To undertake an in-depth exploration of studies that have evaluated design and/or comprehensibility of over-the-counter labels and written medicine information leaflets Methods Database searches were performed using Medline, Embase, International Pharmaceutical Abstracts and PubMed. Studies exploring over-the-counter medicine label and/or leaflet comprehensibility and/or design were identified. Additional author and reference list searches were performed to identify studies which met the inclusion criteria and key terms. Results A total of 35 studies were included in the review, which explored OTC medicine information design and/or comprehensibility via researcher evaluation alone (n = 8) or with consumers (n = 27). Researcher-determined over-the-counter written medicine information leaflet readability (n = 4) has highlighted suboptimal readability, with few studies evaluating over-the-counter leaflet performance using the gold standard method of ‘user testing’ with consumers (n = 2). Variable over-the-counter label comprehensibility was identified in consumer studies, ranging from satisfactory understanding to considerable misunderstanding. The review findings indicate that consumer outcomes were influenced by information design, where implementation of good design principles generally improved over-the-counter label and leaflet performance. Significant diversity existed in study design aspects such as sampling frames, sample sizes and tools used to evaluate over-the-counter medicine information, which hindered the ability to adequately compare various study aspects and findings. Conclusion A wide spectrum of consumer understanding of over-the-counter medicine labels is evident in the literature, with limited studies examining over-the-counter written medicine information leaflet comprehensibility with consumers. The application of good information design principles in over-the-counter labels and leaflets contribute to improved performance. Well-designed consumer studies are needed to ascertain and optimise over-the-counter label and leaflet performance.

Summary In Europe, patient leaflets are supplied as an insert inside all medicine packs. Manufacturers must produce such leaflets according to a template and undertake consultation with target patient groups to ensure it is legible, clear and easy to use, before a licence will be granted. The consultation is usually completed through ‘user testing’, involving individual interviews with lay participants, with both quantitative and qualitative components. After testing, good practice is applied to address shortcomings identified, and testing repeated. The process is described using the example of a patient booklet for lithium therapy. Such testing could benefit any future US process for patient medication information.

Objectives To explore participants' opinions and preferences on tailored written medicines information. 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 exemplar leaflets for a cardiovascular medicine based on the angiotensin-converting enzyme (ACE) inhibitor ramipril, which was tailored for a man aged 55 with hypertension. Reference to other indications of the medicine, children's doses, pregnancy and breast-feeding information were removed. A topic guide directed the discussion and explored preferences and opinions on tailored leaflets. Focus group discussions were recorded, transcribed verbatim and content analysed using adapted cross-case study analysis. Key findings Participants welcomed the concept of tailored information, desiring shorter and more relevant information. Information tailored to their condition or disease was most sought-after, followed by tailoring by age or gender. However, some participants voiced concerns about the potential for the wrong information being given to patients who would be unable to recognise that it was incorrect. Other concerns included how tailoring might impact upon the quality of information available and the feasibility of delivery, especially regarding the legal implications (Australia) and the cost (UK). A key finding was the participants' desire for a truly individualised approach to tailoring medicines information, as opposed to the generalised tailored information provided in the study. Participants said they would value having spoken communication with a healthcare professional at the same time as they received tailored leaflets. Conclusions Most participants welcomed tailored leaflets but overall valued a more personalised approach than the generalised tailored information we provided. Despite concerns about quality and delivery, many felt tailoring written medicines information could improve the relevance of the information to the individual and potentially encourage them to value it.

Objectives The study evaluated the interpretation of, and preferences for, numerical information on side-effect incidence when presented in three different formats. Methods It used a controlled design, with participants allocated at random to receive one of the three formats. Participants were recruited via a pop-up window on the CancerHelp UK website. The sample comprised 129 website users, of whom 96% were women and 86% had cancer, who received frequency information on four side effects of tamoxifen, using one of three risk expressions (percentages, e.g. ‘affects 25% of people’; frequencies, e.g. ‘affects 1 in 4 people’; combined, e.g. ‘affects 1 in 4 people (25%)’). They then interpreted information on tamoxifen and its effect on health, and estimates of side-effect frequency, and then stated a preference from the three risk expression formats. Key findings The results showed that the three formats did not influence participants’ ratings of the information or their side-effect estimates. However, more than half (53%) the participants preferred the combined (frequency and percentage) format. In conclusion, a combined risk expression format performed no worse than percentages or frequencies alone and was preferred by a majority. Conclusions The three risk expression formats did not differ in their effect on participants’ interpretations. However, the preferred format was the combined (frequency and percentage) risk expression.

Pharmacists can influence patients' compliance with prescribed medicines not only by educating and informing patients but also by helping to simplify their medication regimens. This article discusses the measurement of compliance and looks at ways of improving it.

Introduction: Care home residents are at particular risk from medication errors, and our objective was to determine the prevalence and potential harm of prescribing, monitoring, dispensing and administration errors in UK care homes, and to identify their causes. Methods: A prospective study of a random sample of residents within a purposive sample of homes in three areas. Errors were identified by patient interview, note review, observation of practice and examination of dispensed items. Causes were understood by observation and from theoretically framed interviews with home staff, doctors and pharmacists. Potential harm from errors was assessed by expert judgement. Results: The 256 residents recruited in 55 homes were taking a mean of 8.0 medicines. One hundred and seventy-eight (69.5%) of residents had one or more errors. The mean number per resident was 1.9 errors. The mean potential harm from prescribing, monitoring, administration and dispensing errors was 2.6, 3.7, 2.1 and 2.0 (0 = no harm, 10 = death), respectively. Contributing factors from the 89 interviews included doctors who were not accessible, did not know the residents and lacked information in homes when prescribing; home staff’s high workload, lack of medicines training and drug round interruptions; lack of team work among home, practice and pharmacy; inefficient ordering systems; inaccurate medicine records and prevalence of verbal communication; and difficult to fill (and check) medication administration systems. Conclusions: That two thirds of residents were exposed to one or more medication errors is of concern. The will to improve exists, but there is a lack of overall responsibility. Action is required from all concerned.

Objective: To determine whether a programme of self medication for inpatients improves compliance with treatment and knowledge of their drugs after discharge from hospital. Design: Patients were prospectively recruited from four wards: two with a self medication programme and two acting as controls. Ten days after discharge the patients were visited at home. They were questioned about their drugs, and a tablet count was undertaken. Setting: The pharmacy department and four medical wards with an interest in elderly patients at a district general hospital, and the patients9 homes. Patients: 88 patients discharged to their own homes who were regularly taking one or more drugs. Intervention: A hospital self medication programme in which patients are educated about their medicines and given increasing responsibility for taking them in hospital. Main outcome measure: Compliance with and knowledge of the purpose of their medicines 10 days after discharge from hospital. Results: The mean compliance score in patients taking part in the self medication programme was 95% compared with 83% in the control group (difference 12%, 95% confidence interval 4% to 21%; P Conclusion: A self medication programme is an effective aid for improving compliance with and knowledge of patients9 drugs after discharge. Key messages Key messages It results in significantly higher levels of compliance after discharge A small but significant increase in resources is required Most (95%) patients preferred self medication to administration of medicines by nurses in hospital

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

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.

Focal points □ The government proposes an extension to pharmacists' role to medicine management, including services such as medication review □ We found that pharmacist-conducted clinical medication review identified medication related problems in nearly half of the patients seen and a quarter of medicines reviewed □ Pharmacist-conducted clinical medication review is effective in identifying clinical issues related to patients' repeat medication and recommendations are accepted by general practitioners □ There are education and training issues for pharmacy if this model is to be accepted more widely. The pharmacist will need to be part of the primary health care team with access to medical records

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.