Person-centred medicines optimisation policy in England: an agenda for research on polypharmacy

Aim: To examine how patient perspectives and person-centred care values have been represented in documents on medicines optimisation policy in England. Background: There has been growing support in England for a policy of medicines optimisation as a response to the rise of problematic polypharmacy. Conceptually, medicines optimisation differs from the medicines management model of prescribing in being based around the patient rather than processes and systems. This critical examination of current official and independent policy documents questions how central the patient is in them and whether relevant evidence has been utilised in their development. Methods: A documentary analysis of reports on medicines optimisation published by the Royal Pharmaceutical Society (RPS), The King’s Fund, and National Institute for Health and Social Care Excellence (NICE) since 2013. The analysis draws on a non-systematic review of research on patient experiences of using medicines. Findings: The reports varied in their inclusion of patient perspectives and person-centred care values, and in the extent to which they drew on evidence from research on patients’ experiences of polypharmacy and medicines use. In the RPS report, medicines optimisation is represented as being a ‘step change’ from medicines management, in contrast to the other documents which suggest that it is facilitated by the systems and processes that comprise the latter model. Only The King’s Fund report considered evidence from qualitative studies of people’s use of medicines. However, these studies are not without their limitations. We suggest five ways in which researchers could improve this evidence base and so inform the development of future policy: by facilitating reviews of existing research; conducting studies of patient experiences of polypharmacy and multimorbidity; evaluating medicines optimisation interventions; making better use of relevant theories, concepts and tools; and improving patient and public involvement in research and in guideline development

Optimal scaling and contingency tables reveal the mismatch between patients’ attitude and perception towards their asthma medications and complaints during the I-MUR service provision

Asthma prevalence is increasing and the economic loss due to lack of asthma control is €72 billion in EU 28. Pharmacists have a role to play, and a bespoke novel pharmacist-led intervention for asthma patients, called Italian Medicines Use Review (I-MUR), has shown both effectiveness and cost-effectiveness. The I-MUR intervention enables asthma patients to optimise the effect of their medications. This study aimed at assessing the mismatch between patients’ attitude-perception towards their medications and their complaints during the I-MUR service provision. The I-MUR was provided in four different Italian locations; data were collected and analysed using descriptive statistics, optimal scaling and contingency tables. The number of pharmacists and asthma patients involved in the study was 74 and 895 respectively. The majority of patients (72%) did not believe that they had problems with their medications, 78% confirmed that they had full knowledge and understanding of their medications, 75% said that their medications were working and 45% confirmed that they missed a dose. The number of patients who raised complaints was 683 (76%) and the number of complaints raised by each patient ranged between 1 to 5. Only 18% of the patient population reporter having neither medicine-related problems nor asthma-related complaints. The use of optimal scaling and contingency tables unveiled the mismatch between patients’ attitude-perception towards their medicines and the type and number of complaints raised by them during the I-MUR service provision

Measuring medicine-related experiences from the patient perspective: a systematic review

Background There is an increasing drive to measure and so improve patients’ experiences and outcomes of health care. This also applies to medicines, given their ubiquity as health care interventions. Patients’ experiences of using medicines vary and instruments which measure these are seen as an essential component to improve care. We aimed to identify generic measures of patients’ experiences of using prescription medicines and to examine their properties and suitability for use in research or practice. Methods Multiple electronic databases were searched: Medline, Embase, PsycINFO, PsycARTICLES, CINAHL Plus, the PROQOLID®, and Google Scholar. We identified, critically appraised and summarized generic questionnaires assessing one or more aspects of the medicine use experience among adult patients using prescription medicines for chronic conditions, and the process of questionnaire-development, degree of patient-involvement, and/or validation processes. Results 15 questionnaires were included. Of these, nine measures were multidimensional, covering various aspects of medicine use. Six instruments covered only a single domain, assessing a specific facet of using medicines. Domains covered were: effectiveness; convenience, practicalities and/or managing medicines; information, knowledge and/or understanding; side effects; relationships and/or communication with health professionals; impact on daily living and/or social life; general satisfaction; attitudes; beliefs, concerns, and/or perceptions; medical follow-up and/or adherence-related issues; treatment- and/or medicine-related burden, perceived control or autonomy; self-confidence about medicine use; availability and accessibility; and medicine-related quality of life. None of the identified questionnaires covered all domains. Instruments varied in the extent of both patient involvement in their development and in validation. Conclusion There is a scarcity of psychometrically sound, comprehensive, generic measures of experiences of using prescription medicines among adult patients living with chronic illnesses. There is a need for further development and/or validation of existing instruments suitable for use in this populatio

Experiences and Views of Medicine Information Among the General Public in Thailand

Purpose: Written and electronic medicine information are important for improving patient knowledge and safe use of medicines. Written medicine information in Thailand is mostly in the form of printed package inserts (PIs), designed for health professionals, with few medicines having patient information leaflets (PILs). The aim of this study was to determine practices, needs and expectations of Thai general public about written and electronic medicine information and attitudes towards PILs. Patients and Methods: Cross-sectional survey, using self-completed questionnaires, was distributed directly to members of the general public in a large city, during January to March 2019. It explored experiences of using information, expectations, needs and attitudes, the latter measured using a 10-item scale. Differences between sub-groups were assessed, applying the Bonferroni correction to determine statistical significance. Results: Of the total 851 questionnaires distributed, 550 were returned (64.2%). The majority of respondents (88%) had received PIs, but only a quarter (26.2%) had received PILs. Most respondents (78.5%) had seen medicine information in online form. High educational level and income increased the likelihood of receiving PILs and electronic information. The majority of respondents (88.5%) perceived PILs as useful, but 70% considered they would still need information about medicines from health professionals. Indication, drug name and precautions were the most frequently read information in PIs and perceived as needed in PILs. Three-quarters of respondents would read electronic information if it were available, with more who had received a PIL having previously searched for such information compared to those who had not. All respondents had positive overall attitudes towards PILs. Conclusion: Experiences of receiving PILs and electronic medicine information in Thailand are relatively limited. However, the general public considered PILs as a useful source of medicine information. Electronic medicine information was desired and should be developed to be an additional source of information for consumers

Consistency and replicability of a pharmacist-led intervention for asthma patients: Italian Medicines Use Review (I-MUR)

Aim: This study aimed to assess the consistency and replicability of these process measures during provision of the Italian Medicines Use Review (I-MUR). Background: Medication review is a common intervention provided by community pharmacists in many countries, but with little evidence of consistency and replicability. The I-MUR utilised a standardised question template in two separate large-scale studies. The template facilitated pharmacists in recording medicines and problems reported by patients, the pharmaceutical care issues (PCIs) they found and actions they took to improve medicines use. Methods: Community pharmacists from four cities and across 15 regions were involved in the two studies. Patients included were adults with asthma. Medicines use, adherence, asthma problems, PCIs and actions taken by pharmacists were compared across studies to assess consistency and replicability of I-MUR. Findings: The total number of pharmacists and patients completing the studies was 275 and 1711, respectively. No statistically significant differences were found between the studies in the following domains: patients’ demographic, patients’ perceived problems, adherence, asthma medicines used and healthy living advice provided by pharmacists. The proportion of patients in which pharmacists identified PCIs was similar across both studies. There were differences only in the incidence of non-steroidal anti-inflammatory drug use, the frequency of potential drug-disease interactions and in the types of advice given to patients and GPs. Conclusions: The use of a standardised template for the I-MUR may have contributed to a degree of consistency in the issues found, which suggests this intervention could have good replicability

Patients’ use of information about medicine side effects in relation to experiences of suspected adverse drug reactions

Background Adverse drug reactions (ADRs) are common, and information about medicines is increasingly widely available to the public. However, relatively little work has explored how people use medicines information to help them assess symptoms that may be suspected ADRs. Objective Our objective was to determine how patients use patient information leaflets (PILs) or other medicines information sources and whether information use differs depending on experiences of suspected ADRs. Method This was a cross-sectional survey conducted in six National Health Service (NHS) hospitals in North West England involving medical in-patients taking at least two regular medicines prior to admission. The survey was administered via a questionnaire and covered use of the PIL and other medicines information sources, perceived knowledge about medicines risks/ADRs, experiences of suspected ADRs, plus demographic information. Results Of the 1,218 respondents to the survey, 18.8 % never read the PIL, whilst 6.5 % only do so if something unexpected happens. Educational level was related to perceived knowledge about medicines risks, but not to reading the PIL or seeking further information about medicines risks. Over half the respondents (56.0 %) never sought more information about possible side effects of medicines. A total of 57.2 % claimed they had experienced a suspected ADR. Of these 85.9 % were either very sure or fairly sure this was a reaction to a medicine. Over half of those experiencing a suspected ADR (53.8 %) had read the PIL, of whom 36.2 % did so before the suspected ADR occurred, the remainder afterwards. Reading the PIL helped 84.8 % of these respondents to decide they had experienced an ADR. Educational level, general knowledge of medicines risks and number of regular medicines used all increased the likelihood of experiencing an ADR. Conclusion More patients should be encouraged to read the PIL supplied with medicines. The results support the view that most patients feel knowledgeable about medicines risks and suspected ADRs and value information about side effects, but that reading about side effects in PILs or other medicines information sources does not lead to experiences of suspected ADRs

Public confidence in ADR identification and their views on ADR reporting: mixed method study

Purpose: The value of patients as potential reporters into pharmacovigilance systems is acknowledged worldwide and allowed in Thailand. However, nothing is known about the Thai public’s awareness of direct patient reporting facility or their views concerning it. This study aimed to determine confidence among members of the public in identifying suspected ADRs, information sources they use and their views towards direct ADR reporting. Methods: Mixed methods study consisting of self-administered questionnaires (phase 1) and semi-structured, face-to-face interviews (phase 2) with members of the public, recruited in primary care centres, pharmacies and public places during October 2013 to February 2015. All questionnaire respondents reporting an ADR were invited to participate in Phase 2. Written informed consent was made before the start of the interview. Results: There were 414 (17.2%) of 2400 questionnaire respondents who had experienced an ADR, almost half (46%) of whom used their own experience to identify ADRs. Having a degree, having a severe ADR and consulting a physician increased respondent confidence in the association between medicine and suspected ADR. The majority (27) of the 30 interviewees indicated general agreement with patient reporting to regulatory authorities. Four main themes emerged covering reasons for reporting ADRs including expectations of health authorities, healthcare professionals and manufacturers, and helping other people. Awareness of direct reporting was low with a desire for a range of reporting methods. Conclusion: Results indicate support among the Thai general public of direct ADR reporting. Greater promotion of direct reporting by all healthcare professionals is required

Development and validation of a revised instrument to measure burden of long-term medicines use: the Living with Medicines Questionnaire version 3

Objectives To revise the Living with Medicines Questionnaire (LMQ-2), which measures the burden of using prescribed medicines, to include cost and expand side effects and social issues. Methods New statements were developed and validated through cognitive interviews with medicines users and these and a global visual analogue scale (VAS) added to the 42-item LMQ-2. Construct validity was assessed through exploratory and confirmatory factor analyses using an on-line public survey. Criterion-related validity was measured against the Treatment Satisfaction Questionnaire with Medication (TSQM-II) and the EQ-5D-5L, in patients using community pharmacies, general practices and out-patient clinics. Reliability was assessed by test-re-test using on-line public distribution. Results The 58-item interim instrument (n=729) was reduced to 41 items after factor analysis, which confirmed an eight-domain structure: relationships with health professionals, practicalities, interferences, effectiveness, side effects, concerns, cost, autonomy, constructed as medicines burden. All subscales, except autonomy, loaded onto this construct and showed acceptable internal consistency. LMQ-VAS correlated with total LMQ scores (r=0.571). Criterion validation (n=422) demonstrated total LMQ scores negatively correlated with TSQM scores for global satisfaction (r=-0.616); domain scores showed similar correlations: effectiveness (r=-0.628), side-effects (r=-0.597), practicalities (r=-0.529). Total LMQ score was negatively correlated with EQ VAS (r=-0.383) and showed weak/moderate relationships with individual EQ-5D-5L dimensions. Test-retest (n=30) showed intra-class correlation coefficients of 0.954 (total LMQ score), 0.733-0.929 (domain scores) and 0.789 (global item). Conclusion The LMQ-3 instrument has acceptable construct, criterion-related and known-groups validity, and is internally consistent as a measure of medicines burden, although reliability requires further confirmation. It could be used to measure the outcome of interventions designed to reduce the burden of polypharmacy

What happens after an NHS Health Check? A survey and realist review

Background: The National Health Service Health Check in England aims to provide adults aged 40 to 74 with an assessment of their risk of developing cardiovascular disease and to offer advice to help manage and reduce this risk. The programme is commissioned by local authorities and delivered by a range of providers in different settings, although primarily in general practices. This project focused on variation in the advice, onward referrals and prescriptions offered to attendees following their health check. Objectives: (1) Map recent programme delivery across England via a survey of local authorities; (2) conduct a realist review to enable understanding of how the National Health Service Health Check programme works in different settings, for different groups; (3) provide recommendations to improve delivery. Design: Survey of local authorities and realist review of the literature. Review methods: Realist review is a theory-driven, interpretive approach to evidence synthesis that seeks to explain why, when and for whom outcomes occur. We gathered published research and grey literature (including local evaluation documents and conference materials) via searching and supplementary methods. Extracted data were synthesised using a realist logic of analysis to develop an understanding of important contexts that affect the delivery of National Health Service Health Checks, and underlying mechanisms that produce outcomes related to our project focus. Results: Our findings highlight the variation in National Health Service Health Check delivery models across England. Commissioners, providers and attendees understand the programme’s purpose in different ways. When understood primarily as an opportunity to screen for disease, responsibility for delivery and outcomes rests with primary care, and there is an emphasis on volume of checks delivered, gathering essential data and communicating risk. When understood as an opportunity to prompt and support behaviour change, more emphasis is placed on delivery of advice and referrals to ‘lifestyle services’. Practical constraints limit what can be delivered within the programme’s remit. Public health funding restricts delivery options and links with onward services, while providers may struggle to deliver effective checks when faced with competing priorities. Attendees’ responses to the programme are affected by features of delivery models and the constraints they face within their own lives. Limitations: Survey response rate lower than anticipated; review findings limited by the availability and quality of the literature. Conclusions and implications: The purpose and remit of the National Health Service Health Check programme should be clarified, considering prevailing attitudes about its value (especially among providers) and what can be delivered within existing resources. Some variation in delivery is likely to be appropriate to meet local population needs, but lack of clarity for the programme contributes to a ‘postcode lottery’ effect in the support offered to attendees after a check. Our findings raise important questions about whether the programme itself and services that it may feed into are adequately resourced to achieve positive outcomes for attendees, and whether current delivery models may produce inequitable outcomes. Future work: Policy-makers and commissioners should consider the implications of the findings of this project; future research should address the relative scarcity of studies focused on the end of the National Health Service Health Check pathway. Study registration: PROSPERO registration CRD42020163822. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Services and Delivery Research programme (NIHR129209)

Comparison of pharmacist and public views and experiences of community pharmacy medicines-related services in England

Background: Services provided by community pharmacists designed to support people using medicines are increasing. In England, two national services exist: Medicine Use Reviews (MUR) and New Medicines Service (NMS). Very few studies have been conducted seeking views of the public, rather than service users, on willingness to use these services or expectations of these services, or determined whether views align with pharmacist perceptions. Objective: To compare the perceptions of pharmacists and the general public on medicines-related services, particularly MUR and NMS services. Methods: Two parallel surveys were conducted in one area of England: one involved the general public and was administered using a street survey, and the other was a postal survey of community pharmacists. Similar questionnaires were used, seeking views of services, awareness, reasons for using services, and perceived benefits. Results: Response rates were 47.2% (1,000/2,012 approached) for the public and 40.8% (341/836) for pharmacists. Few people had experienced a discussion in a private consultation room or were aware of the two formal services, although their willingness to use them was high. Pharmacists estimated time spent on service provision as 10 minutes for MUR and 12 minutes for NMS, which aligned with acceptability to both pharmacists and the public. Pharmacists underestimated the willingness of the public to wait for an informal discussion or to make appointments for formal services. Both pharmacists and the public had high expectations that services would be beneficial in terms of increasing knowledge and understanding, but public expectations and experiences of services helping to sort out problems fell well below pharmacists’ perceptions. People who had experienced a pharmacy service had different perceptions of pharmacists. Conclusion: Views differed regarding why people use services and key aspects of service delivery. For services to improve, the pharmacy profession needs a better awareness of what the public, especially those with potential to benefit from services, view as acceptable and desirable