Janet Krska

Ibuprofen and diclofenac are nonsteroidal anti-inflammatory drugs widely used worldwide. Spontaneous reporting often results in an underestimation of the incidence of adverse drug reactions (ADRs), and a few studies have been conducted in community settings, particularly in community pharmacies. This study aimed to determine the frequency and characteristics of short-term ADRs associated with ibuprofen and diclofenac in community pharmacy patients. This prospective cohort study was conducted in 15 community pharmacies. A questionnaire from a previous study was modified and tested for content validity. Community pharmacists distributed the questionnaire after dispensing ibuprofen or diclofenac and followed non-responders via telephone and online media platforms. The returned questionnaires were assessed for causality by a pharmacist and three researchers. Descriptive analyses and comparisons between reports on ibuprofen and diclofenac were performed using chi-square and independent t-tests for appropriate outcomes. Of the 590 distributed questionnaires, 279 were included in the analysis. The percentage of participants who reported ADRs to ibuprofen and diclofenac was 33.3%. Among participants with suspected ADRs, the average number of suspected ADRs from diclofenac was higher than from ibuprofen; however, no significant difference was observed (5.5 ± 8.9 and 3.1 ± 3.0, p > 0.05). Of the 347 self-reported ADRs, 45.2% were assessed as probable and possible ADRs. The highest rate of suspected ADRs was in Mental Health (14.4%), followed by the Nose, Throat, Neck, or Voice (9.8%), and the Stomach or Digestive Systems (8.9%), respectively. Diclofenac showed more suspected ADRs than ibuprofen in a community setting. Almost half of the self-reported ADRs were assessed as probable or possible. Strategies for sustaining community pharmacists in monitoring patients and reporting ADRs should be supported.

The World Health Organisation (WHO) has set a target to “improve access to safe, effective, quality and affordable essential medicines and vaccines for all” by 2030 [ 1]. Improved information supporting patients to make better use of available medicines is also essential. Now more than ever, patients need greater vigilance and better access to medicine information to avoid preventable harm, given the increasing shortages of essential medicines, product falsification, and increased access to medicines via unregulated sources. Indeed, the WHO recommends that patients pay attention to medicine packaging and look out for unusual features [ 2]. Written information about medicines seems ubiquitous in many countries, as patient information leaflets (PILs) included in full packs of medicinal products, on the packaging itself, and available on health-related websites. Medicine users perceive the importance of understanding the likely benefits and risks of their medicines and how to use them but may feel overwhelmed by information. Most systematic reviews on written medicine information (WMI) have focused on high-income countries, where it is routinely available and thus where most research has been carried out [ 3, 4]. These have found limited evidence of improved knowledge of or adherence to medicines, that WMI uses complex language and poor visual presentation [ 3] and that PILs were not meeting patients’ needs, lacking the information they sought, but including material perceived as non-essential [ 4].

Objectives: Written medicine information (WMI) is important for ensuring patients understand and use their medicines optimally, but relatively little research has assessed the quality of available WMI. This study assessed the quality of WMI using a sample of leaflets for ibuprofen in the UK and Thailand. Methods: Leaflets were obtained by purchasing a product from retail outlets or community pharmacies, 18 from each country. In the UK, these were patient information leaflets (PILs); in Thailand, they were package inserts PIs not specifically designed for patients. Leaflets were assessed for content, layout, and readability using standard methods and compared to relevant guidelines. Key findings: The UK PILs were uniform and conformed to EU regulatory requirements for content, whereas Thai PIs varied considerably, many failing to include important information required by Thai regulations. Several forms of Thai PIs were found, including some very short leaflets, containing minimal information. The readability of both was rated as poor, all used small font size and had less than desirable white space. Fewer Thai PIs than UK PILs met the Keystone Criteria for ibuprofen. Conclusions: The extent of variation in format and content of Thai WMI could potentially cause confusion and reduce willingness to read it. PILs, conforming to Thai regulatory guidelines, should be provided with medicines instead. Leaflets in both countries would benefit from improved readability and layout.

Background: Verbal and written medicine information are available to the public but the quality, ease of access, ease of understanding and use of these resources varies greatly between countries. Timely access to quality medicine information is essential to support patient safety. Objective: This international cross-sectional survey, conducted in low-to high-income countries, aimed to compare experiences of and preferences for medicine information sources among respondents with recent medicine use. Methods: The survey was originally developed in England (Kent), then adapted and translated for use in southern Thailand (Songkhla), Malaysia (Klang Valley), and central Uganda (Kampala). Data were analysed using simple descriptive statistics and Chi-squared tests. Results: A total 1588 respondents were involved in the study. Community pharmacies were the primary source of medicines in all four countries (40.7 to 65.3%). Most respondents (1460; 92%) had received at least one form of information with their medicine, but provision of written medicine information (WMI) varied between countries. A manufacturer’s leaflet was the most frequent information source for patients in England, while verbal information was common in Thailand, Malaysia and Uganda. There was commonality across countries in the desire for verbal information with or without WMI (1330; 84.8%); aspects of medicine information wanted most frequently were instructions on medicine use (98.3%), indication (98.2%), name (94.4%) and possible side effects (94.3%); and the importance of providing leaflets with all medicines (87.5%). Fewer than 10% in Uganda would use internet based WMI, compared to between 20% and 55% elsewhere. Conclusion: Preferences for medicine information are similar across countries: verbal information is seen as most desirable, and the most wanted aspects of information are common internationally. Accessibility and understandability are key influences on preferred information sources. In-country regulations and practices should ensure that all medicine users can access the information necessary to maximise safe medicine use.

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

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).

Purpose: This study aimed to compare package inserts and patient information leaflets for omeprazole in terms of the quality of and satisfaction with the written medicine information, medication safety knowledge, and perceived benefits and risks. Patients and methods: A cross-sectional, comparative study was conducted at a university hospital in Thailand. Outpatients visiting the pharmacy departments prescribed omeprazole were randomly selected to receive either a package insert or a patient information leaflet. Medication safety knowledge was measured using a set of eight questions. The quality of the written medicine information was measured by the Consumer Information Rating Form. Perceived benefits and risks of the medication were rated using a visual analog scale. Linear regression was used to determine factors associated with perceived benefits and risks. Results: Of the 645 patients, 293 agreed to answer the questionnaire. 157 and 136 patients were given patient information leaflets and package inserts, respectively. Most respondents were female (65.6%), over half had a degree (56.2%). Patients reading the patient information leaflets had slightly higher overall safety knowledge scores than those reading the package inserts (5.88 ± 2.25 vs 5.25 ± 1.84, p=0.01). Using the Consumer Information Rating Form, the patient information leaflets were given significantly higher scores compared to the package inserts for comprehensibility (19.34± 3.92 vs 17.32± 3.52, p< 0.001) and design quality (29.25 ± 5.00 vs 23.81 ± 5.16, p< 0.001). After reading the leaflets, patients receiving the patient information leaflets had significantly higher satisfaction with the information provided (p=0.003). In contrast, those receiving the package inserts rated the risks of omeprazole higher (p=0.007). Conclusion: Demonstrable differences were found from the patient perspective between a package insert and a patient information leaflet for the same medicine, mostly in favour of patient information leaflets. Medicine safety knowledge after reading PI and PIL was similar. However, receiving package inserts provided higher perceived risks from taking the medicine.

Background: Tackling problematic polypharmacy requires tailoring the use of medicines to individual needs and circumstances. This may involve stopping medicines (deprescribing) but patients and clinicians report uncertainty on how best to do this. The TAILOR medication synthesis sought to help understand how best to support deprescribing in older people living with multimorbidity and polypharmacy. Objectives: We identified two research questions: (1) what evidence exists to support the safe, effective and acceptable stopping of medication in this patient group, and (2) how, for whom and in what contexts can safe and effective tailoring of clinical decisions related to medication use work to produce desired outcomes? We thus described three objectives: (1) to undertake a robust scoping review of the literature on stopping medicines in this group to describe what is being done, where and for what effect; (2) to undertake a realist synthesis review to construct a programme theory that describes ‘best practice’ and helps explain the heterogeneity of deprescribing approaches; and (3) to translate findings into resources to support tailored prescribing in clinical practice. Data sources: Experienced information specialists conducted comprehensive searches in MEDLINE, Cumulative Index to Nursing and Allied Health Literature, Web of Science, EMBASE, The Cochrane Library (Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials), Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports, Google (Google Inc., Mountain View, CA, USA) and Google Scholar (targeted searches). Review methods: The scoping review followed the five steps described by the Joanna Briggs Institute methodology for conducting a scoping review. The realist review followed the methodological and publication standards for realist reviews described by the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) group. Patient and public involvement partners ensured that our analysis retained a patient-centred focus. Results: Our scoping review identified 9528 abstracts: 8847 were removed at screening and 662 were removed at full-text review. This left 20 studies (published between 2009 and 2020) that examined the effectiveness, safety and acceptability of deprescribing in adults (aged ≥ 50 years) with polypharmacy (five or more prescribed medications) and multimorbidity (two or more conditions). Our analysis revealed that deprescribing under research conditions mapped well to expert guidance on the steps needed for good clinical practice. Our findings offer evidence-informed support to clinicians regarding the safety, clinician acceptability and potential effectiveness of clinical decision-making that demonstrates a structured approach to deprescribing decisions. Our realist review identified 2602 studies with 119 included in the final analysis. The analysis outlined 34 context–mechanism–outcome configurations describing the knowledge work of tailored prescribing under eight headings related to organisational, health-care professional and patient factors, and interventions to improve deprescribing. We conclude that robust tailored deprescribing requires attention to providing an enabling infrastructure, access to data, tailored explanations and trust. Limitations: Strict application of our definition of multimorbidity during the scoping review may have had an impact on the relevance of the review to clinical practice. The realist review was limited by the data (evidence) available. Conclusions: Our combined reviews recognise deprescribing as a complex intervention and provide support for the safety of structured approaches to deprescribing, but also highlight the need to integrate patient-centred and contextual factors into best practice models. Future work: The TAILOR study has informed new funded research tackling deprescribing in sleep management, and professional education. Further research is being developed to implement tailored prescribing into routine primary care practice. Study registration: This study is registered as PROSPERO CRD42018107544 and PROSPERO CRD42018104176. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 32. See the NIHR Journals Library website for further project information.

Reviews on the role, value, effectiveness and desirable content of written medicine information (WMI) mostly include studies from high-income countries. We reviewed studies from Africa and Asia published between January 2004 and December 2019 to determine (1) the effect of WMI on knowledge and behaviour and (2) whether patients value WMI and their preferences for WMI. We included 16 intervention studies involving almost 3500 participants and 27 surveys of patients/public totalling over 11,000 people. Both the quality of the intervention studies and the reporting quality varied. Surveys were mostly localised, many with inadequate sampling strategies, and hence, were poorly representative of wider populations. However, most included a high proportion of participants with low educational levels. Most of the intervention studies reported significant improvements in knowledge and/or adherence after provision of WMI. Many utilised specially developed WMI in local languages, enhanced by pictograms. Provision of verbal information in addition to WMI showed variable impact. The proportion of people who read WMI, used as an indicator of its value, was reported in 15 surveys, with an overall figure of 74%. The most desirable aspects of WMI reported in 12 studies were indication, side effects, dose/instructions for use, contraindications, precautions and interactions. Nine studies reported local language was desirable. The studies suggest that WMI can improve both knowledge and adherence and is highly valued by people in many countries across Africa and Asia. Mechanisms should be considered by regulatory authorities and manufacturers to facilitate the provision of leaflets in local languages using simple terminology, perhaps enhanced by pictograms. This study is registered with PROSPERO, registration number: CRD42019127001.