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Background Demonstrating a person-centred approach in a consultation is a key component of delivering high-quality healthcare. To support development of such an approach requires training underpinned by valid assessment tools. Given the lack of a suitable pharmacy-specific tool, a new global consultation skills assessment tool: the medicines related-consultation assessment tool (MR-CAT) was designed and tested. Aim This study aimed to test the validity and reliability of the MR-CAT using psychometric methods. Method Psychometric testing involved analysis of participants’ (n = 13) assessment of fifteen pre-recorded simulated consultations using the MR-CAT. Analysis included discriminant validity testing, intrarater and interrater reliability testing for each of the five sections of the MR-CAT and for the overall global assessment of the consultation. Analysis also included internal consistency testing for the whole tool. Results Internal consistency for the overall global assessment of the consultation was good (Cronbach’s alpha = 0.97). The MR-CAT discriminated well for the overall global assessment of the consultation (p Conclusion The MR-CAT is a valid and reliable tool for assessing person-centred pharmacist’s consultations. Moreover, its unique design means that the MR-CAT can be used in both formative and summative assessment.

Background Emergency Department Pharmacist Practitioners (EDPPs) undertake both ‘traditional’ clinical pharmacy work, e.g. check prescriptions, and ‘practitioner’ work, e.g. perform clinical examinations. A recent study found a large variation in the extent and type of care provided. Whilst variation allows services to be tailored to local needs, it is important that care meets the minimum standards that are safe, effective, patient-centred, timely, efficient, and equitable. Objective(s) To develop an EDPP service specification based on views of professional and patient stakeholders, primarily to support providers with delivery of high quality services. Methods Patients, ED pharmacists and other ED healthcare professionals developed standards guided by the Institute of Medicine's quality domains. A panel of six ED pharmacists suggested and agreed on themes that should be included in the service specification. Additional themes were identified through interviews with eight patients who had been cared for by EDPPs as to their expectations of the service. Finally, a multidisciplinary expert panel of healthcare professionals and researchers reviewed and refined the service specification. Results ED pharmacists developed 36 themes with consensus achieved for 25. Additional themes from the patient interviews concerned the communication and behaviour of EDPPs rather than specific clinical activities undertaken. Whilst patients were happy to be cared for by an EDPP working within their competence, for certain conditions (e.g. major trauma) they wanted a doctor as their main care provider. An evidence-based EDPP service specification of 52 criteria grouped into 4 categories was produced: direct patient care (29); other activities (10); general approach (10); and service structures (3). Conclusions As the product of both patient and expert input, EDs could align existing or newly developed services to the specification. Whether or not the specification actually improves the quality of EDPP services requires investigation, as does the absolute quality impact of services.

OBJECTIVES: To survey and explore current approaches to deployment of pharmaceutical care prioritisation tools in acute hospitals in the UK.METHODS: A national online survey was circulated electronically to chief pharmacists of hospitals to determine if they use a prioritisation tool or process. Where such mechanisms exist, respondents were invited to participate in a semistructured telephone interview to explore the development, evaluation and application of their tool and share relevant documentation. Interviews were transcribed and thematically analysed.RESULTS: Seventy hospitals (70/130) used a tool or process to prioritise clinical pharmacy services. Thirty-six interviews were conducted, and two were excluded. The majority of tools had been developed in-house. Few hospitals had undertaken formal evaluations of their prioritisation tool. Pharmacy prioritisation tools ranged in complexity and often included a combination of pharmacy service prioritisation, such as medicines reconciliation, and a section to assign an individual patient prioritisation level. Determining the priority of a patient based on the identification of set indicators instilled confidence in pharmacists by ensuring they were not missing high-risk patients. Electronic prioritisation tools were especially useful at retrieving real-time data to prioritise workload, improving workflow and ensuring continuity in patient care. Drawbacks of using prioritisation tools included lack of tool sensitivity across certain specialties and time spent using the tool if not all information was accessible.CONCLUSIONS: Prioritisation tools were seen to be useful for prioritising workload and ensuring the right patients are seen at the right time. As few hospitals had formally evaluated their tools, it is important to rigorously and systematically develop an evidence-based prioritisation tool that is both useable and acceptable. Further research to evaluate such tools would be needed to ensure it improves patient health outcomes and efficiency in pharmacy services.

BackgroundDemonstrating a person-centred approach in a consultation is a key component of delivering high-quality healthcare. To support development of such an approach requires training underpinned by valid assessment tools. Given the lack of a pharmacy-specific tool, a new global consultation skills assessment tool: the Medicines Related – Consultation Assessment Tool (MR-CAT) was designed and tested.AimThis study aimed to test the validity and reliability of the MR-CAT CAT using psychometric methods.MethodsPsychometric testing involved analysis of participants’ (n = 13) assessment of fifteen pre-recorded simulated consultations using the MR-CAT. Analysis included discriminant validity testing, intrarater and interrater reliability testing, and internal consistency testing for each of the five sections of the MR-CAT. ResultsInternal consistency for the overall global assessment and each of the five sections of the MR-CAT was good (Cronbach’s alpha = 0.97). The MR-CAT discriminated well at the global level (p ConclusionsThe MR-CAT is a valid and reliable tool for assessing person-centred pharmacy consultations. Moreover, its unique design means that the MR-CAT can be used in both formative and summative assessment.

AimTo systematically identify studies of implementing risk management measures when prescribing teratogenic medicines for women of childbearing age and studies reporting risk perceptions of teratogenic medications.MethodsMEDLINE, CINAHL, Scopus, EMBASE, and International Pharmaceutical Abstracts were searched. Studies were included in the risk management section if they reported any of the following risk management measures: teratogenic counseling, contraceptive counseling, pregnancy testing before starting treatment, pregnancy testing during treatment, use of contraception before starting treatment, and use of contraception during treatment. Studies were included in the perceptions section if they reported perceived teratogenic risk as numerical value.ResultsFifty‐five studies were included in the risk management section and seven studies were included in the perceptions sections. Prevalence of risk management measures varied as follows: teratogenic counseling (9.5%–99.3%), contraceptive counseling (6.1%–98%), pregnancy testing before starting treatment (0%–95.1%), pregnancy testing during treatment (12.7%–100%), contraception use before starting treatment (15.7%–94%), and contraception use during treatment (1.7%–100%). A proper estimation of the teratogenic risk was reported for thalidomide (by general practitioners and obstetric/gynecologists), for etretinate (by pregnant women), and for misoprostol (by pregnant and nonpregnant women). An under‐estimation was reported for warfarin and retinoids (by general practitioners and obstetric/gynecologists). And over‐estimation was reported for thalidomide, valproate, lithium, isotretinoin, phenytoin, warfarin and etretinate by different populations.ConclusionConsiderable variation in the implementation of risk management measures when prescribing teratogenic medicines to women of childbearing age is reported in the literature. A common tendency to over‐estimate the risk of teratogenic medications was evident.

Using the WHO pharmacovigilance (PV) indicators as a framework, this study aimed to explore the structures, processes, and outcomes of three Arab countries’ (Jordan, Oman, and Kuwait) PV systems to inform recommendations for countries with nascent PV systems. A mixed-methods design involving document review, semi-structured interviews, and a questionnaire was employed. Fifty-six key informants from the three countries’ national PV centres (NPVCs) and pharmaceutical industry were interviewed. The questionnaire collecting quantitative measures was only completed by Oman and Kuwait’s NPVCs. Using the framework, system strengths were attributed to the presence of “core” structural indicators, including a dedicated and officially recognised NPVC, PV legislation, and a national PV advisory committee, as well as “complementary” structural indicators, e.g., a computerised case-report management system. Contrastingly, weaknesses were attributed to the absence of these indicators plus other “core” structural indicators, namely, regular financial provision and adequate staff. Other weaknesses were attributed to low performance in “core” process and outcome indicators including reporting rates, reporter awareness, and signal detection. Greater governmental prioritisation through the provision of legislative enforcements, resources, and expertise as part of a well-structured system is required. More regional coordination efforts are needed to allow for sharing of expertise in order to bolster nascent systems.

Background: Drug utilization studies are essential to facilitate rational drug use in the society. Aim: In this review, we provide an overview of drug utilization measures that can be used with individual-level drug dispensing data, referencing additional reading on the individual analysis. This is intended to serve as a primer for those new to drug utilization research and a shortlist from which researchers can identify useful analytical approaches when designing their drug utilization study. Results and Discussion: We provide an overview of: (1) basic measures of drug utilization which are used to describe changes in drug use over time or compare drug use in different populations; (2) treatment adherence measures with specific focus on persistence and implementation; (3) how to measure drug combinations which is useful when assessing drug–drug interactions, concomitant treatment, and polypharmacy; (4) prescribing quality indicators and measures to assess variations in drug use which are useful tools to assess appropriate use of drugs; (5) proxies of prescription drug misuse and skewness in drug use; and (6) considerations when describing the characteristics of drug users or prescribers.

AimThis study aimed to investigate the prescribing trajectory, geographical variation and population factors including the socioeconomic status (SES) related to prescribing gabapentinoids in primary care in England.MethodsThis ecological study applied practice-level dispensing data and statistics from the UK National Health Service Digital and Office for National Statistics from 2013-2019. The prescribing of gabapentinoids (in defined daily doses (DDDs)/1000 people) was measured annually and quarterly. General practices were categorised according to the quarterly prescribing in a group-based trajectory model. The one-year prescribing in 2018/19 was associated with practice-level covariates in a mixed-effects multilevel regression; adjusted for the cluster-effects of Clinical Commissioning Groups (CCGs) and mapped geographically.ResultsThe annual national prescription rate increased by 70% from 2800 to 4773 DDDs/1000 people in the time period 2013/14 to 2018/19. General practices were stratified into six trajectory groups. Practices with the highest level and the greatest increase in prescribing (n=792; 9.8%) are mainly located in the north of England and along the east and south coastline. Socioeconomic status, demographic characteristics and relevant disease conditions were significantly associated with the prescribing. For every decrease in the Index of Multiple Deprivation decile (becoming less affluent), prescribing of gabapentinoids significantly increased by 203 (95%CI: 183, 222) DDDs/1000 registrants. ConclusionGabapentinoid prescribing trajectories varied across geographical regions and are associated with socioeconomic status, CCG locality (geography) and other population characteristics. These factors should be considered in future studies investigating the determinants of gabapentinoid prescribing and the risk of harms associated with gabapentinoids.

BackgroundMost patients with mental illness are managed in primary care, yet there is a lack of data exploring potential prescribing safety issues in this setting for this population.ObjectivesExamine the prevalence of, between-practice variation in, and patient and practice-level risk factors for, 18 mental health-related potentially hazardous prescribing indicators and four inadequate medication monitoring indicators in UK primary care.MethodCross-sectional analyses of routinely collected electronic health records from 361 practices contributing to Clinical Practice Research Datalink GOLD database. The proportion of patients ‘at risk’ (based on an existing diagnosis, medication, age and/or sex) triggering each indicator and composite indicator was calculated. To examine between-practice variation, intraclass correlation coefficient (ICC) and median OR (MOR) were estimated using two-level logistic regression models. The relationship between patient and practice characteristics and risk of triggering composites including 16 of the 18 prescribing indicators and four monitoring indicators were assessed using multilevel logistic regression.Results9.4% of patients ‘at risk’ (151 469 of 1 611 129) triggered at least one potentially hazardous prescribing indicator; between practices this ranged from 3.2% to 24.1% (ICC 0.03, MOR 1.22). For inadequate monitoring, 90.2% of patients ‘at risk’ (38 671 of 42 879) triggered at least one indicator; between practices this ranged from 33.3% to 100% (ICC 0.26, MOR 2.86). Patients aged 35–44, females and those receiving more than 10 repeat prescriptions were at greatest risk of triggering a prescribing indicator. Patients aged less than 25, females and those with one or no repeat prescription were at greatest risk of triggering a monitoring indicator.ConclusionPotentially hazardous prescribing and inadequate medication monitoring commonly affect patients with mental illness in primary care, with marked between-practice variation for some indicators. These findings support health providers to identify improvement targets and inform development of improvement efforts to reduce medication-related harm.

Background As Arab countries seek to implement the ‘Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries’, understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). Results Matland’s ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that policy ambiguity and conflict were low in Jordan and Oman, suggesting an “administrative implementation” pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied, suggesting a mixture between “experimental implementation” and “symbolic implementation”. Factors reducing policy ambiguity in Jordan and Oman included: decision-makers’ guidance to implementors, stakeholder involvement in the policy’s development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy’s compliance with internationally recognised standards and the policy’s fit with local capabilities (all three countries), decision-makers’ cooperation with and support of the national centre as well as stakeholders’ agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan). Conclusions Using Matland’s model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.

Background The Kuwaiti drug regulatory authority (DRA) lack a structured classification system for the assessment of imported herbal medicines (HMs), which leads to ambiguity in the registration process. This study aimed to examine the policy development and implementation process in an established HM registration system (Bahrain) and harness lessons to inform recommendations for a suitable HM classification system and explore implementation readiness in Kuwait. Methods A sequential study design was chosen, with data collected in Bahrain (case 1), recommendations formed and readiness for implementation explored subsequently in Kuwait (case 2). With ethics and DRA approval in place, data sources were documentary review of regulatory policies, direct observations of HMs registration processes, and semi-structured interviews with twenty three key officials involved in the HMs registration processes. Data from all three sources were analysed thematically and findings triangulated. Results The classification policy in Bahrain was found to be based on evidence and extensive stakeholder engagement, resulting in a clear and organised HM registration process. The availability of HMs classification policies in other DRAs, officials’ dedication and teamwork, and support by higher authority, were identified as the main facilitators in policy development and successful implementation. Barriers were the diversity of HM classifications worldwide, a lack of staff and resultant workload, and lack of training. Proposed recommendations for Kuwait were to adopt a clear definition of what constituted HMs, and to introduce a Traditional Herbal Registration based on this definition and the product’s characteristics. Interviews in Kuwait showed that almost all participants were in favour of the proposed recommendations and were in support of timely implementation. Interviewees anticipated that consistency in the HM registration process would be the main benefit, increasing reviewer’s confidence in making regulatory decisions. Interviewees also identified potential challenges which may impede successful implementation, including staff shortages, resistance to change by internal and external stakeholders, and the impact of cultural and traditional ways of working. Conclusions Insights into the HM policy development and implementation process in Bahrain, and exploration of Kuwait’s readiness to implement resultant recommendations informed an effective implementation process for a well-designed HMs policy for Kuwait and other Arab countries.

Background Due to a shortage of emergency department doctors and nurses, hospitals have started to employ pharmacists who have additional clinical skills, known as Emergency Department Pharmacist Practitioners, to help deliver services. Objective To describe, compare and define the Emergency Department Pharmacist Practitioner role. Setting UK emergency departments. Method Using a purpose developed questionnaire hosted on a tablet computer, Emergency Department Pharmacist Practitioners were asked to report their contribution to patient care and the wider emergency department over 10 work days. Main outcome measure Emergency Department Pharmacist Practitioners’ work. Results Twenty Emergency Department Pharmacist Practitioners from 15 UK hospitals were recruited. Of 682 patients cared for, 4.8% (n=33) were of blue triage category (least urgent) and 4.1% (n=28) red (immediate need). Specific activities to inform patient diagnosis included clinical examinations (264/682 patients, 38.7%) and the review of investigation/test/procedure results (270, 39.6%). For treatment, EDPPs prescribed a total of 603 medicines (for administration in the ED) to 266 patients (39.0%) and performed procedures for 63 (9.2%). Eleven of the practitioners also took on the role of designated care provider (i.e. the healthcare professional with overall clinical responsibility) for at least some of their patients. From application of the care typology, all 20 practitioners carried out both ‘traditional’ and ‘practitioner’ activity and 9/20 of them sometimes provided more ‘practitioner’ than ‘traditional’ care to individual patients. Seven key role attributes were identified including how these pharmacists support patients with medical complaints and injuries of any severity and at any stage of their visit. Conclusion Emergency Department Pharmacist Practitioners combine traditional clinical pharmacy activities with more hands-on medical practise including being designated care provider. The role is versatile in that care and support provided to patients and the wider emergency department professional team is varied and therefore somewhat adaptable to situations which present.

Introduction Medication safety challenges are common after hospital discharge and an important global health care improvement target [1,2]. ‘Transfers of Care Around Medicines’ (TCAM) services have been suggested as an intervention that may help address this problem, and are designed to enable the referral of patients on discharge from the hospital to a named community pharmacy in the surrounding Clinical Commissioning Group (CCG). A TCAM service was launched by a large NHS Trust in England in February 2019 to enhance medicines communication and optimisation between primary and secondary care following hospital discharge. The TCAM service is delivered through the PharmOutcomes™ platform, and the initial focus of the service was to support patients with new or existing Monitored Dosage Systems (MDS). Aim To evaluate the utilisation of the TCAM service in the host NHS Trust and surrounding CCG through the examination of the nature and outcome of referrals made to community pharmacy. Method Anonymised service delivery data of patients referred from the TCAM service via the PharmOutcomes™ platform between March 2019 – February 2020 were retrospectively examined. The data comprised important variables, including patient demographics, status and time of referrals, and referral outcomes including problems/errors identified with medications and services provided by the community pharmacy such as medicines reconciliation. Study approvals were obtained from the host NHS Trust and the Health Research Authority (HRA); the study was exempt from the University Research Ethics Committee (UREC) approval [2019-7048-10983]. Results A total of 3,033 TCAM referrals to 67 community pharmacies were analysed. Most referrals were for patients aged 70 and above (72%, n=2,195) and 56% (n=1,713/3,033) of the referrals were for female patients. The number of referrals varied between 215 and 310 per month (median 246, Inter quartile range [IQR] 234 - 268). Most referrals (67%, 2,038/3,033) were marked as ‘completed’ by the community pharmacies, with 32.8% (n=995) left uncompleted. The rate of referral completion varied between 59 and 80% per month (median 66.4, IQR 64.5 - 70). Five (0.2%) patients were identified by community pharmacies that had adverse drug reactions (ADRs) from the cohort of 2,038 patients with completed referrals, with 45 (2%, n=45/2,038) identified as having issues that necessitated referral to the general practitioner (GP). The most common reason for referral to GP was medication changes identified from hospital, incorrect repeat prescriptions following discharge, to request a new prescription or weekly MDS, and to inform the GP that the patient has stopped taking their medication. The most common services carried out in community pharmacies following referral were reported as medicines reconciliation (47%, n=954/2,038), followed by review of information (46.7%, n=952/2,038), home delivery of medication (39%, n=798/2,038), review MDS arrangements (23.6%, n=482/2,038), commence MDS (18.6%, n=380/2,038), and pharmacy managed repeat service (12%, n=254/2,038). The main strength of this study is the inclusion of referral data that occurred over a one-year period, while the data were limited in generalisability due to inclusion of one geographical region and only patients using MDS. Conclusion The findings of this study may inform the ongoing development of electronic pharmacy referral systems for use at hospital discharge. References 1. Alqenae FA, Steinke D, Keers RN. Prevalence and Nature of Medication Errors and Medication-Related Harm Following Discharge from Hospital to Community Settings: A Systematic Review. Drug safety. 2020 Mar 3:1–21. 2. World Health Organization. Global patient safety challenge: medication without harm. 2017; p. 1–16. http://apps.who.int/iris/bitstream/10665/255263/1/WHO-HIS-SDS-2017.6-eng.pdf?ua=1&ua=1 . Accessed 20 September 2020.

Aim: To develop a set of prescribing safety indicators related to mental health disorders and medications, and to estimate the risk of harm associated with each indicator. Method: A modified two-stage electronic Delphi. The first stage consisted of two rounds in which 31 experts rated their agreement with a set of 101 potential mental health related prescribing safety indicators using a five-point scale and given the opportunity to suggest other indicators. Indicators that achieved 80% agreement were accepted. The second stage comprised a single round in which 29 members estimated the risk of harm for each accepted indicator by assessing the occurrence likelihood and outcome severity using two five-point scales. Indicators were considered high or extreme risk when at least 80% of participants rated each indicator as high or extreme. Results: Seventy-five indicators were accepted in the first stage. Following the second stage, 42 (56%) were considered to be high or extreme risk for patient care. The 42 indicators comprised different types of hazardous prescribing, including drug-disease interactions (n = 12), drug-drug interactions (n = 9), inadequate monitoring (n = 5), inappropriate duration (n = 4), inappropriate dose (n = 4), omissions (n = 4), potentially inappropriate medications (n = 3) and polypharmacy (n = 1). These indicators also covered different mental health related medication classes, including antipsychotics (n = 14), mood stabilisers (n = 8), antidepressants (n = 6), sedative, hypnotics and anxiolytics (n = 6), anticholinergic (n = 6) and nonspecific psychotropics (n = 2). Conclusion: This study has developed the first suite of prescribing safety indicators related to mental health disorders and medications, which could inform the development of future safety improvement initiatives and interventional studies.

Background: Gonadotropin injections for fertility treatment regimens are usually self-injected, typically over 8 to 12 days during the assisted reproductive technology cycle. Parenteral gonadotropins are available in different formulations and administered through various systems. A user experience study and risk assessment were performed to evaluate different product types for risks to the patient when preparing and administering injections.Methods: Nine women of child-bearing age each prepared and administered injections of six products representing single-and multidose vials of menotropin for reconstitution (Merional® and Menopur®), follicle stimulating hormone (FSH) reusable pen injectors with (Puregon®) and without cartridges (Gonal-f®), and single-use FSH pre-filled pens (Bemfola®). Risk assessments based on user feedback were made with reference to EU regulations for implementing practices for safe use of injectable products. Results: Products requiring reconstitution with diluent in glass ampoules were associated with medium risk for sharps injury and a lower level of user confidence. Pen injectors were considered easy-to-use, with a low risk of sharps injury. Single-use pens were associated with the lowest risk of dosing errors.Conclusions: The study identifies differences in the risks for both sharps injuries and dosing errors between FSH delivery options that practitioners should consider when making a treatment choice.

Background Hospital pharmacists play an essential role in patient care; however, a lack of resources means pharmacists are unable to review all patients daily. Consequently, there is a demand for reliable screening tools to allocate care to patients with urgent and/or complex pharmaceutical needs. Several tools have been developed, but no broad consensus exists on the design of a screening tool to be used in the adult hospital setting. Objective To obtain expert consensus on the design of a pharmaceutical care complexity screening tool for use on admission to hospital. Methods Two Delphi studies were conducted: the first sought to gain consensus from experts including pharmacists, academics and physicians on the components of a pharmaceutical complexity tool, the second to achieve consensus from UK chief pharmacists and clinical service pharmacy managers on the clinical appropriateness and practicality of the tool. Tool components and Delphi statements were identified and refined from our previous systematic review, UK survey and interview study of prioritisation tools. A valid definition for consensus was used. Results Over 300 components were extracted from the interview data and systematic review and then refined for inclusion in the first Delphi study. Thirty-three experts completed Delphi One and consensus was reached on 92 components. Components were grouped into demographic, clinical and medication components and condensed to 33 items, which were included in the first draft of the Adult Complexity Tool for Pharmaceutical Care (ACTPC). The tool stratified patients into highly, moderately or least complex. Forty expert panellists completed Delphi Two and consensus was reached on review frequency and experience of pharmacy practitioner at each level. These decisions were incorporated into the final version of the ACTPC. Conclusions The ACTPC is the first systematically designed and internationally agreed tool for use on medical admission to hospital. It has potential to enable the delivery of targeted patient-centred pharmaceutical care.

ObjectivesTo compare the patterns of 18 physical and mental health comorbidities between people with recently diagnosed type 2 diabetes (T2D) and people without diabetes and how these change by age, gender and deprivation over time between 2004 and 2014. Also, to develop a metric to identify most prevalent comorbidities in people with T2D.DesignPopulation-based cohort study.SettingPrimary and secondary care, England, UK.Participants108 588 people with T2D and 528 667 comparators registered in 391 English general practices. Each patient with T2D aged ≥16 years between January 2004 and December 2014 registered in Clinical Practice Research Datalink GOLD practices was matched to up to five comparators without diabetes on age, gender and general practice.Primary and secondary outcome measuresPrevalence of 18 physical and mental health comorbidities in people with T2D and comparators categorised by age, gender and deprivation. Odds for association between T2D diagnosis and comorbidities versus comparators. A metric for comorbidities with prevalence of ≥5% and/or odds ≥2 in patients with T2D.ResultsOverall, 77% of patients with T2D had ≥1 comorbidity and all comorbidities were more prevalent in patients with T2D than in comparators. Across both groups, prevalence rates were higher in older people, women and those most socially deprived. Conditional logistic regression models fitted to estimate (OR, 95% CI) for association between T2D diagnosis and comorbidities showed that T2D diagnosis was significantly associated with higher odds for all conditions including myocardial infarction (OR 2.13, 95% CI 1.85 to 2.46); heart failure (OR 2.12, 1.84 to 2.43); depression (OR 1.75, 1.62 to 1.89), but non-significant for cancer (OR 1.12, 0.98 to 1.28). In addition to cardiovascular disease, the metric identified osteoarthritis, hypothyroidism, anxiety, schizophrenia and respiratory conditions as highly prevalent comorbidities in people with T2D.ConclusionsT2D diagnosis is associated with higher likelihood of experiencing other physical and mental illnesses. People with T2D are twice as likely to have cardiovascular disease as the general population. The findings highlight highly prevalent and under-reported comorbidities in people with T2D. These findings can inform future research and clinical guidelines and can have important implications on healthcare resource allocation and highlight the need for more holistic clinical care for people with recently diagnosed T2D.

Background Until 2018, NICE guidance recommended the use of a combination of disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate (MTX), in the initial management of people with rheumatoid arthritis (RA). In 2018 the guideline was updated to recommend monotherapy with MTX due to uncertainties in the evidence for combination therapy. However, it remains a requirement for progression onto any biologic that the patient should have persistent high disease activity and/or have intolerance to, a minimum of two DMARDs. The aim of this study was to understand the association between initial treatment strategy and EULAR response at 6 months. Methods This analysis included patients recruited to the longitudinal observational Rheumatoid Arthritis Medication Study (RAMS) in the UK who were DMARD naïve and had symptoms for less than 1 year. Patients were defined as either starting MTX monotherapy or MTX in combination with another DMARD (6 weeks either side of MTX start date) and categorised into EULAR non responders or moderate/ good responders after 6 months. A logistic regression model was applied to test the association between initial treatment strategy and EULAR response at 6 months, adjusting for confounders. Results A total of 948 participants were included in the analysis. MTX monotherapy was prescribed in 72% (n = 678) of patients and combination therapy was prescribed in 28% (n = 270) of patients, the majority of whom received MTX plus hydroxychloroquine (HCQ) (n = 236, 87%). There was no significant difference between the MTX monotherapy and combination therapy groups in EULAR response at 6-months (adjusted odds ratio [aOR] 0.77, 95% CI 0.53 to 1.14). Conclusion In this large UK observational study investigating the effect of treatment strategy within the first 6 weeks of presentation and treatment response at 6 months, there was no significant difference between combination DMARD therapy and MTX monotherapy on EULAR response. Most patients received MTX in combination with HCQ, for which little evidence exists. Disclosures S. Wood None. K. Hyrich Consultancies; ABBVIE. Grants/research support; BMS, PFIZER, UCB. S. Verstappen None. D. Steinke None.

Background Little is known about the epidemiology of medication errors and medication-related harm following transition from secondary to primary care. This systematic review aims to identify and critically evaluate the available evidence on the prevalence and nature of medication errors and medication-related harm following hospital discharge. Methods Studies published between January 1990 and March 2019 were searched across ten electronic databases and the grey literature. No restrictions were applied with publication language or patient population studied. Studies were included if they contained data concerning the rate of medication errors, unintentional medication discrepancies, or adverse drug events. Two authors independently extracted study data. Results Fifty-four studies were included, most of which were rated as moderate (39/54) or high (7/54) quality. For adult patients, the median rate of medication errors and unintentional medication discrepancies following discharge was 53% [interquartile range 33–60.5] (n = 5 studies) and 50% [interquartile range 39–76] (n = 11), respectively. Five studies reported adverse drug reaction rates with a median of 27% [interquartile range 18–40.5] and seven studies reported adverse drug event rates with a median of 19% [interquartile range 16–24]. For paediatric patients, one study reported a medication error rate of 66.3% and another an adverse drug event rate of 9%. Almost a quarter of studies (13/54, 24%) utilised a follow-up period post-discharge of 1 month (range 2–180 days). Drug classes most commonly implicated with adverse drug events were antibiotics, antidiabetics, analgesics and cardiovascular drugs. Conclusions This is the first systematic review to explore the prevalence and nature of medication errors and adverse drug events following hospital discharge. Targets for future work have been identified. Electronic supplementary material The online version of this article (10.1007/s40264-020-00918-3) contains supplementary material, which is available to authorized users.

Aims Contemporary data describing type 2 diabetes prevalence, incidence and mortality are limited. We aimed to (1) estimate annual incidence and prevalence rates of type 2 diabetes in the UK between 2004 and 2014, (2) examine relationships between observed rates with age, gender, socio-economic status and geographic region, and (3) assess how temporal changes in incidence and all-cause mortality rates influence changes in prevalence. Methods Type 2 diabetes patients aged ≥16 years between January 2004 and December 2014 were identified using the Clinical Practice Research Datalink (CPRD). Up to 5 individuals without diabetes were matched to diabetes patients based on age, gender and the general practice. Annual incidence, prevalence and mortality rates were calculated per 10 000 person-years at risk (95% CI). Survival models compared mortality rates in patients with and without type 2 diabetes. Results Prevalence rates of type 2 diabetes increased from 3.21% (3.19; 3.22) in 2004 to 5.26% (5.24; 5.29) in 2014. Incidence rates remained stable, overall, throughout the study period. Higher incidence and prevalence rates were related to male gender and deprivation. Individuals with type 2 diabetes were associated with higher risk of mortality (Hazard ratio 1.26 [1.20; 1.32]). Mortality rates declined in patients with and without diabetes throughout the study period. The incidence and prevalence of type 2 diabetes in patients aged 16 to 34 years increased over time. Conclusions The rising prevalence of type 2 diabetes in the UK over the last decade is probably explained by patients living longer rather than by increasing incidence of type 2 diabetes.

Background: Despite a growing body of evidence in the pharmacological management of people with early rheumatoid arthritis (RA), there is still uncertainty concerning the most effective treatment regimen. Until 2018, guidance for England and Wales stated that everyone with early RA should receive combination therapy with 2 or more conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) in parallel. However, from epidemiological studies and anecdotal information, we know that this has not been the case in practice. Objectives: (i) To determine the proportion of patients with new onset RA who start methotrexate (MTX) either alone or in combination with another csDMARD (ii) to describe which combinations are currently being prescribed and (iii) to describe the characteristics associated with the choice of initial RA treatment strategy Methods: Consecutive patients with RA participating in the Rheumatoid Arthritis Medication Study (RAMS), a large UK study recruiting patients starting MTX for the first time, were eligible. Data on demographics, disease activity, comorbidity and all RA treatments are captured at baseline, 6 and 12 months following start of MTX. Analysis was limited to patients starting MTX within the first 2 years of symptom onset as part of their first treatment regimen for RA. Prevalent users of alternative csDMARDs, defined as use > 6 weeks prior to MTX start, were excluded. Participants were categorised as either starting MTX monotherapy or MTX in combination with another csDMARD (defined as started +/- 6 weeks of MTX start date). Baseline characteristics were compared between monotherapy and combination therapy groups using descriptive statistics. Results: 1,374 patients with a mean (SD) age of 58 (14) years were included in this study; 64% were female. At baseline, 996 (76%) started MTX monotherapy and 316 (24%) started MTX/csDMARD combination therapy (84% with hydroxychloroquine and 16% with sulphasalazine). Patients starting combination therapy were younger (p Conclusion: These data show that despite national guidelines recommending combination csDMARD therapy in all patients diagnosed with RA, over three quarters of patients still started MTX monotherapy. People who were prescribed combination therapy had more severe disease suggesting that prescribers do consider prognosis in their treatment decisions. A majority of patients starting combination therapy did so with hydroxychloroquine, despite a lack of evidence for the benefits of this particular combination in clinical practice. Values are frequency (%) or median (IQR) Abbreviations: HAQ, health assessment questionnaire; DAS, disease activity score; MTX, methotrexate Disclosure of Interests: Sarah Wood Grant/research support from: Pfizer stipend received for MPhil in epidemiology in 2013, Employee of: Employed by GSK in 2012 as a pre-registration pharmacist, Kimme Hyrich Grant/research support from: Grants to institution: BMS, Pfizer, UCB, Suzanne Verstappen: None declared, Douglas Steinke: None declared

Emergency Department Pharmacist Practitioners (EDPPs) undertake both 'traditional' clinical pharmacy work, e.g. check prescriptions, and 'practitioner' work, e.g. perform clinical examinations. A recent study found a large variation in the extent and type of care provided. Whilst variation allows services to be tailored to local needs, it is important that care meets the minimum standards that are safe, effective, patient-centred, timely, efficient, and equitable.To develop an EDPP service specification based on views of professional and patient stakeholders, primarily to support providers with delivery of high quality services.Patients, ED pharmacists and other ED healthcare professionals developed standards guided by the Institute of Medicine's quality domains. A panel of six ED pharmacists suggested and agreed on themes that should be included in the service specification. Additional themes were identified through interviews with eight patients who had been cared for by EDPPs as to their expectations of the service. Finally, a multidisciplinary expert panel of healthcare professionals and researchers reviewed and refined the service specification.ED pharmacists developed 36 themes with consensus achieved for 25. Additional themes from the patient interviews concerned the communication and behaviour of EDPPs rather than specific clinical activities undertaken. Whilst patients were happy to be cared for by an EDPP working within their competence, for certain conditions (e.g. major trauma) they wanted a doctor as their main care provider. An evidence-based EDPP service specification of 52 criteria grouped into 4 categories was produced: direct patient care (29); other activities (10); general approach (10); and service structures (3).As the product of both patient and expert input, EDs could align existing or newly developed services to the specification. Whether or not the specification actually improves the quality of EDPP services requires investigation, as does the absolute quality impact of services.

Background With increased pressure on clinical pharmacy services there is a demand for reliable screening tools to appropriately allocate pharmaceutical care to those patients with most urgent and/or complex needs. Several such tools have been developed, however, they are often locally developed with a lack of agreement on their components. To date, no broad consensual agreement of experts exists on valid components of a pharmaceutical care complexity screening tool in the adult hospital setting. Purpose To obtain consensus on the necessary components of a pharmaceutical care complexity screening tool for use on admission to hospital. Material and methods Complexity tool components were identified and refined in three phases: first, a systematic literature review was conducted to identify existing tools and their components. Second, a national survey and semi-structured telephone interviews identified non-published tools and their components. The obtained components from phase I and II were reviewed by the research team and an expert reference group to remove non-clinical factors and duplicates. Third, an expert Delphi panel, including international leading pharmacists, researchers and clinicians, was recruited by email to take part in a two-round Delphi study. Items were scored. The panel were asked to rank each component according to importance via a web-based anonymised electronic questionnaire using a nine-point Likert-scale. Consensus was set at 67%: items that 67% of people deemed to be important were listed. Ethical approval was not required. Results Forty-one invited experts joined the panel and completed round one, and 33 of them completed the second round. One-hundred and nine of the complexity tool components were initially identified and validated by the panel. After two Delphi rounds, 92 components (84.4%) achieved the limit of agreement for importance. These were grouped into three component types (demographic, clinical-related and medication-related) and reduced to 31 items for inclusion into a screening tool. Conclusion This study systematically and rigorously identified a set of 31 items which are important for assessing pharmaceutical complexity. This information can then be used for the development and refinement of future and current pharmaceutical complexity screening tools that can aid more efficient targeting of hospital clinical pharmacy services. References and/or acknowledgements No conflict of interest.

Pharmacoepidemiology is a method of scientific data analysis employed to investigate and evaluate how drugs are used in a large population, as well as the relationship of the resulting data to an outcome. The outcome could be a benefit (a cure for disease) or a risk (causing an adverse drug reaction or death). Understanding the patient characteristics and other factors that contribute to the risk provides evidence to improve health and demonstrate best practice. The evidence from these studies can be used in guideline development and decision making for treatment options. These data can also be used, with public health information, to develop a pharmaceutical needs assessment to determine populations and areas that would benefit the most from pharmaceutical interventions.

BackgroundPrescribing errors and medication related harm may be common in patients with mental illness. However, there has been limited research focusing on the development and application of prescribing safety indicators (PSIs) for this population.ObjectiveIdentify potential PSIs related to mental health (MH) medications and conditions.MethodsSeven electronic databases were searched (from 1990 to February 2019), including the bibliographies of included studies and of relevant review articles. Studies that developed, validated or updated a set of explicit medication-specific indicators or criteria that measured prescribing safety or quality were included, irrespective of whether they contained MH indicators or not. Studies were screened to extract all MH related indicators before two MH clinical pharmacists screened them to select potential PSIs based on established criteria. All indicators were categorised into prescribing problems and medication categories.Results79 unique studies were included, 70 of which contained at least one MH related indicator. No studies were identified that focused on development of PSIs for patients with mental illness. A total of 1386 MH indicators were identified (average 20 (SD = 25.1) per study); 245 of these were considered potential PSIs. Among PSIs the most common prescribing problem was 'Potentially inappropriate prescribing considering diagnoses or conditions' (n = 91, 37.1%) and the lowest was 'omission' (n = 5, 2.0%). 'Antidepressant' was the most common PSI medication category (n = 85, 34.7%).ConclusionThis is the first systematic review to identify a comprehensive list of MH related potential PSIs. This list should undergo further validation and could be used as a foundation for the development of new suites of PSIs applicable to patients with mental illness.

Introduction: Effective communication is important for delivering patient-centred care and has two components: content (what is said) and process (how it is said). However, assessing communication process is often overlooked. This paper describes the development of a tool for the assessment of communication process in year one British undergraduate MPharm students. Description of innovation: Tool development involved three stages: initial construction (stage 1); testing for inter-rater reliability then revising the tool using consensus methods (stage 2); re-testing to determine inter-rater reliability and usability (stage 3). Evaluation: inter-rater reliability improved following revision of the tool, with kappa score increasing from 0.065 (stage 2) to 0.217 (stage 3). Consensus meetings improved usability, face and content validity. Future plans and implementation: The tool can be adapted according to the learning outcomes being assessed, year of study, and communication scenario. Using it throughout our undergraduate programme has allowed for constructive alignment of teaching and assessment.

Objective: To report 3 cases of subdural bleeding associated with rivaroxaban managed by 3-factor prothrombin complex concentrate (PCC3). Case Summaries: Case 1 presented with a 1-cm thick subdural hematoma (SDH) 12 hours after her last dose of rivaroxaban. Case 2 presented with a right 1-cm acute right SDH with 2 to 3 mm of midline shift 24 hours after his last dose of rivaroxaban. Case 3 presented with a 1.8-cm thick right cerebral convexity hematoma 12 hours after her last dose of rivaroxaban. All patients received 23 to 35 units/kg PCC3 with 1 to 3 units of fresh frozen plasm (FFP) and demonstrated no progression in lesions measured by repeat computed tomography (CT). Two patients were discharged to rehabilitation facilities and 1 patient ultimately died due to the location of the lesion. Discussion: Rivaroxaban has no specific antidote. Current bleeding management strategies are based on expert opinion. The risks and benefits for differing strategies are unclear, and no clinical experience has been reported to date. These cases begin to illuminate differences among choices for managing bleeding associated with Xa inhibitors. Conclusion: In this case series, 25 to 35 units/kilogram PCC3 and FFP 1 to 3 units ceased rivaroxaban-associated bleeding without thrombogenic complications.

Background:Medicines optimisation is essential in the long-term management of rheumatoid arthritis (RA), particularly when considering combinations of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). Community pharmacists are ideally placed to optimise medicines use including monitoring side effects, counselling on dose and frequency and improving medicines adherence; however, in some countries, such as the UK, there are currently no community pharmacy services that address csDMARD use and little is known about the role community pharmacists play in managing RA as a long-term condition.Objectives:The objectives of this qualitative study were to understand community pharmacists’ views of their training, knowledge and current role in the management of RA.Methods:We conducted 9 semi-structured, face-to-face or telephone interviews with community pharmacists based in the UK; all were transcribed verbatim. A topic guide, used to inform the interviews, covered four key areas: 1) knowledge and training, 2) pharmacological management 3) patients and services, 4) potential role. The transcriptions were then imported into NVivo for thematic analysis. A coding framework was developed from continual emerging themes and applied to the transcripts.Results:Five male/4 female participants, the median age was 39 years (range 27 to 42) with a median number of years qualified as a pharmacist of 12 years (range 5 to 20) were included. The participants covered a range of roles including: pharmacist non-manager, pharmacist manager, locum pharmacist, superintendent pharmacist and relief pharmacist.In assessing the current role of community pharmacists, 4 main themes were identified: (1) access to information about the patient’s condition as a barrier, (2) their lack of knowledge in the management of RA, (3) providing practical advice about taking csDMARDs, and (4) exploring the reasons for non-adherence before taking further action. In assessing the potential role of community pharmacists, a further 2 themes were identified: improving access to information about the patient’s condition before the current role can be increased and other barriers to an additional role, including time and funding.In the theme ‘access to information as a barrier’ the most common point made was about the lack of information available to pharmacists on the individual indication for medicines. Pharmacists said this posed a barrier both to current practice and their potential role. No participants suggested the potential for an additional service specifically for RA, but some suggested that current services could be expanded to include RA as a target group. Participants discussed side effect counselling and ensuring access to medicines in detail with patients, but only 2 briefly mentioned discussing the benefits of csDMARDs.Conclusion:This is the first in-depth exploration of the perspectives of community pharmacists on the management of RA in community pharmacy. This study has highlighted several important barriers both environmental and personal including time, education and resources that, if addressed, could allow community pharmacists to play a greater role in the management of RA.Disclosure of Interests:Sarah Wood: None declared, Kimme Hyrich Grant/research support from: Pfizer, UCB, BMS, Speakers bureau: Abbvie, Suzanne Verstappen Grant/research support from: BMS, Consultant of: Celltrion, Speakers bureau: Pfizer, Douglas Steinke: None declared

Besides doctors and dentists, an increasing range of healthcare professionals, such as nurses, pharmacists and podiatrists, can become independent prescribers (IPs). As part of an evaluation for independent prescribing funded training, this study investigated views and experiences of IPs, their colleagues and patients about independent prescribing within primary care. Questionnaires capturing quantitative and qualitative data were developed for IPs, their colleagues and patients, informed by existing literature and validated instruments. IPs were identified following independent prescribing training funded by Health Education England Northwest in 2015-2017. Quantitative data were analysed using descriptive statistics and qualitative data were analysed thematically. Twenty-four patients, 20 IPs and 26 colleagues responded to the questionnaires. Most patient respondents had a long-term medical condition (n = 17) and had regular medicines prescribed (n = 21). IPs were nurses (n = 14), pharmacists (n = 4), one podiatrist (n = 1) and one was unknown. Half of the IPs were current prescribers (n = 10), the other half were still training (to become) IPs (n = 10). Colleague respondents were doctors and nurses (n = 15) other healthcare professionals (n = 8) and practice managers (n = 3). Both current IPs (n = 9) and colleague respondents (n = 25) (strongly) agreed that independent prescribing improved the quality of care provided for patients. Nearly all colleagues were supportive of independent prescribing and believed that they worked well with IPs (n = 25). Patients' perceptions and experiences of their consultations with the IP were mostly positive with the vast majority of respondents (strongly) agreeing that they were very satisfied with their visit to the IP (n = 23). Key barriers and enablers to independent prescribing were centred on IPs' knowledge, competence and organisational factors such as workload, effective teamwork and support from their colleagues. Findings from this study were mainly positive but indicate a need for policy strategies to tackle longstanding barriers to independent prescribing. However, a larger sample size is needed to confirm findings.

Background Methotrexate is usually the first-line disease modifying anti-rheumatic drug (DMARD) for patients with juvenile idiopathic arthritis (JIA), due to its efficacy, the low-cost and favourable safety profile in patients. However, one of the most reported adverse effects of interest (AEIs) of methotrexate is nausea. Objectives The objectives of this analysis were to (i) calculate methotrexate monotherapy drug survival, (ii) describe AEIs over the first two years of treatment, and (iii) investigate factors associated with occurrence of AEIs among children with JIA. Methods Patients with all forms of JIA starting methotrexate monotherapy from both the UK BSPAR Etanercept Cohort Study (BSPAR-ETN) and Biologics for Children with Rheumatic Diseases study (BCRD) were included. Patient characteristics and anti-rheumatic therapy details were collected at treatment start. Follow-up data were collected at six months, one year, and annually thereafter, on changes to anti-rheumatic therapy and any adverse events. AEIs were grouped into gastrointestinal-related (nausea, vomiting, abdominal pain), raised liver enzymes, leukopenia, drug hypersensitivity (injection site reaction), rash, needle phobia, and any other event leading to permanent discontinuation of methotrexate. All person time was included from methotrexate start date until first methotrexate stop date, start of biologic therapy, last patient follow-up date, or 30-June-2017 (study cut-off date), whichever came first. Survival analysis was used to assess time on methotrexate monotherapy and time to first AEI on methotrexate monotherapy. Multivariable logistic regression was used to assess baseline characteristics associated with experiencing an AEI, and a gastrointestinal-related AEI only. Results Of 505 patients starting methotrexate between 01-January-2010 and 30-June-2015 (to allow at least two years of follow-up for all children), median time on monotherapy was 1.5 years (IQR 0.7, 2.3). At two years, 274 (54%) patients were no longer on methotrexate monotherapy. Reasons included: inefficacy (n=174; 64%) mostly due to start of biologic therapy (n=161), adverse events (n=54; 20%), remission (n=24; 9%), and patient/family decision (n=9; 3%). Within the first two years of methotrexate monotherapy, 181 (36%) patients experienced at least one AEI; the most common were gastrointestinal problems (n=116; 53%) and liver enzyme abnormalities (n=42; 19%). No clinical factors were associated with occurrence of any AEI, nor a gastrointestinal-related AEI. Conclusions After two years, over half of the patients were no longer on methotrexate monotherapy, whilst one-third experienced at least one AEI, most commonly gastrointestinal-related problems. Further research focussing on identifying which children will respond and/or experience an AEI with methotrexate is crucial, such that AEIs can be minimised or prevented and treatment benefit maximised. Disclosure of Interest None declared

BackgroundClinical pharmacy services improve patient safety, outcomes, and care quality; however, UK clinical pharmacy services face limited resources, insufficient capacity, and patients who present with increasingly complex medication regimes and morbidities. These indicate a need for the prioritization of pharmacy services. Several prioritization tools have been developed; however, there has been no comprehensive review of such tools to date.ObjectiveA systematic review was conducted to provide a structured overview and description of existing assessment tools with a focus on study quality, themes, tool validity, risk factors, and high-risk drug classes.MethodsSystematic searches for English-language publications (from 1990 to September 2017) were conducted in Embase, Medline, Scopus, International Pharmaceutical Abstracts, and Web of Science. Papers in the inpatient setting and in which the tool users were pharmacists or pharmacy technicians were included. Data on each study (e.g. aim and design) and the structure of tools (e.g. risk factors) from each included study were extracted by 2 independent reviewers. A descriptive analysis was conducted to summarize these tools along with a thematic analysis of study findings. The quality of each paper was assessed using the Hawker method.ResultsNineteen studies involving 17 risk assessment tools were included. Most tools were developed in Europe (76.5%) and published in the last 5 years (82%). Most tools (88%) were designed to identify patients at greatest risk of adverse drug reactions, adverse drug events, or medication errors and to guide appropriate pharmaceutical care. Ten out of 17 tools (59%) were validated. None showed a measurable impact on prescription errors or adverse drug events. Keys themes identified from the studies were the positive impact of risk assessment tools on both patient care and provision of pharmacy services as well as the limitations of risk assessment tools.ConclusionsCurrent assessment tools are heterogeneous in their content, targeting diverse patient groups and clinical settings making generalization difficult. However, an underlying theme of all studies was that tools appear to achieve their aim in directing pharmaceutical care to where it is needed most which might provide reassurance and incentive for greater adoption and development of tools across clinical pharmacy services. However, further research is required to measure objectively the impact of tools on patient outcomes and on workforce efficiency so that comparisons can be made between tools.

BackgroundHerbal medicine (HM) regulation is less developed than that of allopathic medicines, with some countries lacking specific regulations.ObjectiveFor the purpose of informing a registration system for HMs in Kuwait, which does not manufacture but imports all HMs, this study compared the similarities and differences between the current HM registration systems of five countries.MethodsThe five countries were selected as major source countries of HM in Kuwait (United Kingdom (UK), Germany and United States of America (USA)) or because of geographical proximity or size and approach (United Arab Emirates (UAE) and Kingdom of Bahrain). Documentary analysis of HM classification systems was performed by reviewing the regulatory and law documentation of these countries’ drug regulatory authority websites. Data on HM definition, classification and the main requirements for registration were extracted and analysed for similarities and differences.ResultsThere was diversity in the classification of HMs across all five countries including terms used, definitions, type of law, requirements, restrictions and preparation type. The regulatory authorities of the UK, Germany, UAE and Kingdom of Bahrain offer simplified registration for HMs, where plausible efficacy as a result of established traditional use is sufficient. In USA, the concept of traditional use does not exist, instead, the product can be categorised as a dietary supplement where no assessment or evaluation is required prior to marketing.ConclusionsOwing to the inconsistencies in how drug regulatory authorities define HMs, it will be important to design a clear definition of what constitutes a HM in Kuwait, which is a country that does not produce and register its own products but assesses products registered elsewhere.

Objective: To describe the incidence and distribution of ADHD within the United Kingdom, and to examine whether there was any association between ADHD incidence and socioeconomic deprivation. Method: The study used data from the Clinical Practice Research Datalink (CPRD). Patients diagnosed with ADHD before the age of 19 between January 1, 2004 and December 31, 2013 were stratified according to the region in which their general practice was based. Practice Index of Multiple Deprivation (IMD) score was used as a surrogate measure of patients’ deprivation status. Results: ADHD incidence was relatively stable between 2004 and 2013, but peaked in the last 2 years studied. Statistically significant ( p ≤ .05) differences in incidence were observed between U.K. regions. In almost every year studied, incidence rates were highest among the most deprived patients and lowest among the least deprived patients. Conclusion: In the United Kingdom, ADHD may be associated with socioeconomic deprivation.

Polypharmacy, the concurrent use of multiple medications by one individual is a growing global issue driven by an ageing population and increasing prevalence of multi-morbidity[1]. Polypharmacy can be problematic: interactions between medications, reduced adherence to medication, burden of medication to patients, administration time, increased risk of errors and increased cost. Quality improvement methods were applied to identify and highlight polypharmacy patients with the aim of reducing their average number of regular tablets/capsules per day by 25%. The project was delivered within a UK based 27 bedded hospice inpatient unit. A series of PDSA cycles studied interventions focusing on the identification of patients with polypharmacy, the highlighting of these patients to prescribers for review and the views of patients about their medication. For the purposes of the study, polypharmacy was defined as greater than ten regular medicines and/or greater than twenty regular tablets/capsules each day. The interventions tested included patients on regular paracetamol and strong opioids being offered a trial without regular paracetamol, a constipation guide promoting the use of combination laxatives, education of prescribers around dose strengths, checklist of recommendations was placed in case notes and a sticker was used on the medicine chart to highlight patients in need of polypharmacy review. The introduction of a trial without paracetamol and a laxative guide led to reductions in polypharmacy. The sticker and checklist were successful interventions for highlighting patients with polypharmacy. Quality improvement methods were used to plan, try, test and implement simple interventions for patients on the hospice inpatient unit. This has led to a 25% reduction in the average regular tablet/capsules burden , a 16% reduction in the average number of regular medications and a 30% reduction in the average volume of liquid medication per patient without an increase in the use of 'as required' medication or length of stay.

Summary Background Reducing prescribing errors is key to ensuring patient safety. Foundation-year doctors (FYs) have been found to be major contributors to prescribing errors, and often feel poorly prepared for prescribing by their undergraduate education. Numerous studies have reported these findings; however, few studies have introduced meaningful interventions. Methods A questionnaire was sent to FY2s (n = 20) to determine the 15 most commonly prescribed medications on call. These medications and instructions were incorporated into a flashcard that was disseminated to new FY1s at a teaching hospital in the UK. The FY1s were asked to complete a pre- and post-flashcard questionnaire, giving instructions for 10 medications and their confidence in prescribing these medications. A control group at another teaching hospital were given the same questionnaires, but not the flashcard. Results No significant difference in confidence was seen in FY1s at either hospital before the flashcard was issued. Both groups at week 4 demonstrated significant improvements in confidence in prescribing, with those who received the flashcard demonstrating a significantly higher level of confidence in a greater range of medications, compared with those who did not (p

The aim of this article is to describe and compare adherence and persistence with maintenance therapies in patients with asthma or chronic obstructive pulmonary disease (COPD) in the United Kingdom (UK). A retrospective prescribing database cohort was obtained from 44 general practitioner surgeries in National Health Service Forth Valley Scotland. Patients with physician-diagnosed asthma or COPD who received maintenance therapy between January 2008 and December 2009 were included. Five classes of therapy were assessed: inhaled corticosteroids, long-acting beta-agonists, combination therapy inhalers, theophyllines and long-acting muscarinic antagonists. Adherence was calculated using the medication possession ratio (MPR) and persistence was determined using Kaplan-Meier survival analysis for the time to discontinuation (TTD) over 1 year. Two step-wise logistic regressions were performed to assess the contribution of diagnosis to adherence/persistence. A total of 13,322 patients were included in the analysis: 10,521 patients with asthma and 2801 patients with COPD. 25.2% of medication episodes for asthma and 45.6% of medication episodes for COPD were classified as having an adequate medication supply (MPR of 80-120%). The overall median TTD was 92 days (IQR, interquartile range: 50-186 days) for patients with asthma and 116 days (IQR: 58-259 days, comparison p < 0.001) for patients with COPD. Patients with COPD were found to be more likely to achieve an MPR of at least 80% (OR: 1.27, 95% CI: 1.15-1.40), but had a similar likelihood of persistence at 1 year to patients with asthma. Adherence and persistence with respiratory therapies in the UK is relatively low. There is suggestion that patients with COPD may display more adherent behaviours than patients with asthma.

Bacteria belonging to the normal colonic microbiota are associated with the etiology of ulcerative colitis (UC). Although several mucosal species have been implicated in the disease process, the organisms and mechanisms involved are unknown. The aim of this investigation was to characterize mucosal biofilm communities over time and to determine the relationship of these bacteria to patient age and disease severity and duration. Multiple rectal biopsy specimens were taken from 33 patients with active UC over a period of 1 year. Real-time PCR was used to quantify mucosal bacteria in UC patients compared to 18 noninflammatory bowel disease controls, and the relationship between indicators of disease severity and bacterial colonization was evaluated by linear regression analysis. Significant differences were detected in bacterial populations on the UC mucosa and in the control group, which varied over the study period. High clinical activity indices (CAI) and sigmoidoscopy scores (SS) were associated with enterobacteria, desulfovibrios, type E Clostridium perfringens , and Enterococcus faecalis , whereas the reverse was true for Clostridium butyricum , Ruminococcus albus , and Eubacterium rectale . Lactobacillus and bifidobacterium numbers were linked with low CAI. Only E. rectale and Clostridium clostridioforme had a high age dependence. These findings demonstrated that longitudinal variations in mucosal bacterial populations occur in UC and that bacterial community structure is related to disease severity.

ObjectiveTo establish the thoughts of pharmacists using the pharmaceutical assessment screening tool (PAST) when assigning a patient acuity level and establish other decision factors. A patient acuity level is a pharmaceutical assessment of a patient (lowest =1 to highest =3), higher patient acuity levels highlight the requirement for a more intensive pharmaceutical input to reduce potential harm.MethodA questionnaire designed to elicit attitudes about the pharmaceutical assessment screening tool was circulated to 32 pharmacists working in a 900 bed UK university teaching hospital. Respondents were asked to document what patient acuity level they would assign for six theoretical patient cases with an explanation. The data collected was analysed using Microsoft Excel® and further analysis was undertaken about the strength of agreement to PAST using the kappa statistic (Ƙ) using Stata v12 (StataCorp, TX., USA).ResultsThe questionnaire was completed by 28/32 pharmacists (87.5% response rate). The mean confidence (SD) for assigning a patient acuity level (PAL) was 81% (±20%). 26/28 pharmacists (93%) agreed or strongly agreed that professional judgement guided them most when allocating a PAL. The PAL assigned to the case studies presented both over and under estimations compared to the guidance but overall the strength of agreement was considered to be “fair” (Ƙ =0.202).ConclusionPharmacists feel confident about using a pharmaceutical assessment screening tool to help them assign a patient acuity level. However the use of professional judgement to assign an acuity level overrides any predicted level from PAST.