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Medication errors are common in primary care and are associated with considerable risk of patient harm. We tested whether a pharmacist-led, information technology-based intervention was more effective than simple feedback in reducing the number of patients at risk of measures related to hazardous prescribing and inadequate blood-test monitoring of medicines 6 months after the intervention. In this pragmatic, cluster randomised trial general practices in the UK were stratified by research site and list size, and randomly assigned by a web-based randomisation service in block sizes of two or four to one of two groups. The practices were allocated to either computer-generated simple feedback for at-risk patients (control) or a pharmacist-led information technology intervention (PINCER), composed of feedback, educational outreach, and dedicated support. The allocation was masked to general practices, patients, pharmacists, researchers, and statisticians. Primary outcomes were the proportions of patients at 6 months after the intervention who had had any of three clinically important errors: non-selective non-steroidal anti-inflammatory drugs (NSAIDs) prescribed to those with a history of peptic ulcer without co-prescription of a proton-pump inhibitor; β blockers prescribed to those with a history of asthma; long-term prescription of angiotensin converting enzyme (ACE) inhibitor or loop diuretics to those 75 years or older without assessment of urea and electrolytes in the preceding 15 months. The cost per error avoided was estimated by incremental cost-effectiveness analysis. This study is registered with Controlled-Trials.com, number ISRCTN21785299. 72 general practices with a combined list size of 480 942 patients were randomised. At 6 months' follow-up, patients in the PINCER group were significantly less likely to have been prescribed a non-selective NSAID if they had a history of peptic ulcer without gastroprotection (OR 0·58, 95% CI 0·38–0·89); a β blocker if they had asthma (0·73, 0·58–0·91); or an ACE inhibitor or loop diuretic without appropriate monitoring (0·51, 0·34–0·78). PINCER has a 95% probability of being cost effective if the decision-maker's ceiling willingness to pay reaches £75 per error avoided at 6 months. The PINCER intervention is an effective method for reducing a range of medication errors in general practices with computerised clinical records. Patient Safety Research Portfolio, Department of Health, England.

ObjectiveTo examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice.MethodsPragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7–14 days after presentation of prescription followed by another 14–21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected.ResultsAt 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI −£59 to £100, p=0.128) per patient.ConclusionsThe NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice.Trial registration numbersClinicalTrials.gov trial reference number NCT01635361 (http://clinicaltrials.gov/ct2/show/NCT01635361). Current Controlled trials: trial reference number ISRCTN 23560818 (http://www.controlled-trials.com/ISRCTN23560818/; DOI 10.1186/ISRCTN23560818). UK Clinical Research Network (UKCRN) study 12494 (http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494).

Background The concept of pharmaceutical care is operationalized through pharmaceutical professional services, which are patient-oriented to optimize their pharmacotherapy and to improve clinical outcomes. Objective The objective of this study was to estimate the incremental cost-effectiveness ratio (ICER) of a medication review with follow-up (MRF) service for older adults with polypharmacy in Spanish community pharmacies against the alternative of having their medication dispensed normally. Methods The study was designed as a cluster randomized controlled trial, and was carried out over a time horizon of 6 months. The target population was older adults with polypharmacy, defined as individuals taking five or more medicines per day. The study was conducted in 178 community pharmacies in Spain. Cost-utility analysis adopted a health service perspective. Costs were in euros at 2014 prices and the effectiveness of the intervention was estimated as quality-adjusted life-years (QALYs). In order to analyze the uncertainty of ICER results, we performed a non-parametric bootstrapping with 5000 replications. Results A total of 1403 older adults, aged between 65 and 94 years, were enrolled in the study: 688 in the intervention group (IG) and 715 in the control group (CG). By the end of the follow-up, both groups had reduced the mean number of prescribed medications they took, although this reduction was greater in the IG (0.28 ± 1.25 drugs; p  < 0.001) than in the CG (0.07 ± 0.95 drugs; p  = 0.063). Older adults in the IG saw their quality of life improved by 0.0528 ± 0.20 ( p  < 0.001). In contrast, the CG experienced a slight reduction in their quality of life: 0.0022 ± 0.24 ( p  = 0.815). The mean total cost was €977.57 ± 1455.88 for the IG and €1173.44 ± 3671.65 for the CG. In order to estimate the ICER, we used the costs adjusted for baseline medications and QALYs adjusted for baseline utility score, resulting in a mean incremental total cost of −€250.51 ± 148.61 (95 % CI −541.79 to 40.76) and a mean incremental QALY of 0.0156 ± 0.004 (95 % CI 0.008–0.023). Regarding the results from the cost-utility analysis, the MRF service emerged as the dominant strategy. Conclusion The MRF service is an effective intervention for optimizing prescribed medication and improving quality of life in older adults with polypharmacy in community pharmacies. The results from the cost-utility analysis suggest that the MRF service is cost effective.

Background Interprofessional collaborative care such as a split-shared care model involving family physicians and community pharmacists can reduce the economic burden of diabetes management. This study aimed to evaluate the economic outcome of a split-shared care model between family physicians and community pharmacists within a pharmacy chain in managing people with uncontrolled type 2 diabetes and polypharmacy. Method This was a multi-center, parallel arm, open label, randomized controlled trial comparing the direct and indirect economic outcomes of people who received collaborative care involving community pharmacists (intervention) versus those who received usual care without community pharmacist involvement (control). People with uncontrolled type 2 diabetes, defined as HbA1c > 7.0% and taking ≥ 5 chronic medications were included while people with missing baseline economic data (such as consultation costs, medication costs) were excluded. Direct medical costs were extracted from the institution’s financial database while indirect costs were calculated from self-reported gross income and productivity loss, using Work Productivity Activity Impairment Global Health questionnaire. Separate generalized linear models with log link function and gamma distribution were used to analyze changes in direct and indirect medical costs. Results A total of 175 patients (intervention = 70, control = 105) completed the trial and were included for analysis. The mean age of the participants was 66.9 (9.2) years, with majority being male and Chinese. The direct medical costs were significantly lower in the intervention than the control group over 6 months (intervention: -US$70.51, control: -US$47.66, p < 0.001). Medication cost was the main driver in both groups. There were no significant changes in productivity loss and indirect costs in both groups. Conclusion Implementation of split-shared visits with frontline community partners may reduce economic burden for patient with uncontrolled type 2 diabetes and polypharmacy. Trial registration Clinicaltrials.gov Reference Number: NCT03531944 (Date of registration: June 6, 2018).

Limited studies have investigated geographic accessibility to a nearby community pharmacy for elderly which is an essential determinant of the access to medications and pharmacy services. This research identified pharmacy deserts and investigated availability of different types of community pharmacies and their services for elderly enrolled in a State Pharmaceutical Assistance Program (SPAP). The state of Pennsylvania in the US was used as a case to demonstrate the geographic accessibility to community pharmacy and services for elderly enrolled in SPAP. The locations of community pharmacies and households of elderly enrolled in SPAP were derived from Pharmaceutical Assistance Contract for the Elderly programs' database. The street addresses were geocoded and the distance to a nearby community pharmacy was calculated for study sample using the haversine formula. The demographic and geographic data were aggregated to Census Tracts and pharmacy deserts were identified using the predefined criteria. Descriptive statistical analysis was used to determine whether there are statistical differences in the socio-demographic profiles and distribution of different types of community pharmacies and their services in pharmacy deserts and non-deserts. This research used hot spot analyses at county level to identify clusters of pharmacy deserts, areas with high concentration of different racial/ethnic groups and clusters of high densities of chain and independent pharmacies. The Spatial analysis revealed that 39% and 61% Census Tracts in Pennsylvania were pharmacy deserts and non-deserts respectively (p < 0.001). Pharmacy deserts were found to have significantly more females, married and white elderly and fewer blacks and Hispanics compared to pharmacy non-deserts. Pharmacy deserts had significantly fewer chain and independent pharmacies and less delivery and 24-hour services in pharmacies than pharmacy non-deserts. Hot spot analyses showed that clusters of pharmacy deserts were more concentrated in southcentral, northwest and northeast regions of the state which represent rural areas and overlapped with clusters of high concentration of white individuals. The findings suggest that urban-rural inequality, racial/ethnic disparity and differences in availability of pharmacies and their services exist between pharmacy deserts and non-deserts. The methodological approach and analyses used in this study can also be applied to other public health programs to evaluate the coverage and breadth of public health services.

Background The United Kingdom has been at the forefront of enhancing pharmacist roles and community pharmacy services, particularly over the past decade. However, patient and public awareness of community pharmacy services has been limited. Objective To identify and synthesize the research literature pertaining to patient and public perspectives on: existing community pharmacy services, extended pharmacist roles and strategies to raise awareness of community pharmacy services. Search strategy Systematic search of 8 electronic databases; hand searching of relevant journals, reference lists and conference proceedings. Inclusion criteria UK studies investigating patient or public views on community pharmacy services or pharmacist roles from 2005 to 2016. Data extraction and synthesis Data were extracted into a grid and subjected to narrative synthesis following thematic analysis. Main results From the 3260 unique papers identified, 30 studies were included. Manual searching identified 4 additional studies. Designs using questionnaires (n = 14, 41%), semi‐structured interviews (n = 8, 24%) and focus groups (n = 6, 18%) made up the greatest proportion of studies. Most of the studies (n = 28, 82%) were published from 2010 onwards and covered perceptions of specific community pharmacy services (n = 31). Using a critical appraisal checklist, the overall quality of studies was deemed acceptable. Findings were grouped into 2 main themes “public cognizance” and “attitudes towards services” each with 4 subthemes. Discussion and conclusions Patients and the public appeared to view services as beneficial. Successful integration of extended pharmacy services requires pharmacists’ clinical skills to be recognized by patients and physicians. Future research should explore different approaches to increase awareness.

Background The economic burden of asthma, which relates to the degree of control, is €5 billion annually in Italy. Pharmacists could help improve asthma control, reducing this burden. This study aimed to evaluate the effectiveness and cost-effectiveness of Medicines Use Reviews provided by community pharmacists in asthma. Methods This cluster randomised, multi-centre, controlled trial in adult patients with asthma was conducted in 15 of the 20 regions of Italy between September 2014 and July 2015. After stratification by region, community pharmacists were randomly allocated to group A (trained in and delivered the intervention at baseline) or B (training and delivery 3 months later), using computerised random number generation in blocks of 10. Each recruited up to five patients, with both groups followed for 9 months. The intervention consisted of a systematic, structured face-to-face consultation with a pharmacist, covering asthma symptoms, medicines used, attitude towards medicines and adherence, recording pharmacist-identified pharmaceutical care issues (PCIs). The primary outcome was asthma control, assessed using the Asthma-Control-Test (ACT) score (ACT ≥ 20 represents good control). Secondary outcomes were: number of active ingredients, adherence, cost-effectiveness compared with usual care. Although blinding was not possible for either pharmacists or patients, assessment of outcomes was conducted by researchers blind to group allocation. Results Numbers of pharmacists and patients enrolled were 283 (A = 136; B = 147) and 1263 (A = 600; B = 663), numbers completing were 201 (A = 97; B = 104) and 816 (A = 400; B = 416), respectively. Patients were similar in age and gender and 56.13% (458/816) had poor/partial asthma control. Pharmacists identified 1256 PCIs (mean 1.54/patient), mostly need for education, monitoring and potentially ineffective therapy. Median ACT score at baseline differed between groups (A = 19, B = 18; p  < 0.01). Odds ratio for improved asthma control was 1.76 (95% CI 1.33–2.33) and number needed to treat 10 (95% CI 6–28). Number of active ingredients reduced by 7.9% post-intervention ( p  < 0.01). Adherence improved by 35.4% 3 months post-intervention and 40.0% at 6 months ( p  < 0.01). The probability of the intervention being more cost-effective than usual care was 100% at 9 months. Conclusions This community pharmacist-based intervention demonstrated both effectiveness and cost-effectiveness. It has since been implemented as the first community pharmacy cognitive service in Italy. Trial registration TRN: ISRCTN72438848 (registered 5 th January 2015, retrospectively).

BackgroundPharmacist-led management of urinary tract infections has been introduced as a service in the United Kingdom, Canada, United States of America, New Zealand, and Australia. The management of acute uncomplicated urinary tract infections by community pharmacists has gained increasing attention as a potential avenue to alleviate the burden on primary healthcare services.AimThe objectives of the review were to: (1) identify protocols for community pharmacist management of acute uncomplicated urinary tract infections in women aged 16–65 years; (2) outline their key components; and (3) appraise the quality of protocols.MethodA grey literature search was undertaken for protocols intended for use by community pharmacists for the management of acute uncomplicated urinary tract infections in women aged 16–65 years, met the definition of a clinical management protocol and written in English. Their quality was appraised using the Appraisal Guidelines for Research and Evaluation version II instrument.ResultsForty of the 274 records screened were included. Content analysis identified ten key components: common signs/symptoms, differential diagnosis, red flags/referral, choice of empirical antibiotic therapy, nonprescription medications, nonpharmacological/self-care advice, patient eligibility criteria, patient follow-up, dipstick testing recommendations, and recommendations on antimicrobial resistance. The lowest scoring domains in the quality assessment were ‘Editorial Independence’ and ‘Rigour of Development’. Only four protocols were deemed high-quality.ConclusionThe review demonstrates that clinical management protocols for pharmacist-led management of urinary tract infections consist of similar recommendations, despite variation in international practice. However, the findings highlight a deficiency in the quality of most clinical management protocols governing pharmacist-led urinary tract infection management.

Background The PHARMACOP-intervention significantly improved medication adherence and inhalation technique for patients with COPD compared with usual care. This study aimed to evaluate its cost-effectiveness. Methods An economic analysis was performed from the Belgian healthcare payer’s perspective. A Markov model was constructed in which a representative group of patients with COPD (mean age of 70 years, 66% male, 43% current smokers and mean Forced Expiratory Volume in 1 second of % predicted of 50), was followed for either receiving the 3-month PHARMACOP-intervention or usual care. Three types of costs were calculated: intervention costs, medication costs and exacerbation costs. Outcome measures included the number of hospital-treated exacerbations, cost per prevented hospital-treated exacerbation and cost per Quality Adjusted Life-Year. Follow-up was 1 year in the basecase analysis. Sensitivity and scenario analyses (including long-term follow-up) were performed to assess uncertainty. Results In the basecase analysis, the average overall costs per patient for the PHARMACOP-intervention and usual care were €2,221 and €2,448, respectively within the 1-year time horizon. This reflects cost savings of €227 for the PHARMACOP-intervention. The PHARMACOP-intervention resulted in the prevention of 0.07 hospital-treated exacerbations per patient (0.177 for PHARMACOP versus 0.244 for usual care). Results showed robust cost-savings in various sensitivity analyses. Conclusions Optimization of current pharmacotherapy (e.g. close monitoring of inhalation technique and medication adherence) has been shown to be cost-saving and should be considered before adding new therapies.