Matthew J. Boyd

The evidence for the effectiveness of safety alerts in electronic patient medication record systems at the point of pharmacy order entry: a systematic review

BackgroundElectronic Patient Medication Record (ePMR) systems have important safety features embedded to alert users about potential clinical hazards and errors. To date, there is no synthesis of evidence about the effectiveness of these safety features and alerts at the point of pharmacy order entry. This review aims to systematically explore the literature and synthesise published evidence about the effectiveness of safety features and alerts in ePMR systems at the point of pharmacy order entry, in primary and secondary care.MethodsWe searched MEDLINE, EMBASE, Inspec, International Pharmaceutical Abstracts, PsycINFO, CINHAL (earliest entry to March 2012) and reference lists of articles. Two reviewers examined the titles and abstracts, and used a hierarchical template to identify comparative design studies evaluating the effectiveness of safety features and alerts at the point of pharmacy order entry. The two reviewers independently assessed the quality of the included studies using Cochrane Collaboration’s risk of bias tool.ResultsThree randomised trials and two before-after studies met our criteria. Four studies involved integrated care facilities and one was hospital-based. The studies were all from the United States (US). The five studies demonstrated statistically significant reduction in medication errors in patients with renal insufficiency, pregnant women dispensed US Food Drug and Administration (FDA) risk category D (evidence of fetal risk but therapeutic benefits can outweigh the risk) or X (evidence suggests that risk to the fetus outweighs therapeutic benefits) medication, first dispensing of inappropriate medications in patients aged 65 and above, co-dispensing of interacting drugs, and adverse drug events related to hyperkalaemia.ConclusionsThis systematic review shows that the safety features of ePMR systems are effective in alerting users about potential clinical hazards and errors during pharmacy order entry. There are however, problems such as false alerts and inconsistencies in alert management. More studies are needed from other countries and pharmacy practice settings to assess the effectiveness of electronic safety features and alerts in preventing error and reducing harm to patients.

Supporting adherence for people starting a new medication for a long-term condition through community pharmacies: a pragmatic randomised controlled trial of the New Medicine Service

Objective To 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. Methods Pragmatic 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. Results At 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. Conclusions The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice. Trial registration numbers ClinicalTrials.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).

The effect of the electronic transmission of prescriptions on dispensing errors and prescription enhancements made in English community pharmacies: a naturalistic stepped wedge study

Objectives To compare prevalence and types of dispensing errors and pharmacists’ labelling enhancements, for prescriptions transmitted electronically versus paper prescriptions. Design Naturalistic stepped wedge study. Setting 15 English community pharmacies. Intervention Electronic transmission of prescriptions between prescriber and pharmacy. Main outcome measures Prevalence of labelling errors, content errors and labelling enhancements (beneficial additions to the instructions), as identified by researchers visiting each pharmacy. Results Overall, we identified labelling errors in 5.4% of 16 357 dispensed items, and content errors in 1.4%; enhancements were made for 13.6%. Pharmacists also edited the label for a further 21.9% of electronically transmitted items. Electronically transmitted prescriptions had a higher prevalence of labelling errors (7.4% of 3733 items) than other prescriptions (4.8% of 12 624); OR 1.46 (95% CI 1.21 to 1.76). There was no difference for content errors or enhancements. The increase in labelling errors was mainly accounted for by errors (mainly at one pharmacy) involving omission of the indication, where specified by the prescriber, from the label. A sensitivity analysis in which these cases (n=158) were not considered errors revealed no remaining difference between prescription types. Conclusions We identified a higher prevalence of labelling errors for items transmitted electronically, but this was predominantly accounted for by local practice in a single pharmacy, independent of prescription type. Community pharmacists made labelling enhancements to about one in seven dispensed items, whether electronically transmitted or not. Community pharmacists, prescribers, professional bodies and software providers should work together to agree how items should be dispensed and labelled to best reap the benefits of electronically transmitted prescriptions. Community pharmacists need to ensure their computer systems are promptly updated to help reduce errors.

Exploring safety systems for dispensing in community pharmacies: Focusing on how staff relate to organizational components

Background Identifying risk is an important facet of a safety practice in an organization. To identify risk, all components within a system of operation should be considered. In clinical safety practice, a team of people, technologies, procedures and protocols, management structure and environment have been identified as key components in a system of operation. Objectives To explore risks in relation to prescription dispensing in community pharmacies by taking into account relationships between key components that relate to the dispensing process. Methods Fifteen community pharmacies in England with varied characteristics were identified, and data were collected using non-participant observations, shadowing and interviews. Approximately 360 hours of observations and 38 interviews were conducted by the team. Observation field notes from each pharmacy were written into case studies. Overall, 52,500 words from 15 case studies and interview transcripts were analyzed using thematic and line-by-line analyses. Validation techniques included multiple data collectors co-authoring each case study for consensus, review of case studies by members of the wider team including academic and practicing community pharmacists, and patient safety experts and two presentations (internally and externally) to review and discuss findings. Results Risks identified were related to relationships between people and other key components in dispensing. This included how different levels of staff communicated internally and externally, followed procedures, interacted with technical systems, worked with management, and engaged with the environment. In a dispensing journey, the following categories were identified which show how risks are inextricably linked through relationships between human components and other key components: 1) dispensing with divided attention; 2) dispensing under pressure; 3) dispensing in a restricted space or environment; and, 4) managing external influences. Conclusions To identify and evaluate risks effectively, an approach that includes understanding relationships between key components in dispensing is required. Since teams of people in community pharmacies are a key dispensing component, and therefore part of the operational process, it is important to note how they relate to other components in the environment within which they operate. Pharmacies can take the opportunity to reflect on the organization of their systems and review in particular how they can improve on the four key categories identified.

Understanding the epidemiology of avoidable significant harm in primary care: protocol for a retrospective cross-sectional study

Introduction Most patient safety research has focused on specialist-care settings where there is an appreciation of the frequency and causes of medical errors, and the resulting burden of adverse events. There have, however, been few large-scale robust studies that have investigated the extent and severity of avoidable harm in primary care. To address this, we will conduct a 12-month retrospective cross-sectional study involving case note review of primary care patients. Methods and analysis We will conduct electronic searches of general practice (GP) clinical computer systems to identify patients with avoidable significant harm. Up to 16 general practices from 3 areas of England (East Midlands, London and the North West) will be recruited based on practice size, to obtain a sample of around 100 000 patients. Our investigations will include an ‘enhanced sample’ of patients with the highest risk of avoidable significant harm. We will estimate the incidence of avoidable significant harm and express this as ‘per 100 000 patients per year’. Univariate and multivariate analysis will be conducted to identify the factors associated with avoidable significant harm. Ethics/Dissemination The decision regarding participation by general practices in the study is entirely voluntary; the consent to participate may be withdrawn at any time. We will not seek individual patient consent for the retrospective case note review, but if patients respond to publicity about the project and say they do not wish their records to be included, we will follow these instructions. We will produce a report for the Department of Healths Policy Research Programme and several high-quality peer-reviewed publications in scientific journals. The study has been granted a favourable opinion by the East Midlands Nottingham 2 Research Ethics Committee (reference 15/EM/0411) and Confidentiality Advisory Group approval for access to medical records without consent under section 251 of the NHS Act 2006 (reference 15/CAG/0182).

Cost Effectiveness of Support for People Starting a New Medication for a Long-Term Condition Through Community Pharmacies: An Economic Evaluation of the New Medicine Service (NMS) Compared with Normal Practice

BackgroundThe English community pharmacy New Medicine Service (NMS) significantly increases patient adherence to medicines, compared with normal practice. We examined the cost effectiveness of NMS compared with normal practice by combining adherence improvement and intervention costs with the effect of increased adherence on patient outcomes and healthcare costs.MethodsWe developed Markov models for diseases targeted by the NMS (hypertension, type 2 diabetes mellitus, chronic obstructive pulmonary disease, asthma and antiplatelet regimens) to assess the impact of patients’ non-adherence. Clinical event probability, treatment pathway, resource use and costs were extracted from literature and costing tariffs. Incremental costs and outcomes associated with each disease were incorporated additively into a composite probabilistic model and combined with adherence rates and intervention costs from the trial. Costs per extra quality-adjusted life-year (QALY) were calculated from the perspective of NHS England, using a lifetime horizon.ResultsNMS generated a mean of 0.05 (95% CI 0.00–0.13) more QALYs per patient, at a mean reduced cost of −£144 (95% CI −769 to 73). The NMS dominates normal practice with a probability of 0.78 [incremental cost-effectiveness ratio (ICER) −£3166 per QALY]. NMS has a 96.7% probability of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY. Sensitivity analysis demonstrated that targeting each disease with NMS has a probability over 0.90 of cost effectiveness compared with normal practice at a willingness to pay of £20,000 per QALY.ConclusionsOur study suggests that the NMS increased patient medicine adherence compared with normal practice, which translated into increased health gain at reduced overall cost.Trial RegistrationClinicalTrials.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).FundingDepartment of Health Policy Research Programme.

Assessing the safety features of electronic patient medication record systems used in community pharmacies in England

Aims To evaluate the ability of electronic patient medication record (ePMR) systems used in community pharmacies in England to detect and alert users about clinical hazards, errors and other safety problems. Methods Between September 2012 and November 2012, direct on-site observational data about the performance of ePMR systems were collected from nine sites. Twenty-eight scenarios were developed by consensus agreement between a general practitioner and two community pharmacists. Each scenario was entered into the ePMR system, and the results obtained from the assessment of six unique systems in nine sites, in terms of the presence or absence of an alert, were recorded onto a prespecified form. Results None of the systems produced the correct responses for all of the 28 scenarios tested. Only two systems provided an alert to penicillin sensitivity. No dose or frequency check was observed when processing a prescription for methotrexate. One system did not warn about nonsuitability of aspirin prescribed to a child of 14 years of age. In another system, it was not possible to record a patients pregnancy status. None of the six systems provided any warning for diclofenac overdose, high initiation dose of morphine sulfate or significant dose increase. Only one of the systems did not produce any spurious alerts. Conclusions The performance of the ePMR systems tested was variable and suboptimal. The findings suggest the need for minimum specifications and standards for ePMR systems to ensure consistency of performance.

The role of pharmacists in general practice: a realist review

Background: The review was carried out to inform the evaluation of the clinical pharmacists in general practice pilot scheme, a world leading initiative to improve health care delivery in England. Around 500 pharmacists are already working in general practice as part of the pilot, launched in July 2015. Objectives: The review attempts to explain the how pharmacists working in general practice is being implemented in the UK and beyond, what works well, what does not work so well and everything in‐between. Methods: This realist review was conducted to the RAMESES standards. Studies were identified by searching three databases, Medline, Embase and Scopus. Additional papers were gathered from reference lists, Google searches and via the find similar citations feature. Results: A total of 83 papers and articles were initially identified from Medline (19), Embase (31) and Scopus (32). With close reading, the final review consisted of 43 papers relating to 38 studies. Most of the research was undertaken in the field of pharmacy practice and over half of the studies investigated the perspectives of different stakeholders using questionnaires or qualitative methods. Conclusion: The pharmacist working in general practice is still a relatively new concept and further more in‐depth research is still required. However, from this small number of studies, the common barriers and facilitators to the implementation can be identified. The review also lists mechanisms that will be needed to ensure the effective implementation of this initiative.

What proportion of prescription items dispensed in community pharmacies are eligible for the New Medicine Service

BackgroundThe payment structure for the New Medicine Service (NMS) in England is based on the assumption that 0.5% of prescription items dispensed in community pharmacies are eligible for the service. This assumption is based on a theoretical calculation. This study aimed to find out the actual proportion of prescription items eligible for the NMS dispensed in community pharmacies in order to compare this with the theoretical assumption. The study also aimed to investigate whether the proportion of prescription items eligible for the NMS is affected by pharmacies’ proximity to GP practices.MethodsThe study collected data from eight pharmacies in Nottingham belonging to the same large chain of pharmacies. Pharmacies were grouped by distance from the nearest GP practice and sampled to reflect the distribution by distance of all pharmacies in Nottingham. Data on one thousand consecutive prescription items were collected from each pharmacy and the number of NMS eligible items recorded. All NHS prescriptions were included in the sample. Data were analysed and proportions calculated with 95% confidence intervals used to compare the study results against the theoretical figure of 0.5% of prescription items being eligible for the NMS.ResultsA total of 8005 prescription items were collected (a minimum of 1000 items per pharmacy) of which 17 items were eligible to receive the service. The study found that 0.25% (95% confidence intervals: 0.14% to 0.36%) of prescription items were eligible for the NMS which differs significantly from the theoretical assumption of 0.5%. The opportunity rate for the service was lower, 0.21% (95% confidence intervals: 0.10% to 0.32%) of items, as some items eligible for the NMS did not translate into opportunities to offer the service. Of all the prescription items collected in the pharmacies, 28% were collected by patient representatives.ConclusionsThe results of this study show that the proportion of items eligible for the NMS dispensed in community pharmacies is lower than the Department of Health assumption of 0.5%. This study did not find a significant difference in the rate of NMS opportunities between pharmacies located close to GP practices compared to those further away.

‘I expected just to walk in, get my tablets and then walk out’: on framing new community pharmacy services in the English healthcare system

Reconfiguration of the healthcare division of labour is becoming increasingly attractive in the context of increased patient demand and resource constraints. One example is the introduction of extended roles for pharmacists to provide patients additional support to manage their medicines, while also reducing work pressures experienced by other health professionals. Understanding how such policies are framed by those delivering and receiving care has been under-theorised. Using Goffmans frame theory, we examine one newly introduced community pharmacy service (New Medicines Service (NMS)) to illustrate how a policy intended to support patient medicine-taking through the extended roles of pharmacists is framed and where this deviates from its proposed aims. Three themes emerged: (i) the spatial-material artefacts; (ii) existing discursive culture and practice around medicine-taking; and (iii) the NMS interactions that shape and govern framing and subsequent interpretation of the NMS. Our study offers an explanatory and dynamic view of the framing process with important lessons for reconfiguring medicine management policy and practice. As well as illustrating framing as being variegated, complementary or conflicting, it also shows how this plurality and fragility had consequences for patient engagement and sense-making. The consequences for engagement and recommendations for implementing future initiatives are discussed.