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1.  Assessing the safety features of electronic patient medication record systems used in community pharmacies in England 
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.
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.
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 patient's 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.
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.
PMCID: PMC4137832  PMID: 24528252
decision support; electronic patient medication record system; pharmacy computer system; safety alert; safety feature; safety warning
2.  Primary Care Medication Safety Surveillance with Integrated Primary and Secondary Care Electronic Health Records: A Cross-Sectional Study 
Drug Safety  2015;38(7):671-682.
The extent of preventable medication-related hospital admissions and medication-related issues in primary care is significant enough to justify developing decision support systems for medication safety surveillance. The prerequisite for such systems is defining a relevant set of medication safety-related indicators and understanding the influence of both patient and general practice characteristics on medication prescribing and monitoring.
The aim of the study was to investigate the feasibility of linked primary and secondary care electronic health record data for surveillance of medication safety, examining not only prescribing but also monitoring, and associations with patient- and general practice-level characteristics.
A cross-sectional study was conducted using linked records of patients served by one hospital and over 50 general practices in Salford, UK. Statistical analysis consisted of mixed-effects logistic models, relating prescribing safety indicators to potential determinants.
The overall prevalence (proportion of patients with at least one medication safety hazard) was 5.45 % for prescribing indicators and 7.65 % for monitoring indicators. Older patients and those on multiple medications were at higher risk of prescribing hazards, but at lower risk of missed monitoring. The odds of missed monitoring among all patients were 25 % less for males, 50 % less for patients in practices that provide general practitioner training, and threefold higher in practices serving the most deprived compared with the least deprived areas. Practices with more prescribing hazards did not tend to show more monitoring issues.
Systematic collection, collation, and analysis of linked primary and secondary care records produce plausible and useful information about medication safety for a health system. Medication safety surveillance systems should pay close attention to patient age and polypharmacy with respect to both prescribing and monitoring failures; treat prescribing and monitoring as different statistical processes, rather than a combined measure of prescribing safety; and audit the socio-economic equity of missed monitoring.
Electronic supplementary material
The online version of this article (doi:10.1007/s40264-015-0304-x) contains supplementary material, which is available to authorized users.
PMCID: PMC4486763  PMID: 26100143
3.  Is polypharmacy always hazardous? A retrospective cohort analysis using linked electronic health records from primary and secondary care 
Prescribing multiple medications is associated with various adverse outcomes, and polypharmacy is commonly considered suggestive of poor prescribing. Polypharmacy might thus be associated with unplanned hospitalization. We sought to test this assumption.
Scottish primary care data for 180 815 adults with long-term clinical conditions and numbers of regular medications were linked to national hospital admissions data for the following year. Using logistic regression (age, gender and deprivation adjusted), we modelled the association of prescribing with unplanned admission for patients with different numbers of long-term conditions.
Admissions were more common in patients on multiple medications, but admission risk varied with the number of conditions. For patients with one condition, the odds ratio for unplanned admission for four to six medications was 1.25 (95% confidence interval 1.11–1.42) vs. one to three medications, and 3.42 (95% confidence interval 2.72–4.28) for ≥10 medications vs. one to three medications. However, this effect was greatly reduced for patients with multiple conditions; amongst patients with six or more conditions, those on four to six medications were no more likely to have unplanned admissions than those taking one to three medications (odds ratio 1.00; 95% confidence interval 0.88–1.14), and those taking ≥10 medications had a modestly increased risk of admission (odds ratio 1.50; 95% confidence interval 1.31–1.71).
Unplanned hospitalization is strongly associated with the number of regular medications. However, the effect is reduced in patients with multiple conditions, in whom only the most extreme levels of polypharmacy are associated with increased admissions. Assumptions that polypharmacy is always hazardous and represents poor care should be tempered by clinical assessment of the conditions for which those drugs are being prescribed.
PMCID: PMC4093932  PMID: 24428591
hospital admission; multimorbidity; polypharmacy; primary care
5.  Identification of an updated set of prescribing-safety indicators for GPs 
The British Journal of General Practice  2014;64(621):e181-e190.
Medication error is an important contributor to patient morbidity and mortality and is associated with inadequate patient safety measures. However, prescribing-safety tools specifically designed for use in general practice are lacking.
To identify and update a set of prescribing-safety indicators for assessing the safety of prescribing in general practice, and to estimate the risk of harm to patients associated with each indicator.
Design and setting
RAND/UCLA consensus development of indicators in UK general practice.
Prescribing indicators were identified from a systematic review and previous consensus exercise. The RAND Appropriateness Method was used to further identify and develop the indicators with an electronic-Delphi method used to rate the risk associated with them. Twelve GPs from all the countries of the UK participated in the RAND exercise, with 11 GPs rating risk using the electronic-Delphi approach.
Fifty-six prescribing-safety indicators were considered appropriate for inclusion (overall panel median rating of 7–9, with agreement). These indicators cover hazardous prescribing across a range of therapeutic indications, hazardous drug–drug combinations and inadequate laboratory test monitoring. Twenty-three (41%) of these indicators were considered high risk or extreme risk by 80% or more of the participants.
This study identified a set of 56 indicators that were considered, by a panel of GPs, to be appropriate for assessing the safety of GP prescribing. Twenty-three of these indicators were considered to be associated with high or extreme risk to patients and should be the focus of efforts to improve patient safety.
PMCID: PMC3964450  PMID: 24686882
ambulatory care; consensus; general practice; medication errors; patient safety; primary health care; quality indicators
6.  Exploring safety systems for dispensing in community pharmacies: Focusing on how staff relate to organizational components☆ 
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.
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.
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.
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.
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.
PMCID: PMC4330989  PMID: 25108523
Community pharmacy; Human factors; Patient safety; Clinical safety management
7.  Developing consensus on hospital prescribing indicators of potential harms amenable to decision support 
To develop a list of prescribing indicators specific for the hospital setting that would facilitate the prospective collection of high-severity and/or high-frequency prescribing errors, which are also amenable to electronic clinical decision support.
A two-stage consensus technique (electronic Delphi) was carried out with 20 experts across England. Participants were asked to score prescribing errors using a five-point Likert scale for their likelihood of occurrence and the severity of the most likely outcome. These were combined to produce risk scores, from which median scores were calculated for each indicator across the participants in the study. The degree of consensus between the participants was defined as the proportion that gave a risk score in the same category as the median. Indicators were included if a consensus of 80% or more was achieved.
A total of 80 prescribing errors were identified by consensus as being high or extreme risk. The most common drug classes named within the indicators were antibiotics (n = 13), antidepressants (n = 8), nonsteroidal anti-inflammatory drugs (n = 6) and opioid analgesics (n = 6). The most frequent error type identified as high or extreme risk were those classified as clinical contraindications (n = 29 of 80).
Eighty high-risk prescribing errors in the hospital setting have been identified by an expert panel. These indicators can serve as a standardized, validated tool for the collection of prescribing data in both paper-based and electronic prescribing processes. This can assess the impact of safety improvement initiatives, such as the implementation of electronic clinical decision support.
PMCID: PMC3853538  PMID: 23362926
clinical decision support; consensus; drug prescriptions; hospitals; medication errors; quality indicators
8.  The causes of prescribing errors in English general practices: a qualitative study 
The British Journal of General Practice  2013;63(615):e713-e720.
Few detailed studies exist of the underlying causes of prescribing errors in the UK.
To examine the causes of prescribing and monitoring errors in general practice and provide recommendations for how they may be overcome.
Design and setting
Qualitative interview and focus group study with purposive sampling of English general practices.
General practice staff from 15 general practices across three PCTs in England participated in a combination of semi-structured interviews (n = 34) and six focus groups (n = 46). Thematic analysis informed by Reason’s Accident Causation Model was used.
Seven categories of high-level error-producing conditions were identified: the prescriber, the patient, the team, the working environment, the task, the computer system, and the primary–secondary care interface. These were broken down to reveal various error-producing conditions: the prescriber’s therapeutic training, drug knowledge and experience, knowledge of the patient, perception of risk, and their physical and emotional health; the patient’s characteristics and the complexity of the individual clinical case; the importance of feeling comfortable within the practice team was highlighted, as well as the safety implications of GPs signing prescriptions generated by nurses when they had not seen the patient for themselves; the working environment with its extensive workload, time pressures, and interruptions; and computer-related issues associated with mis-selecting drugs from electronic pick-lists and overriding alerts were all highlighted as possible causes of prescribing errors and were often interconnected.
Complex underlying causes of prescribing and monitoring errors in general practices were highlighted, several of which are amenable to intervention.
PMCID: PMC3782805  PMID: 24152487
general practice; medication safety; patient safety; prescribing; primary care; quality
9.  Tools for measuring patient safety in primary care settings using the RAND/UCLA appropriateness method 
BMC Family Practice  2014;15:110.
The majority of patient contacts occur in general practice but general practice patient safety has been poorly described and under-researched to date compared to hospital settings. Our objective was to produce a set of patient safety tools and indicators that can be used in general practices in any healthcare setting and develop a ‘toolkit’ of feasible patient safety measures for general practices in England.
A RAND/UCLA Appropriateness Method exercise was conducted with a panel of international experts in general practice patient safety. Statements were developed from an extensive systematic literature review of patient safety in general practice. We used standard RAND/UCLA Appropriateness Method rating methods to identify necessary items for assessing patient safety in general practice, framed in terms of the Structure-Process-Outcome taxonomy. Items were included in the toolkit if they received an overall panel median score of ≥7 with agreement (no more than two panel members rating the statement outside a 3-point distribution around the median).
Of 205 identified statements, the panel rated 101 as necessary for assessing the safety of general practices. Of these 101 statements, 73 covered structures or organisational issues, 22 addressed processes and 6 focused on outcomes.
We developed and tested tools that can lead to interventions to improve safety outcomes in general practice. This paper reports the first attempt to systematically develop a patient safety toolkit for general practice, which has the potential to improve safety, cost effectiveness and patient experience, in any healthcare system.
PMCID: PMC4060097  PMID: 24902490
Primary health care; Consensus; Patient safety; Quality indicators
10.  Meeting user needs in national healthcare systems: lessons from early adopter community pharmacists using the electronic prescriptions service 
The Electronic Prescription Service release Two (EPS2) is a new national healthcare information and communication technology in England that aims to deliver effective prescription writing, dispensing and reimbursement service to benefit patients. The aim of the study was to explore initial user experiences of Community Pharmacists (CPs) using EPS2.
We conducted nonparticipant observations and interviews in eight EPS2 early adopter community pharmacies classified as ‘first-of-type’ in midlands and northern regions in England. We interviewed eight pharmacists and two dispensers in addition to 56 hours recorded nonparticipant observations as field notes. Line-by-line coding and thematic analysis was conducted on the interview transcripts and field notes.
CPs faced two types of challenge. The first was to do with missing electronic prescriptions. This was sometimes very disrupting to work practice, but pharmacists considered it a temporary issue resolvable with minor modifications to the system and user familiarity. The second was to do with long term design-specific issues. Pharmacists could only overcome these by using the system in ways not intended by the developers. Some felt that these issues would not exist had ‘real’ users been involved in the initial development. The issues were: 1) printing out electronic prescriptions (tokens) to dispense from for safe dispensing practices and to free up monitors for other uses, 2) logging all dispensing activities with one user’s Smartcard for convenience and use all human resources in the pharmacy, and, 3) problematic interface causing issues with endorsing prescriptions and claiming reimbursements.
We question if these unintended uses and barriers would have occurred had a more rigorous user-centric principles been applied at the earlier stages of design and implementation of EPS. We conclude that, since modification can occur at the evaluation stage, there is still scope for some of these barriers to be corrected to address the needs, and enhance the experiences, of CPs using the service, and make recommendations on how current challenges could be resolved.
PMCID: PMC3984715  PMID: 24612966
User-centric approaches; Healthcare ICT; Usability; User experience; Social informatics in healthcare; Electronic prescription service release two
11.  Protocol for the New Medicine Service Study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England 
Trials  2013;14:411.
Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions.
Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England.
Design: parallel group patient-level pragmatic randomized controlled trial.
Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine.
Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies.
Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders.
Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice.
Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice.
Sample size: 250 patients in each treatment arm would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a reduction in patient-reported non-adherence from 20% to 10% in the NMS arm compared with current practice, assuming a 20% drop-out rate.
At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken.
Trial registration
Current controlled trials: ISRCTN23560818
Clinical Trials US ( NCT01635361
PMCID: PMC4220816  PMID: 24289059
12.  Community falls prevention for people who call an emergency ambulance after a fall: an economic evaluation alongside a randomised controlled trial 
Age and Ageing  2012;41(5):635-641.
Objective: we estimated the cost-effectiveness of a community falls prevention service compared with usual care from a National Health Service and personal social services perspective over the 12 month trial period.
Design: a cost-effectiveness and cost utility analysis alongside a randomised controlled trial
Setting: community.
Participants: people over 60 years of age living at home or in residential care who had fallen and called an emergency ambulance but were not taken to hospital.
Interventions: referral to community fall prevention services or usual health and social care.
Measurements: incremental cost per fall prevented and incremental cost per Quality-Adjusted Life Years (QALYs)
Results: a total of 157 participants (82 interventions and 75 controls) were used to perform the economic evaluation. The mean difference in NHS and personal social service costs between the groups was £-1,551 per patient over 1 year (95% CI: £-5,932 to £2,829) comparing the intervention and control groups. The intervention patients experienced on average 5.34 fewer falls over 12 months (95% CI: −7.06 to −3.62). The mean difference in QALYs was 0.070 (95% CI: −0.010 to 0.150) in favour of the intervention group.
Conclusion: the community falls prevention service was estimated to be cost-effective in this high-risk group. Current Controlled Trials ISRCTN67535605. (
PMCID: PMC3424053  PMID: 22695789
economic evaluation; falls prevention; older people
13.  The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review 
The British Journal of General Practice  2013;63(613):e543-e553.
Relatively little is known about prescribing errors in general practice, or the factors associated with error.
To determine the prevalence and nature of prescribing and monitoring errors in general practices in England.
Design and setting
Retrospective case-note review of unique medication items prescribed over a 12-month period to a 2% random sample of patients. Fifteen general practices across three primary care trusts in England.
A total of 6048 unique prescription items prescribed over the previous 12 months for 1777 patients were examined. The data were analysed by mixed effects logistic regression. The main outcome measures were prevalence of prescribing and monitoring errors, and severity of errors, using validated definitions.
Prescribing and/or monitoring errors were detected in 4.9% (296/6048) of all prescription items (95% confidence interval [CI] = 4.4% to 5.5%). The vast majority of errors were of mild to moderate severity, with 0.2% (11/6048) of items having a severe error. After adjusting for covariates, patient-related factors associated with an increased risk of prescribing and/or monitoring errors were: age <15 years (odds ratio [OR] = 1.87, 95% CI = 1.19 to 2.94, P = 0.006) or >64 years (OR = 1.68, 95% CI = 1.04 to 2.73, P = 0.035), and higher numbers of unique medication items prescribed (OR = 1.16, 95% CI = 1.12 to 1.19, P<0.001).
Prescribing and monitoring errors are common in English general practice, although severe errors are unusual. Many factors increase the risk of error. Having identified the most common and important errors, and the factors associated with these, strategies to prevent future errors should be developed, based on the study findings.
PMCID: PMC3722831  PMID: 23972195
general practice; medication errors; prevalence; primary health care
14.  The evidence for the effectiveness of safety alerts in electronic patient medication record systems at the point of pharmacy order entry: a systematic review 
Electronic 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.
We 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.
Three 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.
This 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.
PMCID: PMC3702525  PMID: 23816138
Electronic patient medication record system; Safety feature; Safety alert; Safety warning; Pharmacy order entry system; Decision support; Pharmacy computer system; Medicine supply; Drug alert
15.  The socio-technical organisation of community pharmacies as a factor in the Electronic Prescription Service Release Two implementation: a qualitative study 
The introduction of a new method of transmitting prescriptions from general practices to community pharmacies in England (Electronic Prescription Service Release 2 (EPS2)) has generated debate on how it will change work practice. As EPS2 will be a key technical element in dispensing, we reviewed the literature to find that there were no studies on how social and technical elements come together to form work practice in community pharmacies. This means the debate has little point of reference. Our aim therefore was to study the ways social and technical elements of a community pharmacy are used to achieve dispensing through the development of a conceptual model on pharmacy work practice, and to consider how a core technical element such the EPS2 could change work practice.
We used ethnographic methods inclusive of case-study observations and interviews to collect qualitative data from 15 community pharmacies that were in the process of adopting or were soon to adopt EPS2. We analysed the case studies thematically and used rigorous multi-dimensional and multi-disciplinary interpretive validation techniques to cross analyse findings.
In practice, dispensing procedures were not designed to take into account variations in human and technical integration, and assumed that repetitive and collective use of socio-technical elements were at a constant. Variables such as availability of social and technical resources, and technical know-how of staff were not taken into account in formalised procedures. Yet community pharmacies were found to adapt their dispensing in relation to the balance of social and technical elements available, and how much of the social and technical elements they were willing to integrate into dispensing. While some integrated as few technical elements as possible, some depended entirely on technical artefacts. This pattern also applied to the social elements of dispensing. Through the conceptual model development process, we identified three approaches community pharmacies used to appropriate procedures in practice. These were ‘technically oriented’, ‘improvising’ or ‘socially oriented’.
We offer a model of different work approaches community pharmacies use to dispense, which suggests that when adopting a core technical element such as the EPS2 system of dispensing there could be variations in its successful adoption. Technically oriented pharmacies might find it easiest to integrate a similar artefact into work practice although needs EPS2 to synchronise effectively with existing technologies. Pharmacies adopting an improvising-approach have the potential to improve how they organise dispensing through EPS2 although they will need to improve how they apply their operating procedures. Socially oriented pharmacies will need to dramatically adapt their approach to dispensing since they usually rely on few technical tools.
PMCID: PMC3551639  PMID: 23256484
Community pharmacy; EPS2; Socio-technical; Work practice
16.  The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective 
To explore the opinions of patient reporters to the UK Yellow Card Scheme (YCS) on the importance of the scheme.
Postal questionnaires were distributed on our behalf to all patient reporters submitting a Yellow Card to the Medicines and Healthcare Regulatory Agency (MHRA) between March and December 2008, with one follow-up reminder to non-responders. Qualitative analysis was undertaken of responses to an open question asking why respondents felt patient reporting was important. This was followed up by telephone interviews with a purposive sample of selected respondents.
There were 1362 evaluable questionnaires returned from 2008 distributed (68%) and 1238 (91%) respondents provided a total of 1802 comments. Twenty-seven interviews were conducted, which supported and expanded the views expressed in the questionnaire. Four main themes emerged, indicating views that the YCS was of importance to pharmacovigilance in general, manufacturers and licensing authorities, patients and the public and health professionals. Reporters viewed the YCS as an important opportunity to describe their experiences for the benefit of others and to contribute to pharmacovigilance. The scheme's independence from health professionals was regarded as important, in part to provide the patient perspective to manufacturers and regulators, but also because of dismissive attitudes and under-reporting by health professionals.
Direct patient reporting through the YCS is viewed as important by those who have used the scheme, in order to provide the patient experience for the benefit of pharmacovigilance, as an independent perspective from those of health professionals.
PMCID: PMC3243015  PMID: 21496066
adverse drug reactions; direct patient reporting; pharmacovigilance
17.  Development of prescribing-safety indicators for GPs using the RAND Appropriateness Method 
The British Journal of General Practice  2011;61(589):e526-e536.
In the UK, a process of revalidation is being introduced to allow doctors to demonstrate that they meet current professional standards, are up-to-date, and fit to practise. Given the serious risks to patients from hazardous use of medicines it will be appropriate, as part of the revalidation process, to assess the safety of prescribing by GPs.
To identify a set of potential prescribing-safety indicators forthe purposes of revalidation of individual GPs in the UK.
Design and setting
The RAND Appropriateness Method was used to identify, develop, and obtain agreement on the indicators in UK general practice.
Twelve GPs from across the UK with a wide variety of characteristics assessed indicators for appropriateness of use in revalidation.
Forty-seven safety indicators were considered appropriate for assessing the prescribing safety of individual GPs forthe purposes of revalidation (appropriateness was defined as an overall panel median score of ≥7 (on a 1-9 scale), with no more than three panel members rating the indicator outside the 3-point distribution around the median]. After removing indicators that were variations on the same theme, a final set of 34 indicators was obtained; these cover hazardous prescribing across a range of therapeutic areas, hazardous drug-drug combinations, prescribing with a history of allergy, and inadequate laboratory-test monitoring.
This study identified a set of 34 indicators that were considered, by a panel of 12 GPs, to be appropriate for use in assessing the safety of GP prescribing forthe purposes of revalidation. Violation of any of the 34 indicators indicates a potential patient-safety problem.
PMCID: PMC3145537  PMID: 21801572
consensus; medication errors; primary health care; professional practice; quality indicators; safety
18.  Persistent frequent attenders in primary care: costs, reasons for attendance, organisation of care and potential for cognitive behavioural therapeutic intervention 
BMC Family Practice  2012;13:39.
The top 3% of frequent attendance in primary care is associated with 15% of all appointments in primary care, a fivefold increase in hospital expenditure, and more mental disorder and functional somatic symptoms compared to normal attendance. Although often temporary if these rates of attendance last more than two years, they may become persistent (persistent frequent or regular attendance). However, there is no long-term study of the economic impact or clinical characteristics of regular attendance in primary care. Cognitive behaviour formulation and treatment (CBT) for regular attendance as a motivated behaviour may offer an understanding of the development, maintenance and treatment of regular attendance in the context of their health problems, cognitive processes and social context.
A case control design will compare the clinical characteristics, patterns of health care use and economic costs over the last 10 years of 100 regular attenders (≥30 appointments with general practitioner [GP] over 2 years) with 100 normal attenders (6–22 appointments with GP over 2 years), from purposefully selected primary care practices with differing organisation of care and patient demographics. Qualitative interviews with regular attending patients and practice staff will explore patient barriers, drivers and experiences of consultation, and organisation of care by practices with its challenges. Cognitive behaviour formulation analysed thematically will explore the development, maintenance and therapeutic opportunities for management in regular attenders. The feasibility, acceptability and utility of CBT for regular attendance will be examined.
The health care costs, clinical needs, patient motivation for consultation and organisation of care for persistent frequent or regular attendance in primary care will be explored to develop training and policies for service providers. CBT for regular attendance will be piloted with a view to developing this approach as part of a multifaceted intervention.
PMCID: PMC3390898  PMID: 22607525
High utilisers of care; Primary care; Cognitive behavior therapy; Hypochondriasis; Somatoform disorders; Health care economics and organizations
19.  An embedded longitudinal multi-faceted qualitative evaluation of a complex cluster randomized controlled trial aiming to reduce clinically important errors in medicines management in general practice 
Trials  2012;13:78.
There is a need to shed light on the pathways through which complex interventions mediate their effects in order to enable critical reflection on their transferability. We sought to explore and understand key stakeholder accounts of the acceptability, likely impact and strategies for optimizing and rolling-out a successful pharmacist-led information technology-enabled (PINCER) intervention, which substantially reduced the risk of clinically important errors in medicines management in primary care.
Data were collected at two geographical locations in central England through a combination of one-to-one longitudinal semi-structured telephone interviews (one at the beginning of the trial and another when the trial was well underway), relevant documents, and focus group discussions following delivery of the PINCER intervention. Participants included PINCER pharmacists, general practice staff, researchers involved in the running of the trial, and primary care trust staff. PINCER pharmacists were interviewed at three different time-points during the delivery of the PINCER intervention. Analysis was thematic with diffusion of innovation theory providing a theoretical framework.
We conducted 52 semi-structured telephone interviews and six focus group discussions with 30 additional participants. In addition, documentary data were collected from six pharmacist diaries, along with notes from four meetings of the PINCER pharmacists and feedback meetings from 34 practices. Key findings that helped to explain the success of the PINCER intervention included the perceived importance of focusing on prescribing errors to all stakeholders, and the credibility and appropriateness of a pharmacist-led intervention to address these shortcomings. Central to this was the face-to-face contact and relationship building between pharmacists and a range of practice staff, and pharmacists’ explicitly designated role as a change agent. However, important concerns were identified about the likely sustainability of this new model of delivering care, in the absence of an appropriate support network for pharmacists and career development pathways.
This embedded qualitative inquiry has helped to understand the complex organizational and social environment in which the trial was undertaken and the PINCER intervention was delivered. The longitudinal element has given insight into the dynamic changes and developments over time. Medication errors and ways to address these are high on stakeholders’ agendas. Our results further indicate that pharmacists were, because of their professional standing and skill-set, able to engage with the complex general practice environment and able to identify and manage many clinically important errors in medicines management. The transferability of the PINCER intervention approach, both in relation to other prescribing errors and to other practices, is likely to be high.
PMCID: PMC3503703  PMID: 22682095
Qualitative evaluation; Randomized controlled trial; Pharmacist intervention; Primary care
20.  Bayesian Cohort and Cross-Sectional Analyses of the PINCER Trial: A Pharmacist-Led Intervention to Reduce Medication Errors in Primary Care 
PLoS ONE  2012;7(6):e38306.
Medication errors are an important source of potentially preventable morbidity and mortality. The PINCER study, a cluster randomised controlled trial, is one of the world’s first experimental studies aiming to reduce the risk of such medication related potential for harm in general practice. Bayesian analyses can improve the clinical interpretability of trial findings.
Experts were asked to complete a questionnaire to elicit opinions of the likely effectiveness of the intervention for the key outcomes of interest - three important primary care medication errors. These were averaged to generate collective prior distributions, which were then combined with trial data to generate Bayesian posterior distributions. The trial data were analysed in two ways: firstly replicating the trial reported cohort analysis acknowledging pairing of observations, but excluding non-paired observations; and secondly as cross-sectional data, with no exclusions, but without acknowledgement of the pairing. Frequentist and Bayesian analyses were compared.
Bayesian evaluations suggest that the intervention is able to reduce the likelihood of one of the medication errors by about 50 (estimated to be between 20% and 70%). However, for the other two main outcomes considered, the evidence that the intervention is able to reduce the likelihood of prescription errors is less conclusive.
Clinicians are interested in what trial results mean to them, as opposed to what trial results suggest for future experiments. This analysis suggests that the PINCER intervention is strongly effective in reducing the likelihood of one of the important errors; not necessarily effective in reducing the other errors. Depending on the clinical importance of the respective errors, careful consideration should be given before implementation, and refinement targeted at the other errors may be something to consider.
PMCID: PMC3369915  PMID: 22685559
21.  A pharmacist-led information technology intervention for medication errors (PINCER): a multicentre, cluster randomised, controlled trial and cost-effectiveness analysis 
Lancet  2012;379(9823):136-142.
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, 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.
PMCID: PMC3328846
23.  A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems 
The objective of this review is to describe the implementation of human factors principles for the design of alerts in clinical information systems. First, we conduct a review of alarm systems to identify human factors principles that are employed in the design and implementation of alerts. Second, we review the medical informatics literature to provide examples of the implementation of human factors principles in current clinical information systems using alerts to provide medication decision support. Last, we suggest actionable recommendations for delivering effective clinical decision support using alerts. A review of studies from the medical informatics literature suggests that many basic human factors principles are not followed, possibly contributing to the lack of acceptance of alerts in clinical information systems. We evaluate the limitations of current alerting philosophies and provide recommendations for improving acceptance of alerts by incorporating human factors principles in their design.
PMCID: PMC2995688  PMID: 20819851
Alerts; human factors; medication alerting; patient safety
24.  The case study approach 
The case study approach allows in-depth, multi-faceted explorations of complex issues in their real-life settings. The value of the case study approach is well recognised in the fields of business, law and policy, but somewhat less so in health services research. Based on our experiences of conducting several health-related case studies, we reflect on the different types of case study design, the specific research questions this approach can help answer, the data sources that tend to be used, and the particular advantages and disadvantages of employing this methodological approach. The paper concludes with key pointers to aid those designing and appraising proposals for conducting case study research, and a checklist to help readers assess the quality of case study reports.
PMCID: PMC3141799  PMID: 21707982
25.  Effect of pay for performance on the management and outcomes of hypertension in the United Kingdom: interrupted time series study 
Objective To assess the impact of a pay for performance incentive on quality of care and outcomes among UK patients with hypertension in primary care.
Design Interrupted time series.
Setting The Health Improvement Network (THIN) database, United Kingdom.
Participants 470 725 patients with hypertension diagnosed between January 2000 and August 2007.
Intervention The UK pay for performance incentive (the Quality and Outcomes Framework), which was implemented in April 2004 and included specific targets for general practitioners to show high quality care for patients with hypertension (and other diseases).
Main outcome measures Centiles of systolic and diastolic blood pressures over time, rates of blood pressure monitoring, blood pressure control, and treatment intensity at monthly intervals for baseline (48 months) and 36 months after the implementation of pay for performance. Cumulative incidence of major hypertension related outcomes and all cause mortality for subgroups of newly treated (treatment started six months before pay for performance) and treatment experienced (started treatment in year before January 2001) patients to examine different stages of illness.
Results After accounting for secular trends, no changes in blood pressure monitoring (level change 0.85, 95% confidence interval −3.04 to 4.74, P=0.669 and trend change −0.01, −0.24 to 0.21, P=0.615), control (−1.19, −2.06 to 1.09, P=0.109 and −0.01, −0.06 to 0.03, P=0.569), or treatment intensity (0.67, −1.27 to 2.81, P=0.412 and 0.02, −0.23 to 0.19, P=0.706) were attributable to pay for performance. Pay for performance had no effect on the cumulative incidence of stroke, myocardial infarction, renal failure, heart failure, or all cause mortality in both treatment experienced and newly treated subgroups.
Conclusions Good quality of care for hypertension was stable or improving before pay for performance was introduced. Pay for performance had no discernible effects on processes of care or on hypertension related clinical outcomes. Generous financial incentives, as designed in the UK pay for performance policy, may not be sufficient to improve quality of care and outcomes for hypertension and other common chronic conditions.
PMCID: PMC3026849  PMID: 21266440

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