Evaluation of the implementation of a clinical pharmacy service on an acute internal medicine ward in Italy.

BACKGROUND: Successful implementation of clinical pharmacy services is associated with improvement of appropriateness of prescribing. Both high clinical significance of pharmacist interventions and their high acceptance rate mean that potential harm to patients could be avoided. Evidence shows that low acceptance rate of pharmacist interventions can be associated with lack of communication between pharmacists and the rest of the healthcare team. The objective of this study was to evaluate the effect of a structured communication strategy on acceptance rate of interventions made by a clinical pharmacist implementing a ward-based clinical pharmacy service targeting elderly patients at high risk of drug-related problems. Characteristics of interventions made to improve appropriateness of prescribing, their clinical significance and intervention acceptance rate by doctors were recorded. METHODS: A clinical pharmacy intervention study was conducted between September 2013 and December 2013 in an internal medicine ward of a teaching hospital. A trained clinical pharmacist provided pharmaceutical care to 94 patients aged over 70 years. The clinical pharmacist used the following communication and marketing tools to implement the service described: Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis; Specific, Measurable, Achievable, Realistic and Timely (SMART) goals; Awareness, Interest, Desire, Action (AIDA) model. RESULTS: A total of 740 interventions were made by the clinical pharmacist. The most common drug classes involved in interventions were: antibacterials for systemic use (11.1%) and anti-parkinson drugs (10.8%). The main drug-related problem categories triggering interventions were: no specific problem (15.9%) and prescription writing error (12.0%). A total of 93.2% of interventions were fully accepted by physicians. After assessment by an external panel 63.2% of interventions (96 interventions/ per month) were considered of moderate clinical significance and 23.4% (36 interventions/ per month) of major clinical significance. The most frequent interventions were to educate a healthcare professional (20.4%) and change dose (16.1%). CONCLUSIONS: To our knowledge this is the first study evaluating the effect of a structured communication strategy on acceptance rate of pharmacist interventions. Pharmaceutical care delivered by the clinical pharmacist is likely to have had beneficial outcomes. Clinical pharmacy services like the one described should be implemented widely to increase patient safety.

Factors contributing to medicine-related problems in adult patients with diabetes and/or cardiovascular diseases in Saudi Arabia: a qualitative study.

OBJECTIVES: To investigate the factors contributing to medicine-related problems (MRPs) among patients with cardiovascular diseases (CVDs) and/or diabetes in Saudi Arabia. DESIGN: Qualitative semistructured interviews were conducted. Interviews were audio recorded then transcribed into Microsoft Word. The transcribed interviews were then imported into the qualitative analysis software NVivo where thematic analysis was applied. Thematic synthesis was achieved by coding and developing subthemes/themes from the findings of the interviews. SETTING: Five healthcare centres in Najran, Saudi Arabia. PARTICIPANTS: 25 adult patients with diabetes and/or CVDs. RESULTS: The study cohort included 16 men and 9 women with a median age of 61.8 years (40-85 years). Diabetes was the main condition encountered among 23 patients and CVDs were reported among 18 patients. Perceived factors leading to MRPs were of four types and related to: patient-, healthcare system-, clinical (condition-) and medicine-related factors. Patient-related factors were related to living situation, religious practices, diet/exercise and patients' behaviour towards the condition and medicines. Healthcare system-related factors comprised sources and availability of medicines, ease of access to healthcare system and patient satisfaction with healthcare providers. Clinical (condition-) related factors associated with both the knowledge and control over condition, and effects of the condition among medicines intake. Medicine-related factors included lack of knowledge about medicines and medicine use. CONCLUSIONS: The results of this study uncovered many factors associated with MRPs among patients with CVDs and diabetes in Saudi Arabia, especially in reference to lifestyle and medicine use. Improving communication with healthcare professional alongside the introduction of national clinical guidance would mitigate the unwanted health complications related to medicine use.

Hospitalisation Resulting from Medicine-Related Problems in Adult Patients with Cardiovascular Diseases and Diabetes in the United Kingdom and Saudi Arabia.

Cardiovascular diseases (CVDs) and diabetes (DM) are two interrelated conditions that have a heavy morbidity and mortality burden worldwide. Patients with the two conditions usually take multiple medicines and thus are more susceptible to medicine-related problems (MRPs). MRPs can occur at any stage of the treatment process and in many cases can lead to unplanned hospitalisations. The aim of the study was to determine the prevalence of hospitalisation resulting from MRPs in adult patients with CVDs and/or DM and to identify the main causes, risk factors, and medicine classes involved. A retrospective study included 300 adult patients from two hospitals, one in the United Kingdom and one in Saudi Arabia. To identify MRPs, medical records were reviewed for demographic data, clinical data, laboratory assay, and prescription records. A total of 197 (65.7%) patients had MRPs, of which less than 10% were severe. The main problems were lack of treatment effectiveness and adverse drug reactions. Moreover, polypharmacy and patient non-adherence were the main risk factors contributing to MRPs. The main medicine classes associated with MRPs were insulin and antihypertensive medicines. Further research should address the pharmaceutical care processes employed in treating CVDs and DM, and to empower patients/healthcare providers in tackling MRPs.

An evaluation of paediatric medicines reconciliation at hospital discharge into the community.

OBJECTIVE: A UK national survey of primary care physicians has indicated that the medication information on hospital discharge summary was incomplete or inaccurate most of the time. Internationally, studies have shown that hospital pharmacist's interventions reduce these discrepancies in the adult population. There have been no published studies on the incidence and severity of the discrepancies of the medication prescribed for children specifically at discharge to date. The objectives of this study were to investigate the incidence, nature and potential clinical severity of medication discrepancies at the point of hospital discharge in a paediatric setting. METHODS: Five weeks prospective review of hospital discharge letters was carried out. Medication discrepancies between the initial doctor's discharge letter and finalised drug chart were identified, pharmacist changes were recorded and their severity was assessed. The setting of the review was at a London, UK paediatric hospital providing local secondary and specialist tertiary care. The outcome measures were: - incidence and the potential clinical severity of medication discrepancies identified by the hospital pharmacist at discharge. KEY FINDINGS: 142 patients (64 female and 78 males, age range 1 month - 18 years) were discharged on 501 medications. The majority of patients were under the care of general surgery and general paediatric teams. One in three discharge letters contained at least one medication discrepancy and required pharmacist interventions to rectify prior to completion. Of these, 1 in 10 had the potential for patient harm if undetected. CONCLUSIONS: Medicines reconciliation by pharmacist at discharge may be a good intervention in preventing medication discrepancies which have the potential to cause moderate harm in paediatric patients.

Interventions for reducing medication errors in children in hospital.

BACKGROUND: Many hospitalised patients are affected by medication errors (MEs) that may cause discomfort, harm and even death. Children are at especially high risk of harm as the result of MEs because such errors are potentially more hazardous to them than to adults. Until now, interventions to reduce MEs have led to only limited improvements. OBJECTIVES: To determine the effectiveness of interventions aimed at reducing MEs and related harm in hospitalised children. SEARCH METHODS: The Effective Practice and Organisation of Care Group (EPOC) Trials Search Co-ordinator searched the following sources for primary studies: The Cochrane Library, including the Cochrane Central Register of Controlled Trials (CENTRAL), the Economic Evaluation Database (EED) and the Health Technology Assessments (HTA) database; MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, Proquest Dissertations & Theses, Web of Science (citation indexes and conference proceedings) and the EPOC Register of Studies. Related reviews were identified by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects (DARE). Review authors searched grey literature sources and trial registries. They handsearched selected journals, contacted researchers in the field and scanned reference lists of relevant reviews. They conducted searches in November 2013 and November 2014. They applied neither language nor date limits. SELECTION CRITERIA: Randomised controlled trials, controlled before-after studies and interrupted time series investigating interventions to improve medication safety in hospitalised children (≤ 18 years). Participants were healthcare professionals authorised to prescribe, dispense or administer medications. Outcome measures included MEs, (potential) patient harm, resource utilisation and unintended consequences of the interventions. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data and assessed study quality using the EPOC data collection checklist. We evaluated the risk of bias of included studies and used the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach to assess the quality of the body of evidence. We described results narratively and presented them using GRADE tables. MAIN RESULTS: We included seven studies describing five different interventions: participation of a clinical pharmacist in a clinical team (n = 2), introduction of a computerised physician order entry system (n = 2), implementation of a barcode medication administration system (n = 1), use of a structured prescribing form (n = 1) and implementation of a check and control checklist in combination with feedback (n = 1).Clinical and methodological heterogeneity between studies precluded meta-analyses. Although some interventions described in this review show a decrease in MEs, the results are not consistent, and none of the studies resulted in a significant reduction in patient harm. Based on the GRADE approach, the overall quality and strengfh of the evidence are low. AUTHORS' CONCLUSIONS: Current evidence on effective interventions to prevent MEs in a paediatric population in hospital is limited. Comparative studies with robust study designs are needed to investigate interventions including components that focus on specific paediatric safety issues.

Systematic literature review of hospital medication administration errors in children.

OBJECTIVE: Medication administration is the last step in the medication process. It can act as a safety net to prevent unintended harm to patients if detected. However, medication administration errors (MAEs) during this process have been documented and thought to be preventable. In pediatric medicine, doses are usually administered based on the child's weight or body surface area. This in turn increases the risk of drug miscalculations and therefore MAEs. The aim of this review is to report MAEs occurring in pediatric inpatients. METHODS: Twelve bibliographic databases were searched for studies published between January 2000 and February 2015 using "medication administration errors", "hospital", and "children" related terminologies. Handsearching of relevant publications was also carried out. A second reviewer screened articles for eligibility and quality in accordance with the inclusion/exclusion criteria. KEY FINDINGS: A total of 44 studies were systematically reviewed. MAEs were generally defined as a deviation of dose given from that prescribed; this included omitted doses and administration at the wrong time. Hospital MAEs in children accounted for a mean of 50% of all reported medication error reports (n=12,588). It was also identified in a mean of 29% of doses observed (n=8,894). The most prevalent type of MAEs related to preparation, infusion rate, dose, and time. This review has identified five types of interventions to reduce hospital MAEs in children: barcode medicine administration, electronic prescribing, education, use of smart pumps, and standard concentration. CONCLUSION: This review has identified a wide variation in the prevalence of hospital MAEs in children. This is attributed to the definition and method used to investigate MAEs. The review also illustrated the complexity and multifaceted nature of MAEs. Therefore, there is a need to develop a set of safety measures to tackle these errors in pediatric practice.

Safety of medication use in primary care.

BACKGROUND: Medication errors are one of the leading causes of harmin health care. Review and analysis of errors have often emphasized their preventable nature and potential for reoccurrence. Of the few error studies conducted in primary care to date, most have focused on evaluating individual parts of the medicines management system. Studying individual parts of the system does not provide a complete perspective and may further weaken the evidence and undermine interventions. AIM AND OBJECTIVES: The aim of this review is to estimate the scale of medication errors as a problem across the medicines management system in primary care. Objectives were: To review studies addressing the rates of medication errors, and To identify studies on interventions to prevent medication errors in primary care. METHODS: A systematic search of the literature was performed in PubMed (MEDLINE), International Pharmaceutical Abstracts (IPA), Embase, PsycINFO, PASCAL, Science Direct, Scopus, Web of Knowledge, and CINAHL PLUS from 1999 to November, 2012. Bibliographies of relevant publications were searched for additional studies. KEY FINDINGS: Thirty-three studies estimating the incidence of medication errors and thirty-six studies evaluating the impact of error-prevention interventions in primary care were reviewed. This review demonstrated that medication errors are common, with error rates between <1% and >90%, depending on the part of the system studied, and the definitions and methods used. The prescribing stage is the most susceptible, and that the elderly (over 65 years), and children (under 18 years) are more likely to experience significant errors. Individual interventions demonstrated marginal improvements in medication safety when implemented on their own. CONCLUSION: Targeting the more susceptible population groups and the most dangerous aspects of the system may be a more effective approach to error management and prevention. Co-implementation of existing interventions at points within the system may offer time- and cost-effective options to improving medication safety in primary care.

A systematic review of hospitalization resulting from medicine-related problems in adult patients.

AIMS: Medicine-related problems (MRPs) represent a major issue leading to hospitalization, especially in adult and elderly patients. The aims of this review are to investigate the prevalence, causes and major risk factors for MRPs leading to hospitalization in adult patients and to identify the main medicine classes involved. METHODS: Studies were identified through electronic searches of Medline, Embase, Scopus and International Pharmaceutical Abstracts between January 2000 and May 2013. A systematic review was conducted of both retrospective and prospective studies. Studies included were those involving hospitalization resulting from MRPs in adults (≥18 years old), whereas studies excluded were those investigating drug misuse and abuse and studies investigating MRPs in hospitalized patients. Data analysis was performed using SPSS version 20. RESULTS: Forty-five studies were identified, including 21 that investigated hospitalization resulting from adverse drug reactions, six studies that investigated hospitalization due to adverse drug events and 18 studies that investigated hospitalization due to MRPs. The median prevalence rates of hospitalization resulting from adverse drug reactions, adverse drug events and MRPs were 7% (interquartile range, 2.4-14.9%), 4.6% (interquartile range, 2.85-16.6%) and 12.1% (interquartile range, 6.43-22.2%), respectively. The major causes contributing to MRPs were adverse drug reactions and noncompliance. In addition, the major risk factors associated with MRPs were old age, polypharmacy and comorbidities. Moreover, the main classes of medicines implicated were medicines used to treat cardiovascular diseases and diabetes. CONCLUSIONS: Hospitalization due to MRPs had a high prevalence, in the range of 4.6-12.1%. Most MRPs encountered were prevalent among adult patients taking medicines for cardiovascular diseases and diabetes.

The causes of prescribing errors in English general practices: a qualitative study.

BACKGROUND: Few detailed studies exist of the underlying causes of prescribing errors in the UK. AIM: 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. METHOD: 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. RESULTS: 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. CONCLUSION: Complex underlying causes of prescribing and monitoring errors in general practices were highlighted, several of which are amenable to intervention.

The prevalence and nature of prescribing and monitoring errors in English general practice: a retrospective case note review.

BACKGROUND: Relatively little is known about prescribing errors in general practice, or the factors associated with error. AIM: 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. METHOD: 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. RESULTS: 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). CONCLUSION: 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.

Is Mindful Reflective Practice the way forward to reduce medication errors?

BACKGROUND: Medication errors can seriously affect patients and healthcare professionals. In over 60% of cases, medication errors are associated with one or more contributory; individual factors including staff being forgetful, stressed, tired or engaged in multiple tasks simultaneously, often alongside being distracted or interrupted. Routinised hospital practice can lead professionals to work in a state of mindlessness, where it is easy to be unaware of how both body and mind are functioning. OBJECTIVE: Mindfulness, defined as moment-to-moment awareness of the everyday experience, could represent a useful strategy to improve reflection in pharmacy practice. The importance of reflection to reduce diagnostic errors in medicine has been supported in the literature; however, in pharmaceutical care, reflection has also only been discussed to a limited extent. There is expanding evidence on the effectiveness of mindfulness in the treatment of many mental and physical health problems in the general population, as well as its role in enhancing decision making, empathy and reducing burnout or fatigue in medical staff. Considering the benefits of mindfulness, the authors suggest that healthcare professionals should be encouraged to develop their practice of mindfulness. This would not only be beneficial in relieving stress, increasing attention levels and awareness, but it is believed that the integration of mindfulness and reflective practice in a 'Mindful Reflective Practice' could minimise some of the individual factors that lead to medication errors. CONCLUSIONS: Mindfulness Reflective Practice could therefore represent an important element in pre-registration education and continual professional development for pharmacists and other healthcare professionals.

Adverse Drug Reactions in Children--International Surveillance and Evaluation (ADVISE): a multicentre cohort study.

BACKGROUND: A previous meta-analysis reported that 9.5% of hospitalized children suffered from an adverse drug reaction (ADR); however, reported incidences among studies varied. OBJECTIVE: To enhance the knowledge of ADRs in paediatric hospitalized patients at a global level we investigated the incidence and characteristics of ADRs in hospitalized children in European and non-European countries. METHODS: A prospective observational cohort study was conducted in academic and non-academic hospitals in five countries: Australia, Germany, Hong Kong, Malaysia and the UK. Children aged 0-18 years admitted during a 3-month period (between 1 October 2008 and 31 December 2009) were recruited. The main outcome measures were incidence, causality and outcome of ADRs. RESULTS: A total of 1278 patients (1340 admissions) were included [Australia n = 146 (149 admissions), Germany n = 376 (407), Hong Kong n = 143 (149), Malaysia n = 300 (314) and the UK n = 313 (321)]. The median age was 2 years (interquartile range [IQR] 0-7). Patients received a total of 5367 drugs (median 3; IQR 2-5) and median length of hospital stay was 4 days (IQR 3-7). A total of 380 ADRs were identified in 211 patients. The resultant ADR incidence of 16.5% (95% CI 14.5, 18.7) varied significantly between countries (p < 0.001). The highest incidences were observed in Malaysia and the UK. 65.3% (n = 248) of ADRs were found to be probable, and 24% of the ADRs were serious, with one being fatal. CONCLUSIONS: By comparing data from five countries in Europe, Asia and Australia we have shown that the incidence of ADRs in hospitalized children is at least as high as incidences published in adults. However, the variation between countries was mainly due to different populations and treatment strategies. Particular attention should be given to opioid use in hospitalized children.

Large scale organisational intervention to improve patient safety in four UK hospitals: mixed method evaluation.

OBJECTIVES: To conduct an independent evaluation of the first phase of the Health Foundation's Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. DESIGN: Mixed method evaluation involving five substudies, before and after design. SETTING: NHS hospitals in the United Kingdom. PARTICIPANTS: Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. INTERVENTION: The SPI1 was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. RESULTS: Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P < 0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration--monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)--there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for "difference in difference" 2.1, 99% confidence interval 1.0 to 4.3; P = 0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P = 0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P = 0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. CONCLUSIONS: The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening.

Multiple component patient safety intervention in English hospitals: controlled evaluation of second phase.

OBJECTIVE: To independently evaluate the impact of the second phase of the Health Foundation's Safer Patients Initiative (SPI2) on a range of patient safety measures. Design A controlled before and after design. Five substudies: survey of staff attitudes; review of case notes from high risk (respiratory) patients in medical wards; review of case notes from surgical patients; indirect evaluation of hand hygiene by measuring hospital use of handwashing materials; measurement of outcomes (adverse events, mortality among high risk patients admitted to medical wards, patients' satisfaction, mortality in intensive care, rates of hospital acquired infection). Setting NHS hospitals in England. PARTICIPANTS: Nine hospitals participating in SPI2 and nine matched control hospitals. INTERVENTION: The SPI2 intervention was similar to the SPI1, with somewhat modified goals, a slightly longer intervention period, and a smaller budget per hospital. RESULTS: One of the scores (organisational climate) showed a significant (P = 0.009) difference in rate of change over time, which favoured the control hospitals, though the difference was only 0.07 points on a five point scale. Results of the explicit case note reviews of high risk medical patients showed that certain practices improved over time in both control and SPI2 hospitals (and none deteriorated), but there were no significant differences between control and SPI2 hospitals. Monitoring of vital signs improved across control and SPI2 sites. This temporal effect was significant for monitoring the respiratory rate at both the six hour (adjusted odds ratio 2.1, 99% confidence interval 1.0 to 4.3; P = 0.010) and 12 hour (2.4, 1.1 to 5.0; P = 0.002) periods after admission. There was no significant effect of SPI for any of the measures of vital signs. Use of a recommended system for scoring the severity of pneumonia improved from 1.9% (1/52) to 21.4% (12/56) of control and from 2.0% (1/50) to 41.7% (25/60) of SPI2 patients. This temporal change was significant (7.3, 1.4 to 37.7; P = 0.002), but the difference in difference was not significant (2.1, 0.4 to 11.1; P = 0.236). There were no notable or significant changes in the pattern of prescribing errors, either over time or between control and SPI2 hospitals. Two items of medical history taking (exercise tolerance and occupation) showed significant improvement over time, across both control and SPI2 hospitals, but no additional SPI2 effect. The holistic review showed no significant changes in error rates either over time or between control and SPI2 hospitals. The explicit case note review of perioperative care showed that adherence rates for two of the four perioperative standards targeted by SPI2 were already good at baseline, exceeding 94% for antibiotic prophylaxis and 98% for deep vein thrombosis prophylaxis. Intraoperative monitoring of temperature improved over time in both groups, but this was not significant (1.8, 0.4 to 7.6; P = 0.279), and there were no additional effects of SPI2. A dramatic rise in consumption of soap and alcohol hand rub was similar in control and SPI2 hospitals (P = 0.760 and P = 0.889, respectively), as was the corresponding decrease in rates of Clostridium difficile and meticillin resistant Staphylococcus aureus infection (P = 0.652 and P = 0.693, respectively). Mortality rates of medical patients included in the case note reviews in control hospitals increased from 17.3% (42/243) to 21.4% (24/112), while in SPI2 hospitals they fell from 10.3% (24/233) to 6.1% (7/114) (P = 0.043). Fewer than 8% of deaths were classed as avoidable; changes in proportions could not explain the divergence of overall death rates between control and SPI2 hospitals. There was no significant difference in the rate of change in mortality in intensive care. Patients' satisfaction improved in both control and SPI2 hospitals on all dimensions, but again there were no significant changes between the two groups of hospitals. CONCLUSIONS: Many aspects of care are already good or improving across the NHS in England, suggesting considerable improvements in quality across the board. These improvements are probably due to contemporaneous policy activities relating to patient safety, including those with features similar to the SPI, and the emergence of professional consensus on some clinical processes. This phenomenon might have attenuated the incremental effect of the SPI, making it difficult to detect. Alternatively, the full impact of the SPI might be observable only in the longer term. The conclusion of this study could have been different if concurrent controls had not been used.

The incidence and nature of prescribing and medication administration errors in paediatric inpatients.

OBJECTIVES: To determine the incidence and nature of prescribing and medication administration errors in paediatric inpatients. DESIGN: Prospective review of drug charts to identify prescribing errors and prospective observation of nurses preparing and administering drugs to identify medication administration errors. In addition, incident reports were collected for each ward studied. PARTICIPANTS: Paediatric patients admitted to hospitals and nurses administering medications to these patients. SETTING: 11 wards (prescribing errors) and 10 wards (medication administration errors) across five hospitals (one specialist children's teaching hospital, one nonteaching hospital and three teaching hospitals) in the London area (UK). MAIN OUTCOME MEASURES: Number, types and incidence of prescribing and medication administration errors, using practitioner-based definitions. RESULTS: 391 prescribing errors were identified, giving an overall prescribing error rate of 13.2% of medication orders (95% CI 12.0 to 14.5). There was great variation in prescribing error rates between wards. Incomplete prescriptions were the most common type of prescribing error, and dosing errors the third most common. 429 medication administration errors were identified; giving an overall incidence of 19.1% (95% CI 17.5% to 20.7%) erroneous administrations. Errors in drug preparation were the most common, followed by incorrect rates of intravenous administration. CONCLUSIONS: Prescribing and medication administration errors are not uncommon in paediatrics, partly as a result of the extra challenges in prescribing and administering medication to this patient group. The causes and extent of these errors need to be explored locally and improvement strategies pursued.

Defining off-label and unlicensed use of medicines for children: results of a Delphi survey.

The aim of this Delphi survey is to develop common definitions for unlicensed and off-label drug use in children to be used for research and regulatory purposes. After a literature review on the current status of unlicensed/off-label definitions, a two-stage, web-based Delphi survey was conducted among experts in Europe. Their opinion on concerns, rules and scenarios regarding the unlicensed and off-label use of medicines were obtained. Results were then consulted with the European Medicines Agency (EMEA) before the final proposal was circulated to participants. Eighty-four experts were invited to participate (scientists, health professionals, pharmaceutical companies, regulatory agencies), 34 responded to the first round questionnaire and participated in subsequent rounds. Consensus was reached for the majority of questions. The lowest level of consensus reached was for questions related to a different formulation or if a drug was given although contraindicated. At the final step, 85% of the responding experts agreed on the proposed definition for off-label (use of a drug already covered by a Marketing Authorisation, in an unapproved way) and 80% on the definition for unlicensed (use of a drug not covered by a Marketing Authorisation as medicinal for human use), respectively. Results will facilitate the conduct of pharmacoepidemiological studies and allow comparison between different countries. The Delphi panel agreed that the definitions should be circulated within the scientific community and recommended to be adopted by relevant regulatory authorities.

Electronic prescribing reduced prescribing errors in a pediatric renal outpatient clinic.

OBJECTIVE: To assess the effect of an electronic prescribing (EP) system on the incidence and type of prescribing errors and the number of error-free visits. STUDY DESIGN: This was a before-and-after study conducted in a nephrology outpatient clinic at an acute tertiary care pediatric hospital. RESULTS: A total of 520 patients had 2242 items prescribed on 1141 prescriptions during the study period. The overall prescribing error rate was 77.4% (95% confidence interval [CI] = 75.3% to 79.4%) for handwritten items and 4.8% (95% CI = 3.4% to 6.7%) with EP. Before EP, 1153 (73.3%; 95% CI = 71.1% to 75.4%) items were missing essential information, and 194 (12.3%; 95% CI = 10.8% to 14%) were judged illegible. After EP, only 9 (1.4%; 95% CI = 0.7% to 2.6%) items were missing essential information, and illegibility errors were eliminated. The number of patient visits that were error-free increased from 21% to 90% (69% difference; 95% CI = 64% to 73.4%) after the implementation of EP. CONCLUSIONS: There was a high incidence of errors using handwritten prescriptions in the outpatient setting, with an overall error rate of 77.4%. EP significantly reduced errors related to completeness of prescriptions and eliminated legibility related errors.

Systematic review of medication errors in pediatric patients.

OBJECTIVE: To systematically locate and review studies that have investigated the incidence of medication errors (MEs) in pediatric inpatients and identify common errors. METHODS: A systematic search of studies related to MEs in children was performed using the following databases: MEDLINE (1951-April 2006), EMBASE (1966-April 2006), Pharm-line (1978-April 2006), International Pharmaceutical Abstracts (1970-April 2006), Cumulative Index to Nursing and Allied Health Literature (1982-April 2006), and British Nursing Index (1994-April 2006). Studies of the incidence and nature of MEs in pediatrics were included. The title, abstract, or full article was reviewed for relevance; any study not related to MEs in children was excluded. RESULTS: Three methods were used to detect MEs in the studies reviewed: spontaneous reporting (n = 10), medication order or chart review (n = 14), or observation (n = 8). There was great variation in the definitions of ME used and the error rates reported. The most common type of ME was dosing error, often involving 10 times the actual dose required. Antibiotics and sedatives were the most common classes of drugs associated with MEs; these are probably among the most common drugs prescribed. CONCLUSIONS: Interpretation of the literature was hindered by variation in definitions employed by different researchers, varying research methods and setting, and a lack of theory-based research. Overall, it would appear that our initial concern about MEs in pediatrics has been validated; however, we do not know the actual size of the problem. Further work to determine the incidence and causes of MEs in pediatrics is urgently needed, as well as evaluation of the best interventions to reduce them.