A mixed methods analysis of clozapine errors reported to the National Reporting and Learning System.

PURPOSE: To review and analyse medication errors related to clozapine, an atypical antipsychotic, that were reported to the National Reporting and Learning System (NRLS). METHODS: Following extraction of one year of clozapine related errors from the NRLS, a qualitative analysis (thematic analysis and re-classification) and quantitative analysis was performed. An incident was considered a clozapine error if there was a failure in its medication process (i.e. an error in the prescribing, dispensing, preparing, administering, monitoring or advising of clozapine). RESULTS: "Issues with stock/supply/ordering" was the most common theme derived from the qualitative thematic analysis (n = 338), followed by wrong dose/strength/frequency (n = 221) and medication omissions (n = 202). Most errors occurred in the "administration/supply" medication stage. Over half of reported clozapine incidents involved people 26 to 55 years old (n = 830) and 82% of errors were reported by mental health services (n = 1270). Only 1.5% of reports were classed as moderate/severe harm. CONCLUSION: Issues with availability, stock, and supply were found to be the most common causes. This usually entailed a lack of stock to fulfil a patient's dose/supply. Such incidents could potentially be reduced by improved management of the supply process, and liaison between pharmacy and clinical staff. The implementation of emergency drug cupboards at the discretion of an on-call pharmacist may prove to be a preventative measure for such errors. Despite the potential adverse effects associated with clozapine, very few incidents led to moderate/severe harm. Encouragement of NRLS reporting is recommended for incidents of all degrees of harm.

Minimising harm from missed drug doses.

BACKGROUND: The National Patient Safety Agency reported that more than 21,000 patient-safety incidents, including death, occurred between September 2006 and June 2009 as a result of missed or delayed medication doses. AIM: To identify the number of incidents reported between 2005 and 2013 associated with the oral route not being available. Find ways to improve practice. METHOD: The National Reporting and Learning System was searched for medication incidents categorised as omitted and delayed from 1 January 2005 until 31 December 2013. Search terms were used to filter for incidents associated with the oral route not being available. Qualitative analysis of 200 incident reports identified common themes. RESULTS: In total 1,882 incidents met the search criteria, the majority in hospitals. There were six deaths and 581 harms. The largest number of reports concerned patients who were nil by mouth. Analysis of the medicines described found that the most commonly omitted medicine (17%) was anti-epileptic medication. DISCUSSION: It is estimated that the actual prevalence of omitted doses where the oral route was not available is greater than this paper describes. CONCLUSION: Positive intervention is needed in this area to reduce harm to patients.

A review of medication incidents reported to the National Reporting and Learning System in England and Wales over 6 years (2005-2010).

A review of all medication incidents reported to the National Reporting and Learning System (NRLS) in England in Wales between 1 January 2005 and 31 December 2010 was undertaken. The 526,186 medication incident reports represented 9.68% of all patient safety incidents. Medication incidents from acute general hospitals (394,951) represented 75% of reports. There were relatively smaller numbers of medication incident reports (44,952) from primary care, representing 8.5% of the total. Of 86,821 (16%) medication incidents reporting actual patient harm, 822 (0.9%) resulted in death or severe harm. The incidents involving medicine administration (263,228; 50%) and prescribing (97,097; 18%) were the process steps with the largest number of reports. Omitted and delayed medicine (82,028; 16%) and wrong dose (80,170; 15%) represented the largest error categories. Thirteen medicines or therapeutic groups accounted for 377 (46%) of the incidents with outcomes of death or severe harm. The National Patient Safety Agency (NPSA) has issued guidance to help minimize incidents with many of these medicines. Many recent incidents could have been prevented if the NPSA guidance had been better implemented. It is recommended that healthcare organizations in all sectors establish an effective infrastructure to oversee and promote safe medication practice, including an annual medication safety report. In the future, preventable harms from medication incidents can be further minimized by; the continued use of the NRLS to identify and prioritize important actions to improve medication safety, a central organization continuing to issue medication safety guidance to the service and better methods to ensure that the National Health Service has implemented this guidance.

Standards of lithium monitoring in mental health Ttrusts in the UK.

BACKGROUND: Lithium is a commonly prescribed drug with a narrow therapeutic index, and recognised adverse effects on the kidneys and thyroid. Clinical guidelines for the management of bipolar affective disorder published by The National Institute for Health and Clinical Excellence (NICE) recommend checks of renal and thyroid function before lithium is prescribed. They further recommend that all patients who are prescribed lithium should have their renal and thyroid function checked every six months, and their serum lithium checked every three months. Adherence to these recommendations has not been subject to national UK audit. METHODS: The Prescribing Observatory for Mental Health (POMH-UK) invited all National Health Service Mental Health Trusts in the UK to participate in a benchmarking audit of lithium monitoring against recommended standards. Data were collected retrospectively from clinical records and submitted electronically. RESULTS: 436 clinical teams from 38 Trusts submitted data for 3,373 patients. In patients recently starting lithium, there was a documented baseline measure of renal or thyroid function in 84% and 82% respectively. For patients prescribed lithium for a year or more, the NICE standards for monitoring lithium serum levels, and renal and thyroid function were met in 30%, 55% and 50% of cases respectively. CONCLUSIONS: The quality of lithium monitoring in patients who are in contact with mental health services falls short of recognised standards and targets. Findings from this audit, along with reports of harm received by the National Patient Safety Agency, prompted a Patient Safety Alert mandating primary care, mental health and acute Trusts, and laboratory staff to work together to ensure systems are in place to support recommended lithium monitoring by December 2010.

The Role of Technology in Medication Safety Incidents: Interpretative Analysis of Patient Safety Incidents Data.

This is a study of medication safety incidents reported to the NHS in England (UK) associated with the use of digital technology. An interpretative analysis of 888 incidents reports offers insight into uses and features of this technology associated with medication errors and potential patient harm.

Initiatives to identify and mitigate medication errors in England.

In response to the EU Directive on Pharmacovigilance, the National Health Service (NHS) in England and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK have formed a partnership to work together to simplify and increase medication error reporting, improve data report quality, maximise learning and guide practice to minimise harm from medication errors by sharing incident data. This initiative will facilitate implementation of new requirements for medication error reporting and reduce the need for duplicate data entry by frontline staff. The initiative is also intended to provide new types of feedback from the National Reporting and Learning System run by the NHS England and from the Yellow Card Scheme run by the MHRA and to improve learning at the local level by clarifying medication safety roles and identifying key safety contacts to allow better communication between local and national levels. Finally, the partnership has established a new National Medication Safety Network to provide a forum for discussing potential and recognised safety issues, and for identifying trends and actions to improve the safe use of medicines. This article describes the initiative, the structure of which may act as a template for other countries.

Drug name confusion: evaluating the effectiveness of capital ("Tall Man") letters using eye movement data.

Medication errors commonly involve confusion between drug names that look or sound alike. One possible method of reducing these errors is to print sections of the names in "Tall Man" (capital) letters, in order to emphasise differences between similar products. This paper reports an eye-tracking experiment that evaluates this strategy. Participants had their eye movements monitored while they searched for a target product amongst an array of product packs. The target pack was replaced by a similar distractor in the array. Participants made fewer errors when the appearance of the names had been altered, that is, they were less likely to incorrectly identify a distractor as the target drug. This result was reflected in the eye movement data.

'It's the best of two evils': a study of patients' perceived information needs about oral steroids for asthma.

OBJECTIVES: To explore the sources of patients' knowledge about the potential side-effects of oral steroids prescribed to treat asthma. METHODS: Seventeen in-depth interviews were conducted with patients taking prescribed oral steroid medication (prednisolone) for asthma. The interviews were transcribed verbatim and the data organized according to common themes. RESULTS: All the respondents acknowledged they had no choice but to take oral steroids but they wanted to be informed about the potential side-effects. Respondents reported that they had not received sufficient information about side-effects from their general practitioner (GP). Information was sought from both medical sources (pharmacists and asthma nurses) and non-medical sources (friends and family, self-help groups and the media) to supplement their knowledge. The conclusions drawn about the risks of taking oral steroids were also influenced by respondents' existing beliefs. CONCLUSIONS: Respondents drew upon information about oral steroids from a variety of professional and lay sources. The findings add weight to calls for doctors and patients to share their respective knowledge in consultations. Developing an understanding of the views of GPs about the provision of information about side-effects would help to identify any perceived barriers to a more open exchange of information in the consultation.

A prospective randomised trial on the effect of position in the passive second stage of labour on birth outcome in nulliparous women using epidural analgesia.

OBJECTIVE: To determine whether the rate of instrumental birth in nulliparous women using epidural analgesia is affected by maternal position in the passive second stage of labour. DESIGN: A pragmatic prospective randomised trial. SETTING: Consultant maternity unit in the Midlands. PARTICIPANTS: One hundred and seven nulliparous women using epidural analgesia and reaching the second stage of labour with no contraindications to spontaneous birth. INTERVENTIONS: The lateral versus the supported sitting position during the passive second stage of labour. MEASUREMENTS: Mode of birth, incidence of episiotomy, and perineal suturing. FINDINGS: Recruitment was lower than anticipated (107 vs. 220 planned). Lateral position was associated with lower rates of instrumental birth rate (lateral group 33%; sitting group 52%; p=0.05, RR 0.64, CI for RR: 0.40-1.01; Number-needed-to-treat (NNT)=5), of episiotomy (45% vs. 64%; p=0.05, RR 0.66, CI for RR: 0.44-1.00, NNT=5), and of perineal suturing (78% vs. 86%; p=0.243, RR 0.75, CI for RR 0.47-1.17). The odds ratio for instrumental birth in the sitting group was 2.2 (CI 1.00-4.6). Logistic regression of potential confounder variables was undertaken, due to a large variation in maternal weight between the randomised groups. Of the nine possible confounders tested, only position of the baby's head at full dilation affected the risk of instrumental birth significantly (p=0.4, OR 2.7 where the fetal head was in the lateral or posterior position). Maternal weight did not appear to have any effect. The odds ratio for instrumental delivery for women randomised to the sitting position was slightly higher within the logistic regression model (adjusted OR 2.3). KEY CONCLUSIONS: Women randomised to the lateral position had a better chance of a spontaneous vaginal birth than those randomised to the supported sitting position. Position of the babies head at full dilation had an additional effect on mode of birth. These effects are not conclusively generalizable. RECOMMENDATIONS FOR PRACTICE: The lateral position is likely to be at best beneficial, and at the worst no less harmful than the sitting position for most women and their babies who meet the criteria set for this study. Conclusive evidence for or against the technique should be established using larger trials.

Medicines Reconciliation on Admission to Inpatient Psychiatric Care: Findings from a UK Quality Improvement Programme.

OBJECTIVE: Medication errors are a common cause of avoidable morbidity, and transfer between clinical settings is a known risk factor for such errors. Medicines reconciliation means there is no unintended discrepancy between the medication prescribed for a patient prior to admission and on admission. Our aim was to improve the quality of practice supporting medicines reconciliation at the point of admission to a psychiatric ward. METHODS: An audit-based quality improvement programme (QIP), using the proxy measure for medicines reconciliation of two or more sources of information being consulted about current medicines, and compared. RESULTS: At baseline audit, 42 Trusts submitted data for 1790 patients. At re-audit 16 months later, 43 Trusts submitted data for 2296 patients. While doctors were most commonly identified in Trust policies as having overall responsibility for medicines reconciliation, the task was most often undertaken by pharmacy staff, with most activity occurring within 24 h of admission. The proportion of patients in whom medicines reconciliation was possible was 71% at baseline and 79% at re-audit. In such patients, discrepancies were identified in 25% at baseline and 31% at re-audit; a small proportion of these discrepancies were clearly clinically significant. CONCLUSIONS: This QIP achieved modest improvement in medicines reconciliation practice.

The influence of tall man lettering on drug name confusion: a laboratory-based investigation in the UK using younger and older adults and healthcare practitioners.

BACKGROUND: Medication errors commonly involve confusion between drugs with similar names. One possible method of reducing error is to emphasize differences between the names using 'Tall Man' (uppercase) letters (e.g. cefTAZidime vs cefUROxime). Previous studies investigating this issue have been conducted mainly on university students, and results have been mixed. OBJECTIVE: To investigate the influence of Tall Man lettering on drug name confusion in other key participant groups. STUDY DESIGN: Two separate experiments were conducted. In Experiment 1 (conducted at the University of Glasgow, Scotland, between January 2008 and May 2008), younger and older adults performed a same/different judgement task. In Experiment 2 (conducted at various sites in England between December 2008 and February 2009), healthcare practitioners performed a task based on electronic prescribing. RESULTS: In Experiment 1, both younger and older adults made fewer name confusion errors when names contained Tall Man letters. Response times suggested that Tall Man lettering drew participants' attention to those letters, but that readers did not solely rely on these letters in making their response. In Experiment 2, healthcare practitioners made fewer name confusion errors when the names contained Tall Man letters. CONCLUSIONS: Overall, results showed that Tall Man lettering reduced drug name confusion errors in a series of laboratory-based tasks, in both younger and older adults, and healthcare practitioners. Thus, the current findings offer some support for the use of Tall Man letters as a possible systems change that could be made by both pharmacies and manufacturers in an effort to reduce error caused by drug name confusion.

Labeling of medicines and patient safety: evaluating methods of reducing drug name confusion.

OBJECTIVE: We report three experiments evaluating the proposal that highlighting sections of drug names using uppercase ("tall man") lettering and/or color may reduce the confusability of similar drug names. BACKGROUND: Medication errors commonly involve drug names that look or sound alike. One potential method of reducing these errors is to highlight sections of names on labels in order to emphasize the differences between similar products. METHOD: In Experiments 1 and 2, participants were timed as they decided whether similar name pairs were the same name or two different names. Experiment 3 was a recognition memory task. RESULTS: Results from Experiments 1 and 2 showed that highlighting sections of words using tall man lettering can make similar names easier to distinguish if participants are aware that this is the purpose of the intervention. Results from Experiment 3 suggested that tall man lettering and/or color does not make names less confusable in memory but that tall man letters may increase attention. CONCLUSION: These findings offer some support for the use of tall man letters in order to reduce errors caused by confusion between drug products with look-alike names. APPLICATION: The use of tall man letters could be applied in a variety of visual presentations of drug names--for example, by manufacturers on packaging, labeling, and computer software, and in pharmacies on shelf labels. Additionally, this paper demonstrates two meaningful behavioral measures that can be used during product design to objectively assess confusability of packaging and labeling.