IntroductionPatients admitted to an intensive care unit (ICU) are at high risk for prescribing errors and related adverse drug events (ADEs). An effective intervention to decrease this risk, based on studies conducted mainly in North America, is on-ward participation of a clinical pharmacist in an ICU team. As the Dutch Healthcare System is organized differently and the on-ward role of hospital pharmacists in Dutch ICU teams is not well established, we conducted an intervention study to investigate whether participation of a hospital pharmacist can also be an effective approach in reducing prescribing errors and related patient harm (preventable ADEs) in this specific setting.MethodsA prospective study compared a baseline period with an intervention period. During the intervention period, an ICU hospital pharmacist reviewed medication orders for patients admitted to the ICU, noted issues related to prescribing, formulated recommendations and discussed those during patient review meetings with the attending ICU physicians. Prescribing issues were scored as prescribing errors when consensus was reached between the ICU hospital pharmacist and ICU physicians.ResultsDuring the 8.5-month study period, medication orders for 1,173 patients were reviewed. The ICU hospital pharmacist made a total of 659 recommendations. During the intervention period, the rate of consensus between the ICU hospital pharmacist and ICU physicians was 74%. The incidence of prescribing errors during the intervention period was significantly lower than during the baseline period: 62.5 per 1,000 monitored patient-days versus 190.5 per 1,000 monitored patient-days, respectively (P < 0.001). Preventable ADEs (patient harm, National Coordinating Council for Medication Error Reporting and Prevention severity categories E and F) were reduced from 4.0 per 1,000 monitored patient-days during the baseline period to 1.0 per 1,000 monitored patient-days during the intervention period (P = 0.25). Per monitored patient-day, the intervention itself cost €3, but might have saved €26 to €40 by preventing ADEs.ConclusionsOn-ward participation of a hospital pharmacist in a Dutch ICU was associated with significant reductions in prescribing errors and related patient harm (preventable ADEs) at acceptable costs per monitored patient-day.Trial registration numberISRCTN92487665

Objectives: It is unclear how nurses adjust the double check during injectable medication administration andguarantee patient safety. We used the Functional Resonance Analysis Method (FRAM) to determine the fit betweenthe double check according to the protocol (work-as-imagined) and clinical practice (work-as-done). Weaimed to learn about process variation in order to optimize safety during injectable medication administration. Methods: A qualitative study (February-July 2018) with semi-structured group interviews. An internal medicineand a surgery ward of two Dutch hospitals participated (four wards total). We interviewed nurses about injectable medication administration practices, based on prior observations. A work-as-done model was constructedfor each hospital. The work-as-imagined model was based on the Dutch protocol for safe injectablemedication administration. Results: A total of 27 nurses were interviewed. In both hospitals, nurses split the double check into a digital andphysical check to improve workflow. The digital check was routinely conducted. For the physical check, nursesmade their own risk-impact analysis and assessed staffing, familiarity with the medication, severity of sideeffects, type of 

ObjectiveTo assess medical teams’ ability to recognize adverse drug events (ADEs) in older inpatients.MethodsThe study cohort comprised 250 patients aged 65 years or older consecutively admitted to Internal Medicine wards of three hospitals in the Netherlands between April and November 2007. An independent expert team identified ADEs present upon admission or occurring during hospitalization by a structured retrospective patient chart review. For all ADEs identified, the expert team assessed causality, severity, preventability, and recognition by medical teams.ResultsThe medical teams did not recognize 19.9 % of all ADEs present upon admission {60.4 ADEs [95 % confidence interval (CI) 51.5–70.8] per 100 hospitalizations} and 20.3 % of all ADEs occurring during the hospital stay [47.2 ADEs (95 % CI 39.4–56.5) per 100 hospitalizations]. Unrecognized ADEs were significantly more often ADEs with possible causality (p=0.014, df=1), ADEs caused by medication errors (p<0.001, df=1), and ADEs not manifesting as new symptoms (p<0.001, df=1). The medical teams did not recognize 23.2 % of mild to moderately severe ADEs and 16.5 % of severe, life-threatening, or fatal ADEs. The recognition of ADEs varied with event type.ConclusionsThe recognition of ADEs by medical teams was substantial for those ADEs with evident causality and with clinically apparent and severe consequences. ADEs mimicking underlying pathologies with a lower severity went unrecognized much more often, as did those resulting only in abnormal laboratory values. Tools to improve the recognition of ADEs by medical teams should, therefore, focus on those ADEs that are more challenging to detect.

BackgroundOlder patients are at high risk for experiencing Adverse Drug Events (ADEs) during hospitalization. To be able to reduce ADEs in these vulnerable patients, hospitals first need to measure the occurrence of ADEs, especially those that are preventable. However, data on preventable ADEs (pADEs) occurring during hospitalization in older patients are scarce, and no ‘gold standard’ for the identification of ADEs exists.MethodologyThe study was conducted in three hospitals in the Netherlands in 2007. ADEs were retrospectively identified by a team of experts using a comprehensive and structured patient chart review (PCR) combined with a trigger-tool as an aid. This ADE identification strategy was applied to a cohort of 250 older hospitalized patients. To estimate the intra- and inter-rater reliabilities, Cohen’s kappa values were calculated.Principal FindingsIn total, 118 ADEs were detected which occurred in 62 patients. This ADE yield was 1.1 to 2.7 times higher in comparison to other ADE studies in older hospitalized patients. Of the 118 ADEs, 83 (70.3%) were pADEs; 51 pADEs (43.2% of all ADEs identified) caused serious patient harm. Patient harm caused by ADEs resulted in various events. The overall intra-rater agreement of the developed strategy was substantial (κ = 0.74); the overall inter-rater agreement was only fair (κ = 0.24).Conclusions/SignificanceThe ADE identification strategy provided a detailed insight into the scope of ADEs occurring in older hospitalized patients, and showed that the majority of (serious) ADEs can be prevented. Several strategy related aspects, as well as setting/study specific aspects, may have contributed to the results gained. These aspects should be considered whenever ADE measurements need to be conducted. The results regarding pADEs can be used to design tailored interventions to effectively reduce harm caused by medication errors. Improvement of the inter-rater reliability of a PCR remains challenging.

AIMThe incidence of adverse drug events (ADEs) in surgical and non-surgical patients may differ. This individual patient data meta-analysis (IPDMA) identifies patient characteristics and types of medication most associated with patients experiencing ADEs and suggests target areas for reducing harm and implementing focused interventions. METHODSAuthors of eligible studies on preventable ADEs (pADEs) were approached for collaboration. For assessment of differences among (non-)surgical patients and identification of associated factors descriptive statistics, Pearson chi-square, Poisson and logistic regression analyses were performed. For identification of high risk drugs (HRDs), a model was developed based on frequency, severity and preventability of medication related to ADEs. RESULTSIncluded were 5367 patients from four studies. Patients aged ≥ 77 years experienced more ADEs and pADEs compared with patients aged ≤ 52 years (odds ratios (OR) 2.12 (95% CI 1.70, 2.65) and 2.55 (95% CI 1.70, 3.84), respectively, both P < 0.05). Polypharmacy on admission also increased the risk of ADEs (OR 1.21 (95% CI 1.03, 1.44), P < 0.05) and pADEs (OR 1.85 (95% CI 1.34, 2.56), P < 0.05). pADEs were associated with more severe harm than non-preventable ADEs (54% vs. 32%, P < 0.05). The top five HRDs were antibiotics, sedatives, anticoagulants, diuretics and antihypertensives. Events associated with HRDs included diarrhoea or constipation, abnormal liver function test and central nervous system events. Most pADEs resulted from prescribing errors (90%). CONCLUSIONElderly patients with polypharmacy on admission and receiving antibiotics, sedatives, anticoagulants, diuretics or antihypertensives were more prone to experiencing ADEs. Efficiency in prevention of ADEs may be improved by targeted vigilance systems for alertness of physicians and pharmacists.

ObjectivesMedication administration errors with injectable medication have a high risk of causing patient harm. To reduce this risk, all Dutch hospitals implemented a protocol for safe injectable medication administration. Nurse compliance with this protocol was evaluated as low as 19% in 2012. The aim of this second evaluation study was to determine whether nurse compliance had changed over a 4-year period, what factors were associated over time with protocol compliance and which strategies have been implemented by hospitals to increase protocol compliance.MethodsIn this prospective observational study, conducted between November 2015 and September 2016, nurses from 16 Dutch hospitals were directly observed during intravenous medication administration. Protocol compliance was complete if nine protocol proceedings were conducted correctly. Protocol compliance was compared with results from the first evaluation. Multilevel logistic regression analyses were used to assess the associations over time between explanatory variables and complete protocol compliance. Implemented strategies were classified according to the five components of the Systems Engineering Initiative for Patient Safety (SEIPS) model.ResultsA total of 372 intravenous medication administrations were observed. In comparison with 2012, more proceedings per administration were conducted (mean 7.6, 95% CI 7.5 to 7.7 vs mean 7.3, 95% CI 7.3 to 7.4). No significant change was seen in complete protocol compliance (22% in 2016); compliance with the proceedings ‘hand hygiene’ and ‘check by a second nurse’ remained low. In contrast to 2012, the majority of the variance was caused by differences between wards rather than between hospitals. Most implemented improvement strategies targeted the organisation component of the SEIPS model.ConclusionsCompliance with ‘hand hygiene’ and ‘check by a second nurse’ needs to be further improved in order to increase complete protocol compliance. To do so, interventions focused on nurses and individually tailored to each ward are needed.

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Introduction of a multifaceted medication safety programme in NH facilities by a pharmacy team is a tool towards safer medication administration practice in residents with swallowing difficulties. Commitment on organisational level is, however, vital to achieve sustainable improvements.