Barbara Claus

Impact of computerized physician order entry on medication prescription errors in the intensive care unit: a controlled cross-sectional trial

IntroductionMedication errors in the intensive care unit (ICU) are frequent and lead to attributable patient morbidity and mortality, increased length of ICU stay and substantial extra costs. We investigated if the introduction of a computerized ICU system (Centricity Critical Care Clinisoft, GE Healthcare) reduced the incidence and severity of medication prescription errors (MPEs).MethodsA prospective trial was conducted in a paper-based unit (PB-U) versus a computerized unit (C-U) in a 22-bed ICU of a tertiary university hospital. Every medication order and medication prescription error was validated by a clinical pharmacist. The registration of different classes of MPE was done according to the National Coordinating Council for Medication Error Reporting and Prevention guidelines. An independent panel evaluated the severity of MPEs. We identified three groups: minor MPEs (no potential to cause harm); intercepted MPEs (potential to cause harm but intercepted on time); and serious MPEs (non-intercepted potential adverse drug events (ADE) or ADEs, being MPEs with potential to cause, or actually causing, patient harm).ResultsThe C-U and the PB-U each contained 80 patient-days, and a total of 2,510 medication prescriptions were evaluated. The clinical pharmacist identified 375 MPEs. The incidence of MPEs was significantly lower in the C-U compared with the PB-U (44/1286 (3.4%) versus 331/1224 (27.0%); P < 0.001). There were significantly less minor MPEs in the C-U than in the PB-U (9 versus 225; P < 0.001). Intercepted MPEs were also lower in the C-U (12 versus 46; P < 0.001), as well as the non-intercepted potential ADEs (21 versus 48; P < 0.001). There was also a reduction of ADEs (2 in the C-U versus 12 in the PB-U; P < 0.01). No fatal errors occurred. The most frequent drug classes involved were cardiovascular medication and antibiotics in both groups. Patients with renal failure experienced less dosing errors in the C-U versus the PB-U (12 versus 35 serious MPEs; P < 0.001).ConclusionThe ICU computerization, including the medication order entry, resulted in a significant decrease in the occurrence and severity of medication errors in the ICU.

Augmented renal clearance is a common finding with worse clinical outcome in critically ill patients receiving antimicrobial therapy

INTRODUCTION We describe incidence and patient factors associated with augmented renal clearance (ARC) in adult intensive care unit (ICU) patients. MATERIALS AND METHODS A prospective observational study in a mixed cohort of surgical and medical ICU patients receiving antimicrobial therapy at the Ghent University Hospital, Belgium. Kidney function was assessed by the 24-hour creatinine clearance (Ccr); ARC defined as at least one Ccr of >130 mL/min per 1.73 m2. Multivariate logistic regression analysis: to assess variables associated with ARC occurrence. Therapeutic failure (TF): an impaired clinical response and need for alternate antimicrobial therapy. RESULTS Of the 128 patients and 599 studied treatment days, ARC was present in 51.6% of the patients. Twelve percent permanently expressed ARC. ARC patients had a median Ccr of 144 mL/min per 1.73 m2 (IQR 98-196). Median serum creatinine concentration on the first day of ARC was 0.54 mg/dL (IQR 0.48-0.69). Patients with ARC were significantly younger (P<.001). Age and male gender were independently associated with ARC whereas the APACHE II score was not. ARC patients had more TF (18 (27.3%) vs. 8 (12.9%); P=.04). CONCLUSION ARC was documented in approximately 52% of a mixed ICU patient population receiving antibiotic treatment with worse clinical outcome. Young age and male gender were independently associated with ARC presence.

Importance of Infusion Volume and Pump Characteristics in Extended Administration of β-Lactam Antibiotics

The introduction of a new protocol at Ghent University Hospital (Ghent, Belgium) for the extended administration of piperacillin-tazobactam (TZP) and meropenem drew attention to a potential pitfall that is well-known in daily clinical practice but often neglected, i.e., the contribution of infusion line dead space to the incomplete administration of the drug. The Antibiotic Policy Working Party at the institution implemented an extended 3-h protocol for TZP and meropenem administration in both intensive care units (ICU) and regular wards. The protocol specified that TZP is to be infused as a loading dose of 4.5 g over 30 min, followed by a 3-h infusion of 4.5 g every 6 h, with dosage adjustments according to renal function. For meropenem, a 1-g loading dose over 30 min is to be followed by a 3-h infusion of 1 g every 8 h. Dose regimens are based upon the Belgian version of the Sanford guide (5). Extended administration was chosen since recent research has highlighted the possible benefits (1-4). For the extended administration of both antibiotics, a smaller volume of 50 ml of 0.9% saline was used, compared to the standard 100-ml solutions used previously. The reduction in volume enabled the protocol to be used hospital-wide, including for patients with fluid restrictions. This implementation involved a switch to a new volumetric pump system (Alaris GP volumetric pump and GP 59-type infusion set). It was observed that every replacement of the infusion line resulted in a 40% loss of the prescribed antibiotic dose if the infusion line was not cleared with a compatible solution after the antibiotic infusion. On the other hand, nonreplacement of the infusion line dead space increased the risk of infusion of the degraded product, in particular in view of the issue of stability of meropenem in solution, as the residual volume was infused in the first 75 min of the subsequent 3-h infusion. Indeed, the package leaflet of the Alaris system states that a priming volume of 24 ml is required, which unfortunately was not considered before implementation of the protocol. Dead-space volume replacement is a critical issue (6) that needs to be addressed when the dead space exceeds 10% of the infused volume. The problem described is not dependent on the drug or infusion duration. The detection of this potential problem resulted in a prompt adaptation of the protocol with the requirement of higher solution volumes for non-ICU patients (at least 250 ml) and the use of the more expensive pressurized pumps, where the infusion dead space is less than 1 ml, for ICU patients and patients with fluid restrictions. In parallel, tests are running with a volumetric pump set that enables users to consider the line space at the end of the infusion and deliver the overfill. We wish to draw the attention on the importance of infusion volume and pump characteristics. We hence encourage the inclusion of this information into study method sections in publications on extended infusions.

Chemotherapy drug shortages in paediatric oncology: A 14-year single-centre experience in Belgium

Shortages of chemotherapy are a growing challenge for the healthcare system. We present the burden of drug shortages of chemotherapeutics in the paediatric hemato-oncology unit of a tertiary care hospital and solutions that were used to manage them. Between January 2001 and December 2014, 54 individual shortages were detected, affecting a total number of 21 different drugs. In total, 4127 shortage days were registered with a mean duration of 196.5 SD ± 144.0 days per individual drug shortage. Methotrexate, doxorubicin and carboplatin had the longest supply disruptions. Solutions to address the problems were purchase of a generic alternative, a change of individual treatment plans, cohorting of patients and import from abroad.

Policies for biosimilar uptake in Europe: an overview

Background Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe. Objectives The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake. Methods An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake. Results In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution. Conclusions Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

Expected net benefit of clinical pharmacy in intensive care medicine: a randomized interventional comparative trial with matched before‐and‐after groups

RATIONALE, AIMS AND OBJECTIVES This study evaluated clinical pharmacy costs against drug costs. METHOD We conducted a randomized interventional comparative trial at the surgical intensive care unit (ICU) of Ghent University Hospital, Belgium (period B: group B1 with pharmacist consultation; control group B0). We obtained before (period A) and after (period C) control groups using 1:1 propensity score matching with B1 and B0. Mean daily ICU drug costs with standard error of the mean (SEM) were compared between B1 and B0 (primary analysis) and between matched pairs (AB1, AB0, CB1 and CB0; secondary analysis). For B, we performed a 1000 bootstrapping (by resampling B1 and B0), calculated the benefit-cost ratio using pharmacy time (gross salary) as cost (euros) and drug cost savings as benefit. We performed sensitivity analysis with and without outlier drug costs (i.e. twice the standard deviation). PERSPECTIVE Belgian health care payer. RESULTS In period B, 135 patients were randomized: B0, n = 60; B1, n = 75. Pharmacists provided recommendations in 148/706 (21.0%) therapies with 83.1% acceptance. Mean drug cost difference between B0 (430.6 euros, SEM 406.0) and B1 (221.2 euros, SEM 58.7) (P = 0.870) became significant after excluding outlier drug costs (B0, 184.4 euros, SEM 42.5; B1, 90.5 euros, SEM 17.7; P < 0.001). Recommendations were cost-beneficial (break-even drug costs or savings) in 53.8% of patients with a benefit-cost ratio of 25:1 (confidence interval -5:1 to 94:1). In sensitivity analysis excluding outlier drug costs, B0 costs were significantly higher than both A and C, indicating high baseline expenses in B0. CONCLUSIONS The randomized interventional comparative trial in a small ICU patient group suggested the potential cost-benefit of clinical pharmacy on daily ICU drug costs. However, after matching, this benefit was attenuated. A final conclusion demands a larger randomized trial adopting a similar design with matched controls. Future research should include clinical impact of recommendations.

Vancomycin-induced red man syndrome in pediatric oncology: still an issue?

Red man syndrome is a rare but possibly serious adverse reaction during treatment with intravenous vancomycin. It is extremely important that pediatricians, especially in oncology, recognize this reaction and treat it appropriately. Following two case-reports from a pediatric oncology setting, a series of practical recommendations to prevent or handle red man syndrome are described.

What’s in a drop? Optimizing strategies for administration of drugs in pediatrics

Accurate administration of drugs is an essential part of pharmacotherapy in children. Small differences in the amount of drugs administered, might evoke different clinical effects. This is especially of concern in drugs with a narrow therapeutic index. Guided by a case that was observed in pediatrics, some practical recommendations for the administration of oral drops in children are described.

Experience with the implementation of clinical pharmacy services and processes in a university hospital in Belgium

This article summarizes the experience with the development of clinical pharmacy services in the Ghent University Hospital in Belgium. Implementation of clinical pharmacy services in Belgian hospitals has not been evident because these activities were initially not structurally financed. The aim is to describe the strengths and weaknesses of the clinical pharmacy development process, and the milestones that enhanced the progress. Furthermore, the organisation of clinical pharmacy in the Ghent University Hospital is explained, including back- and front-office activities, seamless pharmaceutical care and medication safety improvement. Some working methods, procedures and tools are explained for different clinical pharmacy services. In particular, the clinical pharmacy projects for geriatric patients as well as the preparation of clinical pharmacy services for the accreditation process are explained. We also reflect on the organisation model and the future development of clinical pharmacy, taking into consideration facilitators and potential barriers.

Colistin and neurotoxicity: recommendations for optimal use in cystic fibrosis patients

Case description The use of i.v. colistin reappeared recently for the treatment of multidrug-resistant Gram negative organisms in the intensive care and cystic fibrosis (CF) setting. According to the latest pharmacokinetic data, a loading dose and high antibiotic doses are given. Two cases of adverse events (paraesthesias, bad taste) were observed immediately after the start of infusion of a high dose of i.v. colistin in adult CF patients at the Ghent University Hospital. Conclusion Recommendations for optimal administration of i.v. colistin in adult CF patients are scarce. This article highlights the importance of mode of administration to avoid toxicity and relates it to recent pharmacokinetic/-dynamic literature.