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Extended and continuous infusions with beta-lactam antibiotics have been suggested as a means of pharmacokinetic and pharmacodynamic optimisation of antimicrobial therapy. Vancomycin is also frequently administered in continuous infusion, although more for practical reasons. A survey was undertaken to investigate the recommendations by the local antibiotic management teams (AMTs) in Belgian acute hospitals concerning the administration (intermittent, extended or continuous infusion) and therapeutic drug monitoring of four beta-lactam antibiotics (ceftazidime, cefepime, piperacillin-tazobactam, meropenem) and vancomycin for adult patients with a normal kidney function. A structured questionnaire survey comprising three domains was developed and approved by the members of the Belgian Antibiotic Policy Coordination Committee (BAPCOC). The questionnaire was sent by e-mail to the official AMT correspondents of 105 Belgian hospitals, followed by two reminders. The response rate was 32 %, with 94 %, 59 %, 100 %, 100 % and 100 % of the participating Belgian hospitals using ceftazidime, cefepime, piperacillin-tazobactam, meropenem and vancomycin, respectively. Comparing intensive care unit (ICU) with non-ICU wards showed a higher implementation of extended or continuous infusions for ceftazidime (81 % vs. 41 %), cefepime (35 % vs. 10 %), piperacillin-tazobactam (38 % vs. 12 %), meropenem (68 % vs. 35 %) and vancomycin (79 % vs. 44 %) on the ICU wards. A majority of the hospitals recommended a loading dose prior to the first dose. For vancomycin, the loading dose and the trough target concentration were too low based on the current literature. This survey shows that extended and continuous infusions with beta-lactams and vancomycin are widely implemented in Belgian hospitals. [ABSTRACT FROM AUTHOR]

Objectives The goal is to develop clinical pharmacy in the Belgian hospitals to improve drug efficacy and to reduce drug-related problems. Methods From 2007 to 2014, financial support was provided by the Belgian federal government for the development of clinical pharmacy in Belgian hospitals. This project was guided by a national Advisory Working Group. Each funded hospital was obliged to describe yearly its clinical pharmacy activities. Results In 2007, 20 pharmacists were funded in 28 pilot hospitals; this number was doubled in 2009 to 40 pharmacists over 54 institutions, representing more than half of all acute Belgian hospitals. Most projects (72%) considered patient-related activities, whereas some projects (28%) had a hospital-wide approach. The projects targeted patients at admission (30%), during hospital stay (52%) or at discharge (18%). During hospital stay, actions were mainly focused on geriatric patients (20%), surgical patients (15%), and oncology patients (9%). Experiences, methods, and tools were shared during meetings and workshops. Structure, process, and outcome indicators were reported and strengths, weaknesses, opportunities, and threats were described. The yearly reports revealed that the hospital board was engaged in the project in 87% of the cases, and developed a vision on clinical pharmacy in 75% of the hospitals. In 2014, the pilot phase was replaced by structural financing for clinical pharmacy in all acute Belgian hospitals. Conclusion The pilot projects in clinical pharmacy funded by the federal government provided a unique opportunity to launch clinical pharmacy activities on a broad scale in Belgium. The results of the pilot projects showed clear implementation through case reports, time registrations, and indicators. Tools for clinical pharmacy activities were developed to overcome identified barriers. The engagement of hospital boards and the results of clinical pharmacy activities persuaded the government to start structural financing of clinical pharmacy.

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., (Copyright © 2013 Elsevier Inc. All rights reserved.)

Objective: To evaluate the type, acceptance rate, and clinical relevance of clinical pharmacist recommendations at the geriatric ward of the Ghent university hospital., Methods: The clinical pharmacist evaluated drug use during a weekly 2-hour visit for a period of 4 months and, if needed, made recommendations to the prescribing physician. The recommendations were classified according to type, acceptance by the physician, prescribed medication, and underlying drug-related problem. Appropriateness of prescribing was assessed using the Medication Appropriateness Index (MAI) before and after the recommendations were made. Two clinical pharmacologists and two clinical pharmacists independently and retrospectively evaluated the clinical relevance of the recommendations and rated their own acceptance of them., Results: The clinical pharmacist recommended 304 drug therapy changes for 100 patients taking a total of 1137 drugs. The most common underlying drug-related problems concerned incorrect dose, drug-drug interaction, and adverse drug reaction, which appeared most frequently for cardiovascular drugs, drugs for the central nervous system, and drugs for the gastrointestinal tract. The most common type of recommendation concerned adapting the dose, and stopping or changing a drug. In total, 59.7% of the recommendations were accepted by the treating physician. The acceptance rate by the evaluators ranged between 92.4% and 97.0%. The mean clinical relevance of the recommendations was assessed as possibly important (53.4%), possibly low relevance (38.1%), and possibly very important (4.2%). A low interrater agreement concerning clinical relevance between the evaluators was found: kappa values ranged between 0.15 and 0.25. Summated MAI scores significantly improved after the pharmacist recommendations, with mean values decreasing from 9.3 to 6.2 (P < 0.001)., Conclusion: In this study, the clinical pharmacist identified a high number of potential drug-related problems in older patients; however, the acceptance of the pharmacotherapy recommendations by the treating physician was lower than by a panel of evaluators. This panel, however, rated most recommendations as possibly important and as possibly having low relevance, with low interrater reliability. As the appropriateness of prescribing seemed to improve with decreased MAI scores, clinical pharmacy services may contribute to the optimization of drug therapy in older inpatients.

Background: Performing bedside clinical recommendations is important for the prevention of adverse drug events. From an economic perspective, the economic value of adverse drug event avoidance needs to be weighed against the labour costs of pharmacists., Objective: To perform a cost analysis of pharmacist interventions with valproic acid, digoxin, methotrexate and penicillin., Setting: Ghent University Hospital in Belgium (1,062-beds)., Method: Interventions for valproic acid, digoxin, methotrexate and penicillin were selected from a clinical pharmacy database, CLINOR. The average number of registered interventions per year was 1,209 (period 2005-mid 2011)., Main Outcome Measure: Cost difference (cost value) between that of the avoided toxicity and that of the intervention (a positive cost value is cost saving)., Results: Per annum, pharmacists performed interventions for valproic acid (n = 18) and digoxin (n = 21); the annual cost value of interventions for valproic acid was €18,853.7 with a standard deviation of €15,020.6; for digoxin it was €41,832.0 ± €15,348.5. With oral methotrexate, accidental toxicity occurs rarely but it can be life threatening. Two important pharmacist interventions were reported per year. The routine switching of penicillin therapy to alternative antibiotics, in patients with previous allergy, may invoke costs rather than benefits (two interventions per year). In half of cases, therapy was reinitiated without any further adverse drug event., Conclusion: Clinically important pharmacy interventions are not automatically cost beneficial. Interventions that prevent digoxin and valproic acid toxicity were cost effective in this setting. The routine advice to switch the antibiotic class for every reported penicillin allergy is unlikely to avoid adverse drug events and challenges the cost value of this intervention. Interventions with methotrexate are relevant because they can be lifesaving. However, due to their low incidence, effective detection of these errors is crucial for reducing harm.

Background: Enhanced oral (po) bioavailability of antimicrobial drugs allows conversion to po therapy once a patient meets defined clinical criteria. This can reduce length of hospital stay, healthcare costs and risk of complications related to intravenous (iv) access. We developed a quality indicator for assessing the appropriate iv-to-po switch of bioavailable antibiotics and evaluated its feasibility and clinical relevance across acute healthcare systems., Methods: The study was designed as a multicentre, multinational observational audit. The indicator was the proportion of inappropriate iv treatments at any point in time in adult patients treated with fluoroquinolones, clindamycin, linezolid or metronidazole. Treatments were prospectively evaluated by a trained physician or clinical pharmacist using predefined clinical criteria. The feasibility of the indicator was evaluated by measuring data availability, data collection workload and sensitivity to improvement, Results: Data were collected over a 3 month period in five university hospitals in Austria, Belgium and Germany and iv treatment was assessed in 211 patients. The indicator was measurable in 99.1% of cases. By intention-to-treat analysis, 37.0% (95% CI 30.5-43.9) of treatments were inappropriate, ranging from 17.5% to 53.8% across hospitals. The median time needed for case assessment and documentation was 29 min., Conclusions: This quality indicator was found to be generally feasible in hospitals across three European countries, and informative about the local need for clinical quality improvement.

Introduction: Trastuzumab (TRAS) is a humanised monoclonal antibody that is targeted against the HER2 growth factor receptor. Over-expression of the receptor occurs in around 15-25% of women with early breast cancer (CA). Four major adjuvant trials compared trastuzumab treatment with observation after neoadjuvant or adjuvant chemotherapy in women with high risk HER2-positive breast cancer. Results of these trials showed that trastuzumab treatment given every 3 weeks for 1 year achieved a significant improvement of disease free survival and overall survival. However, cardiac toxicity occurred more in the trastuzumab arm than in the observation arm resulting in symptomatic congestive heart failure and a significant drop in left ventricular ejection function (LVEF)., Aim of the Study: The purpose of this analysis is to evaluate cardiac toxicity of adjuvant trastuzumab treatment in 30 breast cancer patients. Study parameters were cardiac toxicity assessed by LV function, disease free survival and overall survival., Materials and Methods: Based on the adjuvant trials and in expectation of the reimbursement of trastuzumab in the adjuvant setting, a convention was set up between the Belgian National Institute for Health and Disability Insurance and hospital centres specialized in the treatment of breast cancer. In this convention, trastuzumab was offered to patients diagnosed with invasive, non-metastatic breast cancer with an over-expression of HER2 proven by a positive FISH test. Metastatic lymph nodes or a tumour measuring more than 10 mm had to be present. At least 4 cycles of adjuvant or neoadjuvant chemotherapy had to be given to the patient. Radiotherapy could be administered. The time interval between chemotherapy or radiotherapy and treatment with trastuzumab could not be more than 6 months. LVEF determined by MUGA scan or by ultrasonography at the start of trastuzumab treatment had to be more than 55%., Results: 30 breast cancer patients were treated with adjuvant trastuzumab in our hospital between June 2006 and July 2007. All patients met the inclusion criteria. Six patients stopped trastuzumab treatment because of cardiac toxicity. All these patients had received prior anthracycline neoadjuvant or adjuvant chemotherapy. Five of these patients were found to have a LVEF < 55%, one showing symptoms of congestive cardiomyopathy.The sixth patient was diagnosed with a newly developed tricuspid valve insufficiency grade 3. Follow-up data of 20 months since the start of trastuzumab treatment showed that 27 patients were disease-free. Two patients died because of progressive breast cancer disease. One patient was lost of follow-up., Conclusion: In this small group of breast cancer patients, treated with adjuvant trastuzumab, cardiac toxicity expressed as a decreased left ventricular function seems to have a higher incidence compared to the other adjuvant trials. Therefore, a close cardiac monitoring for several years should be recommended in patients treated with trastuzumab.

Objective: This study measured the impact of three interventions for physicians, in order to implement guidelines for sequential therapy (intravenous to oral conversion) with fluoroquinolones., Setting: A Belgian university hospital with 1,065 beds. Method The first intervention consisted of the hospital-wide publication of guidelines in the local drug letter towards all prescribers. The consumption of fluoroquinolones was measured by means of an interrupted time-series (ITS) analysis 21 months before (period A) and 24 months after publication (period B). The second intervention was an educational interactive session, by infectious disease specialists, to the medical staff of orthopaedics and endocrinology. The third intervention comprised a proactive conversion programme on the abdominal surgery, gastro-enterology and plastic surgery wards, where pharmacists attached a pre-printed note with a suggestion to switch to an oral treatment every time a patient met the criteria for switching. The second and third intervention took place 6 months after the first intervention. Fluoroquinolone treatments were evaluated during a 2 month period before (group 1) and after the introduction of the second (group 2) and third (group 3) intervention., Main Outcome Measure: The monthly ratio of intravenous versus total fluoroquinolone consumption (daily defined doses per 1,000 bed days) was measured to assess the impact of the first intervention. The impact of the second and third intervention was measured in relation to the number of days that intravenous therapy continued beyond the day that the patient fulfilled the criteria for sequential therapy and the antibiotic cost., Results: The ITS demonstrated a reduction of 3.3% in the ratio of intravenous versus total consumption after the publication of the guidelines (P = 0.011). In group 1, patients were treated intravenously for 4.1 days longer than necessary. This parameter decreased in group 2 to 3.5 days and in group 3 to 1.0 day (P = 0.006). The mean additional cost for longer intravenous treatment decreased from 188.0 euro in group 1, to 103.0 euro in group 2 and 44.0 euro in group 3 (P = 0.037)., Conclusion: This study demonstrated that active implementation of guidelines is necessary. A proactive conversion programme by a pharmacist resulted in a reduction in the duration of the intravenous treatment, and the treatment cost.

Objective: To assess the incidence of postoperative wound infections related to treatment with medicinal leeches at Ghent University Hospital., Method: A 2-year retrospective analysis of bacteriologic culture results of soft tissue infections in patients treated with medicinal leeches., Results: Cultures of suspected wound infections were taken and susceptibility testing of isolates was performed on 17 of 47 patients (36.2%). Aeromonas was frequently isolated (18.5%)., Conclusions: A high incidence of infection during and after application of medicinal leeches, despite their external decontamination, necessitates an antibiotic prophylaxis. In particular Aeromonas must be covered, as soft tissue infections with these bacteria can give serious complications. The prophylactic antibiotic should cover the most frequent isolated species taking into account the importance of Aeromonas and the susceptibility pattern. Based on the results, fluoroquinolones seem to be a good choice. The authors believe that practical recommendations to hospital pharmacists on prophylaxis during Hirudo medicinalis treatment, might enhance the safety of it's use by reducing the number of infections.

Objective: The use of hypnosedatives (HSs) in the hospital and at home before admission was registered. Also, the incidence of HSs newly started in the hospital and the incidence of withdrawal in chronic users while in hospital was recorded., Methods: The study population consisted of 517 consecutively admitted patients recruited from 10 wards of the Ghent University Hospital; 493 of them received a questionnaire and were interviewed concerning the use of HSs at home and in the hospital, about the cause and duration of treatment, the type of HSs used, the presence and nature of any concomitant sleep or anxiety disorder. Main outcome measures were the actual use of HSs during hospitalisation as compared with the reported use, the influence of hospitalisation on use of HSs and the assessment of cause and duration of use of HSs., Results: Twenty-nine percent of the study sample took HSs at home and 45.2% while in the hospital. HSs were prescribed to 28.6% of the patients not habituated to chronic use of HSs at home. In contrast, 14.0% of the patients habituated to chronic use of HSs received no sleep medication while in hospital. Patients older than 60 years used more HSs than younger patients. Previous administration of HSs, sleep problems during hospital admission and female sex were predictive of HS-use. The main reason for prescription of HSs in the hospital was continuation of HSs taken at home. The most prescribed HSs were: lormetazepam, lorazepam, alprazolam, diazepam and zolpidem. Almost 10% of the patients were not informed on treatment with HSs. Among the subjects in whom HSs were newly started, 16.0% intended to continue this medication after discharge. Eleven percent took combinations of hypnosedative drugs., Conclusions: The prevalence of prescription of HSs in the university hospital setting is high. Appropriate guidelines are needed to control the use of HSs during hospitalisation and to ensure withdrawal from these drugs upon discharge.

Objective: To test a method for registration of adverse drug reactions (ADRs) resulting in hospital admission and of ADRs occurring during hospital stay. Spontaneous reporting was compared with data from patient interview., Methods: Spontaneous reporting of ADRs by nurses and physicians, as well as patient interviews by pharmacists. This pilot project was carried out in the geriatric ward of the Ghent University Hospital over a period of 8 months in order to develop suitable registration forms and to test feasibility. Causality, severity, type and level of intervention of the reported ADRs were analysed. Reports from physicians and nurses were compared with the data obtained by patient interviews., Results: During the 8 months, for 168 patients, 12 spontaneous reports were received from physicians and nurses. Fifty-six of these patients were interviewed and 32 ADRs were reported. Only 2 ADRs detected by patient interview were also reported spontaneously. The interviews of the 56 geriatric patients indicated that 20% of them were admitted to the hospital because of an ADR. ADRs occurred during hospital stay in another 20% of those patients., Conclusion: Spontaneous reporting by physicians and nurses revealed considerably fewer ADRs than patient interview by pharmacists. Physicians and nurses reported the more serious ADRs that occurred during hospital stay, whereas the interviews revealed more ADRs that caused hospital admission. Our data confirm that ADRs are an important cause of hospital admission of geriatric patients and occur frequently during their hospital stay.

Unlabelled: In 1996-1997, a drug use evaluation (DUE) of human albumin was conducted in the Ghent University Hospital (Belgium) to determine the pattern and appropriateness of the albumin use. The DUE was followed by permanent review of the albumin consumption. This paper describes how the DUE was carried out and how the albumin use in our hospital changed over time., Method: The study was based on criteria for indications and end of treatment, accepted by consensus of the physicians prescribing albumin. Albumin treatment episodes were classified as appropriate or inappropriate according to these criteria., Results: For 115 treatment episodes in 90 patients, the researchers found 21 (18.3%) deviations from the developed criteria. After analysis, half out of them were considered as minor. Most deviations involved starting treatment too early (n = 17). Follow-up results indicated that the overall consumption of albumin dropped by 50.1% from 1994 to 1999, while the consumption of colloid solutions during the same period remained stable., Conclusion: A good compliance with internally developed criteria for indications and end of treatment with human albumin was observed. Discussion with the clinicians involved led to the development of stricter criteria and a continuous decrease in albumin consumption.

Pharmaco-economic evaluations become more important for the reimbursement of pharmaceuticals, and will be obligatory for new pharmaceutical drugs for which an added therapeutic value is claimed and a price premium is proposed by the manufacturer. Therefore, it is important to guide purchasers and providers of pharmaceutical care in their efforts related to the evaluation process. Standard Report Format can support the quality, transparency and exhaustiveness of the data submitted. A multidisciplinary task force developed a Standard Report Format for pharmaco-economic evaluations in Belgium.

The Belgian healthcare system has a tradition of access and equity at affordable prices. As in other countries, the system becomes pressured by increasing healthcare costs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement. Nearly all people in Belgium are covered by compulsory health insurance. The system is paid for by social security, the patients and the federal and regional authorities. The part of the consumption of pharmaceuticals that is charged to insurance was about 62.1 billion Belgian francs (BeF), i.e. about 50% of the pharmaceutical market in 1994. Price setting in Belgium has been rather low due to the positive reimbursement list, where the price of a new drug is compared to existing drugs in a comparable therapeutic class (so-called reimbursement criteria). The expenditure on pharmaceuticals is increasing faster than global funding for public health. In order to control drug budgets, different cost-containment measures have been or are being taken, i.e. a mix of price, reimbursement and volume controls. These cost-containment measures are not necessarily in accordance with a health economic approach. This paper suggests the scope for better implementation of pharmacoeconomic evaluation, which can lead to more flexible reimbursement systems in specific indications. Therefore, a formal recognition of the role of objective economic evaluations is needed for both hospital and ambulatory care. This process should be proceeded by improving the understanding and robustness of pharmacoeconomic evaluations.