Development of clinical pharmacy in Belgian hospitals through pilot projects funded by the government.

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.

Implementation of a multidisciplinary infectious diseases team in a tertiary hospital within an Antimicrobial Stewardship Program.

BACKGROUND: In January 2011, as part of an antimicrobial stewardship program the Antimicrobial Management Team (AMT) at the Ghent University Hospital initiated a multidisciplinary Infectious Diseases Team (MIT) consisting of infectious diseases physicians, clinical microbiologists, and clinical pharmacists. The aim of this study is to describe the type and acceptance rate of recommendations provided by the MIT. METHOD: Prospective, observational study in a tertiary care, university teaching hospital with 1062 beds in non-consecutive hospitalized adult patients, excluding intensive care units and paediatrics. RESULTS: The MIT communicated 432 recommendations in 87 days observed. Of the 293 patients for whom a recommendation was made, the median age was 57 years (range: 16-91 years) and 169 (57·7%) were male. Skin or soft tissue infections (14%), respiratory tract infections (13%), infections without known focus (11%), abdominal infections (11%), and bone infections (8%) were most common. Recommendations were made to perform additional clinical investigation(s) [N = 137 (27%)], to adjust the dose of an antimicrobial drug [N = 42 (8%)], to stop an antimicrobial drug [N = 104 (21%)], to switch from a parenteral to an oral drug [N = 39 (8%)] or to initiate an antimicrobial drug [N = 178 (36%)], with an acceptance rate of 73·0%, 83·3%, 81·7%, 76·9%, and 84·0%, respectively. CONCLUSIONS: The MIT formulated about five recommendations a day primarily focusing on pharmacotherapy, but also on clinical investigations. In both fields, a high acceptance rate was observed.

Development and validation of potential structure indicators for evaluating antimicrobial stewardship programmes in European hospitals.

This study describes the development of structure indicators for hospital antimicrobial stewardship programmes and pilot validation across European hospitals. A multi-disciplinary panel from four European countries developed structure indicators in three steps: identification and listing of indicators, remote ranking of indicators using multi-criteria scoring, selection of indicators in a face-to-face consensus meeting. Additionally, the top-ten indicators were identified as a minimal set of key indicators. A survey was sent to the directors of antimicrobial stewardship programmes in European hospitals. The yes/no answers for the indicators were transformed into numbers in order to calculate the total scores. A list of 58 indicators was selected and categorised into the following topics: antimicrobial stewardship services (12 items), tools (16 items), human resources and mandate (6 items), health care personnel development (4 items), basic diagnostic capabilities (6 items), microbiological rapid tests (2 items), evaluation of microbiological drug resistance data (3 items), antibiotic consumption control (5 items) and drug use monitoring (4 items). The indicator scores, reported by 11 pilot hospitals from five European countries, ranged from 32 to 50 (maximum score = 58) and from 5 to 10 points (maximum score = 10) for, respectively, the complete and the top-ten list. An international panel selected 58 potential structure indicators, among which was a minimal set of ten key structure indicators, that could be useful for assessment of the comprehensiveness and resource-intensity of antimicrobial stewardship programmes. There was significant heterogeneity among participating centres with regard to their score for structural components of effective antimicrobial stewardship.

A survey of beta-lactam antibiotics and vancomycin dosing strategies in intensive care units and general wards in Belgian hospitals.

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.

Methemoglobinemia and hemolytic anemia after rasburicase administration in a child with leukemia.

CASE: We report a case of simultaneous methemoglobinemia and hemolytic anemia, probably related to the use of rasburicase, in a child starting treatment for acute lymphoblastic leukemia (ALL). In addition, the patient developed symptoms of pancreatitis. All complications resolved after 3 days of supportive therapy. CONCLUSION: Although usually well tolerated in pediatrics, physicians prescribing rasburicase should be aware of these possible life-threatening adverse reactions.

Prospective multicentre feasibility study of a quality of care indicator for intravenous to oral switch therapy with highly bioavailable antibiotics.

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.

Basic principles for paediatric care: what ENT professionals should know.

Children undergoing medical or surgical treatment for ENT disorders should receive care from doctors familiar with the specificities of paediatric ENT pathology working in dedicated clinics where there are facilities for the activities that children usually indulge in and accommodation for parents. Many aspects of care for children with ENT problems involve a multidisciplinary team consisting of ENT surgeons working alongside a range of medical and paramedical professionals and nurses specifically trained in childcare, as well as in ENT nursing. Within this multidisciplinary approach, we will discuss some important aspects of the psychosocial approach and nursing, anaesthesia and pharmacotherapy that should be considered in order to raise the safety and quality of patient care in paediatric otorhinolaryngology.

Methemoglobinemia and hemolytic anemia after rasburicase administration in a child with leukemia.

CASE: We report a case of simultaneous methemoglobinemia and hemolytic anemia, probably related to the use of rasburicase, in a child starting treatment for acute lymphoblastic leukemia (ALL). In addition, the patient developed symptoms of pancreatitis. All complications resolved after 3 days of supportive therapy. CONCLUSION: Although usually well tolerated in pediatrics, physicians prescribing rasburicase should be aware of these possible life-threatening adverse reactions.

Cardiac toxicity of trastuzumab: experience at the Ghent Unversity Hospital, Belgium.

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.

Contribution of drug related problems to hospital admission in the elderly.

PURPOSE: To investigate the frequency and type of drug related problems (DRPs) in geriatric patients (> 65 years), and to assess their contribution to hospital admission; to explore the appropriateness of drug therapy according to the Beers' criteria. METHODS: Cross-sectional observational survey of 110 elderly patients admitted during three non-consecutive months to the geriatric ward of a university hospital. Explorative assessment of appropriateness of drug therapy prior to hospital admission based on the Beers' criteria. RESULTS: A DRP was the dominant reason for hospital admission in 14 out of the 110 patients (12.7%); for another 9 patients (8.2%), a DRP was partly contributing to hospital admission. For these 23 patients, adverse drug reactions and noncompliance were the most important types of DRPs. We found no relationship between drug related hospital admission and intake of a drug listed in the Beers criteria for inappropriate drug use in the elderly. Patients admitted for a DRP took more drugs before admission than patients admitted because of other reasons. CONCLUSIONS: DRPs are an important cause for admission on the geriatric ward of our hospital. The drugs causing DRPs in this study were not those listed in the Beers list of inappropriate drugs in the elderly.

Highly effective treatment with tacrolimus ointment in an adolescent with oral graft-versus-host disease.

CASE: We report a case of acute oral graft-versus-host disease in an adolescent, which was successfully treated with tacrolimus 0.1% ointment. CONCLUSION: Although tacrolimus ointment is not licensed for the indication of oral GvHD, this case report provides preliminary evidence for a potential effectiveness of using tacrolimus in case of failure when GvHD is resistant.

Clinical pharmacy in a multidisciplinar team for chronic pain in adults.

The aim of this study was to evaluate the role and the impact of a clinical pharmacist as a member of a multidisciplinary pain team. Although physicians have a good knowledge of pharmacotherapy in the field of pain medication, pharmacy interventions were necessary to enhance the quality of prescribing. On a population of 93 patients, a total of 120 interventions were recorded. The different types of interventions included: provision of information (10.0%), clinical intervention (89.2%) and the provision of a specific product (0.8%). Out of the 107 clinical interventions, a total of 95.3 % interventions were accepted by the physicians. The results highlight the clinical importance of the pharmacy in optimizing drug therapy for adult patients with chronic pain.

Microbiological challenge of four protective devices for the reconstitution of cytotoxic agents.

AIMS: To evaluate the susceptibility to microbial contamination that occurs during simulated handling of protective devices for the preparation of cytotoxic drug solutions. METHODS AND RESULTS: Four devices, i.e. Chemoprotect spike, Clave connector, PhaSeal and Securmix were challenged with low and high inocula of micro-organisms. The cells, transferred to the connected vials during repeated manipulations of the devices were counted by means of solid-phase cytometry. Of the four devices, PhaSeal afforded the lowest transfer of micro-organisms. Secondly, the efficiency of procedures for the disinfection of an artificially contaminated rubber stopper was compared prior to connection of the vial to the PhaSeal device. Spraying or swabbing alone was inadequate, as opposed to a combination of spraying [0.5% or 2.0% (w/v) chlorhexidine in isopropanol] and swabbing [70% (v/v) isopropanol]. CONCLUSIONS: Although Phaseal afforded the lowest transfer of micro-organisms, adequate disinfection of the vial prior to connection remains required. SIGNIFICANCE AND IMPACT OF THE STUDY: Unlike aspects of operator protection, which are well documented, the microbiological safety of protective devices for the preparation of cytotoxic drugs has not been addressed in the literature. This study estimates the susceptibility to microbial contamination during handling of four commonly used devices.

The use of hypnosedative drugs in a university hospital setting.

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.

Cost-reduction analysis of propofol versus sevoflurane: maintenance of anaesthesia for gynaecological surgery using the bispectral index.

BACKGROUND AND OBJECTIVE: The study was designed to compare the costs of propofol versus sevoflurane for the maintenance of the hypnotic component of anaesthesia during general anaesthesia, guided by the bispectral index, for gynaecological laparoscopic surgery. METHODS: Forty ASA Grade I-II female patients scheduled for gynaecological laparoscopy were randomly allocated to two groups. All patients received a continuous infusion of remifentanil (0.25 microg kg(-1) min(-1)) for 2 min. Then anaesthesia was induced with propofol 1% at 300 mL h(-1) until loss of consciousness. To guide the bispectral index between 40 and 60, Group 1 patients received propofol 10 mg kg(-1) h(-1) initially, which was increased or decreased by 2 mg kg(-1) h(-1) steps; Group 2 patients received sevoflurane, initially set at 2 vol.% and adjusted with steps of 0.2-0.4%. The time and quality of anaesthesia and recovery were assessed in two postoperative standardized interviews. RESULTS: Patient characteristics, the propofol induction dose, the bispectral index and the haemodynamic profiles during induction of anaesthesia, and its duration, were similar between the groups. In Group 1, 7.55 +/- 1.75 mg kg(-1) h(-1) propofol and in Group 2, 0.20 +/- 0.09 mL kg(-1) h(-1) liquid sevoflurane were used for maintenance. The cost for maintenance, including wasted drugs, was higher when using propofol (Euro 25.14 +/- 10.69) than sevoflurane (Euro 12.80 +/- 2.67). Postoperatively, recovery profiles tended to be better with propofol; however, the day after discharge no differences were found. CONCLUSIONS: When applying the bispectral index to guide the administration of hypnotic anaesthetic drugs, propofol-based maintenance of anaesthesia was associated with the highest cost. A trend towards a better recovery profile was obtained with propofol. However, on the day after discharge, no differences in quality were observed.

Evaluation of human albumin use in a university hospital in Belgium.

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.

Variation in medical resource utilisation in the management of pulmonary embolism in Belgium.

The objective of this study was to investigate, through a patient chart analysis, the average and the variation in the medical resource use in pulmonary embolism (PE) patients in Belgium, and to find explanatory variables for the possible variation. A sample of patients with confirmed PE (n = 54) from 5 centres was selected. The centres were representative for size and region. The charts were selected at random after applying a set of exclusion criteria, in order to avoid heterogeneity of the sample characteristics. Charts were analysed using a standardised case report form, and medical resource use was collected by an independent researcher. Only medical resources related to the PE were included. On average, it appeared that the management of PE was fairly consistent between the different centres. The total average cost of PE was [symbol: see text] 3394 (St. Err. = [symbol: see text] 323). Nevertheless, large differences were found in the number of diagnostic and follow-up tests. Also, a wide variation in duration of hospital stay was found (average = 14.6, p75-p25 = 9.0), but this effect was not explained by the type of centre nor the region. The two factors that explain duration of hospital stay are the number of days of IV heparin use and the intensity of diagnostic follow-up, as expressed by the number of VQ-scans.

Treatment of bone and joint infections: recommendations of a Belgian panel.

A multidisciplinary panel of Belgian specialists describes the overall therapeutic approach for bone and joint infections. Classification, general methods of investigation, therapeutic options, special circumstances, the role of aminoglycosides and of glycopeptides are described. The possibility of home treatment is discussed, as well as some pharmaco-economic insights.

Pricing and reimbursement of pharmaceuticals 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.