Clinical Pharmacy in Belgium: Budgetary & Organizational Aspects

The aim of this PhD is to evaluate how general clinical pharmacy services can be implemented efficiently and economically to enhance the quality of therapy and patient safety, with a focus on the hospital setting within the Belgian context. In the first chapter of this doctoral thesis, we focused on the evolution of hospital pharmacy services in Belgium. First, a reflection on the traditional services offered by the hospital pharmacy was made. Traditionally, the hospital pharmacist is responsible for the management of different processes such as purchasing, distribution, compounding, follow-up of medication use and possible adverse drug events and billing. Subsequently, the origin and development of clinical pharmacy services in Belgium was specified. The Royal Decree of 04/03/1991 first pointed out the role of the hospital pharmacist as a pharmacotherapeutic care provider. In the early 2000s pilot projects were set up, supported by the government and mainly consisting of the implementation of bedside clinical pharmacy. Besides, doctoral research focused on the implementation of specific guidelines (e.g. documentation of clinical pharmacokinetics in critically ill patients at KU Leuven) and therefore confirmed the role of the clinical pharmacist in e.g. therapeutic drug monitoring. Another essential step was the embedment of clinical pharmacy in the training program of hospital pharmacists through a 3 year interuniversity master after master program. The evolution of the role of the hospital pharmacist was supported by a digital wave in which their tasks are assisted by computerized physician order entry (CPOE) and (advanced) clinical decision support systems (aCDSS). Specific for clinical pharmacy services, these systems present advantages such as the prevention of medication errors and the check for possible drug interactions at the moment of prescribing and administration. The evolutions mentioned above all contributed to the changing role of the hospital pharmacist from box mover to provider of optimal care and exclaim the need for clinical pharmacy services. In the second chapter, we elaborated on defining the research objective of this PhD, namely to study the budgetary and organizational aspects of the implementation of clinical pharmacy services in a university hospital in the Belgian context. In the third chapter, we researched how the pharmacoeconomic impact of bedside clinical pharmacy can be measured and reported to help hospital pharmacists and decision makers with their planning for further deployment or stopping of these services. First, a literature review was conducted. It was shown that at the moment of research, studies presented many shortcomings (e.g. lack of control groups, lack of cost-effectiveness-analyses, neglecting operational costs, not checking the acceptance rate in case of cost-avoidance, …). In order to appraise the quality of pharmacoeconomic studies and to improve the design of future studies, a practical tool (a validated scorecard) was developed. This tool focused both on methodological quality and on transferability. Based on this tool, a new review of recent pharmacoeconomic studies was carried out. This review showed that the quality of pharmacoeconomic reports has improved over the years, what is very promising for future reporting on valorization and cost-effectiveness of clinical pharmacy services and interventions. This might help pharmacy directors in their struggle with policy makers to support the deployment of clinical pharmacy in times of economic constraints. Thanks to methodological correct reports it is possible to decide where to invest. The aim of the fourth chapter of this PhD is to reflect on the implementation of clinical pharmacy services in Belgium, as well as putting it into practice by means of some case studies. Our first focus in this was on clinical decision support systems, since we are convinced they have an important role in the prevention of medication errors in the early stage of prescribing and therefore have an impact on the need for further development of clinical pharmacy. A literature review concerning this matter showed that (a)CDSSs contribute to the quality of pharmacotherapeutic care (e.g. by preventing prescribing errors and by implementing guidelines for evidence based medicine). Moreover, (a)CDSSs can contribute to transparent pharmacoeconomic reporting. Subsequently, an overview of the implemented or explored bedside clinical pharmacy initiatives in Belgium was provided. It appears that most initiatives focus on patients treated with high risk drugs or high risk populations due to their underlying pathophysiology. This risk based approach is obvious knowing that human resources are rather limited, especially in Belgium. A liaison between CDSSs and bedside clinical pharmacy services appeared to be missing. A back-office check of medication appropriateness (COMA) program could provide a response to this need. COMA covers all patients, regardless of their specific underlying pathology and risk profile. By involving a computer algorithm in this process it became possible to screen all new prescriptions and active therapies in order to identify and prioritize potential hazardous situations. In this way, scarce resources can be used optimally to guarantee the same level of safety and follow-up to each patient appealing to the hospital. COMA was implemented in the University Hospitals Leuven and some preliminary results proved the benefit of this service. Moreover, the results also showed that specific clinical rules and their severity in the aCDSS should be reconsidered in order to avoid alert-fatigue. It also showed the need for bedside services on specific wards (e.g. emergency department, hemato/oncology). Additionally, some specific case studies to measure the potential pharmacotherapeutic and -economic impact of specific check of appropropriateness programs were presented. A first case report concerned acid suppressive therapy (AST), as overconsumption of this medication has been reported since this therapy became very accessible and long-term continuation of therapy started often during hospitalization. Using a validated tool it was shown that 43% of initiation of long-term AST in the University Hospitals Leuven was inappropriate. When expanding the same screening tool to 6 other Belgian hospitals in a proof of concept study at least 28% of AST initiation appeared to be inappropriate. Furthermore, the long-term use of AST was reexamined at the moment of discharge and then 60% of the therapies was inappropriately continued. Clinical rules or computer supported COMA might have the opportunity to reduce this unnecessary continuation of AST. We also linked the use of AST during hospitalization to the dispensing data in the public pharmacies to study the long-term use of AST after discharge. It has been shown that inappropriate long-term continuation of AST is underestimated, partly due to the low economic impact of the therapy and the safety profile of the drug; again creating opportunities for COMA and clinical pharmacists. A second case study deals with the timely switch from intravenous to oral bio-equivalent medication. A computer algorithm aided in detecting of patients eligible for subsequent therapy by generating a worklist for the clinical pharmacist providing COMA. This study showed that informing physicians by phone or by electronic note was equally successful, yet sending electronic notes was more effective due to reduced labor costs and was appreciated over phone calls by the prescribers as it didn't disturb the normal flow on the ward. Both case studies showed opportunities for clinical pharmacists to enhance patient safety and quality of care and to reduce drug costs, sometimes by cost-saving but also by cost-avoiding. In the discussion chapter, a reflection of the optimal organization of clinical pharmacy services in the University Hospitals Leuven is provided. To guarantee the same quality and safety to each patient, to use resources in the most optimal way and to keep clinical pharmacy affordable a 3-layered approach is presented. These layers consist of a) CDSS for prescriber guidance at the moment of prescribing and administration, b) a back-office check of medication appropriateness based on validated computer algorithms, risk analysis and the use of clinical rules, c) bedside clinical pharmacy for high risk populations or high risk therapies (e.g. intensive care, geriatrics, pediatrics, emergency department, …). A dynamic interaction between the 3 layers, driven by the hospital pharmacist, guarantees continuously tweaking of the system in order to provide maximal effective care. Since clinical pharmacy services are still evolving, more research will be conducted in the following years in a sequel PhD focusing on advanced COMA in order to support the further deployment of clinical pharmacy services via the presented three layered approach.status: publishe