Renal clinical pharmacy services

Klinisch-pharmazeutische Dienstleistungen im Bereich Nephrologie befassen sich unter anderem mit speziellen Arzneimittel- und Arzneimitteltherapie-assoziierten Problemen in Patienten mit eingeschränkter Nierenfunktion bei chronischer Niereninsuffizienz, terminalem Nierenversagen oder nach Nierentransplantation. Charakteristische Begleiterkrankungen in dieser Patientenpopulation sind häufig. Für den Klinischen Pharmazeuten bieten sich in diesem komplexen Umfeld viele Möglichkeiten einen Beitrag zu leisten und es gibt umfangreiche wissenschaftliche Literatur hierfür. Möglichkeiten umfassen u.a. das Management von Risikofaktoren (z.B. Hypertonie, kardiovaskuläre Erkrankungen und Diabetes), das Management von Begleiterkrankungen (z.B. Anämie, Störungen im Calcium-, Phosphat- und Vitamin-D-Haushalt), sowie die Prävention und das Management von Arzneimittel-assoziierten Problemen. Patienten mit eingeschränkter Nierenfunktion sind besonders empfindlich für Arzneimittel-assoziierte Probleme. Die fehlende Berücksichtigung von Dosierungsempfehlungen bedingt häufig eigentlich verhinderbare Arzneimittelnebenwirkungen. Die Beurteilung der Nierenfunktion und korrekte, an diese angepasste Arzneimitteldosierungen sind unerlässlich, um unerwünschte Arzneimittelwirkungen zu vermeiden und letztendlich eine optimale Patientenversorung zu gewährleisten. Die Existenz von Begleiterkrankungen, deren Schweregrad und verschiedene Verfahren (z.B. Dialyse) beeinflussen die Pharmakokinetik und die Pharmakodynamik von Arzneimitteln und können so zum Auftreten von Arzneimittel-assoziierten Problemen beitragen. Auf der nephrologischen Normalpflegestation einer großen österreichischen Universitätsklinik wurden erfolgreich klinisch-pharmazeutische Dienstleistungen implementiert und durch Beschreibung und Auswertung der klinisch-pharmazeutischen Interventionen und anderen Beiträgen während der Stationsvisiten evaluiert. Häufige Arzneimittel-assoziierte Probleme (z.B. Dosierungsfehler, Gebrauch nicht indizierter Arzneimittel, Fehler in der Dokumentation), häufig betroffene Arzneistoffe (z.B. Antibiotika, Protonenpumpenhemmer, Virustatika), die Akzeptanzrate der vorgeschlagenen Interventionen seitens des ärztlichen Personals und die Beurteilung der Signifikanz wurden erhoben. Die Ergebnisse müssen unter Berücksichtigung methodischer und systematischer Grenzen interpretiert werden. Die vorliegende Arbeit stellt die erste wissenschaftliche Arbeit im Bereich angewandter klinisch-pharmazeutischer Forschung auf nationaler österreichischer Ebene dar. Sie liefert Ergebnisse zur Implementierung klinisch-pharmazeutischer Dienstleistungen und unterstreicht den Beitrag des Klinischen Pharmazeuten in einem diesbezüglich noch in den Kinderschuhen steckenden Umfeld.Renal clinical pharmacy services focus on special drug- and pharmacotherapy-related issues in patients with renal impairment (e.g., chronic kidney disease patients, end-stage renal disease patients, kidney transplantation patients). Patients with renal insufficiency are characterised by several different comorbidities that affect many organ systems. Opportunities for the clinical pharmacist to contribute to the complex care of these patients at various stages and in the aforementioned patient groups are described. Possible areas in which the clinical pharmacist can contribute are risk factor management (e.g., hypertension, cardiovascular disease, and diabetes), management of comorbidities (e.g., anaemia, metabolic bone disease), and prevention and management of drug-related problems (DRPs). Patients with renal impairment are especially susceptible to DRPs. Non-adherence to dosing guidelines often leads to the occurrence of preventable adverse drug events. Accurate assessment of kidney function and assurance of dosage adaptation is key to avoid unwanted drug effects and, ultimately, to ensure optimal patient outcomes. Factors including the severity and prevalence of coexistent medical conditions and different procedures (e.g., form of dialysis) may influence the pharmacokinetics and pharmacodynamics of the drugs used and, therefore, contribute to the occurrence of DRPs. Successful implementation of clinical pharmacy services on an internal nephrology ward was evaluated by describing and evaluating the impact of a clinical pharmacist’s participation during ward rounds. Data on commonly detected DRPs (e.g., dosing issues, use of unindicated drugs, inaccuracies in medical records), performed interventions, affected drugs (e.g., antibiotics, proton pump inhibitors, antivirals), the physicians’ acceptance rate of the suggested interventions, and the significance assessment of the interventions are reported. Limitations to the results and their impact are mainly due to issues in study methodology. This thesis represents the first scientific thesis in the area of applied clinical pharmacy research on a national level in Austria and yields data on its implementation in the renal setting and the clinical pharmacist’s role in the evolving system of clinical pharmacy services

Risks in Antibiotic Substitution Following Medicine Shortage: A Health-Care Failure Mode and Effect Analysis of Six European Hospitals

Introduction: Medicine shortages result in great risk for the continuity of patient care especially for antimicrobial treatment, potentially enhancing resistance rates and having a higher economic impact. This study aims to identify, describe, assess, and assign risk priority levels to potential failures following substitution of antimicrobial treatment due to shortages among European hospitals. Furthermore, the study investigated the impact of corrective actions on risk reduction so as to provide guidance and improve future patient care. Methods: Health-care failure mode and effect analysis (HFMEA) was applied to hospitals in Austria (H-AT), Belgium (H-BE), Croatia (H-CR), Greece (H-GR), Spain (H-SP), and Serbia (H-SR). Multidisciplinary teams identified processes, failure modes, causes, and corrective actions related to antibiotic substitution following medicine shortages. Characteristics of study hospitals as well as severity, probability, and hazard scores (HSs) of failure modes/causes were analyzed using Microsoft Office Excel 2010 and IBM SPSS Statistics® via descriptive and inferential statistics. Results: Through HFMEA, 74 failure modes were identified, with 53 of these scoring 8 or above on the basis of assigned severity and probability for a failure. Severity of failure modes differed before and after corrective actions in H-CR, H-GR, and H-SR (p < 0.005). Their probability differed in all study hospitals (p < 0.005) when compared before and after corrective actions aimed to be implemented. The highest number of failure-mode causes was detected in H-CR (46) and the lowest in H-SP (16). Corrective actions can address failure modes and lower HSs; therein, all teams proposed the following: structuring communication among stakeholders, introducing electronic prescribing, strengthening pharmacists' involvement, and increasing effectiveness of the ward stock assessment. These proposed actions led to HS reductions up to 83%. Conclusion: There is a lack of structure in addressing risks associated with antibiotic substitution following shortages. Furthermore, lack of communication, data scarcity on availability of antibiotics, non-supportive information technology (IT) systems, and lack of internal substitution protocols hinder quick assessment of alternatives addressing patient needs. Nevertheless, the study shows that health-care professionals manage to secure optimal antimicrobial treatment for patients using available IT and human resources

Clinical pharmacy activities in chronic kidney disease and end-stage renal disease patients: a systematic literature review

<p>Abstract</p> <p>Background</p> <p>Chronic kidney disease (CKD) and end-stage renal disease (ESRD) represent worldwide health problems with an epidemic extent. Therefore, attention must be given to the optimisation of patient care, as gaps in the care of CKD and ESRD patients are well documented. As part of a multidisciplinary patient care strategy, clinical pharmacy services have led to improvements in patient care. The purpose of this study was to summarise the available evidence regarding the role and impact of clinical pharmacy services for these patient populations.</p> <p>Methods</p> <p>A literature search was conducted using the <it>Medline</it>, <it>Embase </it>and <it>International Pharmaceutical Abstracts </it>databases to identify relevant studies on the impact of clinical pharmacists on CKD and ESRD patients, regarding disease-oriented and patient-oriented outcomes, and clinical pharmacist interventions on drug-related problems.</p> <p>Results</p> <p>Among a total of 21 studies, only four (19%) were controlled trials. The majority of studies were descriptive (67%) and before-after studies (14%). Interventions comprised general clinical pharmacy services with a focus on detecting, resolving and preventing drug-related problems, clinical pharmacy services with a focus on disease management, or clinical pharmacy services with a focus on patient education in order to increase medication knowledge. Anaemia was the most common comorbidity managed by clinical pharmacists, and their involvement led to significant improvement in investigated disease-oriented outcomes, for example, haemoglobin levels. Only four of the studies (including three controlled trials) presented data on patient-oriented outcomes, for example, quality of life and length of hospitalisation. Studies investigating the number and type of clinical pharmacist interventions and physician acceptance rates reported a mean acceptance rate of 79%. The most common reported drug-related problems were incorrect dosing, the need for additional pharmacotherapy, and medical record discrepancies.</p> <p>Conclusions</p> <p>Few high-quality trials addressing the benefit and impact of clinical pharmacy services in CKD and ESRD patients have been published. However, all available studies reported some positive impact resulting from clinical pharmacist involvement, including various investigated outcome measures that could be improved. Additional randomised controlled trials investigating patient-oriented outcomes are needed to further determine the role of clinical pharmacists and the benefits of clinical pharmacy services to CKD and ESRD patients.</p

A randomized, placebo-controlled, double-blind, prospective trial to evaluate the effect of vildagliptin in new-onset diabetes mellitus after kidney transplantation

<p>Abstract</p> <p>Background</p> <p>New-onset diabetes mellitus after transplantation (NODAT), a frequent and serious complication after transplantation, is associated with decreased graft and patient survival. Currently, it is diagnosed and treated primarily according to existing guidelines for type II diabetes. To date, only a few trials have studied antidiabetic drugs in patients with NODAT. Vildagliptin is a novel dipeptidyl peptidase-4 (DPP-4) inhibitor that improves pancreatic islet function by enhancing both α- and β-cell responsiveness to increased blood glucose. Experimental data show potential protective effects of DPP-4 inhibitors on islet function after exogenous stress stimuli including immunosuppressants. Therefore, the therapy of NODAT with this class of compounds seems attractive. At present, vildagliptin is used to treat type II diabetes as monotherapy or in combination with other antidiabetic drugs, since that it efficiently decreases glycated hemoglobin (HbA1c) values. Additionally, vildagliptin has been shown to be safe in patients with moderately impaired kidney function. This study will evaluate the safety and efficacy of vildagliptin monotherapy in renal transplant recipients with recently diagnosed NODAT.</p> <p>Methods/Design</p> <p>This study is a randomized, placebo-controlled, double-blind, prospective phase II trial. Using the results of routinely performed oral glucose tolerance tests (OGTT) in stable renal transplant patients at our center, we will recruit patients without a history of diabetes and a 2 h glucose value surpassing 200 mg/dl (11.1 mmol/l). They are randomized to receive either 50 mg vildagliptin or placebo once daily. A total of 32 patients with newly diagnosed NODAT will be included. The primary endpoint is the difference in the 2 h glucose value between baseline and the repeated OGTT performed 3 months after treatment start, compared between the vildagliptin- and the placebo-group. Secondary endpoints include changes in HbA1c and fasting plasma glucose (FPG). The safety of vildagliptin in renal transplant patients will be assessed by the number of symptomatic hypoglycemic episodes (glucose <72 mg/dl or 4 mmol/l), the number of adverse events, and possible medication-associated side-effects.</p> <p>Discussion</p> <p>NODAT is a severe complication after kidney transplantation. Few trials have assessed the safety and efficacy of antidiabetic drugs for these patients. The purpose of this study is to assess the safety and efficacy of vildagliptin in renal transplant patients with NODAT.</p> <p>Trial Registration</p> <p>ClinicalTrials.gov NCT00980356</p

The Impact of Clinical Pharmacy Services in a Tertiary Care Center Specialized in Pediatric Hemato-Oncology

Clinical pharmacy services (CPS) have shown beneficial effects on several outcome measures in hospital patients, including the reduction of drug-related problems (DRP) and of therapy costs. Less is known about the impact of CPS in pediatric haemato-oncology, even though this patient population is highly susceptible to DRP. CPS were implemented in a tertiary care children’s hospital specialized in hemato-oncology and hematopoietic stem cell transplantation. The main outcome measures were type and number of DRP, type and number of pharmaceutical interventions (PI), their acceptance rate, and their clinical significance and economic benefit. During 6 months and 32 ward rounds, 275 DRP were identified and addressed by PI. The acceptance of PI was high (73.4%), and up to 80% of PI were rated as very significant or significant by independent external raters. The estimated therapy cost reductions were substantial, approaching at least EUR 54,600 for avoided follow-up costs. Conclusion: CPS improve medication safety in pediatric hemato-oncology and may reduce therapy costs

Pharmacy Practice and Education in Austria

The PHARMINE (&ldquo;Pharmacy Education in Europe&rdquo;) project studied pharmacy practice and education in the European Union (EU) member states. The work was carried out using an electronic survey sent to chosen pharmacy representatives. The surveys of the individual member states are now being published as reference documents for students and staff interested in research on pharmacy education in the EU and in mobility. This paper presents the results of the PHARMINE survey on pharmacy practice and education in Austria. In the light of this, we examine the harmonisation of practice and education in Austria with EU norms

Tackling the challenges of nanomedicines: are we ready?

This review provides an overview of the proceedings of the symposium "Tackling the Challenges of Nanomedicines: Are We Ready?" organized by the International Pharmaceutical Federation (FIP) Hospital Pharmacy Section and Non-Biological Complex Drugs (NBCDs) Working Group at the 2019 FIP World Congress of Pharmacy and Pharmaceutical Sciences. Debate centered on reasons underlying the current complex regulatory landscape for nanomedicines and their follow-on products (referred to as nanosimilars) and the pivotal role of hospital pharmacists in selecting, handling, and guiding usage of nanomedicines and nanosimilars.; The evaluation and use of nanomedicines are recognized among scientific, pharmaceutical, and regulatory bodies as complex. Interchangeability and substitutability of nanomedicines and nanosimilars are confounded by a lack of pharmaceutical and pharmacological equivalence, reflecting the inherent complex nature of these drug products and manufacturing processes. Consequences include implications for clinical safety and efficacy and, ultimately, comparability. Local regulatory approvals of some nanomedicines have occurred, but there is no standard to ensure streamlined evaluation and use of consistent measures of therapeutic equivalence of reference products and their nanosimilars. Hospital pharmacists are expected to be experts in the selection, handling, and substitution of nanomedicines and familiarize themselves with the limitations of current methods of assessing pharmaceutical and clinical equivalence of nanosimilars in order to ensure informed formulary decision-making and eventual patient benefit.; Supportive guidance for pharmacists focusing on the substitutability and/or interchangeability of nanomedicines and their nanosimilars is needed. Current FIP guidance for pharmacists on therapeutic interchange and substitution should be extended to include nanomedicines and nanosimilars