- Email: [email protected]
The Pharmacotherapy-Team: A New Intervention Strategy to Improve Rational Pharmacotherapy and Reduce Prescribing Errors in a Hospital Setting
Clinical Therapeutics included pharmacogenetics-based therapeutic recommendations in their labels and their allele frequencies in Korean population. Methods: We reviewed the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines, and the Dutch Pharmacogenetics Working Group (DPWG) guidelines and crossreferenced it with the drug labels listed by the Food and Drug Administration (FDA; www.fda.gov) and Ministry of Food and Drug Safety of Korea (MFDS; www.mfds.go.kr). The drugs listed by the FDA and MFDS were compared, which reflected either of the CPIC or DPWG guideline. Pharmacogenetic genotype/allele frequencies in Korean, Asian, and Caucasian populations were compared by reviewing the National Center or Biotechnology Information (www. ncbi.nlm.nih.gov) and the supplementary data of CPIC guidelines. Results: Among the marketed drugs in either Korea or U.S.A., the number of drugs recommended for pharmacogenetics-based therapy by the CPIC and DPWG guidelines were 29 and 34, respectively, while the numbers of drugs of which the labels listed by the FDA and MFDS reflected either the CPIC or DPWG guideline were 12 and 14, respectively. Three of the most commonly referenced genes for pharmacogenetics-based therapy were HLA-B, TPMT, and DPYD. In Korean population, the allele frequencies of HLA-B (*1502, *5701, and *5801) were 0.002 - 0.022, 0.005, 0.001, and that of TPMT (*3C and *6) were 0.009 – 0.018 and 0.003 – 0.013, respectively. However the allele frequencies of DPYD were not yet determined. Conclusions: More effort have to be made to implement the CPIC and DPWG guidelines to the drug labels in Korea, and at the same time further investigation of allele frequencies in Korean population is needed
Factor XA Inhibitor Attenuates Renal Interstitial Fibrosis in Mice With Unilateral Ureteral Obstruction Y. Horinouchi1; Y. Ikeda1; M. Imanishi1,2; Y. Zamami1,2; Y. Izawa-Ishizawa1; K. Ishizawa1,2; K. Tsuchiya1; and T. Tamaki1 1 Institute of Biomedical Sciences, The University of Tokushima Graduate School, Tokushima, Japan; and 2Tokushima University Hospital, Tokushima, Japan Background: Renal interstitial fibrosis is a major cause in the progression of chronic kidney diseases (CKD). Recent studies have suggested that Factor Xa (FXa) or its receptor, protease-activated receptor (PAR), plays an important role in the pathophysiology of inflammatory diseases such as diabetic nephropathy and atherosclerosis. However, the involvement of FXa in renal interstitial fibrosis has remained unclear. In this study, we examined the effects of FXa inhibitor on renal interstitial fibrosis by using mice with unilateral ureteral obstruction (UUO), a renal interstitial fibrosis model. Methods: The C57BL/6J mice were divided into 3 groups: UUO with vehicle, UUO with edoxaban (EDO), a FXa inhibitor, and sham operation with vehicle. Results: At one week after surgery, the expression levels of FX and receptors for FXa, PAR-1 and PAR-2, increased in the kidney of UUO mice compared sham-operated mice. EDO treatment inhibited UUOinduced upregulation of the expression of the TGF-β , collagen I, III and fibronectin. Moreover, UUO-induced upregulation of inflammatory cytokines were also abrogated by EDO treatment. In histological analysis, UUO-induced tubulointerstitial fibrosis and macrophage infiltration were suppressed in EDO-treated mice. Conclusions: EDO attenuates renal interstitial fibrosis in UUO mice, at least in part by inhibiting pro-inflammatory activation of macrophages. These results indicate that FXa inhibitor, EDO may be particularly beneficial for the management of CKD, in addition to its antithrombotic activity.
e58
The Pharmacotherapy-Team: A New Intervention Strategy to Improve Rational Pharmacotherapy and Reduce Prescribing Errors in a Hospital Setting J.K. Bekema1,2; D.J. Brinkman1,2; M. Dekker1; M.A. Kuijvenhoven1; M. van Beneden1; and M.A. van Agtmael1,2 1 VU University Medical Center, Amsterdam, The Netherlands; and 2RECIPE (Research & Expertise Center In Pharmacotherapy Education), Amsterdam, The Netherlands Background: Prescribing errors account for a substantial proportion of medication errors, resulting in patient harm and high costs.1,2 Several interventions to reduce prescribing errors by promoting rational prescribing have been introduced in Dutch primary care.3 Although these interventions are promising, a thorough and structural approach to promote rational prescribing in a hospital setting is still lacking. Given the increasing complexity of patients in hospitals (e.g., polypharmacy, multimorbidity, older age), the demanding working environment, and the large number of drugs prescribed, new strategies to improve rational prescribing in this setting are urgently needed. We developed a new intervention strategy to improve rational prescribing and reduce prescribing errors in a hospital setting. Methods: Because of the complexity of the prescribing process, interventions to improve rational prescribing are more likely to be effective if they include a multidisciplinary and multifaceted strategy. Therefore, we set up a Pharmacotherapy-team consisting of 2 physician-clinical pharmacologists, a hospital pharmacist, an internist, a quality consultant and 2 medical students. We use Participatory Action Research (PAR), combining qualitative and quantitative methods (e.g., medication chart review, online survey) to investigate the complex nature of prescribing in hospital settings. This strategy is characterized by the participation of local employers (senior and junior physicians, nurses) in investigating opportunities to improve practice and the subsequent intervention development and implementation. The Pharmacotherapy-team performs in depth prevalence measurements of prescribing errors on wards before and after the intervention phase. Interventions developed in collaboration with local employers, focus on organization-based (e.g., redesigning working process), discipline-based (e.g., improving guideline accessibility), and individual-based (e.g., education) aspects. Conclusions: A multidisciplinary Pharmacotherapy-team with active participation of local employers is a new and unique strategy to thoroughly investigate the complex prescribing process. With this tailored approach we hope to develop effective and sustainable interventions to improve rational prescribing in hospital settings.
References 1. Dean B, Schachter M, Vincent C, Barber N. Prescribing errors in hospital inpatients: their incidence and clinical significance. Qual Saf Health Care 2002;11:340-344. 2. Dutch Hospital Pharmacist Association. Central Medication incidents Registration (CMR). Annual rapport 2014. The Hague, The Netherlands. 3. Hazen A, Sloeserwij V, Zwart D, de Bont A, Bouvy M, de Gier J et al. Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT). BMC Fam Pract 2015;16:76.
How to Deal with Regulation EU 536/2014 on Clinical Trials? A View from the Hospital Clínic Barcelona Research Ethics Committee S. Fernández; N. Riba; J.A. Arnaiz; B. Gómez; A. Bernal; and G. Calvo Hospital Clınic, Barcelona, Spain
Volume 39 Number 8S
Factor XA Inhibitor Attenuates Renal Interstitial Fibrosis in Mice With Unilateral Ureteral Obstruction Y. Horinouchi1; Y. Ikeda1; M. Imanishi1,2; Y. Zamami1,2; Y. Izawa-Ishizawa1; K. Ishizawa1,2; K. Tsuchiya1; and T. Tamaki1 1 Institute of Biomedical Sciences, The University of Tokushima Graduate School, Tokushima, Japan; and 2Tokushima University Hospital, Tokushima, Japan Background: Renal interstitial fibrosis is a major cause in the progression of chronic kidney diseases (CKD). Recent studies have suggested that Factor Xa (FXa) or its receptor, protease-activated receptor (PAR), plays an important role in the pathophysiology of inflammatory diseases such as diabetic nephropathy and atherosclerosis. However, the involvement of FXa in renal interstitial fibrosis has remained unclear. In this study, we examined the effects of FXa inhibitor on renal interstitial fibrosis by using mice with unilateral ureteral obstruction (UUO), a renal interstitial fibrosis model. Methods: The C57BL/6J mice were divided into 3 groups: UUO with vehicle, UUO with edoxaban (EDO), a FXa inhibitor, and sham operation with vehicle. Results: At one week after surgery, the expression levels of FX and receptors for FXa, PAR-1 and PAR-2, increased in the kidney of UUO mice compared sham-operated mice. EDO treatment inhibited UUOinduced upregulation of the expression of the TGF-β , collagen I, III and fibronectin. Moreover, UUO-induced upregulation of inflammatory cytokines were also abrogated by EDO treatment. In histological analysis, UUO-induced tubulointerstitial fibrosis and macrophage infiltration were suppressed in EDO-treated mice. Conclusions: EDO attenuates renal interstitial fibrosis in UUO mice, at least in part by inhibiting pro-inflammatory activation of macrophages. These results indicate that FXa inhibitor, EDO may be particularly beneficial for the management of CKD, in addition to its antithrombotic activity.
e58
The Pharmacotherapy-Team: A New Intervention Strategy to Improve Rational Pharmacotherapy and Reduce Prescribing Errors in a Hospital Setting J.K. Bekema1,2; D.J. Brinkman1,2; M. Dekker1; M.A. Kuijvenhoven1; M. van Beneden1; and M.A. van Agtmael1,2 1 VU University Medical Center, Amsterdam, The Netherlands; and 2RECIPE (Research & Expertise Center In Pharmacotherapy Education), Amsterdam, The Netherlands Background: Prescribing errors account for a substantial proportion of medication errors, resulting in patient harm and high costs.1,2 Several interventions to reduce prescribing errors by promoting rational prescribing have been introduced in Dutch primary care.3 Although these interventions are promising, a thorough and structural approach to promote rational prescribing in a hospital setting is still lacking. Given the increasing complexity of patients in hospitals (e.g., polypharmacy, multimorbidity, older age), the demanding working environment, and the large number of drugs prescribed, new strategies to improve rational prescribing in this setting are urgently needed. We developed a new intervention strategy to improve rational prescribing and reduce prescribing errors in a hospital setting. Methods: Because of the complexity of the prescribing process, interventions to improve rational prescribing are more likely to be effective if they include a multidisciplinary and multifaceted strategy. Therefore, we set up a Pharmacotherapy-team consisting of 2 physician-clinical pharmacologists, a hospital pharmacist, an internist, a quality consultant and 2 medical students. We use Participatory Action Research (PAR), combining qualitative and quantitative methods (e.g., medication chart review, online survey) to investigate the complex nature of prescribing in hospital settings. This strategy is characterized by the participation of local employers (senior and junior physicians, nurses) in investigating opportunities to improve practice and the subsequent intervention development and implementation. The Pharmacotherapy-team performs in depth prevalence measurements of prescribing errors on wards before and after the intervention phase. Interventions developed in collaboration with local employers, focus on organization-based (e.g., redesigning working process), discipline-based (e.g., improving guideline accessibility), and individual-based (e.g., education) aspects. Conclusions: A multidisciplinary Pharmacotherapy-team with active participation of local employers is a new and unique strategy to thoroughly investigate the complex prescribing process. With this tailored approach we hope to develop effective and sustainable interventions to improve rational prescribing in hospital settings.
References 1. Dean B, Schachter M, Vincent C, Barber N. Prescribing errors in hospital inpatients: their incidence and clinical significance. Qual Saf Health Care 2002;11:340-344. 2. Dutch Hospital Pharmacist Association. Central Medication incidents Registration (CMR). Annual rapport 2014. The Hague, The Netherlands. 3. Hazen A, Sloeserwij V, Zwart D, de Bont A, Bouvy M, de Gier J et al. Design of the POINT study: Pharmacotherapy Optimisation through Integration of a Non-dispensing pharmacist in a primary care Team (POINT). BMC Fam Pract 2015;16:76.
How to Deal with Regulation EU 536/2014 on Clinical Trials? A View from the Hospital Clínic Barcelona Research Ethics Committee S. Fernández; N. Riba; J.A. Arnaiz; B. Gómez; A. Bernal; and G. Calvo Hospital Clınic, Barcelona, Spain
Volume 39 Number 8S