Verbesserung der Arzneimitteltherapiesicherheit im ambulanten Sektor bei Patienten mit chronischer Niereninsuffizienz (AMTS-CKD-Studie)

BACKGROUND: Chronic kidney disease (CKD) is one of the most prevalent diseases worldwide. Appropriate ambulatory care is necessary to protect patients from further secondary diseases and developing end-stage renal disease. Adequate medication therapy management, sufficient communication, especially at different ambulatory transition levels, and general practitioners’ implementation of the drug therapy recommended by the nephrologist are essential to ensure successful long-term treatment in the ambulatory setting and to avoid drug-related problems (DRPs). The aim of this study was to improve medicines optimization in patients with CKD by increasing general practitioners’ acceptance of nephrologists’ medication recommendations and reducing DRPs in patients with CKD by involving a clinical pharmacist in the therapeutic team in a nephrology outpatient clinic. METHODS: The prospective, controlled intervention study was conducted in the nephrology outpatient clinic of the Klinikum Fulda gAG, Germany. The control and intervention phases took place successively. Patients with CKD stage 3-5 and at least one concomitant disease, e.g. arterial hypertension or type-2-diabetes, were recruited consecutively in three subgroups (naive, 1 contact, ≥ 2 contacts with the nephrologist) from June 2015 to May 2019. General practitioners’ acceptance of nephrologists’ medication recommendations and frequency of DRPs without (control group; CG) and with (intervention group; IG) a pharmacist’s interventions were compared after 6 months. Pharmaceutical interventions include the development of a Renal-Risk-Drug-list with renally relevant drugs, educational training events for general practitioners and pharmacists between CG and IG, medication therapy management and individual patient counselling. Furthermore, the influence of all pharmaceutical interventions on patients’ adherence, patients’ and general practitioners’ satisfaction and patients’ knowledge of their medications was analyzed, and the effects on a reduction of CKD progression and the improvement of underlying and concomitant diseases were evaluated.   RESULTS: A total of 256 patients (CG=160, IG=96) were recruited during the study period. General practitioners’ acceptance of renally relevant, non-renally relevant and total drug recommendations increased significantly (p<0.001) at the 6 months follow-up (T2) in the subgroup of naive patients, in patients with one prior contact with the nephrologist and in the total study population. The largest increase in the acceptance rate – from 72.8% to 95.5% - was shown in the subgroup of naive patients for renally relevant drugs. Compared to the CG, a significantly higher acceptance was achieved in the IG for recommendations that included the introduction of a new drug, the withdrawal of a drug, a dose reduction, a dose increase and a change of the administration interval (p<0.005). Overall, patients had an average of 2.6 DRPs per patient in the CG and 2.0 DRPs per patient in the IG at the time of recruitment. Compared to the CG, the number of DRPs per patient decreased significantly in the IG at the time of discharge from nephrologist (T0NE) to general practitioner and at T2 in all subgroups (p<0.001). The largest DRP reduction – by 1.6 at T0NE and by 1.9 at T2 – was achieved in patients with ≥ 2 contacts with the nephrologist. Patients in the IG had significantly (p<0.05) fewer non-treated indications, decreased numbers of drugs without given indication, less contraindicated drugs and reduced problems with dosing, administration and adherence at T0NE and T2. Patients’ overall adherence to their drug therapy and patients’ satisfaction with the information received about the medication improved significantly after 6 months in the IG (p<0.001). In the IG, patients' knowledge about their medication increased significantly overall and in the category indication of drug (p<0.001). Within the follow-up period of 6 months, no improvement in the glomerular filtration rate or in the adjustment of concomitant and secondary diseases was achieved by pharmaceutical interventions. CONCLUSIONS: Interdisciplinary collaboration between nephrologist, general practitioners and clinical pharmacist resulted in better medicines optimization for patients with chronic kidney disease by improving general practitioners’ acceptance of renally relevant drug recommendations, especially in patients with newly diagnosed CKD, and by significantly reducing most types of drug-related problems. Pharmacists can be useful members of an interdisciplinary team in the ambulatory care for patients with CKD.