Prevalence and Management of Drug-Related Problems in Chronic Kidney Disease Patients by Severity Level: A Subanalysis of a Cluster Randomized Controlled Trial in Community Pharmacies

RESEARCH Prevalence and Management of Drug-Related Problems in Chronic Kidney Disease Patients by Severity Level: A Subanalysis of a Cluster Randomized Controlled Trial in Community Pharmacies Patricia Quintana-Bárcena, BPharm, PhD; Anne Lord, MSc; Annie Lizotte, MSc; Djamal Berbiche, PhD; and Lyne Lalonde, PhD ABSTRACT BACKGROUND: Drug-related problems (DRPs) are prevalent among chronic kidney disease (CKD) patients. However, little is known about their severity and management by community pharmacists. OBJECTIVES: To (a) describe the prevalence of DRPs by severity level in CKD patients and (b) assess the effect of a training-and-communication network program in nephrology (ProFiL) on these DRPs. METHODS: This is a secondary analysis of a cluster randomized controlled trial evaluating the effect of the ProFiL-program. In 6 CKD clinics, patients at CKD stage 3 or 4 and their community pharmacists were recruited and assigned to the ProFiL group or a usual care (UC) group. Using validated criteria, 2 pharmacists identified DRPs and assessed their severity at baseline and after 12 months. The mean annual change in the number of DRPs per patient by severity level was assessed using a 2-level multivariable linear mixed-effects model. RESULTS: A total of 494 pharmacists and 442 patients participated. At baseline, the prevalence (mean number of DRPs per patient [SD]) of mild DRPs (e.g., requiring dosage adjustment) and moderate DRPs (e.g., drug adherence requiring a monitoring plan) were 0.55 (0.98) and 1.04 (1.51), respectively. After 12 months, an unadjusted incremental annual reduction of 0.34 moderate DRPs (95% CI = -0.66 to -0.01) was observed in the ProFiL group compared with the UC group. After adjustment, no betweengroup differences were observed. CONCLUSIONS: Among patients followed in CKD clinics, most DRPs have a moderate severity requiring specific monitoring by pharmacists. The benefit of continuing education programs, such as ProFiL, to reduce moderate DRPs remains to be determined. J Manag Care Spec Pharm. 2018;24(2):173-81 Copyright © 2018, Academy of Managed Care Pharmacy. All rights reserved. What is already known about this subject • Chronic kidney disease (CKD) patients are at high risk of suffering drug-related problems (DRPs), not only because of their decreased kidney function but also because they receive multiple medications prescribed simultaneously by different physicians. • Nonadherence, adverse events, drug interactions, and inappropriate doses are DRPs frequently observed in CKD patients. www.jmcp.org Vol. 24, No. 2 What this study adds • The most frequently observed DRPs in patients with CKD are nonadherence to drug therapy and the use of drugs not recommended or requiring a dose adjustment in CKD. • Nonadherence is deemed a moderately severe DRP, which requires the community pharmacist to implement a monitoring plan and follow-up. • A training-and-communication network program in nephrology intended for community pharmacists may serve to improve the detection and management of moderately severe DRPs in CKD patients. C hronic kidney disease (CKD) patients are medically complex cases. They take a mean of 10 to 13 medications and are followed by several physicians.1 These factors increase the patients’ risk of drug-related problems (DRPs).2,3 In CKD patients, the prevalence of DRPs has been estimated at 2.8 (95% confidence interval [CI] = 2.3-3.2) DRPs/ patient for creatinine clearance 30-59 mL/min4; and 4-8 DRPs per patient on hemodialysis.4,5 Common DRPs in CKD are adverse events, drug interactions, and inappropriate doses; these DRPs result from decreased kidney function.2,3,6 The mortality rate associated with inappropriate drug use is 40% higher in patients with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m 2 compared with patients without CKD.7 CKD patients also demonstrate poor adherence to pharmacotherapy, particularly cardiovascular medications.8 A large variation has been documented in the prevalence of nonadherence in end-stage renal disease (3%-80%), which may be partly explained by different definitions and measurements of nonadherence.9 Nevertheless, the information about the severity of these DRPs is still limited. In the hospital context, researchers have sought to measure DRP severity in terms of clinical and economic consequences.10,11 So far, no information is available on the severity of DRPs detected among CKD patients followed in an ambulatory setting where community pharmacists play a crucial role in DRP detection and management.12 Moreover, nothing is known about the effect of community pharmacists’ interventions on DRP prevalence by severity level. The objectives of this study were to (a) describe DRP prevalence according to severity in CKD nonhemodialysis patients February 2018 JMCP Journal of Managed Care & Specialty Pharmacy 173 Prevalence and Management of Drug-Related Problems in Chronic Kidney Disease Patients by Severity Level: A Subanalysis of a Cluster Randomized Controlled Trial in Community Pharmacies followed in 6 ambulatory CKD clinics, and (b) assess the effect of a training-and-communication network program in nephrology for community pharmacists on DRP prevalence, when classified by severity level. ■■ Methods Design, Setting, and Participants This project is a secondary analysis of a cluster randomized controlled trial evaluating the effect of a training-and-communication program in nephrology for community pharmacists, the ProFiL program, on the quality of medication use in CKD patients. The ProFiL study has been fully described elsewhere.13 This project was approved by the ethics and research board of the Centre hospitalier de l’Université de Montréal. Participating patients and community pharmacists signed an informed consent form. In short, potentially eligible patients and their community pharmacists in 6 CKD clinics in Quebec, Canada, were invited to participate in the study. Eligible patients met the following criteria: (a) aged ≥ 18 years; (b) an eGFR of 30-59 mL/min/1.73m 2 (stage 3 CKD) or an eGFR of 15-29 mL/ min/1.73m2 (stage 4 CKD), as determined by the most recent laboratory result available in the CKD clinic; (c) speaking English or French; (d) followed by an eligible community pharmacy; and (e) agreeing to be followed by the same community pharmacy for the duration of the study. To be eligible, the pharmacy had to meet the following criteria: If the pharmacy was open 7 days per week, participating pharmacists had to cover at least 35 hours per week for a workload of < 250 prescriptions per day or at least 60 hours per week for a workload of > 250 prescriptions per day; if the pharmacy was open fewer than 7 days per week, participating pharmacists had to cover at least 50% of the working hours. Each cluster, comprising a community pharmacy with pharmacists and patients, was randomly assigned to either the ProFiL group or the control group using a 2:1 ratio (2 (...truncated)