Association of Medication Regimen Complexity With Clinical Endpoints in Pediatric Patients With Cystic Fibrosis

Abstract

OBJECTIVE Cystic fibrosis (CF) patients and caregivers are impacted by the number of pharmacological agents and unique administration needs; however, no data currently assesses how medication regimen complexity impacts clinical outcomes in this population. The objective of this study is to evaluate if an association exists between increased medication regimen complexity and clinical endpoints in pediatric patients with CF. METHODS This retrospective analysis included all pediatric patients with CF (ages 5–20 years) with at least 2 pharmacist encounters and acceptable pulmonary function tests at our pediatric pulmonary clinic during 2017. Each patient's medication regimen was scored using the validated Medication Regimen Complexity Index (MRCI) tool. The primary outcome was the correlation between MRCI score and lung function. Secondary endpoints included growth, number of infections requiring antibiotics, and hospitalizations. RESULTS MRCI scores of the 113 included patients ranged from 2 to 101 points. A negative correlation was found between initial and final MRCI score and initial and final forced expiratory volume in 1 second (FEV1; r = −0.323, p = 0.0005 and r = −0.287, p = 0.0021, respectively). MRCI scores were negatively correlated with BMI percentile for both encounters (r = −0.162 and r = −0.125) but were not significant. Higher MRCI scores were associated with increased use of oral and intravenous antibiotics and hospital admissions. CONCLUSIONS Higher MRCI scores are correlated with a significant decrease in FEV1, increased need for antibiotic therapy, and more hospital admissions in pediatric patients with CF. Larger studies are needed to determine if a correlation exists between MRCI score and growth.

A coordinated approach for managing polypharmacy among children with medical complexity: rationale and design of the Pediatric Medication Therapy Management (pMTM) randomized controlled trial

“…During the 90-day follow up period, we will assess additional exploratory outcomes including Medication Regimen Complexity Index (MRCI) scores and medication counts for all medications, including scheduled, as needed, and over-the-counter medications [ 79 ]. MRCI, a tool developed to measure medication complexity in adult and geriatric populations with polypharmacy, has demonstrated potential for application in pediatric populations and has been associated with increased acute healthcare utilization [ 4 , 61 , 80 - 82 ]. In addition to the previously described patient-level PRO-Sx symptom burden scores, parental completion of the Patient-Health Burden Scale for Family Caregivers (BSFC) and Patient Health Questionnaire (PHQ-9) will be performed at scheduled time points to measure caregiver burden and mental health [ 83 , 84 ].…”

A scoping review of clinical pharmacist and pharmacy technician contributions to cystic fibrosis care

“…Higher MRCI scores (which equate to more complex medication regimens) were associated with a significant decrease in FEV 1 percent predicted, an increased need for antibiotics, and increased rates of hospital admissions in pediatric pwCF. 5 Both studies demonstrate the potential negative impact that complex medication regimens can have on clinical outcomes in pwCF. Pharmacists are well-trained to manage medication complexity as part of a care team, thus providing benefits to both the patient and the health care system.…”

“…3 Since CF is a multiorgan system condition often resulting in multiple comorbidities, people with CF (pwCF) are often prescribed complex therapeutic regimens. 4 In a 2021 retrospective study by Tjugum et al, 5 the average pwCF uses 8-10 medications, which can take 1-3 h to administer these medications each day. In this study, a medication regimen complexity index (MRCI) score was calculated for each pwCF, with higher scores indicating a more complex medication regimen.…”

“…While these complex regimens have improved overall outcomes in pwCF and have increased the median age at death, poor management of these regimens is associated with poor clinical outcomes. 1,5 While outcomes have improved for pwCF, these complex therapeutic regimens can be challenging to manage for pwCF, their caregivers, and providers. Since the introduction of the first Food and Drug Administration (FDA)-approved CFTR modulator, ivacaftor, in 2012, the therapeutic landscape of CF has expanded considerably for pwCF.…”

“…Study outcomes are summarized in As a multi-organ chronic condition, the complexity of CF pharmacotherapy is well documented. 4,5 The current CFF treatment guidelines revolve around the use of oral and inhaled therapies, nutrition support, use of oral anti-inflammatory agents such as azithromycin and ibuprofen, CFTR modulators, and supportive care for other comorbidities (e.g. distal intestinal obstruction syndrome, vitamin D deficiency, CF-related diabetes, etc.).…”