Children with medical complexity have a significant impact on health care cost and outcomes. Children with medical complexity are at risk for substantial polypharmacy and inherent drug-related dangers. In this special article, we describe the integration of clinical pharmacy services into our clinic for children with medical complexity. We review the process that yields results by effectively managing patients’ medications across the continuum of care while also possibly improving health care spending and outcomes.

Complex and chronic diseases have a significant impact on health care cost and outcomes. Patients with chronic medical and mental health conditions account for nearly 90% of the nation’s $3.3 trillion in annual health care expenses.1  Children with medical complexity (CMC) are an emerging population in which health care innovation, including medication management, is imperative to improve health care costs and outcomes. CMC are considered a subgroup of children and youth with special health care needs, which are defined as those who “have or are at increased risk for chronic physical, developmental, behavioral, or emotional conditions who also require health and related services of a type or amount beyond that required by children generally.”2  CMC account for nearly one-third of all pediatric health care expenditures, 25% of hospital days, and >40% of inpatient deaths.3,4  Substantial polypharmacy occurs in pediatric hospitalized patients; children with rare conditions are at even higher risk.5  CMC are also more likely to have emergency department (ED) visits because of adverse drug events.6  To reduce polypharmacy, associated drug risks, and related acute care use, the clinic for children with medical complexity (C-CMC) at our institution integrated pharmacy services into its clinical operations.

Our institution is a freestanding, 367-bed academic pediatric medical center that provides comprehensive specialty care to patients birth to 21 years of age in a 150-county bistate area. In addition to the >40 specialty clinics, our institution has 5 primary care clinics. A primary care clinic dedicated to CMC was established in 2013. Patients served by the C-CMC typically have been diagnosed with numerous and complex, systemic medical conditions requiring technology dependence, periodic procedures, and multiple medications to manage and treat acute and chronic illnesses. The C-CMC is staffed by general academic pediatricians, nurse practitioners, nurses, psychologists, clinical service coordinators, care managers, social workers, and registered dietitians. Three years after the creation of C-CMC, pharmacy services were incorporated into the C-CMC to improve the medication reconciliation process and the delivery of comprehensive medication management. It was also hoped that pharmacist integration would optimize complex therapeutic regimens, thereby, improving patient outcomes.

A pharmacy resident was initially integrated into the C-CMC through an elective rotation aimed at integrating pharmacy services into the clinic workflow and identifying opportunities for future pharmacy support services. During this elective, the pharmacy resident identified 117 medication history discrepancies and documented 120 clinical interventions in the first 15 days. Of these 120 clinical interventions, the most common were identification of needed medication refills (23%), triage of outpatient medication issues (18%), correction of inappropriate dosing (16%), and medication education (13%). These data provided proof of concept of the clinical pharmacist integration into the C-CMC. Less than a year later, a clinic pharmacist was added to the C-CMC. The position was subsequently modified to require a clinical pharmacy specialist position, revealing the increased level of training and skill needed to perform high-level pharmacy services to CMC.

The originality and innovative nature of the C-CMC’s integration of a clinical pharmacist is attributed to its pharmaceutical care. The breadth of current services includes monitoring medications used for multiple conditions, evaluating drug interactions, creating customized medication plans, pursuing prior authorizations, and reconciling medications at times of transitions such as hospital admissions and discharges. Previously described programs that integrated clinical pharmacist services included individual components rather than the full continuum of care.7 

For ambulatory clinic services, the clinical pharmacist conducts medication evaluations at least twice yearly during scheduled routine visits. The clinical pharmacist meets with patients, families, and the health care team to review preventive and routine pharmaceutical care. Four key services are provided by the clinical pharmacist. The first key service is comprehensive medication reconciliation and the development of customized medication plans. Medication reconciliation is not limited to the history provided by the caregiver. It also includes outpatient pharmacy prescription review and manual electronic medical record review. Customized medication plans are then developed in partnership with patients and families. These plans include a list of all prescription and over-the-counter medications (scheduled and as needed) as well as dietary supplements and herbal products. Scheduled medications are reviewed for indications, appropriate timing of administration, potential interactions with other medications being taken, and the primary prescriber responsible for ongoing management and/or adjustment. For medications that are taken as needed, the customized medication plans include directions of when the medications should be administered and how to escalate therapy on the basis of clinical status. In this way, customized medication plans promote safe and consistent medication practices while also allowing for patient individualization and empowerment. Families may also contact the clinical pharmacist between clinic visits when medication questions and concerns arise.

The second service provided by the clinical pharmacist is medication therapy services (MTS). State regulations allow clinical pharmacists to initiate or modify a patient’s medication therapy. In conjunction with physicians, the C-CMC clinical pharmacist is able to select new or different medications, discontinue medications, change the dose or dosing interval, and select a different route of administration for 100 medications and 10 clinical conditions, including asthma, chronic lung disease, seasonal allergies, failure to thrive, gastroesophageal reflux, constipation, atopic dermatitis, vitamin and/or mineral supplementation (including vitamin D deficiency), and menstrual suppression.

The third and fourth services performed by the clinical pharmacist are adverse drug reaction assessment and systemic drug use review of each medication, including drug-disease contraindication, drug-drug interaction, drug-supplement safety, drug-food interaction, drug-patient precaution, dosing, duration of drug treatment, over- and/or underuse, drug dosage modification, adherence concerns, and determination if monitoring is warranted. In addition, to optimize outcomes, the clinical pharmacist may also join patients during additional C-CMC visits if they involve a high degree of medication complexity. These additional visits include medication checks, hospital follow-ups, telehealth visits, in-home visits, and ill or unscheduled appointments. The clinic pharmacist is not only present during clinic hours but also shares a workspace with C-CMC team members. This allows for frequent in-person discussions, involvement in day-to-day activities, and informal medication consultations.

For outpatient-to-inpatient transitions of care, the clinical pharmacist collaborates with the inpatient teams and inpatient pharmacists throughout a patient’s hospitalization. To improve transition from the outpatient to inpatient setting, a comprehensive clinic pharmacist note was developed and is visible to inpatient pharmacists and care teams for reference during hospitalizations. Additionally, after a patient’s admission, the C-CMC clinical pharmacist may communicate directly with inpatient teams to ensure optimal medication management.

For inpatient-to-outpatient transitions of care, within 3 days of hospital discharge, the clinical pharmacist reviews the C-CMC patient’s medication list. To accomplish this, the clinical pharmacist receives a daily report of patients discharged within the previous 24 hours. A complete medication evaluation is then conducted, the patient’s electronic medication list is updated, families are contacted by phone or patient portal to discuss medication changes, and, if necessary, outpatient medication monitoring is arranged. Additionally, the clinical pharmacist provides education to families to ensure their understanding and adherence with the new medication regimen. The intervention is documented in the patient’s medical record, the primary care provider is notified, and, depending on the need, a hospital follow-up appointment may be scheduled.

Step-by-step standard work guidelines were developed detailing each of the previously described processes. These were initially developed at the time of pharmacy integration into our clinic but are continually adapted and improved. All members of the C-CMC team review and provide feedback to each guideline before implementation. In addition, the pharmacist participates in weekly meetings with C-CMC staff and bimonthly meetings with pharmacy leadership. Outside of the C-CMC, physician, pharmacy, and ambulatory leaders have remained stakeholders and champions for continuing to advance pharmacy services in the C-CMC.

We evaluated the impact of integration of a clinical pharmacist into the C-CMC in 4 ways: (1) acute care use, (2) health care spending, (3) patient and C-CMC team satisfaction, and (4) MTS-associated medication changes. To obtain data on acute care use and health care costs on C-CMC patients both within our institution and at outside organizations, we used data from our institution’s accountable care organization (ACO). In our evaluation of acute care use and health care spending, we included only those C-CMC patients with commercial or public insurance aligned with the ACO. In addition, those patients must have been enrolled in one of those insurance types for at least 3 months before joining the C-CMC. Both acute care use and health care spending were measured from the time the clinical pharmacist added MTS. The 3-month baseline period was used as a comparison to the ∼1-year period after the initiation of MTS. Acute care use was measured as ED visits per 1000 visits and hospitalizations per 1000 patient days. Percentage change in acute care use was determined by comparing use in the 3-month baseline period to the use during exposure to the clinical pharmacist intervention in the C-CMC. Health care spending was measured as the reimbursement paid by the C-CMC’s insurance to any health care entity, including hospital, home health care, and pharmacies. Health care spending was calculated as per member per month (PMPM) overall and for outpatient prescriptions. To determine estimates in the percentage change of total changes in health care spending (overall and for pharmacy), we calculated the difference in PMPM while the patient was exposed to the clinical pharmacist intervention from the PMPM during the 3-month baseline. To evaluate the satisfaction of parents and C-CMC team members, surveys were distributed to a convenience sample of 57 caregivers of C-CMC patients while in clinic and to all 23 C-CMC team members. The survey administered to caregivers asked them to select which services provided by the clinical pharmacist were most helpful: following-up on medications after hospitalization, ensuring safe use of medications, conducting MTS, customizing medication plans, and answering medication questions. The survey was also used to collect information on the length of time in the program, use of clinical pharmacy services offered, additional pharmacy services desired, and overall satisfaction with clinical pharmacy services on a Likert scale (1 = worst; 5 = best). Families placed the completed surveys in a designated survey box, to ensure anonymity, before leaving the clinic. In a similar manner, the survey administered to C-CMC team members asked them to rate the services of the clinical pharmacist: increasing patients’ adherence, reducing provider burnout, overcoming barriers to medication access, ensuring safe medication use, and providing patient education. For our fourth area of evaluation, MTS-associated medication changes, we calculated the percentage of C-CMC patients with MTS-associated changes by month over a 6-month period.

Approximately 1 year after implementation of MTS-specific services, 76 patients had been enrolled in insurance aligned with our ACO for at least 3 months before and after joining the C-CMC. Data obtained in December 2018 revealed that pre- and postenrollment, patients had decreased total spending, ED visits, and hospital days (−7%, −22%, and −55%, respectively). Data obtained in January 2020 revealed even more significant decreases in total spending, ED visits, and hospital days (−30%, −42%, and −76%, respectively). Thus, when comparing patient data for that first year to MTS-specific services, we found that data revealed patients had a 23% reduction in total costs, 20% reduction in ED visits, and 21% decrease in hospital days (Fig 1). Although outpatient prescription costs are still higher after enrolling in the C-CMC, outpatient prescription spending decreased by 5% after the initiation of the MTS-specific service (23% increase after enrollment for patients evaluated in December 2018 compared to an 18% increase in January 2020). When PMPM savings are extrapolated over a 12-month period for the number of patients included in the data, overall estimated savings are much greater than the annual salary and benefits for a clinical pharmacist (∼$150 000). However, we recognize that other non–pharmacy-related factors may have contributed to the reduction in health care spending and acute care use.

With regards to the impact of clinical pharmacist integration into C-CMC on satisfaction, 57 families were approached to complete satisfaction surveys, of which 15 surveys (26%) were returned. Most respondents (87%) had been established in the C-CMC for at least 1 year and had interacted with the pharmacist at a minimum of twice yearly before completing the survey. Ninety-four percent of respondents believed the program’s pharmacist improved their child’s health. All respondents rated their overall satisfaction (1 = worst; 5 = best) with the clinical pharmacist as 4 (20%) or 5 (80%). Families found the most value in the pharmacist’s ability to answer medication questions, create customized medication plans, and provide MTS (Fig 2). Among C-CMC team members, 10 individuals (43%) completed the survey. Team members found the most value in the pharmacist’s ability to ensure safety of medications, provide patient education and increase adherence, overcome potential barriers in accessing medications, and help with provider burnout (Fig 3).

In our examination of MTS-associated medication changes, pharmacist-driven MTS increased from 24% initially to 66.5% in 1 year for complex patients in our program. The clinical pharmacist initiated or modified 659 medications during a 6-month time period.

Pharmaceutical care is often compartmentalized into disease state or medication class. However, to optimize outcomes and quality of life in patients with complex conditions, it is important for health care teams to evaluate the whole patient, including all medications for all conditions. This holistic approach to medication management is vital to the care of CMC. Integrating clinical pharmacists into the medical home setting for CMC allows for collaboration that can focus on comprehensive outcomes across the continuum of care.

In our evaluation of the program described here, we found an increase in outpatient prescription costs after enrollment in the program. However, we also found a concomitant decrease in hospitalizations, ED visits, and overall health care spending. The integration of a clinical pharmacist into the C-CMC also received positive family and staff survey responses. Patients and families are key stakeholders in determining health care outcomes, so ensuring each finds value and empowerment in medication management is imperative. Additionally, with the increased risk of medication errors faced by CMC, the integration of clinical pharmacists may help reduce these errors while supporting health care team members.

Limitations to the results were the low response rate to our surveys; we cannot eliminate the possibility of response bias. Given the design of our evaluation, we are unable to demonstrate causation between the clinical pharmacist intervention and our use and health care spending outcomes. Additionally, we were not able to track aspects of prescription writing (such as errors in prescribing, time to completing refill request orders, and time to completion of prior authorization requests) to determine if pharmacist integration into the program positively impacted them.

The increased use and drug therapy–related risks of CMC necessitates immediate attention. Responsibility for medication management requires accountability and leadership in our patients’ care. The CMC program described here has developed a process that yields results by effectively managing patients’ medications across the continuum of care while also possibly improving health care spending and outcomes. The holistic, uncompartmentalized approach to medication management may be easily overlooked, yet it will be vital to the care for complex patients.

We thank Jeffrey Colvin, MD, JD; Nicholas Clark, MD; and Ingrid Larson, DNP, for their contributions.

All authors drafted the manuscript, reviewed and revised the manuscript, and approved the final manuscript as submitted.

FUNDING: No external funding.

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Competing Interests

POTENTIAL CONFLICT OF INTEREST: The authors have indicated they have no potential conflicts of interest to disclose.

FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.