A quality improvement project to address the challenges surrounding zoledronic acid use in children

Abstract

Introduction: Zoledronic acid (ZA) is an intravenous bisphosphonate used to treat pediatric osteoporosis. Adverse events including hypocalcemia and acute phase reaction (APR) are common following first-infusion. The purpose of this report is to describe implementation of a ZA clinical practice guideline and the subsequent process changes to improve adherence to aspects of the protocol related to safety and efficacy.

Methods: Quality assurance was evaluated by chart review over a 5-year period to compare the prevalence of hypocalcemia and APR to published data. A quality improvement (QI) initiative consisting of process changes including the addition of an endocrine RN to coordinate infusions and a shift to patient/family self-scheduling of infusions was conducted. The effect of the interventions on safety (completion of pre- and post-infusion bloodwork) and efficacy (receipt of all prescribed infusions) outcomes was evaluated.

Results: Seventy-two patients received 244 infusions over the period. The frequency of hypocalcemia (22%) and APR (31%) was consistent with prior reports. 99% of patients received pre-infusion bloodwork, 78% received post-first-infusion bloodwork, and 47% received all prescribed infusions. QI initiatives increased the percentage of patients receiving post-first-infusion bloodwork from 67 to 79% and those receiving all infusions from 62 to 74%, but fell short of the goal of 90%.

Conclusions: The implementation of a standardized protocol for ZA use in children was successful in confirming patient eligibility with pre-infusion bloodwork but failed to ensure that patients obtained post-first-infusion bloodwork and received all prescribed infusions. Further efforts to systematize the management of children on ZA are needed.

Keywords: Bisphosphonates; Osteoporosis; Quality assessment; Quality improvement; Zoledronic acid.

Fig. 1

Effect of sequential quality improvement initiatives on adherence to safety and efficacy outcomes in children on zoledronic acid therapy. The percentage of patients that received post-first-infusion bloodwork (to assess for hypocalcemia) within 72 h of infusion increased non-significantly from 67% to a maximum of 79% after the second intervention, the percentage of patients receiving all prescribed zoledronic acid infusion increased non-significantly from 62% to a maximum of 74% after the first intervention. The percentage of patients that had documentation of acceptable pre-infusion bloodwork and vitamin D sufficiency remained > 90% across the entire time period. n denotes denominator for each time period