Impact of Intravenous Opioid Shortage on Managing Pain Crisis in Sickle Cell Disease
Authors: Han Jin , Saraf Santosh L. , Gowhari Michel , Hussain Faiz Ahmed , Jain Shivi , Kavoliunaite Laura , Molokie Robert E. , Gordeuk Victor R 
Published: November 2019

Background: Vaso-occlusive crisis (VOC) is the hallmark complication of sickle cell disease (SCD) (1), and usually requires intravenous (IV) opioid treatment in emergency room (ER) or acute care center (ACC), a designated observation unit to manage uncomplicated VOC (2). Starting October 2017, there was a critical nationwide drug shortage in parental hydromorphone, a commonly used medication to treat VOC. In April 2018 the University of Illinois Health System (UI Health) adopted a standardized pain management protocol that limited opioids in the ER or ACC to two doses of IV or IM morphine and/or oral opioid. This study evaluates the impact of this standardized pain management protocol on managing VOC in SCD. Methods: A total of 373 SCD adults treated at UI Health from May 2017 to Oct 2018 had at least one ER or ACC visit or hospitalization for VOC. Data on VOC-related patient visits to the ACC, ER, and admissions to the inpatient floors were collected from the electronic medical record and evaluated based on three time periods (prior to shortage: May 2017-Oct 2017; transition: Oct 2017-Apr 2018; and post protocol: Apr 2018-Oct 2018). Descriptive statistics, the Cochrane trend test and Jonckheere-Terpstra trend test were used for data analysis. The study was approved by the Institutional Review Board prior to the initiation of chart review. Results: Between May 2017 and Oct 2018, the 373 SCD adult patients had a total of 1,915 ACC, 2,635 ER and 1,832 inpatient visits. After implementation in April 2018, the compliance rate with the standardized pain protocol was 99.7% in the ACC and 85.1% in the ER. In the ACC, the number of visits decreased after standardized pain protocol implementation, whereas the number of visits increased in the ER (Figure 1). The admission rate to the inpatient service from the ACC increased significantly while the admission rate from the ER remained relatively stable (Table 1). The numbers of opioid doses and the total opioid dose to treat VOC decreased in the ACC, but not in ER. Utilization of oral opioids increased in both settings (Table 1). The number of inpatient hospitalizations increased with implementation of the standardized protocol (542 vs. 626 vs. 664), and the 30-day readmission rate increased (49% vs. 51% vs. 57%, p = 0.003), but the length of hospital stay was reduced (p < 0.001). Summary: Implementation of a standardized pain treatment protocol due to the parenteral hydromorphone shortage decreased the utilization of the ACC compared to the ER and the inpatient service, and resulted in reduced opioid dose but increased admission rates from the ACC. The 30-day readmission rate to inpatient service increased but the length of stay was reduced. A standardized pain protocol that limits opioids to two doses in the acute setting may not be an optimal approach. Reference: F. B. Piel, M. H. Steinberg, D. C. Rees, Sickle Cell Disease. N Engl J Med376, 1561-1573 (2017).J. Han et al., Program expansion of a day hospital dedicated to manage sickle cell pain. Am J Hematol93, E20-E21 (2018).

Disclosures
Saraf: Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Research Funding. Gordeuk:CSL Behring: Consultancy, Honoraria, Research Funding; Global Blood Therapeutics: Consultancy, Honoraria, Research Funding; Novartis: Consultancy, Honoraria, Research Funding; Modus Therapeutics: Consultancy, Honoraria; Imara: Research Funding; Ironwood: Research Funding; Inctye: Research Funding; Pfizer: Research Funding; Emmaus: Consultancy, Honoraria.