Clinical Availability of ATRA for Patients With Suspected Acute Promyelocytic Leukemia: Why Guidelines May Not Be Followed

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  • 1 Division of Hematology and Medical Oncology, Department of Internal Medicine, Michigan Medicine and University of Michigan Medical School, Ann Arbor, Michigan;
  • | 2 Division of Hematology and Medical Oncology, Department of Internal Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin; and
  • | 3 Department of Pharmacy Services and Clinical Science, Michigan Medicine, and University of Michigan College of Pharmacy, Ann Arbor, Michigan.

Background: All-trans retinoic acid (ATRA) serves as the backbone of the management of patients with acute promyelocytic leukemia (APL), with guidelines recommending the initiation of ATRA as soon as APL is suspected. As a regional referral center for patients with acute leukemia, those who are suspected of having APL are often transferred to our facility. However, many referring centers are unable to initiate treatment using ATRA. We conducted an exploratory analysis of the clinical availability of ATRA and the factors limiting access to this critical drug. Patients and Methods: The United States was divided into 6 geographic regions: Northwest, Southwest, Central, Southeast, Northeast, and the Great Lakes. Twenty hospitals were randomly selected from states within each of these regions and were surveyed as to whether they typically treated patients with acute leukemia, the availability of ATRA at their institution, and reported reasons for not stocking ATRA (if not available). Results: Less than one-third of hospitals queried (31%) had ATRA in stock. Neither the size of the hospital nor the hospital’s status as academic versus nonacademic (53% vs 31%; P=.08) influenced ATRA availability. Of the hospitals that referred patients with APL, only 14% (7/49) had ATRA readily available. Hospitals that treated patients with APL were more likely to have ATRA available than referring centers (58% vs 14%; P=.000002). Conclusions: Nearly two-thirds of the hospitals surveyed that cared for patients with acute leukemia do not have ATRA immediately available. Moreover, the vast majority of hospitals that refer patients to other centers do not have ATRA. These findings should spur investigation into the impact of immediate ATRA availability on the morbidity and mortality of patients with APL. A call by hematologists nationwide to their formulary committees is warranted to ensure that this lifesaving medication is available to patients suspected of having APL.

Submitted August 26, 2020; final revision received January 4, 2021; accepted for publication January 23, 2021. Published online August 17, 2021.

Author contributions: Data collection and analysis: Bixby. Manuscript analysis, writing, and editing: All authors.

Disclosures: The authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.

Correspondence: Dale Bixby, MD, PhD, Division of Hematology and Medical Oncology, Department of Internal Medicine, Michigan Medicine and University of Michigan Medical School, F4811A University Hospital South, 1500 East Medical Center Drive, Ann Arbor, MI 48109. Email: dbixby@umich.edu
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