The impact of chemotherapy shortages on COG and local clinical trials: a report from the Children's Oncology Group.

TitleThe impact of chemotherapy shortages on COG and local clinical trials: a report from the Children's Oncology Group.
Publication TypeJournal Article
Year of Publication2015
AuthorsSalazar EG, M Bernhardt B, Li Y, Aplenc R, Adamson PC
JournalPediatr Blood Cancer
Volume62
Issue6
Pagination940-4
Date Published06/2015
ISSN1545-5017
KeywordsAntineoplastic Agents, Child, Clinical Trials as Topic, Humans, Neoplasms, Pharmacists
Abstract

BACKGROUND: Oncology drug shortage is associated with increased patient adverse events and decreased enrollment on clinical trials for adult patients; however, the impact of oncology drug shortages has not been well studied in children with cancer.

PROCEDURE: The Children's Oncology Group (COG) distributed a 5-item survey to 226 COG site-specific principal investigators (PI's) and 14-item survey to 161 COG pharmacists to gather data the impact of chemotherapeutic shortages on clinical trials and patient care.

RESULTS: The response rate was 66.4% (150/226) for PI's and 29.8% (48/161) for pharmacists. COG PI's reported daunorubicin (73%), methotrexate (56%), asparaginase/PEG-asparaginase (42%), doxorubicin (26%), thiotepa (21%), and cytarabine (20%) were most commonly in shortage, while COG pharmacists reported daunorubicin (80%), methotrexate (66%), vincristine (21%), thiotepa (41%), asparaginase/PEG-asparaginase (34%), and cytarabine (34%) were most commonly in shortage over the past two years. Pharmacists were twice as likely to report a shortage compared with PI's (OR 2.1, 95% CI: 1.6-2.7, Pā€‰<ā€‰0.0001). Fifty percent (74/147) of COG PI's reported at least one patient enrolled on a clinical trial was impacted by drug shortage, and 66% (98/148) of COG PI's reported at least one patient had clinical care impacted by drug shortage.

CONCLUSIONS: Chemotherapy shortages remain widespread across institutions, hinder clinical trials, and may contribute to adverse events in children with cancer. The increased frequency of chemotherapy shortages reported by pharmacists suggests that pharmacist efforts may mitigate negative impact chemotherapy shortages. Over half of pediatric institutions are implementing recommendations to address shortages, such as cross-institutional collaboration and center-level guidelines.

DOI10.1002/pbc.25445
Alternate JournalPediatr Blood Cancer
PubMed ID25704486
Grant ListU10 CA098543 / CA / NCI NIH HHS / United States
U10 CA180886 / CA / NCI NIH HHS / United States