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

Salazar, Elizabeth; Bernhardt, M. Brooke; Li, Yimei; Aplenc, Richard; Adamson, Peter C.

doi:10.1002/pbc.25445

Cited by 20 publications

(31 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Whether these findings are applicable to idiopathic uveitis patients is less clear. Other factors that may influence medication selection were not able to be captured in our study; these include patient preference, concerns about medication compliance, and regional availability of injectable methotrexate due to drug shortages [ 45 ].…”

Section: Discussionmentioning

confidence: 99%

Medication use in juvenile uveitis patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Registry

et al. 2016

View full text Add to dashboard Cite

BackgroundThere is not yet a commonly accepted, standardized approach in the treatment of juvenile idiopathic uveitis when initial steroid therapy is insufficient. We sought to assess current practice patterns within a large cohort of children with juvenile uveitis.MethodsThis is a cross-sectional cohort study of patients with uveitis enrolled in the Childhood Arthritis and Rheumatology Research Alliance (CARRAnet) registry. Clinical information including, demographic information, presenting features, disease complications, and medications were collected. Chi-square and Fisher’s exact tests were used to assess for associations between medications and clinical characteristics.ResultsNinety-two children with idiopathic and 656 with juvenile idiopathic arthritis (JIA)-associated uveitis were identified. Indication (arthritis or uveitis) for medication use was not available for JIA patients; therefore, detailed analysis was limited to children with idiopathic uveitis. In this group, 94 % had received systemic steroids. Methotrexate (MTX) was used in 76 % of patients, with oral and subcutaneous forms given at similar rates. In multivariable analysis, non-Caucasians were more likely to be treated initially with subcutaneous MTX (P = 0.003). Of the 53 % of patients treated with a biologic DMARD, all received a tumor necrosis factor (TNF) inhibitor. TNF inhibitor use was associated with a higher frequency of cataracts (52 % vs 21 %; P = 0.001) and antinuclear antibody positivity (49 % vs 29 %; P = 0.04), although overall complication rates were not higher in these patients.ConclusionAmong idiopathic uveitis patients enrolled in the CARRAnet registry, MTX was the most commonly used DMARD, with subcutaneous and oral forms equally favored. Patients who received a TNF inhibitor were more likely to be ANA positive and have cataracts.Electronic supplementary materialThe online version of this article (doi:10.1186/s12969-016-0069-5) contains supplementary material, which is available to authorized users.

show abstract

Section: Discussionmentioning

confidence: 99%

Medication use in juvenile uveitis patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Registry

et al. 2016

View full text Add to dashboard Cite

show abstract

“…Combined with prior research demonstrating that these treatments in shortage have led directly to regimen and dosage changes as well as treatment delays, our findings suggest that these shortages remain a significant public health concern for a broad range of cancer patients. 4,36,37 These findings identify the continued need for the FDA and partnering organizations to work with suppliers to prevent new shortages and mitigate those that are not preventable by understanding the underlying contributors to these shortages. 2 The original motivation for this study was to understand how a proposed approach to reduce these shortages, by promoting more suppliers for first-line antineoplastics, might helpto alleviate newshortages.…”

Section: Discussionmentioning

confidence: 99%

ReCAP: Association Between the Number of Suppliers for Critical Antineoplastics and Drug Shortages: Implications for Future Drug Shortages and Treatment

Parsons

Schmidt

Karnad

et al. 2016

JOP

View full text Add to dashboard Cite

QUESTION ASKED: Cancer drug shortages remain common in the United States and may force oncologists to prioritize patients for treatment, improvise standard treatment regimens, and potentially choose unproven treatment options for patients with curable disease. Because increased competition may reduce drug shortages, the objective of our study was to investigate the association between the number of suppliers for first-line breast, colon, and lung antineoplastics and resulting drug shortages.SUMMARY ANSWER: Among 35 antineoplastic drugs approved for first-line treatment of breast, colon, and lung cancer, we saw an overall increase in drug shortages over time (12.5%, 33.3%, and 0% of breast, colon, and lung cancer drugs experienced shortages in 2003 v 40.0%, 37.5%, and 54.5% in 2014). Having a small number of drug suppliers more than doubled the odds of shortages compared with a large number of suppliers (five or more, Table 1), although the results were only statistically significant with three to four suppliers (odds ratio 5 2.6; P 5 .049) but not with one to two suppliers (odds ratio 5 3.49; P 5 .105); however, one of the strongest risk factors for drug shortages was the age of the drug, with older drugs significantly more likely to experience shortages (P , .001). METHODS:Using the 2003-2014 Redbook and national drug shortage data from the University of Utah's Drug Information Service, we used exploratory analysis and generalized mixed models to (1) quantify time trends in first-line drug suppliers and shortages by cancer site and (2) examine the association between the number of suppliers for individual drugs and resulting drug shortages. BIAS, CONFOUNDING FACTOR(S), DRAWBACKS:Although our study provides insights into the relationship between suppliers and drug shortages, we acknowledge the following drawbacks: (1) Information about the supply chain of raw materials, which may affect drug shortages, was not available. (2) As a result of sample size limitations, we were unable to conduct stratified analysis by cancer site. (3) As there is no regulatory requirement to disclose the manufacturer of a product, we could not distinguish drug suppliers from manufacturers as many suppliers participate in contract manufacturing. Despite these limitations, our analysis provides initial insights into the complicated relationship between drug shortages for first-line cancer treatment and the number of companies supplying these drugs. REAL-LIFE IMPLICATIONS:We found that having few drug suppliers (three to four) was associated with increased likelihood of shortages compared with having a large number (five or more) of suppliers, but the relationship was nonlinear. However, we saw that older drugs were the most likely to experience drug shortages. This suggests that policies focused predominately on promoting increases in distinct suppliers and competition may not alleviate shortages of critical cancer drugs. Given the continued Original Contribution HEALTH POLICY Original Contribution HEALTH POLICY significant impact of th...

show abstract

“…Several groups have begun to address drug shortages in pediatric oncology. The Working Group on Drug Shortages in Pediatric Oncology has created recommendations for responding to drug shortages, COG gives guidelines for management of shortages within treatment protocols, the American Society of Health-System Pharmacists has provided guidelines and recommendations, and the American Board of Pediatrics, American Society of Clinical Oncology, and American Society of Pediatric Hematology/Oncology have provided commentary and position statements[ 6 , 7 , 11 , 16 ]. However, given the continued prevalence of drug shortages and their widespread impact, a continued coordinated effort is needed to ensure consistency and provide guidance for implementation.…”

Section: Discussionmentioning

confidence: 99%

Physician approaches to drug shortages: Results of a national survey of pediatric hematologist/oncologists

Beck

Chen

Gordon

2017

WJCO

View full text Add to dashboard Cite

AIMTo evaluate personnel involved in scarce drug prioritization and distribution and the criteria used to inform drug distribution during times of shortage among pediatric hematologists/oncologists.METHODSUsing the American Society of Pediatric Hematology/Oncology (ASPHO) membership list, a 20 question survey of pediatric hematologists/oncologists was conducted via email to evaluate personnel involved in scarce drug prioritization and distribution and criteria used to inform scarce drug distribution.RESULTSNearly 65% of the 191 study respondents had patients directly affected by drug shortages. Most physicians find out about shortages from the pharmacist (n = 179, 98%) or other doctors (n = 75, 41%). One third of respondents do not know if there is a program or policy for handling drug shortages at their institution. The pharmacist was the most commonly cited decision maker for shortage drug distribution (n = 128, 70%), followed by physicians (n = 109, 60%). One fourth of respondents did not know who makes decisions about shortage drug distribution at their institution. The highest priority criterion among respondents was use of the shortage drug for curative, rather than palliative intent and lowest priority criterion was order of arrival or first-come first-served.CONCLUSIONDespite pediatric hematology/oncology physicians and patients being heavily impacted by drug shortages, institutional processes for handling shortages are lacking. There is significant disparity between how decisions for distribution of shortage drugs are currently made and how study respondents felt those decisions should be made. An institution-based, and more importantly, a societal approach to drug shortages is necessary to reconcile these disparities.

show abstract

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

Cited by 20 publications

References 9 publications

Medication use in juvenile uveitis patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Registry

Medication use in juvenile uveitis patients enrolled in the Childhood Arthritis and Rheumatology Research Alliance Registry

ReCAP: Association Between the Number of Suppliers for Critical Antineoplastics and Drug Shortages: Implications for Future Drug Shortages and Treatment

Physician approaches to drug shortages: Results of a national survey of pediatric hematologist/oncologists

Contact Info

Product

Resources

About