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Roth K, Darwish C, Keller MD, Hammer B, Ahmed-Winston S, Escalante E, Madrigal V, Patrick D, Diab Y, Grant C, Hanisch B, Kahn I, Khan S, Moudgil A, Wistinghausen B. Implementation of a tier system for IVIG indications to address IVIG shortage at a tertiary care pediatric medical center. Pediatr Blood Cancer 2024; 71:e30871. [PMID: 38279890 DOI: 10.1002/pbc.30871] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2023] [Revised: 12/15/2023] [Accepted: 01/02/2024] [Indexed: 01/29/2024]
Abstract
BACKGROUND Drug shortages are a common issue that healthcare systems face and can result in adverse health outcomes for patients requiring inferior alternate treatment. The United States recently experienced a national drug shortage of intravenous immunoglobulin (IVIG). Several reported strategies to address the IVIG and other drug shortages have been proposed; however, there is a lack of evidence-based methods for protocol development and implementation. OBJECTIVE To evaluate the efficacy of introducing a multidisciplinary task force and tier system of indications and to minimize adverse effects during a shortage of IVIG. METHODS Faculty members across disciplines with expertise in IVIG use were invited to participate in a task force to address the shortage and ensure adequate supply for emergent indications. A tier system of IVIG indications was established according to the severity of diagnosis, urgency of indication, and quality of supporting evidence. Based on inventory, indications in selected tiers were auto-approved. Orders that could not be automatically approved were escalated for task force review. RESULTS Overall, there were 342 distinct requests for IVIG during the study period (August 1, 2019 to December 31, 2019). All Tier 1 indications were approved. Of all requests, only 2.6% (9) of requests were denied, none of which resulted in adverse effects based on retrospective chart review. Seven patients who regularly receive IVIG had possible adverse effects due to dose reduction or spacing of treatment; however, each complication was multifactorial and not attributed to the shortage or tier system implementation alone. CONCLUSION Implementation of a multidisciplinary task force and tier system to appropriately triage high-priority indications for limited pharmaceutical agents should be considered in health institutions faced with a drug shortage.
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Affiliation(s)
- Kristina Roth
- Department of Pediatrics, Children's National Hospital, Washington, District of Columbia, USA
| | - Christina Darwish
- Department of Pediatrics, Children's National Hospital, Washington, District of Columbia, USA
| | - Michael D Keller
- Division of Allergy & Immunology, Children's National Hospital, Washington, District of Columbia, USA
| | - Benjamin Hammer
- Department of Pharmacy, Children's National Hospital, Washington, District of Columbia, USA
| | - Sameeva Ahmed-Winston
- Division of Blood and Marrow Transplantation, Children's National Hospital, Washington, District of Columbia, USA
| | - Enrique Escalante
- Division of Hospital Medicine, Children's National Hospital, Washington, District of Columbia, USA
| | - Vanessa Madrigal
- Division of Intensive Care, Children's National Hospital, Washington, District of Columbia, USA
| | - DiAnthia Patrick
- Department of Pediatrics, Children's National Hospital, Washington, District of Columbia, USA
| | - Yaser Diab
- Division of Hematology & Oncology, Children's National Hospital, Washington, District of Columbia, USA
| | - Christina Grant
- Division of Genetics, Children's National Hospital, Washington, District of Columbia, USA
| | - Benjamin Hanisch
- Division of Infectious Diseases, Children's National Hospital, Washington, District of Columbia, USA
| | - Ilana Kahn
- Division of Neurology, Children's National Hospital, Washington, District of Columbia, USA
| | - Sairah Khan
- Division of Cardiology, Children's National Hospital, Washington, District of Columbia, USA
| | - Asha Moudgil
- Division of Nephrology, Children's National Hospital, Washington, District of Columbia, USA
| | - Birte Wistinghausen
- Division of Blood and Marrow Transplantation, Children's National Hospital, Washington, District of Columbia, USA
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Jenei K, Lythgoe MP, Vokinger KN. Shortages of essential cancer medicines: who is responsible and what are the possible solutions? Lancet Oncol 2024; 25:23-26. [PMID: 38181805 DOI: 10.1016/s1470-2045(23)00470-9] [Citation(s) in RCA: 5] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/06/2023] [Accepted: 09/14/2023] [Indexed: 01/07/2024]
Affiliation(s)
- Kristina Jenei
- London School of Economics, and Political Science, London WC2A 2AE, UK.
| | - Mark P Lythgoe
- Department of Surgery and Cancer, Imperial College London, Hammersmith Hospital, London, UK
| | - Kerstin N Vokinger
- Faculty of Law and Faculty of Medicine, University of Zurich, Zurich, Switzerland
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Part I: Interactive case: Management of urgent drug shortages. JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY 2022. [DOI: 10.1002/jac5.1726] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
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Kidszun A, Forth FA, Matheisl D, Busch F, Kaltbeitzel L, Kurz S. Ethics education in pediatrics: Implementation and evaluation of an interactive online course for medical students. GMS JOURNAL FOR MEDICAL EDUCATION 2022; 39:Doc55. [PMID: 36540566 PMCID: PMC9733484 DOI: 10.3205/zma001576] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Subscribe] [Scholar Register] [Received: 02/10/2022] [Revised: 08/04/2022] [Accepted: 09/01/2022] [Indexed: 06/17/2023]
Abstract
INTRODUCTION The COVID-19 pandemic has catalyzed the development of online learning formats in virtually all areas of medical education. In pediatric ethics, online learning may not only substitute but also offer specific advantages over traditional classroom teaching. Many pediatricians rate their ethics education as poor and medical ethics education lacks evaluation, especially regarding the students' needs. The aim of this project was to implement and evaluate a novel interactive distance learning approach to engage medical students in pediatric ethics education. METHODS An online ethics course was designed and delivered between May and June 2020. Core item of this course was a moderated, written forum discussion spanning several days. Evaluation was mixed methods. We evaluated the effectiveness of the course in terms of quality of the learning environment with a particular focus on relevance to students as well as interactive learning and reflective thinking. The Constructivist On-Line Learning Environment Survey (COLLES) was used to evaluate six different domains of the course. Data are presented as mean (standard deviation [SD]). The respective score range is 1-5, whereby a score of 4 or 5 means that the participants indicated the corresponding item as frequently or almost always present. RESULTS Responses were available from 104 (78.3%) of the 133 participating students. "Relevance" yielded a score of 4.17 (0.83), "reflective thinking" a score of 4.22 (0.83). "Interactivity" was scored 3.76 (0.99) and "tutor support" 4.72 (0.53). "Peer support" and "interpretation" scored 3.87 (0.98) and 4.49 (0.60), respectively. In qualitative analysis, students particularly valued the structure of the course, the relevance for their professional practice, their active participation and the incentive to reflective thinking. Students also indicated that this was an innovative and exciting format, which fills a current educational gap and should hence be continued beyond the pandemic. CONCLUSION In conclusion, students actively engaged in online learning and perceived this ethics course as highly relevant for their professional practice.
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Affiliation(s)
- André Kidszun
- Johannes Gutenberg-University Mainz, University Medical Center, Department of Pediatric and Adolescent Medicine, Division of Neonatology, Germany
- University of Bern, Bern University Hospital, Inselspital, Department of Paediatrics, Division of Neonatology, Bern, Switzerland
| | - Fiona A. Forth
- Johannes Gutenberg-University Mainz, University Medical Center, Institute for the History, Philosophy and Ethics of Medicine, DFG-Research Training Group “Life Sciences – Life Writing”, Mainz, Germany
| | - Daniel Matheisl
- Medical Center-University of Freiburg, Center for Pediatrics, Department of Neonatology and Pediatric Intensive Care, Freiburg im Breisgau, Germany
| | - Franziska Busch
- University of Bern, Bern University Hospital, Inselspital, Department of Paediatrics, Division of Neonatology, Bern, Switzerland
| | - Lara Kaltbeitzel
- Johannes Gutenberg-University Mainz, University Medical Center, Rudolf Frey Lernklinik, Mainz, Germany
| | - Sandra Kurz
- Johannes Gutenberg-University Mainz, University Medical Center, Rudolf Frey Lernklinik, Mainz, Germany
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Donnelly KA, Zocchi MS, Katy TA, Fox ER, Pines JM, van den Anker JN, Mazer-Amirshahi ME. Prescription Drug Shortages: Pediatric Emergency and Critical Care Medications. Pediatr Emerg Care 2021; 37:e726-e731. [PMID: 30829846 DOI: 10.1097/pec.0000000000001773] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
OBJECTIVES Drug shortages have been increasing over the past 2 decades. There are limited data on drug shortages and their effect on pediatric emergency and critical care. Our objective was to describe pediatric emergency and critical care drug shortages. METHODS Drug shortage data from January 2001 to December 2015 were obtained from the University of Utah Drug Information Services. Shortages were reviewed, identifying agents used in pediatric emergency and critical care. Shortage data were analyzed for the type of drug, formulation, shortage reason, duration, marketing status (generic vs brand name), or if it was a pediatric-friendly formulation, used for a high-acuity condition, or a single-source product. The availability of a substitute was also described. RESULTS Of 1883 products on shortage, 779 were used in pediatric emergency or critical care. The annual number of shortages decreased from 2001 to 2004, but then increased, reaching a high in 2011. The median duration for resolved shortages was 7.6 months (interquartile range, 3.0-17.6 months). The most common category affected was infectious disease drugs. High-acuity agents were involved in 27% of shortages and in 11% of pediatric-friendly formulations. An alternative agent was available for 95% of drugs, yet 43% of alternatives were also affected at some time during the study period. The most common reported reason for a shortage was manufacturing problems. CONCLUSIONS From 2001 to 2015, drug shortages affected a substantial number of agents used in pediatric emergency and critical care. This has had implications to the medications available for use and may impact patient outcomes. Providers must be aware of current shortages and implement mitigation strategies to optimize patient care.
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Affiliation(s)
| | | | - Tamara A Katy
- MedStar Georgetown University Hospital, Washington, DC
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Moss JD, Schwenk HT, Chen M, Gaskari S. Drug Shortage and Critical Medication Inventory Management at a Children's Hospital During the COVID-19 Pandemic. J Pediatr Pharmacol Ther 2021; 26:21-25. [PMID: 33424496 DOI: 10.5863/1551-6776-26.1.21] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/27/2020] [Accepted: 10/14/2020] [Indexed: 11/11/2022]
Abstract
Drug shortages have significantly affected the ability to provide care at pediatric institutions, particularly in the inpatient and critical care settings. The coronavirus disease 2019 (COVID-19) pandemic highlighted additional challenges with drug supply chains. A working group consisting of pharmacy management, clinical pharmacists, and pharmacy buyers met regularly at the beginning of the COVID-19 pandemic. In collaboration with medical staff leadership and the Pharmacy and Therapeutics Committee, we developed a pediatric critical drug list to track essential medications for targeted monitoring. We created an inventory model with easily modifiable input variables related to patient and hospital data. This model was aligned across affiliate health care systems to increase transparency of our hospital's surge capacity for managing patients with COVID-19. Here, we share our framework for modeling drug inventory management at a freestanding children's hospital during a global pandemic.
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Nakamura ZM, MacKay DP, Davis AM, Brassfield ER, Joyner BL, Rosenstein DL. Reconsidering scarce drug rationing: implications for clinical research. JOURNAL OF MEDICAL ETHICS 2020; 47:medethics-2020-106739. [PMID: 33246996 DOI: 10.1136/medethics-2020-106739] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/24/2020] [Revised: 10/15/2020] [Accepted: 10/27/2020] [Indexed: 06/12/2023]
Abstract
Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: (1) clinical use may not have stronger evidence than research use; (2) a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; (3) treatment within the context of a clinical trial may be the standard of care; and (4) research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation.
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Affiliation(s)
- Zev M Nakamura
- Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | - Douglas P MacKay
- Public Policy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Center of Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | - Arlene M Davis
- Center of Bioethics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | - Elizabeth R Brassfield
- Philosophy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- University of North Carolina at Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA
| | - Benny L Joyner
- Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Anesthesiology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | - Donald L Rosenstein
- Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
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Martei YM, Iwamoto K, Barr RD, Wiernkowski JT, Robertson J. Shortages and price variability of essential cytotoxic medicines for treating children with cancers. BMJ Glob Health 2020; 5:bmjgh-2020-003282. [PMID: 33173011 PMCID: PMC7656942 DOI: 10.1136/bmjgh-2020-003282] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/29/2020] [Revised: 08/14/2020] [Accepted: 08/28/2020] [Indexed: 11/30/2022] Open
Abstract
Introduction Low-income and middle-income countries (LMICs) face the largest burden of mortality from childhood cancers with limited access to curative therapies. Few comparative analyses across all income groups and world regions have examined the availability and acquisition costs of essential medicines for treating cancers in children. Methods A cross-sectional survey involved countries in five income groups—low-income (LIC), lower-middle-income (LMC), upper-middle-income (UMC), two high-income country groups (HIC1, HIC2). Physicians and pharmacists reported institutional use, availability, stock outs and prices (brand and generic products) of 34 essential medicines. Price comparisons used US$, applying foreign exchange rates (XR) and purchasing power parity (PPP) adjustments. Medicine costs for treating acute lymphoblastic leukaemia (ALL), Burkitt lymphoma (BL) and Wilms tumour (WT) were calculated (child 29 kg, body surface area 1 m2). Comparisons were conducted using non-parametric Kruskal-Wallis tests. Results Fifty-eight respondents (50 countries) provided information on medicine use, availability and stock outs, with usable price data from 42 facilities (37 countries). The extent of use of International Society of Paediatric Oncology core and ancillary medicines varied across income groups (p<0.0001 and p=0.0002 respectively). LMC and LIC facilities used fewer medicines than UMC and HIC facilities. UMC and LMC facilities were more likely to report medicines not available or stockouts. Medicine prices varied widely within and between income bands; generic products were not always cheaper than brand equivalents. PPP adjustment showed relatively higher prices in UMC and LMC facilities for some medicines. Medicine costs were highest in HICs for ALL (p=0.0075 XR; p=0.0178 PPP-adjusted analyses) and WT (p =<0.0001 XR; p=0.0007 PPP-adjusted). Medicine costs for BL were not significantly different. Conclusion Problems with the availability of essential medicines, dependable supply chains, confidential medicine prices and wide variability in treatment costs contribute to persistent challenges in the care of children with treatable cancers, especially in LMICs.
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Affiliation(s)
- Yehoda M Martei
- Hematology - Oncology Division, University of Pennsylvania, Philadelphia, Pennsylvania, USA
| | - Kotoji Iwamoto
- Health Technology and Pharmaceuticals Programme, World Health Organization Regional Office for Europe, Copenhagen, Denmark
| | - Ronald D Barr
- Pediatric Haematology/Oncology, McMaster University and McMaster Children's Hospital, Hamilton, Ontario, Canada
| | - John T Wiernkowski
- Pediatric Haematology/Oncology, McMaster University and McMaster Children's Hospital, Hamilton, Ontario, Canada
| | - Jane Robertson
- Health Technology and Pharmaceuticals Programme, World Health Organization Regional Office for Europe, Copenhagen, Denmark.,Clinical Pharmacology, University of Newcastle, Waratah, New South Wales, Australia
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A two-stage fuzzy optimization model for scarce drugs supply and ration planning under uncertainty: A case study. Appl Soft Comput 2019. [DOI: 10.1016/j.asoc.2019.105514] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
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Beck JC, Chen B, Gordon BG. Physician approaches to drug shortages: Results of a national survey of pediatric hematologist/oncologists. World J Clin Oncol 2017; 8:336-342. [PMID: 28848700 PMCID: PMC5554877 DOI: 10.5306/wjco.v8.i4.336] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/31/2016] [Revised: 05/04/2017] [Accepted: 07/17/2017] [Indexed: 02/06/2023] Open
Abstract
AIM To 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.
METHODS Using 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.
RESULTS Nearly 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.
CONCLUSION Despite 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.
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Russell HV, Bernhardt MB, Berg S. Using decision modeling to guide drug allocation during a shortage. Pediatr Blood Cancer 2017; 64. [PMID: 27862980 DOI: 10.1002/pbc.26331] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/17/2016] [Revised: 10/11/2016] [Accepted: 10/14/2016] [Indexed: 01/24/2023]
Abstract
BACKGROUND Drug shortages require clinical teams to decide how to allocate drugs in limited supply among their patients. Ethical frameworks are invaluable for promoting rational approaches to drug distribution, but gaps remain between ethical theory and clinical application. The goal of this work was to explore how decision modeling could supplement ethical frameworks to inform drug distribution from the perspective of a clinical team. PROCEDURE We created a hypothetical pediatric oncology clinic with a limited supply of 50,000 mg of methotrexate (MTX) and 21 patients due for treatment on one of six regimens. We constructed a simple decision analytic model to compare the effectiveness of MTX in milligrams per life year saved for each regimen. The robustness of the model was tested under various conditions including alternative drug effectiveness and time horizons. Effects on outcomes and distribution by substituting alternative dosing were explored for each regimen. RESULTS Prescribed therapy for this group of patients required 108,791 mg MTX. Two regimens for three patients required ≥20,000 mg/m2 . If distributed in order of arrival, only seven patients could receive full treatment. If distributed in order of efficiency, 19 patients could receive treatment. If less effective regimens were substituted, 20 patients could receive treatment. The primary driver of efficiency was dose per square meter. CONCLUSIONS In this hypothetical drug shortage, no allocation scenario exists that does not result in a worse outcome for some patients. Evidence of drug efficacy affected the decisions to substitute alternative treatments. First-come-first-served allocation resulted in fewer patients receiving treatment than allocation based on efficiency.
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Affiliation(s)
- Heidi V Russell
- Texas Children's Cancer Center, Baylor College of Medicine, Houston, Texas.,Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas
| | | | - Stacey Berg
- Texas Children's Cancer Center, Baylor College of Medicine, Houston, Texas.,Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas
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