Understanding the Impact of Drug Shortages on Oncology Care Delivery

Overview

This trial studies the impact of drug shortages on oncology care delivery. Gathering information about cancer drug shortages over time may help researchers improve access to drugs during times of shortages.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: January 1, 2023

Detailed Description

PRIMARY OBJECTIVES: I. To prospectively estimate the proportion of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs. SECONDARY OBJECTIVES: I. To prospectively estimate the rate of cancer care delivery problems attributable to a drug shortage of infusional therapeutic oncology drugs for patient populations treated with: a) all cancer drugs, b) all cancer drugs in shortage, and c) each individual cancer drug in shortage. II. To assess strategies practices used during drug shortages (e.g., manage costs, stockpile, hire staff). TERTIARY OBJECTIVES: I. To assess practice factors (e.g., case mix, size, practice type) associated with the likelihood that a practice reports cancer care delivery problems. II. To describe how practice-level strategies in response to drug shortages vary by practice characteristics. III. To describe the possible effects on clinical trials (e.g., unable to enroll a patient or changing to an alternative treatment). IV. To characterize cancer care delivery problems attributable to a shortage of supportive care agents. V. To characterize cancer care delivery problems attributable to a shortage of oral anti-cancer agents. OUTLINE: Practice sites complete a Baseline Drug Shortage Survey, Drug Shortage Incident Reports in real time as cancer care delivery problems occur, and the Quarterly Follow-Up Survey every 3 months for one year (4 total).

Interventions

  • Other: Survey Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Health Services Research (surveys about drug shortages)
    • At baseline, practice sites complete a Baseline Drug Shortage Survey and Pharmacy Baseline Survey; Drug Shortage Incident Reports are completed in real time as cancer care delivery problems occur; and the Quarterly Follow-Up Survey Number Treated Report every 3 months for one year (4 total).

Clinical Trial Outcome Measures

Primary Measures

  • Proportion of NCORP community practices that experience a cancer care delivery problem attributable to a drug shortage of infusional therapeutic oncology drugs
    • Time Frame: Baseline up to 12 months
    • Each incident is defined by the drug in shortage and by each cancer care delivery decision (e.g., whenever a recommended treatment plan is developed). All incidents are collected de-identified and aggregated to the practice site. For each drug in shortage during the year (4 quarters) of observation, will determine the number of practices reporting a care delivery problem due to each drug during any quarter and total number of practices treating patients with the drug during any quarter. Will calculate the proportion of affected practices among practices treating patients with the drug as the ratio of these two numbers. Will calculate mean, median, range and evaluate the shape of the distribution of drug specific estimates.
  • Change to less effective treatment
    • Time Frame: Up to 12 months
    • Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a “change” for this study. The determination of “less effective” will be made by the primary oncology team. “Less effective” treatments can include those that are not the best options per guidelines through the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and other organizations that establish guidelines for oncology care. Given that the primary oncology team is in charge of the patient’s care, they will determine if they think the “change” is “less effective” based on their understanding of the patient’s diagnosis and clinical situation.
  • Change to more toxic treatment
    • Time Frame: Up to 12 months
    • Assessed with the Drug Shortage Incident Report. When the primary oncology team is developing a recommended treatment plan and the preferred drug is in shortage, even if the patient never was treated with the drug in shortage, this is considered a “change” for this study. The practice site staff will verify with the primary oncology team that they perceive this cancer care delivery issue (e.g., change to another drug) to be more toxic than what was intended. Whether the “change” led to a more toxic treatment or regimen will be determined by the primary oncology team. Teams can utilize their pharmacy staff to help determine if the new treatment or regimen has data to support that it would lead to higher toxicity.
  • Delay in treatment
    • Time Frame: Up to 12 months
    • Assessed with the Drug Shortage Incident Report. Each incident is defined by the drug in shortage and by each cancer care delivery decision (e.g., whenever a recommended treatment plan is developed). Any time there is a change to a treatment regimen due to a drug shortage, the primary oncology team should determine whether or not they perceive this change to be a problem for a patient. When there is a drug shortage that results in a potential issue (e.g., missed dose), the practice site staff will verify with the primary oncology team that they actually perceived this cancer care delivery issue as a problem. The same patient may experience multiple cancer care delivery problems over the course of their treatment. Each of these problems should be reported, de-identified, as separate incidents as they occur.
  • Medication error/near miss
    • Time Frame: Up to 12 months
    • Assessed with the Drug Shortage Incident Report. When there is a shortage of oncology drugs and there is a change in dose, administration, or drug, there can be medication errors in dose or concentration (e.g., drug was supposed to be diluted, but is not). A near miss is when the primary oncology team identifies a potential medication error but the drug was not administered to the patient. Oncology teams should rely on pharmacy staff to help identify and define medication errors and near misses.

Secondary Measures

  • Rate of cancer care delivery problems (CCDPs)
    • Time Frame: Up to 12 months
    • For each quarter and every practice, using the Quarterly Follow-Up Survey, will evaluate the rate of CCDPs as the total number of the reported CCDP incidents (numerator) per number of patients treated (denominator). To estimate the numerator, will sum numbers of reported incidents across all drugs in shortage documented in the Infusional Chemotherapy Incident Report. The total number of patients treated within the practice in the quarter (Quarterly Follow-Up Survey) will represent the denominator. To calculate the overall average estimate of the rate (dependent variable) and its 95% confidence interval, will use a generalized linear mixed model (GLMM) with a Poisson link and independent random effects random effects for sub-affiliates considered within the nested structure of National Cancer Institute (NCI) Community Oncology Research Program (NCORP) members, their affiliates and sub-affiliates.
  • Strategies practices use
    • Time Frame: Baseline up to 12 months
    • Strategies practices use in response to drug shortages are collected in the Baseline Drug Shortage Survey and the Quarterly Follow-Up Survey. Will calculate the proportion of practices using a particular practice-level response strategy to drug shortages. This proportion will be calculated for each of the following response strategies: stockpiling, increasing staff time, purchasing from secondary markets, changing route of administration (e.g., oral), and sending patients to another institution.

Participating in This Clinical Trial

Inclusion Criteria

  • Be a primary affiliate or sub-affiliate of an NCORP community site or minority underserved (M/U) community site that is affiliated with the University of Rochester Cancer Center (URCC) NCORP Research Base – Practice sites must have a valid Cancer Therapy Evaluation Program (CTEP) identification number – Practice sites may or may not share a pharmacy – Provide infusional chemotherapy treatment (either inpatient or outpatient) Exclusion Criteria:

  • Practices sites without valid CTEP identification (ID) – Practice sites that do not provide infusional chemotherapy

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Rochester NCORP Research Base
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Elaine Hill, Assistant Professor – University of Rochester NCORP Research Base
  • Overall Official(s)
    • Elaine Hill, PhD, Principal Investigator, University of Rochester NCORP Research Base

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.