Clinical Scorecard: Implementing Drug Allocation Policies Amid a Severe Chemotherapy Shortage
At a Glance
Category
Detail
Condition
Severe carboplatin shortage affecting cancer treatment
Key Mechanisms
A manufacturing facility failed an FDA quality inspection in 2023, prompting a production halt; macroeconomic pressures and just-in-time manufacturing also contribute to persistent drug shortages.
Target Population
Patients at Dana-Farber Cancer Institute requiring carboplatin during the shortage from June 1 through July 17, 2023.
Care Setting
Multisite cancer center with a centralized pharmacy serving the main campus and six regional campuses.
Key Highlights
A multidisciplinary working group developed and implemented a carboplatin allocation plan across all DFCI campuses.
The plan assigned patients to five priority categories using ethical principles including favoring the worst off, maximizing lives and life-years saved, duty to care for existing patients, instrumental value, and reciprocity.
Patients in categories 1 through 3 were intended to receive carboplatin; patients in categories 4 and 5 were not.
The allocation threshold remained unchanged during the shortage because supply stayed at the amount estimated in initial projections.
Clinical groups identified noninferior treatment alternatives, and all groups used a shared definition of cisplatin contraindications.
Guideline-Based Recommendations
Diagnosis
The study evaluated allocation implementation using documented priority categories, intended and actual allocation decisions, and an independent assessment based on structured medical record review.
Management
The DFCI working group included the Ethics Advisory Committee, emergency management, institutional leadership, and representatives of pertinent clinical groups.
The working group recorded relevant information, determined applicable allocation principles, and developed and implemented allocation and communication plans.
The policy intended carboplatin for patients in categories 1 through 3 and withheld it from patients in categories 4 and 5.
Monitoring & Follow-up
The centralized pharmacy monitored chemotherapy supply and demand and maintained a tracking document recording patients assessed, priority categories, and allocation outcomes.
The working group used recent patient volumes and treatment trends to project whether supply would cover demand.
Risks
The article describes persistent, unpredictable cancer drug shortages and ethical difficulties that can compel clinicians, patients, and institutions to make difficult allocation choices.
The source notes that oncologists and pharmacists often manage shortages without dedicated institutional support or formal operational policies.
Patient & Prescribing Data
Patients requiring carboplatin at DFCI during the critical supply constraint period of June 1 through July 17, 2023.
Carboplatin was allocated according to priority categories: categories 1 through 3 were intended to continue treatment, while categories 4 and 5 were not. Clinical groups identified noninferior alternatives for the cancers they managed; cisplatin was never rationed at DFCI.
Clinical Best Practices
Use a purposeful, transparent allocation process that reflects stakeholder perspectives, incorporates pertinent information, is applied consistently, and is enforceable.
Establish a multidisciplinary working group with relevant clinical, pharmacy, ethics, emergency management, and institutional leadership representation.
Document patient priority categories and allocation outcomes in a centralized tracking system.
Identify treatment alternatives and use a shared definition of contraindications to commonly used alternatives.
Communicate and apply allocation criteria consistently across care sites.
