Pediatric oncologists from across the country covened a task force to develop an ethical framework that guides decisions on allocation based on curability, prognosis, and the incremental importance of a drug to a patient’s outcome
Drug shortages are a common occurrence, especially in the pediatric cancer population. A shortage of life-saving chemotherapy and supportive agents has a direct impact on patient lives and also creates ethical challenges for providers. With existing prioritization standards falling short, pediatric oncologists from across the country formed a consortium to develop an ethical framework that guides decisions on allocation based on curability, prognosis, and the incremental importance of a drug to a patient’s outcome.
In their paper published in the Journal of the National Cancer Institute, the authors write that the most common drug shortage in the United States is that of chemotherapy and supportive care agents (CASCA) for cancer, generic sterile injectable in particular. The primary impact of a shortfall of drugs includes delayed administration of life-saving therapy, inferior outcomes, and reduced survival.
To address the problem, a 7-member interdisciplinary and multi-institutional Allocation Task Force, with expertise in pediatric oncology, nursing, psychiatry, research ethics, palliative care, pharmacy, pharmacology, and bioethics, was convened. The panel also included a parent advocate. Using 2 vignettes describing national shortages of methotrexate and vincristine as examples, the task force developed a consensus on an ethical framework for rationing life-saving CASCA. With input from expert consultants, the final document was endorsed by the Children’s Oncology Group and the American Society of Pediatric Hematology/Oncology.
The following is a summary of the framework:
Step I: Mitigation
First response to a shortage of CASCA should be to maximize efficiency and minimize waste. Need for a coordinated effort by multiple stakeholders, including pharmacists, clinicians, hospital administrators, drug manufacturers and distributors, patients and patient advocates, regulators, and members of the drug shortage committee.
Recommended mitigation strategies include:
1. Verify scarcity on the FDA or American Society of Health System Pharmacists drug shortage websites
2. Determine supply and anticipated duration of shortage
3. Anticipate drug needs
4. If the preferred brand or strength is unavailable, contact manufacturer for information on alternate sizes or strengths.
5. Select alternative therapies when possible
6. Cohort patients receiving the similar therapies on same day to share vials mean for single use
7. Borrow or share drug(s) with other institutions
8. Acquire drug via FDA lending
9. Compound drug if possible r acquire from a compounding pharmacy
10. If stable, consider using drug beyond labeled expiration date
Step 2: Allocation
Emphasizing the need for transparency in drug allocation decisions, the task force recommends that the perspectives of patients who are denied access as well as of the drug shortage committee should be considered. Being forced to justify a decision makes for more sound judgement, they write.
Considerations for allocation:
1. Drug allocation should be evidence-based
2. Maximize benefit according to total lives saved/life-years saved given the available supply of drug
3. Incremental importance of a particular drug to a given patient’s prognosis
4. Total amount of the scarce drug required per regimen
5. Phase of therapy
6. In a clinical trial, the standard-of-care backbone should receive priority over investigational use of that drug
7. Trial participants should not receive priority access over non-trial participants
8. Patients and families affected by the drug shortage should be kept informed