Drug Shortages in Community Oncology: Ensuring Access to Chemotherapy

Cassandra Perkey, PharmD, BCOP;Brooke Peters, PharmD, BCOP;Bradley Winegar, PharmD;Manale Maksour, PharmD, BCPS;Jenny Li, PharmD, BCPS, BCOP;Melody Chang, MBA, RPh, BCOP;

Drug shortages and chemotherapy drug shortages in particular are a persistent problem for oncology providers and pharmacists today. This article addresses the pervasive challenges posed by chemotherapy drug shortages in health care, focusing on the robust mitigation strategies in the community oncology setting used by American Oncology Network, LLC (AON). A critical component of shortage management at AON is the drug shortage committee, comprised of interdisciplinary stakeholders who include pharmacists, providers, procurement team members, and financial managers to ensure an organized and thorough approach. The drug shortage committee provides guidance to AON on the use of inventory reporting mechanisms within the electronic medical record, dose rounding, alternative drug source options, and communication to patients and payers. As part of the drug shortage committee, pharmacists work with providers to determine plans for individual patients, assessing appropriateness of treatment delays, drug sequence adjustments, and/or use of alternative drugs based on available evidence and clinical guidelines. Effective communication is paramount not only within AON but to patients and payers. Transparent and timely updates via provider newsletters, patient letters, payer appeals, and AON’s own RxConnect Podcast serve as conduits for disseminating critical information. In the ever-evolving landscape of chemotherapy drug shortages, pharmacists are essential in ensuring conservation of drugs while maximizing patient outcomes.

Drug shortages have become a pervasive and concerning issue within the health care system, affecting patients, providers, and overall public health.^1,2 The prevalence of drug shortages has been attributed to a complex interplay of factors, including manufacturing challenges, regulatory issues, supply chain disruptions, increased demand, and market dynamics.³Essential medications for various conditions ranging from chronic diseases to acute illnesses have been affected, leading to compromised patient care and increased health care costs. Pharmacy budgets have increased by an estimated 5% to 20% as a result.¹ Health institutions often find themselves grappling with the task of finding suitable alternatives and rationing available supplies, posing challenges to providers in selection of treatment and threatening patient outcomes. Addressing the root causes of shortages and implementing effective strategies to ensure a stable drug supply chain are crucial for safeguarding public health and maintaining the integrity of health care delivery.

Shortages of backbone chemotherapy drugs such as carboplatin, cisplatin, and paclitaxel make an especially profound impact on oncology care, as each treats several types of cancer, often with curative intent.^1,2 Scarcity of chemotherapy affects quality of patient care as providers find themselves delaying treatment, reducing doses, or choosing alternative regimens, potentially affecting efficacy.

Community oncology practices, often not part of the 340B Drug Pricing Program, are disproportionately affected because large health systems with 340B eligibility may exert greater influence over drug distributors. Furthermore, the 340B program could encourage hospitals to stockpile low-cost medicines, contributing to shortages and discouraging generic drug manufacturers from investing in production. The American Society of Clinical Oncology (ASCO) has provided feedback on the Stop Drug Shortages Act draft, recommending the suspension of 340B discounts for drugs on the FDA’s shortage list or those at risk of shortage, as explained by ASCO Board Chair Everett E. Vokes, MD, FASCO, in a letter on August 25, 2023.

Therefore, community practices must develop strategies for managing drug shortages and maintaining effective communication. This report outlines the chemotherapy drug shortage management strategies employed by American Oncology Network, LLC (AON).

Quick action by the drug shortage committee at AON is vital to the success of the network amid a shortage. The committee brings together all key stakeholders in shortage management to ensure an organized approach and consistent communication across the network. This committee includes leaders among pharmacy operations, procurement, nursing, providers, and revenue cycle. Pharmacists work closely with the procurement advisers to evaluate the expected shortage duration, locations affected, and ability to obtain the drug from alternative sources. Often, the drug can be procured directly from manufacturers, although sometimes at up to twice the contracted rate AON would typically pay the primary supplier. Depending on these variables, pharmacists work with providers and nurses to assess affected patients for dose-rounding opportunities and weigh pros and cons of treatment delay vs alternative drugs. Revenue cycle informs the drug shortage committee of the financial implications of the proposed strategies to AON and to patients. The drug shortage committee also creates a plan for communication of the shortage not only within AON but also to patients and payers. Steps are outlined for patient education and appeal to payers in cases where a drug in shortage may be insurance preferred.

Reports are created from the electronic medical record (EMR) for each clinic, comparing current drug inventory with upcoming orders to determine when inventory will run out. These reports are provided to pharmacists and nursing leadership with updates as needed depending on the duration of the shortage. Pharmacists use these reports when considering which patients will need therapy modification, balancing time to obtain new insurance authorization for a second-choice drug with the uncertain time to procure more of the drug in shortage.

In times of drug shortages, AON employs the strategic approach of dose rounding to optimize the use of available medication and ensure uninterrupted patient care. This method, which involves rounding doses within a 10% limit, conserves vials to extend use of the current drug supply. The inventory snapshot report details the remaining doses for all patients on the affected drug. Pharmacists adjust doses, rounding to the nearest vial size when possible and adhering to the accepted 10% limit.

Alternative drugs can often be used in the event of drug shortages. To aid in provider decision-making when alternative selection is more complex, pharmacists create tools to help providers select the best drug and dose for each patient based on available evidence/guidelines. These tools include alternative drugs with their respective doses, schedules, references, and guideline classification.

At times, drugs in shortage may be delayed without sacrificing efficacy. One example used in practice was the alternative sequencing of doxorubicin/cyclophosphamide and paclitaxel, with cycles of doxorubicin plus cyclophosphamide given after (rather than before) paclitaxel for patients with breast cancer. This strategy allowed providers to initiate treatment with paclitaxel during a doxorubicin shortage and delay the need for doxorubicin by 8 to 12 weeks. Once patients reached the doxorubicin cycles, the drug was no longer in shortage. This strategy was preferred by some providers over switching to an alternative such as epirubicin.

EMR order sets were created for easy treatment plan modification with alternative drugs. These order sets generally included not only the alternative drug but also prompts for patient education, new insurance authorization, and treatment consent. At times, alternative therapy requires a different infusion duration or schedule (eg, paclitaxel vs nab-paclitaxel) or different premedications. In these cases, other modifications to treatment plans are required that may not be contained in the alternative drug order sets. Pharmacists work with nursing leadership to ensure that the appropriate EMR modifications are made for each patient to ensure safety. Doses are also not included in the order set (dose set at 0 mg) because the drug dose varies by indication/regimen. This promotes mindful dose entry based on the pharmacist-created guidance documents.

Effective communication is pivotal in addressing drug shortages within community oncology settings, ensuring a coordinated response and timely dissemination of critical updates. One key component involves prompt communication to the clinics within AON.

Urgent messages are sent to a wide range of stakeholders, including providers, pharmacy staff, nurses, clinic administrators, financial managers, and revenue cycle personnel. This ensures that all relevant parties are informed about the evolving status of drug shortages and the necessary strategies put forth by the drug shortage committee to mitigate shortage impact. Additionally, a pharmacy and therapeutics committee newsletter and weekly provider newsletter provide updates on drug shortage statuses, serving as valuable resources for AON health care professionals to stay informed and adapt their treatment strategies accordingly.

Moreover, patient communication also plays a crucial role in navigating drug shortages. Clear and transparent communication with patients helps to alleviate concerns, manage expectations, and empower them to actively participate in their care decisions. This communication can take various forms, including in-person discussions during clinic visits, electronic communication platforms, and phone calls. Additionally, standard patient letters are developed to explain various causes of shortages, potential impact on the plan of care, and, if applicable, options for using FDA-approved imported chemotherapy drugs from overseas manufacturers.

Furthermore, communication with payers through formal channels such as appeal letters advocates for patients’ access to necessary medications during shortages. These letters provide detailed information about the shortage situation, its impact on patient care, and the urgency of the situation. By engaging with payers in a transparent and proactive manner, financial teams can work toward securing timely approvals for alternative therapies or expediting access to essential medications, ultimately ensuring continuity of care.

Lastly, to further educate and engage the community in addressing drug shortages, AON has developed a drug shortage podcast series called RxConnect Podcast. These podcast episodes feature pharmacists and practicing oncologists within AON discussing alternative treatment options for disease states affected by drug shortages. By leveraging the expertise of these key thought leaders, the podcast aims to provide valuable insights and guidance to health care providers, patients, and other stakeholders navigating the challenges posed by drug shortages in oncology. This podcast serves as a dynamic platform for sharing best practices, facilitating dialogue, and fostering collaboration within the community to optimize patient outcomes.

About the Authors

Cassandra Perkey, PharmD, BCOP, is a regional clinical pharmacist at American Oncology Network, LLC, in Lexington, Kentucky.

Brooke Peters, PharmD, BCOP, is a clinical pharmacy services manager at American Oncology Network, LLC, in Lexington, Kentucky.

Bradley Winegar, PharmD, is a regional clinical pharmacist at American Oncology Network, LLC, in Arden, North Carolina.

Manale Maksour, PharmD, BCPS, is a regional clinical pharmacist at American Oncology Network, LLC, in Glendale, Arizona.

Jenny Li, PharmD, BCPS, BCOP, is a director of pharmacy solutions at McKesson in Austin, Texas, and previously held the position of clinical pharmacy services manager at American Oncology Network, LLC.

Melody Chang, MBA, RPh, BCOP, is vice president of pharmacy operations at American Oncology Network, LLC, in Fort Myers, Florida.

Interdisciplinary teamwork is vital for mitigation of chemotherapy shortages. Pharmacy, procurement, nursing, and financial teams all contribute to determination of the most effective strategies to ensure the best possible patient outcomes. Pharmacists’ expertise in drug substitution, dosage adjustments, and patient support is essential for maintaining the continuity and effectiveness of cancer treatments during shortages. Furthermore, placing a focus on efficient communication is essential for minimizing the impact of shortages and creating a unified front. AON’s use of newsletters, patient letters, and podcasts reflects a commitment to transparency, education, and collaboration in addressing the challenges of chemotherapy drug shortages. In conclusion, the presented strategies provide a valuable framework for community oncology practices to uphold the integrity of health care delivery amid the persistent threat of chemotherapy drug shortages.

Drug Shortages in Community Oncology: Ensuring Access to Chemotherapy

About the Authors

1. ASHP 2023 Drug Shortages Survey Report. American Society of Health-System Pharmacists. 2023. Accessed August 22, 2023. https://www.ashp.org/-/media/assets/drug-shortages/docs/ASHP-2023-Drug-Shortages-Survey-Report.pdf

2. Drug Shortages: Root Causes and Potential Solutions. FDA. 2019. Updated February 21, 2020. Accessed August 22, 2023. https://www.fda.gov/media/131130/download

3. Current drug shortages. American Society of Health-System Pharmacists. Updated January 8, 2024. Accessed January 24, 2024. https://www.ashp.org/drug-shortages/current-shortages