Oncology Drug Shortages: Causes and Solutions

In this interview, Ryan Motte, PharmD, CSP, Shields Health Solutions, discusses how oncology drug shortages have impacted patients with Chronic Lymphocytic Leukemia and offers solutions to address these shortages.

Please share a little about your affiliation and background.

I am a specialty clinical pharmacist with a focus on oncology and hematology at Shields Health Solutions.

How have cancer drug shortages impacted patients with Chronic Lymphocytic Leukemia (CLL) and their ability to receive appropriate treatment?

Oncology drug shortages, including  those used to treat CLL, can result in disruptions in the timing of chemotherapy treatments, alterations in dose or regimen administered, or even missed doses of medications. If a specific drug is in limited supply, patients might not have another option and be forced to delay treatment or switch to another medication that may be less effective. This can pose serious consequences for patient health and survival and potentially be life threatening.

For example, there was a shortage of fludarabine, a drug used for treating CLL and sometimes used as part of standard allogenic hematopoietic stem cell transplantation. For Chimeric antigen receptor (CAR) T-cell treatment expansion, fludarabine is used as part of its pre-operative regimen. Providers used it in excess amounts and worsened the shortage that was caused by supply chain issues.

Drug allocation may also occur due to drug shortages, meaning that providers can only access small amounts of products week to week. While this ensures fair access, clinicians are unsure if there will be enough product for a patient’s next treatment.

What are some of the causes of the drug shortages?

Drug shortages are multifactorial and normally start with the developers or manufacturers. Supply issues —such as low profit margin, low market size, cost of raw materials, or supply chain issues—are caused by manufacturers who are unwilling and unable to produce enough medications to satisfy the demand.

When their budget is limited, stakeholders purchase a fixed quantity of stock for a fixed duration that fulfills only the current need. An increase in demand may occur—such as previously mentioned scenario of fludarabine shortage—and there is no back-up plan or allocation to meet it.

Disruptions in the supply of raw materials are also frequently responsible for drug shortages. Some ingredients for the drug cannot be manufactured fast enough or there is not enough supply of the ingredients to keep up with the demand. There may be multiple manufacturers of a drug, but only one producer of a raw material used in making the drug which can cause shortages across the board.

In response to low profit margins on medications, a manufacturer might reduce production quantities of certain drugs permanently or temporarily as they shift production or reallocate resources to another product. 

What proactive steps can health care stakeholders, such as pharmacies, wholesalers, and regulatory agencies take to mitigate the impact of drug shortages on patient treatment plans and ensure continuity of care?

Stakeholders can take the following proactive steps to help manage and mitigate drug shortages:

1. Add restrictions to the use of current stock. This could include limiting the stock to specific patients and prioritizing patients who need the drug the most.
2. Increase expiration dates of medication. The US Food and Drug Administration (FDA) has used this strategy before.
3. Establish good communication and transparency among stakeholders and manufacturers with adequate reporting systems to help redistribute the available quantity of short drugs.
4. Develop medical expert platforms comprised of multidisciplinary teams to provide information about future shortages, manage current shortages, and review alternative treatment, stock alternatives, and guidelines for restrictions on medicine.
5. Improve waste management of shortage drugs.
6. Increase communication among stakeholders with regulatory agencies who make proactive actions possible.
7. Implement drug shortage reporting and tracking systems.

During a drug shortage, it is crucial to explore alternative medications and therapeutic options to ensure uninterrupted patient care. Specialty pharmacists, such as those at Shields Health Solutions, can help mitigate drug shortages by informing prescribers of shortages and recommending alternative therapies, investigating supply restoration and planning, substituting medications, and helping to update formularies.

The Federal Drug Administration (FDA) can take certain actions to prevent and resolve drug shortages, such as expedite reviews of new production lines or material sources to increase production, extend product expiration dates if it is safe to do so, and import medicines if they meet safety and effectiveness criteria.

How do you believe the economic burden of these shortages can be minimized for patients, treatment facilities, and payers in general?

Good communication and planning are key steps to minimizing the economic impact of drug shortages. Health care systems spend resources estimated to be at least $359 million per year for labor and $200 million per year to purchase alternative treatment. Proper planning for shortages with defined roles ensures that health systems are not shocked ahead of time and stakeholders can focus time, energy, and labor resources on managing drug shortages. This can be done by assessing inventories, contacting  other health systems sites, identifying alternative drugs or therapeutic equivalents ahead of time, prioritizing patients to receive drugs in short supply, and modifying clinical guidelines to reduce economic burden.