Impossible Choices in Challenging Circumstances

Dealing with decades of drug shortages

Presenter: Karen Hagerty, MD 

Author: Ronan Hsieh, MD, MS 

 

“Cancer drug shortages continue to be a crisis for cancer care.”, said Dr. Karen Hagerty during the Summit on Cancer Health Disparities 2024. The number of drug shortages per quarter is at all-time high, with more than 200 shortages per quarter since 2018. The top five categories of most common drug shortages are central nervous system drugs, antimicrobials, hormone agents, chemotherapy, and fluid and electrolytes.

 

Injectable drugs are more likely to have shortages than non-injectable drugs. The root causes of drug shortage are multidimensional, including legal aspects, financial incentives, foreign government rules, communication between industry and government, etc. For example, only 37% of FDF manufacturing facilities and 13% of API manufacturing facilities are in the U.S., which the U.S. FDA has authority to supervise. The U.S. FDA is unable to monitor the quality, demand and supply of FDF and API manufacturing facilities outside the U.S.

 

The FDA also has no legal authority to inspect raw material manufacturing and fine chemicals manufacturing regardless of the location of a facility. This leads to challenges in drug supply chains as a small accident could lead to disastrous outcomes. Examples of accidents in the last couple of years include destruction of Puerto Rican IV bag manufacturing facilities by Hurricane Maria, shortage of heparin due to massive pig deaths in China, and quality control failure for cancer drugs in Indian facilities.  

 

“Urgent actions are needed.”, said Dr. Karen Hagerty.  

• Improve transparency and communication to health systems and providers.
• Examine economic factors that are driving generic manufacturers out of the market and consider how to stabilize the market.
• Incentivize U.S. production of critical medications

 

Many efforts are made in the Capitol Hill by ASCO. To highlight drug shortages as an ongoing challenge, ASCO will hold a fireside chat in its annual meeting this year. The objectives are to review current market and economic factors that can improve resiliency in the sterile injectable market, and to discuss potential policy changes to help mitigate future cancer drug shortages. We as oncologists will need to continue reporting drug shortages to not just members in the progress but the general public, and we can start by signing ASCO’s letter to add our voices.  

 

Author Bio:

Dr. Ronan Hsieh is an assistant professor of medicine at the University of Washington and a gastrointestinal oncologist at Fred Hutchinson Cancer Center. His primary research interest is drug development in the field of colorectal cancer and gastroesophageal cancer.  

 

No conflict of interest.