Plan Ahead to Ensure Consistency in Patient Care and Communication During Drug Shortages
A manufacturing delay leading to a shipping delay caused the October 2019 vincristine shortage, according to a letter (https://www.fda.gov/media/131865/download) Pfizer sent to its customers on October 18; the U.S. Food and Drug Administration first reported the shortage (https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Vincristine%20Sulfate%20Injection%2C%20USP%20%28Preservative-Free%29&st=c&tab=tabs-4&panels=1) on October 16. It affects both the 1 mg/ml and 2 mg/2 ml single-dose ONCO-TAIN™ glass fliptop vials.
In the letter, Pfizer assured customers that it would “fully meet market need for this product. Based on current forecasts, we believe our next deliveries will meet current patient needs throughout the rest of the year.” The next delivery is expected later this month, and Pfizer said the vincristine supply would fully recover by January 2020.
In just the past 10 years, healthcare providers have been challenged with managing drug shortages in critical cancer treatments (https://journals.lww.com/oncology-times/Fulltext/2011/02250/Critical_Drug_Shortages__Who_s_Minding_the_Store_.1.aspx) such as cytarabine, fluorouracil, doxorubicin, and oxaliplatin (https://journals.lww.com/oncology-times/fulltext/2011/08100/Oncology_Drug_Shortages_Worsening,_Threatening.1.aspx)—and it’s not the first time vincristine has been in short supply (https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70087-0/fulltext). Shortages in the drugs that clinicians use as the backbone of cancer treatment regimens threaten optimal treatment approaches, affect patient and caregiver education, and have the potential to increase cost of care.
In light of the latest vincristine drug shortage, Rowena Schwartz, PharmD, BCOP, professor of pharmacy practice and ONS’s pharmacist liaison, discussed strategies for oncology nurses to address challenges associated with critical drug shortages.
Develop a Plan
First, get a group together to develop an action plan for managing the drug shortage.
“Convene key stakeholders, including those involved with the purchasing, prescribing, formulating, and administration of the agent,” Schwartz recommended. “This will ensure that key pharmacy personnel, providers, and oncology nurses are at the table when discussing the effects the shortage may have on the practice center. If applicable, include clinicians involved in both adult and pediatric care in your practice setting.”
The group should determine the nature and scope of the shortage and prioritize how the drug will be prescribed or substituted if needed.
- How long is the shortage expected?
- What regimens and disease sites are the agent used for?
- Is the drug used as first-line treatment?
- What alternate agents can be considered?
- Will the drug shortage affect any ongoing clinical trials at the institution?
In a time of uncertainty and fear about losing access to a life-saving medication—no matter how temporarily—patients and families need to hear a consistent message about how an institution is planning to continue their treatment.
“Develop talking points for how to communicate the shortage and the plan in place at your institution,” Schwartz said. “Talking points are especially important for nurses, who are primarily responsible for educating patient and families about treatment regimens.”
Prepare for Early Intervention
Just like treating cancer or managing symptoms or adverse events, drug shortages are best addressed early, before they become critical.
Schwartz suggested identifying an institutional point person who is responsible for tracking drug shortages and putting plans in place before a shortage becomes critical. Institutions can also minimize wasting agents in demand by not premaking doses.
Vincristine is not the last cancer drug that will see a shortage. Planning ahead, developing and implementing a plan, and ensuring consistency in how the drug shortage is addressed and communicated is critical and limits surprises for clinicians and patients alike.