When I first met Bill he was frail and frightened. He struck me as a very intelligent man struggling to stay calm. He came to the office accompanied by his wife and two other family members. For months Bill had minimized symptoms of rectal discomfort and bleeding. His initial workup led to a diagnosis of widespread rectal cancer, which showed a favorable K-RAS status. When we discussed his treatment plan Bill made it clear he would have a difficult time being compliant to a regimen that included an oral therapy if he thought that medicine was causing difficult side effects. No problem. We started cetuximab and FOLFOX (folinic acid[leucovorin]/5-fluroruracil[5-FU]/oxaliplatin) and immediately met with great success. His pain and bleeding resolved within just a few weeks, and his tolerance of therapy was exquisite. By his third cycle of treatment, however, we were no longer able to obtain leucovorin, In addition, we were also informed that the infusion pump for his 5-FU would no longer be available. Fortunately, capecitabine would serve as an excellent substitute, and with the clear evidence of an exquisite response to therapy, our hope was that Bill would be comfortable with this treatment plan.
We soon encountered another set of obstacles. We have a patient with limited financial resources, and he is insured by a “difficult” carrier. Because we were changing the treatment plan, preapproval was again required. Obtaining approval again took up valuable time of both nursing and office staff. Moreover, because an oral agent was now involved, Bill was burdened with a much higher copay for his treatment, an added expense that he could ill afford. And because we were dealing with a specialty pharmacy to obtain his new drug. we now confronted the prospects of shipping delays and, therefore, treatment delays.
Shortages of commonly used, inexpensive therapies are putting untoward demands on physicians, who are required to regroup with patients and outline a modified plan. Nurses and other staff members must follow through with the time-consuming processes involved in obtaining additional preauthorizations, and most worrisome is ultimate effect on patients, who are finding their treatment plan altered and, at times, perhaps even compromised.
This new predicament is becoming a frequent item on our oncology problem list, and it is creating added worry. How will the lack of bleomycin affect Fred, who is being treated for testicular cancer? How will the lack of doxorubicin affect Jane, who is being treated for lymphoma? The list of shortages goes on. We find ourselves investing more and more time coordinating alterations in care, purchasing chemotherapeutic agents from different vendors, placing orders to specialty pharmacies, and even tracking down shipping agencies to ensure that they arc delivering on time.
The current shortage in the availability of critical anticancer drugs has emerged as yet another challenge in the fight against cancer and a daily hurdle faced by providers and patients alike. In our office, this translates into time-taxing frustration that affects all of us. From an operational standpoint, we have little alternative but to scramble and come up with the fix, even when we recognize that we are deviating from standards of care that have been established by sound data. Like many other oncologists, I work with an exceptional group of people. They have a can-do attitude and share a common commitment to provide outstanding care for our patients. They also understand well the ominous ramifications when optimal care is compromised for any reason. The current weekly, if not daily, dilemmas posed by drug shortages is demoralizing.
Bill was in for a follow-up visit yesterday, and he looks great. He is experiencing some hand-foot toxicity from capecitabine, but this should be readily manageable. The higher copay for the oral agent is straining his finances. He called his insurance company to request that they eliminate or reduce the copay since it was a direct result of a drug shortage that was beyond his control. They refused. I certainly sympathize with Bill's financial struggles, but so long as he can cover the copay there is less cause for concern over his care being compromised—his new treatment regimen is well established. The same, however, cannot be said for everyone. If and when these people develop recurring disease, the cost will be enormous; to patients, to providers, and to the healthcare system. We will all feel the emotional, physical, and financial consequences of this avoidable failure.
As a society, we marvel at the scientific breakthroughs that emerge from our laboratories. We are inspired and moved by the courage ofcancer survivors. We applaud the dedicated efforts of health care providers as they align with patients to fight the cancer battle. But to fight this battle we need effective ammunition. Perhaps these shortages are attributable to cost-structure issues or manufacturing challenges. If so, these are, by and large, correctable problems. And corrections need to be made, sooner rather than later, as this battle rages on.
The preceding ENDPOINTS articles by Drs. Misleh and Glynn comprise Parts II and III, respectively, of a three-part series of commentaries that address the causes underlying the current dearth of critical anticancer agents, explore the clinical implications of drug scarcity in different practice settings, and consider potential solutions for ending these avoidable shortages that threaten to undermine optimal treatment of patients with GI cancers. Part I of this series was published in the previous issue of GCR. (Gonsalves WI, Grothey A: Waiting in line for cancer treatments? Gastrointest Cancer Res 4:147, 2011.)
