Drug shortages in the United States reached a record number in 2011, where 22 of the 267 drugs in short supply were chemotherapy drugs for cancer treatment.1 While the incidence of drug shortages decreased in 2012, the problem persisted.
Drug shortages have been attributed to many factors, including manufacturing capacity, raw materials shortage, and price control, which are usually beyond the control of healthcare providers. Furthermore, drug shortages can lead to numerous care issues in terms of patient safety and outcomes; ethical decisions surrounding treatment, and provider reimbursement.
Numerous drug therapies are essential for certain patients, and maintaining their survival can be at risk during a drug shortage. During periods when there is a deficiency of certain drugs, shortages have led to increased resource utilization in healthcare, such as increased time to obtain the same drug therapy, educating healthcare staff of changes to current formularies during shortages, adjustments to information technology, increased costs of obtaining drug therapies, and developing plans for importation of specific drug therapies.2
In the case of oncology shortages, alternatives are usually not plentiful as many of these drugs hold very specific indications. For this reason, it can often be difficult to provide patients with the appropriate drugs for managing their disease. Patients often experienced treatment delays, or were sent to another institution for continued treatment because of drug unavailability. Some received no treatment at all. It is believed that these issues will lead to negative patient outcomes, such as reduced efficacy, increased toxicity, or greater cost. While recent data suggest that these shortages have led to increases in disease progression, cancer recurrence, and mortality, concrete evidence is lacking.
Recently, two surveys were released detailing the effects of drug shortages in oncology. The Hematology Oncology Pharmacy Association (HOPA) published survey results earlier this year detailing how oncology drug shortages impacted clinical practice, patient safety, and clinical trials. The survey reported a staggering 93% of survey participants had noted delays in chemotherapy administration or changes in treatment regimens due to drug shortages at their institution.3
Furthermore, 85% of respondents reported increased costs, and 10% reported reimbursement challenges related to drug shortages, with 44% of institutions stating that clinical trials were affected by these shortages. The oncology medications most frequently reported to be in short supply during the preceding 12 months were fluorouracil, leucovorin, liposomal doxorubicin, and paclitaxel.3
A second survey was presented at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting in June. The survey evaluated 214 member responses received between March 2012 and September 2012.4 The results were similar to those from HOPA’s survey; out of 80% of those who experienced a drug shortage during that time period, 94% had that shortage affect their treatment.
An astounding 83% of respondents were unable to prescribe standard chemotherapy for a particular cancer. Thirteen percent of respondents in the survey presented at ASCO stated that they had lower clinical trial enrollment or were forced to suspend participation in a clinical trial as a result of drug shortages. The fact that both surveys revealed equivocal results makes it clear that oncology drug shortages continue to have a severe impact on patient care.
Since it is clear that oncology practice in general is being affected by chemotherapy drug shortages, there is a definitive need for guidelines that instruct oncology professionals on how to manage these shortages. Data for oncology products, specifically, are a high priority because there is a lack of consensus on what steps to take in the absence of appropriate guidelines and comparative effectiveness research.
Oncology drug shortages may be further complicated by denial of reimbursement for alternative drugs by payors or a lack of increase in the alternative oncology reimbursement cost based on disease states. In these instances, healthcare systems are left to fend for themselves and absorb the cost. In addition, larger academic institutions, which usually have more drugs in stock, will likely have to shoulder the responsibility for continued patient care by treating patients who need chemotherapy that smaller oncology practices may not be able to provide.
While oncology professionals are the ones who have to manage the administrative and clinical difficulties that arise from these drug shortages, ultimately, it is the patients who will suffer the most, as the treatment they need may be delayed, or even denied, potentially affecting their chances of surviving their cancer.
1. Coalition of Cancer Cooperative Groups. Fact sheet: drug shortages impacting cancer clinical trials. October 1, 2011. http://www.cancertrialshelp.org/news_content/cancer_drug_shortages_fact_sheet.aspx. Accessed April 13, 2012.
2. Kaakeh R, Sweet BV, Reilly C, et al. Impact of Drug Shortages on U.S. Health Systems. Am J Health Syst Pharm. 2011;68:1811-1819.
3. McBride A, Holle, LM, Westendorf C, et al. National survey on the effect of oncology drug shortages on cancer care. AJHP 2013:70:609-617.
4. Emanuel Z, Shuman K, Chinn D, Gogineni K. Impact of onocology drug shortages. J Clin Oncol. 2013;(suppl; abstr CRA6510).