The country is plagued with drug shortages that have negatively impacted patient care. The FDA maintains a drug shortage database. The American Society of Health-System Pharmacists also have dedicated resources to alert clinicians about this problem. One of the areas in which drug shortages can have the most profound and potentially deadly effect is in oncology. However, little is known about how oncological drugs have been affected by recent drug shortages.
The Hematology Oncology Pharmacy Association developed a 36-item national survey that was sent electronically via Survey Monkey to pharmacy professionals caring for oncology patients. The purpose of the study was to gain insight into the impact of drug shortages on the availability of chemotherapeutic agents and supportive-care agents routinely utilized in cancer care, with a particular focus on patient care, drug costs and resource utilization, safety implications, and effect on clinical trials.
Study participants were instructed to complete one survey per institution from December 9, 2019, to July 1, 2020. Drug shortage was defined as "a supply issue that affects how the pharmacy prepares or dispenses a drug product or influences patient care when providers must use an alternative agent."
The survey inquired about the frequency of drug shortages, the need to reduce doses or seek alternative agents, how often drug shortages impacted oncology drugs, impact of the drug shortage on facility costs (e.g., need to dedicate personnel for procuring drugs in limited supplies and/or identifying alternative agents, reimbursement issues if generic drugs were unavailable and branded drugs needed to be used, procuring drugs from unofficial sources [i.e., the gray market]), effect on medication errors and adverse patient outcomes, how treatment may have deviated from standard therapies due to the shortage, and the impact on clinical trials.
A total of 68 institutions participated in the survey, comprising of community hospitals (43%) and academic medical centers (38%). Forty percent of the facilities were located in the East North Central or South Atlantic region of the United States. Almost all (98%) of facilities had an onsite infusion center, with most providing inpatient and outpatient chemotherapy (84% and 87%, respectively). More than one-half (52%) administered at least 1,000 doses of chemotherapy monthly.
Sixty-four percent of participants experienced one or more oncology drug shortages per month that primarily affected 27 different antineoplastic or supportive-care agents, including (in descending order) vincristine, other (i.e., bleomycin, famotidine, fluorouracil, sodium bicarbonate, tacrolimus, aprepitant, carboplatin, doxorubicin, gemcitabine, fludarabine, granisetron, ibrutinib, IV temozolomide, nelarabine, paclitaxel, thiotepa, vinorelbine, and rantidine), vinblastine, IV immune globulin, leucovorin, Bacillus Calmette-Guerin, atropine, erwinia asparaginase, etoposide, and leuprolide.
Regarding the oncology drugs, 90% of institutions experienced a shortage of epirubicin, flutamide; over 80% experienced a shortage of decitabine, mechlorethamine, and melphalan; and over 70% suffered a shortage of dactinomycin, pentostatin, fludarabine, degarelix, and carmustine. Of these, major delays of 7 or more days were seen for fludarabine, followed by carmustine and pentostatin and degarelix. These shortages impacted patients with a variety of malignancies, with those with acute lymphoblastic leukemia most affected (44%).
Shortages were also seen in antimicrobial agents, antiemetics, and immunosuppressants. A particular concern was that nearly three-quarters of institutions experienced an IV immune globulin shortage, and this led to dose reduction in over 60% of patients, with more than half of facilities restricting usage (58%) or delaying treatment (52%).
Almost two-thirds (64%) of facilities experienced a rise in drug costs, with most increases associated with personnel time needed to deal with drug shortages and with purchasing drugs from the gray market. Drug shortages contributed to 6% of medication errors, which can be especially problematic given the toxic nature of oncologic agents. Additionally, this shortage also was associated with an additional 4% of near-miss medication errors in which the errors were caught before the drugs were administered.
In the case of clinical trials, 13% were affected, resulting in the inability to enroll patients, requirement of additional documentation, and delays in care.
This article provides valuable insight for pharmacists serving oncology patients and lends validation to a common challenge that the profession is seeing in all practice settings.
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