New Research Indicating Serious Potential Risks to Cancer Patients From Oncology Drug Shortages

Newswise — Glenview, IL: The Hematology/Oncology Pharmacy Association (HOPA) has released a survey of oncology pharmacists which warns that oncology drug shortages happen often and have serious negative consequences on cancer patients in the United States. Published in the April 1, 2013 issue of the American Journal of Health-System Pharmacy, the survey was completed by hematology/oncology pharmacists, who care for cancer patients in all phases of treatment and are uniquely positioned to provide insight on oncology drug shortages.

“Although several national surveys have characterized the impact of drug shortages on patient care, this is the first national drug shortage survey to focus on oncology drug shortages. Our survey demonstrates that delays and changes in chemotherapy occur frequently during shortages and ultimately increase the risk of medication errors and cost. Additionally, drug shortages complicate clinical research, which may delay bringing new cancer therapies to patients,” says HOPA President and study coauthor, Lisa M. Holle, PharmD, BCOP.

Key findings show 98% of respondents reported experiencing an oncology drug shortage in 2011 and requires substantial time that is diverted from other important activities for cancer patients. Some 34% of organizations spend 1000 or more personnel hours managing oncology drug shortages, and 85% reported drug shortages increase drug costs to the institution, which may be passed on to the insurer or patient.

Shortages negatively impact the care of patients with cancer, in fact, 93% of respondents reported a delay in chemotherapy administration or change to a different treatment. In addition, shortages prompt the use of alternative regimens, and unfamiliarity with new regimens increases the risk for medication errors and adverse events.

“Use of alternative chemotherapy due to drug shortages is particularly concerning for patient safety. In some cases, similar chemotherapy simply does not exist or there may be limited data available for the alternative drug. Recent data from another study linked use of alternative chemotherapy due to shortages to a greater risk of relapse in Hodgkin lymphoma patients. Our survey also shows that using alternative agents can also be error prone or lead to adverse events,” James M. Hoffman, PharmD, MS, the study’s senior author and Medication Outcomes and Safety Officer at St. Jude Children’s Research Hospital.

In specific cases, respondents mentioned that change to protocols, omission of medications from clinical studies, and stockpiling of drugs were enforced in order to continue clinical trial completion. According to the survey, 44% of institutions claimed drug shortages affected clinical trials, with 44% mainly experiencing delays in patient enrollment and/or 67% choosing not to enroll patients at all.

”Oncology drug shortages can lead to devastating effects, as there is little interchangeability between oncology drug therapies. The loss of one drug, as seen with cytarabine [for treatment of AML], can prevent the effective use of a myriad of chemotherapeutic regimens for leukemia. In other cases, oncology drug shortages may affect numerous disease states as seen with leuocovorin or liposomal doxorubicin. The clinical impact of these shortages has lead to numerous adverse clinical outcomes,” says Ali McBride, PharmD, MS, BCPS, study author. Niesha Griffith, MS, RPh, FASHP, incoming HOPA President, stated that “HOPA is committed to continuing its advocacy efforts and working with government agencies, and other patient and provider organizations who represent the best interests of individuals and their families suffering from this disease.” HOPA feels strongly that individuals with cancer should not shoulder the burden of drug shortages in addition to stresses of cancer and cancer treatment and is committed to advocating methods to avoid and manage future drug shortages. To see more about HOPA’s advocacy efforts, visit (http://www.hoparx.org/Health-Policy/default/health-policy-advo.html).

HOPAHOPA is a nonprofit professional organization launched in 2004 in order to help oncology and hematology pharmacy practitioners and their associates provide the best possible cancer care. HOPA has more than 1900 members and includes oncology pharmacists, as well as pharmacy interns, residents, nurses, technicians, researchers, and administrators specializing in hematology/oncology practice.

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Media contact and to request a copy of the study:Elizabeth ShermanDirector of Marketing and CommunicationsHematology/Oncology Pharmacy Association[email protected]Tel: 847.375.6307Cel: 847.875.7775