Drug shortages hit US oncologists hard

摘要

Abstract:The number of drug shortages in the US has tripled between 2006 and 2012, with drug shortages now affecting most US oncologists and impacting on patient care. There is a need for new guidelines to control drug substitutions and to single out priority populations for relatively scarce drugs.The very real threat of global drug shortages, particularly for cancer treatment [1, 2], shows little sign of abating. The impact of drug shortages on most oncologists in the US is affecting life-saving patient care, according to the findings of the largest study yet to quantify the impact of cancer drug shortages [3]. Of 250 board-certified US oncologists surveyed in late 2012 and early 2013, 83% reported facing a drug shortage in the past six months, and 92% of those said their patients’ treatment had been affected.‘Our results indicate that the vast majority of oncologists in the country are facing wrenching decisions about how to allocate lifesaving drugs when there aren’t enough to go around,’ says the study’s senior author, Dr Keerthi Gogineni [4]. ‘The potential impact of these drug shortages is vast: they’re putting patients at risk and driving up costs of cancer care,’ adds Dr Gogineni, an instructor in the Division of Hematology-Oncology in the University of Pennsylvania’s Abramson Cancer Center. The results of the study were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2013 [3].The shortages recorded in this study have had the greatest impact on drugs to treat paediatric, gastrointestinal and blood cancers, depriving physicians of standard chemotherapies to prescribe across a range of cancers. It is not clear exactly how these shortages will affect patient care, but the potential risks are clear. For example, if a drug has to be substituted while treatment is already underway, there might be no established dose equivalence or known safety profile when the substitute is combined with other therapies. There is also evidence of drug shortages holding back clinical trial progression.Drug shortages are associated with increased costs; as the availability of a drug decreases, the price of that drug, and of its substitutes, increases. The availability of a drug can decrease for several reasons – as a result of manufacturing problems, or because the drug ceases to generate sufficient income for the manufacturer.A critical production facility in the US was closed down in 2011 as a result of manufacturing and quality concerns [5]. The facility produced Johnson & Johnson’s chemotherapy drug Doxil, which is used to treat ovarian cancer, multiple myeloma and AIDS-related Kaposi’s sarcoma, and a generic injectable preservative-free methotrexate, which is used to treat children with leukaemia. The threat to patients was immense, causing the US Food and Drug Administration (FDA) to step in and approve the temporary importation of Sun Pharma Global’s Lipodox (pegylated liposomal doxorubicin) from India as an alternative to Doxil, and to approve APP Pharmaceutical’s generic injectable preservative-free methotrexate. To achieve this, FDA collaborated with industry, patients and their families, and other stakeholders.Gogineni et al. found that oncologists have had to substitute generics in short supply with more expensive branded drugs 60% of the time. In the case of shortages of generic 5 fluorouracil (5FU), 22% of physicians had to switch to the branded drug capecitabine, which costs about 140 times as much as 5FU for one round of colon cancer treatment.The number of drug shortages in the US tripled between 2006 and 2012 [1]. New legislation that will require manufacturers to notify FDA six months is advance of any potential shortage is being drawn up in an effort to guard against future crises. However, the law does not impose penalties on companies that fail to warn FDA, prompting the chairman of ASCO’s Government Relations Committee, Dr Richard L Schilsky, to question its value. ‘If there’s no tee