‘Our results indicate that the vast majority of oncologists in the country are facing wrenching decisions about how to allocate life-saving drugs when there aren’t enough to go around,’ said the study’s senior author, Keerthi Gogineni, in a statement from the University of Pennsylvania. ‘The potential impact of these drug shortages is vast: they are putting patients at risk and driving up [the] costs of cancer care,’ adds Gogineni, an instructor at 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, which was held in Chicago, USA, from 31 May to 4 June 2013 [2].

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. 

Gogineni and co-authors found that oncologists have had to substitute generics in short supply with more expensive brand-name drugs 60% of the time. In the case of shortages of generic 5 fluorouracil (5FU), 22% of physicians had to switch to the brand-name 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 [3]. New legislation that will require manufacturers to notify FDA six months in 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 [are] no teeth in that legislation, some companies may decide not to report as required,’ he has warned.

Despite these efforts to tackle drug shortages, and similar attempts being drawn up worldwide, there is considerable room for improvement. The authors of the University of Pennsylvania study point out the need for guidelines to control drug substitutions and to single out populations that should be given priority for drugs in short supply.

‘This is a dynamic problem, and when we learn about new shortages on the horizon, there is usually not a lot of time to plan for how to deal with them,’ says Gogineni. ‘Guidelines must be rapidly updated and disseminated, both to large academic medical centers and smaller community hospitals and practices.’

Conflict of interest
The authors of the research paper declared that the research was supported in part by a Pfizer Medical and Academic Partnership Research Fellowship in Bioethics.

Editor’s comment
If you are interested in contributing a research paper in a similar area to GaBI Journal, please send us your submission here.

References

1.  Emanuel EJ, Shuman K, Chinn D, Gogineni K. Impact of oncology drug shortages. J Clin Oncol 2013;31(suppl; abstr CRA6510).

2.  Penn Medicine News Release. Cancer Drug Shortages Hit 83 Percent of US Oncologists. 3 June 2013. Available from: http://www.uphs.upenn.edu/news/News_Releases/2013/06/gogineni/

3.  GaBI Online - Generics and Biosimilars Initiative. Drug shortages are persisting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jul 5]. Available from: www.gabionline.net/Pharma-News/Drug-shortages-are-persisting

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2013 Pro Pharma Communications International. All Rights Reserved.