Drug shortages are persisting Posted 08/06/2012

The media are reporting continuing problems on drug shortages, and indeed a worsening situation around the world. Cancer drugs seem to be the most affected.

The June 2012 American Society of Clinical Oncology (ASCO) annual meeting got in the news for the wrong reasons. Amid the success stories like the increasing ability to fight advanced melanoma, NBC News and The Wall Street Journal were reporting the consternation of oncologists and patients alike. Health Blog reports that while the shortage of cancer medications has eased somewhat, there are still shortages of several drugs to treat cancers of the breast, colon and lung, among others.

Rear Admiral Sandra L Kweder, MD, Deputy Director of FDA’s office of new drugs, who spoke at ASCO Annual 2012 Meeting in Chicago, USA, said ‘with regard to oncology drugs we remain extremely concerned about the shortages’.  She added that ‘manufacturing and drug quality problems have accounted for and continue to account for the majority of drug shortages’.  ‘There have been problems in many of these products with things like particles of glass or metal shavings in the vials. Those are not quality problems that can be tolerated on any large scale or for any individual patient,’ she said, ‘No patient should ever be exposed to risks of those sorts. It is not acceptable.’

Hospitals are still having difficulties obtaining certain drugs, including some used to treat cancer. In some instances, pharmacies purchase more of a drug than is needed if they have reason to believe that the drug is becoming scarce, which in turn adds to that scarcity. A Reuters article points to many potential causes for the shortages, including industry consolidation and manufacturing problems. One recent survey indicates that nine out of 10 oncologists in the US have had to deal with cancer drug shortages.

European pharmacists have been chasing supplies of drugs for several years now, with many factors contributing to the shortages. Similarly to the US, these include drug companies not investing enough in the production of drugs that have become cheaper and generic, ‘just-in-time’ practices that leave little margin for problems and changes in distribution practices exacerbating supply difficulties [1]. Shortages affect a wide variety of agents. For instance, sodium bicarbonate, used to allow delivery of high doses of methotrexate, is currently difficult to get, as is leucovorin, employed with cancer drug fluorouracil, itself in short supply.

Uncertainty of supply is also happening in Pakistan. In May 2012, the American Business Council, which represents 65 American drug manufacturers in Pakistan, warned authorities that if matters are not sorted out soon, Pakistan could face shortages of more than 800 drugs. The problem here mainly comes from price controls imposed by the government, which are cutting profits to overly thin margins. Since many active pharmaceutical ingredients are sourced from these countries, it spells bad news for the West, as well as for local patients.

This has led to some bizarre stories, such as Vietnam running out of lethal drugs for criminal executions. The executions of more than 400 death-row prisoners have not been able to go ahead over the past year.

Some progress is being made, however, in May 2012, FDA Commissioner Dr Margaret A Hamburg, reported that FDA’s office of drug shortages had managed to prevent 128 drug shortages. Despite this, the total number of drug shortages has tripled since 2006 and for 2012 they still look set to surpass those of 2011 [2].  Legislation is now being hammered out by the US House and Senate to try to curb further shortages by requiring manufacturers to notify FDA six months in advance of any potential shortage. Some, however, believe the law does not go far enough. The law does not impose fines or other penalties on companies that do not notify FDA, something the cancer doctors’ group ASCO has been pushing for. ‘If there’s no teeth in that legislation some companies may decide not to report as required,’ said Dr Richard L Schilsky, Chairman of ASCO’s Government Relations Committee.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Cancer drug shortages in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 8]. Available from: www.gabionline.net/Pharma-News/Cancer-drug-shortages-in-the-US

2.  GaBI Online - Generics and Biosimilars Initiative. FDA says efforts to prevent drug shortages are working [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Jun 8]. Available from: www.gabionline.net/Pharma-News/FDA-says-efforts-to-prevent-drug-shortages-are-working

Source: Bloomberg, Health Blog, Reuters, The New York Times

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