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More Oncology Drug Shortages
By Edward C. Li, PharmD, BCOP, Drugs and Biologics Editor

Recent news is plentiful with stories about how local hospitals and physician practices are struggling to provide their patients with drugs they critically need in today’s climate of drug shortages. In a previous eBulletin article, we described some ways to cope with the ever-expanding list of drugs that are in short supply. According to the FDA Drug Shortages website, three additional drugs (daunorubicin, thiotepa, and vincristine) have been added to the list of injectable drugs that are in short supply and used for the active treatment of cancer since that article was written. The shortage resolved for one drug previously on the list, which is carmustine. The list of oncology drugs currently experiencing a shortage stands as follows:

Bleomycin
Cisplatin
Cytarabine
Daunorubicin
Doxorubicin
Etoposide
Leucovorin/levoleucovorin
Mechlorethamine
Thiotepa
Vincristine.
As you can see, many of the drugs on this list are critical pieces of well-established chemotherapy regimens. In the short term, the US Food and Drug Administration (FDA) has some ability to help resolve some shortages. However, this ability is somewhat limited, especially if the cause of the shortage is due to circumstances beyond their control. Nonetheless, the FDA may be able to expedite the review of submissions by manufactures for a new product or manufacturing change that, if approved, may help to increase the supply of the drug that is currently experiencing a shortage. Additionally, the FDA works with manufacturers to identify sources of raw material or encourage others to increase production of the drug. Lastly, the FDA can utilize enforcement discretion to temporarily allow the importation of a drug from other countries, although the FDA has maintained that this practice is rare.1 Interestingly, it appears that the FDA is considering allowing the importation of certain oncology products (e.g., cytarabine, thiotepa).2, 3

Recently, legislation that may offer some long-term relief to this crisis was introduced to Congress. The “Preserving Access to Life Saving Medications Act (S. 296)” proposes to establish an early warning system so that manufacturers must report to the US Food and Drug Administration (FDA) on conditions that would likely result in a drug shortage. It also would provide the FDA with the power to impose financial penalties for manufacturers who fail to comply with this reporting.

As more drugs are added to the list of those in short supply, there is growing concern among the public regarding how patients are affected by these shortages. Hopefully, the actions of the FDA and Congress will relieve some of these problems and we will again see an adequate supply of these important medications.

Dick: have you seen this available in the US>????? A Pill that gives men with advanced prostrate cancer an extra 4 months of life has come a

A Pill that gives men with advanced prostrate cancer an extra 4 months of life has come a step closer to being approved for use in Britain. Zytiga is a hormonal drug that cuts of the source of testosterone, which makes prostrate cancer cells grow.
Standard hormone treatments for prostrate cancer blocks production of male hormone in the testes, but recent research shows that tumours can produce their own supply, as does the adrenal gland. Zytiga block all testosterone generation. It can be used in up to 80 per cent of patients with aggressive drug resistant prostrate cancer who have run out of options after exhausting a range of anti-hormonal therapies and chemotherapy. The drug is not available for use on the NHS, but makers Johnson and Johnson have applied for licensing approval in Europe that could be granted by the end of this year. That approval looks more likely after U.S. watchdogs at the Food and Drug Administration gave the green light to the drug there nearly 2 months earlier than expected, following its successful trial. A trial on almost 800 patients in 13 countries found those taking the drug combined with conventional steroid treatment survive ed for about 15 months compared with 11 months on steroid alone.
The study was cut short so all patients could be given Zytiga clinical name abiraterone acetate - after independent monitors determined a clear survival benefit.
Around 250,000 men in the UK are living with prostrate cancer, with 37,000 new cases diagnosed each year. It is the biggest cancer killer after lung cancer, with 10,000 men dying from the disease each year. Zytiga was discovered by British scientists at the institute of Cancer Research.
Professor Johann de Bono, of the ICR said "This news will be incredibly important ot prostrate cancer patients and their families"