Drug Shortages Cause Cancer Patients To Die Sooner
February 3rd, 2012 // 1:26 pm @ jmpickett
This may not come as a surprise, but the ongoing shortages of various prescription drugs – notably, injectables that are used to treat assorted cancers – are not only preventing patients from receiving timely or the most appropriate treatments, but patients are dying sooner than they would otherwise and tumors are recurring more often, according to a survey of oncologists.
“The consequences are real. The quality of cancer care has been materially impacted. It’s disheartening,†says Susan Schwartz McDonald, ceo of National Analysts Worldwide, a market research and consulting firm that queried 204 oncologists last month. “Unfortunately, the prevalence is not really surprising, because we know the shortages have been severe. But this really brings it home… And it’s particularly painful to think about the factors distorting what’s happening in the supply chain.â€
Unless shortages are alleviated, half of the oncologists surveyed expected the situation will worsen, while only 14 percent foresee a reversal. The results come just as yet another bill was introduced on Capitol Hill to combat the problem. The legislation would require the FDA and drugmakers to develop a list of shortages and allow the Drug Enforcement Agency to transfer quotas, among other things.
The survey found little reason for optimism. For instance, 23 percent of oncologists reported that patients were dying a few times a year sooner due to shortages, and 14 percent say this happened every month, while 3 percent claimed this occurred each week. Conversely, 60 percent say they had not seen this happen. Just the same, 40 percent is a big proportion.
Meanwhile, 46 percent of the oncologists report that there were times in the past year when patients were unable to receive timely treatment due to product shortages, and 31 percent report this occurs each month. Another 15 percent said this happens each week and 3 percent lamented that the problem crops up each day.
Equally troublesome, 39 percent of the oncologists reported that patients were unable to receive the best treatment at all and 28 percent this problem occurred each month, while 15 percent complained this happens every week and 2 percent say it occurs every day. This means that just 16 percent of oncologists never encountered this problem.
And 32 percent of the oncologists say their patients experienced a tumor recurrence a few times last year, while 13 percent say this happened each month and 3 percent report the problem arose every week. One percent report the problem was noticed each day. So is the glass half full or half empty? Fifty-one percent reported this was not a problem.
To what extent the legislative efforts will stem the shortages is unclear. The bill that was introduced in the House this week by John Carney, a Democrat from Delaware, and Larry Bucshon, a Republican from Indiana, would require the FDA to take several steps to more aggressively monitor the problem and improve communication within the industry and the medical community. Congressional sources say the bill may be hitched to legislation renewing the Prescription Drug User Fee Act.
Besides developing a so-called critical drug list, which will identify drugs that are vulnerable to shortage, the legislation would require the FDA to notify distributors of an imminent critical shortage, but withhold notification to a distributor if the US Attorney General finds the distributor is involved in gray market shipments (read more here and here).
The bill would also requires the FDA to expedite the review of any application for approval of a drug that is vulnerable to shortage and on the critical drug list, as well as expedite reviews of any request by a drugmaker of a critical drug to approve a change to the manufacturing process or facilities of that drug or to approve an application for an alternate active pharmaceutical ingredient supplier (here is the legislation, which is called the Drug Shortage Prevention Act).
Also, the FDA would be required to notify the DEA of any critical drug on the shortage list and provide info to the US Attorney General to determine whether quotas under the Controlled Substances Act should be increased. This would largely refer to ADHD meds, which have also been in short supply over the past year. Several House Democrats are probing two drugmakers.
