The FDA is actively involved in the monitoring of drug shortages and perhaps some arm-twisting of drug manufacturers to prevent, or mitigate, the problem (see: Drug Shortages). Mr. HIStalk addresses an interesting aspect of this issue, the safety risks in hospitals of working with a presumably equivalent drug purchased from secondary channels at the time of shortages (see: Monday Morning Update 9/26/11). In part, he addresses the complexities of hospital information systems:
[A reader finds] finds this story about hospital drug shortages and the resultant third-party profiteering scary. I’ll elaborate from experience to scare him more. Even if you ignore the possibility of obtaining counterfeit or impure drugs when forced to buy from secondary channels, the patient safety risks with drug shortages are considerable.
- Product packaging and sometimes concentrations differ from what nurses and doctors are used to, greatly increasing the chance of wrong drug / wrong dose errors.
- Sometimes the backup drug is therapeutically similar but chemically inequivalent, meaning doctors are forced to use a drug that wasn’t their first choice and one they may not be all that familiar with, making it more likely that something will go wrong.
- Shortages come and go all the time, so information systems can’t be kept current to steer prescribers to the one currently being used, sometimes requiring IT workarounds that neuter electronic protections such as dose and allergy checking.
- Those drugs may have similar active ingredients that are still different enough to trigger unexpected drug allergies and drug-drug interactions.
My analogy is always this: suppose you’re about to have open heart surgery, but the drugs your surgeon always uses are on shortage, meaning the surgeon will have to compromise with a less-desirable drug that they’ve rarely or never used....The problem here is that everyone involved claims to be innocent and powerless.
One of the major drug shortages now is 5-FU, an older but very effective agent in many chemotherapy regimens for which there may be no adequate substitute (see: 5-FU Added to Drug Shortage List). The cause of these drug shortages is not hard to find (see: Oncology Drug Shortage: An Unintended Consequence of the Medicare Modernization Act and Free-market Forces?). Here is an excerpt from this article:
“It should not come as a surprise that most of the drugs at the top of the shortage list are lower-priced generics. Manufacturing companies have finite capacity. Naturally, there is more profit incentive to produce higher-priced drugs. It is simply a case of the free market at work,” said [healthcare economics expert] Mr. Kalmans. One would think that drug manufacturing companies would see a window of opportunity and step in to fill the shortage, pricing the drugs accordingly. “First, it takes a long time to file and obtain approval for an abbreviated new drug application for generics with the FDA, as well as substantial time to construct and inspect a new manufacturing line and process,” said Mr. Kalmans.
For me, the solution to this problem lies with the FDA. I am thinking that the agency should be able to provide some incentives for the drug manufacturers to manufacture the drugs in chronic short supply. Free market rules get blunted, and distorted, in this highly regulated industry.