At least part of the recently announced shortage in hospital drug supplies has to do with FDA regulations on controlled substances. In Montana, more than 200 drugs have been in short supply at some period over the last year. Among the drugs that are hard to purchase are buprenorphine and amphetamine, two schedule II drugs. These are highly regulated by the DEA and suppliers must estimate how much they will be making and get approval ahead of time. That means they can’t just whip up a batch if demand goes up.
In fact, for many of the drugs on the shortage list it’s a delay in manufacturing that means hospitals may not have what they need when they need it. Valium, ethanol and lorazepam are also on the list as well as generic Ritalin and Propofol.
Hospital pharmacists also point out recent FDA crackdowns on manufacturing practices. Often, if some irregularity is found, it is easier to throw out a whole batch of product, rather than pay for expensive retesting and certification. And then there is the problem of foreign manufacturers who aren’t bound to sales in the US but may still run afoul of FDA regulations before they can sell products here.
As an example, the FDA recently blocked the use of imported Sodium Thiopental (one drug used in executions) because the Indian manufacturer wasn’t approved by them.
So far, the number of fatalities blamed on drug shortages has been low; one estimate puts it at one a month, nationwide. In many cases, another drug or therapy can be substituted, although not always. It is particularly a concern with cancer patients who need life-saving chemo but can’t get the medications.
The FDA is aware of the problem and has emergency methods they can use if necessary. Currently, they are dealing with shortages on a case-by-case, manufacturer-by-manufacturer basis. Public comments were taken through their website about the issue. Any shortage that impacts therapy should be reported to the FDA.
