This is a bad time to get sick — especially in the hospital. While there are a lot of theories, the responsible parties seem unwilling to explain the current plague of major drug shortages, which are so bad that doctors are getting discouraged. Even basic anesthetics are unavailable, leading to postponements of surgery and hospital hoarding:
Imports have not helped anesthesiologists like Dr. Jason Soch, who hears about a new shortage nearly every week during his rotations at several surgical centers in Philadelphia. These are often “workhorse” drugs such as fentanyl, midazolam and propofol, used every day during surgery.
“It seems like as soon as one drug is no longer in shortage, we get an email from the hospital pharmacist that they’re on their last box of another,” he said.
Every disruption forces doctors to change dosing, or give new drug combinations they may not be as familiar with.
“I didn’t envision this when I went to anesthesia,” Soch said. “I’d figured we’d have whatever we needed.”
SCRAMBLING FOR A FIX
The problem has inspired some creative solutions, like a drug shortages mobile application called RxShortages that allows medical and pharmacy staff to track new drug shortages posted on websites, including the FDA’s. Mick Schroeder, a pharmacy resident who created the app, said it has been downloaded about 25,000 times.
Brooke Bernhardt, an oncology pharmacist at Texas Children’s Hospital, said she checks RxShortages at least once a day.
“Unfortunately, at any point we expect a drug to go on back order,” she said.
Szandzik, the pharmacy director at Henry Ford Hospital in Detroit, admits he would buy a larger quantity of drugs than usual if it became available.
“If I have to get one or two months’ supply, I’ll buy it, because our patients need it,” he said. “Hoarding is in the eye of the beholder.”
Reading this made little sense to me, because it seems that in a free market, supply will always exist to meet demand. So I looked further, and saw this shockingly long list of basic hospital drugs of the sort which are supposed to be industry standards, but are not available. Repeatedly the same reason is given:
“cannot provide a reason for the shortage.”
“manufacturing delays.”
“shortage is due to increased demand.”
Really? So why has the manufacture of the drug been discontinued by four companies?
Something does not make sense.
Then there’s Cipro, a very important antibiotic:
Apotex had an import ban on all solid mediations including ciprofloxacin tablets.
Ranbaxy has an FDA import ban on several of their products manufactured in India.
Carlsbad Technology states their shortage is due to raw material shortage.
Marlex is unable to provide a reason for their shortage.
Cobalt was acquired by Watson and Watson started shipping their products in January, 2010.
Major discontinued their ciprofloxacin immediate-release tablets in February, 2010.
Teva discontinued their ciprofloxacin immediate-release tablet, unit dose presentations in June, 2010.
Dr. Reddy cannot provide a reason for the shortage.
Schering has discontinued all Cipro immediate-release tablet presentations.
Diazepam, now made by only one company:
Hospira has diazepam on back order due to manufacturing delays.1
Hospira is the sole supplier of diazepam injection.
The company “cannot estimate a release date.”
Then there’s the mainstay surgical narcotic Fentanyl:
West-Ward acquired Baxter’s fentanyl injection products in May, 2011. The company cannot provide a reason for the shortage.1,2
Hospira states the shortage is due to increased demand and manufacturing delays including quality improvement activities. Hospira is increasing production of the ampules to help meet the demand. 3
The list goes on and on. Even the most basic hospital drug morphine (without which the country would be unable to fight wars or cope with disasters) is in short supply, for similar reasons:
APP states the shortage is due to a change in manufacturing sites.
Hospira states the shortage is due to manufacturing delays.
West-Ward states the shortage is due to increased demand for product. West-Ward has recently changed old Baxter to new West-Ward NDC codes.
IMS (Amphastar) discontinued morphine 1 mg/mL 10 mL Luer-lock syringes in March, 2012 due to low demand for the product.
I guess if the reason isn’t high demand, it might as well be low demand.
What is going on? This sort of thing is normally associated with Third World Countries, not the leader of the free world.
Oh. Maybe we’re not that anymore. Silly me.
Comments
9 responses to “Whatever you do, don’t get sick!”
The next step is to nationalize Big Pharma as a result of this market failure.
Obviously this isn’t a *market* failure. Market participants do not *stop* production during conditions of *rising* shortages. Only government can create conditions like that.
My bet is all those Cipro manufacturers were told by the FDA they can’t sell their product, and were simultaneously slapped with a gag order prohibiting them from saying so. Thus we get BS reasons like “manufacturing delays” and “no reason”. The same probably goes for the other drugs.
Bob Smith is probably right – but there is also the factor of companies sunsetting older drugs with smaller profit margins.
This forces adoption of newer drugs – helping to pay off their development costs, but incurring some risk for patients as the track records of these drugs is less well-known.
Ben, but why now? Are there new regulations on manufacture or something like that?
I don’t think this is a sunsetting issue, since as far as I can tell no replacement drugs are being sold either. Drug companies aren’t stupid enough to sunset a drug without having a replacement available to sell. The big question then becomes why the government (I can find no other rational reason for what’s happening) is creating these shortages.
Occam’s Razor: Somewhere in that monstrosity called Obamacare is a clause or six that has companies being forced to re-tool, jump through new hoops, etc. Companies are re-evaluating whether the increased costs make the drugs unprofitable.
Can’t resist this post…
It’s called “Just In Time” inventory. All those MBA’s who run big pharma’s distribution were trained in the same idiotic business model. Don’t stock in a warehouse any more than what you will ship in the next 30 days. That’s why you see the empty space on the shelf at Walmart for the product you always buy, the one that actually works, and that everyone else buys also.
And it’s why when a real disaster strikes the shelves in the supermarket will empty and not be refilled.
Another potential problem is how many pharmaceuticals are now made in Pakistan, India, and China, among other places. Quality control in these lands is marginal at times, leading to very large percentages of rejections once the drugs are double-checked. Now, the wisdom of having critical pharmaceuticals made in countries whose residents do not especially care for the US or for Western medicine remains open to debate, but the quality control problems are one major choke-point at the moment.
An inordinate fondness for regulation.