Drug Shortages

We take the drugs we find in our cart and in the evil Pyxis machine for granted.

When I go to Ecuador every year, I have to figure out exactly how much of each drug we use, add a fudge figure and buy them all in advance (except the controlled ones which we buy there). That was a little stressful the first time, I have since learned that we can buy most of the drugs we need there anyway.

Now as we recently learned almost all the generic injectable drugs in Canada are produced at a single factory in Lennoxville Quebec, owned by Sandoz which is itself owned by a European company. Some time ago this factory was visited by representatives of the FDA who found safety flaws in their manufacturing process and told them to fix it, essentially shutting down the plant or at least severely curtailing its production while it fixes itself. This happened a few months ago but the shit has only now hit the fan.

Affected are drugs like morphine, fentanyl, rocuronium, glycopyrrolate, ketamine, ondansatron, norepinephrine and protamine (actually it would be shorter to just list what's not affected). Ondansatron is more or less gone once we run out of what is on hand. The rest are currently being rationed. Alternate drugs have been proposed but many of them are also produced by Sandoz. Surgeries have already been canceled in Canada, mostly due to protamine shortages.

The government is acting sluggishly to license drugs from other countries to be imported to Canada and of course companies that could have made these drugs but that have historically been shut out of our market are in no hurry to accomodate us.

A number of observations:

1. How come free market USA has higher standards for drug production than Soviet Canuckistan?
2. Who was the genius who decided that all or most of Canada would buy its drugs from a single source?

Of course this crisis is generating about 500 emails a day for me and numerous meetings (we all know meetings are the best way to solve any problem). As someone whose connection with anaesthesiology goes back to 1986 when I started my residency, the responses of some of my colleagues are quite amusing. A number of people have for example stated that there is absolutely no way they can practise without ondansatron. Suggestions that maybe we should use Pancuronium for longer cases are met with horror. Faced with a potential shortage of glycopyrrolate, last week, I put a note on the white board asking people to consider using atropine when they felt they could, to preserve our supplies. Somebody wrote "Are you nuts?". (I am analyzing the handwriting). Atropine is also made by Sandoz.

The other thing that has become apparent is the amount of wastage. Our recovery room nurses for example when they give a small bolus of morphine, will draw this from a 10 mg ampoule, give two or three mg and waste 7-8 mg, repeating the process over and over on the same patient. This of course comes from pharmacy and nursing who don't want syringes of morphine lying around and of course when morphine was cheap this was not necessarily rational but supportable. Likewise many of my department will not use a multi-dose vial opened by someone else. I suggested that maybe they should, a small number have refused, believing apparently that we have a pyschopath in our department who goes around adulterating other people's vials.

We are also switching to oral medications to spare the IV meds we use. It only took a couple of days to get Pharmacy to supply us with acetaminophen, ibuprofen, dexamethasone and ondansatron which we now give to patients with a sip of water in the holding area. These are supplied in the evil Pyxis machine. Unfortunately they cannot store enough to last all day and the head of Pharmacy was astounded when I told him, we do about 60 cases a day in our OR. I suggested that if there wasn't room in the Pyxis, why didn't he just leave a large bottle of the drugs around in the holding area. I haven't heard back.

Bureaucracy is still slow to respond. I suggested that the oral drugs above might better be given on the ward and suggested a reasonable protocol. I was told firmly that standing orders and protocols must be vetted by a appropriate committees. Not holding my breath on that one.

Shortages are of course going to become more and more frequent. It is much more profitable for a company to make Lipitor than the mostly generic drugs we use. We have already lost Pentothal; I have heard of propofol shortages in Canada. A year ago we were short of ephedrine (also made by Sandoz which may have been a harbinger of things to come). Many people say we should just let the market sort this out (they have after all done such a great job already) and there is very little appetite in our current government to interfere with the natural order of things.