Pharma Shrugs

socialist medicine . . . where everyone suffers equally.

Big Pharma strikes again!

Aren't price controls wonderful!

and Fred - there is no such thing as equal suffering under socialized health care. Take it from me, 1st tier (urban) and 2nd tier (rural).

Not sure what to make of this article.Who/what is causing these shortages? Can gubermint fix it?(rhetorical Q)Can Pharma get away with withholding drugs to drive up prices/demand?

It's okay. The government is going to fix it.

re the bear: I always thought the first tier under socialized health care was that super clinic in Ottawa for our elite politicians and senior civil servants, that the second tier was for folks who could afford to go abroad for health care and that tiers three and four are for suckers, of course.

It is not clear what is causing these shortages.

Mike McCormick nails it @ 7:19. Just ask Jack Layton. Canada's system has some more equal than others.

Jacko goes to a pay as you go {cum} service. Everyone else waits in line. A very long line.

It wouldn't surprise me if over-regulation is the cause of the shortages. So, if the goverment decides to add yet more regulations, expect the problem to get worse. It will be interesting to see if politicians will ever become aware that almost universally make bad situations far worse.

One of the things I've noticed is that expiry dates on drugs constantly get moved downwards. When I see an expiry date on a bottle of Lithium Carbonate, I know that there is some major insanity at work; the only thing that would expire here would be the gelatin capsules which should last many decades and whether or not the Lithium decomposes depends on whether or not one believes in proton decay and that process would take tens of billions of years. Some drugs like epinephrine and nitroglycerine tablets do decompose quickly. Morphine, stored in the dark at controlled temperature does NOT break down and a simple knowledge of basic chemistry will let one know what drugs to dispose of after "expiry" and which ones will be good many decades hence.

N-Acetyl cysteine (NAC) is given as one of the drugs in short supply. Go to any health food store and one will find the shelves full of bottles containing NAC capsules. What is in short supply is NAC solution which, if the hospital pharmacists still knew how to compound, would be easily made up from the widely available NAC from health food stores. Similarly, it doesn't take much brainpower to prepare sterile KCl or MgSO4 or Norepinephrine solutions from the widely available chemicals. Sterile NaCl is used in far too large volumes to make it worthwhile for a hospital pharmacy to prepare their own NaCl solutions. When I was a neurophysiology researcher, we'd regularly prepare drug solutions from various drugs and that was considered to be one of the fundamental skills that any researcher should have.

Every time I've suggested doing something this simple to a hospital pharmacist, they have some regulatory excuse or another of why they can't do it. I suspect that laziness is often the primary cause as it's so much simpler to take a bottle off the shelf and send it to a ward than actually having to weight out chemicals, mix them up and sterilize the resultant solution (milipore filters word great for small quantities of solution)

Loki hits it. We had myriads of new regulations to meet National Stds. Some of the standards were good and some were to create jobs and control.
If you were making a fair profit before whatever ISO standard we are in at present you probably aren't now. Drug makers aren't charities.
The only expiry date I pay much attention on is Acetaminophen.
It isn't just Canada. The US is also having problems with discontinued drugs and limited foreign suppliers.

Loki:

I'm always amazed when I go to get my insulin refilled that the pharmacist tells me "OK, that will be ten to fifteen minutes". I almost want to shout "What, to open the fridge, and bring out the box of pre-packaged cartridges?!". I can see two to three minutes to enter the info into their system, and print the label, but seriously - fifteen minutes.

There's a place around the corner that has a sign out front "Compounding Pharmacy". I'm curious now, and will pay it a visit to see if that's just a slogan, and they only shovel pills from big bottles to smaller ones, or if they can actually gin something up from scratch.

...and a simple knowledge of basic chemistry will let one know what drugs to dispose of after "expiry" and which ones will be good many decades hence.
Posted by: loki at May 30, 2011 8:25 PM

I don't have that "simple knowledge", how can I tell? Is there a list available one could refer to?

Now just a minute old Lori. I was a manager at a hospital pharmacy that had sophisticated lab equipment that would make many complicated intravenous products including epidural steroids. Each batch takes about 2 weeks to make because one must ensure stability and a pyrogen free product that had in it what it said it did. We were good. Too good. We had to shut down when new regulations came in from Health Canada (GMP). No hospital pharmacy could ever meet them because they require very sophisticated equipment, specialized people and are very time consuming.

Of course one can make a solution as described, but no hospital would support the pharmacist or the department if there was an adverse reaction or even a complaint from anyone (nurse, other drug company, patient etc). Ask me how I know.

And pharmacists are generally not lazy (although some technicians can be, LOL). The most stressed health care professionals in hospitals are NOT doctors, nurses or managers. The most stressed employess are the professional support staff ie respiratory therapists, pharmacists and physiotherapists. Data from the University of Ottawa to prove it.

Re expiry dates
Yes, most drugs can last a lot longer than the expiry date on the bottle. The trouble is the drug company has only tested for expiry dates for 2-4 years as required by Health Canada regulations. So there is no data to determine how long a drug is good for.....I am perfectly happy to use many drugs (especially film coated ones) as long as they are properly stored (especially from light, heat and humidity) but no pharmacist can dispense them or be at risk for professional misconduct.

As one can see, regulations for pharmaceuticals in Canada and for pharmacy practice is the worst in health care, if not one of the most onerous in any profession. And that's why it takes longer than one thinks to dispense a medication...

Valencia, you've just proved my point - regulations are the cause of drug shortages. Pyrogen removal is not something I had to worry about in mixing up drug solutions for animals, but I never saw any febrile reactions. LPS is one of the most potent pyrogens around and it comes from bacterial cell walls so not having any bacterial contamination is very important. I'm assuming that one could remove pyrogens by running a drug solution through activated charcoal, but then that would reduce drug concentrations in the solution. Yes, pyrogen removal does complicate things but not nearly as much as government regulation.

One of the things I've noticed about drug reactions is that over 90% of them are psychogenic or coincidental. Someone gets a drug and a reaction develops and the prevailing weltanschauung is that it must be the drug never seeming to take into consideration that the drug was administered to someone with multiple medical problems which might also be the cause. To determine if it was indeed the drug which caused the reaction would require readministration of the drug to the patient to see if the same reaction occurs. In the case where immune sensitization is thought to be the cause, dose of the drug would have to be reduced and it would be nice to have routine in-vitro tests to determine whether or not there was actually a drug reaction that has occurred.

For out of hospital patients, the most common cause of drug reactions is the idiotic lists of extremely likely side effects that pharmacies distribute with each prescription. I did read a study a few years ago which demonstrated that telling a person potential side effects of a new medication increased the incidence of side effects by 3 - 10 times than if the person had been told nothing about the drug before taking it. I know which of my patients are highly suggestible and they invariably experience multiple side effects after reading one of the side-effect forms and taking the medication, or they just bring the Rx to me saying "I won't take this drug because the side effects are too bad". The only way I can get them started on a drug is to give them a sample package from which I've removed the "helpfull" list of side effects.

The only reason I can think of pharmacies distributing these forms is because they probably know that they increase side effects and consequently increase drug sales.

One of the solutions to this problem would be to immediately slash the budget of the oxymoronically named "Health Protection Branch" by 90% which should leave them enough funds to go after the truly dangerous people and give them no time to dream up new regulations.