Drug Shortages

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Last week, I spoke with my father about drug shortages - whether they really exist in our hospitals.

The brief answer is YES. Drug shortages not only exist in hospitals, but also in "the field", as seen by EMS providers. There was a radio program today on NPR, in which the host interviewed James Augustine, MD. Jim Augustine currently works in GA/FLA, but used to be an ER doctor at Miami Valley Hospital in Dayton, where I regularly saw him when I was volunteering as a paramedic on my local fire dept.

Augustine is a "real world" physician, not somebody working in a fantasy land. In addition to being an ER doc, he maintained his EMT certification, and volunteered as a fire fighter on his local fire department. I trust his judgement.

The radio program documented the fact that Oregon paramedics may carry and administer EXPIRED drugs to their patients. Not as any sort of grand cost saving measure, but due to the fact that new (unexpired) drugs are not available. Welcome to the new 3rd world nation....the USA!

"In the Las Vegas, Nevada area, public health officials extended the expiration for drugs on the federal shortage list for up to a year" (somewhat amazing, since we put lethal injection executions "on hold" when the drugs expire, yet it's apparently OK to use expired meds on non-criminals).

"In Arizona, nine EMS agencies or the hospitals where they're based have told the state they can't get all the drugs they need to meet the state's minimum supply that ambulances are required to carry. "

I see drug shortages on a regular basis in my ICU. The shortages range from pain killers (morphine, fentanyl) to paralytics such as Zemuron to sedatives (Versed) to basic electrolytes (salts like magnesium sulfate...Epsom Salts, sodium bicarbonate...Baking Soda, and potassium and phosphorus compounds). These drugs are very basic - not complicated at all.

IMHO, what complicates the availability of basic drugs are several factors:

- FDA stringent regulations controlling the manufacture/testing of the drugs

- low profit margin/selling price of basic meds

- high expectations (perfection) demanded by drug customers & their contingency based, fee-seeking attorneys, and the large financial liability to which drug makers are exposed.

Given these factors, why SHOULD a drug maker continue to supply basic, low profit, high financial risk meds to consumers?

Sad, but true.

Welcome to the Third World!

See:

http://journals.lww.com/em-news/Fulltext/2012/06000/Breaking_News__Short_Term_Ideas_Failing_to.2.aspx

http://hereandnow.wbur.org/2012/08/08/drug-shortage-ambulance

http://bigstory.ap.org/article/paramedics-turn-expired-drugs-due-shortages

Specializes in Trauma.

Part of the reason for the high cost of drugs in the US could be on tv several times a night. I bet I see 3-5 commercials wanting people to join in class action lawsuits because a life saving drug caused a runny nose, or something like that. How many millions of dollars are the drug companies paying out each year to defend themselves in these lawsuits?

The drugs you pay $15 a pill for here and can get in India, or where ever, for $0.50, are they legally produced with the same strict standards as ours? Also, is their gov't subsidizing the cost of those drugs? Don't forget if that pill costs the patient $15 the drug company is not getting $15, everybody else is getting their share of the pie, the hospital, pharmacy, drug rep, etc.

Part of the reason for the high cost of drugs in the US could be on tv several times a night. I bet I see 3-5 commercials wanting people to join in class action lawsuits because a life saving drug caused a runny nose, or something like that. How many millions of dollars are the drug companies paying out each year to defend themselves in these lawsuits?

The amount of money pharmaceutical companies pay out in lawsuits pales in comparison to their marketing budgets, which easily exceed their R&D budgets. And don't conflate lawsuits by the public with legal fines drug companies are forces to pay for misfeasance or malfeasance.

Do you have any idea how much all those television and print ads for all those purple pills (that do no more than the coral-colored pills that just went generic) costs? Or the cost of the perqs drug companies have traditionally handed out to doctors in order to encourage them to prescribe the company's latest new, expensive, under-patent drug?

The big money in litigation is not from people who complain about a runny nose side effect. It's from pharmaceutical companies that do things, often known by managers in the company, that either harm a lot of people, or put the public at serious risk.

KPMG International's newsletter Issues Monitor (June 2011) (PDF file) contains an article entitled "Rising cost of litigation in pharmaceuticals industry" that goes into good detail about the nature of litigation against drug companies.

It's sad that the propagandistic idea that all lawsuits are frivolous or are brought by only by people who want to steal money from those with deep pockets has become so common. In reality, it's often the only recourse that we have to keep a company from riding roughshod over everyone. Remember, a company's only fiduciary responsibility is to their shareholders and their equity.

Specializes in Trauma.
It's sad that the propagandistic idea that all lawsuits are frivolous or are brought by only by people who want to steal money from those with deep pockets has become so common. In reality, it's often the only recourse that we have to keep a company from riding roughshod over everyone. Remember, a company's only fiduciary responsibility is to their shareholders and their equity.

What is sad is that so many people, and their lawyers, see the right lawsuit, against the right company, as a retirement plan.

There were three manufacturers of propofol in 2009; Teva, Hospira, and APP Pharm. All three had to recall batches of propofol and one of the three, Hospira, never resumed production. After suffering a lawsuit, Teva discontinued all further production leaving only a single manufacturer to handle all the demand.

I remember that shortage.....but the single manufacturer is Hospira, as they're the ones who have been supplying us for at least the last year (and I think probably two). And Hospira seems to be having a snag somewhere because we've experienced shortages in the factory-sealed boxes lately. Distributor took it up with them, and they're "investigating". Whatever, as long as I got credit for the missing bottles!

Propofol — there was a circus of recalls within the past few years for contamination with minute stainless steel particles, exotoxic bacteria, hepatitis C.

Instead of making single-use vials, Teva used cheaper (maybe they had a lot of them) larger vials, which were then used on multiple patients, leading to hep C infections when the large vials were reused (for endoscopy, at least). Baxter was sued as well.

Yep. We buy 20ml single use vials by the truckload :)

Specializes in Psychiatric nursing.

I work in psych and we are often unable to get certain drugs from our hospital pharmacy. One example from last week was the unavailablitiy of clozaril 100 mg tabs. Now clozaril is only available in 25mg and 100mg strengh tabs. You also can be giving doses up to 400 or 500 mg in a single dose. This meant that some patients were getting up to 20 pills at one time! And alot of those patients are psychotic and you have to try to convince them that you are not posioning them. Arg!

Specializes in ICU.
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The drugs you pay $15 a pill for here and can get in India, or where ever, for $0.50, are they legally produced with the same strict standards as ours? Also, is their gov't subsidizing the cost of those drugs? Don't forget if that pill costs the patient $15 the drug company is not getting $15, everybody else is getting their share of the pie, the hospital, pharmacy, drug rep, etc.

I think if you asked the regular consumer of prescription meds OUTSIDE the realm of prescription drug coverage (pay for the meds yourself) if they'd prefer a "legal...strictly produced" pill for $15 each, or a generic drug made by a generic off-shore maker (such as Cipla, Ranbaxy, or Cooper in India, to name a few) at $0.50, I think you'd be hard pressed to find many people demanding the $15 US made pill.

There are plenty of people here in the US forced to acquire their meds by not-always-legal means. This may include running up to Canada, down to Mexico, or to their nearest Post Office box for the package from their international pharmacist. When Americans are forced to choose between having a possibly less than 100% safe med, versus not being able to afford any of the med with 100% FDA-blessed safety, they will choose the less than safe approach.

I also believe a large part of the problem is JACHO rules about single dose vials even for the same patient. I work in an ICU and am sick of wasting drugs. I have a patient tonight that gets Versed PRN Q1H 2mg. We have 5mg vials. The correct thing to do is waste 3mg every hour. Versed is often on backorder for our hospital. Same goes for morphine. I remember for a while we had 8mg syringes only and would waste 6-7mg of morphine each dose.

I also believe a large part of the problem is JACHO rules about single dose vials even for the same patient. I work in an ICU and am sick of wasting drugs. I have a patient tonight that gets Versed PRN Q1H 2mg. We have 5mg vials. The correct thing to do is waste 3mg every hour. Versed is often on backorder for our hospital. Same goes for morphine. I remember for a while we had 8mg syringes only and would waste 6-7mg of morphine each dose.

Boy, am I with you on this one! You can't help it if you need 2-3mg of something and there's only a 5mg vial, but at least most of the time they're q4h meds so....ok. But something like you're describing is just a disgusting waste.....and MY unit really needs 2mg amps of Versed, because we typically only USE 2 mg, sometimes 3, rarely 4. And now, I currently have some 5mgs left....and next in line are 50mg/10ml bottles. Seriously?? Changing the concentration, too, means a pita. Thankfully we don't use JACHO; our accreditation body recognizes the med problem and ok's multi-doses under carefully-scrutinized circumstances. So far, we haven't run out of anything just yet...

Specializes in ICU.
I also believe a large part of the problem is JACHO rules about single dose vials even for the same patient. I work in an ICU and am sick of wasting drugs. I have a patient tonight that gets Versed PRN Q1H 2mg. We have 5mg vials. The correct thing to do is waste 3mg every hour. Versed is often on backorder for our hospital. Same goes for morphine. I remember for a while we had 8mg syringes only and would waste 6-7mg of morphine each dose.

For a while, we were out of the 100 mcg vials of fentanyl in our ICU. WHEN we could get the med, it was in 250 mcg "party bottles". Draw out 50-100 mcg, waste the rest.

"party bottles"....LOL.....!

Boy, am I with you on this one! You can't help it if you need 2-3mg of something and there's only a 5mg vial, but at least most of the time they're q4h meds so....ok. But something like you're describing is just a disgusting waste.....and MY unit really needs 2mg amps of Versed, because we typically only USE 2 mg, sometimes 3, rarely 4. And now, I currently have some 5mgs left....and next in line are 50mg/10ml bottles. Seriously?? Changing the concentration, too, means a pita. Thankfully we don't use JACHO; our accreditation body recognizes the med problem and ok's multi-doses under carefully-scrutinized circumstances. So far, we haven't run out of anything just yet...

I can't believe there are nurses who still do not see the value in single use vials.

I wonder what the patients with Hep C in the Vegas clinic, which helped to result in the infamous propofol shortage, would say about multidose bottles.

The problem is with the shortage, not with the safety rules.

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