Drug Shortages

  1. 5
    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/Full...ling_to.2.aspx

    http://hereandnow.wbur.org/2012/08/0...tage-ambulance

    http://bigstory.ap.org/article/param...-due-shortages
    Last edit by Joe V on Aug 8, '12
    Szasz_is_Right, sapphire18, Hoozdo, and 2 others like this.
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  3. 31 Comments so far...

  4. 3
    I have little sympathy for the drug manufacturers. They continue to soak American consumers for billions in profits for drugs they sell for a fraction of the cost elsewhere in the world. The FDA extends patents, sometimes for a decade or more, every time a manufacturer comes up with a new use for a drug about to go generic. Americans pay full price for drugs that have been available as generics (some even over-the-counter) for many years outside of our borders.

    Many of the drugs these companies sell, they didn't even develop. A sales representative of a very popular antipsychotic drug (you would know the name immediately; it has been advertised on television) let slip that his company did not develop this drug; it was invented by a pharmaceutical company in Japan and his company only manufactures it under license. This hasn't stopped them from soaking Americans for billions of dollars for a drug they didn't even develop.
    lindarn, Fiona59, and chaka_1709 like this.
  5. 5
    Quote from Orca
    I have little sympathy for the drug manufacturers. They continue to soak American consumers for billions in profits for drugs they sell for a fraction of the cost elsewhere in the world. The FDA extends patents, sometimes for a decade or more, every time a manufacturer comes up with a new use for a drug about to go generic. Americans pay full price for drugs that have been available as generics (some even over-the-counter) for many years outside of our borders.

    Many of the drugs these companies sell, they didn't even develop. A sales representative of a very popular antipsychotic drug (you would know the name immediately; it has been advertised on television) let slip that his company did not develop this drug; it was invented by a pharmaceutical company in Japan and his company only manufactures it under license. This hasn't stopped them from soaking Americans for billions of dollars for a drug they didn't even develop.
    The licensing and purchase of patents is common in all areas of manufacture and is not limited to pharmaceutical companies. Just because someone licenses a drug to manufacture what does that have to do with anything? Why don't you purchase the license to manufacture and then give away the drug for free?

    Patents and the ability to make a profit is the only reason why we have the amazing drugs like Remicade and Prolia. You think a company would invest hundreds of millions of dollars in manufacturing infrastructure and research to simply give a drug away? Patents are limited by a period of time for a reason, to allow the company to make a limited profit.

    If Eli Lilly could not make a profit then they would not have invested the research in developing vancomycin...
  6. 1
    This drug shortage is a real problem. Hospitals get first dibs, so a lot of hospital-based providers don't realize how bad it is. My brother is a paramedic and they only recently got Ativan back in stock. They'd been having to either use recently expired meds under special permission or use Versed - which is great for sedation but doesn't do a lot for seizures.
    Not_A_Hat_Person likes this.
  7. 5
    Most of the money pharmaceutical companies (certainly the large ones) take in goes to marketing. Their saturation advertising on cable channels, so that people are encouraged to wheedle prescription from their physicians doesn't come cheap. The fact is that, while drug companies conduct trials, and a lot of drugs don't make it through the process, most of the drugs are discovered on the government's dime, through research in federal labs or through federal money grants to universities and to corporations. I know a researcher in Maryland (where a lot of such research is done) who works for a private company that's developing a particular vaccine is getting government grants — gifts, essentially — the government will gain no equity stake.

    The process of validating the effectiveness of a drug is long and expensive, and it's a double-edged sword. Rapid approvals lead toward some drugs that turn out to have dangerous side effects that affect a large number of the drug's users. Slow approval leads to people suffering with a malady that might respond well to a drug that's years away from widespread deployment. There are no easy answers, but is certain cases, if the need is great enough, companies can obtain waivers a fast-track approval.

    The problem is that major drug companies don't want to deal with low-profit drugs (i.e., many generics) that would provide a steady but low income. The companies have the fiduciary responsibility to serve their shareholders, not the public, so they don't bother with those drugs. Among them are vaccines (low profit/high risk) or orphan drugs (drugs with a very small market). In those cases, the unfettered free market does not serve the best interests of the public.

    Perhaps, at least for orphan drugs, the government should finance research, as they do now, and when the orphan drug is ready to be marketed, buy the patent from the company. It would provide a good return on investment for the company, while allowing people with devastating but treatable illnesses to have access to the drugs they need.

    Is whose interest is it that antiretroviral therapy for HIV is so costly in the U.S.?
  8. 1
    Quote from Orca
    I have little sympathy for the drug manufacturers. They continue to soak American consumers for billions in profits for drugs they sell for a fraction of the cost elsewhere in the world. The FDA extends patents, sometimes for a decade or more, every time a manufacturer comes up with a new use for a drug about to go generic. Americans pay full price for drugs that have been available as generics (some even over-the-counter) for many years outside of our borders. ---snip---
    Oooookay.....that being said (drug makers are eeeeevil capitalist profiteers, seeking to make mucho-dollars in profit for drugs made for much less $$$)...

    Why are we unable to provide basic drugs in the USA (stuff like mag sulfate, morphine, fentanyl, potassium phosphate, sodium phosphate)?? It's not all about the exorbitant prices charged for meds in the current market. IMHO, it's a lot more complicated than that single factor.

    I sort of agree with you about the ridiculous prices charged by domestic drug makers. Why should I pay $15 per tablet here in the US, when I can buy the same med from India (legal, I dunno) for about $0.50?

    That being said, there's absolutely no good reason for the unavailability of basic, simple meds here in the US. I attribute this lack of supply to government over-regulation and exposure of the manufacturer to lawsuit-happy consumers.
    sapphire18 likes this.
  9. 0
    Quote from CrufflerJJ
    I attribute this lack of supply to government over-regulation and exposure of the manufacturer to lawsuit-happy consumers.
    It has nothing to do with companies not marketing drugs in which there is little profit? Why would a drug company bother when it can put its funds into marketing a little purple pill that does nothing more than the previous pink pill that's gone generic does?

    Aside from liability, selling vaccines is logistically complex, and profits are low. Developing them into a marketable product is very complicated as well. Why bother, when there may be yet another patentable proton pump inhibitor that's no more effective than the previous one, but might be a marketing bonanza?

    We are paying for the lion's share of the development of most new drugs through taxes.
  10. 2
    Our hospital is always out of drugs due to the drugs not being able to be purchased. Fentanyl, morphine, compazine, lasix, ativan, zofran etc. these aren't rare drugs. I work in med surg and they are some of the most used iv meds not some rare medication only drawn up once a year.
    dudette10 and Tragically Hip like this.
  11. 1
    I run an ambulatory surgery center and we're routinely being alerted for this drug shortage or that one. Propofol, a mainstay MUST HAVE in our facility, goes on the short availability list from time to time--ridiculous. Versed became short many months ago, and I STILL can't get the quantity/concentrations I want and/or need because of limitations in supply, and maximums allowed per facility order.

    And then it was esmolol.....and atropine.....c'mon!

    It's not like these are new-fangled drugs, with sudden unforseen bursts of demand.
    sapphire18 likes this.
  12. 3
    We don't have that many med shortages where I work. However I was speechless when a nurse I work with mentioned that her chemo drug, the only one to treat her cancer, will soon be unavailable.


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