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October 30, 2014

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With 300 drugs in short supply, Southern Nevada officials worry, Senate takes action

Career emergency medical services official John Hammond calls it the worst crisis he’s ever seen in Southern Nevada.

“The drug shortage is affecting everybody,” said Hammond, a field representative with the Southern Nevada Health District with over 20 years experience in emergency response. “We’re trying desperately to extend the stock that we have ... and there’s other medications that can be used in place of these medications, but in our realm, it’s hard to shift gears quickly.”

Individual drug shortages are part of the ebb and flow of life in the medical industry: Manufacturing plant shutdowns, public demand and price shocks can often take drugs temporarily off the market.

But not usually this many at once.

Over the past few years, medical personnel in Nevada and across the nation have been noting a particularly troubling build-up in the number of go-to drugs, and even their go-to alternatives, that have become difficult or impossible to procure.

According to a running list of drug shortages on the Food and Drug Administration’s website, almost 300 drugs in various strengths and doses are in short supply — more than triple the number of drug shortages in 2005. The list encompasses everything from prescription pain medications to chemotherapy drugs.

It’s become so bad that even Congress has taken notice.

Lawmakers are attempting to pass new regulations that both parties believe will help pharmaceutical companies avoid most shortages and give medical service providers time to prepare for the unavoidable ones.

Under the proposed rules, pharmaceutical companies planning to discontinue production of a drug would be required to notify the government at least six months before doing so. That would give hospitals and caregivers time to seek the drug elsewhere and potentially let other manufacturers step up their production.

The proposed changes are part of the FDA bill the Senate passed by an overwhelming 96-to-1 vote Thursday and an expansion of rules President Barack Obama issued last year as an executive order requiring pharmaceutical companies “to provide adequate advance notice” before stopping production of a drug.

“Congress can’t solve every problem in this country. But this is one problem we can solve with cooperation from drug manufacturers,” Sen. Harry Reid said on the floor last week. “When the FDA gets early warning from manufacturers that shortages are coming, it can act quickly to find alternate sources of medication and ease supply problems.”

But not everybody in Nevada is quite so sure.

“If you ever follow the FDA’s website, you’ll see the reason drugs go offline is for a lot of nasty things,” said Carolyn Cramer, legal counsel for the Nevada Board of Pharmacy. “They find glass shards in the production line ... or they are controlled substances and there are limits set by the [Drug Enforcement Agency], and when you hit that limit, there’s no more product available.

“There are shortages for a lot of different reasons, some economic, some patient safety, and it would be really tough for people to be able to predict with any accuracy.”

Take, for example, the drug propofol — a common anesthetic that achieved unfortunate infamy from its role in Michael Jackson’s death. The ongoing shortage of propofol began after two of the three major manufacturing companies issued recall notices in the wake of a contamination scandal that started in a Las Vegas clinic. Manufacturing never regained its initial pace after that unpredictable event.

Or consider the long-running shortages of dextrose-50, a standard drug on ambulances used to stabilize diabetics that have injected too much insulin. It’s in shortage not because the drug manufacturers won’t make dextrose-50, but because there aren’t enough available syringes to package it in.

That shortage has had measurable economic effects in Southern Nevada. When emergency service agencies can’t stock their trucks and kits with dextrose-50, which Hammond estimates costs about $5 per dose, they turn to a drug called Glucagon, which can cost as much as $227 per dose.

Last week, for example, Reid cited one particular drug as he made a public plea for support of the FDA bill: Taxol, or paclitaxel, a common chemotherapy drug that suddenly fell into shortage late last year. According to the American Society of Health-System Pharmacists, only two of the drug’s manufacturers voluntarily stopped making the product. Others cited a lack of raw materials and increased demand for the drug.

“It’s a perfect storm: Regulatory changes have occurred. Production changes have occurred. The cost structure has changed,” Hammond said. “All these things taken separately, you can adjust, but they all came at the same time while the country was in a weakened economic state, and it just perpetrated this problem.”

The blow has been intensified by increased consolidation in the drug industry in recent years. According to a paper by John LaMattina, former president of global research and development at Pfizer, “out of the 42 members of the Pharmaceutical Research and Manufacturers of America in 1998, only 11 remain today.”

If a mishap occurs, or if a drug stops being profitable for a manufacturer, there are few other companies to step into the breach to ameliorate the blow.

That’s left local medical providers scrambling to find alternate coping solutions.

Last month, the medical advisory board of the Southern Nevada Health District, which coordinates and oversees emergency services for the area, decided to answer the drug shortage problem by extending the shelf-life of drugs by decree.

Now there are a handful of drugs — including dopamine, used to increase blood pressure; morphine, a pain medication; magnesium sulfate, used to stop seizures during pregnancy; and etomidate, which helps paramedics intubate — that Southern Nevada paramedics are allowed to use for at least six months after the printed expiration date, and, upon review, for another six months after that.

“The thing with expiration dates on medication is that they’re very conservatively labeled,” Hammond said. “Studies have been done showing that if they’re stored appropriately, they last much longer. But when it’s 110 degrees in the desert, you are reducing the life of the medication.”

Hammond said he has noticed emergency agencies are finding it slightly easier to adjust to shortages since Obama issued his executive order mandating warnings and is hopeful that the even stronger provisions in the Senate bill will smooth things even further.

Early warnings, however, are not as helpful as actually having more of the crucial drugs available for purchase. But there’s no easy source to get more.

“You have to realize that most of the drugs in this country, they’re coming from FDA-approved sources, but they’re not necessarily made in this country. And you can’t make somebody make more if they don’t want to,” Cramer said. “Everybody always thinks, ‘Well, Canada’s drugs are from U.S. manufacturers,’ but that’s not necessarily true. If the government allows drugs in from other sources, you have drugs that can come from literally anywhere in the world. So there’s a whole lot to consider.”

The Senate’s FDA bill did consider some of those points. It freed up drug inspectors to focus more on drugs being shipped into the country. But efforts to pass an amendment to allow drugs to be imported from Canada failed on a 43-to-54 vote. Reid voted against the measure, while Nevada Sen. Dean Heller supported it.

“You’re always left doing a risk-benefit analysis,” Cramer said. “That’s what doctors do every day; it’s what pharmacists do every day. You’ve got somebody in front of you right now, and they need that drug, and you want to get it to them. If you need that drug, you need that drug.

“Any efforts that they make to address the issue will help. Everybody’s trying to help a patient.”

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  1. Other than assuring integrity, quality of drugs, and safety of drugs and medical services, the scope and authority of the FDA interferring in adverse ways should stop. We live in the "information age," and have certified and degreed doctors and medical personnel, all able to determine appropriate use and care of drugs and services. All drugs/substances need to have restrictions taken off of them.

    That brings us to the "Drug Wars" because of all this government/nanny-state involvement. Decriminalize all the opiates, marijuana, etc., and watch prices drop, bloodshed end, and the rebalancing of market and use. Prohibition created MORE problems than it solved. Time and time again, we have found that we cannot legislate behavior. People who want the drink, substances, or drugs will find a way to get them, always.

    Over a hundred years ago, the USA began to criminalize drugs and politicians created government departments to provide job favors for their cronies. Eventually, we have the monsterous bureaucracy and very expensive FDA, having excessive power over the lives of free citizens here in the USA.

    Purity of supply, research and development,and quality assurance should be what the FDA is concerned with. Lawmakers should be lifting restrictions and stripping the FDA of police power.
    Problem will be solved.

    Blessings and Peace,
    Star

  2. Reading between the lines: we can't import from Canada because of Congressional restrictions but we can import for elsewhere??? Problems of Congressional making AGAIN.

  3. If you want something done, get the casinos to do it.

  4. Not enough syringes for $5 dextrose-50 (note the small case 'd'), but enough for $227 Glucagon - what a coincidence!
    @Star, remember a lot of what the FDA does is nowadays influenced by for-profit drug companies. "Purity of supply, research and development,and quality assurance" was the original intent of the FDA, but that has been co-opted by corporate interests out to pad their bottom line. A lot of what government does wrong has the influence of big business behind it.

  5. Drug Corporations are there to make a Profit, Nothing Else. Corporations are not Moral beings and we should not be expected them to run a Public Service.
    The Government should have the ability to contract for any drug in short supply, since Drug companies will stop producing medications that do not meet their profit objectives, just like Any other business.

  6. It should a real cautionary, what Bob635 posted, "Having worked for the pharmaceutical industry for 15 years, this is clearly both market and supply chain manipulation for more profit and greed.

    The FDA and the government aren't smart enough to realize what is going on.

    In other countries with national health care, the government buys huge quantities of all drugs under a national supply agreement.

    There never are any shortages or supply problems.

    The government also checks the quality of all purchased drugs. There are no black market drugs or quality problems.

    Too bad for the US and its people. Just another reason to nationalize the health care industry.
    And stop this extortion of the US 99%."

    Our LAWMAKERS need to pay attention to this problem and fix it. Or is it a matter of BIG PHARMA controlling them?

    Blessings and Peace,
    Star

  7. Good reason to stick with the Democrats and deny drug importation from Canada.

    Good reason to stick with the Democrats and bow to Big Pharma campaign contributions by not allowing the several different measures that would lower drug costs and increase availability and that were voted down by the Do Nothing Democrate Senate.

    Unless it's spending more that we don't have, the Senate Democrats led by My Obstructionist himself Harry Reid can be counted on to do nothing when something is needed.