Medication Shortages Continue To Plague the US

At one time or another, we may have gone to a doctor to receive help with a medicalMH900448643 condition. More often than not the medical issue has been resolved when the physician writes a prescription for some wonder drug.

You take that order to your local pharmacy, get the medication filled and administer it as prescribed. In due time, the medical issue either goes away or at least becomes manageable.

MB900409125But what would happen if you stopped at your local pharmacy and your pharmacist handed the prescription right back to you and said, “This drug is unavailable. There’s a severe shortage.” We, as patients, rarely give medication supply issues a thought. In our advanced medical system, the pharmaceuticals we require always seem available.

What if they weren’t? Pharmaceutical shortages in the United States are becoming a major medical issue. The number of new and long-term medication shortages has increased by almost 300% between 2007 and 2012, and the shortages are being viewed as a permanent part of the American medical system structure.

The drug categories most affected are those involved in treating severe medicalMH900308894 conditions. The most common shortages were for generic sterile injectable pharmaceuticals, particularly IV fluids and chemotherapy drugs.

Other formulas in dangerous short supply include the heart medication nitroglycerin and cisatracurium, a drug that is used to paralyze muscles during surgery and for patients on ventilators. Without these medications, such life-saving procedures would not be possible.

Erin Fox, the director of the University of Utah’s Drug Information Service and a contributor of data for this analysis, stated, “We are at a public health crisis when we don’t have the medicines to treat acutely ill patients…” In some cases, doctors have had to ration chemotherapy drugs in their clinics or have been forced to use less effective alternatives.

There are several contributing factors that create drug shortages: 1) There are only three manufacturers that produce 71% of this country’s sterile injectable cancer drugs and any production issues (like raw material delays or quality control issues) result in production delays that become more difficult to eventually overcome, 2) many of the factories that make generic sterile injectable medications are aging and this makes the production lines prone to quality control problems that result in either temporary manufacturing shutdowns or closings of entire factories, 3) pharmaceutical companies that manufacture these drugs have not expanded production adequately to account to the increased need of these specific life-saving drugs, and 4) changes in Medicare reimbursements and group purchasing organization’s negotiated rates have driven down prices that pharmaceutical makers receive for their products, making production of these medications less profitable.

MH900321056So, as a nation, what are we doing about this pharmaceutical shortage crisis? In 2012, the US Food and Drug Administration was given additional power to manage the shortages and the US Government Accountability Office was designated to evaluate the FDA’s response to this problem.

With this new law, drug manufacturers were then required to alert the FDA of potential shortages before they become critical so that the industry as a whole could react more effectively to increase production of a medication on the verge of being unavailable.

A recent Congressional hearing on this matter discovered that the number of new shortages actually declined in 2012 for the first time in several years. Additionally, it was shown that the 2013 data indicated similar downward trends in medication shortages.

Ultimately, the solution to this problem is to require that the various entities in the nation’s healthcare system be responsible for maintaining adequate pharmaceutical supplies, and the recent data analysis suggests that this is happening.

Thoughts? Comments? I’d love to hear them!

About James J. Murray, Fiction Writer

With experience in both pharmaceutical manufacturing and clinical patient management, medications and their impact on one’s quality of life have been my expertise. My secret passion of murder and mayhem, however, is a whole other matter. I’ve always loved reading murder mysteries and thrillers, and longed to weave such tales of my own. Drawing on my clinical expertise as a pharmacist and my infatuation with the lethal effects of drugs, my tales of murder, mayhem and medicine will have you looking over your shoulder and suspicious of anything in your medicine cabinet.
This entry was posted in About James J. Murray, About Medications/Pharmacy, Blog Writers, Blogging, Cheap Generic Drugs, Chemotherapy Supply Shortage Issues, Drug Shortages in the US, FDA and Drug Supply Shortages, Generic Drug Safety, Generic Drugs, Generic Drugs in the US, IV Medication Supply Issues, Medication Safety Issues, Medication Shortages in the US, Pharmaceutical Shortages in the US, Pharmacy/Pharmaceuticals, Prescription Trends, Reasons for Medication Shortages in the US, Shortages in the US Drug Distribution Chain, The Pharmacy Profession and tagged , , , , , , , , , , , , , , , , , . Bookmark the permalink.

8 Responses to Medication Shortages Continue To Plague the US

  1. wrLapinsky says:

    Jim,
    Another disturbing piece of information, but one that a lot more people need to be aware of. Short of assuming the problem with fix itself, there are only two paths to a solution. Government, and capitalism. The government continues to demonstrate its inability to manage anything complex, is very slow to change, stifles innovation, and makes most decisions on the basis of politics instead of the public interest. This is not unique to the US government, and historically the ability of a government to react gets worse the more it tries to take over. In this case, the government has clamped down on prices without considering the side effects of that — those side effects that you outline quite well. We aren’t saving money, we are wasting money when the right drug is not available and a less-effective alternative is forced on doctors. Delays or bad outcomes significantly increase the cost of care delivery.
    Walt

  2. John Holton says:

    Only three manufacturers produce 71% of the injectable drugs needed for chemotherapy? The solution is pretty obvious: get more manufacturers to produce injectable drugs for chemotherapy. Find the reasons that more manufacturers don’t produce chemotherapy drugs and remove the barriers. My guess is that many of those bottlenecks are in Washington.

    • Thanks for your comments, John. I’ve only shown the “tip of the iceberg”, so to speak. Read further comments for some specific reasons injectable drugs (like chemotherapy meds) are in such short supply and what can be done to improve the situation. All the best!

  3. If you want to understand the REAL root cause of the drug shortages, read our 9/3/13 New York Times oped,”How a Cabal Keeps Generics Scarce”:http://www.nytimes.com/2013/09/03/opinion/how-a-cabal-keeps-generics-scarce.html. Then sign our Change.org petition demanding that Congress address it. Here’s the link: http://chn.ge/1d8sRck.

    Phillip L. Zweig MBA
    Executive Director
    Physicians Against Drug Shortages
    http://www.physiciansagainstdrugshortages.com
    http://www.philliplzweig.com

    • Phillip, thanks for your interesting comments and for the links to further information on this crisis. I especially appreciate the link to the petition page and hope my readers will take your advice and sign the petition to get the attention of Congress.
      Many thanks for sending the information and the link. All the best!

  4. Arlee Bird says:

    I hadn’t heard about this disturbing issue and what involving Washington isn’t disturbing. I’m sure it all boils down to money. Somebody somewhere wants more. There’s never a shortage of political posturing and corporate strategizing.

    Lee
    Wrote By Rote
    An A to Z Co-host blog

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