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Gregg Madden

USA Leader Signs Order to counteract Drug Shortages 02-18-2012 - 0 views

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started by Gregg Madden on 12 Apr 12
  • Gregg Madden
     
    President Barack Obama released an executive order for the Food and Drug Administration to do everything possible to detect and stop drug shortages in the united states which have been an issue for years and have recently reached record degrees.

    Flash forward to late-February, once we watched the Food and Drug Administration scramble avoiding shortages of two critical cancer drugs, showing just how big the problem is as the country faced potential danger of running out of Doxil, used to treat ovarian cancer and AIDS-related ingredients like Methotrexate, to address leukemia in kids.

    As a short-term fix, the FDA let provisional deliveries of Lipodox (akin to Doxil) from Canada, and pharmaceutical company Hospira sped up a one-month method to obtain Methotrexate here from some sort of plant in India. The FDA is going to try fast-tracking an application with another pharmaceutical manufacturer to provide Methotrexate.

    Yes, these issues were temporarily put off, none of us should rest easy.

    We spoke with supply chain experts and drugstore managers within the country, I hear two topics repeated often: the issue seems to be not going away anytime soon and it'™s costing tonnes of cash.

    Jill Jones of Shandi Medicine and health in Gainsville, Fla., says the drug shortage situation the new normal.€ She reports that this health system'™s pharmacy workers spends hours every day looking for alternative therapies and pills in a variety of forms or doses. The money necessary for buying drugs has increased by as much as 17 times in some cases, but the medical center pays the high costs. As she put it,"We don'™t balk on the prices. We normally would probably split hairs, but we now have no choice. 

    They also have no choice because patients are in dire need of the medication, for major pain management and often for lifesaving therapies. “We haven’t up to this point had to do anything dramatic or make up your mind that comprises patient treatment, ” said Selzo. “The worst case scenario is always to not have enough doasage amounts. ”

    Doug Bowen, vice leader of supply chain with Banner Health, (whom I interviewed for this issue - see page xx) agrees that drug shortages are a major problem, calling the situation “a play. ”

    Bowen says Banner Health allocates a great deal of staff time to “managing these shortages” because they “try to track off product. ”

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    In response to the President'™s executive document, on Feb. 21 the Food and Drug Administration put out provisional guidance for the pharmaceutical industry on telling the government of incoming lack of supply of prescription drugs and health products.

    The same day, the Obama administration released a document indicating that the executive paper work order has been successful in preventing 112 shortages. According to the statement,€in part, this (prevention) resulted from the government's call for voluntarily notification on the Food and Drug Administration of potential shortages. Notification on the potential shortage is crucial: with enough forward cautionary, FDA can take action to help stop a potential drug shortage. And since President Obama signed his account manager order, voluntary notifications have increased five-fold.€

    Even though administration is pointing to highlight its victories, the supply chain experts I speak with know there'™s a great deal of work still to do to guarantee the best and cost-effective delivery of pills throughout the healthcare system.

    Let us not allow that tiny but influential win to distract us from the very real pharmaceutical supply challenges that persist. This problem should matter to all of us, not just supply chain executives, and we cannot drop sight of the crisis as long as patients are in danger of not receiving the drugs they have to win the battle for a lives.

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