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Thread: Drugmakers: FDA rules to blame for drug shortages

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    Drugmakers: FDA rules to blame for drug shortages

    OK.....what do you think of this one? http://www.stltoday.com/news/nationa...7a4a78c22.html

    Hospitals across the country are running out of key drugs used in surgeries and to treat some diseases, including cancer, causing doctors to turn to older treatments.

    In some cases, hospitals are paying higher prices to get their patients necessary care because wholesalers are hoarding needed medicines.

    Part of the shortage is being caused by manufacturing issues and quality-control problems at a number of companies as they respond to the federal government’s crackdown on drug safety. The quality issues can include toxins and "particulate matter" in medicines and workers inaccurately filling out the required paperwork to verify that the drugs, as well as the devices used to intravenously deliver the products to patients, are safe and effective.

    Even after a company restarts production of a drug, it takes time to catch up to the back orders. And injectable drugs in particular, unlike pills and tablets, tend to require long lead times to produce.

    "These are the worst shortages I have ever seen," said Thomas Wheeler, a hospital pharmacist for three decades and director of pharmacy for Advocate Illinois Masonic Medical Center in Chicago. "The most troubling aspect is that it is critical drugs for which there are limited alternatives. Many are involved in cancer care and surgery."

    About 150 drugs — triple the number just five years ago — are in short supply, according to the American Society of Health-System Pharmacists. About 60 of those are considered by federal health officials as "medically necessary," and they include prescription medicines used to treat or prevent serious diseases or other medical conditions.

    Drugmakers say they are following tougher safety rules put in place by the U.S. Food and Drug Administration, which has intensified scrutiny to avoid allowing unsafe medicines on the market. The FDA came under fire for its role in monitoring the painkiller Vioxx, which was pulled off the market in 2004 by its manufacturer, Merck & Co., after the drug was linked to heart attacks and strokes.

    The drug shortage is being exacerbated by consolidation in the pharmaceutical industry, which leaves fewer companies making drugs. For example, Teva Pharmaceuticals Ltd. makes generic forms of some cancer medications. So when quality issues temporarily closed its plant in Irvine, Calif., in April, medical professionals were faced with limited supplies of an array of cancer drugs.

    In addition, some drug companies have stopped making older, generic injectable drugs, which typically aren’t as profitable as newer brand-name medicines. That puts additional production pressure on the remaining makers of generic treatments.

    Teva decided last year to stop making propofol, a popular anesthetic for surgeries and other medical procedures, because of a quality issue with the drug in 2009. The company said in a prepared statement that its "existing, approved technology is not suitable to ensure that we can consistently produce the product to Teva’s high quality standard."

    Teva’s decision came around the time another propofol maker, Hospira Inc. of Lake Forest, Ill., had to stop shipping the drug because of quality issues in its production process. Last summer, the FDA allowed Hospira to begin production again. But the company said its new manufacturing process needed a time to increase production and fill back orders.

    The drug shortages have attracted the attention of members of Congress. Last week, Sens. Amy Klobuchar, D-Minn., and Bob Casey, D-Pa., introduced legislation that would require drugmakers to give the FDA early notification "when a factor arises that may result in a shortage," according to a joint statement.

    "Several major hospitals in our state have experienced shortages that are jeopardizing patient care, and this bill will provide the knowledge required to help address and prevent future shortages," Casey said. "Knowledge is one of the most important tools for combating problems associated with drug shortages, which are a growing threat to public health in Pennsylvania and across the U.S."

    Hospitals are finding ways to deal with the lack of availability.

    At Provena Health, which has six facilities in the Chicago suburbs and Illinois, products in short supply have had to be moved "from one hospital to another," spokeswoman Lisa Lagger said.

    Other hospitals are dealing with the supply problem by turning to older medicines. While those drugs can be just as effective, the lack of familiarity among medical professionals can lead to improperly calculated dosages.

    About 35 percent of the health care professionals responding to a survey on drug shortages said they "experienced an error that could have led to patient harm during the past year," according to an Institute for Safe Medication Practices study released in September.

    There were more than 1,000 "errors and adverse patient outcomes" reported by those in the survey. Those errors and adverse outcomes were tied to more than 50 drugs on the shortage list that became abruptly unavailable, the institute said at the time the study was released.

    Some hospitals are escalating the training of doctors, nurses and others who administer the older drugs, which can require larger dosages or have different side effects than newer treatments.

    Some medical facilities have turned to secondary suppliers when their primary source for drugs has run out of needed medicines. And that has caused hospitals to pay double or more for certain drugs because they are working with a supplier that normally doesn’t supply them with large volumes of a product.

    Advocate pharmacists last week said it had to buy certain dosages of the drug neostigmine, used to reverse the effects of "paralyzing agents" commonly used in surgeries, for $11.50 per vial compared with the usual price of $1.50 to $6.50 per vial from their primary wholesaler, which ran out of the medicine.

    "This is a national problem," Advocate’s Wheeler said.

    The drug industry believes the issue will resolve itself relatively soon, and companies say the government’s tougher rules should make consumers and medical professionals feel more confident about their products.

    Teva said its Irvine facility will begin producing cancer medications, including many in short supply, next month.

    And Hospira has increased spending on its manufacturing facilities and quality systems, and the company hopes to be caught up with production by the second quarter.

    On a conference call with analysts and investors earlier this month, Hospira chief executive Christopher Begley said the company’s efforts to meet the FDA’s "higher benchmark" will help the company in the long term.
    "We see light at the end of the tunnel," Begley said.

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