Shortages of Important Drugs Give Rise to Concerns Over Safety of “Grey Market” Replacements

72199_1959_02272012.jpgShortages of certain prescription medications are nothing new to most pharmacists, hospitals, and doctors. According to the American Hospital Association, nearly 99.5 percent of U.S. hospitals reported some drug shortages in the first half of 2011, with 44 percent experiencing shortages of more than twenty drugs and 78 percent rationing drug supplies to deal with shortages. The Food and Drug Administration (FDA) reports that the number of drugs reported to be in short supply has increased from around 55 in 2006 to 178 in 2011, and the number could go as high as 350 for 2011 when statistics become available. Aside from basic problems of availability of medications to patients who might desperately need them, the situation also lends itself to unscrupulous behaviors like price gouging and hoarding. The nonprofit research and advocacy group CorpWatch recently issued a report on concern over “grey markets” that spring up for certain drugs that are in demand but also in short supply.

“Grey markets” can endanger patients not only by charging high prices for drugs, but also by removing key quality control procedures and the professional safeguards enjoyed when dealing with licensed doctors and pharmacists. The CorpWatch report describes how a New Hampshire woman found her routine appointments for cancer treatment cancelled when the hospital could no longer obtain her medication. Her particular medication, doxorubicin, trade name Doxil, is used to treat breast cancer and many other forms of cancer, and it is one of the few possible treatments for many people.

The CorpWatch report claims that Doxil’s manufacturer, Johnson & Johnson, actually subcontracts many of the stages of production, which has caused significant delays in production schedules for the drug. A single facility in Ohio manufactures Doxil, according to the Los Angeles Times, and it reportedly cannot keep up with demand. The plant closed temporarily due to concerns over product safety, which only made the shortage worse.

The FDA recently announced that it has approved the importation of shipments of substitutes for Doxil and another cancer drug, methotrexate, from foreign manufacturers. Lipodox, a drug manufactured by Indian company Sun Pharma Global, will temporarily replace Doxil. Australian company Hospira will send shipments of its version of methotrexate, a drug used to treat childhood leukemia. At best, these shipments will cover shortages for no more than a few months. Doctors interviewed by the New York Times stressed that this solution is extremely temporary.

The concern for medication error attorneys is that drug shortages and the solutions they often encourage, particularly substitute drugs and “grey market” drugs, make medication errors and injuries more likely. Doctors with extensive knowledge of a particular, commonly-used drug that is presently in short supply may not know all the possible side effects of a substitute medication. This is especially true of drugs manufactured abroad and imported specifically to offset a shortage. As for the quality of the imported drugs, as imperfect as the FDA might be, at least doctors generally know how it works and can often trust its recommendations. This is not to say that drugs manufactured abroad are not safe, but they do create possible risks that doctors may not know about.

The Maryland pharmacy error attorneys at Lebowitz & Mzhen are skilled at assessing liability and damages for injuries caused by medication errors and helping their clients obtain compensation. For a free consultation to review your case, contact us today online or at (800) 654-1949.

More Blog Posts:

Online Pharmacies Offer Savings, but Also Present Risks, Pharmacy Error Injury Lawyer Blog, January 19, 2012
Hospitals and Pharmacies Hit by Nationwide Drug Shortages, Pharmacy Error Injury Lawyer Blog, November 3, 2011
Drug Alert Warns Epinephrine Syringe Shortage Could Lead to Dosing Error Risks, Pharmacy Error Injury Lawyer Blog, June 30, 2010
Photo credit: ‘Medicine Capsule’ by Pam Roth on stock.xchng.

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