6/2014, Drug Shortages: The Scary Reality of a World Without Meds

http://www.rd.com/health/healthcare/drug-shortages/

A Shocking Epidemic

It seems unfathomable in our high-tech medical system, but in 2007, 154 drugs were in shortage, a number that almost tripled to 456 in 2012, according to the U.S. Government Accountability Office.

Threatening medical-care options and patients’ lives, drug shortages have occurred in almost every pharmaceutical category. Antibiotics, cancer drugs, anesthesia, pain control, reproductive and gynecological drugs, cardiac medicine, psychiatric drugs, and intravenous-feeding solutions have all been in varying degrees of short supply or not available at all. Recently, nitroglycerin, an emergency room staple used to treat heart attack patients, has been in such severe scarcity that its sole U.S. manufacturer has restricted hospitals to 40 percent of their usual orders. A study published this March in the Mayo Clinic Proceedings attributed more than 15 documented deaths since 2010 to either lack of treatment or the switch to an inferior drug as a result of medication shortages…

Medicare reform imposed certain price controls on generic drugs, but, due to a loophole, these controls are lifted if a manufacturer stops making the drug for six months…

Predatory middlemen are making the situation even worse. A congressional investigation led by Rep. Elijah Cummings, a Baltimore Democrat, has found that shady secondary wholesalers buy up drugs in shortage and resell them, often at exorbitant prices. This explains, in part, the haphazard ebb and flow of the shortages that makes them particularly hard to handle: One day the medicine is just gone, but there’s plenty the next…

Shortages are leading hospitals and patients to get drugs from less regulated and potentially less safe sources, such as drug compounders…

In a recent study from the University of Pennsylvania presented at the 2013 annual meeting of the American Society of Clinical Oncology, 83 percent of oncologists and hematologists said they’ve faced cancer drug shortages, and of those, nearly all said their patients’ treatment had been affected by drug shortages…

Even the FDA has been boxed into a corner. After the cancer drug Doxil became unavailable in late 2011, the FDA made an emergency provision to allow an Indian generic-drug company, Sun Pharma Global, to temporarily export a similar generic drug, Lipodox, which is not approved in the United States. Although patients and doctors applauded the move, Sun Pharma has faced repeated past FDA sanctions for poor quality. (In 2009, U.S. marshals raided its U.S. manufacturing plant and shut down production.)…

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