A Shocking EpidemicIt 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.
Though the FDA has scrambled to alleviate the crisis and physicians have become deft at juggling or substituting treatments, there is no comprehensive solution to this drug-supply breakdown, which has persisted for a complex array of reasons.
The first is all about money. As generic drug prices have dropped, so have manufacturers’ profits. As a result, some manufacturers have failed to invest in infrastructure and quality control. To ensure safety, the FDA has taken regulatory actions that have halted supplies, with sterile injectable drugs, such as pain meds and chemotherapy, dominating the shortage list. (These are the most complex and costly generics to make.) The business model of just-in-time manufacturing—in which companies make drugs as patients need them but do not stockpile extra—leaves no margin for unexpected events.
Noting that there are no shortages of big profit-generators, like Viagra, many practitioners and patients suspect less-than-honorable motives by drugmakers. Some experts suggest that manufacturers may have financial incentive to temporarily stop production of a drug. 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.
Limited manufacturing capacity is an important factor too. Over half the drugs on the FDA shortage list had only one or two manufacturers, according to a report by the IMS Institute for Healthcare Informatics. Some blame hospital buying groups, middlemen that purchase drugs and supplies for many of the nation’s hospitals, which have awarded contracts to some manufacturers and not others, thereby suppressing competition and innovation. The result is that for any given drug, there may be only one or two generic manufacturers left to produce it, which can lead to shortages.
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.
But as experts debate the cause of the shortages, there is no disagreement over their devastating impact. They’ve turned pharmacists into professional beggars and have forced doctors to change treatment protocols on the fly—in some cases, turning routine care into a roll of the dice. They’ve stopped clinical trials and have led to the suspension of the death penalty in some states that use lethal injection.
Shortages are leading hospitals and patients to get drugs from less regulated and potentially less safe sources, such as drug compounders, specialty pharmacies that mix medications for individual patients. Some compounding pharmacies, which are not subject to regulation as stringent as that for drug manufacturers, have taken advantage of this and started churning out large volumes of drugs. But this can lead to safety issues. Such dangers became vividly clear in 2012, after contaminated steroids from the New England Compounding Center led to an outbreak of meningitis that killed 64 patients. A 2013 report by the Health and Human Services inspector general found that drug shortages have led 68 percent of U.S. hospitals to turn to compounders to make versions of medicine in short supply.
Patients today have to cope not only with being sick or choosing between treatment options but also with the possibility that the drug they need may be available solely from a risky source—or not at all.
Read more: http://www.rd.com/health/healthcare/drug-shortages/#ixzz36JrrLxps
Behind any shortage you will find government policy or regulations. A few years ago the government decided to regulate the price of flu vaccine. Everybody should be able to buy it at a cheap price, yes? The government also refused to protect manufacturers from lawsuits. All American companies left the vaccine business. That year there was a tremendous shortage. Since then the government has negotiated with foreign suppliers, who, presumably, are not subject to lawsuits. One of the companies early on had been shut down by regulators for unsafe practices. As a result the vaccine was the only product it had at that time. Ain’t well intentioned policies grand?
Have YOU noticed that under ObamaCare, nearly all traditional medical problems (heart, lung, kidney, brain, etc.) are provided for less and less...with the patient absorbing the majority of the cost, but anything sexually related, such as sex changes, abortion, birth control and a plethora of other sexually-related things, are covered nearly completely! What is the message here?
Current FDA drug shortages list (bookmark):
http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
This is why it is a really good idea to be friends with a knowledgeable “compounding” pharmacist. Because if a medicine becomes unavailable, he might be able to fabricate a close facsimile. He also might know some over the counter or prescription alternatives.
Importantly, doctors are not pharmacists, and generally only know a fraction of such tricks.