For most people the current generic drug scarcity simply means that the pharmacist handling their prescription will substitute another product for the one the doctor specified but for hospitals the situation is dire.
The Institute for Safe Medication Practices (ISMP) worries that it is “exhausting a tremendous amount of hospital resources”. Its president Michael R Cohen says that at least 15 deaths have been blamed on hospitals substituting unfamiliar drugs for the usual generics and making dosing errors.
Trustee magazine’s Howard Larkin notes that hydromorphone, which is stronger than morphine, was administered at morphine-level dosages and resulted in two deaths then, according to the Fiscal Times, in Alabama because sterile pre-mixed liquid nutrition was not available, hospital staff had to prepare it manually which resulted in the entry of bacterial contamination that killed nine.
Shortage of 178 Medications
A convergence of factors seems to be causing the current shortage of at least 178 medications, a threefold increase since 2005.
First of all, comes Medicare legislation dictating the need for affordable generic drugs which squeezes manufacturers' profits to such an extent that they decide to terminate production or crank out only limited supplies. Then hospitals and 'gray market' wholesalers stockpile particularly scarce medications, in one case because of need in the other for profit. Next a tough Food and Drug Administration screening system clamps down on questionable manufacturing processes. Finally companies face difficulties in getting acceptable drug components.
The situation is so bleak that on November 18, 2011 President Obama signed an executive order urging the FDA to speed up its approval of new drug manufacturers and thus increase production.
“Older and Less Efficient Production Facilities”
Dr Bruce A Chabner of Massachusetts General Hospital wrote, in his article “Drug Shortages – a Critical Challenge for the Generic Drug Market” in the October 31, 2011 New England Journal of Medicine, “The list of generic drugs in short supply across all medical specialties is astounding and includes antibiotics, anesthetic agents, antihypertensive medications, and common electrolyte solutions and vitamins.“ He says generic drugs are made in “older and less efficient production facilities”.
Researchers at the IMS Institute for Healthcare Informatics found that most of the shortages were in generic injectable medications and cancer treatments and that Teva Pharmaceuticals and Hospira made half of them. Murray Aitken, the institute’s executive director told Reuters’ Alina Selyukh that when companies stop production and leave drug supply in the hands of one or two manufacturers it “doesn't provide a lot of flexibility when one might have a manufacturing problem ... Part of the story is there may not be sufficient economic incentive currently in this sector of the market."
Ten Major Generic Drug Suppliers
Jack Kay of Apotex told the Globe & Mail’s Carly Weeks that a major problem his company faces is finding good active ingredients that meet governmental standards. Many originate in China and India where quality control is frequently non-existent.
Fierce Pharma.com lists ten major generic drug suppliers that serve the US market. They are; Israel’s Teva, Germany’s Sandoz, India’s Dr Reddy’s, Canada’s Apotex, US-based Mylan Labs, Watson Pharmaceuticals, Par Pharma, Hospira, Mallinkrodt and Greenstone, a division of Pfizer. The FDA spot-checks all of them and sends out tough letters outlining any infractions it finds.
Expediting Approval of Alternative Manufacturers
Recently, the FDA has signaled that it is hastening inspection of new or refurbished facilities and expediting approval of alternative manufacturers from the United States and abroad. If that goes ahead current drug shortages may become a thing of the past.
Ann Berkeley - Over some years, I covered major news events - the capture of James Earl Ray, Martin Luther King's murderer, the hippie phenomenon, the ...
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