The controversy over prescription drug shortages continues to rage as meds either remain unavailable for treatment and clinical trials or are being sold at high prices on the gray market. At least 15 patient deaths have been reported, a congressional probe is under way, legislation has been introduced and President Obama issued an executive order (seehere and here). In the latest effort to better understand the exact nature of the problem, IMS Health has examined some of the nuances and characteristics, and reports these findings....
The problem is actually highly concentrated in that 83 percent of the drugs for which shortages exist are generics, and 82 percent are injectables, according to IMS. On one hand, these represent a small part of the overall market, but involve critical drugs used to treat cancer, infections, cardiovascular disease, central nervous system conditions and pain. Oncology drugs comprise 16 percent of the meds in short supply, the market research firm finds, affecting nearly 550,000 patients annually. Anti-infectives are a close second at 15 percent. The shortages involve a large number of suppliers, but most of the meds are made by only or two companies.. More than 100 drugmakers supply 168 meds included on the shortages list maintained by the FDA and the American Society of Health-System Pharmacists, but 51 percent of the drugs have only one or two suppliers. And 13 drugmakers have stopped supplying meds on the shortages lists within the past two years, suggesting supplies of still more meds are likely since the slack would not be picked up by other drugmakers (here is the list).
Nine of the companies, or their affiliates have supplied 20 or more products, including Hospira, Teva, Boehringer Ingelheim and Fresenius Kabi, which supplied more than 50 products each. The Boehringer unit, known as Ben Venue Laboratories, blamed capacity constraints, but did not publicly acknowledge ongoing quality control problems that were documented by regulators (see this).
The total supply volume for many of meds in short supply has actually been stable or growing - the total monthly supply volume for all meds on the list has increased 4 percent over the past five years, IMS writes. And, for more than half of the listed drugs, total supply is relatively stable or has increased. At the same time, IMS finds that "significant volatility" exists among suppliers, and this is a new trend.
For instance, for 75 drugs, "supply volume has fallen substantially. A subset of products has experienced supply declines of more than 20 percent in recent months, compared with a three-year base period ending in 2009," IMS writes. "The per-capita supply of injectables has fallen more than 30 percent in 13 states, suggesting significant treatment protocol disruption for patients." Which states? Hawaii, Arizona, Arkansas, Ohio, Massachusetts, Delaware, West Virginia, Florida, Maryland, Nevada, New Jersey, Kentucky and South Carolina.
What to do? IMS suggests an early warning System for drug shortages that should include risk identification, demand forecasting, a volatility index and predictive modeling (you can read the full IMS report here). Separately, the American Medical Association panel of delegates is expected to vote today to require drugmakers to report shortages (see this).
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