[Ip-health] Medication Shortages Surge To Record In 2011
Riaz K Tayob
riaz.tayob at gmail.com
Wed Jan 4 01:10:32 PST 2012
[low margin drugs, vicious competition in the generics sector,
competition with BigPharma that has a patent cushion, perhaps a
production centred bias is needed in addition to a treatment access one?]
Medication Shortages Surge To Record In 2011
Medication Shortages 2011
LINDA A. JOHNSON 01/ 3/12 06:27 PM ET AP
TRENTON, N.J. — The number of new prescription drug shortages in 2011
shot up to 267, well above the prior record and about four times the
number of medication shortages in the middle of the last decade.
Figures just released by the University of Utah Drug Information
Service, which tracks national drug shortages, show there were 56 more
newly reported drug shortages in the U.S. last year than in 2010, when
there were 211. By contrast, there were only 58 drug shortages reported
As the drug shortages worsen, so does their impact on patient care,
particularly in hospitals. The inability to get crucial medicines has
disrupted chemotherapy, surgery and care for patients with infections
and pain. At least 15 deaths since 2010 have been blamed on the
shortages, which have set a record high in each of the last five years.
"At the beginning of the year, we were on a pace of about a shortage
every day," Erin R. Fox, manager of the service, told The Associated
Press. "Luckily, that pace has definitely diminished."
She noted the Food and Drug Administration has said it has prevented
more than 100 new shortages in 2011. That's partly because of an
executive order President Obama issued on Oct. 31 to address the
shortages, with provisions requiring more manufacturers to report
potential shortages in advance to the FDA.
But Fox is still worried because many of the current shortages won't be
resolved anytime soon, based on reports from several key manufacturers
that have had to shut down production because of contamination or other
quality problems. For some medicines, there may be only one other
manufacturer, which doesn't have the capacity to fill the gap
immediately or completely.
In addition, Fox said some of the more recently reported shortages are
very difficult for hospital pharmacists and other staff to manage. She
noted new shortages of sedatives widely used in surgery, including
Valium, Versed and lorazepam. Another big problem is the recent shortage
of the opioid painkiller fentanyl.
"It is used like water in hospitals, for everything from moms giving
birth and ICU patients to the ER," Fox said.
Her service provides hospitals with lists of alternative drugs to those
in short supply, but for some medicines the alternatives also are hard
to find, and switching to an unfamiliar drug can result in dosage errors.
Most of the drugs in short supply are sterile injected drugs that are
the workhorses of hospitals and are normally inexpensive because they've
long been available as generics.
The FDA says the main reason for the shortages is manufacturing
deficiencies leading to production shutdowns. Other reasons include
companies ending production of some drugs with tiny profit margins,
consolidation in the generic drug industry and limited supplies of some
Besides disrupting patient care, the shortages have delayed clinical
trials comparing experimental drugs to older ones and have led to
unprecedented price gouging, with hospitals sometimes having to pay
outrageous markups for scarce drugs. In one case that's among those
under investigation by Congress, a vendor outside the normal supply
chain offered to sell a hospital a vial of a cancer drug that normally
costs about $12 for more than $990.
The FDA and several members of Congress have been holding hearings since
September to identify reasons for and possible solutions to the shortages.
"I hope that we won't have another record-breaking year" in 2012, Fox
said. "But I'm not optimistic."
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