[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 
in 2004.

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 
ingredients.

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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