WASHINGTON (Reuters) - At the Henry Ford Hospital in Detroit,
pharmacists are using old-fashioned paper spreadsheets to track their
stock of drugs in short supply - a task that takes several hours each
day.
Most of the hospital's medicines - an estimated
$100-million supply a year - are tracked by automated systems that allow
for quick reorders when the supply runs low. But these automated
systems, designed to help the hospital avoid purchases and storage costs
of unused pills and vials, do not work if it is uncertain when the next
batch of drugs will come in.
A few hundred medicines make the list of drugs in short
supply: anesthetics, drugs for nausea and nutrition, infection
treatments and diarrhea pills. A separate list has scarce cancer drugs
for leukemia or breast cancer.
"Now we have to go through the pharmacy and count those
drugs on a daily basis ... to make sure we don't run out," said Ed
Szandzik, director of pharmacy services at the hospital for over a
decade.
The growing scarcity of sterile, injectable drugs is
one of the biggest issues confronting hospitals across the country, and
will be a key issue at the annual American Society of Clinical Oncology
meeting in Chicago this weekend.
Health officials blame the shortages on industry
consolidation that has left only a handful of generic manufacturers of
these drugs, even as the number of drugs going off-patent is growing.
Some drugmakers have been plagued by manufacturing problems that have
shut down multiple plants or production lines, while others have stopped
producing a treatment when profit margins erode too far.
Some medicines have been periodically short in the
past, doctors and pharmacists say, but the number of drug shortages has
escalated in recent years, jumping from 56 in 2006 to 250 last year,
according to U.S. Food and Drug Administration figures.
Generic drugmakers like U.S.-based Hospira Inc and
Israeli Teva Pharmaceutical Industries say they are building new
facilities to prevent future shortages.
But in the meantime, pharmacies around the country are
counting pills, begging neighboring hospitals for extra supplies and
scouring the Internet for news of additional supply disruptions.
When rumors surface of an impending shortage, some
pharmacies rush to buy up more than they need, likely leading to bigger
shortages, analysts and other pharmacists said.
All of this requires regular attention from hospitals
to manage the crisis. At Children's National Medical Center in
Washington, D.C., pharmacists and administrators meet weekly to discuss
just how dire the situation is for different medicines.
"Every Wednesday before we have that (meeting), I have a
bit of anxiety," said Ursula Tachie-Menson, acting chief of the
hospital's pharmacy division. She spends about 30 percent of her time
each week addressing shortage-related problems.
"Out of all the (21) years I have been practicing,
these drug shortages have been one of the biggest challenges," she said.
EARLY WARNING SYSTEM
The FDA has been acting under an October executive
order from President Barack Obama to fill in the gaps. It has had
success getting an early warning from drug companies when they foresee a
new shortage, allowing the agency to persuade other manufacturers to
increase their production or look overseas to guarantee supply.
"I can tell you that there's not a single company I'm
aware of out there that isn't talking to the FDA," said David Gaugh,
head of regulatory sciences at the Generic Pharmaceutical Association,
referring to the trade group's members.
The FDA said early notification has helped prevent 128
shortages in six months. It also estimates the rate of new shortages is
slowing, with half the number of new scarce drugs this year compared to
last.
But surveys and anecdotes continue to pile up, showing
doctors' efforts to find scarce drugs have not gotten easier. This
month, a website for U.S. oncologists, MDLinx, surveyed 200 doctors and
found more than 90 percent of them have experienced shortages of key
cancer drugs.
CANCER, ANESTHESIA, NUTRITION
A clinical nutrition group, the American Society for
Parenteral and Enteral Nutrition, found that 70 percent of the
800-member nurses, doctors, and pharmacists who responded to an online
survey said they had seen shortages of adult injectable multi-vitamins,
used for basic nutrition for patients with intestinal issues.
More than a quarter were not giving their patients
multi-vitamins because of the shortages, placing them at risk of severe
vitamin deficiencies that can lead to issues like anemia, due to a lack
of folate, or scurvy, which happens when people do not get vitamin C.
In extreme cases, a deficiency of a type of B vitamin called thiamine can lead to cardiac arrest or death.
"This is an act of daily living for people now," said
Jay Mirtallo, president of the group. "How that can be acceptable, I
don't understand."
When a drug is not available, doctors have to seek
alternatives, which may not work as well or cost more money. Others have
to ration limited supplies of a life-saving treatment to only those who
need it most.
Dr. Steven Allen, a specialist in blood cancers at
North Shore University Hospital in New York, recently treated a young
woman who had suffered several relapses of a life-threatening cancer
known as acute lymphoblastic leukemia.
Allen found a combination that involved thiotepa, an older drug his patient had not tried and could tolerate.
"When I ordered it, I was informed that there was none
available, and it couldn't be obtained," said Allen, also chair of the
committee on practice at the American Society of Hematology. He
substituted a similar drug, but one that the woman had already taken.
"We tried to make up a dose that was equivalent to thiotepa and hoped
for the best. ... But I think it may have compromised her care."
On May 14, the FDA announced it would allow temporary
imports of thiotepa made by Italian company Adienne Pharma &
Biotech, to relieve manufacturing delays at Bedford, Ohio-based Bedford
Laboratories, a unit of the private German company Boehringer Ingelheim
that is the only approved manufacturer for the United States. Bedford
said in April it does not know when further shipments would be available
once its supplies run out.
Imports have not helped anesthesiologists like Jason
Soch, who hears about a new shortage nearly every week during his
rotations at several surgical centers in Philadelphia. These are often
"workhorse" drugs such as fentanyl, midazolam and propofol, used every
day during surgery.
"It seems like as soon as one drug is no longer in
shortage, we get an email from the hospital pharmacist that they're on
their last box of another," he said. Every disruption forces doctors to
change dosing, or give new drug combinations they may not be as familiar
with.
"I didn't envision this when I went to anesthesia," Soch said. "I'd figured we'd have whatever we needed."
SCRAMBLING FOR A FIX
The problem has inspired some creative solutions, like a
drug shortages mobile application called RxShortages that allows
medical and pharmacy staff to track new drug shortages posted on
websites, including the FDA's. Mick Schroeder, a pharmacy resident who
created the app, said it has been downloaded about 25,000 times.
Brooke Bernhardt, an oncology pharmacist at Texas
Children's Hospital, said she checks RxShortages at least once a day.
"Unfortunately, at any point we expect a drug to go on back order," she said.
Ed Szandzik, the pharmacy director at Henry Ford
Hospital in Detroit, admits he would buy a larger quantity of drugs than
usual if it became available.
"If I have to get one or two months' supply, I'll buy
it, because our patients need it," he said. "Hoarding is in the eye of
the beholder."
Some distributors and manufacturers prevent hoarding by
allocating drugs based on historical demand. Other pharmacists say it
is natural to want to buy more to ensure supply.
"Why did it ever have to get to this point in the first
place?" said Szandzik. "It takes a lot of hours, a lot of labor, a lot
of luck to make sure our patients are safe. ... And I don't see it
getting better for a while."
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