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The next 12 months could see a noticeable easing of
the chronic shortages that have wreaked havoc in the
generic injectable pharmaceutical industry, as the U.S.
Food and Drug Administration green-lights revamped
"Our vendors and manufacturers say they see con-
tinued rebuilding of internal infrastructure during the rest of 2012,
with more products coming into the market starting in the third and
fourth quarters," says Craig Coulter, director, Pharmacy Strategic
Sourcing for HealthTrust.
Barring some major catastrophe, manufacturers tell HealthTrust
the supply of mission-critical drugs should be much improved by
the end of 2012, and much of the problem should be significantly
mitigated in 2013.
At the same time, Coulter and Stephanie Thompson, PharmD,
BCPS, HealthTrust director of Clinical Pharmacy Services (now
director of clinical economics, HCA Clinical Excellence), caution
that renewed stability won't prevent occasional spot shortages
caused by temporary manufacturing or delivery interruptions or
gray market opportunists. They also note the price of stability is
higher costs for even generic versions of these drugs.
Still, the anticipated turnaround can't come soon enough for
HealthTrust members or vendors, as the situation has only wors-
ened with time.
"Our members really want answers to this issue. Their pharmacy
budgets have been devastated, and patients are seeing higher
charges for those drugs." Thompson says. "There's very little
that members can do at their level, and that's the biggest source
of frustration they have."
According to member responses in HealthTrust's Annual Drug
Shortages Impact Survey, more than 98 percent of respondents
experienced a shortage of one or more drugs in 2011 and 2012.
According to HealthTrust, a record-breaking 211 medications
were scarce at some point in 2010, and 267 shortages were logged
in 2011. Even more sobering, 72 percent of respondents reported
experiencing daily shortages in 2012 compared to 47 percent in
2011. And more than 26 percent reported a significant adverse
patient outcome over the last 12 months as a direct result of drug
Nationwide, virtually all hospitals confront shortages of mission-
critical drugs, and at least 15 deaths have been linked to the crisis. It
has added hundreds of millions of dollars to pharmacy and operating
budgets and to the costs of patient care. And it has created untold
confusion and concern among patients and their families.
How Did We Get Here?
While the overall problem of drug shortages in the U.S. market is
multifaceted and complex, the reasons for the current situation of
prolonged, chronic drug shortages can be reduced to two primary
factors: years of inadequate FDA oversight and lax manufacturing
quality control, Coulter says.
After revelations about intentionally adulterated heparin
surfaced in 2008, the FDA reacted by ordering immediate im-
plementation of stricter current good manufacturing practices
(cGMP). While vigorous enforcement of cGMP has, in the long
run, been good for the country, the FDA did so without adequately
considering how such a move would impact the U.S. generic
injectables market, Coulter says.
"The generic injectables industry was caught unprepared,
because the FDA had been lax with cGMP for so long," Coulter
adds. "And industry was slow to react at first until the FDA made
some examples, and then they responded either by introduc-
ing numerous new quality assurance steps or by shutting down
troubled production lines."
These actions severely interrupted supplies and inventories
dried up quickly. In some cases, there were only one or two
manufacturers worldwide of a specific medication or Active
Pharmaceutical Ingredient (API), so backup producers were
scarce or non-existent.
"To fully comply with cGMP requirements, many manufactur-
ers have had to make significant investments in new production
Forecast for Supply of
Brighter for 2013
continued on page 24
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