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September 12, 2014 – ASHP News - Hospira on Thursday announced the recall of a single lot of heparin sodium injection in response to a confirmed report of a human hair contaminating the product.
The recall affects 500-mL flexible plastic containers of heparin sodium in 0.9% sodium chloride injection, lot 41-046-JT, with a labeled expiration date of November 1, 2015. The lot was shipped nationwide from June through August of this year.
According to Hospira, the hair was found between the tube and the film at the round seal of the unused administrative port on one side of the container. The company is investigating the root cause of the problem.
For assistance with product returns, contact Stericycle at 855-201-4337 from 8:00 a.m. to 5:00 p.m. ET Monday through Friday.
Two other injectable products from Hospira were recalled earlier this month.
Lots 35-730-LL and 35-745-LL of buprenorphine hydrochloride injection in needleless syringes were recalled on September 9 because retained samples did not meet stability specifications or are expected to be out of specification before the product's February 1, 2015, expiration date.
Hospira stated that two adverse events have been reported for this lot, but it is not known whether the incidents were related to the amount of pseudobuprenorphine, a known impurity in buprenorphine pharmaceuticals.
The recalled lots were shipped from December 2013 through January 2014. Questions about product returns should be directed to Stericycle at 877-275-6842.
Hospira on September 4 recalled 0.5% bupivacaine hydrochloride injection, lot 37-268-DK, packaged in 30-mL single-dose vials, after confirming a report of iron particles embedded in the glass.
The vials have a January 1, 2016, expiration date and were shipped to customers from May to July 2014.
- See more at: http://www.ashp.org/menu/News/PharmacyNews/NewsArticle.aspx?id=4106#sthash.mqakU7Mo.dpuf
September 30, 2014 – Healthcare Finance News - Hospitals and health systems try their best to anticipate and meet the demand for specific drugs. But drug shortages – whether due to outbreaks of specific illnesses or unanticipated supply bottlenecks – are a fact of life in the medical world.
An American Journal of Health-System Pharmacy (AJHP) survey released earlier this year showed that 98 percent of pharmacy directors “reported at least one drug shortage during the previous month.”
This year alone, U.S. hospitals have had to cope with a shortage of intravenous saline solutions, while hospitals in the Midwest this month have reported shortages of albuterol, a drug used in concentrated form to treat children with respiratory problems. Drug shortages jeopardize the ability of hospitals and health systems to deliver medications to patients in a timely manner, if at all. Forty-three percent of AJHP survey respondents reported treatment delays related to drug shortages, while 21 percent said patients have been referred to and from other facilities.
“The potential for delayed patient treatments related to drug shortages are well documented in the literature,” said Ross Day, director of pharmacy for Novation, a healthcare supply chain services company with more than 100,000 members. “In addition, the incremental labor expenses associated with the day-to-day management of drug shortages within the hospital pharmacy environment are also well documented.”
Indeed, AJHP survey respondents cited numerous extra costs generated from activities required to manage oncology drug shortages, including “increasing inventory, increasing staff time devoted to managing shortages, implementing strategies to minimize product waste, and identifying substitution protocols.”
“The ongoing shortage of I.V. solutions in the U.S. could be the most costly as hospitals are spending a significant amount time managing inventory due to limited supply,” Day said.
An analysis released earlier this year by healthcare performance improvement alliance Premier Inc. estimates that it costs U.S. hospitals $230 million annually just to purchase more expensive generic drugs for shortage drugs. This doesn’t include additional labor costs related to drug shortages, which add about $216 million a year. For hospitals and health systems struggling to cope with cuts mandated by the Affordable Care Act, that adds up to a lot of money.
The good news is that annual new drug shortages in the U.S. peaked at 267 in 2011, dropping to 204 the year after and 140 in 2013, according to the University of Utah Drug Information Service. However, active shortages reached a four-year high (to 306) in the second quarter of this year.
“While it’s encouraging that the number of newly reported drug shortages is trending down, the fact that the number of active shortages remains very high continues to contribute to negative clinical and economic implications for hospital pharmacists and buyers,” Day said.
Respondents to another Premier survey said they rely on a number of strategies to cope with ongoing drug shortages, including adding back-up inventory, better communicating information about shortages to internal stakeholders, and rationing or implementing restrictions.
October 1, 2014 – Reuters - Two tiny companies are preparing to challenge some of the world's largest drug makers in the battle for dominance in the $3 billion global market for influenza vaccines, armed with little more than tiny tobacco plants.
The use of plants to produce life-saving pharmaceuticals captured global attention when it was revealed that the Ebola drug ZMapp is produced in the leaves of tobacco plants.
Even as Ebola cases multiply in West Africa, a far greater market for plant-based biopharmaceuticals will likely be influenza vaccines used to fight pandemics, industry experts said. Making vaccines from plants may turn out to be faster and cheaper than current methods which use chicken eggs to grow the virus needed to make the vaccines.
Leading producers such as GlaxoSmithKline Plc and Sanofi SA need six months to produce flu vaccine once scientists identify the dominant virus expected to circulate during flu season. Vaccine production from tobacco plants by Quebec City-based Medicago or Bryan, Texas-based Caliber Biotherapeutics could do it in weeks.
"Seven to 10 years from now, plants might be the dominant vaccine-production system," said Brett Giroir, an M.D. and CEO of Texas A&M Health Science Center in Bryan. Texas A&M has one of three U.S. facilities tasked by the government with being ready to produce and deliver 50 million doses of flu vaccine in just 12 weeks. It is working with Caliber toward that goal.
If the upstarts succeed, they will make little difference to the tobacco industry, which regards even a $3 billion market as marginal. But they could threaten the pharma giants that dominate flu vaccine production - or be gobbled up by them.
Medicago is now testing its flu vaccine in elderly people, who are most at risk, and plans to launch a large human trial in 2016. "We hope to hit the market in 2019," said Jean-Luc Martre, director of government affairs.
Tobacco plants could be enlisted in the fight against flu even sooner if a pandemic hit. The 50 million doses that labs like Texas A&M's pledged they'd be able to produce in a few months can't be manufactured in today's egg-based systems.
"If there is a need for it that requires plant-based production, we'd turn to Caliber," said Giroir, referring to an accelerated vaccine-production schedule to counter a flu pandemic.
WAITING FOR CHICKEN EGGS
Each year, manufacturers including Sanofi, Novartis, the Medimmune unit of AstraZeneca and GSK make about 155 million doses of flu vaccine for the U.S. market alone, growing the virus in chicken eggs. Usually the doses, which protect against strains that experts predicted the previous February, are ready in time and in sufficient quantity.
But if the strain that appears during flu season was not the one experts forecast, the vaccines might not work. The appearance of H1N1 swine flu in 2009-2010 took experts by surprise, and the flu was already on its second wave before a vaccine was ready; an estimated 61 million people in the U.S. got swine flu and 12,500 died.
Failures such as that led the U.S. government to award $400 million in start-up funding to three Centers for Innovation in Advanced Development and Manufacturing (CIADMs) to boost biodefense and preparedness for pandemic flu.
"There's no way you can produce 50 million doses in 12 weeks" with current production technology, said Giroir. "But plant-based production could."
While one chicken egg can produce one or two doses of flu vaccine, one tobacco plant can produce 50 at a fraction of the cost.
The Defense Advanced Research Projects Agency (DARPA), an arm of the Defense Department that funds cutting-edge research, is impressed enough with the potential of tobacco-plant production systems to have awarded multi-million-dollar grants to both Medicago and Caliber, and so far the support has paid off.
In a 2012 DARPA challenge, Medicago, jointly owned by Philip Morris International and Mitsubishi Tanabe Pharma Corp, produced 10 million doses of H1N1 flu vaccine in just a month in tobacco plants inside its sprawling North Carolina greenhouses. In animal tests, the experimental vaccine successfully triggered the production of protective antibodies against H1N1.
All the company had to go on was part of the virus's genetic sequence. But while in egg-based production whole flu viruses are injected into the eggs, where they replicate and form the basis for the vaccine, all that's really needed to trigger immunity are the proteins that stud the virus's coat.
Those proteins, called hemagglutinins, are what the immune system attacks. They can be produced by splicing the hemagglutinin gene into almost any kind of cell; Medicago uses harmless bacteria to carry the hemagglutinin genes into the tobacco plant leaves.
Technicians at the greenhouses in North Carolina then soak 36-day-old Nicotiana benthamiana plants (cousins of those used for cigarettes) upside down in a liquid containing the Trojan Horse bacteria, explained chief scientist Marc-Andre D'Aoust. Through a process called vacuum infiltration, air is drawn out of the leaves and they suck up the bacteria.
After growing in special chambers for a week, the leaf cells are churning out hemagglutinins. Extracted, purified, and combined with other bits of the virus, they form the basis for a vaccine.
To succeed, the companies will have to persuade the U.S. Food and Drug Administration not only that the vaccine is safe and effective, as clinical trials are designed to show, but also that the hemagglutinin or other proteins can be extracted from the leaves cleanly and that the largely-untested manufacturing process yields a uniform, reliable product.
Major vaccine makers are cautious about the new technology. “We tend to avoid publicly speculating on what future technologies we might embrace,” said Robert Perry, a Glaxo spokesman said.
"Today, all of our flu-vaccine production is in (chicken) eggs," said Rene Labutat, vice-president of manufacturing for Sanofi. "But we are looking at the recombinant approach, including in mammalian cells, algae, fungi and plants."
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