fined $1.55 million for missing drugs
An investigation into 20,000 tablets of prescription narcotics missing from
St. Joseph's Medical Center in Stockton has led to Dignity Health, the
state's largest hospital chain, paying a $1.55 million penalty for
mishandling medications, federal prosecutors said Wednesday.
Investigators claimed Dignity Health facilities in the Sacramento area -
including St. Joseph's hospital in Stockton - failed to properly record
hundreds of transactions involving controlled substances and had
insufficient procedures and controls on the distribution of such drugs.
In its agreement with the U.S. Attorney's Office in Sacramento, the hospital
will pay $1.25 million immediately, while the remaining $300,000 penalty
will be deferred as Dignity Health institutes a two-year plan to correct its
record-keeping systems and improve its ability to detect and prevent
diversion of prescription drugs.
Reported losses of more than 20,000 tablets of hydrocodone, an opioid
narcotic, from the outpatient pharmacy at St. Joseph's triggered a Drug
Enforcement Administration investigation of Dignity Health in late 2010 and
2011. A DEA audit revealed significant shortages of a number of the
controlled substances at the pharmacy, and further investigation revealed
that several Dignity Health locations failed to keep the required records.
Prosecutors said Dignity Health executive leadership worked cooperatively
with the DEA and the U.S. Attorney's Office throughout the probe.
Visit the Record for the report.
FDA warns of
deadly dangers of powdered caffeine
The death of an Ohio teenager is prompting the Food and Drug Administration
to warn consumers about the dangers of consuming pure powdered caffeine sold
online. Even a teaspoon of the powder could be lethal ‚ÄĒ it is equivalent to
25 cups of coffee. Logan Stiner, 18, of LaGrange, OH, died May 27 after
consuming the product, officials said. The FDA said it is investigating
caffeine powder and will "consider taking regulatory action."
Teenagers and young adults may be particularly drawn to the powder, which is
a stimulant. Caffeine powder is marketed as a dietary supplement and is
unregulated, unlike caffeine added to soda. FDA spokeswoman Jennifer Dooren
said those who drink coffee, tea or soda may be aware of caffeine's less
serious effects, like nervousness and tremors, and may not realize that the
powdered form is a pure chemical. "The difference between a safe amount and
a lethal dose of caffeine in these powdered products is very small," she
said. Symptoms of caffeine overdose or toxicity include rapid or erratic
heartbeat, seizures, vomiting, diarrhea and disorientation.
Visit NBC News for the story.
‚ÄėThere is no such
thing as Ebola‚Äô
‚ÄúI don‚Äôt believe in Ebola,‚ÄĚ Craig Manning‚Äôs local driver told him as he
chauffeured the viral emergency specialist through Freetown, Sierra Leone,
where infection rates are rising. The man came from a rural part of the
country where people were already dying from the virus. He was adamant, like
many others in his community, that ‚Äúthere is no such thing as Ebola.‚ÄĚ
He is wrong. The epidemic, the deadliest on record, continues to batter
Sierra Leone, Guinea and Liberia, with 85 new cases and 68 new deaths
reported in only four days earlier this month, according to the World Health
Organization (WHO). Sierra Leone bore the brunt of new infections and
deaths, with 49 new cases and 52 deaths reported. The total number of cases
stands at 982, with 613 deaths as of July 17.
Yet, as the Ebola virus continues to spread in West Africa, so do the
rumors. Some say you can contract Ebola from a motorcycle helmet. Others say
you can cure the deadly virus by drinking Nescaf√© mixed with cocoa and sugar
‚ÄĒ or with two large onions. It‚Äôs Manning‚Äôs job to take onions out of the
A health communications strategist with the Viral Special Pathogens Branch
of the Centers for Disease Control and Prevention, Manning was sent to
Guinea at the first outbreak of the Ebola crisis in March. When one of his
colleagues, Pierre Roland, an expert on Ebola, gave a presentation at the
U.S. Embassy in Conakry about mitigating risks of transmission, Manning
recorded him. He then had the edited 30 second snippets translated into 10
local languages and broadcast over local radio stations and TV.
When the virus spread to Sierra Leone, Manning followed it, teaming up with
BBC Media Action to bring together radio station managers from across the
country to help spread the word.
Manning said aggressive intervention is necessary to prevent more people
from becoming infected, but ensuring local populations understand Ebola
first is essential. For instance, in areas where the virus has spread,
relatives wash bodies by hand before funerals, putting families at risk of
‚ÄúPeople do not easily accept the idea that teams will take their deceased
loved one, put them in a bag and bury them somewhere different,‚ÄĚ said
Manning. ‚ÄúThe challenge is to strike a balance.‚ÄĚ
This balance demands communication, according to WHO spokesperson Daniel
Doctors Without Borders has been unable to gain access to some affected
areas due to hostility from the people there. Local communities fear
outsiders are bringing the virus with them or want to exterminate the
infected, since so few who get treatment return alive.
WHO is helping coordinate information sessions on Ebola to train local
leaders how the virus is transmitted and how people can stop it.
WHO has been operating emergency Ebola hotlines in the affected countries
that get 200 to 300 calls a day. The organization is exploring text
messaging, since 40 percent of affected populations use mobile phones.
Doctors Without Borders have brought anthropologists on board in an attempt
to better understand the traditions and cultures of the people they are
While expert advice is important, the key to getting the message through to
communities in more isolated areas is building a network of local
spokespersons and engaging religious and cultural leaders.
There have been small victories. Manning said his driver had come to trust
Visit the Washington Post for the article.
different? Shape and color changes may prompt lapses
In a decade, Americans have saved an estimated $1.2 trillion by taking
generic drugs instead of the high-priced originals. But the booming market
in copycat prescription pharmaceuticals - coupled with insurance companies'
efforts to keep healthcare costs low - often means that when they refill a
prescription, patients get a familiar medication in a new shape or color.
That may be a bad idea, a new study says.
Research suggests that switches in a given medication's color or shape may
prompt many patients to discontinue needed medicine. The authors of the
study - a group of prescription drug researchers from Boston's Brigham and
Women's Hospital - urge the Food and Drug Administration to rethink its
hands-off policy when it comes to regulating the appearance of generic
It's a timely problem. In recent years, the makers of dozens of the nation's
most prescribed medications have lost their exclusive marketing rights to
drugs they developed. And generic manufacturers have rushed in to offer
less-expensive generic versions of those drugs. Statin medications, blood
pressure drugs, antidepressants and sleep aids that were long available in
just one form are now offered in shapes and colors that differ from the
first-to-market drugs they imitate.
Under FDA rules, all generic versions of the statin drug Lipitor (known as
atorvastatin), for instance, must have the same active ingredient as the
original, and that medication must be delivered in the same way. But the
generic versions of Lipitor are typically different from one another, and
the Pfizer-made original, in size, shape, color and formulation.
The drug manufacturers who make these generics negotiate deals with
pharmacies, mail-order pharmacy benefit managers and hospital formularies,
which are constantly shopping for the best prices. As a result, a mail-order
pharmacy, for instance, may dispense one generic manufacturer's statin drug
one month and refill it a month later with the same drug made by a different
manufacturer. Unwitting patients will often have no idea why this month's
prescription medication looks different from last month's.
The authors surmised that such patients may lose confidence in their
medication's safety or effectiveness, or that the change causes the kind of
confusion that leads to medication errors such as failing to take one drug
or doubling up on another. Most of the patients studied were sent home from
the hospital with a number of prescription medications, so keeping
medication schedules straight would probably have been challenging enough
even before the pharmacy dispensed medications that are changed in color or
The latest study compared heart attack victims who, after leaving the
hospital, continued for a year to take common heart medications with similar
patients who discontinued their medications in the year following their
heart attack. Among those who lapsed in taking medications to prevent a
second heart attack, the discontinuation followed a change in the shape or
color of the pill they were dispensed in 7% of the cases.
More than color changes, a reconfiguration of a pill's shape raised the
likelihood of a patient failing to adhere to his or her medication regimen.
In a recent study focusing on epilepsy drugs, the same researchers found a
similar pattern, in which changes in a pill's shape made a bigger impact
than changes in its color.
Compared with those who continued to take their heart medications, those who
lapsed were 30% more likely to have experienced a change in their
medication's shape or color, the researchers found.
The study was published in the Annals of Internal Medicine.
Visit the Chicago Tribune for the study.
AbbVie is biggest
to quit U.S. address in $55 billion Shire deal
AbbVie Inc. agreed to buy Shire Plc for about 32 billion pounds ($54.8
billion), becoming the latest U.S. healthcare company to shift its tax
residence abroad in a record surge in industry deals.
AbbVie Inc. and Shire Plc‚Äôs deal will make AbbVie the largest U.S. company
to move its legal address abroad to lower its taxes as U.S. lawmakers seek
ways to curb the transactions.
The acquisition comes in a record period of pharmaceutical deals. It will
allow North Chicago, IL-based AbbVie to move its legal residence, though not
its operations, to the U.K., lowering its tax rate in 2016 to 13 percent
from 22 percent.
Shire‚Äôs drugs for attention deficit hyperactivity disorder and rare diseases
will diversify AbbVie‚Äôs portfolio, dominated by the rheumatoid arthritis
Analysts asked if the deal was done primarily for tax reasons. ‚ÄúThis is a
transaction that we believe has excellent strategic fit, well beyond the tax
impact,‚ÄĚ AbbVie Chief Executive Officer Richard Gonzalez said on a
conference call. ‚ÄúWe wouldn‚Äôt be doing it if it was just for the tax
impact.‚ÄĚ At the same time, Gonzalez said the higher corporate tax rate in
the U.S. is pushing companies abroad. ‚ÄúCompanies like ours need access to
our global cash flows,‚ÄĚ he said. ‚ÄúToday we‚Äôre at a disadvantage compared to
our foreign competitors, and that‚Äôs the debate we should be having around
inversions and our tax code.‚ÄĚ
The U.S. government has been scrutinizing so-called tax inversions, and
Senator Ron Wyden, a Democrat from Oregon, is proposing a bill that would
make them more difficult to do. A congressional panel estimated this year
that preventing future inversions would preserve $19.5 billion in otherwise
forgone tax revenue over the next 10 years.
In the negotiations, Shire sought protection in case the U.S. passes a law
undercutting the tax gains and puts the deal‚Äôs closing at risk, said two
people with knowledge of the matter. The agreement calls for AbbVie to pay
Shire a breakup fee of 3 percent of the deal‚Äôs value, or about $1.6 billion,
or reimburse costs of not less than $500 million, if the purchase falls
through, according to the statement.
AbbVie was split off from Abbott Laboratories in January of last year,
creating a brand-drug company out of the larger healthcare conglomerate
that‚Äôs now focused on medical devices and nutrition products. Abbott was
involved in a tax inversion this month as well, selling part of its
off-patent drugs business to Mylan Inc., allowing the generic drugmaker to
shift its legal address abroad.
Visit Bloomberg for the article.
Drug alert - Lack
of sterility assurance in sterile drug products by Downing Labs
FDA is alerting healthcare professionals and consumers not to use drugs
marketed as sterile produced by Downing Labs LLC, also known as NuVision
Pharmacy, in Dallas, as they may be contaminated. Administration of a
non-sterile drug product intended to be sterile may result in serious and
potentially life-threatening infections or death.
FDA investigators inspected NuVision and observed insanitary conditions that
result in a lack of sterility assurance of purportedly sterile drug products
produced by the company, which puts patients at risk (Form FDA-483 issued
July 16, 2014). The inspection revealed sterility failures in 19 lots of
drug products intended to be sterile, endotoxin failures in three lots of
drug products, and inadequate or no investigation of these failures.
Endotoxins are substances found in certain bacteria that cause a wide
variety of serious reactions such as fever, shock, changes in blood
pressure, and in other circulatory functions.
Healthcare professionals should immediately check their medical supplies,
quarantine any sterile drug products from NuVision, and not administer them
to patients. Patients who have received any drug product produced by
NuVision and have concerns should contact their healthcare professional.
Read the FDA Drug Alert.
with assisting illegal pharmacies
Federal authorities on Thursday charged FedEx with assisting illegal
pharmacies by knowingly delivering painkillers and other dangerous drugs to
customers without prescriptions.
The indictment was filed in federal court in San Francisco, and the
Department of Justice announced the charges in Washington, DC. The
indictment alleges that FedEx Corp. conspired with two related online
pharmacies for 10 years ending in 2010.
The Memphis, TN-based delivery company is accused of shipping powerful
sleeping aid Ambien, anti-anxiety medications Valium and Xanax, and other
drugs to customers who had no legitimate medical need and lacked valid
FedEx insists it did nothing wrong. FedEx first disclosed the federal
investigation in a regulatory filing in November 2012. The company said at
that time it had done nothing wrong and intended to fight any charges.
Rival shipping company UPS Inc. paid $40 million last year to resolve
similar allegations, and the Atlanta-based company said it would ‚Äė‚Äėtake
steps‚Äô‚Äô to block illicit online drug dealers from using its delivery
Both companies said in regulatory filings that they were served with grand
jury subpoenas between 2007 and 2009. The investigation of the country‚Äôs two
largest shippers stems from a blitz against online pharmacies that was
launched in 2005 in San Francisco. Since then, dozens of arrests have been
made, thousands of websites shuttered, and tens of millions of dollars and
pills seized worldwide as investigators continue to broaden the probe beyond
Google Inc. agreed to pay $500 million to settle allegations by the Justice
Department that it profited from ads for illegal online pharmacies.
A federal jury in 2012 convicted three men of operating illegal pharmacies
that used FedEx and UPS to deliver drugs without proper prescriptions. Seven
others were convicted in San Francisco previously. (Associated Press)
Visit the Boston Globe for the article.
vaccine 'shows promise'
Scientists say they have developed the world's first vaccine against dengue
fever seen to work in large-scale trials. Research in the Lancet
journal suggests more than 50% of children who are given the vaccine are
protected against the disease. Half the world's population is at risk of
catching the mosquito-borne virus.
Experts say though the long-awaited study is promising, vaccines with
greater effectiveness are crucial. There are currently no treatments to
prevent dengue fever - an illness which affects more than one million people
In the largest late-stage trial of a vaccine to date, researchers from five
centers across Asia treated 6,000 children aged between two and 14 years
old. Some 56% were seen to have protection against the virus at the end of
two years. It worked best for children with certain subtypes of the virus
and those who had been exposed to it before.
And the vaccine had an even greater impact on severe forms of the disease,
reducing the number of people needing treatment in hospital and preventing
80% of cases of hemorrhagic fever - a potentially life-threatening
Lead author Dr Maria Rosario Capeding, from the Research Institute for
Tropical Medicine in the Philippines, told the BBC: "Given that dengue is a
major public health problem in most Asian countries the findings have the
potential to have a huge impact on public health.
Prof Martin Hibberd of the London School of Hygiene and Topical Medicine who
was not involved in the study said: "The biology of dengue is complex and
has troubled researchers for many years. ‚ÄúI am very glad they have tackled
this, but I am disappointed the vaccine is only 56% effective - much lower
than our normal targets. Nevertheless this is the most significant reduction
we have seen to date - the best we have so far. And many nations spend huge
amounts of money trying to prevent the spread of this disease."
He suggests people who have been given the vaccine should be monitored for
at least five years to ensure it remains effective and safe. And further
questions need to be addressed, including how much of an impact it will have
in other parts of the world.
Sanofi-Pasteur, the company funding the research, plans to apply for
approval once the results of its second trial across Latin America and the
Caribbean have been analyzed.
Visit BBC for the study.