Archive for September, 2007

FDA Warns Consumers about Counterfeit Drugs from Multiple Internet Sellers

The Food and Drug Administration (FDA) is cautioning U.S. consumers
about dangers associated with buying prescription drugs over the
Internet. This alert is being issued based on information the agency
received showing that 24 apparently related Web sites may be involved
in the distribution of counterfeit prescription drugs.

On three occasions during recent months, FDA received information that
counterfeit versions of Xenical 120 mg capsules, a drug manufactured
by Hoffmann-La Roche Inc. (Roche), were obtained by three consumers
from two different Web sites. Xenical is an FDA-approved drug used to
help obese individuals who meet certain weight and height requirements
lose weight and maintain weight loss.

None of the capsules ordered off the Web sites contained orlistat, the
active ingredient in authentic Xenical. In fact, laboratory analysis
conducted by Roche and submitted to the FDA confirmed that one capsule
contained sibutramine, which is the active ingredient in Meridia, an
FDA-approved prescription drug manufactured by Abbott Laboratories.

While this product is also used to help people lose weight and
maintain that loss, it should not be used in certain patient
populations and therefore is not a substitute for other weight loss
products. In addition the drug interactions profile is different
between Xenical and sibutramine, as is the dosing frequency;
sibutramine is administered once daily while Xenical is dosed three
times a day.

Other samples of drug product obtained from two of the Internet orders
were composed of only talc and starch. According to Roche, these two
samples displayed a valid Roche lot number of B2306 and were labeled
with an expiration date of April 2007. The correct expiration date for
this lot number is actually March 2005. Pictures of the counterfeit
Xenical capsules provided by Roche can be viewed at
http://www.fda.gov/bbs/topics/news/photos/xenical.html.

Roche identified the two Web sites involved in this incident as
brandpills.com and pillspharm.com. Further investigation by FDA
disclosed that these Web sites are two of 24 Web sites that appear on
the pharmacycall365.com home page under the “Our Websites” heading.
Four of these Web sites previously have been identified by FDA’s
Office of Criminal Investigations as being associated with the
distribution of counterfeit Tamiflu and counterfeit Cialis.

At this point, it appears that these Web sites are operated from
outside of the United States. Consumers should be wary, if there is no
way to contact the Web site pharmacy by phone, if prices are
dramatically lower than the competition, or if no prescription from
your doctor is required. As a result, FDA strongly cautions consumers
about purchasing drugs from any of these Web sites which may be
involved in the distribution of counterfeit drugs and reiterates
previous public warnings about buying prescription drugs online.

The Marketing of Drugs - Part III

WITH vast and profitable markets up for grabs, drug companies are
aggressively reaching beyond doctors and taking their marketing
messages directly to consumers.

Some of their promotional strategies have become hard to miss. Nightly
news broadcasts — a beloved habit for aging Americans — are brought
to you by the makers of prescription medications for high cholesterol,
arthritis, Alzheimer’s disease and erectile dysfunction; an Internet
search for a specific symptom, or a visit to any popular health site,
will bring up sponsored links and blinking ads for at least one
prescription medication used to treat that symptom; fans of NASCAR see
Viagra advertised every time No. 6 Mark Martin’s car rounds the track.
And women paging through a magazine for tips on reducing clutter can
scarcely avoid the faces and personal stories of actresses who are
managing their depression, osteoporosis or hot flashes with a
brand-name pill.

In 1997, the FDA loosened regulations governing the advertisement of
prescription medications directly to consumers. The change set off
explosive growth in marketing aimed at a general audience long on
interest and — compared with physicians — short on professional
skepticism. Today, drug makers spend roughly $5 billion a year to run
advertising campaigns that use many of the same appeals that marketers
use to sell breakfast cereal and toothpaste.

A study published in the Annals of Family Medicine’s January-February
issue analyzed the messages of 38 advertisements then running during
prime-time TV and found that 95% used emotional appeals to sell the
medication, often framing prescription-drug use as a means to regain
lost control over some aspect of life. None mentioned lifestyle change
as an alternative to product use, although roughly 1 in 5
advertisements suggested it might be a useful complement to the drug.
One in 4 described the causes of the disease the advertised drug
treats, who is at risk for it or how frequently the condition occurs
in the population. The study’s authors, led by UCLA researcher
Dominick L. Frosh, suggested that without such information, consumers
would have little reason to see prescription medication as a solution
that involves risks as well as possible benefits.

In all, 58% portrayed the advertised drug as a medical breakthrough –
a pharmaceutical twist on Madison Avenue’s “new and improved” message.

“It is time to ban direct-to-consumer advertising of prescription
drugs,” wrote Dr. Kurt Stange, editor of the Annals, in an
accompanying editorial. The advertisements consumers see “distort the
relationship between patients and clinicians. [They] manipulate a
patient’s agenda and steal precious time away from an evidence-based
primary care clinician agenda that is attempting to promote healthy
behavior, screen for early-stage treatable disease and address mental
health.”

Even after 23 major pharmaceutical companies agreed to a new slate of
voluntary guidelines limiting their advertising, Stange wasn’t buying
it. Self-monitoring, he wrote, “is not working . . . and cannot
realistically be expected to work.”

PhRMA, the drug manufacturers’ industry group, says direct-to-consumer
advertising empowers patients to take an active role in their
healthcare and spurs them to discuss symptoms, diseases and treatment
options with their doctors that might otherwise go unraised. The
industry group frequently cites a 2002 survey of consumers that found
that 43% were spurred by a prescription-drug ad to look for more
information about the drug or their health.

Although direct-to-consumer advertising has spurred the most political
and professional debate, it is only the most visible means of
prescription-drug marketing aimed at the consumer. To build markets
and encourage consumer loyalty to their products, drug makers have
invested heavily in a tactic known to public relations professionals
as “third-party marketing.” Through voices, groups and activities that
seem independent of them — but frequently are not — drug companies
have found another way to get their messages to consumers.

‘Third-party’ approach
ACCORDING to an article published in the British Medical Journal in
2003, the top five public relations firms specializing in healthcare
earned $300 million in 2002. These firms “are expert at ‘third-party
technique’ — helping the drug industry separate the message from what
could be seen as a self-interested messenger,” wrote authors Bob
Burton and Andy Rowell.

Last October, a commentary in the New England Journal of Medicine
detailed one little-noticed third-party marketing venture.
Underwritten by Eli Lilly, the campaign was designed to increase the
use in hospitals of a drug commercially known as Xigris, for the
treatment of sepsis, or blood poisoning. A preliminary study had
suggested some safety concerns with Xigris, and an FDA advisory panel
had urged more thorough study of the drug before its approval. But in
2001, the FDA approved its entry into the market. The controversy
appeared to sap first-year sales of Xigris, which fell short of
Lilly’s expectations.

Lilly’s response was to secure the services of a small public
relations firm, New York-based Belsito and Co. Belsito would begin
spreading the word to physicians and media outlets specializing in
medical news that Xigris was being rationed and that physicians were
being “systematically forced,” because of the drug’s high cost, to
decide which patients would live and which would die. A $1.8-million
educational grant from Lilly would fund the creation of a group of
physicians and bioethicists — named the “Values, Ethics and Rationing
of Care Task Force” — to study this rationing and its ethical
implications. And a Surviving Sepsis campaign was launched “in theory
to raise awareness of severe sepsis and generate momentum toward the
development of treatment guidelines,” wrote Dr. Peter Q. Eichacker and
two fellow investigators based at the National Institutes of Health,
in the NEJM.

Lilly’s financial inspiration of the campaign aimed at physicians,
patients groups and the media was not apparent to many of the
audiences reached. But its effect was quite clear, concluded a case
study of the campaign done by the Council of Public Relations Firms:
Sales of Xigris “have begun to trend upwards. Through the first
quarter of 2004, Xigris sales were up 36%.”

In such campaigns, public relations companies operate as off-site
extensions of a drug company’s marketing department. But sometimes,
the relationship of a drug company and a third-party voice is more
complex. The tie between patient-advocacy groups and drug companies is
a good example.

Drug makers richly support the nation’s proliferating patient-advocacy
groups, and only a handful of the charitable organizations refuse the
sponsorship of pharmaceutical firms, says Georgetown University’s Dr.
Adriane Fugh-Berman, who has studied these ties. That link presents
rich marketing opportunities for corporate sponsors with an interest
in reaching the patients the organizations advise and represent,
Fugh-Berman says. But it also raises real questions about the
independence of patients groups, she adds.

In marketing trade publications, the value of patients’ groups is
widely touted. As friends and allies to potential customers, groups
dedicated to patients who suffer from a specific condition can be
powerful marketing tools. Patients seek information and emotional
support from these groups, and trust them as an unbiased source of
advice. Groups that empower patients to seek treatment are eager to
foster awareness of their disease and, in the process, expand their
membership. When they are successful, patients groups have a natural
market-building effect.

But drug makers have the deep pockets, and patients groups — until
they’re very large and well-established — are constantly scrambling
for money. As a result, according to those calling for reform, the
relationship is not always an alliance of equals.

“There’s an inherent conflict of interest,” says Merrill Goozner,
editor of Integrity in Science, a publication of the Washington-based
watchdog group the Center for Science in the Public Interest. “The
question becomes, ‘Are you doing the best for the patients you
represent, or are you doing the best for your sponsors?’ ”

Goozner says that patient-advocacy groups are especially vulnerable to
carrying drug companies’ messages, untempered by skepticism, directly
to their members. “They’re desperate” for a cure or treatment, he
says. “And no one likes to be told that this latest breakthrough is
not all it’s been cracked up to be,” especially when it’s being pushed
by a company that’s been generous with funding, he adds.

Last October, the magazine New Scientist published a survey gauging
the dependence of randomly selected U.S. patients’ groups on drug
manufacturers. Combing through the tax returns, annual reports and
voluntary disclosures of 29 nonprofit patient-advocacy groups, the
publication found that most accepted financial backing by companies
developing or producing drugs used to treat patients supported by the
group. In some groups, such as the American Heart Assn., the drug
makers’ financial backing was huge ($23 million in 2005) but
represented a small portion (4%) of revenue. For seven groups,
donations from interested drug companies represented more than
one-fifth of revenue. The Depression and Bipolar Support Alliance said
it received more than half of its 2005 funding from the drug industry,
and the Colorectal Cancer Coalition got 81% of its funding from drug
makers.

New Scientist’s probe found that some donations appeared directly tied
to marketing interests. In 2003 and 2004, when the drug giant Pfizer
was developing a drug to treat restless leg syndrome, it was a major
donor to the Restless Legs Syndrome Foundation. But in 2005, after
Pfizer announced it had abandoned development of the potential drug,
its donations to the patient group dried up.

Many of the best-known groups, including the Alzheimer’s Assn.,
American Cancer Society and American Diabetes Assn., typically have a
board of physicians who vet the scientific accuracy of the information
they provide to patients. And most solicit “unrestricted” grants that
allow them freedom to use the drug makers’ donations as they see fit.

But even large groups often provide a gateway to the products of
corporate sponsors, say those who have surveyed them. Many list
FDA-approved medicines available to treat the disorder that is their
focus and provide Web links that lead patients directly to marketing
sites. And many offer their corporate sponsors access to their
members, a potential gold mine of direct-marketing opportunity.

The corporate-donor pitch posted on the website of the national
infertility patient group, Resolve, is typical of many patient groups.
“Whether you become a site sponsor, a resource partner, or a sponsor
of Resolve’s chats, [the group’s website] is the ideal place for your
company to market its products and services to thousands of men and
women across the country,” the appeal states. Among the benefits the
group lists for becoming a member of the group’s “Corporate Council”
are access to data on utilization of the group’s programs and services
and “the opportunity to establish topics and sponsor special briefings
for patients, the medical community and public policy makers.” Serono
and Organon, both makers of prescription medication used to treat
infertility, are among the group’s corporate sponsors.

Patient groups also mobilize patients — sometimes armies of them –
to push for coverage of prescription drugs by insurance companies and
states’ Medicare and Medicaid agencies. To pharmaceutical companies,
this can make or break the market prospects for a new drug because 80
million Americans — among them, the heaviest prescription-drug users
– receive healthcare coverage through Medicare and Medicaid, and
roughly 155 million have prescription drug coverage through private
insurance companies.

Strength in numbers

WHEN insurers balk at reimbursing patients for new prescription
medications, these groups typically swing into action, rallying
sufferers to appear before public and consumer panels, contact
lawmakers, and provide media outlets a human face to attach to a
cause. Infertility patients mobilized by Resolve, for instance, have
been extremely effective in extending states’ insurance coverage of
infertility treatments. Groups such as the Depression and Bipolar
Support Alliance have fielded experts and patients who have done the
same for psychiatric conditions. And a wide range of patient groups,
most with substantial backing from the makers of erectile dysfunction
drugs, have mounted successful campaigns to get wary insurers to cover
drugs such as Levitra, Viagra and Cialis.

The Marketing of Drugs - Part II

AS guardians of the nation’s prescription pads, doctors are the
gatekeepers that stand between American patients and the
pharmaceutical companies that have drugs to sell them.

Physicians’ choices — whether to medicate, with which medication,
generic vs. brand-name drug, and for how long — profoundly affect
sales of a drug company’s products. So pharmaceutical manufacturers
focus the bulk of their marketing budgets to influence those choices.
The drug companies’ promotional efforts reach into physicians’
offices, pervade their medical specialty organizations and often shape
the messages that doctors receive in educational settings.

“There is a big bucket of money sitting in every office” a drug
representative visits, said an AstraZeneca marketing director in a
widely circulated newsletter interview. “Every time you go in, you
reach your hand in the bucket and grab a handful,” said Mike
Zubillaga, who was fired after his blunt comments made their way onto
the Internet last April.

Each day in the United States, an army of roughly 100,000
pharmaceutical company sales reps storms the waiting rooms and offices
of the nation’s 311,000 office-based physicians. Called “detailers” –
and earning, on average, $81,700 per year — they are the smiling,
well-dressed men and women often seen in a physicians’ waiting room
toting a cavernous briefcase and making small-talk with the
receptionists. Their ranks have more than doubled in the last 10 years.

Sales reps say they want nothing more than to drop off drug samples
that doctors can dispense at no cost to their patients, and to brief
physicians on the FDA-approved benefits and risks of the prescription
drugs their companies make. That’s an accurate job description. But it
doesn’t nearly capture the sophistication of their efforts or the
complex web of relationships that marketing departments cultivate with
physicians. In recent years, drug-company insiders have come forward
to detail the enticements, persuasive techniques and market-tracking
systems that their organizations use to nudge doctors’ prescribing
decisions to boost sales. The picture they provide is of an industry
in hot pursuit of physicians’ hearts and minds.

Relationships with drug reps
THE inducements that doctors accept are more than just pads, pens and
gadgets such as the Viagra calculator that stands up on its base when
the “on” button is pushed. A national survey of doctors published in
the April 2007 New England Journal of Medicine found that 94% of
physicians in the six specialties studied reported some type of
relationship with pharmaceutical companies’ representatives. Most
(83%) received food in their workplace, or accepted drug samples (78%)
proffered by visiting representatives. Thirty-five percent reported
that drug companies had reimbursed them for the cost of attending
professional meetings or company-sponsored sessions that satisfied a
physician’s “continuing medical education” requirement. And 28%
received payments for consulting with a drug company, giving lectures
or enrolling patients in trials.

The American Medical Assn. and the pharmaceutical industry group PhRMA
adopted non-mandatory codes of conduct in 2002 that discourage the
offering or acceptance of items that bring only “personal benefit” to
a physician. Shahram Ahari, a former drug rep with Eli Lilly, says
that in many cases, those guidelines have given the practice of
gift-giving “a nice veneer of respectability.”

But the practice’s impact is often unaltered — and may even be
greater than when drug reps were permitted to offer extravagant gifts
such as theater tickets and golf bags. That is because psychologists
have shown consistently that a small token or gesture of friendship
often inspires a sharper sense of obligation in the recipient than
does a showy gift, for which reciprocation is impossible.

Moreover, Ahari says, “the amount of money invested in gifts hasn’t
changed. In the past, I could spend $100 on a golf club and give it to
you. Now, I can spend $100 on a textbook you need so you can spend
your own $100 on that golf club.”

Sales reps bear many gifts, but none is more important than the
prescription drug samples they bring to doctors. In 2003, the
pharmaceutical industry distributed $16.4 million worth of them to
doctors, according to PhRMA, the industry’s most important trade group.

“For me, that’s access,” Ahari says. “The doctors are first grateful
that you’re giving them samples, because it makes them seem like a
hero to patients . . . and when they feel that sense of gratitude,
they feel obliged to spend some time with the drug rep delivering
them.” But in the end, it is the patient who often will pay more,
because even a short course of sample use builds customer loyalty to a
brand-name drug, even when a generic or a cheaper, older drug might be
just as effective.

Among the not-so-well-kept secrets of the medical world is the
physical attractiveness of the men and women who make up the
pharmaceutical sales-rep force. “It seems pretty cynical,” says UCLA
internist Dr. Martin Shapiro. “I mean, the people that do the
detailing aren’t your average-looking individuals.”

Ahari laughs at the description. Pharmaceuticals’ marketing
departments look to hire “young, attractive people, quite charismatic”
– and scientific training is completely optional, says Ahari, now a
researcher at the UC San Francisco’s School of Pharmacy, who describes
his former profession on a website ( www.Pharmedout.org) devoted to
exposing drug company marketing practices.

“They’re looking for gender icons — cheerleaders and ex-military
types — fun to be with, someone with whom you’d like to have a beer
or watch a game,” Ahari says. To establish friendship and assure
access to a physician, a detailer “will scour a doctor’s office for
objects — a tennis racquet, Russian novels, ’70s rock music,” wrote
Ahari and Adriane Fugh-Berman, a Georgetown University physician, in
an article published by the Public Library of Medicine in April.

Small practices and family physicians are most intensively courted.
And doctors whose prescribing practices are not circumscribed by
healthcare companies or hospital formularies get extra attention as
well. According to the New England Journal of Medicine survey
published last April, family practitioners reported they met with
pharmaceutical-company detailers, on average, 18 times per month, more
than four times the average for all doctors that was reported in a
2000 study. Trailing not far behind them were internists (10 meetings
per month), cardiologists (nine) and pediatricians (eight).

Outside the confines of a doctor’s office, pharmaceutical marketing
efforts become more extravagant.

At physicians’ association meetings and at conferences and seminars
that provide “continuing medical education” for doctors, drug-company
sponsorship is substantial. Both have become important venues for
courting physicians over meals and in appealing venues. Both provide
opportunities for drug companies, indirectly, to pay speaking fees to
favored physicians. And a recent Senate Finance Committee report
concluded that, in spite of efforts to stem the practice, both are
used by pharmaceutical companies to boost physicians’ prescribing of
their products.

Sponsorship of seminars
AT a recent hearing of the Senate Committee on Aging, Dr. Jerome
Kassirer of Tufts University School of Medicine described meetings of
medical societies and associations as “mini-circuses, replete with
enormous glittering displays and hovering attractive personnel.
Although couched as education,” he added, “these marketing efforts are
thinly disguised bribes.”

UCLA internist Shapiro, who as president of the Society for General
Internal Medicine in 2002 sought to limit drug company sponsorship,
calls it “the walk of shame.” At almost every major medical meeting he
attends, he said, “there are these opportunities to get free things
that are questionable — and that clearly are not intended to sharpen
the rational decision-making skills of a physician, but to have an
impact . . . on how they prescribe medications.” It’s not enough, he
added, to close your eyes and walk past them: Pharmaceutical company
money has largely underwritten the programs doctors will attend and
the administration of the professional association that organizes the
event.

Medical societies “have become dependent on the infamous ‘unrestricted
grant’ from numerous pharmaceutical companies,” Dr. J. Gregory
Rosenthal, a Toledo, Ohio-based retinal surgeon, told the Senate
Committee on Aging in June. “In this context, ‘unrestricted’ means,
‘Use this for whatever you want, but if you ever want another, don’t
displease us.’ ”

Physicians’ “continuing medical education” requirements also have
provided drug companies ripe marketing opportunities, experts say. In
2005, drug companies spent $1.12 billion to fund sessions that
physicians attend to maintain their license to practice.

In recent years, new guidelines have sought to distance those grants
from companies’ marketing departments. Still, the Senate report noted,
“drug companies routinely fund educational grants to support programs
that favorably discuss the companies’ newer and more lucrative
products, thereby encouraging physicians to prescribe these products
and, ultimately, driving sales.” Where doctors are typically a
skeptical audience for direct pitches, “when the favorable message is
delivered in the context of education — even if corporate sponsorship
is disclosed — there is an imprimatur ofcredibility and
independence,” investigators noted.

Some of those programs appear to have been forums for pushing
“off-label” uses for prescription drugs, a back-door means of
expanding its market. About one-fifth of prescriptions that doctors
write are for off-label uses — to treat a condition other than that
for which FDA has found a drug safe and effective. Although it’s legal
for doctors to write off-label prescriptions, it is illegal for a drug
manufacturer to market its drugs for off-label uses.

In 2004, Warner-Lambert (now a division of Pfizer Inc.) paid $430
million to settle claims that it was using continuing education grants
to promote off-label uses of Neurontin, an epilepsy drug. In 2005,
Serono Laboratories paid $704 million to settle claims in a case that
alleged it was using educational programs to boost sales of the AIDS
drug Serostim for off-label uses.

The 50 state attorneys general who accepted the settlement of the
Neurontin case have used $21 million to establish the Consumer and
Prescriber Grant Program, www.ohsu.edu/cpgp/, designed to provide
healthcare professionals and consumers information related to
prescription drugs and their marketing.

Consider Ordering From Tech Lectures

I recently did something that I thought was the right thing to do in
helping a former student with her hospitalization bills. I generally
have no problem in helping others in need, but this did set me back
very much as I paid a hospital bill in excess of ten thousand dollars.

I suppose most of us would have seen that if we cannot afford this,
than we cannot help. I saw this, but I also saw a young lady who had
no insurance and a former student that had so very much potential in
the betterment of her life.

Call me very kind or stupid as they both seem to equate to each other
in certain situations. I suppose a few who know the specifics would
of done the same thing, but most would of simply closed the door as we
tend to think of our own needs over others.

Anyways due to this I need help and am asking for you to order from
Tech Lectures yourself or find someone who may find Tech Lectures to
be of value to them. Yes there is a fee, but for those who have not
tried Tech Lectures, much is offered in specific Pharmacy Technician
CE offerings and in the value of actually learning something. Also,
the Tech Lectures Review Manual/Workbook has helped many in the
passing of the national exam and always includes FREE email support.

I am proud and not one to beg…so I am asking for orders and not
donations. Your help during this time will be greatly appreciated.

The Marketing of Drugs - Part I

FOR many Americans, a doctor’s decision to prescribe medication is
something of a sacred transaction. A physician considers the patient
and symptoms and chooses the best drug for the job, drawing upon years
of training and clinical experience. It is an exchange conducted in a
hushed sanctuary, far from the heat and noise of the marketplace — a
place where cool judgment reigns.

That sanctuary has been breached. Today, drug manufacturers do
everything in their considerable power to ensure that their brand-name
prescription medications are on the lips of patients and in the minds
of physicians every time the two meet across an exam table. A growing
chorus of critics says their efforts have begun to rewrite the
dialogue between patient and doctor, influence physicians’ judgments
and open the act of prescribing to forces more profit-minded than sacred.

In 2006, drug-makers spent almost $5 billion to reach out to consumers
with direct advertising. But the glossy magazine ads and
buzz-generating TV spots are just the most visible parts of a campaign
to build and nourish markets for brand-name prescription products. The
world’s pharmaceutical companies spend an estimated $19 billion
annually to woo doctors. They sponsor teaching programs and research
at universities across the country, gaining goodwill along the way.
They give money to patient groups. They hire public relations firms to
share patient stories of illness and triumph.

In a nation that consumed $279-billion worth of prescription
medications in 2006 — spending 80% of that on brand-name products –
their efforts appear to be paying off. Americans filling a
prescription choose brand-name products 37% of the time, even though
three-quarters of all prescription drugs in the U.S. are available in
cheaper generics.

“The most effective marketing is the marketing you’re not aware of,”
says Dr. Peter Rost, a one-time pharmaceutical company marketing
executive who has become an Internet-based industry watchdog. “If you
see an ad, you know it’s marketing. But if a friend or your doctor
talks to you about a drug, you don’t.”

Now the size, scope and apparent effectiveness of drug companies’
marketing efforts has begun to prompt cries of foul even from within
the medical establishment, which has long been silent about its
growth. In a handful of state legislatures across the country,
lawmakers already have acted to blunt drug-company marketing, and many
more are considering similar measures. Lawmakers on Capitol Hill have
suggested that federal legislation may come next.

At stake, critics say, are patients’ health, the nation’s healthcare
budget and, ultimately, the trust and esteem in which Americans hold
their physicians. Costs rise as more doctors prescribe brand-name
drugs when cheaper, older or more effective drugs might be available.

Under-treated conditions that threaten the lives and wellness of large
swaths of the population — illnesses such as diabetes and high blood
pressure — may get less attention than conditions such as erectile
dysfunction or insomnia, for which pharmaceutical firms have new and
potentially more profitable offerings. And patients may be steered
toward newer drugs with risks and side effects that are less
well-known, in lieu of medications with a longer history of safe use.

“There is nothing fundamentally wrong with advertising products,” Dr.
Jerome P. Kassirer, a former editor of the New England Journal of
Medicine, told a Senate committee recently. “But when financial
incentives yield inappropriate or dangerous care, when they
inordinately raise the cost of care, when they risk patients’ lives in
clinical trials, and when they damage the profession, they have gone
too far.”

The pharmaceutical industry counters by arguing that its marketing
efforts are needed to recoup the cost of drug development and that
they introduce Americans to medicines that can save lives and improve
well-being. The industry’s sponsorship of research and education
pushes the process of drug discovery and development forward,
drug-makers say. Companies’ marketing to physicians keeps busy
clinicians abreast of new therapies and scientific advances in a
fast-changing landscape. And their advertising of drugs in mass-media
outlets educates patients and improves their communication with
doctors, they add.

And drug marketing improves the economic vitality of the nation, a
representative of the drug industry’s largest trade group, PhRMA, said
at a recent Senate hearing. Prompted by drug industry marketing, more
patients in recent years have sought out a doctor, and more doctors
have looked for signs of under-treated conditions such as depression,
diabetes and asthma among patients, Marjorie E. Powell, an attorney
for PhRMA, said to the Senate Select Committee on Aging in late June.
Citing a pair of studies published in 2003, Powell said that in the
long run, increasing treatment of such chronic conditions should drive
down the nation’s healthcare bill.

Diabetes, the 21st century epidemic

So you’re finding yourself thirsty all the time — a lot more than
usual. Or you’ve been really, really tired lately. Can’t seem to get
enough sleep.

Maybe you’ve dropped a bunch of weight — without even trying. Funny,
but these days, it seems you always have to go pee, even when you’ve
just gone.

You dismiss it all as just something you’re going through. Something
that will pass.

Well, it could be that you’ve developed something that’s going to
stick around for the rest of your life.

You could be one of the almost 250 million people around the world who
has diabetes. A third of those people aren’t even aware they have the
condition. Forty-six per cent of them are between 40 and 59 years old.
Quick facts 2007 2025
World population (billions) 6.6 7.9
Number of people aged 20-79 years with diabetes (millions) 246 380
World diabetes prevalence (%) 7.5 8.0
Source: Diabetes Atlas: International Diabetes Federation
(Read the article)

Go Walgreens!

A jury awarded $25.8 million Friday to the family of a cancer patient
who was given a wrong prescription, had a stroke and died several
years later, lawyers said.

Beth Hippely was prescribed Warfarin, a blood thinner, in 2002 to
treat breast cancer. The prescription filled at a Walgreens pharmacy
was 10 times what her doctor prescribed, court documents said.

The Polk County Circuit Court jury found the prescription error caused
a cerebral hemorrhage resulting in permanent bodily injury, disability
and physical pain. The mother of three died in January at the age of 46.

A 19-year-old pharmacy technician, with little training, misfiled the
prescription, according to court documents.

The lawsuit was filed in 2003 by Hippely, her husband Deane Hippely
and their children against the Deerfield, Ill.-based Walgreen Co. for
negligent breach of duty and wrongful death.

“Beth Hippely died unnecessarily because this tenfold overdose with
Warfarin by the pharmacy she trusted caused her cancer to come back
with a vengeance and it interrupted all of her cancer treatments,” her
lawyer Chris Searcy said. “They have been seeking justice for almost
five years and this was a case that screamed out for justice.”

A statement released by the company expressed sympathy for the Hippely
family.

“We’re truly sorry for what the Hippely family has been through, and
we’ve personally apologized to them,” Walgreens spokeswoman Carol
Hively said in a statement. “We have been, and continue to be, the
leader in pharmacy safety initiatives. We had hoped the verdict would
have been fair and reasonable.”

Hively said the company had not decided if it would appeal the decision.

Study Indicates Abbreviations Pose Threat to Patient Safety

Although abbreviations in health care may be efficient, their use
comes at the expense of patient safety, according to a new study
published in the September 2007 issue of The Joint Commission Journal
on Quality and Patient Safety. The findings of this study provide
further support for The Joint Commission’s “Do Not Use” list of
abbreviations that is part of its National Patient Safety Goals. The
study also suggests the need to consider additions to the “Do Not Use”
list.

Although abbreviations are known causes of medication errors, the
study-The Impact of Abbreviations on Patient Safety-is the first to
examine the exact characterization and impact of these errors. The
study collected and analyzed data through a retrospective review of
errors resulting from abbreviations as reported to the United States
Pharmacopeia’s MEDMARX®, a national database for medication errors,
from 2004 through 2006.

The study found that nearly 5 percent of all errors reported to
MEDMARX® during this time period were attributable to abbreviations.
This analysis of nearly 30,000 medication error reports involving
abbreviations suggests that health care organizations should consider
additions to the “Do Not Use” list. Candidates for an expanded list
include drug name abbreviations (for example, PCN, DCN, TCN), stem
abbreviations (amps, nitro, succs), µg (mcg), cc (mL), and dose
scheduling (BID, TID, QID).

The authors of the study, led by Luigi Brunetti, Pharm.D., a clinical
assistant professor at the Ernest Mario School of Pharmacy at Rutgers,
The State University of New Jersey, note that communication is the
leading cause of sentinel events and that abbreviation use hinders
communication. Sentinel events are unexpected occurrences involving
death or serious physical or psychological injury, or the risk
thereof, that are tracked by The Joint Commission.

The study also characterizes error-prone abbreviations as preventable
problems that are a logical area for improvement.

“Accurate communication in the health care environment is a critical
component of patient safety. Our analysis of errors reported to the
USP MEDMARX® medication error reporting system confirms that
abbreviation usage contributes to lapses in communication and may lead
to patient harm,” says Brunetti.

The notable findings in the study include:

* The most common abbreviation resulting in a medication error was
the use of “qd” in place of “once daily,” accounting for 43.1 percent
of all errors.

* The other most common abbreviations resulting in medication
errors were “U” for units, “cc” for mL, “MSO4″ or “MS” for morphine
sulfate, and decimal errors.

* Eighty-one percent of the errors occurred during prescribing,
while errors during transcribing and dispensing were much less
frequent, representing only 14 percent and 2.9 percent of errors,
respectively.

* Abbreviation errors originated more often from medical staff in
comparison to nursing, pharmacy, other health care providers, and
non-health care providers.

* The three most common types of abbreviation-related errors were
prescribing, improper dose/quantity, and incorrectly prepared medication.

The study also found that in nearly 40 percent of the errors in which
abbreviations were identified as the cause of error, the exact
abbreviation was unidentified. The authors urge individuals and
organizations reporting medication errors to include the key points
that adequately describe the error, including the cause of the error,
a brief description of the cause (in the case of abbreviations, which
abbreviation), the contributing factors, the outcome, staff involved,
and the point in the medication process when the error occurred in
order to learn from the errors and improve patient safety.

Germs - They’re Everywhere

I am instructing a Medical Asepsis class and have come up with great
information and better understanding of pathogens (disease causing
microorganisms) and infectious diseases as well. Anyways here is an
interesting blurp I came across.

Something to think about when you are making those IV’s

Joe Medina, CPhT

———–
Disgusted by Port-A-Potties? Freaked out by fast-food restrooms?
Believe it or not, picnic tables and ATMs may harbor more germs.

A new report puts our germ fears into perspective. In a nationwide
telephone survey of 1,000 adults, each adult was asked to rate the
surfaces they considered germy. Those answers were then compared with
real studies of bacteria on various surfaces.

You guessed it: The bulk of germs are hiding where you least suspect
– playground equipment, the phone receiver, ATMs, and elevator buttons.

“This survey shows that people have a false sense of security when it
comes to germs,” says Charles Gerba, a.k.a. “Dr. Germ,” a professor of
environmental microbiology at the University of Arizona, in a news
release.

It’s a real health problem, because 80% of infections are spread by
hand, Gerba says. The solution is proper hand hygiene with soap and
water or an alcohol-based sanitizer, he says.

Among his survey’s findings:

* 64% think public restroom doorknobs have more germs than a
typical ATM but a typical ATM has been proven to have more germs
because of the number of dirty hands that touch each of these items.
* 75% think the toilet seats in fast food restaurants have the
most germs — but airplane toilet seats are worse.
* 76% assumed that Port-A-Potties were off-the-chart germ wise –
but picnic tables actually have more germs.

The germ facts:

* At home, the kitchen sink is one of the places with the most
germs — harboring more germs than the bathroom. The most contaminated
sites are those that tend to remain moist. The dishcloth, toilet bowl,
garbage can, refrigerator, and bathroom doorknob are also high on the
list.
* At work, phone receivers harbor more germs than any surface –
even more than the toilet seats. Desktops, keyboards, and elevator
buttons are also on the workplace top germ-covered list.
* In public places, playground equipment, escalator handrails,
shopping cart handles, picnic tables, and Port-A-Potties are top germ
carriers.

Also, only 17% of Americans wash their hands after shaking hands –
yet 51% wash them after sneezing or coughing. It’s part of the
misconception that germs are spread in the air rather than by hand
contact.

About E-Coli

You can’t see it, smell it or taste it. But food or water tainted with
E. coli O157:H7 can leave you fighting for your life, especially if
your immune system is compromised or you’re very young or very old.

Seven people died and more than 2,300 others fell ill in Walkerton,
Ont., in May 2000, in Canada’s worst-ever E. coli outbreak after the
bacteria got into the town’s water supply. The source of the
contamination was manure spread on a farmer’s field near one of the
town’s wells.

While the Walkerton case was unusual, health authorities across the
country normally deal with a few thousand cases of E. coli illness a
year. In the U.S., it’s estimated that 73,000 people are sickened by
the bacteria every year and 61 people die.

While the vast majority of people fully recover from a bout of E. coli
within a week to 10 days, some people will spend the rest of their
lives dealing with the after-effects of the illness.
What is E. coli and where does it come from?

E. coli, short for Escherichia coli, is a type of bacteria commonly
found in the intestines of animals and humans. There are hundreds of
strains of the bacterium, but E. coli O157:H7 has been identified as
the most dangerous to people, producing a powerful toxin that can
cause severe illness.

It was first recognized in the United States in 1982, when an outbreak
of severe, bloody diarrhea was traced to contaminated hamburgers,
leading to the illness to be dubbed as “hamburger disease.”

E. coli O157:H7 can contaminate ground beef during the butchering
process. If it is present in the intestines of the slaughtered animal,
it can get into the meat as it is ground into hamburger.
How does E. coli spread?

While E. coli is most often found in meat, it is not limited to it.
The bacteria is also found in unpasteurized milk and apple cider, ham,
turkey, chicken, roast beef, sandwich meats, raw vegetables, cheese
and contaminated water. In September 2006, an E. coli outbreak that
killed three people and made more than 200 ill was traced to spinach
grown in California. Bean and alfalfa sprouts have also been recalled
due to E. coli contamination.

Fruits and vegetables that grow close to the ground are susceptible to
E. coli contamination if, for example, improperly composted cattle
manure is used as a fertilizer.

E. coli, salmonella and cryptosporidium can also be found in
unpasteurized juice. Children, the elderly and people with compromised
immune systems are encouraged to drink pasteurized juice or boil
unpasteurized juice before consuming it.

Once someone has eaten contaminated food, the infection can be passed
person-to-person, by hand-to-mouth contact. The bacteria are most
often spread from person-to-person.
What are the symptoms of E. coli O157:H7?

Symptoms — characterized by severe abdominal cramping — can appear
within hours, but could also take up to 10 days to show up. Some
people may also be afflicted with bloody diarrhea or non-bloody
diarrhea. Frequently, no fever is present.

Some people may show no symptoms at all, but can still carry the
bacteria and pass it on to people who will become sick.
How is it treated?

In most cases, symptoms clear up on their own within five to 10 days.
The use of antibiotics is not recommended.

But in a small number of cases, E. coli contamination can lead to a
condition called hemolytic uremic syndrome (HUS). This is a
life-threatening condition that is treated in hospital intensive care
units. It kills three to five per cent of people who come down with
it. Some people who recover still have to contend with lifelong
complications that can include blindness, paralysis and kidney failure.
How does E. coli get in the water?

According to the U.S. Environmental Protection Agency, the presence of
E. coli in water is a strong indication of recent sewage or animal
waste contamination.

E. coli comes from human and animal wastes. During precipitation, E.
coli may be washed into creeks, rivers, streams, lakes, or
groundwater. When these are used as sources of drinking water — and
the water is not treated or inadequately treated — E. coli may end up
in drinking water.
What precautions can I take to minimize my risk?

Proper food handling techniques can go a long way towards preventing
exposure to E. coli. All ground meats should be cooked thoroughly so
the center is no longer pink. Other steps you can take include:

* Refrigerate or freeze meat as soon as possible after buying it
and then thaw frozen meat in the refrigerator, not on the counter.
* Place cooked meat on clean plates. Don’t re-use dishes that have
been in contact with raw meat.
* Use a digital food thermometer when cooking ground beef, which
should be cooked to an internal temperature of at least 71 C (160 F).
* Serve cooked meat immediately or keep it hot (60 C or 140 F).
* Clean and sanitize countertops and utensils after contact with
raw meat.
* Don’t store raw and cooked food together.
* If you marinate meat, don’t use the liquid as a dip or to pour
over cooked meat.
* Drink only pasteurized milk or cider.
* Drink water from a supply known to be safe. If you have a
private water supply (well) it should be tested several times a year.

Since most cases of E. coli contamination are passed from person to
person, good personal hygiene is critical to protecting yourself:

* Wash your hands thoroughly and frequently.
* Don’t handle food if you are suffering from diarrhea.
* Wash raw fruits and vegetables thoroughly before cooking or
cutting them.
* Sanitize food preparation surfaces and utensils.

Anyone known to be infected with E. coli, should not share dishes,
cutlery or glasses with anyone else. Their towels, face cloths and
bedding should be washed separately in hot water and bleach.

« Previous PageNext Page »