Online pharmacy weblog

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.

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THE pharmaceutical industry defends its promotional spending as a
service to science, physicians and patients. Advertising to patients
helps motivate them to improve their health, manufacturers say, and
detailing doctors keeps them abreast of new therapies and scientific
advances.

Those activities also, indisputably, boost sales. As marketing budgets
climbed toward a 2006 high of $28 billion, sales of prescription drugs
have never been higher. According to estimates published by the Kaiser
Family Foundation, the number of individual prescriptions filled in
the United States rose from 2.9 billion in 1999 to 3.7 billion in
2006; in 1994, Kaiser calculated that each American filled on average
7.9 prescriptions per year, including refills; by 2005, that number
had risen to 12.4.

For every 10% increase in direct-to-consumer advertisements within a
class of similar drugs, sales of drugs in that class (say,
antidepressants or erectile dysfunction drugs) went up 1%, Kaiser
found in a 2003 study. In 2000, direct-to-consumer advertising alone
boosted drug sales 12%, at an additional cost of $2.6 billion to
consumers and insurers.

Of more than 10,000 drugs on the U.S. pharmaceutical market, half of
all marketing budgets are used to promote 50 brand-name medications,
according to a 2003 study in the journal Clinical Therapy. And those
50 drugs are the ones that sell the best.

Prodding patients to prod their physicians, apparently, works. In
2006, a Kaiser Family Foundation survey of 834 office-based physicians
found that 28% of doctors said patients “frequently” asked for
prescription drugs by name after seeing an advertisement. Although
about half said they typically responded by suggesting lifestyle
changes, 14% of the physicians said they would, in many cases,
prescribe a different drug in the same class as the one the patient
requested. And 5% readily acknowledged that they frequently would
prescribe the drug the patient requested.

Physicians see marketing’s effects on their patients every day. But
ask the doctors whether the marketing influences their clinical
judgments or prescribing behavior, and a chill will descend upon the
room, say those who have run the experiment.

“Physicians are heavily socialized to believe that they have risen
above the normal human foibles,” said Harvard University’s David
Blumenthal, co-author of the most recent survey detailing doctor-drug
company interactions. “They clearly recognize that physicians are
human and subject to normal human influences; they just have a lot of
trouble seeing themselves as subject to that.”

Not immune to marketing

BLUMENTHAL finds it revealing that most physicians do not extend to
their colleagues the same trust. In a widely cited 2001 study
published in the American Journal of Medicine, 84% of young physicians
surveyed said they believed that drug industry promotions, including
gifts and meals, influenced the prescribing practices of fellow
physicians. Although most of these doctors acknowledged they were
besieged by back-slapping, sample-toting, gift-giving drug
representatives, 61% said they considered themselves immune to
marketing’s effects.

They are not. A 1994 study found that hospital-based doctors were more
likely to request the addition of brand-name prescription drugs to
their institution’s medicine chest after they had met with sales
representatives detailing those drugs.

Studies published in 1988 and 1992 found that physicians who attended
continuing medical education programs sponsored by drug companies, or
who accepted funding for travel and lodging to attend them, were
significantly more likely to prescribe that company’s drug than those
who did not.

Several studies have found that physicians who accept and hand out
free samples to their patients are far more likely to prescribe those
drugs than those who don’t take or have no access to samples.

Last April, the online medical journal Public Library of Science
published a study tracking the effect of doctor-detailing by sales
reps working for Warner-Lambert, maker of the anti-epileptic drug
Neurontin. The study showed that, following even a brief encounter
with a marketing representative detailing Neurontin, almost half of
the 97 physicians examined found their briefings highly educational
(even when research evidence presented was scant or poor) and
indicated they would step up prescriptions of the drug.

Dr. Andrew Leuchter has spent much of the last two years heading a
UCLA committee convened to redraft guidelines for physicians’
interactions with drug companies. He has faced the skepticism of
physicians when the subject of drug company influence is raised.

“They ask, ‘Do you really think that my medical decision-making can be
influenced by the fact that someone bought me a pizza?’ ” Leuchter said.

“They’re quite sobered” when confronted with the mounting pile of
evidence that it can, he added.

Subtly powerful
DR. Kurt Stange, the editor of the Annals of Family Medicine who
called for an end to consumer advertising of drugs, said the effects
of a detailing visit can be subtle. But, he added, these encounters
are made all the more powerful when physicians either deny or ignore
their influence.

“You’re not overtly thinking, ‘I’m going to prescribe this drug
because I got a pen,” Stange said. “You’re just thinking, ‘What will
help this patient?’ and you’ve been bombarded with advertisements, and
the name is always before you. . . . You have to have a fair amount of
self-awareness to notice that.”

In the end, advocates of reform say, there is no stronger evidence
that drug marketing influences behavior than the simple fact that drug
companies do market their products — and that they are spending more
money doing it than ever before. The makers of the nation’s
bestselling drugs field on average 4,000 sales representatives to
detail doctors, staff booths at medical meetings and organize trips
and meals for doctors, and spend more than $1 billion per year to
market drugs to physicians alone. They spend, all told, roughly $5
billion a year to advertise directly to consumers. Though they are not
counted in marketing budgets, the funds they dispense to support
research, medical professional organizations and patient-advocacy
groups run into the billions.

In terms of cold, hard return-on-investment, that money was well
spent, says a study unveiled in 2001. Tracking prescription sales for
391 drugs and company marketing budgets from 1995 through 1999,
Dartmouth College marketing professor Scott Neslin has calculated,
down to the penny, how well increases in marketing pay off.

Each additional dollar spent on advertising in medical journals
brought $5 worth of sales of a drug, Neslin found, and an extra dollar
devoted to sponsorship of continuing medical education and
professional meetings yielded an average of $3.56 in sales. A dollar
spent on physician-detailing generated sales, on average, was worth
$1.72. But in the case of the most aggressively marketed drugs, that
dollar generated sales of more than $10.

Appealing directly to consumers was lucrative, Neslin found, but a
little less than wooing physicians. Each dollar spent on
direct-to-consumer advertising generated, on average, increased sales
of $1.37.

Such calculations flesh out a self-evident truth, said, UCLA’s Dr.
Martin Shapiro, a past president of the Society of General Internal
Medicine and an advocate of reform in the relationship: “These are
large and sophisticated organizations. . . . They would not be
spending that money if it didn’t work.”

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Labor Day: How it Came About; What it Means

“Labor Day differs in every essential way from the other holidays of
the year in any country,” said Samuel Gompers, founder and longtime
president of the American Federation of Labor. “All other holidays are
in a more or less degree connected with conflicts and battles of man’s
prowess over man, of strife and discord for greed and power, of
glories achieved by one nation over another. Labor Day…is devoted to
no man, living or dead, to no sect, race, or nation.”

Labor Day, the first Monday in September, is a creation of the labor
movement and is dedicated to the social and economic achievements of
American workers. It constitutes a yearly national tribute to the
contributions workers have made to the strength, prosperity, and
well-being of our country.

Founder of Labor Day

More than 100 years after the first Labor Day observance, there is
still some doubt as to who first proposed the holiday for workers.

Some records show that Peter J. McGuire, general secretary of the
Brotherhood of Carpenters and Joiners and a cofounder of the American
Federation of Labor, was first in suggesting a day to honor those “who
from rude nature have delved and carved all the grandeur we behold.”

But Peter McGuire’s place in Labor Day history has not gone
unchallenged. Many believe that Matthew Maguire, a machinist, not
Peter McGuire, founded the holiday. Recent research seems to support
the contention that Matthew Maguire, later the secretary of Local 344
of the International Association of Machinists in Paterson, N.J.,
proposed the holiday in 1882 while serving as secretary of the Central
Labor Union in New York. What is clear is that the Central Labor Union
adopted a Labor Day proposal and appointed a committee to plan a
demonstration and picnic.

The First Labor Day

The first Labor Day holiday was celebrated on Tuesday, September 5,
1882, in New York City, in accordance with the plans of the Central
Labor Union. The Central Labor Union held its second Labor Day holiday
just a year later, on September 5, 1883.

In 1884 the first Monday in September was selected as the holiday, as
originally proposed, and the Central Labor Union urged similar
organizations in other cities to follow the example of New York and
celebrate a “workingmen’s holiday” on that date. The idea spread with
the growth of labor organizations, and in 1885 Labor Day was
celebrated in many industrial centers of the country.

Labor Day Legislation

Through the years the nation gave increasing emphasis to Labor Day.
The first governmental recognition came through municipal ordinances
passed during 1885 and 1886. From them developed the movement to
secure state legislation. The first state bill was introduced into the
New York legislature, but the first to become law was passed by Oregon
on February 21, 1887. During the year four more states — Colorado,
Massachusetts, New Jersey, and New York — created the Labor Day
holiday by legislative enactment. By the end of the decade
Connecticut, Nebraska, and Pennsylvania had followed suit. By 1894, 23
other states had adopted the holiday in honor of workers, and on June
28 of that year, Congress passed an act making the first Monday in
September of each year a legal holiday in the District of Columbia and
the territories.

A Nationwide Holiday

The form that the observance and celebration of Labor Day should take
were outlined in the first proposal of the holiday — a street parade
to exhibit to the public “the strength and esprit de corps of the
trade and labor organizations” of the community, followed by a
festival for the recreation and amusement of the workers and their
families. This became the pattern for the celebrations of Labor Day.
Speeches by prominent men and women were introduced later, as more
emphasis was placed upon the economic and civic significance of the
holiday. Still later, by a resolution of the American Federation of
Labor convention of 1909, the Sunday preceding Labor Day was adopted
as Labor Sunday and dedicated to the spiritual and educational aspects
of the labor movement.

The character of the Labor Day celebration has undergone a change in
recent years, especially in large industrial centers where mass
displays and huge parades have proved a problem. This change, however,
is more a shift in emphasis and medium of expression. Labor Day
addresses by leading union officials, industrialists, educators,
clerics and government officials are given wide coverage in
newspapers, radio, and television.

The vital force of labor added materially to the highest standard of
living and the greatest production the world has ever known and has
brought us closer to the realization of our traditional ideals of
economic and political democracy. It is appropriate, therefore, that
the nation pay tribute on Labor Day to the creator of so much of the
nation’s strength, freedom, and leadership — the American worker.

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Close to $63 billion worth of branded drugs are set to lose their patents between 2007 and 2012, paving the way for generic replicas.
This year, to date, the biggest drug to lose its patent has been Sanofi-Aventis’ $2.2-billion sleep medication, Ambien.

This spawned the approval of 13 generic equivalents of zolpidem tartrate within two days, under a cluster approval, a process that now
is being adopted by the Food and Drug Administration to quickly bring more drugs to market. (Sanofi-Aventis’ extended-release Ambien CR isn’t available in generic versions.) Generics approvals were given to companies including Teva, Mylan, Dr. Reddy’s and Watson. Prasco has released an authorized generic.

Another cluster approval this year was awarded for generic Lamisil tablets (terbinafine hydrochloride). The FDA approved products from
companies including Apotex, Aurobindo Pharma, Dr. Reddy’s, Glenmark and Wockhardt. This antifungal medication from Novartis saw annual U.S. sales of approximately $687 million for the 12 months ended March 2007, according to IMS Health data.

At the end of last year, the FDA approved the first generic versions of GlaxoSmithKline’s Wellbutrin XL (bupropion hydrochloride)
extended-release tablets, which are indicated for the treatment of major depressive disorder. WeHbutrin XL was the 21st highest-selling
brand name drug in the United States in 2005, with sales totaling $1.3 billion, and Anchen Pharmaceuticals was first to market with the
generic product, for which it received 180 days of marketing exclusivity. There are now generics available from Watson and Teva.
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Also toward the end of 2006, Pfizer lost patent protection on Norvasc, the world’s most-prescribed branded medicine for treating hypertension. The FDA approved generic amlodipine besylate 2.5 mg, 5 mg and 10 mg tablets from Mylan, giving the generic drug maker 180 days of exclusivity on the market. This period now has expired, and other generics are on the market from companies including Teva,
Ranbaxy and Roxane Laboratories.

Still to come this year is a genetic version of Schering-Plough’s Clarinex. This drug was launched in 2002 when Schering-Plough lost its
patent on the antihistamine blockbuster Claritin. Clarinex is, essentially, a tweaked version of its predecessor, and sales have been
disappointing: $722 million in 2006, a fraction of the $3 billion a year the drug maker saw for Claritin. Clarinex loses its patent on Oct. 1.

Migraine medication Imitrex from GSK lost its patent in June. GSK has granted Dr. Reddy’s authorized generic status for sumatriptan
succinate, which is expected to launch at the end of next year.

Meridian from Abbott Labs loses its patent protection on Dec. 11. This obesity drug had global sales of $345 million worldwide last year, $60 million of which originated in the United States. Generic versions of this drug may not be as attractive to manufacturers since the launch this year of FDA-approved OTC product Alli from GSK.

Pfizer’s antihistamine Zyrtec loses patent protection on Dec. 25. The FDA has granted tentative approval to an abbreviated new drug
application from Caraco for cetirizine hydrochloride, 5 mg and 10 mg immediate release tablets. Zyrtec had U.S. sales of approximately
$1.21 billion for the 12-month period ended Dec. 31, 2006, according to IMS Health data.

The last patent expiration of this year looks likely to be schizophrenia medication Risperdal from Janssen Pharma, which had annual sales of $4 billion.

Moving into 2008, branded drug patents will be falling by the wayside. Depakote (Abbott), Fosamax (Merck), Advair (GSK), Serevent (GSK), Effexor XR (Wyeth), Lamictal (GSK) and Topamax (Ortho McNeil) are all expected to go head-to-head with genetic competition.

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