BAKER CHIROPRACTIC OFFICE - DR. JOHN RAYMOND BAKER, D.C.- A DOCTOR IN TEXAS

JOB OPENING IN LONGVIEW TEXAS

2007-09-25T04:45:00.000-07:00

BAKER CHIROPRACTIC, PA , one of the friendliest Doctor's offices in Longview, has a position available right now for the right applicant. For details, please click
http://positionavailable.blogspot.com
If you are interested in getting into health care in a ground level position, contact Baker Chiropractic about this job opening.

repeal of treatment planning rule

2007-06-14T22:42:00.001-07:00

<MedicalBenefits@tdi.state.tx.us> 6/13/2007 7:15 PM >>>The Texas Department of Insurance, Division of Workers' Compensation has announced that repeals of two workers' compensation rules will be submitted to the Texas Register. The rules are the Prospective Review of Medical Care Not Requiring Preauthorization (PRM) rule and the Treatment Planning rule.The PRM rule is no longer needed due to the adoption of treatment guidelines for the workers' compensation system. To view the news release concerning PRM, please click on the following link: http://www.tdi.state.tx.us/wc/news/2007/news200776.html .The treatment planning rule was adopted last December as one of several disability management rules but the effective date was postponed due to concerns expressed by system participants. The repeal of the treatment planning rule will not affect the other disability management rules including those adopting treatment and return-to-work guidelines for Texas. To view the news release concerning treatment planning, please click on the following link:
http://www.tdi.state.tx.us/wc/news/2007/news200779.html ."June 12, 2007
TDI Will Change Disability Management Requirements
FOR IMMEDIATE RELEASEJune 12, 2007News Release
FOR MORE INFORMATIONJohn Greeley @ (512) 804-4202
Austin, TX – The Texas Department of Insurance (TDI) announced that a workers’ compensation rule to require treatment planning for injured employees (28 Texas Administrative Code §137.300) will be repealed. This rule was adopted along with other disability management rules in December, 2006. The effective date for treatment planning was postponed until September 1, 2007, however, as the agency attempted to address ongoing concerns from system participants.
A repeal of the treatment planning rule will be submitted to the Texas Register. Since the rule has not become effective, system participants will not be required to meet the rule’s requirements.
“System participants support the concept of treatment planning, but many also agree that implementation will require significant business and administrative process changes,” Commissioner of Workers’ Compensation Albert Betts said. “We were concerned that participants would not be able to initiate treatment planning without some lapses in care for injured employees.”
Dr. Howard Smith, Medical Advisor for TDI’s Division of Workers’ Compensation, said TDI plans to work with health care providers and insurance carriers on a treatment planning pilot program.
“This treatment planning pilot will allow us to identify opportunities for improved communication and efficient delivery of appropriate medical care,” Smith said.
Since publication of the adopted disability management rules, system participants expressed the need for additional time to establish processes to appropriately address required treatment planning. Participants also argued for additional time to communicate and develop treatment planning parameters that are mutually acceptable to health care providers and insurance carriers.
Disability management rules requiring the use of workers’ compensation treatment guidelines and return-to-work guidelines became effective May 1, 2007 and will remain in effect."

BAKER CHIROPRACTIC,PA - NOW ON TEXAS TRUE CHOICE

2007-06-13T11:25:00.000-07:00

Baker Chiropractic,PA is now on the list of providers for Texas True Choice Insurance, which is the health insurance covering city workers in Longview Texas.

So, if you are on Texas True Choice and need Chiropractic, please call 903-753-5400 to make an appointment to come in for an examination.

Thanks for visiting our site.

SOMBRA , BIOFREEZE, TENS UNITS

2007-05-16T04:32:00.000-07:00

Baker Chiropractic, PA not only is the place for excellent care in Longview Texas, but we also carry a line of products to ease your muscle spasm and pain.

We carry Sombra, a pepper based liniment which offers warm relief to pain.

We also carry soothing, cool biofreeze, the green gel that soothes those tense muscles.

We also carry Transcutaneous Electrical Muscle Stimulators for those patients treated at Baker Chiropractic who may need an alternative pain management method.

And last but certainly not least, we carry the fine therapeutic line of pillows from Mellow Out Spa , Inc.

Please come in at 1420 McCann St., Longview Texas, in the Brookwood Shopping Village, or call us at 903-753-5400.

http://bakerchiro.sprinterweb.net

2007-03-18T19:37:00.000-07:00

http://bakerchiro.sprinterweb.net

Biological Basis For Teenage Mood Swings Found

2007-03-12T11:24:00.000-07:00

From http://www.medicalnewstoday.com/healthnews.php?newsid=65035

A new US study has revealed that teenage mood swings may be explained by biological changes in the adolescent brain.

The research is published in the journal Nature Neuroscience.

Mood swings and anxiety, often caused by stress, are well known characteristics of puberty.

A physiologist at the State University of New York, Sheryl Smith, and her research colleagues experimented on female adolescent mice and showed that their brains respond to stress in a different way to adults and pre-pubescent individuals.

Anxiety is regulated by the brains's principal inhibitory neurotransmitter, GABA (gamma-amino-butyric-acid) which counteracts the effect of glutamate, an excitatory neurotransmitter in the brain's limbic system.

Stress causes the release of a steroid known as THP (allopregnanolone) which in adult and pre-pubescent individuals increases the "calming" effect of GABA in the limbic system. However, Smith and her team found that THP had the opposite effect in adolescent mice.

It would appear that THP has two roles, one in the limbic system where it helps to calm things down, and another in the hippocampus where in adolescents it hots things up. The hippocampus is important for emotion regulation.

This paradoxical role of THP, said Smith and her team, is the reason for the adolescent brain behaving differently.

The underlying mechanism appears to be different levels of expression of a type of receptor known as the "alpha4betadelta" GABAA receptor in the hippocampal brain region known as CA1.

In adults and pre-adolescents, the receptors are in low numbers so the overall effect of THP is a calming one.

However, in adolescents, the expression of these receptors is high, so for these individuals the anxiety raising effect of THP in the hippocampus outweighs the calming effect it has in the limbic system.

Smith and her team were able to reverse the puberty effect in the mice by genetically altering the number of receptors.

The net effect is that whatever the teenage person's reaction to stress is likely to be, whether to cry or be angry, it will be "amplified". While to adults it may seem like an overreaction, to the teenager it is the only thing they can do, said the researchers.

This study is thought to be the first to suggest an underlying physiological, as opposed to a behavioural-psychological explanation for teenage mood swing

TREATED BAD BY INSURANCE CARRIER ?

2007-03-10T06:33:00.000-08:00

I see injured workers every day. As a treating doctor, daily I am confronted with insurance carriers who deny, dispute, foot drag, and some, act in a way that may constitute "bad faith".

Patients get upset. But, how will things get changed? Patients who are unrepresented by attorneys, patients who cannot afford to hire attorneys specializing in Work Comp, but who are advised by ombudsman, often lose Benefits Review Conferences (BRC) and Contested Claims Hearings (CCH), and, after reading the decisions, I believe these folks ought NOT to have lost, because there is a preponderence of medical opinion in their favor.

Perhaps you alone cannot change the system, but I contend that if ENOUGH weight is brought to bear on the Department of Insurance about perceived wrongdoing by insurance carriers, and enough media people (television stations, radio, newspapers, bloggers) bring the issue to the public attention, there is certainly a stronger possibility that some positive changes will occur.

If no one complains, or not enough complain, the system will get worse and worse and worse.

Perhaps the easiest way to contact the Texas Department of Insurance, Work Comp division, is via e-mail WorkersComp@tdi.state.tx.us .

To write a snail mail letter of complaint :
Texas Department of Insurance
Division of Workers' Compensation
7551 Metro Center Drive
Suite 100
Austin, TX 78744-1609
You may also contact the Field Office nearest you

In probably the only time in history, Dr. John Raymond Baker,DC and the Texas Medical Association are in agreement

2007-03-09T15:00:00.000-08:00

There is the old saying about the enemy of my enemy is my friend. I just discovered that I and the TMA are in agreement about something. Both of us agree that Gardasil, also known as the "cervical cancer vaccine" (though that is a misnomer and it is not a vaccine against cervical cancer) should NOT be mandated by the state of Texas.

"Earlier this month, Gov. Rick Perry issued an executive order that made Texas the first state to mandate the vaccine for young girls. Perry said his goal was to protect future generations from cervical cancer, which afflicts 10,000 U.S. women a year.
Perry has been rebuked by social conservatives, who say his promotion of the vaccine condones pre-marital sex, and legislators who say he exceeded his constitutional powers by issuing the executive order.
The Texas Medical Association, too, has said that the vaccine shouldn't be mandated, citing, in part, the high cost of the three-shot regimen, which starts at $360."
-http://www.chron.com/disp/story.mpl/headline/metro/4588270.html

We must note that, as cited above, the cost of the three shot regimen STARTS at $360.00.
Now imagine if, as Gov. Perry would have it, every female child in a certain age range, would be mandated to take the shot. Can you say "millions of dollars for Merck". It just so happens, that the same day Gov Perry signed the executive order mandating the Merck medicine be given to girls...his "campaign" received a "contribution" of $5000.00.

Perry says it was just a "coincidence".

Yeah, and light hitting the head of my bed just "coincides" with the sun rising.

Get ready for Spring and Summer

2007-03-09T05:01:00.000-08:00

Well, the hours in the day are getting longer, the weather is getting warmer, and it won't be long before you will be getting active in the outdoors. If that knee or back or neck is holding you back, isn't it about time you had it seen about and got the kind of treatment to get you back to shape?

Call 903-753-5400 today and make an appointment with Dr. John Raymond Baker,DC .

Check out another news portal

2007-03-08T04:26:00.000-08:00

http://johnraymondbaker.php1h.com/mambo/

CLOSING DATES FOR CHRISTMAS

2006-12-20T08:46:00.000-08:00

BAKER CHIROPRACTIC, 1420 MCCANN ROAD, LONGVIEW TEXAS, WILL BE CLOSING AT ONE (1) PM ON FRIDAY, 22ND OF DECEMBER, AND WILL REOPEN ON WEDNESDAY, THE 27TH OD DECEMBER, 2006.

WE APPRECIATE EACH AND EVERY ONE OF OUR PATIENTS AND WISH EVERYONE, MERRY CHRISTMAS AND HAPPY HOLIDAYS, AND WISH YOU THE VERY HAPPIEST, HEALTHIEST, AND MOST JOYOUS SEASON.

DR. JOHN RAYMOND BAKER,DC AND STAFF OF BAKER CHIROPRACTIC, PA
903-753-5400

TAMMY GRADUATES WITH TWO ASSOCIATE DEGREES

2006-12-17T14:28:00.000-08:00

http://www.healingtexas.com/tammygraduates.rm

2006-12-17T14:20:00.000-08:00

HAPPY THANKSGIVING

2006-11-23T13:17:00.000-08:00

OUR OFFICE IS CLOSED IN HONOR OF THE HOLIDAYS THIS THURSDAY AND FRIDAY, THE 23RD AND 24TH OF NOVEMBER, BUT WE SHALL RETURN ON MONDAY.

MEDICAL ERRORS...MORE

2006-10-20T18:23:00.000-07:00

=============================================================

editor's note- Recently, as indicated here and elsewhere, in Texas, a CRAZY thing happened, well, more like, a horrible abuse of the legal system happened. The Texas Medical Association, which has no mandate to oversee any profession (The Texas Medical Board, http://www.tmb.state.tx.us/ oversees practice of medicine in Texas) , filed a lawsuit against the Texas Board of Chiropractic Examiners, claiming , among other things, that Chiropractic Doctors should not be allowed legally to diagnose their own patients. The Texas Meddlesome Assn...er..uh "Texas Medical ASSn" says they did so, in order to "protect citizens of Texas".

This is ridiculous to the point of absurdity.

If the Texas Meddlesome ASSn, or "Texas Medical Association" as they prefer to be called,
cares so much about protecting the public, perhaps they should clean up their OWN profession.
Please read the following article.

http://metasearch.com/

The Quality of Health Care

Medical Error and Patient Injury: Costly and Often Preventable

Research Report

Andrew H. Smith, AARP Public Policy Institute

September 1998

Table of Contents:

Public Perception of Patient Safety and Medical Error

Incidence of Medical Error and Injury

Drugs and Medical Injury

Costs Resulting from Medical Injury

Why Do Medical Errors Happen, and How Should the Problem Be Addressed?

Addressing the Problem from a Systems Approach

Current Efforts to Address Medical Error From a Systems Perspective

Conclusion

Footnotes

Patient injuries that result from preventable medical errors are widespread
and costly.¹
One recent study found that more than one in six hospitalized patients suffered
medical injuries that prolonged their hospital stays.²
It has been estimated that total annual costs associated with injuries resulting
from medical error may be as high as $200 billion, the equivalent of nearly one
out of every five dollars spent on health care in America.³
Estimates of the frequency of medical errors and injuries and the costs
associated with them vary considerably, but even the most conservative estimates
indicate that the problem is widespread, very costly, and requires serious
attention.⁴

Preventable medical error and injury are of particular concern for older
people because there is evidence that they are injured at a substantially higher
rate than patients in other age groups. As

Figure 1 indicates, patients age 65 and older experience medical injury two
to four times as often as patients in age groups under the age of 45, according
to a landmark study published in 1991, the most recent age-specific data
available.⁵
Advancing age was the only demographic characteristic -- not gender, race,
ethnicity, or income -- associated with a significantly increased incidence of
medical injury and of injury due to "negligence."⁶
The evidence suggests that costs associated with preventable medical error and
injury, both in terms of human suffering and dollars spent by the Medicare
program to treat injured beneficiaries, are very significant.

Public Perception of Patient Safety and
Medical Error

There is a substantial amount of public concern about patient safety.⁷
In a 1997 national survey, respondents rated the current health care system as
only "moderately safe" -- safer than nuclear power and food handling, but less
safe than airplane travel and the workplace.⁸
(See

Table 1.) Forty-two percent of those surveyed said that they had been
involved, either personally or through a friend or relative, in a situation
where a medical mistake was made. Fifty-two percent of respondents stated that
they were satisfied with the measures currently in place to prevent medical
mistakes, but a large minority, 42 percent, said they were not satisfied.⁹
Not surprisingly, most of those who reported that they were not satisfied with
current measures were those who had been involved in some way with a medical
mistake.¹⁰

Table 1. Perceived Safety of Various Environments
Environment	Mean Scores
Airline travel	5.2
Workplace	5.2
Health care	4.9
Food handling	4.4
Nuclear power	4.2
Scores: 7=Safe, 1=Unsafe. Source: National Patient Safety Foundation at the AMA, "Public Opinion of Patient Safety Issues." Survey conducted by Louis Harris & Associates, September 1997.

Incidence of Medical Error and Injury

As noted above, recent estimates of the incidence of medical errors resulting

in injuries¹¹
reach as high as 17.7 percent of hospitalizations.¹²
One important study of medical injury is the 1990 Harvard Medical Practice Study
(Harvard Study), a population-based study of injuries resulting from medical
care during hospitalizations in New York. This study found that nearly 4 percent
of patients suffered an injury that caused their hospital stays to be prolonged,
or resulted in measurable disability.¹³
The Harvard Study, which used reviews of medical records to detect medical
injuries, found that almost 14 percent of those identified as having suffered
medical injury died as a result of their injuries. If the rate of deaths
resulting from medical error identified by the Harvard Study in New York were
consistent with rates in the other 49 states, that would mean that 180,000
Americans die annually as a result of medical injuries.¹⁴
That figure would be comparable to the number of deaths that would occur if
three jumbo-jets crashed every two days,¹⁵
and is approximately four times the number of traffic fatalities that occur
annually in America.¹⁶

Consistent with other studies that have found that most medical injuries are
due to errors, the Harvard Study determined that 69 percent of the medical
injuries identified were due to error, and were, therefore, preventable.¹⁷

Studies conducted more recently indicate that medical injury may be
substantially more common than suggested in the Harvard Study. Using a method
more likely to capture incidents of medical error than the earlier study,
Andrews and her colleagues found that 17.7 percent of patients whose care was
observed experienced at least one serious adverse event per hospitalization.¹⁸
The frequency of medical injuries was linked to severity of illness and length
of hospital stay, with the likelihood of experiencing a medical injury
increasing by 6 percent per day of hospitalization. One or more causes¹⁹
of medical injuries were determined in just over one half of cases in the study.
In 37.8 percent of cases, the adverse events were found to have been caused by
an individual; 15.6 percent had interactive causes; and 9.8 percent were due to
administrative decisions. Although 17.7 percent of patients experienced medical
injuries that prolonged their hospital stays, the study found that only 1.2
percent filed claims for compensation for their injuries.

Drugs and Medical Injury

Drugs have been found to be among the most common causes of medical injury.
In the Harvard study, 19.4 percent of the injuries detected were related to the
use of drugs, while the Andrews study determined that 9.3 percent of injuries
were medication-related.²⁰

A large percentage of adverse drug events (ADEs) have serious consequences,
and many of them are preventable. Bates and his colleagues found that of all
ADEs identified in their study, 1 percent were fatal, 12 percent
life-threatening, 30 percent serious, and 57 percent significant. Of ADEs that
were determined to have been preventable, 20 percent were life- threatening, and
43 percent were serious. (See

Figure 2.) Overall, 28 percent of the ADEs were judged preventable, but of
life-threatening and serious ADEs, 42 percent were determined to have been
preventable.²¹
Bates found rates of 6.5 ADEs and 5.5 potential ADEs per 100 non-obstetrical
admissions to tertiary-care hospitals. Classen and colleagues found that adverse
drug events complicated 2.43 percent of hospital admissions, adding
significantly to length of hospital stays and to costs.²²

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of Page

Costs Resulting from Medical Injury

The costs associated with injuries resulting from medical error are quite
substantial. As noted above, one recent estimate placed the total costs
associated with medical injury at as much as $200 billion annually.²³

Most studies that attempt to estimate costs associated with medical error
have focused on injuries resulting from the use or misuse of medications. In
their 1995 study, Johnson and Bootman estimated that costs associated with
drug-related illness and death that resulted primarily from patient
non-compliance, and inappropriate prescribing, and/or monitoring by health care
professionals equal $76.6 billion annually.²⁴
The costs calculated for drug-related illness and death were limited to those
that arose from medication use or misuse in an outpatient setting, with the
largest component of costs resulting from drug-related hospitalizations.²⁵

The ADEs identified in the Classen study, half of which were identified as
preventable, added 1.91 days to the mean length of hospital stays and resulted
in increased costs per stay of $2,262.²⁶

In a follow up to their earlier study, Bates and colleagues determined that
an additional 2.2 days of hospitalization were required for patients
experiencing an ADE, at an average added cost of $3,244. For ADEs identified as
preventable, patients stayed in the hospital an average of 4.6 extra days, at an
average additional cost of $5,857.²⁷

Why Do Medical Errors Happen, and How Should the
Problem Be Addressed?

1. Negligent and/or incompetent providers

As a recent survey reveals, many people believe that medical errors and
injuries occur because there are just too many "bad doctors" and other health
care professionals performing in a negligent manner.²⁸
Medical injury is viewed as primarily the result of allowing incompetent and/or
careless providers to continue in the practice of medicine, and of hospital
under-staffing and other cost-cutting practices.²⁹
It has frequently been observed that relatively few providers are sanctioned by
the medical profession and/or state entities charged with enforcing standards of
medical practice despite evidence of widespread negligence.³⁰

Those who believe that medical negligence and an ineffective oversight system
are largely responsible for medical error and injury have responded in a number
of ways. For example, they promoted the development and use of a practitioner
databank. As a result, the National Practitioner Data Bank (NPDB) was created.
The NPDB collects and releases information (to authorized entities) relating to
medical malpractice payments, adverse licensure actions, certain types of
professional review actions, and reports of Medicare and Medicaid sanctions
taken against physicians, dentists, and some other health care practitioners.³¹
They have also defended the laws that govern medical malpractice actions against
a strong effort from the medical community to enact legal reforms that would
curtail malpractice litigation.³²

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2. Inevitable human error and systems failures

A contrasting view holds that the problem of medical error and injury results
primarily from systems failures. Proponents of this view acknowledge that there
are incompetent and impaired providers who commit errors that result in patient
injury, and that few physicians face disciplinary actions. However, they
observe, there is little evidence that negligence is the major cause of medical
error, or that rooting out negligent and incompetent providers would solve the
problem.

Those who subscribe to a "systems approach" to medical error, drawing on
psychological and human factors research, argue that human beings, no matter how
careful and conscientious they are, will make mistakes.³³
They also note that because the practice of medicine is complex, there are a
great many opportunities for mistakes to occur, and that the high level of
complexity makes it unrealistic to depend on promoting individual perfection as
the method to avoid mistakes that result in patient injury. For example, in one
study of an intensive care unit, it was determined that patients received an
average of 178 "activities" each day.³⁴
The average number of errors per patient per day was 1.7, or slightly less than
1 percent. Thus, the unit was functioning correctly 99 percent of the time.³⁵
Leape notes, however, that even an accuracy rate of 99.9 percent may not prove
adequate, noting that a 99.9 percent accuracy rate would translate to:

Two unsafe landings at O'Hare airport each day;

16,000 pieces of lost mail per hour; and

32,000 bank checks deducted from the wrong account every hour.³⁶

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of Page

Addressing the Problem from a Systems
Approach

One medical specialty, anesthesiology, has already made significant
improvements in its safety record. Mortality resulting from errors in anesthesia
has been reduced by 95 percent over the past 15 years.³⁷

Recognizing system factors, rather than carelessness or incompetence as the
most important causes of medical error, anesthesiologists designed fail-safe
systems and developed and implemented training programs to avoid errors.³⁸

The success story in anesthesiology illustrates the possibilities and
problems for other areas of medical practice. Errors and the resulting injuries
in anesthesiology, unlike those in many areas of medical practice, tend to be
dramatic and severe.³⁹
Information about incidents and the circumstances surrounding them were,
therefore, available to those attempting to understand the problems, and the
reasons the errors occurred were often transparent. These factors were conducive
to understanding the problems and developing approaches to correct them.

A number of scholars believe that the most important reason that medicine has
failed to develop more effective ways to prevent error is that, except in the
case of the practice of anesthesiology, there has been little opportunity to
study the reasons that errors occur. Information about medical error is
inadequate for researchers because most errors go unreported. Unlike errors in
anesthesiology, which, as noted above, cannot easily be hidden, errors occurring
in other areas of medical practice tend to be less frequently obvious and
dramatic in effect. In what some call medicine's culture of blame, there
is good reason not to volunteer information that an error has occurred when it
might otherwise remain undiscovered. In the medical culture, error cannot be
accepted; physicians are taught in medical school and during residency to learn
and practice error-free medicine, i.e., to be perfect. Error is treated
as a moral failing,⁴⁰
and it is not surprising that mistakes are driven "underground."

Advocates of the systems approach argue that, for medicine to enjoy the
success observed in anesthesiology, it is essential to overcome the barriers to
full reporting of medical errors. For researchers to devise ways to prevent
and/or to absorb⁴¹
errors and prevent injuries, they must learn precisely how and why errors and
their resulting injuries take place. They must have access to detailed and
comprehensive information on errors, and full information can be obtained only
if there is full disclosure of errors.

Current Efforts to Address Medical Error
From a Systems Perspective

A number of initiatives have been developed to study and address the problem
of medical error using a systems approach. Examples include:

The National Coordinating Council for Medication Error Reporting and
Prevention (NCC MERP), an organization of pharmacy and health care
professional groups, the U.S. Food and Drug Administration, the U.S.
Pharmacopoeia, and consumer organizations, among others, has developed
numerous recommendations to prevent medication errors. These recommendations,
addressed to pharmaceutical manufacturers, packagers and repackagers,
hospitals and hospital pharmacies, outpatient pharmacies, physicians and other
health care personnel, should lead to the safer use of drugs in all settings.
Among NCC MERP's recommendations: (1) print warnings only on caps and
ferrules of injectables; (2) make intravenous drug names visible on both sides
of the container; and (3) print drug names in type that is at least as large
as company names and logos.⁴²

The organization is also encouraging the use of its "Medication Error Index
for Categorizing Errors," a new indexing system that will help researchers to
track medication errors in a consistent, systematic manner.⁴³
Widespread use of the index should result in the efficient collection and
compilation of data on medication error, and thereby allow the development of
recommendations that could lessen the chance for patient injury.
The National Patient Safety Foundation at the AMA (NPSF) and the National
Patient Safety Partnership (NPSP) constitute two major initiatives to (1)
study medical error and (2) develop systems-based responses to reduce the
incidence of medical error and absorb errors when they do occur so that the
errors do not reach the patient.

The NPSF was founded by the American Medical Association in 1997, but is
now an independent foundation supported by a broad range of organizations,
including health care professional organizations, consumer organizations,
insurance companies, managed care organizations, and academicians. The NPSP
was founded by the U.S. Veterans Administration, and like the NPSF, has a
broad range of participating organizations. The NPSF and NPSP have recently
linked their efforts to promote research into the causes and cures for medical
error and injury. Among the projects they are working on together are:

(1) an effort to design a voluntary, confidential, non-punitive system
that would promote the reporting of essential data that would allow
researchers to learn the nature of systems failures that lead to injury; and

(2) a survey of health care providers and the medical culture as it
relates to patient safety.

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of Page

Conclusion

The systems approach has been successfully employed in non-health care
settings that are, like health care, high risk enterprises. Both the airline
industry's Aviation Safety Reporting System (ASRS) and the National Aeronautics
and Space Administration's (NASA) "Close-Call" reporting system were developed
through use of the systems approach.⁴⁴

As noted above, the success achieved in anesthesiology through the use of a
systems approach to improve patient safety strongly suggests that applying that
approach would be appropriate in other areas of medical practice. Before systems
changes to prevent medical error and patient injury can be devised and
implemented, the weaknesses in the complex systems of medical care that allow,
or even promote, medical errors must be identified and understood. A great deal
of research must be performed before the goal of substantially reducing rates of
preventable injury can be realized.

The systems approach promises significant reductions of preventable medical
error and injury in the future. It cannot, however, eliminate current and future
needs for patient compensation when a preventable injury does occur, despite
systems improvements. Neither can it adequately address errors/injuries that
arise from provider incompetence and/or impairment. Those are matters that must
continue to be addressed through legal and administrative mechanisms.

The work of the NPSF, NPSP, and NCC MERP, among other organizations, to
coordinate and support research and disseminate its results, should lead to
safer medical practice, fewer patient injuries, and reduced health care costs.
Success in preventing or absorbing medical error should prove beneficial to
Medicare beneficiaries, who most frequently suffer medical injuries, and could
save the Medicare program billions of dollars currently devoted to treating
preventable medical injuries.

Footnotes

¹ "Medical error" may be defined as "an unintended act (either of
omission or commission) or one that does not achieve its intended outcomes."
Leape, Lucien. "Error in Medicine." Journal of the American Medical
Association 272(23):1851-57 (Dec. 21, 1994).

² Andrews, Lori B., Carol
Stocking, Thomas Krizek, et al. "An Alternative Strategy for Studying Adverse
Events in Medical Care." Lancet 349:309-13 (Feb. 1, 1997).

³ Perrone, J. "Designing a Safer, Smarter Health Care System: AMA
Foundation Looks at Ways to Prevent Mistakes," American Medical News
40(40):1 (Oct. 27, 1997).

⁴ Reduction of medical error
is listed as one of "Six National Aims" in the Report of the President's
Advisory Commission on Consumer Protection and Quality in the Health Care
Industry (March 1998).

⁵ Patients, Doctors, and Lawyers: Medical Injury, Malpractice
Litigation, and Patient Compensation in New York. The Report of the Harvard
Medical Practice Study to the State of New York. Harvard Medical Practice
Study, 1990, 6-23.

⁶ Ibid.

⁷ "Public Opinion of Patient Safety Issues: Research Findings,"
National Patient Safety Foundation at the AMA, September 1997.

⁸ Ibid.

⁹ Ibid.

¹⁰ Ibid.

¹¹ "Medical injuries" here refer to "iatrogenic injuries," i.e.,
injuries or conditions resulting from treatment by physicians or surgeons.

¹² Andrews, et al. (1997).

¹³ Harvard Medical Practice Study (1990).

¹⁴ Leape (1994).

¹⁵ Ibid.

¹⁶ There were 43,910 deaths in 1997 resulting from motor vehicle
accidents. National Center for Health Statistics. "Births, Marriages, Divorces,
and Deaths for February 1997. Monthly Vital Statistics Report." 46: 2. (1997).

¹⁷ Leape (1994).

¹⁸ Andrews and her colleagues used a prospective, observational
approach that followed the care of all patients admitted over a period of time
to three units of a teaching hospital, as opposed to the Harvard Medical
Practice Study that used retrospective reviews of medical records. Andrews, et
al. (1997).

¹⁹ "Interactive causes" refers to "interactions between individuals,
or between individuals and hospital entities, or between hospital entities, such
as the failure of a consultant team to communicate adequately with the
requesting team." Andrews, et al. (1997) at p. 311.

²⁰ Harvard Medical Practice
Study (1990).

²¹ Bates, David W., David J. Cullen, Nan Laird, et al. "Incidence of
Adverse Drug Events and Potential Adverse Drug Events: Implications for
Prevention." Journal of the American Medical Association 274(1): 29-34
(July 5, 1995).

²² Classen,, David C., Stanley L. Pestotnik, R. Scott Evans, et. al.
Adverse Drug Events in Hospitalized Patients," Journal of the American
Medical Association 277(4):301-06 (Jan. 22/29, 1997).

²³ Perrone (1997).

²⁴ Johnson, Jeffrey A. and J. Lyle Bootman. "Drug-Related Morbidity
and Mortality: A Cost-of-Illness Model," Archives of Internal Medicine
155:1949-56 (Oct. 6, 1995). This estimate includes all types of medication
error, both preventable and non-preventable. It does not include costs
associated with injuries that are the result of unforseeable
allergic/idiosyncratic responses or those that occur when the provider knows
that there are risks associated with a drug but prescribes it anyway because, in
his/her judgment, the potential benefits outweigh the risks.

²⁵ When indirect costs due to non-compliance are added to the direct
cost figures, total economic costs rise to approximately $100 billion. Berg, J.S.,
J. Dischler, J.J. Raia, and N. Palmer-Shevlin, "Medication Compliance: A
Healthcare Problem," Annals of Pharmacotherapy 27(9):S3-S22 (1993).

²⁶ Ibid.

²⁷ Bates, David W., Nathan Spell, David J. Cullen, et al. "The Costs
of Adverse Drug Events in Hospitalized Patients," Journal of the American
Medical Association 277(4):307-11 (Jan. 22/29, 1997).

²⁸ See Richards, Edward P. and Katharine C. Rathbun, Law and the
Physician: A Practical Guide. Little, Brown, and Co.:New York (1996).

²⁹ Ibid.

³⁰ See, for example, Public Citizen, "16,638 Questionable Doctors."
(March 1998). It is noted that, although there have been more disciplinary
actions taken against physicians recently, few have been required to stop
practicing medicine, even for a short time. In 1996, 16,638 physicians were
disciplined by state boards or federal agencies. The rate of "serious
disciplinary actions" was 3.96 per 1,000 doctors (2,731 actions).

³¹ Title IV of the Health Care Quality Improvement Act of 1986 (P.L.
99-660) established the National Practitioner Data Bank (NPDB). Regulations
governing the NPDB may be found at 45 CFR Part 60. The information in the NPDB
is available only to state licensing boards, hospitals and other health care
entities, professional societies, certain Federal agencies, and others as
specified in the law. Only hospitals are mandated by law to query the Data Bank.

³² Nonetheless, many states passed "tort reform" measures in the wake
of the alleged medical malpractice insurance crisis of the late 1980s. They
included such measures as placing caps on possible damage awards (particularly
on awards for "pain and suffering"), restrictions on statutes of limitations,
limitations of plaintiff attorneys' fees, and other measures to discourage
potential complainants from filing malpractice actions.

³³ For a brief overview of relevant developments in cognitive
psychology and human factors research, see Leape, p. 1853 (1994).

³⁴ An "activity" is defined as any interaction between health care
personnel and patients that presents an opportunity for an adverse patient
outcome.

³⁵ Leape (1994).

³⁶ W.E. Deming, written communication quoted in Leape (1994).

³⁷ Orkin, P.K. "Patient Monitoring During Anesthesia as an Exercise
in Technology Assessment." In Saidman, L. J. and N.T. Smith, eds. Monitoring in
Anesthesia 3rd Ed. London, England: Butterworth Publishers, Inc. (1993).

³⁸ See Gaba, D.M., "Human Errors in Anesthetic Mishaps,"
International Anesthesiology Clinics 27(3):137-47 (Fall 1989). Also see
Cooper, J.B., R.S. Newbower, and P.J. Kitz, "An Analysis of Major Errors and
Equipment Failures in Anesthesia Management: Considerations for Prevention and
Detection," Anesthesiology 60(1):34-42 (Jan. 1984).

³⁹ Leape, p. 1856 (1994).

⁴⁰ Ibid.

⁴¹ It is recognized that errors are inevitable in any human endeavor,
including the provision of health care. Error "absorption" refers to the notion
that well-designed error prevention systems will "absorb" errors, keeping them
from reaching the patient and causing injury.

⁴² See U.S.P., "Medications Errors Council Recommends Changes to
Medical Product Packaging and Labeling," The Standard (Sep. 16, 1997).

⁴³ U.S.P., "Medication Errors Council Promotes Categorization Index,"
The Standard (October 1996).

⁴⁴ See Helmreich, R.L. "Managing Human Error in Aviation,"
Scientific American 276(5):62-67 (May 1997).

Top
of Page

Written by Drew Smith, AARP Public Policy Institute

September 1998

©1998 AARP

May be copied only for noncommercial purposes and with attribution; permission
required for all other purposes.

Public Policy Institute, AARP, 601 E Street, NW, Washington, DC 20049

ABSTRACT OF THE HARVARD MEDICAL PRACTICE STUDY

2006-10-19T20:56:00.000-07:00

Brennan T, Leape L, Laird N, Hebert L, Localio A, Lawthers A, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991;324:370-6.[Abstract]

Abstract

BACKGROUND. As part of an interdisciplinary study of medical injury and malpractice litigation, we estimated the incidence of adverse events, defined as injuries caused by medical management, and of the subgroup of such injuries that resulted from negligent or substandard care. METHODS. We reviewed 30,121 randomly selected records from 51 randomly selected acute care, nonpsychiatric hospitals in New York State in 1984. We then developed population estimates of injuries and computed rates according to the age and sex of the patients as well as the specialties of the physicians. RESULTS. Adverse events occurred in 3.7 percent of the hospitalizations (95 percent confidence interval, 3.2 to 4.2), and 27.6 percent of the adverse events were due to negligence (95 percent confidence interval, 22.5 to 32.6). Although 70.5 percent of the adverse events gave rise to disability lasting less than six months, 2.6 percent caused permanently disabling injuries and 13.6 percent led to death. The percentage of adverse events attributable to negligence increased in the categories of more severe injuries (Wald test chi 2 = 21.04, P less than 0.0001). Using weighted totals, we estimated that among the 2,671,863 patients discharged from New York hospitals in 1984 there were 98,609 adverse events and 27,179 adverse events involving negligence. Rates of adverse events rose with age (P less than 0.0001). The percentage of adverse events due to negligence was markedly higher among the elderly (P less than 0.01). There were significant differences in rates of adverse events among categories of clinical specialties (P less than 0.0001), but no differences in the percentage due to negligence. CONCLUSIONS. There is a substantial amount of injury to patients from medical management, and many injuries are the result of substandard care.

SO MANY MEDICAL ERRORS...SO LITTLE TIME

2006-10-19T20:41:00.000-07:00

Since the Texas Medical Association set themselves
up to decide what is safe and what is not, and to pursue a course of suing the
Board of Chiropractic Examiners in Texas because they don't think Chiropractic
Doctors should be able to diagnose their patients, I thought I should look more
into the Medical Doctor's side of safety, since the pretext of the lawsuit by
the TMA was "protecting the safety of Texas citizens" (my interpretation of
their assertion).

There are so MANY errors committed by Medical
doctors, that a government page is setup to classify them.

A	Back to Top

Active Error (or Active Failure) – The terms
"active" and "latent" as applied to
errors were coined by
James Reason.(1 ,2)
Active errors occur at the point of contact between a human and some aspect of a
larger system (eg, a human-machine interface). They are generally readily
apparent (eg, pushing an incorrect button, ignoring a warning light) and almost
always involve someone at the frontline.
Latent errors (or
latent conditions), in contrast, refer to less apparent failures of
organization or design that contributed to the occurrence of errors or allowed
them to cause harm to patients.

Active failures are sometimes referred to as errors at the "sharp
end," figuratively referring to a scalpel. In other words, errors at the
sharp end are noticed first because they are committed by the person closest to
the patient. This person may literally be holding a scalpel (eg, an orthopedist
who operates on the wrong leg) or figuratively be administering any kind of
therapy (eg, a nurse programming an intravenous pump) or performing any aspect
of care. To complete the metaphor, latent errors are those at the other end of
the scalpel—the "blunt
end"—referring to the many layers of the health care system that affect the
person "holding" the scalpel.

1. Reason JT. Human Error. New York, NY: Cambridge University Press; 1990. [
go
to PSNet listing ]

2. Reason J. Human error: models and management. BMJ. 2000;320:768-770. [

go to PubMed ]

Adverse Drug Event (ADE) – An adverse event involving medication use.

Examples:

anaphylaxis to penicillin

major hemorrhage from heparin

aminoglycoside-induced renal failure

agranulocytosis from chloramphenicol

As with the more general term
adverse event,
there is no necessary relation to error or poor quality of care. In other words,
ADEs include expected adverse drug reactions (or "side effects") defined below,
as well as events due to error.

Thus, a serious allergic reaction to penicillin in a patient with no prior such
history is an ADE, but so is the same reaction in a patient who does have a
known allergy history but receives penicillin due to a prescribing oversight.

Ignoring the distinction between expected medication side effects and ADEs due
to errors may seem misleading, but a similar distinction can be achieved with
the concept of preventability. All ADEs due to error are preventable, but other
ADEs not warranting the label
error may also be
preventable.

Adverse Drug Reaction – Adverse effect produced by the use of a
medication in the recommended manner. These effects range from "nuisance
effects" (eg, dry mouth with anticholinergic medications) to severe reactions,
such as anaphylaxis to penicillin.

Adverse Event – Any injury caused by medical care.

Examples:

pneumothorax from central venous catheter placement

anaphylaxis to penicillin

postoperative wound infection

hospital-acquired delirium (or "sun downing") in elderly patients

Identifying something as an adverse event does not imply "error,"
"negligence," or poor quality care. It simply indicates that an undesirable
clinical outcome resulted from some aspect of diagnosis or therapy, not an
underlying disease process.

Thus, pneumothorax from central venous catheter placement counts as an adverse
event regardless of insertion technique. Similarly, postoperative wound
infections count as adverse events even if the operation proceeded with optimal
adherence to sterile procedures, the patient received appropriate antibiotic
prophylaxis in the peri-operative setting, and so on. (See also
iatrogenic)

Anchoring Error (or Bias) — Refers to the common
cognitive trap of allowing first impressions to exert undue influence on the
diagnostic process. Clinicians often latch on to features of a patient's
presentation that suggest a specific diagnosis. Often, this initial diagnostic
impression will prove correct, hence the use of the phrase "anchoring heuristic"
in some contexts, as it can be a useful rule of thumb to "always trust your
first impressions." However, in some cases, subsequent developments in the
patient's course will prove inconsistent with the first impression. Anchoring
bias refers to the tendency to hold on to the initial diagnosis, even in the
face of disconfirming evidence.

1. Redelmeier DA. Improving patient care. The cognitive psychology of missed
diagnoses. Ann Intern Med. 2005;142:115-120.

[go to PubMed]

2. Croskerry P. Cognitive forcing strategies in clinical decisionmaking. Ann
Emerg Med. 2003;41:110-120.

[go to PubMed]

3. Croskerry P. The importance of cognitive errors in diagnosis and strategies
to minimize them. Acad Med. 2003;78:775-780.

[go to PubMed]

APACHE –The Acute Physiologic and Chronic Health Evaluation (APACHE)
scoring system has been widely used in the United States. APACHE II is the most
widely studied version of this instrument (a more recent version, APACHE III, is
proprietary, whereas APACHE II is publicly available); it derives a severity
score from such factors as underlying disease and chronic health status.(1,2)
Other points are added for 12 physiologic variables (ie, hematocrit, creatinine,
Glasgow Coma Score, mean arterial pressure) measured within 24 hours of
admission to the ICU. The APACHE II score has been validated in several studies
involving tens of thousands of ICU patients.

1. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of
disease classification system. Crit Care Med. 1985;13:818-29.[

go to PubMed ]

2. Knaus WA, Wagner DP, Zimmerman JE, Draper EA. Variations in mortality and
length of stay in intensive care units. Ann Intern Med. 1993;118:753-61.[

go to PubMed ]

Authority Gradient – Refers to the balance of decision-making power or
the steepness of command hierarchy in a given situation. Members of a crew or
organization with a domineering, overbearing, or dictatorial team leader
experience a steep authority gradient. Expressing concerns, questioning, or even
simply clarifying instructions would require considerable determination on the
part of team members who perceive their input as devalued or frankly unwelcome.

Most teams require some degree of authority gradient; otherwise roles are
blurred and decisions cannot be made in a timely fashion. However, effective
team leaders consciously establish a command hierarchy appropriate to the
training and experience of team members.

Authority gradients may occur even when the notion of a team is less well
defined. For instance, a pharmacist calling a physician to clarify an order may
encounter a steep authority gradient, based on the tone of the physician's voice
or a lack of openness to input from the pharmacist. A confident, experienced
pharmacist may nonetheless continue to raise legitimate concerns about an order,
but other pharmacists might not.

Availability Bias (or Heuristic) — Refers to the tendency to assume, when
judging probabilities or predicting outcomes, that the first possibility that
comes to mind (ie, the most cognitively "available" possibility) is also the
most likely possibility. For instance, suppose a patient presents with
intermittent episodes of very high blood pressure. Because episodic hypertension
resembles textbook descriptions of pheochromocytoma, a memorable but uncommon
endocrinologic tumor, this diagnosis may immediately come to mind. A clinician
who infers from this immediate association that pheochromocytoma is the most
likely diagnosis would be exhibiting availability bias. In addition to
resemblance to classic descriptions of disease, personal experience can also
trigger availability bias, as when the diagnosis underlying a recent patient's
presentation immediately comes to mind when any subsequent patient presents with
similar symptoms. Particularly memorable cases may similarly exert undue
influence in shaping diagnostic impressions.

1. Redelmeier DA. Improving patient care. The cognitive psychology of missed
diagnoses. Ann Intern Med. 2005;142:115-120.

[go to PubMed]

2. Croskerry P. Cognitive forcing strategies in clinical decisionmaking. Ann
Emerg Med. 2003;41:110-120.

[go to PubMed]

3. Croskerry P. The importance of cognitive errors in diagnosis and strategies
to minimize them. Acad Med. 2003;78:775-780.

[go to PubMed]

B	Back to Top

Bayesian Approach – Probabilistic reasoning in which test results (not
just laboratory investigations, but history, physical exam, or any aspect for
the diagnostic process) are combined with prior beliefs about the probability of
a particular disease. One way of recognizing the need for a Bayesian approach is
to recognize the difference between the performance of a test in a population
vs. in an individual. At the population level, we can say that a test has a
sensitivity and specificity of, say, 90%—ie, 90% of patients with the condition
of interest have a positive result and 90% of patients without the condition
have a negative result. In practice, however, a clinician needs to attempt to
predict whether an individual patient with a positive or negative result does or
does not have the condition of interest. This prediction requires combining the
observed test result not just with the known sensitivity and specificity, but
also with the chance the patient could have had the disease in the first place
(based on demographic factors, findings on exam, or general clinical gestalt).

Benchmark – A "benchmark" in health care refers to an attribute or
achievement that serves as a standard for other providers or institutions to
emulate.

Benchmarks differ from other "standard of care" goals, in that they derive from
empiric data—specifically, performance or outcomes data. For example, a
statewide survey might produce risk-adjusted 30-day rates for death or other
major adverse outcomes. After adjusting for relevant clinical factors, the top
10% of hospitals can be identified in terms of particular outcome measures.
These institutions would then provide benchmark data on these outcomes. For
instance, one might benchmark "door-to-balloon" time at 90 minutes, based on the
observation that the top-performing hospitals all had door-to-balloon times in
this range.

In the present example regarding infection control, benchmarks would typically
be derived from national or regional data on the rates of relevant nosocomial
infections. The lowest 10% of these rates might be regarded as benchmarks for
other institutions to emulate.

The article below provides an excellent discussion of the principles of
benchmarking and the specific steps in using outcomes data to generate
benchmarks.

Kiefe CI, Weissman NW, Allison JJ, et al. Identifying achievable benchmarks of
care: concepts and methodology. Int J Qual Health Care. 1998;10:443-47. [

go to pubmed ]

Blunt End – The "blunt end" refers to the many layers of the health care
system not in direct contact with patients, but which influence the personnel
and equipment at the “sharp
end” who do contact patients. The blunt end thus consists of those who set
policy, manage health care institutions, design medical devices, and other
people and forces, which, though removed in time and space from direct patient
care, nonetheless affect how care is delivered.

Thus, an error programming an intravenous pump would represent a problem at the
sharp end, while the institution’s decision to use multiple different types of
infusion pumps, making programming errors more likely, would represent a problem
at the blunt end. The terminology of “sharp” and “blunt” ends corresponds
roughly to “active
failures” and “latent
conditions.”

C	Back to Top

Checklist – Algorithmic listing of actions to be performed in a given
clinical setting (eg, Acute Cardiac Life Support [ACLS] protocols for treating
cardiac arrest) to ensure that, no mater how often performed by a given
practitioner, no step will be forgotten. An analogy is often made to flight
preparation in aviation, as pilots and air-traffic controllers follow
pre-take-off checklists regardless of how many times they have carried out the
tasks involved.

Clinical Decision Support System (CDSS) – Any system designed to improve
clinical decision making related to diagnostic or therapeutic processes of care.
CDSSs thus address activities ranging from the selection of drugs (eg, the
optimal antibiotic choice given specific microbiologic data [1])
or diagnostic tests (2)
to detailed support for optimal drug dosing (3 ,4)
and support for resolving diagnostic dilemmas.(5)

Structured antibiotic order forms (6)
represent a common example of paper-based CDSSs. Although such systems are still
commonly encountered, many people equate CDSSs with computerized systems in
which software algorithms generate patient-specific recommendations by matching
characteristics, such as age, renal function, or allergy history, with rules in
a computerized knowledge base.

The distinction between decision support and simple reminders can be unclear,
but usually reminder systems are included as decision support if they involve
patient-specific information. For instance, a generic reminder (eg, “Did you
obtain an allergy history?”) would not be considered decision support, but a
warning (eg, “This patient is allergic to codeine.”) that appears at the time of
entering an order for codeine would be.

1. Evans RS, Pestotnik SL, Classen DC, et al. A computer-assisted management
program for antibiotics and other antiinfective agents. N Engl J Med.
1998;338:232-238.

[

go to PubMed ]

2. Harpole LH, Khorasani R, Fiskio J, Kuperman GJ, Bates DW. Automated
evidence-based critiquing of orders for abdominal radiographs: impact on
utilization and appropriateness. J Am Med Inform Assoc. 1997;4:511-521.

[

go to PubMed ]

3. Walton RT, Harvey E, Dovey S, Freemantle N. Computerised advice on drug
dosage to improve prescribing practice. Cochrane Database Syst Rev.
2001:CD002894.

[

go to PubMed ]

4. Chertow GM, Lee J, Kuperman GJ, et al. Guided medication dosing for
inpatients with renal insufficiency. JAMA. 2001;286:2839-2844.

[

go to PubMed ]

5. Friedman CP, Elstein AS, Wolf FM, et al. Enhancement of clinicians'
diagnostic reasoning by computer-based consultation: a multisite study of 2
systems. JAMA. 1999;282:1851-1856.

[

go to PubMed ]

6. Avorn J, Soumerai SB, Taylor W, Wessels MR, Janousek J, Weiner M.
Reduction of incorrect antibiotic dosing through a structured educational order
form. Arch Intern Med. 1988;148:1720-1724.

[

go to PubMed ]

Close Call – An event or situation that did not produce patient injury,
but only because of chance. This good fortune might reflect robustness of the
patient (eg, a patient with penicillin allergy receives penicillin, but has no
reaction) or a fortuitous, timely intervention (eg, a nurse happens to realize
that a physician wrote an order in the wrong chart). Such events have also been
termed "near miss"
incidents.

Competency – Having the necessary knowledge or technical skill to perform
a given procedure within the bounds of success and failure rates deemed
compatible with acceptable care.

Complexity Science (or Complexity Theory) - Provides an approach to
understanding the behavior of systems that exhibit non-linear dynamics, or the
ways in which some adaptive systems produce novel behavior not expected from the
properties of their individual components. Such behaviors emerge as a result of
interactions between agents at a local level in the complex system and between
the system and its environment.(1,2)

At first, this may sound indistinguishable from the “systems thinking” commonly
encountered in the patient safety literature. Some people probably use these
terms loosely and occasionally interchangeably, but complexity theory differs
importantly from systems thinking in its emphasis of the interaction between
local systems and their environment (such as the larger system in which a given
hospital or clinic operates). It is often tempting to ignore the larger
environment as unchangeable and therefore outside the scope of quality
improvement or patient safety activities. According to complexity theory,
however, behavior within a hospital or clinic (eg, non-compliance with a
national practice guideline) can often be understood only by identifying
interactions between local attributes and environmental factors.

Another key feature of complexity theory is the emphasis on achieving deep
understanding of a given problem prior to engaging in efforts to change
practice. For instance, instead of simply identifying that providers’ behavior
fails to comply with some target guideline and then implementing an “off the
shelf” means of achieving behavior change (eg, a financial incentive),
complexity theorists might identify what currently works well in a given
practice and the attitudes or structures that provide the basis for what works
well. This process may then reveal an important negative interaction between
local values and perceptions about the national guideline. A more effective
change strategy may then emerge in which the national guideline is adapted for
the local setting. The alternative approach of attempting to force behavioral
change may lead to no improvement or, worse, perverse collateral effects. This
phenomenon is certainly familiar when the complex adaptive system in question is
an ecosystem; complexity theorists advocate that we view health care systems
through a similar lens and not rush into change strategies, however plausible
they may seem. The two references below provide concrete examples to flesh out
the ideas of complexity theory and distinguish it from other major theories of
organizational behavior.(1,2)

1. Rhydderch M, Elwyn G, Marshall M, Grol R. Organisational change theory
and the use of indicators in general practice. Qual Saf Health Care.
2004;13:213-217.

[

go to PubMed ]

2. Plsek PE, Wilson T. Complexity, leadership, and management in healthcare
organisations. BMJ. 2001;323:746-749.

[

go to PubMed ]

Computerized Physician Order Entry or Computerized Provider Order Entry
(CPOE) – Refers to a computer-based system of ordering medications and often
other tests. Physicians (or other providers) directly enter orders into a
computer system that can have varying levels of sophistication. Basic CPOE
ensures standardized, legible, complete orders, and thus primarily reduces
errors due to poor handwriting and ambiguous abbreviations. Almost all CPOE
systems offer some additional capabilities, which fall under the general rubric
of Clinical Decision Support System (CDSS). Typical CDSS features involve
suggested default values for drug doses, routes of administration, or frequency.
More sophisticated CDSSs can perform drug allergy checks (eg, the user orders
ceftriaxone and a warning flashes that the patient has a documented penicillin
allergy), drug-laboratory value checks (eg initiating an order for gentamicin
prompts the system to alert you to the patient’s last creatinine), drug-drug
interaction checks, and so on. At the highest level of sophistication, CDSS
prevents not only errors of commission (eg, ordering a drug in excessive doses
or in the setting of a serious allergy), but also of omission. (For example, an
alert may appear such as, "You have ordered heparin; would you like to order a
PTT in 6 hours?" Or, even more sophisticated: "The admitting diagnosis is hip
fracture; would you like to order heparin DVT prophylaxis?")

Confirmation Bias - Refers to the tendency to focus on evidence that
supports a working hypothesis, such as a diagnosis in clinical medicine, rather
than to look for evidence that refutes it or provides greater support to an
alternative diagnosis.(1,2)
Suppose that a 65-year-old man with a past history of angina presents to the
emergency department with acute onset of shortness of breath. The physician
immediately considers the possibility of cardiac ischemia, so asks the patient
if he has experienced any chest pain. The patient replies affirmatively. Because
the physician perceives this answer as confirming his working diagnosis, he does
not ask if the chest pain was pleuritic in nature, which would decrease the
likelihood of an acute coronary syndrome and increase the likelihood of
pulmonary embolism (a reasonable alternative diagnosis for acute shortness of
breath accompanied by chest pain). The physician then orders an EKG and cardiac
troponin. The EKG shows nonspecific ST changes and the troponin returns slightly
elevated.

Of course, ordering an EKG and testing cardiac enzymes is appropriate in the
work-up of acute shortness of breath, especially when it is accompanied by chest
pain and in a patient with known angina. The problem is that these tests may be
misleading, since positive results are consistent not only with acute coronary
syndrome but also with pulmonary embolism. To avoid confirmation in this case,
the physician might have obtained an arterial blood glass or a D-dimer level.
Abnormal results for either of these tests would be relatively unlikely to occur
in a patient with an acute coronary syndrome (unless complicated by pulmonary
edema), but likely to occur with pulmonary embolism. These results could be
followed up by more direct testing for pulmonary embolism (eg, with a helical CT
scan of the chest), whereas normal results would allow the clinician to proceed
with greater confidence down the road of investigating and managing cardiac
ischemia.

This vignette was presented as if information were sought in sequence. In many
cases, especially in acute care medicine, clinicians have the results of
numerous tests in hand when they first meet a patient. The results of these
tests often do not all suggest the same diagnosis. The appeal of accentuating
confirmatory test results and ignoring nonconfirmatory ones is that it minimizes
cognitive dissonance.(3)

A related cognitive trap that may accompany confirmation bias and compound the
possibility of error is “anchoring
bias”—the tendency to stick with one’s first impressions, even in the face
of significant disconfirming evidence.

1. Croskerry P. The importance of cognitive errors in diagnosis and
strategies to minimize them. Acad Med. 2003;78:775-780.

[

go to PubMed ]

2. Redelmeier DA. Improving patient care. The cognitive psychology of missed
diagnoses. Ann Intern Med. 2005;142:115-120.

[

go to PubMed ]

3. Pines JM. Profiles in patient safety: confirmation bias in emergency
medicine. Acad Emerg Med. 2006;13:90-94.

[

go to PubMed ]

Crew Resource Management – Crew resource management (CRM), also called
crisis resource management in some contexts (eg, anesthesia), encompasses a
range of approaches to training groups to function as teams, rather than as
collections of individuals. Originally developed in aviation, CRM emphasizes the
role of "human factors"-the effects of fatigue, expected or predictable
perceptual errors (such as misreading monitors or mishearing instructions), as
well as the impact of different management styles and organizational cultures in
high-stress, high-risk environments.

CRM training develops communication skills, fosters a more cohesive environment
among team members, and creates an atmosphere in which junior personnel will
feel free to speak up when they think the something is amiss. Some CRM programs
emphasize education on the settings in which errors occur and the aspects of
team decision making conducive to "trapping" errors before they cause harm.
Other programs may provide more hands-on training involving simulated crisis
scenarios followed by debriefing sessions in which participants assess their own
and others' behavior.

Critical Incidents – A term made famous by a classic human factors study
by Cooper (1)
of “anesthetic mishaps,” though the term had first been coined in the 1950s.
Cooper and colleagues brought the technique of critical incident analysis to a
wide audience in health care but followed the definition of the originator of
the technique.(2)
They defined critical incidents as occurrences that are “significant or pivotal,
in either a desirable or an undesirable way,” though Cooper and colleagues (and
most others since) chose to focus on incidents that had potentially undesirable
consequences. This definition by itself conveys little—what does “significant or
pivotal” mean? It is best understood in the context of the type of investigation
that follows, which is very much in the style of
root cause
analysis. Thus, “significant or pivotal” means that there was significant
potential for harm (or actual harm), but also that the event has the potential
to reveal important hazards in the organization. In many ways, it is the spirit
of the expression in quality improvement circles, “every defect is a treasure.”(3)
In other words, these incidents, whether
close calls or
disasters in which significant harm occurred, provide valuable opportunities to
learn about individual and organizational factors that can be remedied to
prevent similar incidents in the future.

1. Cooper JB, Newbower RS, Long CD, McPeek B. Preventable anesthesia
mishaps: a study of human factors. Anesthesiology. 1978;49:399-406.

[

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2. Flanagan JC. The critical incident technique. Psychol Bull.
1954;51:327-358.

[

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3. James BC. Every defect a treasure: learning from adverse events in
hospitals. Med J Aust. 1997;166:484-487.

[

go to PubMed ]

D	Back to Top

Decision Support – Refers to any system for advising or providing
guidance about a particular clinical decision at the point of care. For example,
a copy of an algorithm for antibiotic selection in patients with community
acquired pneumonia would count as clinical decision support if made available at
the point of care. Increasingly, decision support occurs via a computerized
clinical information or order entry system. Computerized decision support
includes any software employing a knowledge base designed to assist clinicians
in decision making at the point of care.

Typically a decision support system responds to "triggers" or "flags"—specific
diagnoses, laboratory results, medication choices, or complex combinations of
such parameters—and provides information or recommendations directly relevant to
a specific patient encounter. For instance, ordering an aminoglycoside for a
patient with creatinine above a certain value might trigger a message suggesting
a dose adjustment based on the patient's decreased renal function.

E	Back to Top

Error – An act of commission (doing something wrong) or omission (failing
to do the right thing) that leads to an undesirable outcome or significant
potential for such an outcome. For instance, ordering a medication for a patient
with a documented allergy to that medication would be an act of commission.
Failing to prescribe a proven medication with major benefits for an eligible
patient (eg, low-dose unfractionated heparin as venous thromboembolism
prophylaxis for a patient after hip replacement surgery) would represent an
error of omission.

Errors of omission are more difficult to recognize than errors of commission but
likely represent a larger problem. In other words, there are likely many more
instances in which the provision of additional diagnostic, therapeutic, or
preventive modalities would have improved care than there are instances in which
the care provided quite literally should not have been provided. In many ways,
this point echoes the generally agreed-upon view in the health care quality
literature that underuse far exceeds overuse, even though the latter
historically received greater attention. (See definition for for
Underuse,
Overuse, Misuse.)

In addition to commission vs. omission, three other dichotomies commonly appear
in the literature on errors:
active failures
vs. latent conditions,
errors at the "sharp end"
vs. errors at the "blunt
end," and slips vs.
mistakes.

Error Chain – Error chain generally refers to the series of events that
led to a disastrous outcome, typically uncovered by a
root cause
analysis. Sometimes the chain metaphor carries the added sense of
inexorability, as many of the causes are tightly coupled, such that one problem
begets the next. A more specific meaning of error chain, especially when used in
the phrase break the error chain, relates to the common themes or categories of
causes that emerge from root cause analyses. These categories go by different
names in different settings, but they generally include (1) failure to follow
standard operating procedures (2) poor leadership (3) breakdowns in
communication or teamwork (4) overlooking or ignoring individual fallibility and
(5) losing track of objectives. Used in this way, break the error chain is
shorthand for an approach in which team members continually address these links
as a crisis or routine situation unfolds. The checklists that are included in
teamwork training programs have categories corresponding to these common links
in the error chain (e.g., establish team leader, assign roles and
responsibilities, monitor your teammates).

F	Back to Top

Face Validity – The extent to which a technical concept, instrument, or
study result is plausible, usually because its findings are consistent with
prior assumptions and expectations.

Failure Mode and Effect Analysis (FMEA) – Error analysis may involve
retrospective investigations (as in
Root Cause
Analysis) or prospective attempts to predict "error modes." Different
frameworks exist for predicting possible errors. One commonly used approach is
failure mode and effect analysis (FMEA), in which the likelihood of a particular
process failure is combined with an estimate of the relative impact of that
error to produce a "criticality index." By combining the probability of failure
with the consequences of failure, this index allows for the prioritization of
specific processes as quality improvement targets. For instance, an FMEA
analysis of the medication dispensing process on a general hospital ward might
break down all steps from receipt of orders in the central pharmacy to filling
automated dispensing machines by pharmacy technicians. Each step in this process
would be assigned a probability of failure and an impact score, so that all
steps could be ranked according to the product of these two numbers. Steps
ranked at the top (ie, those with the highest "criticality indices") would be
prioritized for error proofing.

Failure to Rescue – "Failure to rescue" is shorthand for failure to
rescue (ie, prevent a clinically important deterioration, such as death or
permanent disability) from a complication of an underlying illness (eg, cardiac
arrest in a patient with acute myocardial infarction) or a complication of
medical care (eg, major hemorrhage after thrombolysis for acute myocardial
infarction). Failure to rescue thus provides a measure of the degree to which
providers responded to adverse occurrences (eg, hospital-acquired infections,
cardiac arrest or shock) that developed on their watch. It may reflect the
quality of monitoring, the effectiveness of actions taken once early
complications are recognized, or both.

The technical motivation for using failure to rescue to evaluate the quality of
care stems from the concern that some institutions might document adverse
occurrences more assiduously than other institutions.(1,2)
Therefore, using lower rates of in-hospital complications by themselves may
simply reward hospitals with poor documentation. However, if the medical record
indicates that a complication has occurred, the response to that complication
should provide an indicator of the quality of care that is less susceptible to
charting bias.

Initial studies of mortality and complication rates after surgical procedures
indicated that lower rates of failure to rescue correlated with other plausible
quality measures.(1,2)
Rates of failure to rescue have since served as outcome measures in prominent
studies of the impacts of nurse-staffing ratios (3,4)
and nurse educational levels (5)
on the quality of care. Examples of the specific "rescue-able" adverse
occurrences in such studies include pneumonia, shock, cardiac arrest, upper
gastrointestinal bleeding, sepsis, and deep venous thrombosis.(4)
Death after any of these in-hospital occurrences would count as failure to
rescue, on the view that early identification by providers can influence the
risk of death.

The AHRQ technical report that developed the AHRQ Patient Safety Indicators (6)
reviews the evidence supporting failure to rescue as a measure of the quality
and safety of hospital care. Although failure to rescue made the final set of
approved indicators, the expert panels that reviewed each candidate indicator
identified some unresolved concerns about its use. For instance, patients with
advanced illnesses may be particularly difficult to rescue from complications
such as sepsis and cardiac arrest. Moreover, patients with advanced illness may
not wish "rescue" from such complications. The initial studies that examined
failure to rescue focused on surgical care, where these issues may not be as
problematic. Nonetheless, the concept of failure to rescue is an important one
and finds increasing application in studies of health care quality and safety.

1. Silber JH, Williams SV, Krakauer H, Schwartz JS. Hospital and patient
characteristics associated with death after surgery. A study of adverse
occurrence and failure to rescue. Med Care. 1992;30:615-629.

[

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2. Silber JH, Rosenbaum PR, Schwartz JS, Ross RN, Williams SV. Evaluation of
the complication rate as a measure of quality of care in coronary artery bypass
graft surgery. JAMA. 1995;274:317-323.

[

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3. Aiken LH, Clarke SP, Sloane DM, Sochalski J, Silber JH. Hospital nurse
staffing and patient mortality, nurse burnout, and job dissatisfaction. JAMA.
2002;288:1987-1993.

[

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4. Needleman J, Buerhaus P, Mattke S, Stewart M, Zelevinsky K.
Nurse-staffing levels and the quality of care in hospitals. N Engl J Med.
2002;346:1715-1722.

[

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5. Aiken LH, Clarke SP, Cheung RB, Sloane DM, Silber JH. Educational levels
of hospital nurses and surgical patient mortality. JAMA. 2003;290:1617-1623.

[

go to PubMed ]

6. McDonald KM, Romano PS, Geppert J, et al. Measures of Patient Safety
Based on Hospital Administrative Data—The Patient Safety Indicators. Rockville,
MD: Agency for Healthcare Research and Quality; 2002. AHRQ Publication No.
02-0038.

Available at:

http://www.ahrq.gov/clinic/evrptfiles.htm#psi.

Forcing Function – An aspect of a design that prevents a target action
from being performed or allows its performance only if another specific action
is performed first. For example, automobiles are now designed so that the driver
cannot shift into reverse without first putting her foot on the brake pedal.
Forcing functions need not involve device design. For instance, one of the first
forcing functions identified in health care is the removal of concentrated
potassium from general hospital wards. This action is intended to prevent the
inadvertent preparation of intravenous solutions with concentrated potassium, an
error that has produced small but consistent numbers of deaths for many years.

H	Back to Top

Health Literacy – Individuals' ability to find, process, and comprehend
the basic health information necessary to act on medical instructions and make
decisions about their health.(1)

1. Ad Hoc Committee on Health Literacy for the Council on Scientific Affairs
AMA. Health literacy: report of the Council on Scientific Affairs. JAMA.
1999;281:552-7. [

go to PubMed ]

Heuristic – Loosely defined or informal rule often arrived at through
experience or trial and error (eg, gastrointestinal complaints that wake
patients up at night are unlikely to be functional). Heuristics provide
cognitive shortcuts in the face of complex situations, and thus serve an
important purpose. Unfortunately, they can also turn out to be wrong.

The Health Insurance Portability and Accountability Act (HIPAA) – The
Health Insurance Portability and Accountability Act of 1996 (HIPAA) contains new
federal regulations intended to increase privacy and security of patient
information during electronic transmission or communication of "protected health
information" (PHI) among providers or between providers and payers or other
entities.

"Protected health information" (PHI) includes all medical records and other
individually identifiable health information. "Individually identifiable
information" includes data that explicitly linked to a patient as well as health
information with data items with a reasonable potential for allowing individual
identification.

HIPAA also requires providers to offer patients certain rights with respect to
their information, including the right to access and copy their records and the
right to request amendments to the information contained in their records.

Administrative protections specified by HIPAA to promote the above regulations
and rights include requirements for a Privacy Officer and staff training
regarding the protection of patients' information.

High Reliability Organizations (HROs) – High reliability organizations
refer to organizations or systems that operate in hazardous conditions but have
fewer than their fair share of adverse events. (1,2)
Commonly discussed examples include air traffic control systems, nuclear power
plants, and naval aircraft carriers. (3,4)
It is worth noting that, in the patient safety literature, HROs are considered
to operate with nearly failure-free performance records, not simply better than
average ones. This shift in meaning is somewhat understandable given that the
“failure rates” in these other industries are so much lower than rates of errors
and adverse events in health care. This comparison glosses over the difference
in significance of a “failure” in the nuclear power industry compared with one
in health care. The point remains, however, that some organizations achieve
consistently safe and effective performance records despite unpredictable
operating environments or intrinsically hazardous endeavors. Detailed case
studies of specific HROs have identified some common features, which have been
offered as models for other organizations to achieve substantial improvements in
their safety records. These features include:

Preoccupation with failure—the acknowledgment of the high-risk,
error-prone nature of an organization’s activities and the determination to
achieve consistently safe operations.

Commitment to resilience—the development of capacities to detect
unexpected threats and contain them before they cause harm, or bounce back
when they do.

Sensitivity to operations—an attentiveness to the issues facing workers at
the frontline. This feature comes into play when conducting analyses of
specific events (eg, frontline workers play a crucial role in root cause
analyses by bringing up unrecognized latent threats in current operating
procedures), but also in connection with organizational decision making, which
is somewhat decentralized. Management units at the frontline are given some
autonomy in identifying and responding to threats, rather than adopting a
rigid top-down approach.

A culture of
safety, in which individuals feel comfortable drawing attention to
potential hazards or actual failures without fear of censure from management.

1. Weick KE, Sutcliffe KM. Managing the Unexpected: Assuring High
Performance in an Age of Complexity. San Francisco, CA: Jossey-Bass; 2001.

2. Reason J. Human error: models and management. BMJ. 2000;320:768-770.

[

go to pubmed ]

3. LaPorte TR. The United States air traffic control system: increasing
reliability in the midst of rapid growth. In: Mayntz R, Hughes TP, eds. The
Development of Large Technical Systems. Boulder, CO: Westview Press; 1988.

4. Roberts KH. Managing high reliability organizations. Calif Manage Rev.
1990;32:101-113.

Hindsight Bias – In a very general sense, hindsight bias relates to the
common expression “hindsight is 20/20.” This expression captures the tendency
for people to regard past events as expected or obvious, even when, in real
time, the events perplexed those involved. More formally, one might say that
after learning the outcome of a series of events—whether the outcome of the
World Series or the steps leading to a war—people tend to exaggerate the extent
to which they had foreseen the likelihood of its occurrence.

In the context of safety analysis, hindsight bias refers to the tendency to
judge the events leading up to an accident as errors because the bad outcome is
known. The more severe the outcome, the more likely that decisions leading up to
this outcome will be judged as errors. Judging the antecedent decisions as
errors implies that the outcome was preventable. In legal circles, one might use
the phrase “but for,” as in “but for these errors in judgment, this terrible
outcome would not have occurred.” Such judgments return us to the concept of
“hindsight is 20/20.” Those reviewing events after the fact see the outcome as
more foreseeable and therefore more preventable than they would have appreciated
in real time.

Psychologist Baruch Fischhoff drew attention to the importance of this problem
in a classic paper published in 1975 (1),
since which time multiple examples of the impacts of this bias have been
explored in the psychology literature.

The impact of hindsight on judgments by peer reviewers regarding the quality of
clinical care in medicine has also been demonstrated.(2)
One of the case-based discussions in “Quality Grand Rounds,” published in
Annals of Internal Medicine, provides a detailed exploration of the extent
to which difficult decisions are cast as errors after an undesirable outcome
occurs.(3)

1. Fischhoff B. Hindsight ? foresight: the effect of outcome knowledge on
judgment under uncertainty [reprint of Fischhoff B. Hindsight does not equal
foresight: the effect of outcome knowledge on judgment under uncertainty. J of
Exp Psychol: Hum Perform and Perception. 1975;1:288–299.]. Qual Saf Health Care.
2003;12:304-112.

[

go to PubMed ]

2. Caplan RA, Posner K., Cheney FW. Effect of outcome on physician judgments
of appropriateness of care. JAMA. 1991;265:1957-1960.

[

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3. Hofer TP, Hayward RA. Are bad outcomes from questionable clinical
decisions preventable medical errors? A case of cascade iatrogenesis. Ann Intern
Med. 2002; 137:327-333.

[

go to PubMed ]

Human Factors (or Human Factors Engineering) – Refers to the study of
human abilities and characteristics as they affect the design and smooth
operation of equipment, systems, and jobs. The field concerns itself with
considerations of the strengths and weaknesses of human physical and mental
abilities and how these affect the systems design. Human factors analysis does
not require designing or redesigning existing objects. For instance, the now
generally accepted recommendation that hospitals standardize equipment such as
ventilators, programmable IV pumps, and defibrillators (ie, that each hospital
pick a single type, so that different floors do not have different
defibrillators) is an example of a very basic application of a
heuristic from
human factors that equipment be standardized within a system wherever possible.
In general, human factors engineering examines a particular activity in terms of
its component tasks and then considers each task in terms of: physical demands,
skill demands, mental workload, and other such factors, along with their
interactions with aspects of the work environment (eg, adequate lighting,
limited noise, or other distractions), device design, and team dynamics.

I	Back to Top

Iatrogenic – An adverse effect of medical care, rather than of the
underlying disease (literally "brought forth by healer," from Greek iatros, for
healer, and gennan, to bring forth); equivalent to
adverse event.

Incident Reporting – Refers to the identification of occurrences that
could have led, or did lead, to an undesirable outcome. Reports usually come
from personnel directly involved in the incident or events leading up to it (eg,
the nurse, pharmacist, or physician caring for a patient when a medication error
occurred) rather than, say, floor managers.

Incident reporting represents a species of the more general activity of
surveillance for errors, adverse events, or other quality problems. From the
perspective of those collecting the data, incident reporting counts as a
passive form of surveillance. It relies on those involved in target
incidents choosing to provide the desired information. More active
methods of surveillance range from activities such as going to gatherings of
frontline workers and asking if any recent incidents have occurred (1)
to retrospective medical record review (2)
to direct observation.(3)
Compared with medical record review and direct observation, incident reporting
captures only a fraction of incidents.(3 ,4)

Despite their low yield, spontaneous incident reporting systems have some
advantages, including their relatively low cost and the involvement of frontline
personnel in the process of identifying important problems for the organization.
The involvement of frontline workers, however, also raises the issue of
confidentiality. Because incident reports tend to come from personnel involved
in the incidents, these personnel may have legitimate concerns about the effects
reporting will have on their performance records. To encourage reporting, some
organizations make incident reporting anonymous. In other words, personnel can
report an incident without identifying themselves.

Absent anonymity, some incident reporting systems assure confidentiality
regarding the identity of individuals who submit reports. The Aviation Safety
Reporting System (http://asrs.arc.nasa.gov)
represents a confidential reporting system. As long as the persons reporting
incidents have not committed any breaches of professional conduct, their
identities remain in strict confidence and play no role in the investigations.

1. Weingart SN, Ship AN, Aronson MD. Confidential clinician-reported
surveillance of adverse events among medical inpatients. J Gen Intern Med.
2000;15:470-477.

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2. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and
potential adverse drug events. Implications for prevention. ADE Prevention Study
Group. JAMA. 1995;274:29-34.

[

go to PubMed ]

3. Flynn EA, Barker KN, Pepper GA, Bates DW, Mikeal RL. Comparison of
methods for detecting medication errors in 36 hospitals and skilled-nursing
facilities. Am J Health Syst Pharm. 2002;59:436-446.

[

go to PubMed ]

4. Cullen DJ, Bates DW, Small SD, Cooper JB, Nemeskal AR, Leape LL. The
incident reporting system does not detect adverse drug events: a problem for
quality improvement. Jt Comm J Qual Improv. 1995;21:541-548.

[

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Informed Consent – Refers to the process whereby a physician informs a
patient about the risks and benefits of a proposed therapy or test. Informed
consent aims to provide sufficient information about the proposed treatment and
any reasonable alternatives that the patient can exercise autonomy in deciding
whether to proceed.

Legislation governing the requirements of, and conditions under which, consent
must be obtained varies by jurisdiction. Most general guidelines require
patients to be informed of the nature of their condition, the proposed
procedure, the purpose of the procedure, the risks and benefits of the proposed
treatments, the probability of the anticipated risks and benefits, alternatives
to the treatment and their associated risks and benefits, and the risks and
benefits of not receiving the treatment or procedure.

Although the goals of informed consent are irrefutable, consent is often
obtained in a haphazard, pro forma fashion, with patients having little true
understanding of procedures to which they have consented. Evidence suggests that
asking patients to restate the essence of the informed consent improves the
quality of these discussions and makes it more likely that the consent is truly
"informed."

[
Procedures For Obtaining Informed Consent ]

J	Back to Top

Just Culture — The phrase “just culture” was popularized in the patient
safety lexicon by a report (1)
that outlined principles for achieving a culture in which frontline personnel
feel comfortable disclosing errors—including their own—while maintaining
professional accountability. The examples in the report relate to transfusion
safety, but the principles clearly generalize across domains within health care
organizations.

Traditionally, health care’s culture has held individuals accountable for all
errors or mishaps that befall patients under their care. By contrast, a just
culture recognizes that individual practitioners should not be held accountable
for system failings over which they have no control. A just culture also
recognizes many individual or “active”
errors represent predictable interactions between human operators and the
systems in which they work. However, in contrast to a culture that touts “no
blame” as its governing principle, a just culture does not tolerate conscious
disregard of clear risks to patients or gross misconduct (eg, falsifying a
record, performing professional duties while intoxicated).

In summary, a just culture recognizes that competent professionals make mistakes
and acknowledges that even competent professionals will develop unhealthy norms
(shortcuts, “routine rule violations”), but has zero tolerance for reckless
behavior.

1. Marx D. Patient Safety and the “Just Culture”: A Primer for Health Care
Executives. New York, NY: Columbia University; 2001. Available at:

http://www.mers-tm.net/support/marx_primer.pdf

L	Back to Top

Latent Error (or Latent Condition) – The terms "active" and "latent" as
applied to errors were
coined by James Reason.(1 ,2)
Latent errors (or latent conditions) refer to less apparent failures of
organization or design that contributed to the occurrence of errors or allowed
them to cause harm to patients. For instance, whereas the
active failure
in a particular adverse event may have been a mistake in programming an
intravenous pump, a latent error might be that the institution uses multiple
different types of infusion pumps, making programming errors more likely. Thus,
latent errors are quite literally "accidents waiting to happen."

Latent errors are sometimes referred to as errors at the "blunt
end," referring to the many layers of the health care system that affect the
person "holding" the scalpel. Active failures, in contrast, are sometimes
referred to as errors at the “sharp
end,” or the personnel and parts of the health care system in direct contact
with patients.

1. Reason JT. Human Error. New York, NY: Cambridge University Press; 1990.

[

go to PSNet listing ]

2. Reason J. Human error: models and management. BMJ. 2000;320:768-770.

[

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Learning Curve – The acquisition of any new skill is associated with the
potential for lower-than-expected success rates or higher-than-expected
complication rates. This phenomenon is often known as a "learning curve." In
some cases, this learning curve can be quantified in terms of the number of
procedures that must be performed before an operator can replicate the outcomes
of more experienced operators or centers.

While learning curves are almost inevitable when new procedures emerge or new
providers are in training, minimizing their impact is a patient safety
imperative. One option is to perform initial operations or procedures under the
supervision of more experienced operators. Surgical and procedural simulators
may play an increasingly important role in decreasing the impact of learning
curves on patients, by allowing acquisition of relevant skills in laboratory
settings.

M	Back to Top

Magnet Hospital Status – Refers to a designation by the Magnet Hospital
Recognition Program administered by the American Nurses Credentialing Center.
The program has its genesis in a 1983 study conducted by the American Academy of
Nursing that sought to identify hospitals that retained nurses for longer than
average periods of time. The study identified institutional characteristics
correlated with high retention rates, an important finding in light of a major
nursing shortage at the time.(1)
These findings provided the basis for the concept of “magnet hospital” and led
10 years later to the formal Magnet Program.

Without taking anything away from the particular hospitals that have achieved
Magnet status, the program as a whole has its critics. In fact, at least one
state nurses’ association (Massachusetts) has taken an official position
critiquing the program, charging that its perpetuation reflects the financial
interests of its sponsoring organization and the participating hospitals more
than the goals of improving health care quality or improving working conditions
for nurses.(2)

Regardless of the particulars of the Magnet Recognition Program and the lack of
persuasive evidence linking magnet status to quality, to many the term “magnet
hospital” connotes a hospital that delivers superior patient care and, partly on
this basis, attracts and retains high-quality nurses.

1. Magnet hospitals. Attraction and retention of professional nurses. Task
Force on Nursing Practice in Hospitals. American Academy of Nursing. ANA Publ.
1983;(G-160):i-xiv, 1-135.

[

go to PubMed ]

2. Position Statement On the "Magnet Recognition Program for Nursing
Services in Hospitals" and Other Consultant-Driven Quality Improvement Projects
that Claim to Improve Care [Massachusetts Nurses Association Web site]. November
2004.

Available at:

http://www.massnurses.org/pubs/positions/magnet.htm.

Medical Emergency Team – The concept of medical emergency teams (also
known as rapid response teams) is that of a cardiac arrest team with more
liberal calling criteria. Instead of just frank respiratory or cardiac arrest,
medical emergency teams respond to a wide range of worrisome, acute changes in
patients’ clinical status, such as low blood pressure, difficulty breathing, or
altered mental status. In addition to less stringent calling criteria, the
concept of medical emergency teams de-emphasizes the traditional hierarchy in
patient care in that anyone can initiate the call. Nurses, junior medical staff,
or others involved in the care of patients can call for the assistance of the
medical emergency team whenever they are worried about a patient’s condition,
without having to wait for more senior personnel to assess the patient and
approve the decision to call for help.

Medication Reconciliation — Patients admitted to a hospital commonly
receive new medications or have changes made to their existing medications. As a
result, the new medication regimen prescribed at the time of discharge may
inadvertently omit needed medications that patients have been receiving for some
time.(1) Alternatively, new medications may unintentionally duplicate existing
medications. For example, a physician might prescribe a calcium channel blocker
to a patient who has hypertension but is already taking another medication from
the same drug class.

Such unintended inconsistencies in medication regimens may occur at any point of
transition in care (e.g., transfer from an intensive care unit to a general
ward), not just hospital admission or discharge. Medication reconciliation
refers to the process of avoiding such inadvertent inconsistencies across
transitions in care by reviewing the patient’s complete medication regimen at
the time of admission/transfer/discharge and comparing it with the regimen being
considered for the new setting of care.

In July 2004, the Joint Commission for Accreditation of Healthcare Organizations
(JCAHO) announced 2005 National Patient Safety Goal #8 to "accurately and
completely reconcile medications across the continuum of care."(2) The JCAHO
does not stipulate the details of the reconciliation process or who should
perform it. While most hospitals cannot afford to hire pharmacists to take on
this role, it is worth noting that more rigorous positive studies of medication
reconciliation have tended to involve pharmacists performing the medication
history and reconciliation process.(3-5)

1. Tam VC, Knowles SR, Cornish PL, Fine N, Marchesano R, Etchells EE. Frequency,
type and clinical importance of medication history errors at admission to
hospital: a systematic review. CMAJ 2005;173:510-515.

2. Using medication reconciliation to prevent errors. Sentinel Event Alert.
Issue 35 - January 25, 2006. Available at:

http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_35.htm.
Accessed May 15, 2006.

3. Schnipper JL, Kirwin JL, Cotugno MC, et al. Role of pharmacist counseling in
preventing adverse drug events after hospitalization. Arch Intern Med
2006;166:565-571.

4. Coleman EA, Smith JD, Raha D, Min SJ. Posthospital medication discrepancies:
prevalence and contributing factors. Arch Intern Med 2005;165:1842-1847.

5. Cornish PL, Knowles SR, Marchesano R, et al. Unintended medication
discrepancies at the time of hospital admission. Arch Intern Med
2005;165:424-429.

Mental Models – Mental models are psychological representations of real,
hypothetical, or imaginary situations. Scottish psychologist Kenneth Craik
(1943) first proposed mental models as the basis for anticipating events and
explaining events (ie, for reasoning). Though easiest to conceptualize in terms
of mental pictures of objects (eg, a DNA double helix or the inside of an
internal combustion engine) mental models can also include "scripts" or
processes and other properties beyond images. Mental models create differing
expectations, which suggest different courses of action. For instance, when you
walk into a fast-food restaurant, you are invoking a different mental model than
when in a fancy restaurant. Based on this model, you automatically go to place
your order at the counter, rather than sitting at a booth and expecting a waiter
to take your order.

Mistakes – In some contexts,
errors are dichotomized
as “slips” or
“mistakes,” based on the cognitive psychology of task-oriented behavior.
Attentional behavior is characterized by conscious thought, analysis, and
planning, as occurs in active problem solving. Schematic behavior refers to the
many activities we perform reflexively or as if acting on “autopilot.”
Complementary to these two behavior types are two categories of error: slips and
mistakes.

Mistakes reflect failures during attentional behaviors, or incorrect choices.
Rather than lapses in concentration (as with slips), mistakes typically involve
insufficient knowledge, failure to correctly interpret available information, or
application of the wrong cognitive “heuristic” or rule. Thus, choosing the wrong
diagnostic test or ordering a suboptimal medication for a given condition
represent mistakes. A slip, on the other hand, would be forgetting to check the
chart to make sure you ordered them for the right patient.

Distinguishing slips from mistakes serves two important functions. First, the
risk factors for their occurrence differ. Slips occur in the face of competing
sensory or emotional distractions, fatigue, and stress; mistakes more often
reflect lack of experience or insufficient training. Second, the appropriate
responses to these error types differ. Reducing the risk of slips requires
attention to the designs of protocols, devices, and work environments—using
checklists so key steps will not be omitted, reducing fatigue among personnel
(or shifting high-risk work away from personnel who have been working extended
hours), removing unnecessary variation in the design of key devices, eliminating
distractions (eg, phones) from areas where work requires intense concentration,
and other redesign strategies. Reducing the likelihood of mistakes typically
requires more training or supervision. Even in the many cases of slips, health
care has typically responded to all errors as if they were mistakes, with
remedial education and/or added layers of supervision.

Metacognition – Metacognition refers to thinking about thinking—that is,
reflecting on the thought processes that led to a particular diagnosis or
decision to consider whether biases or cognitive short cuts may have had a
detrimental effect. Numerous cognitive biases affect human reasoning.(1-3)

In some ways, metacognition amounts to playing devil's advocate with oneself
when it comes to working diagnoses and important therapeutic decisions. However,
the devil is often in the details—one must become familiar with the variety of
specific biases that commonly affect medical reasoning. For instance, when
discharging a patient with atypical chest pain from the emergency department,
you might step back and consider how much the discharge diagnosis of
"musculoskeletal pain" reflects the sign out as a "soft rule out" given by a
colleague on the night shift. Or, your might mull over the degree to which your
reaction to and assessment of a particular patient stemmed from his having been
labeled a "frequent flyer." Another cognitive bias is that clinicians tend to
assign more importance to pieces of information that required personal effort to
obtain (4)
(eg, the additional symptom elicited by your history compared with that given by
a colleague, or the lab result obtained though numerous phone calls.)

While metacognition refers to the general process of reflecting on the
possibility of cognitive biases affecting clinical diagnoses and decisions,
"cognitive forcing functions" refer to specific approaches to looking for such
biases.(1,5)
Just as a computer programmer might routinely check for errors during the
"debugging" process, clinicians should likewise consider routinely employing
cognitive strategies to check for "bugs." These should take into account the
different types of biases known to affect cognition (reviewed in the articles
below [1-3,5]),
details of the clinical context, and even personal details (eg, recognition that
you like to follow hunches or trust your initial gestalt).

1.
Croskerry P. The importance of cognitive errors in diagnosis and strategies to
minimize them. Acad Med. 2003;78:775-80. [

go to pubmed ]

2.
Croskerry P. Achieving quality in clinical decision making: cognitive strategies
and detection of bias. Acad Emerg Med. 2002;9:1184-1204. [

go to pubmed ]

3.
Graber M, Gordon R, Franklin N. Reducing diagnostic errors in medicine: what's
the goal? Acad Med. 2002;77:981-92. [

go to pubmed ]

4.
Redelmeier DA, Shafir E, Aujla PS. The beguiling pursuit of more information.
Med Decis Making. 2001;21:376-381. [

go to pubmed ]

5.
Croskerry P. Cognitive forcing strategies in clinical decisionmaking. Ann Emerg
Med. 2003;41:110-20. [

go to pubmed ]

N	Back to Top

Near Miss – An event or situation that did not produce patient injury,
but only because of chance. This good fortune might reflect robustness of the
patient (eg, a patient with penicillin allergy receives penicillin, but has no
reaction) or a fortuitous, timely intervention (eg, a nurse happens to realize
that a physician wrote an order in the wrong chart). This definition is
identical to that for
close call.

Normal Accident Theory – Though less often cited than
high
reliability theory in the health care literature, normal accident theory has
played a prominent role in the study of complex organizations. The phrase and
theory were developed by sociologist Charles Perrow (1)
in connection with a careful analysis of the accident at the Three Mile Island
nuclear power plant in 1979, among other industrial (near) catastrophes. In
contrast to the optimism of high reliability theory, normal accident theory
suggests that, at least in some settings, major accidents become inevitable and,
thus, in a sense, "normal."

Perrow proposed two factors that create an environment in which a major accident
becomes increasingly likely over time: "complexity" and "tight coupling." The
degree of complexity envisioned by Perrow occurs when no single operator can
immediately foresee the consequences of a given action in the system. Tight
coupling occurs when processes are intrinsically time-dependent–once a process
has been set in motion, it must be completed within a certain period of time.
Many health care organizations would illustrate Perrow’s definition of
complexity, but only hospitals would be regarded as exhibiting tight coupling.
Importantly, normal accident theory contends that accidents become inevitable in
complex, tightly coupled systems regardless of steps taken to increase safety.
In fact, these steps sometimes increase the risk for future accidents through
unintended collateral effects and general increases in system complexity.

Approximately 10 years after normal accident theory appeared, Scott Sagan, a
political scientist, conducted a detailed examination of the question of why
there has never been an accidental nuclear war (2)
with a view toward testing the competing paradigms of normal accident theory and
high reliability theory. The results of detailed archival research initially
appeared to confirm the predictions of high reliability theory. However,
interviews with key personnel uncovered several hair-raising near misses. The
study ultimately concluded that good fortune played a greater role than good
design in the safety record of the nuclear weapons industry to date.

Even if one does not believe the central contention of normal accident
theory–that the potential for catastrophe emerges as an intrinsic property of
certain complex systems–analyses informed by this theory’s perspective have
offered some fascinating insights into possible failure modes for high-risk
organizations, including hospitals.

1. Perrow C. Normal Accidents: Living with High-Risk Technologies.
Princeton, NJ; Princeton University Press; 1999. [
go
to PSNet listing ]

2. Sagan SD. The Limits of Safety: Organizations, Accidents and Nuclear
Weapons. Princeton, NJ: Princeton University Press; 1993. [
go
to PSNet listing] ]

Normalization of Deviance – Normalization of deviance was coined by Diane
Vaughan in her book

The Challenger Launch Decision: Risky Technology, Culture, and Deviance at NASA
(1),
in which she analyzes the interactions between various cultural forces within
NASA that contributed to the Challenger disaster. Vaughn used this expression to
describe the gradual shift in what is regarded as normal after repeated
exposures to “deviant behavior” (behavior straying from correct [or safe]
operating procedure). Corners get cut, safety checks bypassed, and alarms
ignored or turned off, and these behaviors become normal—not just common,
but stripped of their significance as warnings of impending danger. In their
discussion of a catastrophic error in healthcare, Mark Chassin and Elise Becher
used the phrase “a culture of low expectations.”(2)
When a system routinely produces errors (paperwork in the wrong chart, major
miscommunications between different members of a given healthcare team, patients
in the dark about important aspects of the care), providers in the system become
inured to malfunction. In such a system, what should be regarded as a major
warning of impending danger is ignored as a normal operating procedure.

1.
Vaughan D. The Challenger launch decision: risky technology, culture and
deviance at NASA. Chicago, IL: University of Chicago Press; 1996.

2.
Chassin MR, Becher EC. The wrong patient. Ann Intern Med 2002;136:826-833.[

go to pubmed ]

O	Back to Top

Onion – The "onion" model illustrates variables that affect the multiple
levels of a hierarchal system in which a task is performed and errors occur.

P	Back to Top

Patient Safety – Freedom from accidental or preventable injuries produced
by medical care.

Pay for Performance – (sometimes abbreviated as “P4P”) Refers to the
general strategy of promoting quality improvement by rewarding providers
(meaning individual clinicians or, more commonly, clinics or hospitals) who meet
certain performance expectations with respect to health care quality or
efficiency.

Performance can be defined in terms of patient outcomes but is more commonly
defined in terms of processes of care (eg, the percentage of eligible diabetics
who have been referred for annual retinal examinations, the percentage of
children who have received immunizations appropriate for their age, patients
admitted to the hospital with pneumonia who receive antibiotics within 6 hours).

Pay-for-performance initiatives reflect the efforts of purchasers of health
care—from the federal government to private insurers—to use their purchasing
power to encourage providers to develop whatever specific quality improvement
initiatives are required to achieve the specified targets. Thus, rather than
committing to a specific quality improvement strategy, such as a new information
system or a disease management program, which may have variable success in
different institutions, pay for performance creates a climate in which provider
groups will be strongly incentivized to find whatever solutions will work for
them.

A brief overview of pay for performance in general, with references and Web
sites for specific programs can be found in the reference below.

1. Pawlson LG. Pay for performance: two critical steps needed to achieve a
successful program. Am J Manag Care. November 2004 (suppl).

Available at:

http://www.ajmc.com/Article.cfm?Menu=1&ID=2771

Plan-Do-Study-Act – Commonly referred to as PDSA (or PDCA, for Plan-Do-Check-Act),
refers to the cycle of activities advocated for achieving process or system
improvement. The cycle was first proposed by Walter Shewhart, one of the
pioneers of statistical process control (see glossary definition for
run charts) and
popularized by his student, quality expert W. Edwards Deming. The PDSA cycle
represents one of the cornerstones of continuous quality improvement (CQI). The
components of the cycle are briefly described below:

Plan: Analyze the problem you intend to improve and devise a plan to
correct the problem.

Do: Carry out the plan (preferably as a pilot project to avoid major
investments of time or money in unsuccessful efforts).

Study: Did the planned action succeed in solving the problem? If not, what
went wrong? If partial success was achieved, how could the plan be refined?

Act: Adopt the change piloted above as is, abandon it as a complete
failure, or modify it and run through the cycle again. Regardless of which
action is taken, the PDSA cycle continues, either with the same problem or a
new one.

The references below discuss PDSA cycles and the
interpretation of articles reporting quality improvement activities driven by
the PDSA approach.

1. Walley P, Gowland B. Completing the circle: from PD to PDSA. Int J Health
Care Qual Assur Inc Leadersh Health Serv. 2004;17:349-358.

[

go to PubMed ]

2. Speroff T, James BC, Nelson EC, Headrick LA, Brommels M. Guidelines for
appraisal and publication of PDSA quality improvement. Qual Manag Health Care.
2004;13:33-39.

[

go to PubMed ]

3. Speroff T, O'Connor GT. Study designs for PDSA quality improvement
research. Qual Manag Health Care. 2004;13:17-32.

[

go to PubMed ]

Potential ADE – A potential adverse drug event is a medication error or
other drug-related mishap that reached the patient but happened not to produce
harm (eg, a penicillin-allergic patient receives penicillin but happens not to
have an adverse reaction).

Production Pressure – Represents the pressure to put quantity of
output—for a product or a service—ahead of safety. This pressure is seen in its
starkest form in the “line speed” of factory assembly lines, famously
demonstrated by Charlie Chaplin in Modern Times, as he is carried away on
a conveyor belt and into the giant gears of the factory by the rapidly moving
assembly line. The dark reality of production pressures was also vividly
described in Fast Food Nation (1)
in the section on workers in meat-packing factories. The furious pace at which
they must work—standing side by side and wielding sharp knives—to keep up with
the line speed often results in serious, even dismembering, injuries.

In health care, production pressure refers to delivery of services—the pressure
to run hospitals at 100% capacity, with each bed filled with the sickest
possible patients who are discharged at the first sign that they are stable, or
the pressure to leave no operating room unused and to keep moving through the
schedule for each room as fast as possible. In a survey of members of the
American Society of Anesthesiologists (2),
half of respondents stated that they had witnessed at least one case in which
production pressure resulted in what they regarded as unsafe care. Examples
included elective surgery in patients without adequate preoperative evaluation
and proceeding with surgery despite significant contraindications.

Production pressure produces an organizational culture in which frontline
personnel (and often managers as well) are reluctant to suggest any course of
action that compromises productivity, even temporarily. For instance, in the
survey of anesthesiologists (2),
respondents reported pressure by surgeons to avoid delaying cases through
additional patient evaluation or canceling cases, even when patients had clear
contraindications to surgery.

1. Schlosser E. Fast Food Nation. Boston, MA: Houghton Mifflin; 2001.

2. Gaba DM, Howard SK, Jump B. Production pressure in the work environment.
California anesthesiologists' attitudes and experiences. Anesthesiology.
1994;81:488-500. [

go to PubMed ]

R	Back to Top

Rapid Response Team - See
Medical
Emergency Team

Read-Backs – When information is conveyed verbally, miscommunication may
occur in a variety of ways, especially when transmission may not occur clearly
(eg, by telephone or radio, or if communication occurs under stress). For names
and numbers, the problem often is confusing the sound of one letter or number
with another. To address this possibility, the military, civil aviation, and
many high-risk industries use protocols for mandatory "read-backs," in which the
listener repeats the key information, so that the transmitter can confirm its
correctness.

Because mistaken substitution or reversal of alphanumeric information is such a
potential hazard, read-back protocols typically include the use of phonetic
alphabets, such as the NATO system ("Alpha-Bravo-Charlie-Delta-Echo...X-ray-Yankee-Zulu")
now familiar to many. In health care, traditionally, read-back has been
mandatory only in the context of checking to ensure accurate identification of
recipients of blood transfusions. However, there are many other circumstances in
which health care teams could benefit from following such protocols, for
example, when communicating key lab results or patient orders over the phone,
and even when exchanging information in person (eg, "sign outs" and other such
handoffs).

Red Rules - Rules that must be followed to the letter. In the language of
non-health care industries, red rules “stop the line.” In other words, any
deviation from a red rule will bring work to a halt until compliance is
achieved. Red rules, in addition to relating to important and risky processes,
must also be simple and easy to remember.

An example of a red rule in health care might be the following: “No hospitalized
patient can undergo a test of any kind, receive a medication or blood product,
or undergo a procedure if they are not wearing an identification bracelet.” The
implication of designating this a red rule is that the moment a patient is
identified as not meeting this condition, all activity must cease in order to
verify the patient’s identity and supply an identification band.

Health care organizations already have numerous rules and policies that call for
strict adherence. So what is it about red rules that makes them more than
particularly important rules? The reason that some organizations are using this
new designation is that, unlike many standard rules, red rules are ones that
will always be supported by the entire organization. In other words, when
someone at the frontline calls for work to cease on the basis of a red rule, top
management must always support this decision. Thus, when properly implemented,
red rules should foster a culture of safety, as frontline workers will know that
they can stop the line when they notice potential hazards, even when doing so
may result in considerable inconvenience or be time consuming and costly, for
their immediate supervisors or the organization as a whole.

Root Cause Analysis (RCA) – A structured process for identifying the
causal or contributing factors underlying
adverse events
or other
critical incidents.(1,2)
The key advantage of RCA over traditional clinical case reviews is that it
follows a pre-defined protocol for identifying specific contributing factors in
various causal categories (eg, personnel, training, equipment, protocols,
scheduling) rather than attributing the incident to the first error one finds or
to preconceived notions investigators might have about the case. For instance,
in a case involving a patient who mistakenly received someone else’s invasive
cardiac procedure,(3)
the initial reaction of many hearing about the case might be: the nurse should
have checked the wrist band. Or, how could the doctor not have looked at the
face of the patient on the operating table? Traditionally, an internal review of
such a case would do little more than reiterate these "first stories"(4)—typically
involving errors committed by personnel at the "sharp
end"—and miss the "second stories" that emerge from more detailed,
open-minded investigation.

Though the definition of RCA emphasizes analysis, the single most important
product of an RCA is descriptive—a detailed account of the events that led up to
the incident. For instance, in the case mentioned above,(3)
the detailed catalogue of events leading up to the "wrong person procedure"
included 17 distinct errors, rather than one or two "so-and-so should have
checked such-and-such" errors.

Root cause analysis is still a widely used term, but many now find it
misleading. Critics of the term argue that there are no true "causes," so much
as "contributing factors." This is not entirely a semantic distinction. As
illustrated by the
Swiss cheese model, multiple errors and system flaws must come together for
a critical incident to reach the patient. Labeling one or even several of these
factors as "causes" fosters undue emphasis on specific "holes in the cheese"
rather than the overall relationships between different layers and other aspects
of system design. Accordingly, some have suggested replacing the term "root
cause analysis" with "systems analysis."(5)

Specific resources that facilitate carrying out RCAs or "systems analyses" can
be found at:

Root Cause Analysis (RCA). Veterans Affairs National Center for Patient Safety
Web site.

Available at:
http://www.patientsafety.gov/rca.html.

Taylor-Adams S, Vincent C. Systems analysis of critical incidents: the London
Protocol. London, UK: Clinical Safety Research Unit, Imperial College London;
2004.

Available at:

http://www.csru.org.uk/downloads/SACI.pdf.

1. Wald H, Shojania KG. Root cause analysis. In: Shojania KG, Duncan BW,
McDonald KM, Wachter RM, eds. Making Health Care Safer: A Critical Analysis of
Patient Safety Practices. Evidence Report/Technology Assessment No. 43 from the
Agency for Healthcare Research and Quality: AHRQ Publication No. 01-E058; 2001.

Available at:

http://www.ahrq.gov/clinic/ptsafety/chap5.htm

2. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight SD, Mannos DM. The
Veterans Affairs root cause analysis system in action. Jt Comm J Qual Improv.
2002;28:531-545.

[

go to PubMed ]

3. Chassin MR, Becher EC. The wrong patient. Ann Intern Med.
2002;136:826-833.

[

go to PubMed ]

4. Cook RI, Woods DD, Miller C. A Tale of Two Stories: Contrasting Views of
Patient Safety. National Patient Safety Foundation at the AMA: Annenberg Center
for Health Sciences, Rancho Mirage, CA; 1998.

Available at:
http://www.npsf.org/exec/front.html.

5. Vincent CA. Analysis of clinical incidents: a window on the system not a
search for root causes. Qual Saf Health Care. 2004;13:242-243.

[

go to PubMed ]

Rule of Thumb (same as
heuristic) –
Loosely defined or informal rule often arrived at through experience or trial
and error (eg, gastrointestinal complaints that wake patients up at night are
unlikely to be functional). Heuristics provide cognitive shortcuts in the face
of complex situations, and thus serve an important purpose. Unfortunately, they
can also turn out to be wrong.

The phrase "rule of thumb" probably has it origin with trades such as carpentry
in which skilled workers could use the length of their thumb (roughly one inch
from knuckle to tip) rather than more precise measuring instruments and still
produce excellent results. In other words, they measured not using a "rule of
wood" (old-fashioned way of saying ruler), but by a "rule of thumb."

Run Charts – A type of "statistical process control" or "quality control"
graph in which some observation (eg, manufacturing defects or adverse outcomes)
is plotted over time to see if there are "runs" of points above or below a
center line, usually representing the average or median. In addition to the
number of runs, the length of the runs conveys important information. For run
charts with more than 20 useful observations, a run of 8 or more dots would
count as a "shift" in the process of interest, suggesting some non-random
variation.

Other key tests applied to run charts include tests for "trends" (sequences of
successive increases or decreases in the observation of interest) and "zigzags"
(alternation in the direction—up or down—of the lines joining pairs of dots). If
a non-random change for the better, or "shift," occurs, it suggests that an
intervention has succeeded. The expression "moving the dots" refers to this type
of shift.

Further information about run charts and statistical process control can be
found at:

Yeung S, MacLeod M. Using run charts and
control charts to monitor quality in healthcare [NHS Scotland Web site]. May
2004.

Available at:

http://www.show.scot.nhs.uk/indicators/Tutorial/TUTORIAL_GUIDE_V4.pdf

Mohammed MA. Using statistical process
control to improve the quality of health care. Qual Saf Health Care.
2004;13:243-245.

[

go to PubMed ]

S	Back to Top

Safety Culture – Safety culture and culture of safety are frequently
encountered terms referring to a commitment to safety that permeates all levels
of an organization, from frontline personnel to executive management. More
specifically, "safety culture" calls up a number of features identified in
studies of
high
reliability organizations, organizations outside of health care with
exemplary performance with respect to safety.(1,2)
These features include:

acknowledgment of the high-risk, error-prone nature of an organization’s
activities

a blame-free environment where individuals are able to report errors or
close calls without fear of reprimand or punishment

an expectation of collaboration across ranks to seek solutions to
vulnerabilities

a willingness on the part of the organization to direct resources for
addressing safety concerns (3)

The Veterans Affairs system has explicitly focused on
achieving a culture of safety, in addition to its focus on a number of specific
patient safety initiatives.(4)
The impact of such efforts are very difficult to assess, but some tools for
quantifying the degree to which organizations differ with respect to "safety
culture" have begun to emerge.(5)

1. Roberts KH. Managing high reliability organizations. Calif Manage Rev.
1990;32:101-113.

2. Weick KE. Organizational culture as a source of high reliability. Calif
Manage Rev. 1987;29:112-127.

3. Pizzi L, Goldfarb N, Nash D. Promoting a culture of safety. In: Shojania
KG, Duncan BW, McDonald KM, Wachter RM, eds. Making Health Care Safer: A
Critical Analysis of Patient Safety Practices. Evidence Report/Technology
Assessment No. 43 from the Agency for Healthcare Research and Quality: AHRQ
Publication No. 01-E058; 2001.

[

Available at: http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat1.section.61719
]

4. Weeks WB, Bagian JP. Developing a culture of safety in the Veterans
Health Administration. Eff Clin Pract 2000;3:270-276.

[

go to pubmed ]

5. Singer SJ, Gaba DM, Geppert JJ, Sinaiko AD, Howard SK, Park KC. The
culture of safety: results of an organization-wide survey in 15 California
hospitals. Qual Saf Health Care. 2003;12:112-118.

[

go to pubmed ]

Sentinel Event – An
adverse event in
which death or serious harm to a patient has occurred; usually used to refer to
events that are not at all expected or acceptable—eg, an operation on the wrong
patient or body part. The choice of the word "sentinel" reflects the
egregiousness of the injury (eg, amputation of the wrong leg) and the likelihood
that investigation of such events will reveal serious problems in current
policies or procedures.

Sensemaking – A term from organizational theory that refers to the
processes by which an organization takes in information to make sense of its
environment, to generate knowledge, and to make decisions. It is the
organizational equivalent of what individuals do when they process information,
interpret events in their environments, and make decisions based on these
activities. More technically, organizational sensemaking constructs the shared
meanings that define the organization's purpose and frame the perception of
problems or opportunities that the organization needs to work on.

Karl Weick, at the University of Michigan Business School, has written an
excellent book on the subject, titled Sensemaking in Organizations.(1)
Weick also discussed a specific example of what happens when organizational
sensemaking breaks down.(2)
This example, the Mann Gulch fire, was subsequently brought to the attention of
a wider audience by Don Berwick in his speech Escape Fire.(3)

1. Weick KE. Sensemaking in Organizations. Thousand Oaks, CA: SAGE
Publications; 1995.

[

go to PSNet listing ]

2. Weick KE. The collapse of sensemaking in organizations: the Mann Gulch
disaster. Adm Sci Q. 1993;38:628-652.

[

go to PSNet listing ]

3. Berwick DM. Escape Fire: Lessons for the Future of Health Care. New York,
NY: The Commonwealth Fund; 2002.

[

go to PSNet listing ]

Sharp End – The “sharp end” refers to the personnel or parts of the
health care system in direct contact with patients. Personnel operating at the
sharp end may literally be holding a scalpel (eg, an orthopedist who operates on
the wrong leg) or figuratively be administering any kind of therapy (eg, a nurse
programming an intravenous pump) or performing any aspect of care.

To complete the metaphor, the "blunt
end" refers to the many layers of the health care system that affect the
scalpels, pills, and medical devices, or the personnel wielding, administering,
and operating them.

Thus, an error in programming an intravenous pump would represent a problem at
the sharp end, while the institution’s decision to use multiple types of
infusion pumps (making programming errors more likely) would represent a problem
at the blunt end.

The terminology of “sharp” and “blunt” ends correspond roughly to “active
failures” and “latent
conditions.”

Situational Awareness – Situational awareness refers to the degree to
which one’s perception of a situation matches reality. In the context of crisis
management, where the phrase is most often used, situational awareness includes
awareness of fatigue and stress among team members (including oneself),
environmental threats to safety, appropriate immediate goals, and the
deteriorating status of the crisis (or patient). Failure to maintain situational
awareness can result in various problems that compound the crisis. For instance,
during a resuscitation, an individual or entire team may focus on a particular
task (a difficult central line insertion or a particular medication to
administer, for example). Fixation on this problem can result in loss of
situational awareness to the point that steps are not taken to address
immediately life-threatening problems such as respiratory failure or a pulseless
rhythm. In this context, maintaining situational awareness might be seen as
equivalent to keeping the “big picture” in mind. Alternatively, in assigning
tasks in a crisis, the leader may ignore signals from a team member, which may
result in escalating anxiety for the team member, failure to perform the
assigned task, or further patient deterioration.

Six Sigma - Refers loosely to striving for near perfection in the
performance of a process or production of a product. The name derives from the
Greek letter sigma, often used to refer to the standard deviation of a normal
distribution. By definition, 95% of a normally distributed population falls
within 2 standard deviations of the average (or "2 sigma"). This leaves 5% of
observations as “abnormal” or “unacceptable.” Six Sigma targets a defect rate of
3.4 per million opportunities—6 standard deviations from the population average.

When it comes to industrial performance, having 5% of a product fall outside the
desired specifications would represent an unacceptably high defect rate. What
company could stay in business if 5% of its product did not perform well? For
example, would we tolerate a pharmaceutical company that produced pills
containing incorrect dosages 5% of the time? Certainly not. But when it comes to
clinical performance—the number of patients who receive a proven medication, the
number of patients who develop complications from a procedure—we routinely
accept failure or defect rates in the 2% to 5% range, orders of magnitude below
Six Sigma performance.(1)

Not every process in health care requires such near-perfect performance. In
fact, one of the lessons of Reason’s
Swiss cheese model
is the extent to which low overall error rates are possible even when individual
components have many “holes.” However, many high-stakes processes are far less
forgiving, since a single “defect” can lead to catastrophe (eg, wrong-site
surgery, accidental administration of concentrated potassium).

One version of Six Sigma commonly emulated in health care derives from an
approach developed at General Electric (2)
and consists of five phases summarized by the acronym DMAIC: Define, Measure,
Analyze, Improve, and Control.(3)
Although this process is somewhat reminiscent of the
Plan-Do-Study-Act
(PDSA) approach to continuous quality improvement, the resemblance can be
misleading. Whereas PDSA seeks successive incremental improvements, Six Sigma
typically strives for quantum leaps in performance, which, by their nature,
often necessitate major organizational changes and substantial investments of
time and resources at all levels of the institution. Thus, a clinic trying to
improve the percentage of elderly patients who receive influenza vaccines might
reasonably adopt a PDSA-type approach and expect to see successive, modest
improvements without radically altering normal workflow at the clinic. By
contrast, an ICU that strives to reduce the rate at which patients develop
catheter-associated bacteremia virtually to zero will need major changes that
may disrupt normal workflow.(4)
In fact, the point of choosing Six Sigma is often that normal workflow is
recognized as playing a critical role in the unacceptably high defect rate.

Several examples (4 -6)
of the successful application of Six Sigma methodology to improving patient
safety are listed below.

1. Chassin MR. Is health care ready for Six Sigma quality? Milbank Q.
1998;76:565-591, 510.

[

go to PubMed ]

2. Buck CR Jr. Improving the quality of health care. Health care through a
Six Sigma lens. Milbank Q. 1998;76:749-753.

[

go to PubMed ]

3. Benedetto AR. Six Sigma: not for the faint of heart. Radiol Manage.
2003;25:40-53.

[

go to PubMed ]

4. Frankel HL, Crede WB, Topal JE, Roumanis SA, Devlin MW, Foley AB. Use of
corporate six sigma performance-improvement strategies to reduce incidence of
catheter-related bloodstream infections in a surgical ICU. J Am Coll Surg.
2005;201:349-358.

[

go to PubMed ]

5. Castle L, Franzblau-Isaac E, Paulsen J. Using Six Sigma to reduce
medication errors in a home-delivery pharmacy service. Jt Comm J Qual Patient
Safety. 2005;31:319-324.

[

go to PubMed ]

6. Chan AL. Use of Six Sigma to improve pharmacist dispensing errors at an
outpatient clinic. Am J Med Qual. 2004;19:128-131.

[

go to PubMed ]

Slips (or Lapses) – In some contexts,
errors are dichotomized
as “slips” or “mistakes,”
based on the cognitive psychology of task-oriented behavior. Attentional
behavior is characterized by conscious thought, analysis, and planning, as
occurs in active problem solving. Schematic behavior refers to the many
activities we perform reflexively or as if acting on “autopilot.” Complementary
to these two behavior types are two categories of error: slips (or lapses) and
mistakes.

Slips refer to failures of schematic behaviors, or lapses in concentration (eg,
overlooking a step in a routine task due to a lapse in memory, an experienced
surgeon nicking an adjacent organ during an operation due to a momentary lapse
in concentration). Mistakes, by contrast, reflect incorrect choices. A mistake
would be choosing the wrong diagnostic test or ordering a suboptimal medication
for a given condition represent mistakes. Forgetting to check the chart to make
sure you ordered them for the right patient would be a slip.

Distinguishing slips from mistakes serves two important functions. First, the
risk factors for their occurrence differ. Slips occur in the face of competing
sensory or emotional distractions, fatigue, and stress; mistakes more often
reflect lack of experience or insufficient training. Second, the appropriate
responses to these error types differ. Reducing the risk of slips requires
attention to the designs of protocols, devices, and work environments—using
checklists so key steps will not be omitted, reducing fatigue among personnel
(or shifting high-risk work away from personnel who have been working extended
hours), removing unnecessary variation in the design of key devices, eliminating
distractions (eg, phones) from areas where work requires intense concentration,
and other redesign strategies. Reducing the likelihood of mistakes typically
requires more training or supervision. Even in the many cases of slips, health
care has typically responded to all errors as if they were mistakes, with
remedial education and/or added layers of supervision.

Standard of Care – What the average, prudent clinician would be expected
to do under certain circumstances. The standard of care may vary by community
(eg, due to resource constraints). When the term is used in the clinical
setting, the standard of care is generally felt not to vary by specialty or
level of training. In other words, the standard of care for a condition may well
be defined in terms of the standard expected of a specialist, in which case a
generalist (or trainee) would be expected to deliver the same care or make a
timely referral to the appropriate specialist (or supervisor, in the case of a
trainee). Standard of care is also a term of art in malpractice law, and its
definition varies from jurisdiction to jurisdiction. When used in this legal
sense, often the standard of care is specific to a given specialty; it is often
defined as the care expected of a reasonable practitioner with similar training
practicing in the same location under the same circumstances.

Structure-Process-Outcome Triad – Quality has been defined as the “degree
to which health services for individuals and populations increase the likelihood
of desired health outcomes and are consistent with current professional
knowledge."(1)
This definition, like most others, emphasizes favorable patient outcomes as the
gold standard for assessing quality. In practice, however, one would like to
detect quality problems without waiting for poor outcomes to develop in such
sufficient numbers that deviations from expected rates of morbidity and
mortality can be detected. Avedis Donabedian first proposed that quality could
be measured using aspects of care with proven relationships to desirable patient
outcomes.(2 ,3)
For instance, if proven diagnostic and therapeutic strategies are monitored,
quality problems can be detected long before demonstrable poor outcomes occur.

Aspects of care with proven connections to patient outcomes fall into two
general categories: process and structure. Processes encompass all that is done
to patients in terms of diagnosis, treatment, monitoring, and counseling.
Cardiovascular care provides classic examples of the use of process measures to
assess quality. Given the known benefits of aspirin and beta-blockers for
patients with myocardial infarction, the quality of care for patients with
myocardial infarction can be measured in terms of the rates at which eligible
patients receive these proven therapies. The percentage of eligible women who
undergo mammography at appropriate intervals would provide a process-based
measure for quality of preventive care for women.

Structure refers to the setting in which care occurs and the capacity of that
setting to produce quality. Traditional examples of structural measures related
to quality include credentials, patient volume, and academic affiliation. More
recent structural measures include the adoption of organizational models for
inpatient care (eg, closed intensive care units and dedicated stroke units) and
possibly the presence of sophisticated clinical information systems.
Cardiovascular care provides another classic example of structural measures of
quality. Numerous studies have shown that institutions that perform more cardiac
surgeries and invasive cardiology procedures achieve better outcomes than
institutions that see fewer patients. Given these data, patient volume
represents a structural measure of quality of care for patients undergoing
cardiac procedures.

1. Lohr KN, ed. Medicare: A Strategy for Quality Assurance. Washington, DC:
National Academy Press; 1990.

2. Donabedian A. Evaluating the quality of medical care. Milbank Mem Fund Q.
1966;44 (suppl):166-206.

[

go to PubMed ]

3. Donabedian A. Explorations in Quality Assessment and Monitoring. The
definition of quality and approaches to its assessment. Vol 1. Ann Arbor, MI:
Health Administration Press; 1980.

[

go to PSNet listing ]

Swiss Cheese Model – James Reason developed the "Swiss cheese model" to
illustrate how analyses of major accidents and catastrophic systems failures
tend to reveal multiple, smaller failures leading up to the actual hazard.(1)

In the

model, each slice of cheese represents a safety barrier or precaution
relevant to a particular hazard. For example, if the hazard were wrong-site
surgery, slices of the cheese might include conventions for identifying
sidedness on radiology tests, a protocol for signing the correct site when the
surgeon and patient first meet, and a second protocol for reviewing the medical
record and checking the previously marked site in the operating room. Many more
layers exist. The point is that no single barrier is foolproof. They each have
"holes"; hence, the Swiss cheese. For some serious events (eg, operating on the
wrong site or wrong person), even though the holes will align infrequently, even
rare cases of harm (errors making it "through the cheese") will be unacceptable.

While the model may convey the impression that the slices of cheese and the
location of their respective holes are independent, this may not be the case.
For instance, in an emergency situation, all three of the surgical
identification safety checks mentioned above may fail or be bypassed. The
surgeon may meet the patient for the first time in the operating room. A hurried
x-ray technologist might mislabel a film (or simply hang it backwards and a
hurried surgeon not notice), "signing the site" may not take place at all (eg,
if the patient is unconscious) or, if it takes place, be rushed and offer no
real protection. In the technical parlance of accident analysis, the different
barriers may have a common failure mode, in which several protections are lost
at once (ie, several layers of the cheese line up). An aviation example would be
a scenario in which the engines on a plane are all lost, not because of
independent mechanical failure in all four engines (very unlikely), but because
the wings fell off due to a structural defect. This disastrous failure mode
might arise more often than the independent failure of multiple engines.

In health care, such failure modes, in which slices of the cheese line up more
often than one would expect if the location of their holes were independent of
each other (and certainly more often than wings fly off airplanes) occur
distressingly commonly. In fact, many of the systems problems discussed by
Reason and others—poorly designed work schedules, lack of teamwork, variations
in the design of important equipment between and even within institutions—are
sufficiently common that many of the slices of cheese already have their holes
aligned. In such cases, one slice of cheese may be all that is left between the
patient and significant hazard.

1. Reason J. Human error: models and management. BMJ. 2000;320:768-770.

[

go to PubMed ]

Systems Approach – Medicine has traditionally treated quality problems
and errors as failings on the part of individual providers, perhaps reflecting
inadequate knowledge or skill levels. The "systems approach," by contrast, takes
the view that most errors reflect predictable human failings in the context of
poorly designed systems (eg, expected lapses in human vigilance in the face of
long work hours or predictable mistakes on the part of relatively inexperienced
personnel faced with cognitively complex situations). Rather than focusing
corrective efforts on reprimanding individuals or pursuing remedial education,
the systems approach seeks to identify situations or factors likely to give rise
to human error and implement "systems changes" that will reduce their occurrence
or minimize their impact on patients. This view holds that efforts to catch
human errors before they occur or block them from causing harm will ultimately
be more fruitful than ones that seek to somehow create flawless providers.

This "systems focus" includes paying attention to
human factors
engineering (or ergonomics), including the design of protocols, schedules,
and other factors that are routinely addressed in other high-risk industries but
have traditionally been ignored in medicine. Relevant concepts defined elsewhere
in the glossary include
root cause
analysis, active
failures vs.
latent conditions, errors at the "sharp
end" vs. errors at the "blunt
end," slips vs.
mistakes, and the
Swiss cheese model.

T	Back to Top

"Time outs" – Refer to planned periods of quiet and/or interdisciplinary
discussion focused on ensuring that key procedural details have been addressed.
For instance, protocols for ensuring correct site surgery often recommend a
"time out" to confirm the identification of the patient, the surgical procedure,
site, and other key aspects, often stating them aloud for double-checking by
other team members. In addition to avoiding major misidentification errors
involving the patient or surgical site, such a time out ensures that all team
members share the same “game plan” so to speak. Taking the time to focus on
listening and communicating the plans as a team can rectify miscommunications
and misunderstandings before a procedure gets underway.

Triggers – Refer to signals for detecting likely adverse events. For
instance, if a hospitalized patient received naloxone (a drug used to reverse
the effects of narcotics), the patient probably received an excessive dose of
morphine or some other opiate. In the emergency department, the use of naloxone
would more likely represent treatment of a self-inflected opiate overdose, so
the trigger would have little value in that setting. But, among patients already
admitted to hospital, a pharmacy could use the administration of naloxone as a
“trigger” to investigate possible adverse drug events.

A common setting in which triggers have been employed is monitoring
anticoagulation with warfarin.(1 -3)
Triggers might consist of elevated laboratory measures of anticoagulation (eg,
International Normalized Ratio [INR] > 3) or any administration of vitamin K,
which reverses the effects of warfarin and therefore would likely signal the
need to correct particularly worrisome levels of anticoagulation.

In many studies, triggers alert providers involved in patient safety activities
to probable adverse events so they can review the medical record to determine if
an actual or potential adverse event has occurred. In cases in which the trigger
correctly identified an adverse event, causative factors can be identified and,
over time, interventions developed to reduce the frequency of particularly
common causes of adverse events (such as anticoagulant problems [1 -3]).
In these studies, the triggers provide an efficient means of identifying
potential adverse events after the fact.

The traditional use of triggers has been to generate these retrospective
reviews. However, using triggers in real time has tremendous potential as a
patient safety tool. In one study of real-time triggers in a single community
hospital, for example, more than 1000 triggers were generated in 6 months, and
approximately 25% led to physician action and would not have been recognized
without the trigger.(4)

As with any alert or alarm system, the threshold for generating triggers has to
balance true and false positives. The system will lose its value if too many
triggers prove to be false alarms.(5)
This concern is less relevant when triggers are used as chart review tools. In
such cases, the tolerance of “false alarms” depends only on the availability of
sufficient resources for medical record review. Reviewing four false alarms for
every true adverse event might be quite reasonable in the context of an
institutional safety program, but frontline providers would balk at (and
eventually ignore) a trigger system that generated four false alarms for every
true one.

1. Hartis CE, Gum MO, Lederer JW Jr. Use of specific indicators to detect
warfarin-related adverse events. Am J Health Syst Pharm. 2005;62:1683-1688.

[

go to PubMed ]

2. Lederer J, Best D. Reduction in anticoagulation-related adverse drug
events using a trigger-based methodology. Jt Comm J Qual Patient Saf.
2005;31:313-318.

[

go to PubMed ]

3. Cohen MM, Kimmel NL, Benage MK, et al. Medication safety program reduces
adverse drug events in a community hospital. Qual Saf Health Care.
2005;14:169-174.

[

go to PubMed ]

4. Raschke RA, Gollihare B, Wunderlich TA, et al. A computer alert system to
prevent injury from adverse drug events: development and evaluation in a
community teaching hospital. JAMA. 1998;280:1317-1320. Erratum in: JAMA.
1999;281:420.

[

go to PubMed ]

5. Edworthy J, Hellier E. Fewer but better auditory alarms will improve
patient safety. Qual Saf Health Care. 2005;14:212-215.

[

go to PubMed ]

U	Back to Top

Underuse, Overuse, Misuse – For process of care, quality problems can
arise in one of three ways: underuse, overuse, and misuse.

“Underuse” refers to the failure to provide a health care service when it would
have produced a favorable outcome for a patient. Standard examples include
failures to provide appropriate preventive services to eligible patients (eg,
Pap smears, flu shots for elderly patients, screening for hypertension) and
proven medications for chronic illnesses (steroid inhalers for asthmatics;
aspirin, beta-blockers, and lipid-lowering agents for patients who have suffered
a recent myocardial infarction).

“Overuse” refers to providing a process of care in circumstances where the
potential for harm exceeds the potential for benefit. Prescribing an antibiotic
for a viral infection like a cold, for which antibiotics are ineffective,
constitutes overuse. The potential for harm includes adverse reactions to the
antibiotics and increases in antibiotic resistance among bacteria in the
community. Overuse can also apply to diagnostic tests and surgical procedures.

“Misuse” occurs when an appropriate process of care has been selected but a
preventable complication occurs and the patient does not receive the full
potential benefit of the service. Avoidable complications of surgery or
medication use are misuse problems. A patient who suffers a rash after receiving
penicillin for strep throat, despite having a known allergy to that antibiotic,
is an example of misuse. A patient who develops a pneumothorax after an
inexperienced operator attempted to insert a subclavian line would represent
another example of misuse.

W	Back to Top

Workaround – From the perspective of frontline personnel trying to
accomplish their work, the design of equipment or the policies governing works
tasks can seem counterproductive. When frontline personnel adopt consistent
patterns of work or ways of bypassing safety features of medical equipment,
these patterns and actions are referred to as “workarounds.” Although
workarounds “fix the problem,” the system remains unaltered and thus continues
to present potential safety hazards for future patients.

A case on AHRQ WebM&M (Transfusion
“Slip”) describes a potentially fatal near miss in which the blood samples
drawn for crossmatching from husband and wife trauma victims were inadvertently
swapped. The error was caught when an alert laboratory technician noted that the
wife’s blood type differed from that recorded previously at the same hospital. A
comment on the

forum provides a striking example of a workaround. The reader noted that
after a similar incident had occurred at another hospital, the organization
instituted a policy requiring two screens for all transfusion crossmatches. The
intention was that, by requiring two separate samples, any mislabeled sample
would lead to a discrepancy with the other sample and provide a warning that
would virtually eliminate the risk of transfusion errors due to mislabeled
samples. However, frontline personnel at the hospital created a workaround: they
routinely drew both crossmatch samples from the same needle stick, saving them
time and patients discomfort, but completely undermining the value of double
samples to avoid labeling errors.

As pointed out by a second reader on the forum, the appearance of a workaround
at that hospital was expected because the new policy doubled the work associated
with a common task in order to prevent a very uncommon error—one that virtually
none of them would ever have encountered.

From a definitional point of view, it does not matter if frontline users are
justified in working around a given policy or equipment design feature. What
does matter is that the motivation for a workaround lies in getting work done,
not laziness or whim. Thus, the appropriate response by managers to the
existence of a workaround should not consist of reflexively reminding staff
about the policy and restating the importance of following it. Rather,
workarounds should trigger assessment of workflow and the various competing
demands for the time of frontline personnel. In busy clinical areas where
efficiency is paramount, managers can expect workarounds to arise whenever
policies create added tasks for frontline personnel, especially when the extra
work is out of proportion to the perceived importance of the safety goal.

SECOND NEWS PORTAL LAUNCED ON 15 OCTOBER 2006

2006-10-15T17:54:00.000-07:00

http://johnraymondbaker.php1h.com is the second news portal for Baker Chiropractic added today!

OUR GENERAL MANAGER, MRS. TAMMY BAKER, IS IN NURSING SCHOOL

2006-10-13T09:40:00.000-07:00

Our general manager, Ms. Tammy Baker, is
currently in Nursing School at the University of Texas

We are very proud of Ms. Baker for being able to help this practice, and to go
to school full time.

Her goal is to get her Doctor of Nurse
Practitioner degree. We can't wait !

Another information portal for BAKER CHIROPRACTIC launched

2006-10-13T04:50:00.000-07:00

The growing list of BAKER CHIROPRACTIC, PA informational portals has increased again.

We launched http://bakerchiropractic.orgfree.com
yesterday and it seems to be working fine.

Have a great day!

WordPress Blog added

2006-10-11T18:02:00.000-07:00

A new information portal is born and launched. The address is
http://bakerchiropractic.wordpress.com and is going great. Wordpress is quality blogging software, and BAKER CHIROPRACTIC, PA is proud to be able to include this site in its information portal news network.

Injured Worker...Do You Feel All Alone?

2006-09-26T19:35:00.000-07:00

You've been a good worker for some time. Always on time, working hard to do a full day's work. Suddenly, you get hurt, and now, you worry that you are being targeted for termination.

On top of this, you are hurting, and may have numbness in the arms or legs. You don't know how bad you are injured. What do you do? WHAT DO YOU DO?

You NEED a treating doctor who has years of experience in treating injured workers.
You NEED a treating doctor who cares about your problems.
You NEED a treating doctor who does the right things to find out how bad you are hurt.

Dr. John Raymond Baker,DC is such a doctor.

You aren't alone when you have the resources of BAKER CHIROPRACTIC on your side.

Call 903-753-5400 today!

LINKS FOR THIS SITE...

2006-09-26T06:01:00.000-07:00

TWO MORE BAKER CHIROPRACTIC NEWS PORTALS GO LIVE...

2006-09-13T08:01:00.000-07:00

http://johnraymondbaker.php1h.com

and

http://bakerchiro.php1h.com

went live, and will be updated.

Yet ANOTHER new Baker Chiropractic site goes live...Longviewdoctor.com

2006-09-01T08:23:00.001-07:00

We have even another news and information portal online now.

Located at http://www.longviewdoctor.com
it provides news and contact information for Baker Chiropractic of Longview.

Check it out.

Another New Site goes Live - HealingTexas.com

2006-09-01T08:23:00.000-07:00

Our Newest site, HEALINGTEXAS.COM went live today. Please check it out.

Our newest website just went live today.

2006-08-31T12:28:00.000-07:00

Our newest website just went live today.

http://www.johnraymondbaker.com was launched and is a big success.

Check it out when you get a chance.

~Doc

Nurses suffer from work-related low back pain more often than workers in other professions

2006-08-22T19:17:00.000-07:00

Nurses suffer from work-related low back pain more often than workers in other professions

Nurses offer care and comfort, but they often end up with a pain in the back for their efforts, the results of a new study show.
"Nurses suffer from work-related low back pain more often than workers in other professions," said Edgar Vieira, a doctoral student in the University of Alberta Faculty of Rehabilitation Medicine and lead author of the study.

Most often, nurses hurt their backs while turning bed-ridden patients or transferring them among stretchers, beds and chairs, Vieira said, adding that orthopedic and intensive care unit (ICU) nurses have the highest rates of low back pain among all nurses. According to the study, 65 per cent of orthopedic nurses and 58 per cent of ICU nurses develop debilitating low back pain at some point in their careers.

"If a patient is unconscious, nurses will try to turn him every two hours or so to prevent him from getting bed sores. If you consider that nurses often work 12 hours shifts, the amount of lifting in one shift adds up a lot, and you can see how the job could be very hard to manage physically," said Vieira.

However, Vieira believes a few simple changes may prevent nurses from sustaining injuries. For example, providing nursing with access to more mechanical lifting devices would help reduce the risks, he said, adding that mechanical lifting devices are currently used only about 15 per cent of the time.

"Also, hospital rooms are often small, and nurses have to move furniture around so that they can do their jobs--most of the time lifting devices wouldn't even fit in these rooms," added Vieira, whose study appeared this month in the Journal of Advanced Nursing.

Providing bigger, uncluttered rooms to work in would help nurses, as would hiring more staff to share the workload, Vieira said.

Preventing work related low back pain is a humanitarian issue, and efforts to address the controllable risk factors are essential, Vieira said. He also noted that such injuries incur a great expense to taxpayers.

"Most individuals that suffer low back pain carry on with their normal activities after a few days, but in about seven per cent of cases, the pain persists and worsens, limiting daily activity and work. About 70 per cent of worker compensation costs are generated by the cases in which the absence from work lasts six months or longer. So, the best thing for everyone is to prevent disabilities, and the best way to do this is to prevent causation of the injuries.

"We hope we can raise awareness of this problem by improving working conditions and educating nurses about how to reduce the number of work-related low back pain injuries that they suffer, because right now the incidences of it are way too high," Vieira said.

http://www.news-medical.net/?id=19297

"To see a wrong and not expose it, is to become a silent partner to its continuance."

2006-08-20T11:15:00.000-07:00

"To see a wrong and not expose it, is to become a silent partner to its continuance."
- Dr John Raymond Baker

China touts initial success with first AIDS vaccine

2006-08-20T11:12:00.000-07:00

BEIJING (AFX) - China said initial test results of its first AIDS vaccine showed it could protect people against the HIV virus.

None of the participants in the clinical trial's first phase showed severe adverse reactions after 180 days and some showed immunity to the HIV-1 virus 15 days after receiving the vaccine, the State Food and Drug Administration said.

'Initially, this indicates the vaccine is effective in stimulating the body's immunity,' the administration said in a statement on its website.

Researchers are still analysing the outcome of the initial trial before deciding whether further tests would be carried out, it said.

Kong Wei, the research team leader from Jilin University, told China Daily the initial results were 'truly inspiring' although he said it is still too early to claim success.

The first phase tests began in March last year in southwestern China's Guangxi region, with 49 healthy men and women aged between 18-50 participating, the newspaper said.

The Ministry of Science and Technology said another 800 volunteers, including those from high-risk groups, will be needed for the second and third phases of the trial, the report added.

However, testing to ensure the vaccine's safety and effectiveness could take years.

China started its own research into an AIDS vaccine in 2003 and has already invested over 100 mln yuan into projects for the treatment and prevention of the disease, China Daily said.

SOURCE

The Cost of Disease Care in the United States

2006-08-19T17:34:00.000-07:00

The United States of American has a health crisis. That may seem pretty self evident if you have looked at the facts and statistics, but you would be surprised at how many people mistakenly believe that the USA has the "best healthcare in the world".

Nothing could be farther than the truth. The fact is, the USA has the most EXPENSIVE DISEASE CARE in the world.

In fact, the World Health Organization report found this :
The U. S. health system spends a higher portion of its gross domestic product than any other country but ranks 37 out of 191 countries according to its performance, the report finds.

The WHO (World Health Oranization) did a study on which countries have the best healthcare, based on various criteria.

France was found to top the list in developed countries.

The full report is found here http://www.who.int/whr/en/

Here is more on their findings
"WORLD HEALTH ORGANIZATION
ASSESSES THE WORLD'S HEALTH SYSTEMS

The World Health Organization has carried out the first ever analysis of the world’s health systems. Using five performance indicators to measure health systems in 191 member states, it finds that France provides the best overall health care followed among major countries by Italy, Spain, Oman, Austria and Japan.

The findings are published today, 21 June, in The World Health Report 2000 – Health systems: Improving performance.

The U. S. health system spends a higher portion of its gross domestic product than any other country but ranks 37 out of 191 countries according to its performance, the report finds. The United Kingdom, which spends just six percent of gross domestic product (GDP) on health services, ranks 18th . Several small countries – San Marino, Andorra, Malta and Singapore are rated close behind second- placed Italy.

WHO Director-General Dr Gro Harlem Brundtland says: "The main message from this report is that the health and well-being of people around the world depend critically on the performance of the health systems that serve them. Yet there is wide variation in performance, even among countries with similar levels of income and health expenditure. It is essential for decision- makers to understand the underlying reasons so that system performance, and hence the health of populations, can be improved."

Dr Christopher Murray, Director of WHO’s Global Programme on Evidence for Health Policy. says: "Although significant progress has been achieved in past decades, virtually all countries are underutilizing the resources that are available to them. This leads to large numbers of preventable deaths and disabilities; unnecessary suffering, injustice, inequality and denial of an individual’s basic rights to health."

The impact of failures in health systems is most severe on the poor everywhere, who are driven deeper into poverty by lack of financial protection against ill- health, the report says.

"The poor are treated with less respect, given less choice of service providers and offered lower- quality amenities," says Dr Brundtland. "In trying to buy health from their own pockets, they pay and become poorer."

The World Health Report says the main failings of many health systems are:

Many health ministries focus on the public sector and often disregard the frequently much larger private sector health care.

In many countries, some if not most physicians work simultaneously for the public sector and in private practice. This means the public sector ends up subsidizing unofficial private practice.

Many governments fail to prevent a "black market" in health, where widespread corruption, bribery, "moonlighting" and other illegal practices flourish. The black markets, which themselves are caused by malfunctioning health systems, and low income of health workers, further undermine those systems.

Many health ministries fail to enforce regulations that they themselves have created or are supposed to implement in the public interest.

Dr Julio Frenk, Executive Director for Evidence and Information for Policy at WHO, says: "By providing a comparative guide to what works and what doesn’t work, we can help countries to learn from each other and thereby improve the performance of their health systems."

Dr Philip Musgrove, editor-in-chief of the report, says: "The WHO study finds that it isn’t just how much you invest in total, or where you put facilities geographically, that matters. It’s the balance among inputs that counts – for example, you have to have the right number of nurses per doctor."

Most of the lowest placed countries are in sub-Saharan Africa where life expectancies are low. HIV and AIDS are major causes of ill-health. Because of the AIDS epidemic, healthy life expectancy for babies born in 2000 in many of these nations has dropped to 40 years or less.

One key recommendation from the report is for countries to extend health insurance to as large a percentage of the population as possible. WHO says that it is better to make "pre-payments" on health care as much as possible, whether in the form of insurance, taxes or social security.

While private health expenses in industrial countries now average only some 25 percent because of universal health coverage (except in the United States, where it is 56%), in India, families typically pay 80 percent of their health care costs as "out-of- pocket" expenses when they receive health care.

"It is especially beneficial to make sure that as large a percentage as possible of the poorest people in each country can get insurance," says Dr Frenk. "Insurance protects people against the catastrophic effects of poor health. What we are seeing is that in many countries, the poor pay a higher percentage of their income on health care than the rich."

"In many countries without a health insurance safety net, many families have to pay more than 100 percent of their income for health care when hit with sudden emergencies. In other words, illness forces them into debt."

In designing the framework for health system performance, WHO broke new methodological ground, employing a technique not previously used for health systems. It compares each country’s system to what the experts estimate to be the upper limit of what can be done with the level of resources available in that country. It also measures what each country’s system has accomplished in comparison with those of other countries.

WHO’s assessment system was based on five indicators: overall level of population health; health inequalities (or disparities) within the population; overall level of health system responsiveness (a combination of patient satisfaction and how well the system acts); distribution of responsiveness within the population (how well people of varying economic status find that they are served by the health system); and the distribution of the health system’s financial burden within the population (who pays the costs).

"We have created a new tool to help us measure performance," says Dr Murray. "As we develop it further and strengthen the raw data used for these measures in the years to come, we believe this will be an increasingly useful tool for governments in improving their own health systems."

Other findings in the annual WHO report include:

In Europe, health systems in Mediterranean countries such as France, Italy and Spain are rated higher than others in the continent. Norway is the highest Scandinavian nation, at 11th .

Colombia, Chile, Costa Rica and Cuba are rated highest among the Latin American nations – 22nd, 33rd, 36th and 39th in the world, respectively.

Singapore is ranked 6th , the only Asian country apart from Japan in the top 50 countries.

In the Pacific, Australia ranks 32nd overall, while New Zealand is 41st.

In the Middle East and North Africa, many countries rank highly: Oman is in 8th place overall, Saudi Arabia is ranked 26th , United Arab Emirates 27th and Morocco, 29th.

In 1970, Oman’s health care system was not performing well. The child mortality rate was high. But major government investments have proved to be successful in improving system performance. "Oman’s success shows that tremendous strides can be accomplished in a relatively short period of time," says Dr Murray.

Information in the WHO report also rates countries according to the different components of the performance index.

Responsiveness: The nations with the most responsive health systems are the United States, Switzerland, Luxembourg, Denmark, Germany, Japan, Canada, Norway, Netherlands and Sweden. The reason these are all advanced industrial nations is that a number of the elements of responsiveness depend strongly on the availability of resources. In addition, many of these countries were the first to begin addressing the responsiveness of their health systems to people’s needs.

Fairness of financial contribution: When WHO measured the fairness of financial contribution to health systems, countries lined up differently. The measurement is based on the fraction of a household’s capacity to spend (income minus food expenditure) that goes on health care (including tax payments, social insurance, private insurance and out of pocket payments). Colombia was the top-rated country in this category, followed by Luxembourg, Belgium, Djibouti, Denmark, Ireland, Germany, Norway, Japan and Finland.

Colombia achieved top rank because someone with a low income might pay the equivalent of one dollar per year for health care, while a high- income individual pays 7.6 dollars.

Countries judged to have the least fair financing of health systems include Sierra Leone, Myanmar, Brazil, China, Viet Nam, Nepal, Russian Federation, Peru and Cambodia.

Brazil, a middle-income nation, ranks low in this table because its people make high out-of-pocket payments for health care. This means a substantial number of households pay a large fraction of their income (after paying for food) on health care. The same explanation applies to the fairness of financing Peru’s health system. The reason why the Russian Federation ranks low is most likely related to the impact of the economic crisis in the 1990s. This has severely reduced government spending on health and led to increased out-of-pocket payment.

In North America, Canada rates as the country with the fairest mechanism for health system finance – ranked at 17-19, while the United States is at 54-55. Cuba is the highest among Latin American and Caribbean nations at 23-25.

The report indicates – clearly – the attributes of a good health system in relation to the elements of the performance measure, given below.

Overall Level of Health: A good health system, above all, contributes to good health. To assess overall population health and thus to judge how well the objective of good health is being achieved, WHO has chosen to use the measure of disability- adjusted life expectancy (DALE). This has the advantage of being directly comparable to life expectancy and is readily compared across populations. The report provides estimates for all countries of disability- adjusted life expectancy. DALE is estimated to equal or exceed 70 years in 24 countries, and 60 years in over half the Member States of WHO. At the other extreme are 32 countries where disability- adjusted life expectancy is estimated to be less than 40 years. Many of these are countries characterised by major epidemics of HIV/AIDS, among other causes.

Distribution of Health in the Populations: It is not sufficient to protect or improve the average health of the population, if - at the same time - inequality worsens or remains high because the gain accrues disproportionately to those already enjoying better health. The health system also has the responsibility to try to reduce inequalities by prioritizing actions to improve the health of the worse-off, wherever these inequalities are caused by conditions amenable to intervention. The objective of good health is really twofold: the best attainable average level – goodness – and the smallest feasible differences among individuals and groups – fairness. A gain in either one of these, with no change in the other, constitutes an improvement.

Responsiveness: Responsiveness includes two major components. These are (a) respect for persons (including dignity, confidentiality and autonomy of individuals and families to decide about their own health); and (b) client orientation (including prompt attention, access to social support networks during care, quality of basic amenities and choice of provider).

Distribution of Financing: There are good and bad ways to raise the resources for a health system, but they are more or less good primarily as they affect how fairly the financial burden is shared. Fair financing, as the name suggests, is only concerned with distribution. It is not related to the total resource bill, nor to how the funds are used. The objectives of the health system do not include any particular level of total spending, either absolutely or relative to income. This is because, at all levels of spending there are other possible uses for the resources devoted to health. The level of funding to allocate to the health system is a social choice – with no correct answer. Nonetheless, the report suggests that countries spending less than around 60 dollars per person per year on health find that their populations are unable to access health services from an adequately performing health system.

In order to reflect these attributes, health systems have to carry out certain functions. They build human resources through investment and training, they deliver services, they finance all these activities. They act as the overall stewards of the resources and powers entrusted to them. In focusing on these few universal functions of health systems, the report provides evidence to assist policy-makers as they make choices to improve health system performance.

The World Health Report 2000 (1) consists of a message from the WHO’s Director-General, an overview, six chapters and statistical annexes. The chapter headings are "Why do health systems matter?", "How well do health systems perform?", Health services: well chosen, well organized?", "What resources are needed?", "Who pays for health systems?", and "How is the public interest protected?"

(1) The World Health Report 2000 – Health systems: Improving performance.
Published by the World Health Organization, Geneva, Switzerland
Price: 15 Swiss francs (10.50 Swiss francs in developing countries)
ISBN 92 4 156198 X"

======SNIP===========
The fact is, to even CALL what the allopathic system in the United States practices as "healthcare"...is a sad joke. The reason? What HEALTH CARE is going on? Health, according to the World Health Organization in 1946, was defined as:

"Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity" (WHO, 1946)"

Oddly (and perhaps very little "health" was being found), WHO modified that definition to include health as the ability to lead a "socially and economically productive life".

Thus, if someone who was in "health" per the WHO 1946 definition, presented to the office of an M.D. (allopathic doctor), what "CARE" would be given him or her? What "HEALTHCARE"...or, what CARE is given to the healthy? NONE.

Now, let it be someone who is clearly ill or sick, or in DISease, then a great amount of care is available (IF there is someone to pay for it). Thus, it is very clear that, the major, allopathic, MD controlled medical system, is not in any sense a healthcare system, but is, in point of fact, a DISEASE CARE system.

Newest Web Sites

2006-08-16T18:54:00.001-07:00

Baker Chiropractic, PA is always making more sites to better inform and share the great news about Chiropractic care found at our office, and the BAKER CHIROPRACTIC EXPERIENCE in particular.

our newest sites are here:

http://bakerchiropractic.6te.net
http://bakerchiropractic.prophp.org
http://bakerchiropractic.110mb.com

Chiropractic spinal manipulation for low back pain of pregnancy: a retrospective

2006-08-16T18:54:00.000-07:00

Chiropractic spinal manipulation for low back pain of pregnancy: a retrospective

Chiropractic spinal manipulation for low back pain of pregnancy: a retrospective case series.

Lisi AJ.

University of Bridgeport College of Chiropractic. anthony.lisi@med.va.gov

Low back pain is a common complaint in pregnancy, with a reported prevalence of 57% to 69% and incidence of 61%. Although such pain can result in significant disability, it has been shown that as few as 32% of women report symptoms to their prenatal provider, and only 25% of providers recommend treatment. Chiropractors sometimes manage low back pain in pregnant women; however, scarce data exist regarding such treatment. This retrospective case series was undertaken to describe the results of a group of pregnant women with low back pain who underwent chiropractic treatment including spinal manipulation. Seventeen cases met all inclusion criteria. The overall group average Numerical Rating Scale pain score decreased from 5.9 (range 2-10) at initial presentation to 1.5 (range 0-5) at termination of care. Sixteen of 17 (94.1%) cases demonstrated clinically important improvement. The average time to initial clinically important pain relief was 4.5 (range 0-13) days after initial presentation, and the average number of visits undergone up to that point was 1.8 (range 1-5). No adverse effects were reported in any of the 17 cases. The results suggest that chiropractic treatment was safe in these cases and support the hypothesis that it may be effective for reducing pain intensity.

MeSH Terms:
Adult
Female
Humans
Low Back Pain/therapy*
Manipulation, Chiropractic*
Pain Measurement
Pregnancy
Pregnancy Complications*
Retrospective Studies
Treatment Outcome

PMID: 16399602 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=16399602&dopt=Citation

The Emerging Healthcare Crisis

2006-07-19T20:38:00.000-07:00

More and more, people who have serious medical problems and who need hospitalization or surgery,
or conservative care, are finding themselves without any means of paying for it. As this niumber grows, we will find ourselves, as a nation, in a deeper crisis.

Given the large amounts of money currently being wasted in Iraq, and in other government projects, it is a simple and clear SHAME that we do not have a national health insurance plan.

This republic (and we ARE a republic by definition, not a democracy) has a legal duty, per the constitution, to provide for the general welfare.

The government is NOT living up to that responsibility.

We NEED a national healthcare plan NOW. Millions of people without access to necessary healthcare, is NOT the mark of a great nation, nor of a prosperous nation.

Migraine And Heart Disease In Women Linked

2006-07-19T19:00:00.000-07:00

http://news.worldfitneBy Victor D'Angelo
Women of middle-age or older who have migraine headaches with aura symptoms are said to be at an increased risk for a heart attack , stroke , or deathWomen of middle-age or older who have migraine headaches with aura symptoms are said to be at an increased risk for a heart attack, stroke, or death.This is according to the Journal of the American Medical Association. Migraines with auras are headaches that are visual that cause you to see spots and flashes. A new study from the Brigham and Women’s Hospital found that women who have these headaches have twice the risk at getting a severe heart attack when compared to a women without the headaches.Only 130 women out of nearly 28,000 studied died over 10 years of study.ss.ca/news/071906/MigraineAndHeartDiseaseInWomenLinked.php

Continuing Education Seminar in Galveston

2006-07-19T18:32:00.000-07:00

We are in Galveston this week at a continuing education seminar. The weather is beautiful, and the temperature is a big relief from the 105 degree heat in Longview.
The picture is a view from the hotel room.

We will be closed on 19, 20, and 21 July to attend seminar.

2006-07-15T12:06:00.000-07:00

We will be closed on Wednesday, 19, 20,21 of July as we are going out of town to a seminar.

For any patients who need to reschedule, please call 903-753-5400 on Monday or Tuesday to reschedule your visit.

Thank you.

UCLA Study Finds Same Genes Act Differently in Males and Females; Discovery May Explain Gender Gap in Disease Risk, Drug Response

2006-07-08T06:15:00.000-07:00

http://www.newsroom.ucla.edu/page.asp?RelNum=7177
Scientists may have revealed the origin of the battle of the sexes—in our genes.
UCLA researchers report in a new study that thousands of genes behave differently in the same organs of males and females—something never detected to this degree. The study, published in the August issue of the journal Genome Research, sheds light on why the same disease often strikes males and females differently, and why the genders may respond differently to the same drug.

"We previously had no good understanding of why the sexes vary in their relationship to different diseases," said Xia Yang, Ph.D., first author of the study and postdoctoral fellow in cardiology at the David Geffen School of Medicine at UCLA. "Our study discovered a genetic disparity that may explain why males and females diverge in terms of disease risk, rate and severity."

"This research holds important implications for understanding disorders such as diabetes, heart disease and obesity, and identifies targets for the development of gender-specific therapies," said Jake Lusis, Ph.D., co-investigator and UCLA professor of human genetics.
The UCLA team examined brain, liver, fat and muscle tissue from mice, with the goal of finding genetic clues related to mental illnesses, diabetes, obesity and atherosclerosis. Humans and mice share 99 percent of their genes.

The scientists focused on gene expression—the process by which a gene's DNA sequence is converted into cellular proteins. With the help of genomic-research company Rosetta Inpharmatics, the team scrutinized more than 23,000 genes to measure their expression level in male and female tissue.

What they found surprised them. While the function of each gene was the same in both sexes, the scientists found a direct correlation between gender and the amount of gene expressed.
"We saw striking and measurable differences in more than half of the genes' expression patterns between males and females," said Dr. Thomas Drake, co-investigator and UCLA professor of pathology. "We didn't expect that. No one has previously demonstrated this genetic gender gap at such high levels."

UCLA is the first to uncover a gender difference in gene expression in fat and muscle tissue. Earlier studies have identified roughly 1,000 sex-biased genes in the liver, and other research has found a combined total of 60 gender-influenced genes in the brain—about one-tenth of what the UCLA team discovered in these organs.

Even within the same organ, researchers identified scores of genes that varied in expression levels between the sexes. Gender consistently influenced the expression levels of thousands of genes in the liver, fat and muscle tissue. This effect was slightly more limited in the brain, where hundreds—not thousands—of genes showed different expression patterns.

"Males and females share the same genetic code, but our findings imply that gender regulates how quickly the body can convert DNA to proteins," Yang said. "This suggests that gender influences how disease develops."

The gender differences in gene expression also varied by tissue. Affected genes were typically those most involved in the organ's function, suggesting that gender influences the more important genes with specialized roles, not the rank-and-file.

In the liver, for example, the expression of genes involved in drug metabolism differed among men and women. The findings imply that male and female livers function the same but work at different rates.

"Our findings in the liver may explain why men and women respond differently to the same drug," Lusis said. "Studies show that aspirin is more effective at preventing heart attack in men than women. One gender may metabolize the drug faster, leaving too little of the medication in the system to produce an effect."

"At the genetic level, the only difference between the genders is the sex chromosomes," Drake said. "Out of the more than 30,000 genes that make up the human genome, the X and Y chromosomes account for less than 2 percent of the body's genes. But when we looked at the gene expression in these four tissues, more than half of the genes differed significantly between the sexes. The differences were not related to reproductive systems—they were visible across the board and related to primary functions of a wide variety of organs."

The UCLA findings support the importance of gender-specific clinical trials. Most medication dosages for women have been based on clinical trials primarily conducted on men.

"This research represents a significant step forward in deepening our understanding of gender-based differences in medicine," said Dr. Janet Pregler, director of the Iris Cantor-UCLA Women's Health Center. The center's executive advisory board, a group of businesswomen interested in advancing women's health, helped fund the study.

"Many of the genes we identified relate to processes that influence common diseases," Yang said. "This is crucial, because once we understand the gender gap in these disease mechanisms, we can create new strategies for designing and testing new sex-specific drugs."

The National Heart, Lung, and Blood Institute; the National Institute of Diabetes and Digestive and Kidney Diseases; and the UCLA National Center for Excellence in Women's Health also supported the study. Co-authors included Susanna Wang, Leslie Ingram-Drake and Arthur Arnold, all from UCLA, and Eric Schadt of Rosetta Inpharmatics, a subsidiary of Merck & Co., Inc.

Tips on Paperwork, Forms, and Insurance

2006-07-07T18:34:00.000-07:00

Tips on Paperwork, Forms, and Insurance
by Tammy Baker, General Manager, BAKER CHIROPRACTIC,PA
1420 McCann Road, Longview Texas 75601

Paperwork is a necessary part of healthcare these days. It may be a pain to fill out, but believe it or not, each page is necessary, and helps us help you.

If you are a new patient, please bring in all documentation and paperwork that you have at home that relates to your condition or problem.

This is especially true for workers compensation (work comp) cases. If you have the outcomes of benefit review conferences, contested claims hearings, designated doctor visits, required medical exams, MRI exams, EMG reports, etc., we really need this information during the consultation or initial examination, so please bring all these papers with you.

Before you visit, try to make a written list of all the symtoms you are having, and the questions you wanted to ask.

Also, make notes about things like your date of accident or injury, or how the problem started and how long you have had it. This will help speed up filling out the paperwork, and will help job your memory when Dr. Baker takes your history.

A little preparation for your visit not only speeds things along, but helps us have access to the kind of information and documentation we need.

If you have had examinations or MRIs done or other tests, try to go by and pick up a copy of these to bring with you.

These may be time consuming, but in the end, it will help your visit go smoother, be quicker, and help Dr. Baker to help you more.

~Tammy Baker, General Manager

Location of BAKER CHIROPRACTIC,PA

2006-07-07T11:33:00.000-07:00

As we are enjoying greater number of new patients coming to our office, I wanted to include some graphics of our location.

We are located on McCann Road, a major road in Longview, at 1420 McCann Road, in the middle of the Brookwood Shopping Village. The Shopping Village has a sign out front that looks like this (left).

Our office looks like this in front :

Man's brain rewired itself, doctors contend

2006-07-04T06:17:00.000-07:00

Nerve connections severed in accident nearly 20 years ago
By Karen Kaplan, Los Angeles Times | July 4, 2006

LOS ANGELES -- Terry Wallis awoke from a coma-like state 19 years after tumbling over a guardrail in a pickup truck and falling 25 feet into a dry riverbed. Now doctors armed with some of the latest brain-imaging technology think they may know part of the reason why.

Wallis showed few outward signs of consciousness, but his brain was methodically rebuilding the white-matter infrastructure necessary for him to interact with the outside world, researchers reported yesterday in the Journal of Clinical Investigation.

``I believe it's a very, very slow self-healing process of the brain," said Henning Voss, lead author of the study and a physicist at Weill Cornell Medical College's Citigroup Biomedical Imaging Center.

Wallis emerged from a minimally conscious state in 2003 at the age of 39 and uttered his first word since Ronald W. Reagan was in the White House: ``Mom." Since then, the onetime mechanic from Big Flat, Ark., has regained the ability to form sentences and recovered some use of his limbs, though he still can't walk or feed himself.

Using both Positron Emission Tomography scans and an advanced imaging technique called diffusion tensor imaging, the researchers examined Wallis's brain after he regained full consciousness, and found that cells in the relatively undamaged areas had formed new axons, the long nerve fibers that transmit messages between neurons.

``In essence, Terry's brain may have been seeking out new pathways to reestablish functional connections to areas involved in speech and motor control -- to compensate for those lost due to damage," said the study's senior author, Dr. Nicholas Schiff, a neurologist at the Weill Cornell Medical College in New York.

Schiff cautioned that Wallis was a ``1 in 300 million" case. But Dr. Steven Laureys, a neurologist at the University of Liege in Belgium, said the findings will force doctors to reconsider the way they treat patients who are in minimally conscious and persistent vegetative states.

``It does show there are changes happening" in the brain, said Laureys, who coauthored a commentary that also appears in the journal. ``It obliges us to reconsider old dogmas."

In a minimally conscious state, a patient shows intermittent signs of awareness but generally is unable to interact with the outside world. It is a less severe condition than a persistent vegetative state, in which the patient is awake but has no awareness of herself or her surroundings.

Terri Schiavo, the Florida woman at the center of a right-to-die battle, had been in a persistent vegetative state for 15 years when her husband won a court order to have her feeding tube removed last year.

Neurologists believe that the longer a patient remains in a minimally conscious or persistent vegetative state, the lower the chances for recovery. As a result, such patients are often neglected by doctors and insurance companies, and it can be difficult for family members to find facilities that will accept them, Laureys said.

In his last few years at Stone County Nursing and Rehabilitation Center in Mountain View, Ark., Wallis's family began to notice that Terry, a Ford enthusiast, would grunt when a Chevrolet commercial came on the television. They said he answered questions by blinking his eyes.

About two years before he regained full consciousness, he began taking the antidepressant Paxil, which his doctors think may have contributed to his recovery.

Within a week of his first utterance, Wallis began speaking in simple sentences. Once paralyzed from the neck down, he can now point with his left hand and move both legs.

The researchers scanned Wallis's brain eight months after his awakening and found strong evidence that axons were making new connections in the cerebellum, the region that controls movement. The activity was stronger than in the brains of 20 healthy people scanned for the sake of comparison, and seemed to correlate with Wallis's physical improvement, Voss said.

When his brain was rescanned 18 months later, signs of growth in the cerebellum had leveled off, and other areas of the brain were using more energy.

Wallis's language skills improved during that time; he learned to count to 25 without interruption, and his speech became more intelligible.

But when the researchers looked for evidence of increased activity in the language centers of his brain, they found none.

``Maybe we just missed it, or maybe the language areas are unusable because important connections are missing," said Voss, who theorizes that another part of the brain may have picked up the slack.

Voss and his colleagues also scanned the brain of a car accident victim who is still minimally conscious, and they found significant axonal regrowth as well.

That patient, however, has not shown corresponding clinical improvement, according to the study.

BAKER CHIROPRACTIC,PA celebrates nine months in practice in Longview .

2006-07-03T21:38:00.000-07:00

BAKER CHIROPRACTIC,PA celebrates nine months in practice in Longview .

Baker Chiropractic, PA , on July 3rd, 2006, celebrated nine months in practice in Longview Texas.

We opened our doors on October 3rd , 2005 and have had a wonderful time ever since then.

Dr. John Raymond Baker, general manager Tammy Bennett-Baker, Manager Amy Tidwell, Therapy assistant Erin Threadgill, and Insurance Manager, Nikki Henderson, want to extend our thanks to Longview, and the many, many patients that have welcomed us, and shown their confidence in us as healthcare providers.

We will be closed on the 4th of July to celebrate the holidays with our families, but will be open again on the 5th of July.Have a safe and happy 4th of July and thank you to all our patients.~Dr. John Raymond Baker, Tammy Baker, Amy Tidwell, Erin Threadgill, and Nikki Henderson

New Drug for Treatment of Macular Degeneration- Lucentis

2006-07-01T11:29:00.000-07:00

http://www.fortwayne.com/mld/newssentinel/news/local/14947715.htm

Drug stopped vision loss in clinical trialsFDA approves Lucentis treatmentBy Jennifer L. Boenjboen@news-sentinel.comThe first drug showing promise of reducing vision loss caused by macular degeneration, which affects 1.7 million Americans 50 or older, was approved Friday by the U.S. Food and Drug Administration.

Lucentis, made by Genentech, was found in clinical trials to stabilize vision in 95 percent of patients. What is most promising, said Fort Wayne retinal surgeon Dr. Gohar Salam, is that 25 percent of patients treated regularly with Lucentis improved their vision by three additional lines on the standard eye exam chart.

“It’s still not a cure, but it’s a significant step forward,” Salam said.Macular degeneration’s symptoms hit Anneliese Remington, 80, of Fort Wayne quickly. “In March, my great-grandson was ice skating at McMillen Park. When he was done, I tried to get down the bleachers and I could hardly see,” she recalled.

At home she looked at a printed grid on the refrigerator, given to her by her ophthalmologist. The normally straight lines appeared wavy, a key sign of macular degeneration.“It was so scary,” she said. Her ophthalmologist referred her to Salam, who diagnosed an advanced form of the disease called wet macular degeneration.

Remington’s first treatment, photodynamic therapy, was ineffective, so Salam suggested an experimental treatment, an earlier form of the just-approved drug. “In three to four weeks, I noticed marked improvement,” Remington said. “My right eye is still not as good as the left, but I can see much better and I feel safer behind the wheel.”Macular degeneration, the most common cause of legal blindness in people over 60, according to the National Institutes of Health, is a progressive disease of the center part, or macula, of the retina of the eye.

A person 65 or older today has a one-in-four chance of developing the disease. During the 2000 Census, 25,615 people 65 and older lived in Fort Wayne. As America grays, the disease portends a health and social crisis in the making – by 2020, 6 million Americans could be blind from some form of eye disease.

Macular degeneration causes loss of central vision, making facial recognition, reading and watching movies and television difficult or impossible. Salam describes the retina as the “wallpaper” on the inside of the back of the eye. The light-sensitive retina converts light and images into nerve impulses that travel up the optic nerve to the brain. The brain’s interpretation of the images is how we see.

People with age-related macular degeneration, or AMD, may not notice the subtle hallmark vision changes: vertical objects or lines may be a little off kilter, appearing bent; areas of gray appear in the center when focusing on an object. Peripheral vision remains, so someone with advanced disease may be considered legally blind yet retain a small ring of vision.
Lucentis is a first-line cousin to a cancer drug called Avastin, also made by Genentech.

“Researchers knew Avastin kills new blood vessels in cancer,” Salam said. Abnormal growth of blood vessels is a complication of advanced macular degeneration. Genentech changed the molecule size of Avastin so it could better penetrate the retina when injected into the eye.Salam, who participated in clinical trials for Avastin while waiting for Lucentis to be approved by the FDA, offered it to patients such as Remington in whom other treatments failed.
Although no treatment exists as yet for advanced, or wet, AMD, drugs such as Lucentis, and its forerunner Macugen, can delay progression of vision loss by AMD. Made by Pfizer, Macugen was FDA-approved in December 2004, and has shown improvement in stabilizing the disease in 70 percent of cases; Lucentis’ rate is 95 percent.

Remington may need additional treatments with Lucentis. For best results, injections every four weeks are prescribed. But Remington, whose condition stabilized after just one injection, may be given Macugen, which is injected every six weeks, or put on a regimen combining both treatments, Salam said.

“It is the scariest thing to lose one’s eyesight,” Remington said, adding that she is glad she agreed to use the drug at a time when it was still in the experimental stage. Possible side effects from Lucentis include eye redness and irritation, with less common side effects of cataracts, infection, retinal tears and detachment. In clinical trials, 4.2 percent to 4.6 percent of patients given Lucentis for two years suffered a stroke or heart attack, compared to 3 percent patients in the control group.Nevertheless, “These are good breakthroughs,” Salam said. But early detection is still the cornerstone of keeping AMD from robbing vision.For people who have had routine vision exams during adulthood, beginning at age 55 they should undergo annual exams involving dilation of the eyes by an optometrist or ophthalmologist: “The earlier people come, the better the outcome,” Salam said.

'Disease symptoms
The most common form of age-related macular degeneration of the eye is dry AMD (see graphic). One reason the disease may go unnoticed is that it may develop in only one eye, although that is less common. In 10 percent of people with dry AMD, a form called wet AMD develops. Normally straight lines becoming wavy is a symptom of this most severe and advanced form of AMD. Damage to the macula occurs rapidly, and vision loss is greater than in dry AMD. While there is no definite cause, the most significant risk factors for AMD are age and smoking, said Fort Wayne retinal surgeon Dr. Gohar Salam. Other factors include cardiovascular disease, diabetes, high blood pressure and family history of the disease. Women are at greater risk than men, and obesity may also increase risk.

WHAT IS "DOUBLE DIPPING" ?

2006-06-29T05:26:00.000-07:00

WHAT IS "DOUBLE DIPPING" ?
I tend to be a stickler on definitions, because, if we don't have a clear understanding of what is meant when people are using a term, confusion will result.

Thus, when I heard that a work comp carrier representative had used the term "double dipping", I had to find out what the heck it meant.

Initially, one would think this retarded and ambiguous term would mean that you were going to get TWO SCOOPS of ice cream on your cone instead of one. Maybe it means you get rocky road with your chocolate.

Of course, it could be a term unique to those who chew tobacco, and double dipping could mean getting a double load of "chaw" (i.e. chew).

But, double dipping COULD mean you use your Frito scoopable chip to get two loads of cheese on one scoop.

But, how would these apply to Work Comp? Clearly, insurance carriers are not giving out ice cream, not dispensing cheese dip, nor even chewing tobacco.

So, we have to "dip" deeper into the matter.

One possible clue as to what SOME carrier reps might mean when they throw this term around, is found in an article on Texas Mutual website

From http://www.texasmutual.com/news/stories2006Q2.shtm (selected portion used pursuant to FAIR USE doctrine)

"May 23, 2006 - Texas Mutual Insurance Company reports that, in unrelated cases, the Travis County grand jury indicted Carlos Torres and Shantel Babineaux on workers’ compensation fraud-related charges. Both workers were allegedly double-dipping, a term investigators use for claimants who collect workers’ comp income benefits by saying they are unable to work while they are actively employed."

So, THAT'S WHAT THEY MEAN when they use that retarded term!

So, let's investiage this idea a bit further.

Let's say a worker is actually employed in TWO jobs that he does daily.
It is not against the law to work two jobs.

Let's say one job is very physically challenging and one could get hurt easily, and involves heavy lifting, twisting, bending etc.
The other job is extremely light in nature. It only involves filing paperwork, no heavy lifting, no bending...in fact, a very , very light work description, job rating.

Scenario...this worker gets hurt on the job on the very physical job.
His injury is such he presents to a treating doctor. A history and exam are taken, radiographic examination done, even an MRI is done. The results indicate that, at this time, it is contraidicated that the patient continue working on the heavy duty job. THERE IS NO LIGHT DUTY ON THE HEAVY DUTY JOB.

The treating doctor fills out a 73 work status report taking the patient off work with regard to the job he was injured on, since there is no light duty or restricted duty available. In other words, the patient has to be 100 percent able to do heavy duty work.

But, he is physically able to do his second job, and if the duties of the second job were available on the heavy job, he could be returned to work.

But, the 73 work status, ONLY APPLIES to whether the worker can return to the JOB ON WHICH HE WAS INJURED...it does NOT apply to a second job in which he was not injured.

Therefore, there is no reason he cannot continue working at the second job, since he is fit and able to perform those extremely light and non-physically challenging duties.

Thus, he is properly and legally off work with regard to the job on which he was injured, but continues to be gainfully employed and working on job number two.

If one re-reads the "double dipping" definition, this employee / injured worker, would be "double dipping" because it does not stipulate he is working at the same job, just that he is getting work comp benefits, and remains actively employed.

Thoughts?

California Appeals Court Upholds $2.65 Million Bad Faith Award Against Insurer

2006-05-28T06:58:00.000-07:00

Upholds $2.65 Million Bad Faith Award Against Insurer
http://www.metnews.com/articles/2006/cent052406.htm
"Award Not Excessive Where Mishandling of Claim Drove Insured to Seek Therapy, Court Says

By KENNETH OFGANG, Staff Writer/Appellate Courts

A Sacramento couple whose insurer’s mishandling of their claim drove the husband to drink, sent the wife to a therapist, and injured their marriage and their business are entitled to keep the more than $2 million awarded by a jury for bad faith, the Third District Court of Appeal ruled yesterday.

The justices affirmed an award of $638,000 in compensatory damages and $2.015 million in punitive damages to Charles and Terese Polisso. A Sacramento Superior Court jury concluded the Polissos were entitled to that sum because Century Surety Co. wrongly refused to defend a claim against their business, Kinzel Glass Co.

The claim had its origins in a 1996 contract in which Kinzel and S.W. Allen Construction, Inc. agreed that Kinzel would install seven glass panels in an underground viewing chamber being built by the U.S. Forest Service near Lake Tahoe. Before the project was completed, however, a heavy rain caused the creek to overflow and submerge the viewing chamber, triggering a series of events that resulted in damage to the glass.

Defense Tendered

Allen sued, naming Kinzel Glass and “CHARLES A. POLISSO...an individual doing business as KINZEL” as defendants, claiming that faulty workmanship was responsible for the damage and that the Forest Service was dissatisfied with the glass as a result. Kinzel tendered its defense to Century Surety Co., from which it had purchased a commercial lines policy covering liability, as well as damage to its glass.

Century brought a declaratory action against Kinzel, Charles Polisso, and Allen to determine what coverage obligations, if any, it had. The Polissos counterclaimed against Century for refusing to defend them in Allen’s suit and to pay for damage to the glass.

Century attorney Callie O’Hara opined that there was no obligation to defend or provide coverage. The company then advised the Polissos that it was denying their claim, but had obtained an extension of time to file and had instructed its lawyers to prepare and file an answer as a courtesy.

Reservation of Rights

Evidence later presented in the bad faith suit showed that at one point, O’Hara advised Century that there was enough evidence to show a “potential” for coverage, triggering a duty to defend in the Allen suit. The company then retained new counsel and notified Charles Polisso that it would provide a defense under a full reservation of rights, but would not provide independent counsel or cover the property damage.

While the litigation was pending, O’Hara recommended that Century file a declaratory action against the Polissos and seek reimbursement of defense costs. The Polissos subsequently retained their own counsel, whom Century originally agreed to pay at its usual rates, but who was owed nearly $70,000 by the end of trial, which resulted in a net zero between the Polissos and Allen.

In the bad faith suit, the Polissos contended that after five years of litigation, with reigning uncertainty as to the outcome and as to whether their defense costs would be paid, they were under tremendous personal stress and had lost their business lease. Because the company had occupied its former premises since 1949 and had to move to a less desirable location, they lost a good deal of business, they said.

Jurors agreed that Century had acted in bad faith, holding the company liable for business and personal injury damages and legal fees sustained in the underlying suit.

Justice Coleman Blease, writing for the Court of Appeal, rejected the company’s contention that it could not be held liable for bad faith because there was a good faith dispute over coverage. While Century could have disputed coverage in good faith, Blease explained, it could not reasonably dispute that it had a duty to defend.

The justice went on to conclude that the punitive damage award was not excessive. It was within the range of reasonableness according to recent U.S. Supreme Court decisions, the justice said, and reflected the reprehensibility of the insurer’s five-year pattern of mishandling the claim.

The case is Century Surety Company v. Polisso, 06 S.O.S. 2550."

Myth of Chiropractic-Caused Strokes Debunked by Medical Researchers

2006-05-28T06:38:00.000-07:00

http://biz.yahoo.com/prnews/060527/nysa011.html?.v=43Myth of Chiropractic-Caused Strokes Debunked by Medical Researchers
Saturday May 27, 2:51 pm ET

CHANDLER, Ariz., May 27 /PRNewswire/ -- A recent billboard advertisement, carried on the side of a bus in Bridgeport, Conn., is the latest in a series of attacks on chiropractic that use scare tactics and misinformation to undermine the growth of the profession, according to the World Chiropractic Alliance (WCA).

The advertisement, which asks "Injured by a chiropractor?" directs readers to a website run by an organization calling itself the "Chiropractic Stroke Victims Awareness Group." No information is available in the ad or at the website as to who finances the group.

WCA President Terry A. Rondberg, DC, noted that he wasn't surprised by the aggressive attack. "In recent years, chiropractic has made tremendous inroads into the American health care system. The increased popularity of a wellness approach that doesn't rely on drugs and surgery is very threatening to some elements of our society. They have a huge financial interest in eliminating chiropractic."

In 1990, the American Medical Association was found guilty in federal court of conspiring with other medical organizations in a "lengthy, systematic, successful and unlawful boycott" designed to eliminate chiropractic as a competitor. Many health care officials say that, although barred from many of the illegal practices formerly used, the drug and medical industry still engage in anti-chiropractic campaigns. The consensus is that many of the operations are being conducted using anonymous "front" organizations."

Contrary to the billboard's message, medical research has shown that chiropractic is extremely safe, particularly when compared to medical treatment. The incidence of stroke following chiropractic adjustments has been estimated at fewer than 1 to 3 incidents per million adjustments.

Medical researchers have admitted that chiropractic care carries far less of a stroke risk than medical treatment. "Indeed, most interventions by allopathic physicians have a higher complication rate than chiropractic interventions," said Philip Lee, MD, a co-investigator of a research survey presented at the American Heart Association's 19th International Joint Conference on Stroke and Cerebral Circulation.

What to do when your family doctor says "I don't treat car wreck injuries" or I don't "DO" Workers Comp

2006-05-27T11:58:00.000-07:00

Many people have a personal physician or "family doctor" who they go to for treatment of colds, hayfever, diabetes, or whatever.

But, get hurt on the job or get injured in a car wreck, and suddenly, you find your MD or DO doesn't want to help you out!

What do you do....What DO YOU DO?

Well, if you are in the East Texas area, you are in luck.

Whether you are in Tyler, Kilgore, Longview, Gilmer, Gladewater, Marshall, Lindale, Mineola,
or even in Nacogdoches, you have a doctor available who DOES "DO" car accidents and Work Comp.

Dr. John Raymond Baker,DC, of BAKER CHIROPRACTIC in Longview, received is license in Texas back in 1989 and, since then, has treated thousands of patients.

He has considerable hands on experience in dealing with the challenges of both auto accident injuries and on the job injuries. Also, he is a level two ADL doctor, and works with attorneys in this area as well as far away as Dallas. Need an MRI or CT scan? Dr. Baker regularly orders these advanced imaging procedures. Need an EMG? No problem. Need a consult with an orthopaedic surgeon, hand surgeon, neurosurgeon,or neurologist? Dr. John Raymond Baker will work hard to try to find you the best specialist possible in this area.

As Work Comp doctors get fewer and fewer, Dr. Baker has resisted the pressures many other doctors have succumbed to. Many have dropped out because of the insurance carriers constant denials and disputes and refusals to pay.

Because Dr. Baker realizes that many patients desparately need a treating doctor, Dr. Baker has continued to hang in there, and provide the patients with a doctor who cares about their situation. If you need a doctor who cares, and who puts patient's first, consdier calling BAKER CHIROPRACTIC, PA today in the Brookwood Shopping Center.

Even if you have to drive as far as Nacogdoches, it's worth it to find a doctor who is there for his patients, and no on vacation in the Bahamas.

Call 903-753-5400 today and schedule your appointment!

Hours are 9 am to 1 pm and 3 pm to 630 pm Monday through Friday.

Neurtontin deal

2006-05-26T23:47:00.000-07:00

From http://www.sierratimes.com/06/05/26/71_158_158_30_11522.htm
Neurontin Deal - Slap On The Hand To Pfizer
by Ms. Evelyn Pringle
"
The off-label prescribing of drugs has become a serious problem over the past decade. Doctors are adjusting dosage levels and prescribing drugs for medical indications and treatment durations for which the drugs were never approved or intended.
When the FDA approves a drug, it also approves the labeling for the drug, which explains the manner in which the medication is to be used. While physicians may prescribe approved drugs as they see fit, its against the law for drug companies to promote drugs for uses outside of the approved labeling but they do it all the time.

Neurontin remains the most notorious example of an illegal, but highly successful, off-label marketing campaign. The drug was approved for the limited use of treating epileptic seizures but nonetheless, became an overnight blockbuster with sales that soared from $97.5 million in 1995, to more than $2.5 billion in 2003.

While Neurontin might be the most notorious, it is certainly not the only problem. A study published in the May 8, 2006, Archives of Internal Medicine, determined that more than one out of every 7 prescriptions written for 160 commonly used drugs were for off-label uses that lacked scientific support.

The study was based on information from the IMS Health National Disease and Therapeutic Index that defines drug prescribing patterns and provides market data on drug companies.

In 2001, an estimated 150 million prescriptions, or 21% of prescriptions written, were for off-label use, according to the Archives study.

To reach its results, the study first determined whether a prescription was off-label and then assessed the level of available scientific evidence supporting the use, through the Drugdex system, a comprehensive summary of evidence supporting off-label uses of prescription drugs.

The study found that 73%, or 109 million off-label prescriptions, had little or no supporting evidence. The study does not explain why doctors prescribe so many drugs off-label but one explanation may be that "both physicians and patients have misunderstood the role of the FDA," the study's lead author Randall Stafford says.

"I think there's sort of a presumption that if a drug has made it onto the market," he notes, "the FDA has vouched for its safety and efficacy for all of its potential uses."

One way drug companies have been able to increase the off-label sale of drugs is by influencing doctors in public institutions, and state policy makers, who are involved in the development of drug formularies that list which drugs will be used in state institutions and by persons covered by government health care programs like Medicaid and Medicare.

Allen Jones, a former Pennsylvania fraud investigator, explains that each state has a menu of approved drugs that doctors must prescribe to persons in state institutions. "Before a drug can be prescribed by a state physician for somebody in the state system," he says, "it has to be on the list."

According to Mr Jones, the drug companies "have bought the decision-making process from our government officials all the way down to the guy who decides what drugs get on the formulary."

Doctors who sit on the expert panels and decide which drugs will be on the lists, he says, are paid by drug companies to give positive opinions in order to circumvent the FDA approval process.

"The FDA has no control over what an individual doctor does or says," Mr Jones explains, "the pharmaceutical industry has funded a mechanism whereby they can gather favorable opinions."

"They then amplify and magnify those opinions," he says, "and put them in the form of a treatment protocol that can be implemented in any state with the approval of a few key decision-makers."

Stacking the deck with industry friendly "experts" is apparently common. An investigation by the scientific journal Nature found "extensive" financial connections between drug companies and the advisory panels, with as many as 70% of the panels affected. In one instance, Nature found every member of a panel had received payments from the company making the drug that was recommended.

In the summer of 2002, Mr Jones discovered an off-the-books account where drug companies were depositing "educational grants" from which state officials and policy makers involved in developing Pennsylvania's drug list were receiving payments.

"We had state officials accepting $2,000 honorariums," he noted, "and physicians who were taking trips, perks and gratuities."

One of the officials Mr Jones named in his investigation was the state pharmacist, Steven Fiorello. In April 2005, the State Ethics Commission fined Fiorello over $27,000 after finding that he repeatedly took money from drug makers, Pfizer and Janssen, while serving on the panel that decided which drugs could be given at 9 state mental hospitals. The commission's report cited repeated failures to disclose his income from the drug companies.

On June 10, 2005, Senators Chuck Grassley and Max Baucus announced the beginning of an investigation by the Senate Finance Committee, which has oversight responsibility for government health care programs, into the practice where drug companies give money to state governments.

"The drug companies call the awards educational grants," their press release said, "but the senators are concerned that the dollars are more focused on product promotion than education."

The Senators said their inquiry was based on reports that companies have awarded grants as inducements to prescribe medications the companies produce.

In some cases, they said, "such grants to state agencies may have prompted those agencies to develop programs leading to over-medication of patients at the expense of patient health or to unnecessary expense for taxpayers."

"We need to know how this behind-the-scenes funneling of money is influencing decision makers," Senator Grassley said. "The decisions result in the government spending billions of dollars on drugs."

In recent years, investigations into the prescribing patterns for people on Medicaid and Medicare has led to the discovery of a drastic increase in off-label prescribing to children and the elderly of drugs never approved for use with children and the elderly.

One class of drugs found to be prescribed off-label most often without scientific support are psychiatric medications. In 96% of the psychiatric drugs prescribed off-label, the Archive study found support was lacking.

According to the report, Death by Medicine (2003), by Gary Null, PhD; Carolyn Dean MD, ND; Martin Feldman, MD; Debora Rasio, MD; and Dorothy Smith, PhD, a study on prescription drug use by the elderly conducted by Medco Health Solutions found that 6.3 million senior citizens received more than 160 million prescriptions and a total of 7.9 million medical alerts were triggered by off-label prescribing, with 2.2 million alerts indicating excessive dosages unsuitable for seniors, and about 2.4 million indicating clinically inappropriate drugs for the elderly.

Drug companies have promoted the off-label use of psychiatric drugs with children even after their own studies have shown the drugs to be dangerous. In 2004, New York attorney general, Eliot Spitzer, filed a lawsuit against GlaxoSmithKline for withholding studies that raised doubts about the effectiveness and safety of Paxil in treating children and revealed that more than 2 million prescriptions for Paxil were written off-label to treat children in 2002.

In late 2004 the FDA ordered black box warnings on all SSRI antidepressants after it was discovered that drug makers had suppressed studies that showed the drugs were linked to an increased risk of suicide in children.

Documents that have surfaced during litigation reveal that drug makers knew about this risk before the SSRI antidepressants arrived on the market but continued to find ways to get doctors to prescribe the drugs to kids. A report by Express Scripts, Inc, a pharmacy benefit manager, titled "Trends in the Use of Antidepressants in a National Sample of Commercially Insured Pediatric Patients," shows that between1998 and 2002, the overall use of antidepressants among children increased from 160 children per 10,000 in 1998, to 240 per 10,000 in 2003.

Tom Woodward's daughter Julie hung herself after being prescribed the antidepressant, Zoloft, off-label. He is angry at the Bush administration and the FDA for failing to protect the public against drug companies who hide studies that show drugs are dangerous when given to children.

"It is clear that the FDA is a political entity and its leadership has protected the economic interests of the drug industry," he says.

According to Mr Woodward, officials in leadership positions have strong ties to the industry. "FDA's chief counsel Daniel Troy has spent his career defending the drug industry," he noted, "if a study does not favor a drug, the public never hears about it."

"Under the Bush administration," Mr Woodward said, "the FDA has placed the interests of the drug industry over protecting the American public."

He points out that 86% of the millions of dollars in campaign contributions by drug companies went to Bush and Republican candidates and wants to know, "what did Pfizer, Eli Lilly, and GlaxoSmithKline Beecham buy?"

A recent study reveals that even when the FDA does add a black box warning to a label, the highest form of drug safety alert available, doctors will continue to prescribe the drug.

The February 14, 2006 Archives of Internal Medicine featured a report on a study where researchers reviewed the records of 324,548 patients seen at several Boston area medical facilities between January 1, 2002 and December 31, 2002 and found that 33,778 patients were prescribed a drug that had a black box label, and 2,354 of those prescriptions were written contrary to the guidance set forth in black box warning.

The study found that in about 1,000 cases, patients were taking one drug at the same time as another when the warning said that taking the 2 drugs together should be avoided, and in about 90% of the cases, a drug was prescribed to treat a condition for which the drug was not approved.

According to Death by Medicine, each year approximately 2.2 million US hospital patients experience adverse drug reactions to prescribed medications and experts say many are caused by prescribing drugs for uses not approved.

The dangerous off-label prescribing practices have come under scrutiny in recent years because so many of the drugs are covered by government health care programs, and lawmakers charged with oversight of programs like Medicaid and Medicare became suspicious about the skyrocketing prescription drug costs.

In some of the largest cases involving Medicaid and Medicare fraud, former industry employees came forward with information about marketing schemes and filed lawsuits under the False Claims Act.

The Washington DC based Taxpayors Against Fraud, is a non-profit organization dedicated to combating fraud against the federal government through the promotion and use of the qui tam provisions of the False Claims Act.

Qui tam is a mechanism that allows persons with evidence of fraud to bring suit on behalf of the government. TAF educates the public about the FCA and its qui tam provisions and provides assistance to whistleblowers and their attorneys and sometimes files amicus curiae briefs on important issues.

TAF also has a staff of lawyers and other professionals who are available to assist anyone interested in the FCA and publishes the False Claims Act and Qui Tam Quarterly Review.

Whistleblower lawsuits are proving to be highly effective in exposing fraud. Of the10 top FCA Medicaid fraud recoveries to date, the top 5 are whistleblower cases against drug companies.

According to TAF, during FY 2004, between October 1, 2003 and September 30, 2004, the US Department of Justice settled 3 whistleblower cases against drug companies for a total of over $800 million, raising the total recoveries in such cases by nearly 50% to $2.46 billion.

Two of the settlements involved both criminal fines and civil penalties. The recoveries included $290 million in criminal fines, $275 million in civil penalties and damages to the federal government, and nearly $235 million to state governments. All three settlements involved allegations of fraud against Medicaid.

Two of the cases began as lawsuits filed under the FCA by whistleblowers and the third began as a case under the Texas Medicaid Fraud Prevention Act.

The defendant in one case was the nation’s largest drug maker, Pfizer, with annual sales of $30 billion. The conduct at issue concerned a Pfizer subsidiary, the Parke-Davis Division of Warner-Lambert, acquired by Pfizer in 2000.

Drug maker Schering-Plough was the defendant in the other 2 cases.

Government recoveries from Pfizer totaled $430 million, and the two Schering settlements were $345 million and $27 million.

This is the second FCA whistleblower settlement entered into by Pfizer, and the second largest drug maker settlement ever when measured by the combined civil recovery of $430 million and the criminal fine of $240 million.

The Pfizer case broke new legal ground by recovering losses to Medicaid resulting from the illegal off-label promotion of a drug for uses other than those approved as safe and effective.

At the time of the settlement in May 2004, Pfizer's drug, Neurontin, ranked 9th among all drugs sold in the US, with annual sales of $2.7 billion, according to IMS Health, “Leading 20 Products by U.S. Sales, Moving Annual Total, June 2004,” www.imshealth.com

The whistleblower, David Franklin, a former medical liaison for Parke-Davis, who filed the FCA lawsuit, received a $24.6 million settlement, when Warner-Lambert agreed to plead guilty to two felonies to settle charges that it fraudulently promoted Neurontin for a wide variety of unapproved uses.

Among the tactics the DOJ found the company using to achieve its goal of increasing off-label use of Neurontin were the following:

(1) Encouraging sales reps to provide one-on-one sales pitches, or "details," to physicians about off-label uses of Neurontin;

(2) Utilizing medical liaisons, who represented themselves, often falsely, as neutral scientific experts on Neurontin, to promote off-label uses, working in tandem with the sales reps to directly sell Neurontin to physicians for off-label uses;

(3) Paying doctors to allow a sales reps to see patients with the doctor and to participate in discussing the treatment plan;

(4) Paying physicians, through both direct payments, and trips, hotel rooms, dinners and other benefits, to attend meetings termed “consultant” or “advisory” meetings or “speaker bureau trainings” in which doctors received listened to presentations about off-label uses;

(5) Implementing frequent teleconferences in which doctors were paid to speak about Neurontin on off-label topics to other doctors; and

(6) Sponsoring independent "medical education" events on off-label uses where there was actually extensive input from the company on topics, speakers, content, and participants.

"Neurontin was marketed for four broad categories of unapproved use: pain, psychiatric use, monotherapy and dosage," the DOJ stated. In fact, the company promoted the drug for so many unapproved uses, the DOJ said, "some employees referred to the list of these uses as the “snake oil” list."

In the settlement agreement, the company admitted that it aggressively marketed the drug by illicit means for unapproved uses including pain, bipolar disorder, migraines, and drug and alcohol withdrawal.

The prosecutors described the harm that resulted from the off-label scheme as: (1) health care reimbursement programs such as Medicaid paid more in reimbursement; (2) consumers paid for ineffective, experimental use and may have been improperly medicated; (3) improper medication could have resulted where Neurontin was not as effective as another approved drug; and (4) unnecessary exposure of patients to adverse side effects of Neurontin.

The prosecutors said Warner-Lambert turned Neurontin into a blockbuster drug with promotional tactics like paying doctors "honoraria" to listen to sales pitches on the off-label use of the drug and by treating physicians to luxury trips to Florida, Hawaii, and Atlanta for the 1996 Olympics.

According to court documents filed in the case, doctors were paid honoraria to listen to presentations that took place at: “Bus to Yankee Stadium,” “World Yacht Cruise” and “Braves Stadium.”

On one weekend in April 1996, the DOJ discovered that Warner-Lambert had arranged 2 weekend “consultant” meetings, one at the Jupiter Beach Resort in Palm Beach, Florida, and the other at the Ritz-Carlton in Aspen, Colorado. Both were 3 day affairs, for which each attendee received a $250 cash payment, plus airfare, and all other expenses paid at the resort, and the doctors who acted as faculty were also paid between $1,500 and $2,000.

According to the DOJ, the total cost for the Jupiter Beach weekend was approximately $361,000 for about 100 doctors, meaning the price per doctor was about $3,000, and the cost of the Aspen weekend ran about the same.

Documents showed that both meetings included presentations on off-label topics such as “Neurontin: Use as Monotherapy,” and “Reduction of Pain Symptoms During Treatment with Gabapentin,” that were designed to present information to the attendees, rather than to receive information from consultants.

One advisory board was treated to an extravaganza at the 1996 summer Olympics in Atlanta, Georgia. Along with free Olympics tickets valued at $650 each, the company staged an Epilepsy Advisory Meeting, at the Chateau Elan Winery and Resort, in Atlanta.

The brochure for the event describes the resort as: "Chateau Elan has made a name for itself as a fine winery. It is now earning a reputation as a one-of-a-kind resort... Here, you’ll enjoy all the comforts and amenities you’d expect of a fine resort, mellowed by the warm ambiance of a French country inn."

"During your meeting breaks," the brochure says, "you will have the opportunity to play a round at one of three accessible golf courses, swim, play tennis, explore the Georgia hill country by foot or by horseback, or escape to Chateau’s European style spa for a pampering body treatment...."

For this event, records show the company paid all expenses for 18 advisers and their spouses, and each adviser was given $750 in cash for spending. In planning the Olympics advisory board meeting, a company document obtained by the DOJ, referred to the cost of the event as a “$3 million investment.”

Another example of the lavish meetings doctors attended for free, was the Western Advisory Board Meeting, held at the Grand Wailea Resort, Hotel & Spa in Maui, Hawaii in April 2000.

Only one of the attendees resided in Hawaii and the company paid for all of the others to fly to Hawaii for a two night stay at the resort to attend only 3 hours of meetings, all on off-label uses of Neurontin, according to the DOJ.

In planning this meeting, the company targeted doctors whose uses for Neurontin were only off-label and "evidence shows this event was promotional, not an independent, scientific meeting," according to the DOJ's sentencing memorandum.

The DOJ said Parke-Davis held hundreds of meetings where doctors were paid to attend, and paid even more to speak and that Parke-Davis was especially interested in two types of physicians: (1) those who prescribed large amounts of anti-convulsants; and (2) those who had a prominent reputation.

These doctors were often referred to as the “movers and shakers” or “thought leaders” because of their influence, and were recruited as spokespersons on behalf of Neurontin.

Parke-Davis paid key “thought leaders” well who could be counted on to deliver a strongly favorable message on off-label use. At least 20 of these doctors, the DOJ said, were paid more than $50,000 over time for speaking on the company’s behalf. In fact, some received in excess of $250,000.

Corporate documents show, the DOJ says, that the company focused its attention on recruiting doctors from major teaching hospitals to serve as "Neurontin champions."

For example, documents show that Dr Steven Schachter, a professor at Harvard Medical School and a physician at Beth Israel Deaconess Medical Center in Boston received $71,477 between May 1994 and September 1997, and a Dr B.J. Wilder, a former professor of neurology at the University of Florida, was paid more than $300,000 for speeches given between 1994 and 1997. Six other doctors, including some from top medical schools, the DOJ said, received more than $100, 000 each.

The most common forums for speakers were consultant and advisory board meetings, where doctors were gathered to listen to a presentation. Parke-Davis justified holding these meetings, because it entered into pro forma consultant agreements with the physician attendees and doctors were paid anywhere from $250-$2,500 to serve as consultants or advisers.

In one 6-month period alone, the DOJ said, Park-Davis held over 50 meetings and despite being called “consultant” meetings, the actual objective was to provide off-label information to the doctors rather than to receive information from the consultants.

During its investigation, the DOJ discovered that doctors were misled into believing that educational programs they attended were independent programs when they were actually led by the drug maker. For example, prosecutors found a Ward-Lambert relationship with a company known as Physicians World where Warner-Lambert employees transferred to Physicians World to run the company's speakers bureau.

At the same time, a division of Physicians World, known as Professional Post-Graduate Services, purported to be an independent education provider for a program on anticonvulsants for pain, when in fact, Ward-Lambert staff planned and developed the program and thousands of US doctors took the classes.

This program was provided to thousands of doctors all around the country and in each instance, the materials stated that they were created in compliance with ACCME guidelines, which prohibited content control by Parke-Davis as a condition of accreditation, and required disclosure of all financial affiliations.

The materials did not disclose the relationship between Physicians World and Parke-Davis, and did not disclose the financial links between Parke-Davis and each of the faculty members, all of whom were paid consultants, the DOJ said.

For instance, one physician was a regular Neurontin speaker who had received payments of more than $10,000 and yet by the listing of each faculty member, there was an asterisk indicating “no significant financial or other affiliation reported."

"This evidence," the US attorney said, "demonstrates that Parke-Davis knew that these events were unlawful promotional activities."

Another method of promoting face-to-face was the preceptorship, or “shadowing.” This involved paying a doctor to allow a sales rep to follow the doctor through the course of a day seeing patients. In one example, a sales rep did a preceptorship with a neurologist and after they saw a teenage patient, the doctor and the sales rep discussed treatment options.

The sales rep advised the doctor to increase the Neurontin dose and at the same time, taper the patient off other epilepsy medication to reduce side effects, thus resulting in Neurontin being used for monotherapy. According to the sales rep, as recorded in a voice mail sent in to the company obtained by the DOJ: “I really felt I made a difference. I saw the actual prescription generated in front of me... and I certainly felt that me being there, I had some influence on that medical decision.”

Another patient seen was a 65 year old veteran who suffered neuralgia with pain in his limbs. The patient developed blurred vision while on Neurontin; and the sales rep told the doctor that such side effects are mild and transient and so the doctor kept the patient on the drug. In the sales rep’s own words: “I felt like I influenced that particular situation. So again, another prescription was generated for us. Overall, the day went, you know, very well. And we had the immediate impact of two prescriptions written.”

The DOJ said the drug maker decided not to seek an expanded use for Neurontin with the FDA because it would have required solid proof from clinical trials so instead, the company boosted sales through promotional strategies, even for conditions where studies had indicated that Neurontin was not effective.

In his sentencing Memorandum the US Attorney noted: "One of the psychiatric uses for which Neurontin was promoted ... bipolar disorder, was particularly troubling because the Company had very weak evidence of Neurontin's efficacy in treating this condition."

"Indeed," the prosecutor wrote, "in one study ... the placebo was as effective or more effective than was Neurontin."

Moreover, the DOJ found the company paid no attention even when the FDA did refuse to approve an additional use. For instance, Parke-Davis sought approval for use as a monotherapy on September 16, 1996, but because one of 2 clinical trials submitted with the application showed no demonstrable monotherapy efficacy, on August 26, 1997, the FDA rejected the application.

Nonetheless, the DOJ found that Parke-Davis had actively promoted the drug for monotherapy before it applied for approval, and after the FDA rejected its application right through at least 2000, when slides, lecture summaries and audiotapes obtained by the DOJ demonstrate that Parke-Davis continued to promote Neurontin for monotherapy without ever mentioning the fact that the FDA had rejected its application.

Documented examples listed by the DOJ, of statements made after the FDA's non-approval include a marketing event in 1998, where Parke-Davis went so far as to state that Neurontin was “now approved as monotherapy for seizures.”

In his whistleblower lawsuit, Mr Franklin explained how Warner-Lambert had hired two marketing firms to write favorable articles about the unapproved uses of Neurontin and to find doctors willing to sign their names as the authors. The marketing firms, he said, were paid $12,000 for the articles and the doctors were paid $1,000 for signing off as authors.

The off-label scheme proved to be highly successful. By government estimates, citing company documents and independent market research, by 2002, 94% of Neurontin's sales were for off-label use, up from 40% in 1995.

At the time of the settlement in 2004, Vermont Attorney General, William Sorrell, noted that a 30-day supply of Neurontin at a common dose sold for $205.

Under the terms of the settlement agreement, Pfizer agreed to:

(A) plead guilty to inadequately labeling of Neurontin and to introducing Neurontin into interstate commerce for unapproved purposes, which, by virtue of its prior violation of the Food, Drug & Cosmetic Act, constitute felony violations of the Act, and to pay a $240,000,000 criminal fine;

(B) settle its False Claims Act and other civil liabilities and to pay the Government $83,600,000, plus interest, in civil damages for losses suffered by the federally funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

(C) settle its civil liabilities to the 50 states and the District of Columbia in an amount of $68,400,000, plus interest, in civil damages for losses suffered by the state-funded portion of the Medicaid program as a result of off-label promotion of Neurontin;

(D) settle its civil liabilities to the Consumer Protection divisions of 50 states and the District of Columbia state attorney general’s offices in an amount of $38,000,000, plus interest, in civil damages for losses suffered by consumers and to fund a remediation program designed to offset the impact of the improper marketing of Neurontin; and

(E) comply with the terms of an amendment to the corporate compliance program of its parent, Pfizer, which, among other things, proscribes off-label marketing and requires training of employees and audits of its marketing practices.

At the time of the settlement, Pfizer issued a statement that said the illegal practices took place before Pfizer acquired Warner-Lambert in 2000. However, even if true, sales figures reveal that Pfizer was still reaping the benefits of the scheme at the time of the settlement.

For instance, on August 19, 2004, USA Today noted that: "Pfizer's confession that the success of one of its top drugs was built partly on fraud may have been humbling, but it isn't hurting the bottom line. Neurontin sales last quarter rose 32% from a year ago, and 2004 sales should pass last year's $2.7 billion."

"With few exceptions," USA said, "state Medicaid programs pay for Neurontin just as before and so do major insurers."

Pfizer's denials also rang hollow at the time due to the fact that the company's regulatory filings showed the DOJ was also scrutinizing its off-label marketing of the Genotropin growth hormone and a federal grand jury in Maryland was taking testimony from former Pfizer employees about the diabetes drug, Rezulin, that was pulled off the market in 2000 after it was linked to over 60 liver-related deaths.

But as far as fearing the FDA, the drug companies had no fear and apparently for good reason. documents unearthed in litigation reveal that the FDA was well aware of the company's off-label marketing scheme eight years before the settlement. In July, 1996, FDA official, Lesley Frank, wrote to Parke-Davis and said in part:

"Parke-Davis may be promoting Neurontin for ‘off-label’ uses ... in printed promotional materials, in detail or sales presentations to physicians, and through the use of company-solicited physician participation in a series of teleconferences.

"These promotions of Neurontin for off-label uses included, but were not limited to, its use in chronic pain, bipolar disorders, and other psychiatric conditions. As you are aware, Neurontin’s only approved indication was for adjunctive therapy in the treatment of partial seizures with and without secondary generalization in adults with epilepsy."

Documents show that after 11 months, Parke-Davis responded and denied all allegations and the FDA simply accepted the company's denial and the issue was dropped.

As part of the settlement with the DOJ, Warner-Lambert pleaded guilty only to conduct that occurred before August 21, 1996, even though illegal conduct is documented as occurring much later than 1996.

This part of the agreement made it possible for Pfizer to continue to participate in government health care programs despite an August 21, 1996, health care fraud law that would have led to its exclusion.

In addition to financial fraud, the company pleaded guilty to criminal misbranding of the drug in promotional and advertising material claiming that "the drug is safe and effective for uses which have not been approved by the FDA."

Pfizer's settlement with the DOJ did not cover damages for any patients who may have been harmed by Neurontin and those patients are entitled to file personal injury lawsuits.

Pfizer is currently engaged in multi-district litigation (MDL). On October 26, 2004, the Judicial Panel on Multidistrict Litigation consolidated nearly all Neurontin off-label cases in the US District Court for the District of Massachusetts.

The JPML is a panel of seven federal judges chosen by the Chief Justice of the US Supreme Court that decides on the appropriateness of establishing an MDL, and where the MDL should reside. The MDL brings together lawsuits with common claims to determine pretrial matters.

The MDL primarily involves cases of consumers who purchased Neurontin for off-label uses that Pfizer knew showed no efficacy but more lawsuits have been filed on behalf of persons who suffered adverse effects when Neurontin was prescribed for off-label uses. The first Neurontin trial is expected to take place later this year or early 2007.

In 2004, the New York law firm of Finkelstein & Partners filed several lawsuits and announced plans to file many more. At the time, the firm’s senior partner, Andrew Finkelstein, said he had gathered the names of 160 people who committed suicide and 2000 more who attempted suicide while taking Neurontin.

In addition to handling lawsuits, for more than 2 years Mr Finkelstein's law firm has been warning the FDA about patients committing suicide while taking Neurontin and asked the FDA numerous times to add a black box warning to Neurontin's label about the risk of suicide in patients taking the drug. As of October 2005, Mr Finkelstein has been contacted by the relatives of 425 people who committed suicide while on Neurontin.

After a year of inaction by the FDA, on March 21, 2005, Mr Finkelstein wrote a letter to the FDA's Dr Russell Katz and said in part: "Enclosed you will find two hundred fifty eight MedWatch forms ... Each represents a suicide of an American who was on Neurontin when he or she took his or her own life."

Mr Franelstein told Dr Katz the "complete inaction by the FDA to warn an unknowing population that was relying upon the FDA to require warnings for potential adverse events from off-label usage is deplorable."

"Since our conversation of March 31, 2004," he wrote, "my firm has learned of seventy four additional suicides that occurred after that date."

"Many of these suicides likely could have been prevented," he said, "had both the treating physician and unsuspecting families been armed with full knowledge of the risks of suicide that was known to both the FDA and the manufacturer."

Neurontin was recommended for approval by the Neuropharmacolgical Drug Products Division of the FDA in 1992, and according to Mr Finkelstein, at that time, Mr Katz oversaw the FDA’s analysis of the clinical data supplied by the sponsor seeking approval to sell Neurontin.

Mr Finkelstein obtained the FDA’s 1992 analysis of the New Drug Application for Neurontin, and in reviewing the data, he told Dr Katz he found "shocking information."

"During your evaluation of serious adverse events that occurred during original clinical trials," he advised Dr Katz in the letter, "the risk of Neurontin causing suicide was both known and a major concern."

The FDA reviewer from your Division, Mr Finkelstein pointed out, "specifically stated in December, 1992:

"Serious adverse events may limit the drug’s widespread usefulness. Depression, while it may not be an infrequent occurrence in the epileptic population, may become worse and require intervention or lead to suicide, as it has resulted in some suicidal attempts during clinical trials.

"In fact, during the clinical trials ... Neurontin was attributable to four people actually attempting suicide, two more having depression with suicidal ideations and twenty two participants reporting depression so severe it required pharmacologic intervention.

"Additionally," he said, "nineteen of the seventy eight participants who reported depression during the clinical trials had no prior history of depression."

"Clearly," Mr Finkelstein wrote, "the FDA did not approve this drug with any expectation of use beyond the approved indication."

"Even though the FDA knew Neurontin caused depression that may lead to suicide and that Neurontin’s effects were never fully tested on people who suffered from chronic pain, bipolar disorder or other psychiatric conditions," he told Dr Katz, "the FDA acted with no urgency."

Mr Finkelstein reminded Dr Katz of the company's 2004 conviction for fraud in the DOJ case and said: "The complicity by the FDA in Parke-Davis’s scheme to defraud physicians and consumers is more egregious than the underlying fraud itself."

"The governmental body charged with the responsibility of protecting the health and safety of Americans has done absolutely nothing to prevent entirely preventable deaths," he continued. "Such complicity borders on criminality," he added.

On October 14, 2005, Mr Finkelstein wrote another letter to Dr Katz and summarized the efforts by his law firm to get the FDA to warn people about the risk of suicide over 2 years and began by saying: "Due to the continued public danger facing a substantial class of prescription drug users, I am compelled to write to you regarding the FDA’s ineffective oversight related to appropriate warnings for Neurontin."

"On March 31, 2004," he reminded Mr Katz, "you were advised of thousands of serious psychiatric adverse events that occurred while Americans were taking Neurontin."

"At that time," he said, "the FDA recognized a potential imminent health crisis existed, yet nothing was done to require enhanced warning labels."

"Due to the FDA’s inaction," Mr Finkelstein continued, "my firm filed a citizen’s petition on May 17, 2004 with the hope that the FDA would investigate the potential for Neurontin contributing to self-injurious behavior."

In addition to the black box warning, the Petition asked that a Dear Doctor letter be sent to health care providers cautioning them to be on alert for increased depression in patients taking Neurontin.

"The FDA took six (6) months to respond," Mr Finkelstein told Dr Katz, "and stated no decision had been reached and more time was needed to investigate."

"All investigations, if any," he wrote, "have been couched in secrecy and not open to public scrutiny while the same serious health crisis continues."

"Regrettably," the letter concluded, "this is an example of why the American people have lost faith in the FDA's ability to protect them from unsafe drugs."

"While your real motivations are not known at this time," he advised, "it is clear your interest is not in discovering the truth or protecting the health and safety of the American people."

Author, Dr Marcia Angell, also recognizes the massive influence that drug companies exert over the FDA, Congress, and doctors, and how this influence is harming Americans.

After she resigned as interim editor-in-chief of the New England Journal of Medicine in 2000, Dr Angell decided to write a book about the biases in clinical trials but in doing her research, says she discovered that "all roads led back to drug companies."

Her book, "The Truth about Drug Companies: How They Deceive Us and What to Do About It," provides an indepth account of the entanglements between Big Pharma and every area of the health care field including government agencies, doctors, medical journals, Congress, and universities, as well as how these relationships harm the public.

During an August 18, 2004 interview with Business Week Online, Dr Angell told reporter Amy Tsao, that she saves her harshest criticism for her fellow physicians and the medical profession as a whole. "After all," she said, "the industry is in business to make money, but that isn't what doctors and medical schools should be doing."

"They don't have to be in bed with the drug companies," she said. "But they are."

Dr Angell explained how drug companies finance most of the continuing education seminars for doctors, as well as meetings of professional societies, and how they lavish all kinds of gifts on doctors including dinners in fancy restaurants and trips to exotic resorts.

"And they provide speakers and meals for interns and residents in teaching hospitals," she told Business Week.

All of which, she says, adds to the high cost of prescription drugs. "The profession should acknowledge that this is all a form of marketing," she said, "which adds to the prices of prescription drugs."

"Doctors should take responsibility for their own education and buy their own meals," Dr Angell said.

The most perverse examples of off-label marketing involve drugging children. In 2001, Dr Stefan Kruszewski, a Harvard-trained psychiatrist working for the Pennsylvania Department of Public Welfare, began investigating the widespread off-label use of psychotropic drugs and found cases of what he calls "horrendous polypharmacy."

The first disturbing pattern he noticed was that an overwhelming number of patients were being prescribed Neurontin to treat conditions like anxiety, depression, psychosis and impotence. "The FDA had not approved using that drug for mental illnesses," he noted.

Dr Kruszewski found patients on as many as 5 medications at the same time, something he says is "hard to justify."

One of the most disturbing cases he found was a mentally retarded 15-year-old girl who was supposedly being treated for being defiance and sexual promiscuity.

Dr Kruszewski discovered that the girl was on 11 different drugs, including five anti-psychotics, even though she had no diagnosis of a psychiatric disorder. "She was so overmedicated," he said, "that she had trouble getting out of bed or standing up by herself."

"Although physicians can choose to prescribe virtually any medication for any condition," he explains, "the promotion of Neurontin remains the subject of intense scrutiny since Pfizer’s off-label promotion was previously the subject of civil and criminal penalties by the US Department of Justice."

"In my opinion as a clinical and academic psychiatrist," Dr Kruszewski says, "Neurontin's link to severe emotional and cognitive disturbances, including mania, depression, suicide and memory loss, continues to be the most egregious aspect of Neurontin's promotion."

"It causes suffering, morbidity and death," he noted, "problems that Pfizer and the current generic makers of Neurontin have failed to make known to consumers and potential victims,“ he said.

Attorney, Zena Crenshaw, Executive Director for National Judicial Conduct and Disability Law Project, agrees that off-label prescribing is a major problem and says any drug manufacturer even suspected of such "market expansion" should be called to the carpet.

"The idea of salesmen hyping drugs to doctors," she says, "for conditions beyond those for which the products were approved is unnerving."

"Considering that even dire prescription drug warnings probably reflect a minimum level of adequate care," she warns, "prescribing drugs off-label should seem universally hazardous."

When Dr Kruszewski warned his superiors that off-label use of the drugs was not only harmful to patients but could also expose the state to liability from lawsuits by injured patients, he was told "it's none of your business."

When Dr Kruszewski continued to voice his concerns he was told to quit digging up dirt and when he refused to let go he was fired. He has since filed a whistleblower lawsuit against state officials and 6 drug companies including Pfizer alleging among other things, that the defendants: "through the use of political friendships, money and other emoluments, effectively achieved a level of influence with Pennsylvania's state government that allowed them to abuse state finances and state citizens with impunity."

The Government Accountability Project (GAP) is a nonprofit public interest group that promotes government and corporate accountability by advancing occupational free speech, defending whistleblowers, and empowering citizen activists.

The GAP is assisting Dr Kruszewski with his lawsuit against the drug giants. Mark Cohen, an attorney with the GAP, describes whistleblowers like Dr Kruszewski as "regular people who have been pushed beyond the limits their consciences can bear."

"They feel a moral duty to set the situation right," he says.

"They can no longer "go along to get along" in the face of wrongdoing," he explains. "And they can't simply opt out -- take another job and keep their lips sealed -- and ignore the wrongdoing," he says.

"But if "right" and "wrong" mean anything," Mr Cohen says, "they feel they don't really have a choice but to blow the whistle."

"Of course, they do so at great personal risk," he says he recognizes. "Speaking up puts their current job in jeopardy and it threatens to brand them as trouble-makers with other employers."

In fact, people who do expose the highly profitable Medicaid fraud or off-label practices often find themselves fired like Dr Kruszewski. However, the False Claims Act now provides a cause of action for whistleblowers with remedies that include reinstatement to their job, 3 times the wages lost, compensatory damages, and attorney’s fees.

For more information for injured parties go to Lawyers and Settlements.com

(Evelyn Pringle is a columnist for OpEd News and an investigative journalist focused on exposing corruption in government and corporate America)"