Patient care and recovery statistics demonstrate that the United States has a medical care system with which Americans are less satisfied than other citizens in developed countries. There are many reasons for this: correlation between health and socioeconomic status; non-universality; federal government is not involved in medical planning although it purchases a large percentage of the 14% health care GNP; lobbying and special interest group interference; and political opposition to restraining medical developments.
Life expectancy for men is valuated at 71.8 years and for women, 78.8 years. From a natural lifespan perspective, this is one of the lowest survival rates of any developed country in the world. Preventable medical errors must then be factored in for the 44 to 98,000 people who die each year and the lowered survival rate is forced even lower — and is preventable.
Medical errors account for nearly $29 billion in annual revenue, making this the eighth leading cause of death in the U.S. Medical spending has escalated exponentially against the possibility of medical malpractice litigation. Despite these grim facts, the FDA consistently reports that the problems are systemic — i.e., mechanical or not human in origin — and not the medical care provider’s fault or responsibility.
In a historically closed group of professionals, Doctors rarely — if ever — speak out against current medical practice, one another, or the agencies through which they network for supplies and support.
Dr. Lucian L. Leape changed that in 1994 by submitting his scathing dissertation, “Error in Medicine,” to the Journal of the American Medical Association.
Discussing iatrogenic injury — defined as “induced by a physician’s words or therapy” — Dr. Leape reported an iatrogenic injury rate of 20% and mortality rate of 20% in 1964. In 1981, this figure rose to 36% and 25% respectively, with 50% of the injuries involving “adverse drug reactions and applications.” By 1991, a rough figure of 1,189,576 — or 14% die each year as the result of iatrogenic injuries; with 64% of acute heart insult preventable and directly resulting from medication reactions.
Dr. Leape further went on to report that iatrogenic injury is underreported and often dismissed as irrelevant to the patient’s reason for treatment. When a specific area of error is sought out, however, the numbers are “distressingly high.” Citing numerous autopsy investigations, rates for iatrogenic mortality rose as high as 35 — 40% and one intensive care unit study reported an average of 1.7 errors per day per patient with approximately 29% “potentially serious or fatal.”
To graphically demonstrate the effects of a 1% error rate — often cited as very low and nominally important by defensive medical posturing — a table has been prepared for purposes of comparison in un-like industry.
Iatrogenic Study Comparison
2 unsafe landings per day at O’Hare International
US Postal Service
16,000 pieces of lost mail per hour
32,000 bank checks deducted from wrong accounts per business hour
From this modest comparison, it can be clearly seen that the medical industry’s propensity for viewing medical errors as “isolated and unusual incidents” is dangerously inaccurate.
Updating his statistics, Dr. Leape reported on a nationwide study of iatrogenesis conducted by the National Patient Safety Foundation (NPSF), a group sponsored by the American Medical Association (AMA). The 1997 statistics — based on a 14% mortality ratio — report medical error in hospital settings are now as high as 3 million, or 420,000 inpatient deaths, and costing in excess of $200 billion per year. Nationally, over 100 million Americans report being affected by medical iatrogenesis at some point in their illnesses.
One critical reason for such iatrogenic errors is the manner in which medical professionals are trained in the United States. Medical professionals — particularly Doctors — are trained that mistakes are unacceptable measures of failure and are therefore viewed as character flaws and negligence. Medical schools further instill a sense of “savior’ and “godlike presence’ in students, thereby circumventing a healthy ego and self-accountability, attempting thereby to morph error-prone human nature into machine-like perfection.
When errors occur, none are taught the proper way to handle them; medical schools disavow their existence and fail to prepare the human for inevitable machine failures. This medical ‘infallibility model’ breeds dishonesty and a visceral urge to ‘cover up’ mistakes rather than own up to them and correct them in the best possible manner.
Problematic to the unique individual attempting to stand accountable and desirous of correcting mistakes in a timely and professional manner is the lack of peer support, error handling processes, error sharing among professionals, or emotional support by higher positioned professionals. Blame is inevitably laid upon the fallible human while the ‘invented machine’ is often disassembled and dismantled for having made the error.
Even with Dr. Leape’s bravely open-discussion and revelations of medical inside situations and previously ‘secretive’ iatrogenic mortal mistakes, the effect was not the desired one; medical error continues to soar.
In response to this and other medical reports / surveys, the Federal Drug Administration (FDA) devised a four-tiered approach when attempting to reduce medical errors: national focus on patient safety; mandatory and voluntary reporting systems designed to assist medical professionals in recognizing and learning from mistakes; raise national standards and expectations through professional groups, oversight, and group purchasers; and implement safety practices at the delivery level.
In 1998, then President Clinton setup the Advisory Commission on Consumer Protection and Quality in the Health Care Industry, the Quality Interagency Coordination Task Force (QulC), the National Forum for Health Care Quality Measurement and Reporting, the Advisory Commission on Consumer Protection and Quality in the Health Care Industry, and the Agency for Healthcare Quality and Research (AHRQ). All very well-intentioned and impressive sounding programs, none of these initiatives have quelled the surging tide of medical error and malpractice.
The FDA studied statistics and reports from the Center for Disease Control (CDC), the Veteran’s Administration (VA), the Agency for Healthcare Research and Quality (AHRQ), and its own agency to determine practical and measurable means by which to control iatrogenesis and other medical mistakes.
The Drug-Related Morbidity Solution
The FDA — in response to high levels of public pressure and as a result of the orthogonal studies conducted over several years, began feasibility study and development of the “Bar Code Label for Human Drug Products and Blood” Rule.
The proposed solution involves several mandates and operational specifications, to include:
saving lives through properly administered drugs and biological products;
requiring manufacturers and other handlers to affix barcodes to drug packaging and blood product packaging;
Require hospitals to employ the Medication Administrations Recording (MAR) Systems which use bar code scanning technology;
Purchase of a Bar Code dispensing unit; and Compliance within 3 years of the final ruling.
Significant to this ruling is the fact that hospitals and other medical structures will not be required to equip their facilities with a bar coding system; this falls to those who manufacture, package, repackage, and dispense such products. Package dosing and drug samples will be excluded from the ruling.
The following table presents the FDA’s anticipated cost structure for the medical bar code implementation:
Anticipated Hospital Costs
Potential Hospital Efficiencies
$4,783.3 million to $7,643 million
$451.5 million to $721.5 million
Bar Coding: Technology Whose Time has Long Passed and Come Again
For many years now, medical professionals have used bar coded labels for medical supplies and floor-issued products. This has a two-fold objective — to minimize billing errors and maximize institutional profits.
For example, when a patient requires a number of supplies at bedside for dressing changes, sticky labels are attached to each individual product. The nurse, Doctor, or ancillary medical care provider removes the label from the package and affixes it to the patient’s chart. Upon patient release, the hospital or other medical facility has a trackable record of all supplies used by this individual during his stay.
Considering the astronomical costs for medical care and supplies today, this has proven to be an efficient way to ensure fewer patient and insurance overbillings and affords an accounting system whereby the hospital may provide documentation and a reasonable semblance of accountability for the amount of charges issued to the patient. Recent studies showed over billing on more than 22% of hospital itemization invoices; this practice has quelled some of this error.
From a strictly pragmatic approach, then, why have hospitals and pharmaceutical companies not bar coded biological supplies?
There are several reasons for this avoidance. Medicine has a very low markup potential for medical facilities providing administration and monitoring. Supplies have no ceiling or controls to limit the costs; for example, a simple Tylenol â„¢ tablet has been reported as costing $3.55 cents each when administered through the hospital’s pharmacy; band-aids have been quoted as costing over $2.00 per unit and so on. No agency regulates how much a facility can charge for these supplies. Return on Investment (ROI) is key to a medical facility’s ability to operate at a profit and — despite the non-philanthropic realities — hospitals are businesses and often privately-held ones, at that. Bottom line is often not about lives saved, but dollars earned.
Another reason for product bar coding and not pharmaceutical is drug control and reporting. Sadly, many pharmacists and medical providers abuse the drug supply in their facility and — unless a controlled and triplicate-issue drug — many Schedule II and III drugs find themselves in individual pockets for non-prescribed use. If the federal government is able to track such products with more efficiency, drug use and misuse would be exposed to the harsh light of public and political pressures, even criminal consequences.
Cost for implementation is another reason for the lag in bar coding for life-saving drug administration. Hospitals — again in business for profit — are reluctant to revamp entire processes unless forced to do so. The FDA mandate with biological product bar coding impacts the manufacturer, distributor, and repackager’s bottom line, not the hospitals. Without Federal intervention, however, hospitals would have to front the costs; something they are extremely unwilling to do.
A final reason — although certainly not an extensive listing — for this avoidance is the morphology of the medical profession over the last several years. The use of computing technology in patient care has only been in place — and only in the larger hospitals and clinics — for the last 10 years; resistance to change is strong in these settings. Part of this resistance comes from the way medical schools train students in process, another from human tendencies to resist change at every opportunity. The concept of mandatory training — always scheduled for off-duty hours — is anathema to many nurses and doctors.
Early Compliant Hospitals
On the upside of the requirement to change, many hospitals have seen the value of bar coding when saving lives.
The Licking Memorial Hospital system in Ohio employs a hand-held bar code scanning system. This involves the process from the moment a patient enters the facility; the patient bracelet, charts, and so on. This system “improves the medication process by catching errors that were not previously recorded, such as giving medication doses too close together,” says Debbie Young, the hospital’s vice president of patient care and a former nurse.
Although only in place since June, 2004, it is now used to administer 95% of all medications and the hospital plans to use it in full implementation before the FDA ruling mandates use in 2007.
According to Health Leader’s Magazine
, “Only about five percent of U.S. hospitals now routinely use such systems, according to industry consultants.” The article further explains that pioneering hospitals — those who have voluntarily adopted bar coding technology — are reporting in excess of 85% success rates in avoiding medication errors.
With FDA mandates, hospitals will be forced to comply to bar-coding requirements by 2007. With costs in the bar coding industry steadily falling, hospitals may be pleasantly surprised at the relatively low investment for the assuredly high return.
For example, when a patient is given the wrong medication, the results can be simple to correct and manage or they can be deadly. According to Steve Rough, director of pharmacy at the University of Wisconsin Hospital and Clinics in Madison — currently involved in installing its own, in-house bar-coding system, the average cost to a hospital for medication errors, per patient is approximately $4,600.00 in follow-up care. He further reports, “If you avoid 100 errors, that’s a $460,000 ROI for bar coding.” Not a bad ROI when hospital administrations look at the output vs. income.
All the talk of cost, change, learning curves, and so on doesn’t factor in the cost of lost lives. In the 1999 issue of the Institute of Medicine of the National Academies, a report titled To Err is Human: Building a Safer Health System “lays out a comprehensive strategy by which government, health care providers, industry, and consumers can reduce preventable medical errors. Concluding that the know-how already exists to prevent many of these mistakes, the report sets as a minimum goal a 50% reduction in errors over the next five years.”
In order to meet this goal, the committee seeks a balance between regulatory and fiscally-based processes, clearly delineating between professionals and organizational entities. Arguably, then, reform which only affects the margins of society is scant relief for the millions of people who die every decade from medical misjudgment and error or systemic fault.
Lives are lost every day; some to avoidable causations, others to the unavoidable. An overall attitude found in the modern American patient is one of implicit trust in anyone who bears a medical title. While a certain amount of trust must be present for a symbiotic and successful outcome, people make mistakes.
When a medical practitioner injects or introduces chemicals into the human body, they must have a working knowledge of a plethora of details: body weight, dosage, intended effects, potential side-effects, interactivity among other drugs, and so on. The weight of such responsibility can be enormous. This is measured in the high rate of suicides among medical professionals.
Now, factor in the general fear of illness and death by the average patient. Unwilling or unable to be an active partner in their own care plan, the medical professional must make all choices for them during their stay; diet, exercise, schedules, care objectives, results-orientation, and so on. They must also factor in the holistic factors such as family dynamics, discharge conditions, and so on.l
Enter human error. The medical professional has been on call for 36 hours without rest, dealing with a wide span of medical conditions and demands. Despite the old edict to ‘check the label three times before checking the patient’s wristband, then check that label again’, people fail to keep security measures in the forefront with impenetrable consistency. A non-diabetic gets a dose of insulin and goes into shock, a patient with severe medicine-related allergies is given a shot of the very medication which causes the distress. Chaos reigns. Antidotal measures are put into place as soon as the problem is recognized, but often, that time comes too late. The patient dies and the staff goes into mourning and a state of nervous fear: who will be held accountable? Who will be fired over the incident? Will someone lose a hard earned license? The grief over the death is palpable — very few people entering medicine have no empathy for humans — and the condition on the floor steadily deteriorates.
We have looked at how the medical error affects the staff and patient, but what about other patients, families, businesses, and communities? The ripple effect is not seen only in business. The patients on the same floor feel the impact in the altered quality of care, patients on other floors hear the news through the ‘grapevine’ and not always accurately, the deceased family is shocked into a premature state of grief, lawyers lay in wait for such litigations, businesses lose key employees, the local and national economy feels the sting of loss, communities lose leaders, followers, workers, and friends. It is easy to see that one misjudgment often has far-reaching effects.
Bar coding; a simple solution to a huge problem; a process which will save lives, promote longevity and quality of life, avoid legal actions, financial losses, reputation and licensure losses, and so much more.
The band-aids have known this was the right way to go for years.
Brennan, T.A., Leape, L.L., Laird, N.M. et al. (1991). Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J. Med, 324(6), 370-6.
Centers for Disease Control and Prevention. CDC antimicrobial resistance and antibiotic resistance — general information. Retrieved December 11, 2004, from Center for Disease Control database.
Fourth Decennial International Conference on Nosocomial and Healthcare-Associated Infections. (2000). Morbidity and Mortality Weekly Report, 49(7), 138.
HCUPnet, Healthcare Cost and Utilization Project. Agency for Healthcare Research and Quality, Rockville, MD. Accessed December 11, 2004 .
Leape, L.L. (1994). Error in medicine. JAMA, 272(23), 1851-7.
Lazarou J, & Pomeranz B.H. (1998). Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA . 15; 279(15), 1200-5.
McLean, V.A. (1997, October 9). Nationwide poll on patient safety: 100 million Americans see medical mistakes directly touching them. McLean, VA, National Patient Safety Foundation, p. B7.
Rabin R. ( 2003). Caution about overuse of antibiotics. Newsday.
Starfield, B. (2000). Is U.S. health really the best in the world? JAMA, 284(4), 483-5.
Starfield, B. (2000). Deficiencies in U.S. medical care. JAMA, 284(17), 2184-5.
The Society of Actuaries Health Benefit Systems Practice Advancement Committee. (2003). The Troubled Healthcare System in the U.S. Accessed December 11, 2004.
Thomas, E.J., Studdert, D.M., Burstin, H.R., et al. (2000). Incidence and types of adverse events and negligent care in Utah and Colorado. Med Care, 38(3), 261-71.
Thomas, E.J., Studdert, D.M., Newhouse, J.P., et al. (1999). Costs of medical injuries in Utah and Colorado. Inquiry, 36(3), 255-64.
U.S. National Center for Health Statistics. (2003). National Vital Statistics Report, 51;5.
Weinstein, R.A. (1998). Nosocomial Infection Update. Emerg Infect Dis, 4(3), 416-20.
Additional reviewed resources
â€¢ Food & Drug Administration: www.fda.gov
â€¢ Center for Drug Evaluation & Research:
â€¢ FDA Proposes Bar Codes for Drugs, Blood: www.fda.gov/oc/initiatives/barcode-sadr/
â€¢ Code of Federal Regulations:
â€¢ Uniform Code Council:
â€¢ Health Industry Business Communications Council: www.hibcc.org
â€¢ ISO Automatic identification and data capture techniques (JTC1/SC31) www.iso.ch/iso/en/stdsdevelopment/tc/tclist/TechnicalCommitteeStandardsListPage.TechnicalCommitteeStandardsList?COMMID=
Courtesy of the FHIMSS
Joch, Alan, Raising the Bar. Health Leaders Magazine, July 2003.
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