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.

The Analysis

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

Industry

Failure Percentage

Result

Aviation

0.1%

2 unsafe landings per day at O'Hare International

US Postal Service

16,000 pieces of lost mail per hour

Banking

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'...

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:

Present Value

Annualized

Regulatory Costs

$53.1 million

$5.1 million

Anticipated Hospital Costs

$7,204.3 million

$680 million

Social Benefits

$41,381.3 million

$3,906.1 million

Potential Hospital Efficiencies

$4,783.3 million to $7,643 million

$451.5 million to $721.5 million

Net Benefits

$34,123.9 million

$3,221 million

Bar Coding: Technology Whose Time has Long Passed and Come Again

A Summary

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 ™ 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…