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Iatrogenic Illness: A Primer for Nurses.

Iatrogenic illness is a term that is used frequently but not clearly understood. This overview of diseases incurred as a consequence of medical treatment explores evolving definitions and the epidemiology of these problems. In addition, a number of strategies to reduce the incidence of these illnesses and the implications of this problem for nurses are presented.

Iatrogenic illness (II) is a familiar term that most nurses have difficulty defining with precision. Because its meaning has evolved appreciably over time and is still somewhat vague, understanding the evolution, epidemiology, and effects of II is a significant priority for nurses. This is especially true given recent nationwide publicity about nursing errors and their negative consequences for patients and families.

The term "iatrogenic illness" was first coined by Bleuler in his 1924 Textbook of Psychiatry (see Bleuler, 1936). At that time he used it to refer to a patient's psychological distress brought on by a physician's incorrect diagnosis. In Bleuler's scenario, the poor patient is literally "worried sick" by an early and incorrect dire prognosis. In the years following World War II, the use of the term became more widespread and its meaning broadened. As the pace of medical progress accelerated, increasing numbers of diagnostic and therapeutic tools were added to the therapeutic armamentarium. However, medicine's growing sophistication and complexity also opened the door to increased numbers of errors and unanticipated sequaele. One reaction to the mounting numbers of medically induced ills was simply to shrug them off as the necessary price of progress. Authors referred to iatrogenic ills as the price paid for medical progress (Barr, 1956; Moser, 1956). During the 1950s, II was implicitly taken to refer to recently introduced therapies, and there was the assumption that "tried and true" therapies, properly administered, were unlikely to cause harm.

In the early 1960s, the definition of iatrogenic disease began to broaden appreciably. "Tried and true" as well as new therapies, and minor as well as major harms, were also gradually subsumed under the iatrogenic heading. However, by the mid-`60s, the definition of the term widened to increase not only the negative sequelae of sound and sanctioned treatment, but complications resulting due to faulty or contraindicated care (Sharpe & Faden, 1998). In the `70s and `80s, the increased emphasis on patients' rights and the necessity for informed consent reinforced the trend to include all preventable adverse events (AEs) as iatrogenic illnesses.

Current reference sources define Il as adverse mental or physical conditions induced as a result of treatment (Thomas, 1997) or caused by exposure to the environment of a health care facility, "including fears instilled in patients by remarks or questions of examining physicians" (Anderson, Anderson, & Glanze, 1998, p. 783). This latter definition obviously includes all nosocomial illnesses. It may also be noted that although the root iatro literally means physician, the term has long since broadened to include problems generated by any health care provider, including nurses. Thus, while the term iatrogenic illness still retains a certain degree of elasticity, current consensus seems to support a definition that includes a very wide range of AEs from mild to fatal, often implying that many of them are preventable.

History and Epidemiology

Although the term iatrogenic might not have been coined until 1924, awareness that attempts to heal can sometimes have untoward consequences goes back almost to the dawn of history. The Code of Hammurabi, dating back to the middle of the second millennium B.C., refers to penalties for physicians whose attempts to cure actually do harm. In The Odyssey, Homer referred to the baneful effects of some drugs. Hippocrates, the Greek father of medicine, evidenced concern about the possibility of physicians harming their patients when trying to help them. Similar concerns were expressed by commentators from the medieval Islamic world to those of colonial America. Often the language used by these critics of medical practice, from Pliny the Elder to Thomas Jefferson, was less than tactful and etched in acid.

Unfortunately, although the criticism may have been stinging, statistics on the extent of iatrogenic ills are almost entirely lacking before the 19th century. Of course, the state of the healing arts and a plethora of anecdotal evidence might allow us to infer that a great many treatments turned out to be counterproductive -- all too often to the point of relieving patients of the cares of this world.

Even for the 19th century, inferential statistics must be used to estimate the extent of the problem. Hospitals, already with very poor reputations, were not anxious to gather and publish statistics that would only serve to place them in an even worse light. In the interest of protecting the profession's reputation, The American Medical Association, founded in 1847, urged upon its members what amounted to a code of confidentiality regarding any incompetence or deficiency on the part of colleagues. As late as the early years of the 20th century, there was a great reluctance on the part of the medical community to gather specific statistical information that could prove embarrassing. Although the medical community might have been understandably reluctant to engage in self-criticism, injured patients and their lawyers grew increasing willing to expose such cases to public view in the courts.

Needless to say, the aspect of II of primary interest to the law concerned malpractice. This was usually defined as departure from the generally accepted professional standards of treatment. In the early 19th century such a definition created a good deal of confusion, since at the time there were various schools of medicine whose approaches to treatment differed sharply from one another. In addition, there were few suits filed when death resulted from treatment, because in such cases it was almost impossible to prove malpractice, the evidence having been buried with the patient.

Taking the incidence of malpractice suits as an indication of the extent of adverse events must be done with some major reservations. Not all those who suffered medical harms filed suits; and no doubt some who filed suits had suffered no real harm. Furthermore, the number of suits filed may be more reflective of changing public attitudes concerning suing for malpractice than of the increasing incidence of adverse events (De Ville, 1990).

However, even with all these caveats, the statistics on the rising tide of malpractice cases seem to indicate that medical harms constituted a serious problem in antebellum America. It was also a problem that evidenced no sign of lessening as medical progress accelerated from the middle of the 19th century to the middle of the 20th. Indeed, during the first half of the 20th century the incidence of such cases increased 50% faster than the population as a whole (Sandor, 1957). Worse yet, in just 2 decades from the 1950s to the 1970s the number of claims per physician per year multiplied tenfold; and from the '70s to the '90s it doubled again (Sharpe & Faden, 1998). Apparently, perceived errors is a long-standing, widespread problem that has shown little sign of fading away with the march of medical progress.

Turning from a very qualified reliance on litigation statistics to more recent investigations, a number of analytical problems hinder determining the general extent of II. Although there have been scores of such studies going back to the 1950s, they differ widely on how IIs were defined and measured and the tools employed in the research. An important variable in many of these studies was the subjective opinions of the researchers as to what constituted a case of II. Not surprisingly, the character of the populations studied also varied quite dramatically, ranging from ICU admissions to ED admissions and from an elderly population at a VA hospital to neonatal units.

Although some studies were retrospective, most were prospective. The sizes of the populations studied were often impressive, usually in the hundreds or thousands, and in several cases ranging into the hundreds of thousands. Some studies included the entire populations of various hospitals and were concerned with a broad range of AEs; other researchers narrowed their studies to such groups as ICU or ED admissions. Some investigations were limited to adverse drug events (ADEs), while others concentrated on very specific problems, such as iatrogenic anemia or ulnar nerve injury. Extensive, descriptive lists of such studies can be found in the Appendix of Sharpe and Faden (1998) and in Appendix C of Kohn, Corrigan, and Donaldson (1999). It might also be noted that interest in iatrogenic ills has not been limited to the United States. Revealing studies have taken place in a number of other countries, such as Australia, Denmark, France, Germany, Italy, Spain, and Russia. Although there has been great diversity in the character of these studies, it is still possible to make several general observations about the epidemiology of IIs.

A significant percentage of medical problems are of an iatrogenic character. It is estimated that they account for 2% to 10% of outpatient consultations and from 6% to 12% of hospital admissions. Estimates of how many hospitalized patients can expect to contract a nosocomial, II range from 2% to 36%, depending on the causes and character of the hospitalization (Brennan et al., 1991; Darchy, Le Mere, Figueredo, Bavoux, & Domart, 1999; Sharpe & Faden, 1998;). Kohn et al. (1999), in their report issued by the Institute of Medicine's Committee on the Quality of Health Care in America, estimate that the number of annual deaths in America due to medical errors ranges from 44,000 to 98,000. They place the total cost of such errors at between $37.6 billion and $50 billion a year.

Adverse drug events seem to be the leading form of II. The vast Harvard Medical Practice Study conducted by Brennan et al. (1991) found that ADEs were the most common form of iatrogenic disease (ID) (the most current term for II), among hospitalized patients, with 19% of the total. This same study ranked wound infection (14%) as the second most common ID. When analyzing the character of the IDs that are responsible for hospital admissions, ADEs again played a prominent role (Hallas, Haghfelt, Gram, Grodum, & Damsbo, 1990; Lakshmanan, Hershey, & Breslau, 1986; Stambouly & Pollack, 1990). Of course, it is not surprising that since medication is the most common form of medical intervention, it is also the most frequent cause of ID. The exhaustive Institute of Medicine study confirms this dubious distinction (Kohn et al., 1999).

Iatrogenic complications are life threatening in 10% to 26% of cases (Darchy et al., 1999). The incidence of death caused by IDs naturally varied dramatically depending on the population studied. Emergency department and ICU admissions with IDs experienced relatively high mortality rates; however, the Harvard Medical Practice Study that surveyed many hospitals and a broad range of services concluded that 13.6% of iatrogenic ills led to death.

Not surprisingly, two typically vulnerable groups are particularly at risk from IIs: the elderly and children. While Jahnigen (1982), Colt and Schapiro (1989), and Darchy et al. (1999) chronicle the risks run by seniors, the IOM study highlights the fact that children are also prime candidates for adverse drug events. The 23 studies of underdiagnosis in elderly people provided by Gorbien et al. (1992) are especially disturbing.

There is strong indication that 25% to 50% of IIs were preventable (Bates et al., 1995; Bigby et al., 1987; Sharpe & Faden, 1998). These preventable harms were attributable to all manner of individual errors and system failures. Finally, despite many efforts to address the problem, the incidence of II (with rare exception) has not notably declined in recent years. For example, one study noted a more than eightfold increase in outpatient deaths due to medication errors between 1983 and 1993 (Phillips, Christenfeld, & Glynn, 1998). Darchy and colleagues (1999) concluded at the end of their study of admissions to ICUs in France that, "despite 25 years of experience with high-technology medicine, ID still has a negative impact on the health and resources of society" (p. 71).

Attempts to Address the Problem

The presence of II is so widespread and its character so diverse that efforts to reduce its prevalence are necessarily diffuse and multidimensional. The sources of iatrogenic diseases are almost legion, ranging from medications to surgical procedures, diagnostic tests to therapeutic regimens, and human errors to system failures. Iatrogenic disease can be likened to a pervasive plague circulating beneath the surface of modern health care. At any time and anywhere it may manifest itself to blight the lives of unsuspecting patients and caregivers.

Despite the difficulties involved, numerous efforts have been undertaken to reduce the threat posed by this plague. Since it is widely acknowledged that a substantial number of these medical harms are preventable, various measures have been recommended to reduce their prevalence. However, these suggestions are often of a character that makes their implementation a major challenge, given the priorities and traditional mindsets that often pervade today's health care delivery system. "To Err is Human: Building a Better Health System," the 1999 report issued by the Institute of Medicine, examines a broad range of approaches to this problem. Perhaps the most important of its recommendations is a call for creating a national Center for Patient Safety through which the federal government might bring some order out of the well-intentioned chaos that presently marks all the diverse efforts to reduce medical harm. Studies by Bogner (1994) and Sharpe and Faden (1998) are also replete with insightful suggestions on how to confront the problem.

It has been suggested that the first step in curtailing II is the continued development of active surveillance and monitoring programs (Sharpe & Faden, 1998). These would be designed not to stigmatize individuals, but rather to identify the extent, character, and etiology of medical harms in a given population. This approach has already met with some success in addressing nosocomial infections (Haley, 1992). The Center for Disease Control's (CDC) National Nosocomial Infections Surveillance system and the guidelines it publishes are valuable weapons in the war against IDs. Even at that, the CDC still estimates that nosocomial ills continue to cost the nation billions of dollars a year, as well as untold human suffering.

In addition, there is a growing array of government, professional, and private agencies that have joined in this effort. However, as the IOM report states, "Although existing efforts to improve patient safety are valuable, they are inadequate" (Kohn et al., 1999, p. 59). It should also be noted that implementing such programs for outpatients will be even more challenging than for inpatients.

A second approach calls for turning to computer technology as an important weapon in the fight against IDs. Computerized patient records can make necessary information readily available to the increasing numbers of different providers in various places who are involved in the care of a single patient. Quality of patient care and treatment outcomes can also be more easily tracked and analyzed using computerized databases. In addition, computerizing the pharmacopeia, from writing prescriptions to filling them, can build into the system safeguards not previously available (Raschke et al., 1998).

A third initiative calls for borrowing from the business world the idea of continuous quality improvement (CQI). This form of monitoring focuses on the system as a whole, rather than on the performance of individuals. However, it also calls for a major shift in the culture of health care providers. Its success depends on the frank admission of errors and their open discussion of the best way to improve patient outcomes. As Leape (1994) pointed out, "the most important reason physicians and nurses have not developed more effective methods of error prevention is that they have a great deal of difficulty in dealing with human error when it does occur. The reasons are to be found in the culture of medical practice" (p. 2). The effectiveness of any monitoring system is likely to be reduced by under-reporting occasioned by fear of personal liability. The more litigation protectors are put into place and such fears are banished, the more complete such reporting is likely to become.

Efficacious CQI may necessitate a new perspective on malpractice liability. This might involve a shift to no-fault or enterprise liability systems. The latter calls for shifting liability from individuals to institutions. If the necessary information to combat ID is to be gathered, both the shibboleths of doctor infallibility and individual responsibility must be significantly modified. The culture of privileged information and unwillingness to admit fallibility will have to give way to candid cooperation to assure continuous quality improvement.

There are at least some signs of movement in this direction. For example, JCAHO has revised its protocol for dealing with medical errors, making the process less punitive and more likely to facilitate remediation. The AMA has also established a National Patient Safety Foundation to identify risks, analyze errors, and suggest solutions to reduce medical harms. The National Coordinating Council for Medication Error Reporting and Prevention, as well as the United States Pharmacopeia's Practitioner Reporting Network, collect and identify common patterns of medication errors (Carothers, 1998). Such programs can provide detailed information on the character and scope of the problem, without which we can hardly hope for success in combating it.

Another hedge against iatrogenesis, like those previously cited, is easier to suggest than to implement. It is simply education. Schools of nursing and medicine should socialize their students into an acceptance of the fallibility of health care professionals. Medical errors should be viewed as always possible and thus preventable by proactive awareness. Even terms that carry a connotation of guilt, such as "death rounds," could well be deleted from the patois of the profession.

In addition, health care providers should not only keep current with the latest information in their fields, but (more challenging) they should develop the ability to evaluate this material critically. A surprisingly large number of medical treatments have not been validated by exacting experimental evidence as to their general effectiveness (Sharpe & Faden, 1998). There is a long-standing tradition in health care to accept authority without scrutinizing the actual basis of the authority's judgements. Such scrutiny takes time and effort; and time is a precious commodity in the frenetic world in which most professionals live. Today, professionals want information presented quickly and concisely. As a case in point, there is strong indication that many physicians get much of their knowledge about medications from drug company promotional literature. Although handy and convincingly presented, such sources can hardly be viewed as unbiased.

On a more optimistic note, the federal government's Agency for Healthcare Research and Quality is continuing to provide evidence-based information on an increasing number of treatments via its Patient Outcome Research Team studies and its National Guideline Clearinghouse. The availability via the Internet of MEDLINE and other valuable databases also has the potential for keeping health care providers better informed than ever. In addition, cautionary material has been published in various specialties, alerting physicians to specific iatrogenic problems. Examples of such can be found in the fields of neurology (Biller, 1998; Evans, 1998), pediatrics (Kassner, 1985), and pharmacology (D'arcy & Griffin, 1986). Anesthesiologists have also shown an aggressive interest in identifying the causes of errors in their specialty and in designing systems to prevent their recurrence (Leape, 1994). However, even with the aid of the Internet and a growing number of evidence-based studies, it takes time and effort to keep current. This challenge is exacerbated by the growing avalanche of available information and by the competing calls on the time of busy professionals.

These suggestions are admittedly wide ranging and are not likely to be widely embraced until agencies appear that can wield sufficient power to spur their adoption. The recommendations in the report of the IOM's Committee on Quality of Health Care in America, if implemented, could go far in meeting this pressing need (Kohn et al., 1999). Indeed, since the publication of the IOM report both the Congress and the White House have responded with a wide range of proposals to implement many of its recommendations (Pear, 2000).

Implications for Nursing

Iatrogenic illnesses can involve nurses in two ways: as threats to their patients and as threats to themselves. The primary defense that nurses can afford to their patients is their own proactive alertness to any possible complications of an iatrogenic character. As indicated above, the number of IDs is legion. Because patients have been or will be undergoing diagnoses or therapy, they are prime potential candidates for II. Nurses should think of every one of their patients as wearing a big, bold target, with a sign above inviting II to strike! Awareness that this is the case is one of the best defenses against this invidious threat. Specifically, a number of excellent cautionary guides are available, such as those by Russell (1999) on nosocomial infections and Carothers (1998) on medication errors.

But nurses must also protect themselves from the peculiar complications that these ills can pose to their professional lives. First, there is the question of malpractice suits. Second, there is the exceedingly unpleasant issue of dealing with acts of commission or omission by fellow health care providers that may harm patients. Third, there is the question of rendering testimony (expert or otherwise) in cases involving alleged malpractice.

As Varga (1998) pointed out: "Discussion of malpractice does not lend itself to a quick overview" (p. 56). Although one should not let the specter of a malpractice suit hang constantly over one's head like a sword of Damocles, one should nevertheless be aware of such an unpleasant possibility. Some rudimentary safeguards follow. First, nurses must be as completely current as possible with the standards of care that apply to their professional duties. These are available from a variety of governmental and professional sources. Second, nurses should document all care and events in as much detail as they possibly can. Whenever the slightest doubt arises as to the appropriateness of a given order, nurses should go through appropriate channels to get confirmation and document the actions and outcomes. Whenever situations with the potential to cause patient harm develop, from chronic understaffing to equipment inadequacies, they should be documented. Third, good charting -- complete, specific, and objective -- is another necessity for survival in this litigious world. A good paper trail can often provide good protection for both nurses and their patients.

Fourth, nurses are encouraged to familiarize themselves thoroughly with the details of their malpractice insurance policies. Not to do so can lead to unpleasant surprises! Everyone makes mistakes, and one of the biggest mistakes in nurses' professional careers could be ignorance of the specifics of their malpractice coverage. Like just about everything else in our modern world, the details of malpractice coverage can be more complex than most nurses might realize (Tammelleo, 1997).

Fifth, Fiesta (1994) reminds nurses, "All experienced risk managers know that the number one requirement for a malpractice lawsuit is not malpractice but an unhappy patient ... Thus the ability to communicate caring and compassion in an honest manner is important in the prevention of malpractice cases" (p. 5). Good bedside manner is no substitute for professional competence, but it is a vital complement to it in ensuring patient satisfaction.

Turning to the actions of colleagues and co-workers, nurses enter another quagmire of emotional, ethical, and legal questions. In this litigious world, nurses can well be held liable for failure to take appropriate action when they become aware that defects in the system or deficits in colleagues' performance might result in medical harm. This may also apply to a colleague's off-duty conduct. Mantel (1999) asserted, "In some states ... remaining silent [about such conduct] can result in charges that you allowed, or aided in, your colleague's negligence or malpractice" (p. 74).

The obvious first step nurses should take in such circumstances is to discuss the problem with the individuals involved. If problems cannot be resolved, they should be reported up the chain of command, with full documentation given. Finally, there is the last resort -- whistle-blowing -- going outside the agency or institution involved. Although the term whistle-blowing has a rather negative connotation, it is a practice often made necessary by the threat presented by iatrogenic ills. However, as Anderson (1990) pointed out, "We need to be sensitized to the fact that whistle-blowers are not enemies of the people. They are our patient advocates; the watchdogs of our practice and the guardians of professional excellence" (p. 11). Calling attention to such circumstances is not pleasant since it may precipitate a collision with co-workers and/or employers. Nurses who have challenged the authority of other members of the health care team, such as physicians and supervisors, have sometimes had to pay a high price for doing so (Anderson, 1990; Fiesta, 1994). It addition, according to Sloan (1999), "There is no universal whistleblower protection for those who advocate for the public good" (p. 65). Current federal whistle-blower legislation only provides protection in cases involving fraud against the government, while the National Labor Relations Act's coverage in such cases is far from firm. Since state laws vary so greatly and since other variables might cloud a given case, it is wise to seek legal counsel before reaching for that whistle.

Whether nurses report problems through the chain of command or have recourse to the last resort, whistle-blowing, they can expect to earn the animus of those adversely affected by their actions. On the other hand, failure to report a situation with the potential for medical harm could lead to the nurse becoming a co-defendant if such harm eventually ensues.

Finally, II may cast nurses in the role of witness in a legal proceeding involving other parties. This can happen in either of two ways. Although not one of the litigants, nurses may be called to testify concerning events about which they have knowledge. Many such witnesses take the stand willingly, while others must be induced to do so by court order. In either case, if nurses are called upon to testify, it is in their best interest to be thoroughly prepared. Although the litigants certainly have a stake in the testimony, so do the nurses testifying. In addition to the suggestions that may be rendered by attorneys, there are other helpful sources available to potential witnesses (Faherty, 1995; Leech Hofland, 1990; Lisko, 1996; Mandell, 1993).

A second scenario that might lead nurses to the witness stand is one in which they offer to provide "expert testimony." Although the weight of the testimony rendered by nurse expert witnesses will vary with the particulars of each case, one thing that will not vary is the need for the expert witness to be well versed in all the ramifications of assuming such a role (Horsley, 1995; Pesto, 1991).

Conclusion

Iatrogenic ills have been with us for seemingly as long as human beings have attempted to succor help and heal one another. The more sophisticated attempts to heal have become, the more numerous the untoward consequences of such efforts have become. Despite all the marvels of modem medicine, IDs continue to blemish providers' efforts. Although there may be great disparities in the many studies done of this problem, they all lead to the same conclusion: iatrogenic illness is an ongoing threat. However, it is one that nurses can do something about, if they have the will to do so. It will take time, effort, and determination, but the ills prevented and the lives saved are well worth the effort. Nursing's stake in this problem is enormous. All too frequently, nurses see what IDs do to their patients and how they can disrupt the workplace and colleagues' professional lives. While at long last some steps are being taken to address this problem, the nursing profession still has a long way to go. It is the responsibility of everyone to make every effort to protect patients and nurses from the often preventable harms caused by iatrogenic illness.

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Dawn M. Cook, MSN, RN, is Assistant Professor of Nursing, Ashtabula Campus, Kent State University, Ashtabula, OH.
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