Critics hit ED providers with lack of protocols on addressing ADRs
Critics hit ED providers with lack of protocols on addressing ADRs
Viagra scare raises issues of identifying adverse drug reactions in patients
Recent events have focused the medical community's attention on the need for rapid identification and triage of patients who present with signs of adverse drug reactions (ADRs). The deaths surrounding the ill-advised use of Viagra, the sexual potency drug, in combination with other medications, have heightened attention to the need in emergency medicine for speedy identification and triage of ADR in presenting patients.
But are emergency professionals properly trained and equipped to do so?
According to one emergency physician, who has advocated for increasing the body of knowledge of ADR among emergency providers, the answer is no. A lack of formal hospital protocols for properly identifying non-hospital induced ADRs in the emergency department (ED) has hampered physicians' ability to understand and appreciate the often life-threatening needs of these patients, says Keith Burkhart, MD, an emergency physician at Milton S. Hershey Medical Center in Hershey, PA.
One of the reasons for this, according to Burkhart, is that emergency physicians, by training, have not been sufficiently informed about the harmful metabolic effects of certain drugs on their patients. "As emergency providers, we have been trained to look at more traditional medical causes of illnesses that are not ordinarily drug-induced," Burkhart says.
Hospitals lack formal protocols for ADRs
Then, too, the subject has until recently attracted little attention outside of the pharmacology community, largely because the underlying causes of ADR and the nature of drug metabolism itself have been poorly understood. But advancements in research in the past decade are making the field more accessible to physicians, Burkhart adds.
Nevertheless, hospitals have generally allowed physicians individually to consider adverse drug events as a possible cause when diagnosing cases of gastrointestinal bleeding or abdominal pain in certain patients. And they have done little to monitor or treat the ADR in any formal way, Burkhart says. Therefore, aside from the assistance provided by local poison centers and some medical societies in assisting emergency physicians, the field is virtually uncharted territory.
But, even among the best informed providers, focusing on ADR in presenting patients has generally taken a backseat to more probable medical causes such as severe ulcer or cardiac episodes. And, although the possibility of an adverse reaction to a medication is considered a possibility, it often becomes the causal factor of last resort.
"It's usually thought of when everything else has been ruled out," says Burkhart, who is also the director of the Central Pennsylvania Poison Center housed at Hershey Medical Center. The 504-bed hospital is part of the Pennsylvania State University-Geisinger Health System based in Danville.
The result has been that many physicians have been unable to consider or identify ADR, even when it is most obvious. The elderly, for example, are the most prone to a harmful drug reaction because they are routinely taking multiple medications, often simultaneously, for more than one unrelated ailment.
Yet, despite this high exposure to ADR in the elderly, set, formal protocols don't exist among emergency specialists to identify the underlying cause of the presenting complaint and to treat it efficiently or in a timely manner, Burkhart states. The apparent reluctance by physicians to give ADR a higher priority on the causality scale concerns physicians such as Burkhart, who believes that such adverse events directly and indirectly represent more than 10% of all hospital admissions. (For a comparison of ADRs effects on patients, see the graph on p. 89.)
"Unless certain hospitals or practice committees within specialty societies take an interest in the subject and undertake their own internal programs, I've never heard of any set universal protocols being established," Burkhart says.
The subject has taken on a sense of urgency because, aside from the Viagra scare, physicians and pharmacologists have expressed growing concern with the quality and efficacy of an increasing number of post-marketed drugs available to consumers.
Reported cases of ADR keeps growing
According to the Food and Drug Administration (FDA) in Rockville, MD, the number of reported adverse drug events (ADEs) involving over-the-counter and prescription medications has more than tripled to more than 170,000 cases in a decade. In nearly 25% of these cases, hospitalization was the most reported serious outcome. Today, the FDA receives about 250,000 reports annually involving possible ADR. (Editor's note: Researchers distinguish ADEs from ADRs to include any event linked to an improper drug use, including poisoning or overdosing on controlled substances, while ADR generally involves a negative drug metabolism or interaction by two or more drugs.)
In June, Pfizer, the maker of Viagra, warned emergency physicians about the probable effects of the medication on patients who are regularly using nitrates for a cardiac disorder. The letter, written by Richard L. Siegal, MD, a Pfizer medical director and former emergency physician, was published on the Internet immediately following the deaths of several Viagra users. As of July, some 16 men had died after using the product.
At nearly the same time, the drug maker Roche Holding AG withdrew Posicor, a highly touted hypertension drug, after the product was on the market less than a year. Test results showed predictable negative interactions with up to 15 other popular medications, including Viagra. Meanwhile, American Home Products, another drug maker, yanked its painkiller Duract from the market after reports that four patients died after using the drug and eight needed liver transplants.
Similar events prompted The Wall Street Journal to publish an article relaying doubts about the safety of many available drugs when used in combination. "While pharmaceutical manufacturers test their concoctions on several thousand subjects to monitor side effects and efficacy, the real experiment begins only after a drug hits the market," the article stated.1
As a result of these and other mishaps, MedWatch, the FDA's chief drug monitoring system, has come under fire by physicians and consumer advocates. Critics charge that the system has failed to do its job and is plagued with problems, including an alleged over-dependence on drug company data.
For providers, questions regarding the safety of drugs used in combination have a far more immediate impact, says David W. Bates, MD, MSc, a researcher in the department of medicine at Brigham and Women's Hospital in Boston, MA. Physicians not only face a daily challenge when treating patients presenting with a possible ADR, they also need to address a potential ADR threat involving the medications they order for their patients when seen in the hospital or office.
Bates has written extensively about the incidence of hospital-induced ADR and its financial costs. He says that preventive measures, which work well in addressing hospital-induced ADRs, are also appropriate in setting up an identification protocol for possible ADR in presenting patients.
Experts cite computers for accurate ADE data
"Computerized approaches are ideal for [monitoring the incidence of ADRs] because reliability can approach 100%, while methods that rely on human inspection will always miss some errors," wrote Bates and his colleagues in a 1995 study.2
Network computers can help physicians not only track individual patients and their medication histories, but they also provide pharamcological data on potential side effects and negative reactions of drug combinations, says Burkhart. As yet, only poison centers possess that level of information about drugs' effects.
In a separate study of computer-based ADE monitoring, Bates and colleagues found that the conventional method for tracking such cases has primarily been patient chart reviews. But these methods, although usually accurate, are extremely expensive and time-consuming.
After comparing a computerized tracking system designed for the study with conventional chart reviews, researchers found that computers identified 45% of cases of ADEs, while the chart method uncovered 65%. However, the ADEs identified by computer were more likely to be classified as severe, the researchers stated.
And the reliability of the computerized information was far more certain than the chart review method. In effect, researchers concluded that computer-based monitoring systems are an efficient approach to measuring ADE frequency and gauging the effectiveness of prevention programs.3
In addition to computerized tracking, the Bates study recommends that providers maintain "a system of collecting and feeding back data about ADEs." Reporting of ADEs to poison centers and state health officials is mandatory as a way of understanding these events on a wider scale, Burkhart says. The Joint Commission on Accreditation of Health Care Organizations in Oakbrook Terrace, IL requires such reporting. Yet, most hospitals generally keep reports to themselves and typically identify only 5% of cases, according to Bates.
Furthermore, providers must look for preventable ADEs, not just ADRs. Preventable ADEs are more likely to cause serious injuries, according to the Bates research, because ADRs are rarer and, by comparison, are inconsistent in effect, and they are areas in which improvement is most possible.
A 1997 Journal of the American Medical Association editorial about ADEs seemed to summarize medicine's emerging viewpoint on the subject. "We have become all too familiar with the dark side of the industrial model of medicine in which physicians become vendors," wrote Jerry Avorn, MD, a member of the department of medicine at Brigham and Women's Hospital in Boston. The body of existing research on ADE prevention "illustrates that a 'systems' approach to thinking about health care services can also be used for nobler purposes."
References
1. Jeffrey NA, Langreth R. Viagra's lesson: New drugs, unknown risks. The Wall Street Journal June 10, 1998:B1-B10.
2. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. JAMA 1995; 274:29-34.
3. Jha AK, Kuperman GJ, Teich JM, et al. Identifying adverse drug events: Development of a computer-based monitor and comparison with chart review and stimulated voluntary report. JAMA 1998;5:305-314.
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