Is your pharmacy sufficiently stocked? Lack of key supplies is a liability risk
Is your pharmacy sufficiently stocked? Lack of key supplies is a liability risk
Study finds most hospitals don’t keep needed drugs
An eye-opening study has found that few hospitals stock enough antidotes for treating common poisonings for even a single patient, even though some of the drugs can be purchased for only a few dollars. The study raises the possibility that the same problem could occur with other types of drugs necessary to respond in an emergency; risk managers say the revelation is disturbing, but the solution may not be all that simple.
The study was conducted by researchers at the Rocky Mountain Poison and Drug Center and the University of Colorado Health Sciences Center in Denver.1 They surveyed 137 hospital pharmacy directors in Colorado, Montana, and Nevada, the area covered by the regional poison center, to determine whether antidotes for poisoning and drug overdose are available in facilities that provide emergency care. The answer in most cases was "no."
The results were surprising to researchers. Steven R. Lowenstein, MD, MPH, an emergency medicine physician at the University of Colorado, says the study results raise questions about the effectiveness of the elaborate systems most states have in place to respond to poisoning.
"What good is all the knowledge and the training and the 800 numbers if we don’t have the antidote on the shelf?" Lowenstein asks. "We’ve made preparations to treat poisoning, but no one really thought of whether we have all these medications on hand. All the preparation is kind of fruitless without the antidote."
Aside from the obvious clinical implications of not being able to save a patient without the needed antidote, the study raises serious risk management concerns. If your hospital fails to save a patient’s life simply because the needed antidote is not in the pharmacy, a plaintiff’s attorney will not have a difficult time arguing that the hospital was negligent.
Although the Colorado study was narrow in its focus, it raises the question of just what a hospital should be expected to keep on hand. To assess what poisoning antidotes are kept handy, the researchers asked hospital pharmacy directors how much they stocked of eight antidotes. These were the antidotes and their uses:
• antivenin (Crotalidae) polyvalent, to treat North American pit viper venom;
• cyanide antidote kit, to treat cyanide poisoning;
• deferoxamine mesylate, to treat iron overdose;
• digoxin immune Fab, to treat digoxin overdose;
• ethanol, to treat methanol and ethylene glycol (antifreeze) poisoning;
• naloxone hydrochloride, to treat opiate overdose;
• pralidoxime chloride, to treat exposure to organophosphate insecticides;
• pyridoxine hydrochloride, to treat isoniazid poisoning.
Insufficient stocking was defined as less than the amount needed to initiate treatment of one seriously poisoned 154-pound patient. The proportion of hospitals with an insufficient stock of the eight antidotes ranged from 2% for naloxone to 98% for digoxin immune Fab. Only one hospital had sufficient amounts of all eight antidotes.
The median number of insufficiently stocked antidotes was four. That means ED clinicians would have a 50/50 chance of finding the antidote you need, Lowenstein says. In 14 hospitals, naloxone was the only antidote stocked in sufficient amounts.
Researchers noted a pattern associated with the antidote stocking. Smaller and rural hospitals were less likely to stock the antidotes, as were hospitals that lacked a formal review process for antidote stocking. Half the pharmacy directors reported that their facilities had formal review processes for antidote stocking, and all but one said they would appreciate formal guidelines on what antidotes to stock.
Other than the current Colorado study, no such guidelines are available. The Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, requires that hospital medical staff and the pharmacy director determine which antidotes to stock.2
The Colorado study involved hospitals only in that region, but the researchers say they believe the results would be similar across the country. Other studies have raised doubts about antidote stores in Arizona, California, and Tennessee.3-5
The eight drugs in the study were selected because they are commonly needed and must be used within minutes in cases of serious poisoning, meaning the drug has to be in stock at the hospital. Transferring the patient to another hospital or waiting for a rush antidote delivery is not an option. Obtaining an antidote from another hospital usually takes a minimum of one hour and often much longer, Lowenstein notes.
For those eight drugs, then, the need to stock them is non-negotiable for any hospital providing emergency care, Lowenstein says. "If there is a specific antidote that you know you will never need, such as if you just don’t have snakes in your area at all, you could get by without having that one on hand," he explains. "But that would be very unusual. For most hospitals, these eight drugs are mandatory."
But the good news is that the eight antidotes are not just the eight most important ones. They are, essentially, all the available antidotes for poisoning and overdose, with the exception of medications and substances used otherwise in the hospital and thus commonly available. A few other antidotes are not as time-sensitive for administration, so having them immediately available is not as much of a concern.
"Antidotes are a small area in toxicology and there just aren’t that many," the doctor explains. "These are not sentinel drugs that stand for a bigger problem. This is the whole problem as far as antidotes are concerned."
More than 2 million poisonings occur annually in the United States, according to the researchers. At least 250,000 of those patients will need treatment with a specific antidote.
While disturbed by the study results, the researchers point out that the problem is easily solved by placing a drug order and writing a check. To stock every one of the eight drugs in amounts necessary to treat one seriously poisoned 154-pound patient, the researchers estimated a total drug cost of $9,751.04. Most of that cost comes from the digoxin immune Fab; the 20 vials necessary for one patient cost $8,039.80. The snakebite antivenin, the second most expensive, costs $941.50 for five vials.
The cheapest antidote is the 70 g of ethanol, at $2.59. Despite that negligible price, 71.7% of the hospitals surveyed did not have enough on hand to treat one patient, according to the study.
"This is an oversight that we’ve all shared in, but it’s so easily correctable," Lowenstein says. "This is a good news study because we’re pointing out a deficiency that you can easily correct in 48 hours with a drug delivery."
Nevertheless, the study raises risk management concerns by showing that many hospitals could find themselves unable to provide poisoning and overdose treatment that would be the standard of care for an emergency provider. The Colorado researchers presented their research to the Joint Commission, where Lowenstein says it raised eyebrows.
"They’re quite interested because they never thought about this either," he says.
Don’t wait for Challenger event’
The antidote study may be a warning to risk managers concerning the inadequate stocking of pharmaceuticals, says Charles Self, JD, director of risk management and insurance at the University of Alabama at Birmingham Medical Center. He sees two reasons to take note of the study results. First, the study clearly shows the need to stock the specified antidotes in most hospitals. But also, Self suggests, it can be seen as a warning that the same deficiencies could occur with other types of drugs needed at hospitals.
Because many drugs are needed very infrequently, hospitals may just be waiting until the day they need the drug and don’t have it. Self warns against that sort of carelessness, saying it can only lead to patient injury and liability for the hospital.
"If you ever had a patient die because you didn’t have the medication you needed, you’d be sure to take notice and make sure it didn’t happen again. I call that a Challenger event,’" Self says, referring to the fatal explosion of the space shuttle Challenger in 1986. "You wait till the O-ring blows and then you fix it. That’s not good risk management."
The lack of needed medications can set up a facility for a malpractice case that would be hard to defend, he says. While he knows of no cases involving medications that were not on hand, Self has seen many cases in Alabama alleging that a facility should have had on hand a particular piece of equipment, such as a defibrillator, because the facility provided a particular type of service, such as emergency care. The defense usually is that the small clinic or hospital could not afford the equipment or would rarely eed it.
"More often than not, they don’t win that argument," he says. "The standard of care is a national one, so it is not a good defense to say, We’re too small and rural to have what everyone else has.’ I can’t imagine the defense would work any better with pharmaceuticals."
The best defense would be to show that you considered the problem in advance and made a reasonable decision based on the facts, Self advises. A jury still may decide you made the wrong decision, but the jury almost certainly would rule against you if it appeared you made no reasonable effort to stock the right drugs.
"The only caveat is that juries don’t like decisions based solely on economics," Self says. "You’ll want to . . . explain that you had limited resources, so you had to choose."
Small facilities face bigger challenge
As for the poison antidotes, Self says he suspects that most large, tertiary care centers like his own have adequate supplies of all the antidotes. With smaller facilities, he sees more of a challenge. The eight antidotes may be non-negotiable in the opinion of the poison specialists, but Self says smaller hospitals will face budgeting dilemmas with any type of pharmaceuticals.
(For ideas on how to minimize the liability associated with inadequate pharmaceutical stocking, see the story on p. 4.)
Hospitals face a constant battle to keep drug waste down, and large facilities can routinely throw away millions of dollars in unused medications every year. For that reason, Self says risk managers will have a difficult time convincing pharmaceutical committees and formulary managers to stock every drug that might be needed at some point. Judgment calls always will be necessary, Self says, and he accepts the idea that certain drugs, like the eight poison antidotes, might be mandatory no matter how much they cost.
Lowenstein points out that the cost of stocking drugs may be less of an issue with antidotes than with many other necessary medications. With the exception of digoxin immune Fab, the eight antidotes are relatively inexpensive and have a comparatively long shelf life. If stored properly, the two most expensive antidotes (digoxin immune Fab and crotalid snake antivenin) have a shelf life of five years. And some manufacturers will replace expired antidotes for free, he says.
"The only real reason I can see for not stocking these antidotes is that they have become orphan drugs because they may not be needed very often," Lowenstein says. "That is not acceptable."
References
1. Dart RC, Stark Y, Fulton B, et al. Insufficient stocking of poisoning antidotes in hospital pharmacies. JAMA 1996; 276:1,508-1,510.
2. Joint Commission on Accreditation of Healthcare Organizations. Accreditation Manual for Hospitals. Oakbrook Terrace, IL; 1992.
3. Dart RC, Duncan C, McNally JT. Effect of inadequate antivenin stores on the medical treatment of crotalid envenomation. Vet Hum Toxicol 1991; 33:267-269.
4. Kanatani MS, Kearney TE, Levin RH, et al. Treatment of toxicologic emergencies: an evaluation of Bay Area hospital pharmacies and its impact on emergency planning. Vet Hum Toxicol 1992; 34:319.
5. Chyka PA, Conner HG. Availability of antidotes in rural and urban hospitals in Tennessee. Am J Hosp Pharm 1994; 51:1,346-1,348.
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