Experts push the systems approach to reduce hospital medication errors

Bringing pharmacists and patients together critical to success

A general consensus has emerged among national pharmacy organizations and academic researchers on the merits of a systems-based analysis of medication error correction and prevention. Now, selling the approach to hospital administrators, pharmacy directors, and the rank and file is at hand.

Richard Cook, MD, director of the National Patient Safety Founda tion’s cognitive technologies laboratory at the University of Chicago, has researched and written extensively on patient safety, complex system failures, and human performance. He acknowledges that the "systems approach" seems to contradict a lot of commonly held assumptions and that it sometimes meets with a great deal of resistance, largely because it seems easier to blame the individual than to change long-held procedures.

"We’re all Stalinists," Cook says, "because we want to blame individuals instead of fixing the system. Stalinists thought their system was perfect but that people kept trying to sabotage it. We see modern health care in the same way: as a perfect world except for the people messing it up. In reality, it is the opposite. The world is full of hazards, and people actually work to make it safer."

According to proponents of the systems approach, one of the main reasons accidents are often blamed on human error is "hindsight bias." Because investigators already know an accident happened, they tend to think practitioners should have seen it coming.

One of the classic examples of a systems failure is in cases of drug- drug reactions. Studies have shown that by the time a patient receives a medication, coordination and review of that patient’s medical history have not made it from records to pharmacy to nursing, if the history was adequately compiled to begin with. Any resulting adverse reaction often leads to finger-pointing. In many cases, simply linking departmental computers would have been a workable systems solution because it would allow any medication concerns in a patient’s medical history to be highlighted along the way.

In terms of automation, observational studies have found that 24-hour dispensers or storage cabinets often are checked less frequently as technology has advanced. In the past, caregivers could check each other’s work. More recently, it’s been shown that automated dispensers are checked more frequently at the front end, when bulk drugs are loaded, but less frequently at the back end, when medications are placed in patient envelopes.

Failures beget complexity

Cook says organizations tend to react to failure by "blaming and training." There’s a call for sanctions and new regulations, rules, and technology. Those interventions can make the system even more complex and introduce new forms of failure. The whole cycle then repeats itself. The point is not to add another layer of protocol, but to see where the existing system failed, he explains.

"When we actually look at the details, we find out that failure occurs differently than the way we thought," says Cook. "So the solutions may be different, too. Many of the things we often propose to do have side effects, like computer order-entry systems, bar coding, things like that. They can improve system performance, but they come with their own problems as well."

Due to advances in automation, systems analyses have been championed largely by pharmacy. One of the first major documents to shed light on the pros and cons of automation and medication errors as part of the systems analysis was the White Paper on Automation in Pharmacy, which was detailed in the February 1999 issue of Drug Utilization Review. The document was commissioned by a coalition of seven national pharmacy organizations.

"In the pharmacy world, there is already a movement to simplify the systems — to have smaller formularies, for example," Cook says. "There’s an awareness of the problems caused by drugs with sound-alike names. We know the visual identification of drugs is made more difficult when you switch suppliers, but we switch suppliers all the time. [The process of systems analysis] is an ongoing activity. What effect each possible change will have on safety is the subject of hot debate."

The Institute for Safe Medication Practices (ISMP) in Warminster, PA, is actively engaged in the process. The agency often is asked to perform systems analyses of the medication process for health care organizations. ISMP has identified 10 common weaknesses in medication systems and categories that include patient information; drug information; communication of drug information; labeling, packaging, and drug nomenclature; drug storage, stocking, and standardization; drug device acquisition, use, and monitoring; environmental stressors; competence and staff education; patient education; quality processes; and risk management.

ISMP president Michael Cohen says when his agency goes into a hospital to do a systems analysis, every facet is covered.

"We spend three days at the hospital. We speak to everyone: nurses, doctors, and phar macists. We go into the operating rooms, we go through the computer system, we look at all the records to see how well they are communicating drug orders. We’ll ask the nurses how they communicate drug information to patients. Our reports are quite detailed, and they’re up to 30 to 40 pages long. We focus on the system, not the staff. We don’t single anyone out. It is a completely objective review, which is very helpful."

How is information shared?

Cohen says it is crucial to make sure everyone involved in patient care has access to complete patient and drug information.

"When you look at an error, you have to ask whether you had all the information you needed. Was it because you didn’t know the patient had kidney disease, for example, and therefore got the wrong drug? Even something like not having the correct patient bed number can matter."

According to the National Consumers League, lack of information about drugs is one of the main reasons almost 50% of American patients do not comply with their medication regimes. ISMP found that pharmacy staff are not routinely involved in direct patient education. It recommends the implementation of automatic educational consultations by pharmacists when patients are receiving certain classes of medications or being discharged on more than five medications.

Similarly, ISMP found that pharmacists often are unavailable for face-to-face communication on patient care units, meaning they are not present when medication is prescribed and administered — the stages when errors occur most often. ISMP therefore recommends moving the pharmacist into patient care areas.

Recent studies have demonstrated the benefits of such communication, including one published in the Journal of the Amer ican Medical Association over the summer (1999; 282:267-270) and covered in DUR last month. Researchers led by Lucian Leape, MD, of the Harvard School of Public Health, found that when pharmacists went on rounds in the intensive care unit, medication errors were reduced substantially. (See DUR, November 1999, p. 168, for details.)

Cook points out that many system fixes are a matter of providing for quality face-to-face communication. "We tend to use the computer as a communications device or fancy telex, which is why studies like Leape’s are so interesting. Communication by direct contact is a much more reliable system than entering information into a computer and expecting people who receive the information to understand what you are doing and why you are doing it, with no context. That is why Leape’s research is so attractive. There’s a real important lesson in that kind of study: People make safety, not technology."

ISMP’s findings support that lesson. The organization reports that policies for handling conflicts over medication use often are ineffective or absent. Moreover, it found that flawed communication contributes to some 10% of the serious errors that occur during drug administration. It recommends that institutions develop a process that clearly specifies the steps practitioners should take to resolve drug therapy conflicts.

Other recommendations involve the dispensing of medications. ISMP warns that removing drugs from labeled containers and putting them in cups for administration greatly increases the chance the medication will be given to the wrong patient. The agency recommends using original containers throughout the entire process, right up to administration.

A critical eye on automation

Another issue is the use of automated dispensing technology. ISMP says the lack of safety procedures and inadequate check systems can result in storage errors. The organization also says medications should not be available routinely for administration to patients without appropriate order screening by pharmacists.

Cohen agrees with Cook’s statement that technology meant to improve safety sometimes can have the opposite effect.

"Over the last year, we had 20 reports related to IV infusion pumps used to administer critical care drugs. The manufacturers have put in a little computer where you enter the patient’s weight, the dose ordered by the doctor and the concentration of the drug, and the rate is calculated for you. This was designed to reduce errors, but using it actually can increase them, because you have to make three separate entries. The technology made the system more complex instead of simplifying it."

There’s another consideration most practitioners will be able to relate to, particularly staff who transcribe orders: environmental stressors. When transcribing is done in an area with a high frequency of noise, interruptions, and constant activity, ISMP says the process is vulnerable to slip-ups. It cites a study that found those distractions are responsible for three quarters of transcription or computer-order entry errors.

The health care system is already complex, and it is becoming even more so. Cook says the health care system is constantly changing at all levels: organizational, technical, managerial, social, and political. Those levels affect each other, so improving safety depends on understanding those interactions. People are adapting to the changes all the time, so the system is in a constant state of flux. To improve safety, health care providers, including pharmacists, must try to anticipate the impact of those changes and act on them.

"Pharmacy is moving toward a knowledge-based role and away from the traditional role of dispensing medications. This is part of the shifting professional base. Safety is created by what you do in your work everyday, not by the technology or policies. Safety emerges from the technical work that you do," Cook says.

[Editor’s note: To receive a reprint of the White Paper on Automation in Pharmacy, contact lead author Ken Barker, PhD, Department of Pharmacy Care Services, Auburn (AL) University. Telephone: (334) 844-5152.]


Richard Cook, MD, Director, Cognitive Technologies Laboratory, National Patient Safety Foundation, University of Chicago. Telephone: (773) 702-1234. Web:

Michael Cohen, MS, FASHP, President, Institute for Safe Medication Practices, Warminster, PA. Tele phone: (215) 947-7797. Web: