High-Alert Medications Require Heightened Vigilance

It’s hard to imagine medical practice today without the use of painkillers, sedatives, and blood thinners. But some of the most powerful drugs prescribed to patients can also cause harm, earning them the dubious distinction of “high-alert medications.” The classification is helping those concerned with patient safety to draw attention to the risks associated with certain drugs, even when used as intended, and the steps that can be taken to prevent injury.

Reducing harm from high-alert medications was one of the interventions in IHI’s 5 Million Lives Campaign, a follow-on to the successful 100,000 Lives Campaign. “Most hospitals have been working to improve the safety of high-alert medications for a long time,” says Frank Federico, RPh, an IHI Director. “But when you ask if they still need help with it, there is a resounding ‘yes.’”
The Institute for Safe Medication Practices (ISMP) includes 19 categories of drugs in its list of high-alert medications. IHI’s intervention focused on four categories — anticoagulants (which prevent blood from clotting), narcotics and opiates (used for pain management), insulin (which regulates blood glucose levels), and sedatives (which sedate patients prior to procedures or during their hospital stay) — because they represent areas of greatest harm and greatest opportunity for improvement. The most common types of harm associated with these medications include hypotension (abnormally low blood pressure), bleeding, hypoglycemia (unusually low glucose, or blood sugar, levels), delirium, lethargy, and bradycardia (a dangerously slow heart rate).
Experts say it’s not only important for hospitals to develop safer systems for high-alert medications; patients and families also need to be involved, since some of these drugs may be used at home. Concrete recommendations are included in the Campaign’s How-to Guides on medication reconciliation and high-alert medications. IHI’s Frank Federico says, “Patients and families should know about interactions their medications might have with other drugs or foods, realize the importance of taking medications on the recommended schedule, and recognize the importance of including these medications on their medication lists.” For example, Federico says that foods with a high Vitamin K content, such as kale or other dark leafy vegetables, counteract the effects of warfarin, a widely-used anticoagulant.
Errors aren’t necessarily more common with high-alert medications, but the consequences can be especially serious. And studies suggest this applies across the board. For example:
  • In one study, anticoagulants accounted for 4 percent of preventable adverse drug events (ADEs) and 10 percent of potential ADEs.
  • Even with appropriate dosing, many patients may experience harm from narcotics. The most common kinds of harm include oversedation, respiratory depression, confusion, lethargy, nausea, vomiting, and constipation.
  • Insulin, used to treat diabetes and elevated blood sugars in post-operative patients, is often associated with hypoglycemia and hyperglycemia (excessively high glucose levels). Hypoglycemia is the most common complication of insulin therapy, and is an extremely frequent adverse event in hospitals worldwide.
  • If used inappropriately, sedatives can result in oversedation, hypotension, delirium, and lethargy, and may contribute to the risk of falling. In one study of ADEs on six hospital units, 42 percent of preventable ADEs were associated with the use of multiple sedatives.
  • Warfarin (an anticoagulant) and insulin are estimated to cause one in every seven adverse drug events treated in emergency departments, and more than a quarter of all estimated hospitalizations.
(For references, please see the 5 Million Lives Campaign’s How-to Guide: Prevent Harm from High-Alert Medications.)
The Institute for Safe Medication Practices recommends that high-alert medications should be “packaged differently, stored differently, prescribed differently, and administered differently than others.” In addition, hospitals should design and use “forcing functions,” processes that make it impossible to do the wrong thing. In the case of high-alert medications, this means developing methods and using technology that make it impossible for the drug to be given in a potentially lethal manner.
IHI’s patient safety Campaign experts suggest three safety principles to effectively guide high-alert medication practices: 
  1. Design standardized processes to prevent errors and harm;
  2. Design methods to identify errors and harm when they occur; and
  3. Design rescue protocols to mitigate the harm.
These principles are apparent in some of the ways in which hospitals working with IHI are improving the safety of high-alert medications.
Missouri Baptist Medical Center
At Missouri Baptist Medical Center in St. Louis, Missouri, Patient Safety Officer Nancy Kimmel says the hospital has worked steadily to improve the safe handling of all medications, and data show they’ve been successful: Average ADEs per 1,000 doses dropped from 2.3 in January 2001 to 0.16 in May 2006. The hospital began to focus more specifically on high-alert medications in 2002 when it joined an IHI program called Quantum Leaps in Patient Safety.
“We divided the goals up among several teams,” says Kimmel. “We have a diabetes management team working on insulin safety, as well as an anticoagulant group and a pain team looking at pain medications and sedatives.” Standardization and education are major goals for each group, to ensure that both staff and patients learn about the proper use of these special medications.
Kimmel says that the teams also use the IHI Global Trigger Tool for Measuring Adverse Events to help them identify ADEs. The IHI Global Trigger Tool lays out a way to conduct random and retrospective reviews of patients’ medical records in order to identify triggers, such as the administering of a reversal agent, that may indicate that something unintended or harmful occurred. The patterns that have emerged have led the hospital to automate some of the record review so that certain information now triggers an automatic alert.
For example, an alert is issued to clinical pharmacists — either by pager or a designated printer for hand delivery — whenever a patient’s glucose level drops below 50, which is a danger sign; or when orders are placed for medications typically used to reverse an adverse drug reaction, such as Vitamin K for internal bleeding or benadryl for an allergic reaction; or when a patient who is or has recently been taking the anticoagulant warfarin appears to be at risk for internal bleeding, based on a standardized method for measuring coagulation called the International Normalized Ratio (INR). “The INR relates to how long it takes for a patient’s blood to clot,” explains Kimmel. “The higher the number, the longer it takes. When the INR is five or greater, the system flags it because the patient is at greater risk for internal bleeding, such as a gastrointestinal or intracranial bleed.” The alert brings the potential danger to the immediate attention of clinicians and clinical pharmacists who evaluate and intervene if necessary.
Standard order sets were also designed by the teams to reduce variation in medication orders. For many medications, and particularly for some high-alert drugs, this is not a simple task. For example, there are different types of insulin, and different choices within each type, with very different qualities in terms of when and how they take effect. “It can be very confusing for the nursing staff who are trying to make sure that they have the right kind of insulin and are giving it in the right dose at the right time,” says Kimmel. Add to that some sound-alike brands — Novolog and Novolin, which Kimmel says have very different properties — and it becomes clear how easy it might be to make a mistake.  
Today, most patients at Missouri Baptist who require insulin are placed on standardized insulin order sets, which cuts down on the opportunities for mistakes. Achieving consensus when physicians are accustomed to making independent choices based on their training or preferences can be challenging. “You have to develop the forms with the medical providers, along with the staff who have to carry out the orders,” says Kimmel. “With their input, you can create a form that makes their jobs easier, and then they are more likely to use the form and to get their colleagues to use it.”
Physicians at Missouri Baptist are encouraged but not required to use the standard order sets for insulin. Not so when it comes to certain types of pain medication, says Kimmel. Standard order sets are required for all patients placed on patient-controlled analgesia (PCA), in which patients can self-administer pain medication intravenously by means of a computerized pump. “There are different concentrations of narcotics, and depending on the concentration, you dose it differently. Our standardized order sets use a single concentration for each narcotic, and also include automatic orders for a bowel prep so patients don’t get constipated, which is a very common side effect of narcotics,” says Kimmel. “Doctors who want their patients on a PCA have to use the form.”
Kimmel says that technology and automation are important components of the hospital’s success at improving medication safety, “but they aren’t the key. The key is to get the prescribing right in the first place, and to use automation to let you know when something isn’t right.”
An example of this, she says, is the hospital’s use of point-of-care bar code medication administration, which matches medications to patients. “The system issues a warning if there is a mismatch or a wrong dose. We have ‘smart pumps’ for IV meds, and if a wrong dose is programmed into the pump, there’s an alert that the programmed dose is outside the hospital’s defined limits, and instructions to the pump’s user to stop and re-evaluate,” says Kimmel. 
Kimmel emphasizes that success in reducing medical errors of all kinds — and especially those involving high-alert medications — requires continuous vigilance and multiple strategies. “There is always more work to do,” she says. “It takes lots of small changes to produce big results.”
Duke University Hospital
Another tool to help reduce unintended effects of high-alert medications involves identifying patients ahead of time who may be at higher risk. At Duke University Hospital in Durham, North Carolina, Medication Safety Officer Lynn Eschenbacher, PharmD, says a careful review of four years’ worth of adverse drug events has helped staff learn how to identify such patients. “With PCAs, for example, patients with morbid obesity, depression, renal insufficiency, sleep apnea, and who are older than 70 are at higher risk for oversedation,” says Eschenbacher, a certified Black Belt in Six Sigma, a quality improvement methodology that aims to eliminate defects.
These risk factors are noted by a clinician during the patient’s pre-op visit, and the information is entered into the patient’s electronic medical record, which triggers a bold red alert on the record. “When the patient comes in for surgery, the anesthesiologist sees this crucial information,” says Eschenbacher. In fact, everyone who cares for the patient in the hospital sees the embedded alert, which not only serves to remind clinicians to be especially vigilant for any signs of adverse reactions to the medications, but also may actually trigger different medications or additional care.
For example, says Eschenbacher, “If a patient has sleep apnea, the alert triggers a consult with respiratory therapy. If a morbidly obese patient needs opiates, the system calculates the dosage based on lean body weight rather than total body weight, because in higher doses some opiates (such as fentanyl) are absorbed by the fat tissue and can leach into the central nervous system and cause harm. The system also disallows morphine orders for patients with failing kidneys because of the likelihood that a dangerous metabolite can build up.”  
Eschenbacher says one of the things that make dealing with high-hazard drugs particularly tricky is that they have such a narrow therapeutic window. “Take anticoagulants, for example,” she says. “If you give a patient too much, it can cause internal bleeding. But if you don’t give them enough, they can have a clot which can lead to a pulmonary embolism.” Careful dosing and careful monitoring are essential, she says, which is why patients at Duke who are on a PCA are monitored every two hours for the first 24 hours, and beyond that if necessary.
Eschenbacher also advocates patient education as part of an overall plan to reduce medication harm, particularly aimed at giving patients realistic expectations about pain. “Some patients think they will have no pain after surgery,” she says, “and that’s just not realistic. Our slogan is ‘Managing Your Pain, Caring for Your Safety.’ We have flyers [in English and Spanish] that explain to patients that they will have some pain, but we will work with them to manage it as effectively as possible.” This understanding about pain plays an important role in preventing potential overdoses when patients are discharged and managing pain at home, says Eschenbacher.
Fairview Health Services
At Fairview Health Services in Minneapolis, Minnesota, a large integrated health system of seven hospitals, the safe use of medications has been at the forefront of improvement work for many years, says Steven Meisel, PharmD, Director of Medication Safety. “We have done lots of work on standard order sets, documentation, and monitoring, and have used the IHI Trigger Tool for Measuring ADEs for five or six years. Based on that, we’ve developed our own tool that looks specifically at high-alert medications,” says Meisel.
Because the IHI Trigger Tool methodology suggests a random sample of  20 medical records per month, Meisel says he and his colleagues felt it would not be a “sharp enough” instrument to pick up all incidences of harm from high-hazard medications. “We developed a tool that looks at every trigger associated with anticoagulants, anti-diabetes medications, narcotics, and sedatives,” he says.
Across all Fairview hospitals, work groups have been focusing on each category of high-hazard medication, and are currently working on multiple initiatives based on the opportunities revealed by the targeted trigger tool and the results of a “gap analysis” that Meisel and his colleagues conducted using IHI’s How-to Guide: Prevent Harm from High-Alert Medications, and the hospital’s 2006 medication error data. “We’ve identified 10 to 15 things to work on,” says Meisel, including improving understanding of and adherence to inpatient insulin protocols; improving the dosing of narcotics and sedatives; making sure the system’s expertise on pain management is made available to the smaller regional hospitals; and improving the coordination between when patients have their blood sugar tested, receive their meals, and have their insulin administered.  
Fairview isn’t only recently getting on this train, says Meisel. “We’ve approached narcotic oversedation thoughtfully for many years,” he says, “and we’ve probably already taken 30 to 40 steps to improve. In 2004, for example, we had 25 serious narcotic-related events; in 2006, that number was down to 10.” Interventions range from using standard order sets for certain pain medications to taking practical precautions to prevent potential errors. “For example,” says Meisel, “hydromorphone, an intravenous pain medication, comes in 2-millileter syringes. But the usual dosage is 0.2 mg, so our pharmacy repackages it. This takes a lot of work, but it’s important.”
Meisel says that the organization’s anticoagulant clinics have also contributed to improved safety for outpatients taking anticoagulants such as warfarin. These special clinics, which Fairview established in 2004, offer case management of outpatient warfarin therapy and teach patients how to use their anticoagulant medications safely, and what danger signs to look for that might indicate problems related to the medication. “These anticoagulation clinics work. In 2005, none of the patients enrolled in a clinic had to be admitted to the hospital for an adverse drug event,” Meisel says.
IHI’s Frank Federico says that warfarin clinics such as the one at Fairview illustrate that it’s possible to educate and involve patients in the safe use of their medications; further, creating these outpatient opportunities is as important as building reliable inpatient processes. “With medications that span the continuum of care, patients have a huge role to play,” he says. “It is our obligation to provide the education and the tools so they can exercise their involvement as effectively as possible.”
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