Minneapolis—What keeps you up at night when it comes to medication safety? A misplaced decimal point leading to a 10-fold dosing error? A contaminated batch of compounded IV drugs? A medication given to the wrong patient? Serious clinical adverse events, some tragic, occur every day in health care; many involve drug therapy, which is the most common intervention in medicine. Whatever the source, no health system is invulnerable. Is your hospital prepared for the unthinkable?

“Many health care systems think they have a crisis plan, but they don’t,” said Frank Federico, RPh, executive director at the Institute for Healthcare Improvement (IHI) in Cambridge, Mass. “Often it’s only in someone’s head. It’s not written, not practiced, not tested,” he noted during a crisis management session at the 2013 Summer Meeting of the American Society of Health-System Pharmacists.

“A plan must describe a well-defined process that you can rely on in times of extraordinary stress,” added Elizabeth Ennis, MD, the chief medical officer of Baptist Health System in Birmingham, Ala., who also spoke at the session. “Without one, you decrease your ability to assess the crisis, intervene and resolve it.”

A standing crisis management team under the direction of the organization’s chief executive is also an integral component, Mr. Federico continued. Ideally, the team can assemble immediately in response to a serious clinical event and members have clearly delineated responsibilities. Team members may include the hospital’s chief medical officer, chief nursing officer, chief public relations officer, legal counsel, an ethicist, a patient representative and a pastoral care counselor, according to an IHI white paper co-authored by Mr. Federico, “Respectful Management of Serious Clinical Adverse Events” (bit.ly/14VRdVL).

The IHI recommends that, during a crisis, the team check in daily—multiple times if necessary; maintain highly disciplined documentation; listen carefully and be prepared to hear things it doesn’t want to hear; expect an inquiry from external accrediting and regulatory agencies; and embrace speed and flexibility. To assess a response plan’s viability, Mr. Federico advised that the team walk through the steps the organization will take for a variety of crisis situations—hypothetical or based on actual events elsewhere. The process provides instant feedback on the hospital’s level of preparation and gaps that need filling.

The effectiveness of a crisis response often hinges on putting the well-being of patients and their families first, not the hospital’s image. That means ensuring that the patient is safe or, in the event of a patient’s death, that family members receive whatever support they need, that they’re heard and that their questions are answered candidly. According to the IHI, a sensitive and open response to a crisis, coupled with deliberate measures to prevent a recurrence, can build good will and enhance a hospital’s standing in the community, even at a time fraught with the potential to cause serious and lasting damage to its reputation. Studies also have shown that such an approach reduces the chances that litigation will be brought against the hospital: As honesty and full disclosure about a serious medical or medication error increase, the risk for a lawsuit decreases (Front Health Serv Manage 2012;28:13-28).

A Nightmare Scenario

In March 2011, the nightmare scenario struck the Baptist Health System—an organization that prided itself on its safety record—when 12 patients at two of its four hospitals in Alabama were infected with Serratia marcescens. Six of the infected patients died. Three more deaths occurred at three other Alabama hospitals. The source of the infection was traced to contaminated batches of total parenteral nutrition (TPN) produced by Meds IV Pharmacy, a Birmingham compounder. The toll could have been much higher had not an infection preventionist at Shelby Baptist Hospital noticed an unusually high number of S. marcescens bacteremia present over just four days. All infected patients had been receiving TPN.

Dr. Ennis learned about the events while vacationing in Alaska and returned immediately to join the crisis response in full swing. Before her return, the hospital notified the compounding pharmacy, which contacted all facilities t

hat purchased its TPN solutions. Dr. Ennis asked the pharmacy to sequester all products from the supplier, which included several agents in addition to the TPN solution. “At that point, we still didn’t know where the break in sterility had occurred, and we had to assume that anything from the compounder could be contaminated,” she said. A joint federal–state investigation found that a faulty filtration process at the compounding pharmacy allowed S. marcescens in tap water to pass into batches of amino acids that were incorporated into the TPN solution.

Baptist Health’s crisis response dictated that all relevant individuals within the system be kept current on all developments. “Our CEO was engaged and we kept in constant communication with all of our facilities,” she added. “There are also mechanisms for communication within a single facility, with our board of directors, and with all clinicians involved in a serious adverse event.” In this particular crisis, Dr. Ennis and the system’s chief nursing officer spoke often with patients and family members, she noted.

Baptist Health learned several valuable lessons as a result of working through the TPN contamination crisis, Dr. Ennis stressed. First and foremost, “Be honest and honorable and it will sustain you through a disaster like this,” she advised. “Be diligent in notifying everyone who needs to know what’s happening, such as the CDC [Centers for Disease Control and Prevention], the state board of pharmacy, hospitals outside of your system—anyone who’s relevant. That can take many, many phone calls, but it has to be done. Truthfulness in disclosure to all affected people is crucial, including patients, families and employees.”

Patients Not the Only Victims

Dr. Ennis underscored the importance of addressing the needs of a staffer who unwittingly has a hand in an error that causes patient harm. For exampe, if your facility experiences a TPN error similar to what occurred at Baptist Health, she said, “you can’t forget about the nurse who administered the [infusion].”

Indeed, employees often are overlooked in the wake of a crisis. “Patients and family come first, but it’s equally important to ensure that hospital staff are also safe and well cared for,” the IHI’s Mr. Federico said. “We tend to forget that they are secondary victims and they carry the burden of an event.” Staff connected to the events leading to a crisis may feel guilt, anguish and depression and struggle to do their work. That’s a recipe for additional mistakes, and hospitals would do well to offer those who need it support, such as professional counseling and reassurance that a bad system, not a bad person, caused the crisis.

Focusing on Error Prevention

The ability to respond to a crisis quickly and effectively is invaluable. Far more desirable, of course, is to avert crises. That requires a “focus on essential factors and designing systems that prevent errors in the first place,” Mr. Federico said. One prime area where pharmacists can make a difference, he noted, is reducing the number of drugs taken unnecessarily, especially by elderly patients. By one estimate, more than 40% of Americans aged 65 years or older use five or more different medications weekly (Arch Intern Med 2004;164:1957-1959). Older patients tend to be more sensitive to drug side effects.

It’s not uncommon, Mr. Federico said, to hear of elderly patients whose symptoms of dementia and confusion disappeared after they stopped taking certain medications. “Pharmacists can recognize polypharmacy, which I define as ‘more drugs than a patient can handle,’ and point out to prescribers inappropriate medications that are being prescribed.” They also can consider which medications for chronic diseases that, although appropriate for younger patients, will not benefit an older population, he said, adding that the Beers Criteria for Inappropriate Medication Use in Older Adults is a valuable guide for making treatment decisions, Mr. Federico added.

Because drugs are the most common intervention in health care, they are frequently a component in errors. Mr. Federico argued that focusing on pharmacists in such cases is misguided because medication errors are hospital problems, not pharmacy problems, and, therefore, require a hospital-wide response. “Pharmacists can play a vital role when the medication management system goes wrong, and they’re well placed to take a lead in finding solutions, but they must be supported by a multidisciplinary team,” he said.

A Mathematical Approach To Preventing Drug Errors

James Broselow, MD, an emergency room physician and chief medical officer of eBroselow, LLC, has taken a different angle of attack against medication errors, endeavoring to “take the math” out of medicine. Dr. Broselow is the latest recipient of the Institute for Safe Medication Practices Lifetime Achievement Award. He is best known for developing the Broselow Tape, which greatly reduces the need for practitioners to make treatment calculations (e.g., drug doses, equipment size and defibrillator voltage) while they are contending with the intense pressure of pediatric emergencies.

A similar arithmetical quandary underlies many medication errors, Dr. Broselow noted during the ASHP session. Computations are constantly in play when drugs are manipulated in the hospital: diluting IV agents, dose conversions, metric conversions, reconstituting powders, figuring a dose based on patient weight, to name a few. According to one study, 80% of 10-fold dosing errors go unrecognized, and more than one-third of drug dilutions are done improperly (J Patient Saf 2009;5:79-85).

“I don’t think we realize how much time and effort is spent on math,” he said. And whereas CPOE helps reduce prescribing errors, it doesn’t address mistakes related to drug preparation and administration. Dr. Broselow asserted that such failures are responsible for 40% of medication errors. So he developed a web-based system, called Artemis, which is designed to reduce that number, particularly in acute care settings. Artemis merges the parameters of the physician’s order with a bar-code scan of the drug vial to produce standardized and precise information about how to mix and administer the medication. Administration guidelines, pump settings and warnings also are displayed further along in the medication management process when a clinician scans the bar code applied to the final preparation. “The goal is to standardize and automate the entire process,” explained Dr. Broselow. “After all, alerts are helpful, but it’s best not to make the mistake in the first place.”

Artemis is available commercially (bit.ly/14lX30a) and is being used in more than 200 hospitals, primarily in the United States, Dr. Broselow noted via email. He declined to give specific information regarding pricing, but said the system would be “inexpensive for a hospital; it usually doesn’t need to be a budgeted item.”

Natasha Nicol, PharmD, the director of medication safety for Cardinal Health, which organized and moderated the seminar, said Dr. Broselow’s system “removes many complex calculations needed to prepare compounded drugs, and it removes the need for people to remember things. We need more solutions like that.”

Among Dr. Nicol’s goals was to make the audience recognize the astounding complexity of many health care processes and understand that many of the processes are broken. Flaws in our health networks are inevitable because every component, every system and subsystem, is designed and implemented by fallible humans, “but we continue to be too complacent about how things work in health care,” she said. “We continue to accept the situation because we were trained that this is the way things are. That attitude has to change. Sometimes, we make it so complex and so difficult to do the right thing that it’s really a wonder we get anything at all done correctly. I hope the seminar opened people’s eyes and expanded their imaginations so they see that these systems can be simpler, and by simplifying them, we make them safer.”

Drs. Ennis and Nicol and Mr. Federico reported no relevant financial conflicts of interest. Dr. Broselow is the founder of eBroselow, which markets the Artemis drug dosing and tracking system.