Chicago—Know your data, speak senior leadership’s language, and use proven methodologies to build a culture of safety that yields lasting change, L. Hayley Burgess, PharmD, urged pharmacy leaders at the American Society of Health-System Pharmacists annual leadership conference.

Most adverse events are caused by a system failure, not individual recklessness or incompetence, said Dr. Burgess, the director of medication safety and systems innovations for the Hospital Corporation of America, in Nashville, Tenn. As a result, pharmacists need to live and breathe failure mode effects analysis (FMEA) and root cause analysis (RCA), and become the champions and leaders of these methodologies in their facilities, she said.

“If you are implementing a new technology and you are not doing an FMEA before it goes live, shame on you, because you need to know the unintended consequences of what you do,” Dr. Burgess stressed. “If you are not looking for [those events,] you won’t find them until it’s too late.”

FMEA “is also a great team builder. Everybody’s working toward a solution together. Collectively, we know a lot, and we can point out all the different needs and all the different spaces where we can hurt someone.”

Allen J. Vaida, PharmD, BSc, the executive vice president of the Institute for Safe Medication Practices (ISMP), commented in an interview that FMEA and RCA are both useful tools but added that pharmacy leaders need to make sure staff undergo training in their use, as well as other methodologies, such as Lean process improvement. By doing so, he noted, when RCAs and FMEAs are conducted, they are done appropriately and effectively.

“Often we find [facilities] using the Lean methodology, but if they didn’t do a good RCA, they may be looking at the wrong process,” Dr. Vaida said. “When you get a group of individuals in an organization going through an event investigation and going through an RCA, they might not appreciate all of the other risks that they should be addressing,” unless some people have thorough training in the techniques.

Dr. Burgess stressed the importance of asking physicians and nurses for feedback on what the pharmacy department can do better and where they believe the next harmful event could occur. “They will tell you, and then you need to act on it if you ask the question,” she said.

Dr. Burgess also encouraged pharmacy leaders to tap the full range of safety improvement strategies. “We spend an awful lot of time on education and information, and it’s not that it’s not important,” she said. “But policies and procedures, checklists and double checks, standardization and protocols, automation and computerization, and forcing functions and constraints should all be part of the mix.” In every one of these key areas, “there is something you can do to prevent harm.”

It is also important to know when it makes more sense to outsource certain services, Dr. Burgess noted. In short, “Don’t do things you don’t do very often and don’t do well,” she stressed. In the case of total parenteral nutrition, for example—a service that requires complex safety checks and workflows— “think about who else can do it and do it better,” she said. “If we’re smart about how we venture into [safety], we don’t have to own every piece of it. Own what you can manage and own what your expertise is.”

Overcoming Barriers

The barriers for pharmacists often are more cultural than informational, Dr. Burgess noted. “We have more information and more data than we know what to do with,” she said. But the ability to use that information to create meaningful change means aligning pharmacy’s goals with those of senior leadership.

“If I don’t understand how the leaders of my company behave and what the culture is for RCA—if I don’t understand our mission and our values and drive toward that in all of my actions, and map back to what the expectation is in my company—I’m not going to have good outcomes,” she said.

Unity with leadership—the sense that “we are in this together”—makes lasting improvement possible, Dr. Burgess said. “I know how my leadership responds when I pull the alarm and say something is wrong—that we have identified something that is going to hurt someone. They listen and they understand. If that’s not occurring in your organization, you need to understand why.”

And don’t wait for leadership to show interest in you, she said. Take the reins. If administration has not already engaged you in a conversation about pharmacy’s future with health care reform, “then you need to be knocking on their door and telling them where you believe pharmacy’s role is. If you don’t, you will be left behind,” and you will have your role defined for you, rather than determining your department’s own destiny and advancing your practice.

“Why is your program any more special than the 10 other people who are going to your leadership asking for money or time? They need to know the financial side. Know your elevator speech. Have your story ready.”

According to Dr. Vaida, pharmacists can connect with leadership by using the ISMP Medication Safety Self-Assessment and other tools ( to show how the organization can address Joint Commission standards or Centers for Medicare & Medicaid Services requirements.

“You’ve got to be able to relay to leadership that what you are doing is not only going to improve care but is also going to decrease readmissions and decrease adverse events that may fall into those ‘never’ events that you may not get paid for,” Dr. Vaida said. “You have to have that full picture of the organization.”

A Framework for Change

Changing organizational approaches to safety is almost never easy, so implementation tools can be an effective facilitator, Dr. Burgess noted. She encouraged the use of the “4A” model—awareness, ability, accountability and action—as a framework for sustainable change. Is everyone on your staff aware of your data and your gaps, and of how well equipped you are to close them? If you don’t have the staff, budget or technology, “it doesn’t mean that you can’t do it, but know the barriers that are ahead of you. Don’t set your people up to fail,” she said.

Be clear about what you are asking your staff to do; create metrics, timelines and a dashboard so that everyone is on the same page; use a project management tracking tool to monitor progress; and hold people accountable, she added. “If I believe it is important enough to ask them to do it, then I need to measure whether or not it was done. [Accountability] is not a bad thing.”

Actions can include daily team briefings and huddles to review harmful events of the past 24 hours and discuss potential harmful events in the coming day. Other useful actions include walk-arounds, team improvements based on FMEA and RCA, safety improvement contests, and team discussions of key events covered in the Quarterly Action Agenda and other publications of the ISMP (​newsletters).

“Share those on your director of pharmacy calls every month,” Dr. Burgess said. Choose one or two relevant items to discuss and “make it easy; make it actionable.”