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National Medication Safety Managers See Big Picture

Donna Young

As a pharmacist in a national medication safety role, Patricia C. Kienle, medication safety manager for the pharmacy management business of Cardinal Health, spends about 90% of her time traveling the nation visiting the 300 inpatient facilities that her company manages.

The facilities range in size from "tiny critical access hospitals" to 1800 beds, she said.

"It almost takes somebody who has had a good deal of experience to be in a role like this," she said. "A lot of it is presentation skills. This position is a mixture of the ability to write some things, to present to others, and to kind of think on your feet as you're challenged, particularly by medical staff, about what's a better way of doing things."

A major focus for Kienle and her colleague, pharmacist Lee Murdaugh, during hospital visits is ensuring that facilities are meeting medication management standards and National Patient Safety Goals set by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO).

"We assess the whole hospital's compliance with those standards and goals and actually spend a lot of time not just in the pharmacy but on the nursing units, in the [operating room], with nursing staff, medical staff, and [making] presentations to boards of directors concerning medication safety," Kienle said. "So we kind of get involved in the whole system and how their medication process runs and if there's any holes in it."

In her role, Kienle said, she is able to share successful problem-solving schemes with a "broad array" of hospitals.

"We can take ideas that we've seen in one place and provide them to another," she said.

Some hospitals recognize potential safety issues, she noted, but they are not always aware of how, "in a practical manner," they could fix a problem.

Hospitals are being more assertive about informing the public that they are promoting patient safety, Kienle said.

"That seems to be a consistent mantra," she added.

Lieutenant Colonel Jasper W. Watkins III, deputy Army pharmacy program manager for patient safety and directorate of health policy and services in the Office of the Army Surgeon General, wears multiple hats in his job.

He assists Colonel Mike Heath, the pharmacy consultant to the Army Surgeon General, in the day-to-day activities of managing pharmacy automation requirements to ensure that JCAHO'S National Patient Safety Goals are met by the Army Medical Command (MedCom) and the Department of Defense (DOD).

Watkins also serves as the medication-use safety coordinator assisting MedCom's quality management and patient safety programs at Fort Sam Houston in Texas.

He is charged with educating MedCom personnel about their roles and responsibilities in medication-use safety and establishing an environment of trust, cooperation, and communication to facilitate an interdisciplinary, proactive approach to improving medication-use and patient safety.

"I also make sure that pharmacy is integrated in the responsive health care system that we have in the Army and in the DOD and make sure that we in pharmacy demonstrate the critical attributes that show a culture of safety," Watkins said.

He is responsible for assisting DOD's Patient Safety Center in identifying effective strategies for increasing adverse-event reporting by military treatment facilities through the use of the United States Pharmacopeial Convention's MedMARx system, a Web-based database for hospitals to anonymously report and track medication errors in a standardized format.

Watkins also ensures that Army pharmacists and pharmacy technicians are current with credentialing and clinical practice guidelines.

Watkins said that his time as an officer-in-residence in patient safety with the American Society of Health-System Pharmacists (ASHP), in which he completed a 12-month Army Training With Industry program, provided him with the skills to handle his multiple roles with the Army.

"I can say with conviction that it was through my time at ASHP and my role with Kasey [K. Thompson, ASHP's director of the Patient Safety, Practice Standards, and Quality Division] that allowed me to come into the Army Medical Department and make a difference in contributing to the quality management team in the military health systems," he extolled.

One of Watkins's main responsibilities is acting as program manager for DOD's bar-code-implementation planning for its military treatment facilities.

Watkins has sought advice from experts at FDA, the Department of Veterans Affairs (VA), the Institute for Safe Medication Practices (ISMP), and ASHP.

"I'm enlisting the help of all of the national leaders so that when the Department of Defense starts their initiative and the individual medical treatment facilities start their implementation according to the JCAHO standards, they will not have to scramble for a plan because we will already have a plan initiated for them," he said.

JCAHO is requiring hospitals to have a plan for implementing bar-code technology for matching patient identification to medications by January 2007, Watkins noted.

"That's my mission and my vision is to . . . have a plan so that DOD medical treatment facilities can implement bar coding," he said.

Bar coding has also been a major focus for Mary E. Burkhardt, program manager for VA's National Center for Patient Safety.

She works closely with VA's National Bar Code Medication Administration (BCMA) Joint Program Office.

One recent bar-coding project for Burkhardt was helping to coordinate the agency's BCMA Breakthrough Series, which involved 30 VA teams that worked on bar-code system improvement.

The project brought technical experts, such as the standards organization Uniform Code Council, together with "people who work in the trenches," Burkhardt said.

The first meeting in the series was held last October in San Francisco, California, and a second meeting was held in April in Dallas, Texas.

Burkhardt and her team also held teleconferences to discuss various issues, such as medication-related events and how to aggregate root-cause analyses, she said.

Burkhardt is also responsible for alerting facilities about problems with drug products.

In March, her team was able to notify VA medical centers about a nasal spray product that was contaminated with the pathogen Burkholderia cepacia about a week before FDA released an alert.

Burkhardt worked closely with VA's pharmacy benefits management, the distributor, and FDA on the situation, she said.

"It's like we're an early warning-signal system," she said.

When it suspects that there may be a potential problem with a drug's safety, FDA contacts VA to inquire if any of its medical centers have reported reactions with the product, she added.

Burkhardt also recently worked on a major upgrade of VA's software for allergy-related adverse drug reactions to standardize input into the system so that more potential events get tracked.

She also helps train staff for VA's consolidated mail outpatient pharmacy in health care failure mode and effect analysis.

As assistant vice president for patient safety for HCA, a Nashville, Tennessee, company that manages about 190 hospitals, Alicia B. Perry's job is to be "forward thinking and help plan and look for what the hospitals need to be thinking about for the future related to patient safety," she said.

Perry said her goal is to help find good practices at one facility and "cross-pollinate," or share those best practices companywide so that "learning doesn't stay in the silos."

A top priority for Perry is ensuring that HCA-managed facilities meet four patient safety goals: (1) putting patients first, (2) moving from blaming people to improving processes, (3) advancing the use of technology, and (4) improving the use of data to measure appropriately.

As part of her responsibilities, Perry said, she manages her company's medication safety "improvement schedule," a list of requirements for hospitals to work on independently.

Perry helps design the tools and resources for HCA hospitals to use for improvement, she said, but "they're pretty skeleton tools and resources because we really want the hospitals to use their creativity to come up with the best solutions. And then we reshare those solutions back with all of the hospitals. We're trying to leverage best practice across the company."

Each of HCA's facilities has an interdisciplinary medication safety team rather than one person designated as a medication safety officer, Perry noted.

"Our advocation has been over a team approach so that more people are involved to move the company forward together," she said.

Perry is also overseeing technology improvements related to the health system's electronic medication administration record, bar coding, and computerized prescriber-order-entry systems.