To Fly (or not): Starting a Medication Safety Program

Author: Dr. Dennis E. Schellhase
Assoc. Prof. of Pediatrics, Pediatric Pulmonology & Hospital Medicine,
University of Arkansas for Medical Sciences,
Dir., Pediatric Pulmonology Fellowship Program, Assoc. Dir., Pediatric Global Health Program, Patient Safety Officer, Arkansas Children’s Hospital

Behind the times
As I sat down to write and began to review the increasing literature related to reducing harm due to adverse drug events (ADEs), I realized that we start several years behind. In the past decade, a growing number of programs have implemented successful safety initiatives to reduce pediatric ADEs based primarily upon W. Edward Deming’s method of improvement model1-4. We have just begun to step away from the hierarchical top down approach of innumerable policies and procedures and to slowly and gingerly move toward a frontline approach to improve quality and safety utilizing the method of improvement model. We are not far from the drawing board and the steps to flying may yet be bumpy, painful, and difficult. But we want to fly; more than that, we want to soar.

What you don’t know will hurt you
Previously we became aware of problems with our medication management practices through the reporting of serious patient harm to our risk management group and the follow-up case review process. Based upon this method of discovery, we supposed harm due to ADEs to be rare. But we were about to be surprised! In April 2012, we implemented safety surveillance software ( that allows frontline staff to report events that have or may produce harm. During the first six months of use, there have been almost 800 medication events reported, of which just over 50% reached the patient and 13% required some sort of intervention. Several events have been serious safety events. Although luck is not a strategy, we feel awfully lucky that things aren’t worse. Dramatic harm discovered through the case review process seems to be only the tip of the proverbial iceberg!

Where have we been
In reality, we knew that ADEs were occurring, but they were dealt with through interventions, more education, and the formal policies of several committees. Informally, a nurse-pharmacy group worked on improving nursing practices and a medication safety group worked on decreasing administration errors. These groups brought forward barcoding and other frontline solutions to improve medication safety. But a few years ago both of these groups were disbanded after a major restructuring of our administrative processes. However, after the occurrences of several serious ADEs involving significant dosing errors, we realized that a multi-disciplinary medication safety group needed to be resurrected.

Mind the gap
The event that launched our medication safety group involved a serious Vancomycin dosing error in a patient admitted through our emergency department (ED). The initial response of the institution was to remove Vancomycin from the ED. However, there was considerable concern that this would result in unacceptable delays in giving Vancomycin and possibly other antimicrobials in a timely manner to septic and immunocompromised children. Bringing together frontline representatives from the pharmacy, nursing, physican, safety, and administrative staff to bridge the gap between no Vancomycin and some Vancomycin resulted in a unique solution for our ED that allowed safer dose calculation, double checking, and dispensing as well as timely drug administration. This framework for working together resulted in the formation of our medication safety working group.

What should we be doing?
Since this initial success, our medication safety working group has struggled to know its role in dealing with ADEs. We have looked at several aspects of medication administration: physician ordering, pharmacy dispensing, and nursing administration. We have been sidetracked by recent FDA concerns regarding the use of Sildenafil in children with pulmonary hypertension and Simply Thick® in neonates and young infants with dysphagia. Our efforts are ongoing. However, are we just a reactionary group or do we truly want a comprehensive medication safety program? At this juncture, we remain in formation and must soon decide whether to be reactive or proactive, to fly low or high.

Anticipated addition
In evaluating medication management, it became evident that we need a medication safety officer who can work with the pharmacy, nursing, physician, quality improvement, safety, and other frontline staff in designing and implementing processes for ADE prevention. This person will 1) become an integral part of our medication safety working group and play a pivotal role in our medication safety program; 2) need broad knowledge of pharmacy, hospital, unit, and clinical processes related to safe medication management practices; 3) need to be able to work across several disciplines and with a number of groups involved in medication practices. If it were not for the issue of being extremely knowledgeable, this person probably needs to be a highly adept politician!

I’ll get back with you on that
So I am brought back to the thoughts I had when I first started writing--as we develop and build our medication safety program, what are our goals and objectives, how do we engage frontline staff, how do we move from various silos of work to integration of our medication management practices, how do we design and implement safer processes, and where do we begin? We know the problem, we know that we sincerely want to reduce harm to children under our care, we are assembling the team, but the outcome, whether we fly or not, is yet to be determined. I will have to get back with you on that, perhaps in another year. In the meantime, your advice, thoughts, and ideas would be greatly appreciated.

1. Pediatrics 2006; 118:e1124-1129. Leonard MS, Cimino M, Shaha S, et al. Risk Reduction for Adverse Drug Events Through Sequential Implementation of Patient Safety Initiatives in a Children’s Hospital.
2. Pediatrics 2008; 122:e861-866. Sharek PJ, McClead RE, Taketomo C, et al. An Intervention to Decrease Narcotic-Related Adverse Drug Events in Children’s Hospitals.
3. Pediatrics 2011; 128:e438-445. Tham E, Calmes HM, Poppy A, et al. Sustaining and Spreading the Reduction of Adverse Drug Events in a Multicenter Collaborative.Pediatrics 2011; 129:e1334-1342.
4. Gazarian M, Graudins LV. Long-term Reduction in Adverse Drug Events: An Evidence-Based Improvement Model.