Connie M. Larson, PharmD, and
Deb Saine, MS, RPh, FASHP, FSMSO
Pharmacy Purchasing & Products: What factors prompted you to co-author/co-edit the Medication Safety Officer’s Handbook, published this year by the American Society of Health-System Pharmacists?
Connie Larson: In recent years, organizations have begun investing more heavily in practitioner FTEs to actively manage the many complex medication safety challenges inherent in health care. As more health system leaders recognize the benefits of designating a specific staff member as the medication safety officer (MSO), the need for evidence-based resources to guide medication safety initiatives has likewise increased.
Deb Saine: I began my career in medication safety more than 20 years ago, when the concept of designating a specific individual to oversee medication safety was new in health systems. Since that time, the position has progressed and expanded exponentially as hospitals seek to prevent patient harm related to medication use. As more professionals became MSOs, there has been a corresponding increase in medication safety interest expressed in networking sessions, meetings, and local and national pharmacy conventions. Sharing information at these events proved extraordinarily helpful for MSOs, and after attending conferences for several years I began identifying common areas of concern unique to the MSO position. The utility of a handbook comprising valuable data to guide both MSOs first entering the field, as well as currently practicing MSOs to further develop their knowledge and practice, became apparent.
Numerous medication safety training options are available for pharmacists who wish to transition into the role of the MSO or expand their professional development (see SIDEBAR).
PP&P: What is the role of the MSO?
Larson and Saine: Although MSOs may be employed at different levels of an organization—either for an individual hospital, an entire health system, or at the corporate level—their overarching goal is the same: to prevent patient harm. The foundation of achieving this goal is creating and maintaining a responsible safety culture throughout an organization. Developing a culture where safety guides decisions at all levels of practice is a fundamental responsibility of the MSO.
To develop a robust safety program, a variety of mechanisms to highlight safety issues are required, including education sessions that encourage active staff engagement, role modeling, and gathering safety information from various resources. Begin with an evaluation of existing systems to identify the current strengths and weaknesses of your program; this will allow you to develop improvement strategies using a process improvement framework. Utilizing every possible source of relevant information—including internal knowledge (eg, event reports, near misses, safety rounds, technology data mining) and external knowledge (eg, professional literature, newsletters, networking)—will best ensure an accurate appraisal of current practice vs best practice. Because patient care involves numerous health care providers, the MSO must be cognizant of educating and training all staff involved in the medication use process. The ASHP statement on the role of the medication safety leader is particularly useful (available at http://www.ashp.org/DocLibrary/BestPractices/MedMisStLeader.aspx).
PP&P: Describe a typical day in the life of an MSO.
Saine: One of the most fulfilling aspects of being an MSO is the variety of activities I am involved with on a daily basis. Those who thrive in a fast-paced environment and enjoy addressing and resolving various challenges are particularly suited to the role of MSO. Daily tasks may include responding to urgent safety concerns, reviewing event reports, participating in safety rounds, and attending meetings to discuss a variety of safety-related topics. MSOs typically attend meetings with a multidisciplinary team that is tasked with developing a comprehensive approach to patient care, including the continuum of care, sentinel event, root cause analysis, and lean process management groups. On any given day, the MSO may work with the pediatric, ED, critical care, or medical imaging teams. In addition, the MSO is called on frequently to offer a medication safety perspective, as well as to provide information on regulatory and accreditation standards. The MSO also is influential in developing and reviewing policies and procedures (P&Ps) and order sets.
Larson: The University of Illinois Hospital & Health Sciences System utilizes a proactive patient safety program that requires timely event action and follow-up, especially in the case of patient harm. These crucial consultations are always first priority and are addressed immediately. Other regular tasks include medication safety document and clinical care guideline development, as well as revision of P&Ps. Throughout the day, staff often brings medication safety–related concerns to my attention. Drug shortages provide an ongoing source of nearly daily consideration. The medication safety challenges that arise from drug shortages require attention to detail to ensure safe use. It is often necessary to collaborate with the Medication Safety Committee members outside of regular meetings, and seek out input from other key individuals to identify and implement proactive error prevention strategies.
PP&P: What are the ideal attributes of an MSO?
Larson: A collaborative nature is the most important quality in an MSO. Excellent communication skills and the desire to collaborate across departments are essential qualities for ensuring the success of multidisciplinary medication safety initiatives. The ability to relate to colleagues in different departments and appreciate the challenges they face when managing medications will best ensure medication safety issues are appropriately addressed. Staff will feel more comfortable working with the MSO and provide valuable input into P&Ps that accurately reflect a process that can be consistently followed.
Other useful attributes of an effective MSO include an understanding of all aspects of the medication-use system, human factors knowledge, awareness of the holistic nature of health care systems, and familiarity with performance improvement methodologies and tools. Leadership skills, active listening, and time and project management also are critical to success, as is the ability to function on a proactive rather than reactive basis.
Saine: Three qualities are crucial to ensuring an MSO’s success: resilience, patience, and persistence. The MSO’s challenge is to make change happen while often having little or no formal authority. These qualities are necessary to negotiate agreement among diverse interdisciplinary practices, and drive process change. In addition, an MSO must possess a strong understanding of the medication-use system, knowledge of performance improvement methodologies and tools, change management concepts, and Just Culture. Success is dependent on excellent leadership skills, including assertiveness; the ability to communicate clearly; and the ability to think holistically about the medication-use process throughout all departments. Also, due to the variable nature of job requirements, the ability to transition quickly from one task to another, project management expertise, and prioritization and analytical skills are critical.
PP&P: What process should a hospital follow to implement a new MSO position?
Saine: Begin by making a case to justify the creation of the position. Oftentimes hospitals will use a combination of its own experiences, near misses, and professional literature to gain administrative support. Information from the Institute of Medicine, National Quality Forum, and ASHP also are valuable to include as supporting documentation to identify the scope and remarkable potential of the MSO position. Meeting with currently practicing MSOs to discuss how to plan for, develop, and implement the position also may be helpful.
There are many options to consider for reporting structure; however, reporting to senior management affords the MSO authority and empowerment to facilitate change and align safety efforts with other key leaders.
Larson: The pharmacy director should champion the project and coordinate the development of the MSO position, working with risk management and quality improvement staff. The new position may attract a seasoned medication safety practitioner, or there may be a qualified candidate within the pharmacy department who could transition into the role. Discuss the implementation of the MSO position with staff early on in the process and explain how this person will work with and help the staff; hopefully they will accept the MSO and buy-in to the change.
PP&P: What elements should be included in medication safety training for staff?
Larson: Educating staff on human factors concepts—exploring how and why errors occur—will help them understand and appreciate when they may be vulnerable to making mistakes and what steps can be taken to prevent these errors. For example, in one exercise a paragraph is presented that contains rearranged letters; although the words are misspelled, it is still possible to read and understand the paragraph. This highlights how the brain processes information and why staff may sometimes mix up drugs. In addition, storytelling can be a powerful educational tool to make staff aware that medication errors do not only occur in other hospitals, rather, they can—and do—occur in their own organization. Humanize these stories, make it clear to staff that medication errors are not just numbers; they affect real people.
Saine: Medication safety training should begin during a new employee’s orientation and continue regularly thereafter. The MSO should describe the role of the MSO, discuss relevant safety concepts, and should stress the importance of event reporting and include hands-on experience. Staff should go through the actual event report process as part of their training. Next, be sure to describe the hospital’s medication use system and key medication management policies, as well as regulations, accreditation, critical standards, and National Patient Safety Goals. Throughout this process, it is vital to provide education on medication use technologies, including how to address alerts, warnings, and messages in order entry systems, bar code verification systems, and smart pumps. It may also be wise to discuss the medication safety resources available and the identification and role of various internal committees that address medication safety concerns.
PP&P: How can the MSO help prevent patient harm throughout the entire medication use process?
Saine and Larson: The MSO is responsible for ensuring medication safety at all stages of drug use—procurement, documentation, transcribing, preparing, dispensing, administration, documentation, and monitoring. Assessing each element of the process separately, while understanding the essential connections between them, and identifying the potential areas where errors could occur, is critical. Be aware that changing processes in any medication use process may have unforeseen consequences that influence other care areas or departments. For example, changing a concentration of an IV infusion due to shortage not only impacts dispensing and storage, but also may necessitate change in prescribing order sets (paper or electronic), smart pump libraries, paper “drip charts,” flow sheets, and procedural area protocols. Active communication among all stakeholders is necessary to mitigate any repercussions.
The MSO may choose to employ different frameworks for process improvement, including plan-do-check-act (PDCA), failure mode effects analysis (FMEA), root cause analysis (RCA), lean, or Six-Sigma, each of which has its own set of tools. Various error-prevention strategies can be used to reduce the likelihood of medication errors. Remember that systems change—such as error-proofing, standardization, or simplification—is more effective than providing re-education. Having robust P&Ps in place is central to process improvement, but do not assume that because P&Ps are in place they are being adhered to. The MSO should regularly walk around, observe practices, ask questions, and collect data to evaluate the effectiveness of P&Ps.
Various technologies and automation solutions can assist in ensuring a safe medication process. The benefits of computerized provider order entry, bar code verification for medication dispensing or administration, automated dispensing cabinets, and smart infusion pumps are clear. Deciding which technologies will provide the most benefit for your institution requires close assessment, as well as a strong understanding of the overarching safety goals of the hospital.
PP&P: What are the most important elements of developing and maintaining a culture of safety?
Larson: As an MSO and patient safety advocate, effective leadership is essential to ensure a culture of safety. As a leader, the MSO must be visible, accessible, and credible. When staff clearly understand and accept the expectation of P&P adherence, they are more likely to view the entire medication use process from a safety perspective.
Saine: Stress the components of a Just Culture, a practice that represents a balanced approach. While Just Culture emphasizes the role of systems in error, it also focuses on behavioral choices and personal accountability. It is helpful to apply the Swiss cheese model of system failure to illustrate how and why errors occur.
Engage staff by including them in safety-related activities, such as safety rounds, daily safety calls, event follow-ups, lean projects, and problem-solving sessions. Add safety considerations as a standing discussion point at the top of meeting agendas to ensure medication safety is addressed consistently and proactively.
The Medication Safety Officer’s Handbook can be purchased at the ASHP book store: http://store.ashp.org/Default.aspx?TabId=216&ProductId=4228
Connie M. Larson, PharmD, earned a doctor of pharmacy degree from the University of Illinois at Chicago College of Pharmacy and currently serves as associate director of pharmacy, safety, and quality and medication safety officer at the University of Illinois Hospital & Health Sciences System in Chicago.
Deb Saine, MS, RPh, FASHP, FSMSO, is the program manager, medication safety, at Valley Health/Winchester Medical Center in Winchester, Virginia. She has authored numerous articles and has presented internationally on the topic of medication safety, and served in ASHP leadership positions. Deb received her BS in pharmacy from the University of Toledo and an MS in management from Antioch University.
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