Establish a Successful Medication Safety Program 
Most hospital pharmacists are aware of the many statistics in the literature describing the incidence of medication errors and harm that occur due to adverse drug events (ADEs), as well as the cost of harm. ADEs are the most frequently cited cause of significant harm and death among hospitalized patients¹ and at least 1.5 million preventable ADEs occur each year in the United States.² Similarly, most hospital pharmacy professionals are aware of the deaths of nine patients earlier this year in Alabama due to contaminated total parenteral nutrition.³ However, isolated cases of serious medication errors that cause death may be less well known. A fatal medication error reported in the ISMP Medication Safety Alert newsletter earlier this year relayed a tragic outcome involving a six-week-old infant who died after receiving a parenteral nutrition solution that contained 60 times the amount of sodium prescribed.⁴

While reports of millions of people experiencing serious ADEs each year is difficult to comprehend, the death of one baby due to medication error is not. Because compounding and other types of serious medication errors can—and do—happen at any hospital, pharmacy leaders must take every step possible to decrease this risk. Pharmacists must assume an important leadership role to reduce patient safety risks, optimize the safe function of medication management systems, and align pharmacy services with national initiatives that measure and reward quality performance. The grave nature of the potential hazards and serious harm associated with medication error clearly demonstrate the need for a successful medication patient safety program, ideally led by a pharmacy medication safety officer. 



Develop an Effective Medication Safety Program
A medication safety program should not be segregated from a hospital’s overall patient safety and quality program, although it should be led by the pharmacy department under the direction of the medication safety officer with support from the pharmacy and therapeutics (P&T) committee. The foundation of a successful program is a dedicated, willing pharmacist leader. The program should fit with the goals and objectives of the hospital’s overall plan. It is prudent to begin the program with a strategic medication patient safety plan that starts with a goal statement and lists manageable goals. For example, initial goals could include: 

• Identify high-risk medications or processes in the medication use system and implement changes that reduce the number of medication errors leading to harm or the potential for harm; focus on your organization’s top three high alert/harmful medications and develop metrics to measure results 
• Increase medication error, ADE, and adverse drug reaction reporting by all hospital staff
• Communicate regularly to hospital staff regarding medication errors, including case examples, and increase awareness of medication error safety metrics (report back to staff)
• Recognize hospital staff for their medication error reporting effortsThe strategic plan should be approved by the P&T committee and medical executive committee to increase awareness, solicit feedback, develop buy-in and support from multiple disciplines, and should be reviewed by risk management and patient safety as well.

An ideal medication safety program involves a variety of disciplines as team members, including medical staff (key patient and medication safety advocates, especially those with strong pharmacy support), nurses, pharmacists, respiratory care, the emergency department, operating room, anesthesiology, staff from hospital-based clinics, hospital departments (ie, radiology, the GI lab, cardiac catheterization lab), risk management, the patient safety department, and hospital administration. 

Pharmacy-driven Leadership 
Because pharmacists are the medication safety experts, pharmacist leadership is key to the implementation of medication safety initiatives. Regulatory agencies and national organizations, including ASHP and the National Quality Forum, hold pharmacists accountable for safe medication use. Pharmacists must earn the respect of other disciplines and hospital departments and be recognized in the hospital culture as the experts on safe medication use. 

One way to accomplish this is to demonstrate and showcase successes of pharmacy-led medication use safety initiatives to as many forums as possible, especially at clinical and administrative levels; for example, meetings that include high-level physician and nursing representation—such as the total quality council, medical executive committee meetings, and patient safety committee meetings—are ideal. For credibility, this requires data and outcome measures. Pharmacy leadership and the medication safety officer should engage a physician champion(s) supporting medication safety; key nursing leaders who respect and support pharmacy; hospital administrators, including the chief executive officer, chief quality officer, and vice president; the patient safety officer; the hospital director of accreditation/regulatory compliance; risk management/patient safety department leadership; and quality improvement department leadership. Support from a well-respected physician champion is vital to the project’s success—if your facility does not have one, it is essential to investigate interested parties and enlist one.

Expectations for the Medication Safety Officer 
A medication safety officer should be a practitioner—preferably a pharmacist—chosen by hospital and pharmacy administration to serve as the leader and expert in safe medication use to improve safety throughout the hospital. Their mission should be to prevent patients from being harmed by medications and their use. This individual must be a patient safety advocate who puts patients first, and not a department or specific profession, and exhibits an unyielding passion for patient and medication safety above all else; an ideal medication safety officer exhibits a never-give-up attitude. He or she must challenge the organization to review all medication use systems and processes for areas of risk, always remembering the patient who is at the end of the medication use process. 

Knowledge of hospital medication use processes from prescribing to administration and monitoring is vital to the individual’s success in this important position. A medication safety officer is responsible for considering the big picture of the facility specifically, and also the health system holistically. Inherent in the job function is the ability to work with versus against the hospital culture. This position requires an intricate understanding of how the organization is structured, including any politics among departments and any sensitive dynamics. If the organization has a patient safety plan, the medication safety officer should obtain a copy and ensure proper alignment with the medication safety plan. Experience in clinical pharmacy and pharmacy operations are important to the position; if the individual does not have these skills, he or she should build relationships and utilize the skill sets of others (eg, unit-based pharmacists or clinical specialists). 

It is helpful for the officer to be knowledgeable of, and if possible, experienced in, regulatory compliance (TJC, CMS, and/or the department of health), as patient medication safety and regulatory compliance are tied closely together. The medication safety officer also should have an understanding of human factors engineering and Just Culture concepts. Most importantly, the medication safety officer will be expected to provide safety solutions for medication events and ADEs (see Table 1 for a list of responsibilities and attributes of an effective medication safety officer). 



Click here to view a larger version of this Table

The medication safety officer should appeal to the director of pharmacy when additional funds are required for safety initiatives. Discuss serious or potentially serious local or national medication errors related to specific patient safety initiatives, such as implementing smart pumps. Utilize the help of the risk management and patient safety department to justify costs. Highlighting any pending legal suits and associated costs, and using medication error and ADE metrics, can help prove your case.

Once the medication safety officer is established as an integral part of the facility’s safety culture, he or she should maximize effectiveness by taking the job requirements and expectations to the next level. He or she should become a member of national safety organizations, such as ASHP, the Institute for Healthcare Improvement, the National Patient Safety Foundation, and the American Society of Medication Safety Officers, and should network with safety officers from other facilities. Sharing medication safety issues and actions via list serves or professional networking sites and utilizing external safety resources—for example, TJC, ISMP, ASHP, the Institute for Healthcare Improvement, National Quality Forum, FDA, and the National Coordinating Council for Medication Error Reporting and Prevention—will ensure fresh ideas and help solve complicated medication concerns. Sharing stories of actual medication events with colleagues and at conferences will ensure greater impact than speaking in abstract concepts. The medication safety officer must consistently engage frontline staff and respond promptly to staff concerns to earn respect and gain their trust so that they are comfortable coming forward with patient safety issues. Establish the expectation that when a safety breach is uncovered, staff at all levels of the organization will recognize the safety issue and report directly to the medication safety officer. 

Create a Medication Safety Committee 
A multidisciplinary medication safety committee, as a subcommittee of the P&T committee, led by the medication safety officer or pharmacist, is vital to a successful medication safety program. This committee is responsible for discussing and evaluating frontline staff’s medication safety concerns, as well as reviewing harmful or potentially harmful medication events reported or detected. A thorough review of medication error and ADE metrics is essential to such a committee. Individuals on this team should review national medication safety reports (eg, ISMP Medication Safety Alert newsletters) and evaluate drug shortage issues that could potentially impact patient safety. For example, a shortage of HYDROmorphone 1-mg and 2-mg syringes requires the use of higher dose 4-mg syringes, which could lead to an overdosing error or EPINEPHrine emergency syringe shortage, which requires the use of different concentrations and could lead to wrong dose errors. The committee should review and discuss medication use policies impacting medication safety (eg, intravenous use of ketamine). This group should hold patient safety dialogues to define issues and develop common goals and priorities for performance improvement initiatives, and also establish accountability to accomplish action agenda items. Involving representatives from frontline staff, including clinical staff and pharmacy technicians, will be helpful to increase staff’s level of support for medication safety initiatives and to utilize their process knowledge. 

Members of the committee may include medical staff representatives (specifically key patient and medication safety advocates, especially those with strong pharmacy support), nurses, pharmacists (committee leaders), respiratory care providers, and representatives from the following key departments: emergency department, the OR, anesthesiology, hospital-based clinics, hospital departments (radiology, the GI lab, and cardiac catheterization lab), risk management, the patient safety department, the patient safety officer, hospital administrators, and nursing leadership. 

Leadership from the Pharmacy Director
The pharmacy director’s role should focus on empowering the medication safety officer to facilitate safety endeavors and improvements in a supportive environment that validates an overall hospital culture of safety. For efforts to be successful, hospital and pharmacy leadership must back the medication safety officer by providing the necessary staffing, technology, and any additional resources required to carry out the initiatives of the medication safety program. The support and confidence of both the pharmacy director and the physician champion are essential to ensure the medication safety officer can successfully implement changes to improve processes. 

Keeping up-to-date with technology developments and providing a formal review of technologies being considered for purchase, as well as an implementation plan after purchases have been made, are critical to ensure technologies are aligned with patient safety in mind. In the event technology purchases have been made without the knowledge/approval of pharmacy and the medication safety officer, the pharmacy director should intervene. 

Safety Tools
Once a medication safety program has been developed and put into action, steps should be taken to ensure continued success. Technology should be integrated into the facility’s safety culture. If used with their safety features in place, smart pumps, computerized physician order entry, automated dispensing cabinets with scanning technology, bar code medication administration, and pharmacy robotics can improve upon and ensure success of the efforts of the medication safety program. 

Focus safety efforts by drug class based on the likelihood to cause harm, using metrics on preventable ADEs. For example, top harmful drug classes often include opioids, insulins, anticoagulants, and antibiotics. Use metrics to track top high-alert medications, classes, severity, and steps in the medication use process. The use of clinical dashboards can be helpful when tracking improvements over time. Dashboards can easily track medication safety initiatives over time and demonstrate to hospital administrators at a glance that improvements are being made (to view a sample dashboard, visit http://www.ihi.org/knowledge/Pages/Measures/ADEsper1000Doses.aspx). 

To ensure long-term compliance to new medication safety processes, develop a quality improvement indicator with a numerator and denominator and track improvement. For instance, for automated medstation scanning-on-restock compliance, the indicator would be the number of restocks scanned by a pharmacy technician and the denominator would be the total number of restocks that require scanning. 

Conclusion
The success of a collaborative and comprehensive medication safety program is dependent on a hospital-wide culture of patient safety, including a safety infrastructure, led by an empowered medication safety officer and supportive pharmacy director. Developing a strategic medication safety plan is essential to ensure patients receive the safest and most effective care during their hospital stay. The dire results of inaction demonstrate clearly that hospital and pharmacy leadership must address patient safety concerns proactively.

References

1. Starfield B. Is US health really the best in the world? JAMA. 2000; 284(4):483-485.
2. Committee on Identifying and Preventing Medication Errors, Aspden P, Wolcott J, Bootman JL, Cronenwett LR, eds. Preventing Medication Errors: Quality Chasm Series. Washington, DC: The National Academies Press; 2007.
3. Sack K and Williams T. Deaths of 9 Alabama Patients Tied to Intravenous Supplement. The New York Times. 3/30/2011. http://www.nytimes.com/2011/03/31/us/31intravenous.html Accessed September 9, 2011.
4. ISMP. Another tragic parenteral nutrition compounding error. ISMP Medication Safety Alert! April 21, 2011. http://www.ismp.org/newsletters/acutecare/articles/20110421.asp Accessed September 9, 2011. 

Joanne Kowiatek, RPh, MPM, FASHP, is an oncology pharmacist at the University of Pittsburgh Medical Center (UPMC) Cancer Centers and an adjunct assistant professor at the University of Pittsburgh School of Pharmacy in Pittsburgh, Pennsylvania. She previously served as UPMC pharmacy manager, medication patient safety. Joanne received a BS in pharmacy from the University of Pittsburgh and a masters of public management in health systems from Carnegie Mellon University’s H. John Heinz III School of Public Policy and Management. She also is director-at-large elect on the ASHP Section for Inpatient Care Practitioners Executive Committee. Joanne has authored numerous journal articles and book chapters contributing to medication safety literature.