ASHP Guidelines on Preventing Medication Errors in Hospitals
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Medication Safety–Guidelines 267 ASHP Guidelines on Preventing Medication Errors in Hospitals Purpose The purpose of these guidelines is to provide the phar- macists with practical recommendations and best practices The goal of medication therapy is the achievement of defined for preventing and mitigating patient harm from medication therapeutic outcomes that improve a patient’s quality of life errors in the health-system setting. These guidelines are pri- while minimizing patient risk.1 There are inherent risks, both marily intended to apply to the acute care setting because of known and unknown, associated with the use of medica- the special collaborative processes established in this setting tions (prescription and nonprescription). This document ad- (i.e., formulary system, pharmacy and therapeutics com- dresses medication errors, defined as any preventable event mittee, widespread use of automation and electronic health that may cause or lead to inappropriate medication use or records [EHRs], and opportunity for increased interaction patient harm while the medication is in the control of the among healthcare providers). However, many of the ideas healthcare professional, patient, or consumer. Such events and principles in these guidelines may be applicable to prac- may be related to professional practice, healthcare products, tice settings outside of the acute care setting, especially in procedures, and systems, including prescribing, order com- health systems. munication, product labeling, packaging, and nomenclature, Medication errors can occur at any point of the medi- 7 compounding, dispensing, distribution, administration, edu- cation-use system. For the purposes of these guidelines, the cation, monitoring, and use.2 medication-use system is defined in Figure 1. The landmark Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System, published Planning for Safe Medication Practices in 1999, increased the national focus on improvements and 3 the prevention of errors in patient safety. This report drew Safe medication practices begin with placing medication attention to the significant problem of medical errors in the safety as anorganizational and departmental priority, and healthcare system, one type of which is medication errors. implementing a system that will support these practices. Other reports published after 1999 have drawn attention to The organization must have a comprehensive program that patient safety improvement efforts, including 5-, 10-, and includes a medication safety leader, key elements in place 4-6 15-year updates after To Err Is Human, as well as the 2007 to provide the structure for safe medication practices, and a release of IOM’s Preventing Medication Errors: Quality successful strategic plan.10 Key supporting elements include 7 Chasm Series. While the original IOM report increased a culture of safety built on principles of just culture that is awareness of the significant risk of medical errors, the pace supported at all levels of the organization (from the C-suite 6 of change is slow, and there is more work to be completed. to the frontline), an event-reporting system, an interdisci- The outcomes or clinical significance of many medi- plinary medication safety team, a continuous improvement cation errors may be minimal, with few or no consequences philosophy regarding evaluation of errors and harm, and that adversely affect a patient. In addition, numerous medi- strong designs that assess and reduce the risk of errors. If cation errors go unrecognized and are not detected or re- any of these are not well developed, the organization should ported. Tragically, however, some medication errors result address them through the planning process in order to meet 8 in serious patient morbidity or mortality. Thus, medication the continuing goal of ensuring patient safety. errors (including close calls) must not be taken lightly, and A culture of patient safety, based on the principles of risk-reduction strategies and systems should be established just culture, provides a solid foundation for safe and effec- to prevent or mitigate patient harm from medication errors. tive systems and teamwork. In a just culture, safety is valued, 9 Reason stated that humans are imperfect, and errors reporting of safety risks is encouraged without penalization, should be expected. A system-based approach should be and the staff, leadership, and board of trustees are held ac- undertaken at institutions to prevent future errors; this ap- countable using a clear and transparent process that evaluates proach strives to change worker conditions and build de- the errors.8 The evaluation process separates events arising fenses, barriers, and safeguards to prevent errors from oc- from a flawed system design or inadvertent human error from 9 curring or mitigate the harm if errors do occur. Blaming behavioral choices that compromise safety11; there may be healthcare workers involved in errors or passively encourag- consequences when unjustifiable risk is knowingly taken by ing them to be more careful will not prevent errors since it an individual.10 A just culture environment should also in- does not change the underlying conditions that contributed clude a support system for second victims. Second victims to the error. are defined as healthcare providers who are involved in an The pharmacist should participate in multidisciplinary unanticipated adverse patient event, a medical error, or a pa- committees of the organization and take an active role in tient-related injury and become victimized in the sense that the evaluation and monitoring of the medication-use process the provider is traumatized by the event.12,13 Programs should throughout the hospital or healthcare system to examine be established to support the second victims and to educate and improve systems to ensure that medication processes healthcare professionals about the second-victim effect.14 are safe. Furthermore, health-system pharmacists have the A system for reporting and reviewing errors is an es- responsibility and expertise to lead collaborative, multidis- sential component of a medication safety system; the goal is ciplinary efforts to prevent medication-related problems that to enhance patient safety and prevent patient harm. Errors 10 can result in patient harm. and close calls should be reported and analyzed (e.g., root 268 Medication Safety–Guidelines Figure 1. This diagram is a modification of the Joint Commission’s medication management system, with the addition of 2 steps: patient admission and discharge. These steps were added to appropriately encompass issues that arise during admission and discharge (e.g., medication history and reconciliation errors, patient education barriers). cause analysis [RCA]) to identify the causes and develop tion identify medication safety risks within its system so measures to prevent similar occurrences.5,15,16 Other event that it can prioritize and plan for improvements. Proactive detection methods, such as trigger tools, chart review, data risk assessment tools, such as assessments available from from technology, and direct observation, should be consid- the Institute for Safe Medication Practices (ISMP) (www. ered to complement error-reporting efforts. There are a num- ismp.org/selfassessments/default.asp), may be used to iden- ber of commercially available software systems for online tify opportunities for improvement through a gap analysis.21 reporting and analysis of medication errors. ISMP also offers other risk assessment and best-practice A multidisciplinary medication safety team provides a tools that focus on specific areas, such as automated dis- collaborative and systematic approach to addressing medi- pensing cabinets (ADCs) and anticoagulation.22 ASHP also cation safety issues and problems as well as proactively as- publishes policy positions and guidelines that are national sessing risk.17 In order to ensure overall success, a medica- best practices (www.ashp.org/Pharmacy-Practice/Policy- tion safety leader, preferably a pharmacist, should lead the Positions-and-Guidelines). A failure modes and effects medication safety efforts throughout the organization. The analysis (FMEA) and a gap analysis are other methods that “ASHP Statement: Role of the Medication Safety Leader” can be used to complete a risk assessment. These proactive is an important guide.11 A pharmacist position dedicated to tools are used to identify the risk of failure before it occurs medication safety should be developed to ensure that phar- so that systems can be designed to minimize risk. Examples macists are key safety leaders in the organization. of where these tools can be applied include when evaluating Lastly, the organization must evaluate and adopt tech- high-alert medication processes as well as medication–re- nologies that will help reduce the risk of medication errors lated equipment (Appendix B).8,23 and help prevent patient harm.18,19 Pharmacists must be in- volved in technology decisions to ensure the safety and ef- Reducing the Risk of Errors. Organizations should pro- fectiveness of technology that impacts the medication-use spectively design and implement strategies to reduce cer- process.20 The application of individual technologies will be tain types of errors in order to prevent patient harm. Areas discussed in subsequent sections. that must be addressed are high-risk populations, high-risk processes, high-alert medications, and easily confused drug Risk Assessment. The process of