ASHP Guidelines on Preventing Medication Errors in Hospitals

Medication Safety–Guidelines 267

ASHP Guidelines on Preventing Medication Errors in Hospitals

Purpose

The goal of medication therapy is the achievement of defined therapeutic outcomes that improve a patient’s quality of life while minimizing patient risk.1 There are inherent risks, both known and unknown, associated with the use of medica- tions (prescription and nonprescription). This document ad- dresses medication errors, defined as any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient, or consumer. Such events may be related to professional practice, healthcare products, procedures, and systems, including prescribing, order com- munication, product labeling, packaging, and nomenclature, compounding, dispensing, distribution, administration, edu- cation, monitoring, and use.2

The landmark Institute of Medicine (IOM) report To Err Is Human: Building a Safer Health System, published in 1999, increased the national focus on improvements and the prevention of errors in patient safety.3 This report drew attention to the significant problem of medical errors in the healthcare system, one type of which is medication errors. Other reports published after 1999 have drawn attention to patient safety improvement efforts, including 5-, 10-, and 15-year updates after To Err Is Human,4-6 as well as the 2007 release of IOM’s Preventing Medication Errors: Quality Chasm Series.7 While the original IOM report increased awareness of the significant risk of medical errors, the pace of change is slow, and there is more work to be completed.6

The outcomes or clinical significance of many medi- cation errors may be minimal, with few or no consequences that adversely affect a patient. In addition, numerous medi- cation errors go unrecognized and are not detected or re- ported. Tragically, however, some medication errors result in serious patient morbidity or mortality.8 Thus, medication errors (including close calls) must not be taken lightly, and risk-reduction strategies and systems should be established to prevent or mitigate patient harm from medication errors.

Reason9 stated that humans are imperfect, and errors should be expected. A system-based approach should be undertaken at institutions to prevent future errors; this ap- proach strives to change worker conditions and build de- fenses, barriers, and safeguards to prevent errors from oc- curring or mitigate the harm if errors do occur.9 Blaming healthcare workers involved in errors or passively encourag- ing them to be more careful will not prevent errors since it does not change the underlying conditions that contributed to the error.

The pharmacist should participate in multidisciplinary committees of the organization and take an active role in the evaluation and monitoring of the medication-use process throughout the hospital or healthcare system to examine and improve systems to ensure that medication processes are safe. Furthermore, health-system pharmacists have the responsibility and expertise to lead collaborative, multidis- ciplinary efforts to prevent medication-related problems that can result in patient harm.10

The purpose of these guidelines is to provide the phar- macists with practical recommendations and best practices for preventing and mitigating patient harm from medication errors in the health-system setting. These guidelines are pri- marily intended to apply to the acute care setting because of the special collaborative processes established in this setting (i.e., formulary system, pharmacy and therapeutics com- mittee, widespread use of automation and electronic health records [EHRs], and opportunity for increased interaction among healthcare providers). However, many of the ideas and principles in these guidelines may be applicable to prac- tice settings outside of the acute care setting, especially in health systems.

Medication errors can occur at any point of the medi- cation-use system.7 For the purposes of these guidelines, the medication-use system is defined in Figure 1.

Planning for Safe Medication Practices

Safe medication practices begin with placing medication safety as anorganizational and departmental priority, and implementing a system that will support these practices. The organization must have a comprehensive program that includes a medication safety leader, key elements in place to provide the structure for safe medication practices, and a successful strategic plan.10 Key supporting elements include a culture of safety built on principles of just culture that is supported at all levels of the organization (from the C-suite to the frontline), an event-reporting system, an interdisci- plinary medication safety team, a continuous improvement philosophy regarding evaluation of errors and harm, and strong designs that assess and reduce the risk of errors. If any of these are not well developed, the organization should address them through the planning process in order to meet the continuing goal of ensuring patient safety.

A culture of patient safety, based on the principles of just culture, provides a solid foundation for safe and effec- tive systems and teamwork. In a just culture, safety is valued, reporting of safety risks is encouraged without penalization, and the staff, leadership, and board of trustees are held ac- countable using a clear and transparent process that evaluates the errors.8 The evaluation process separates events arising from a flawed system design or inadvertent human error from behavioral choices that compromise safety11; there may be consequences when unjustifiable risk is knowingly taken by an individual.10 A just culture environment should also in- clude a support system for second victims. Second victims are defined as healthcare providers who are involved in an unanticipated adverse patient event, a medical error, or a pa- tient-related injury and become victimized in the sense that the provider is traumatized by the event.12,13 Programs should be established to support the second victims and to educate healthcare professionals about the second-victim effect.14

A system for reporting and reviewing errors is an es- sential component of a medication safety system; the goal is to enhance patient safety and prevent patient harm. Errors and close calls should be reported and analyzed (e.g., root

268 Medication Safety–Guidelines

cause analysis [RCA]) to identify the causes and develop measures to prevent similar occurrences.5,15,16 Other event detection methods, such as trigger tools, chart review, data from technology, and direct observation, should be consid- ered to complement error-reporting efforts. There are a num- ber of commercially available software systems for online reporting and analysis of medication errors.

A multidisciplinary medication safety team provides a collaborative and systematic approach to addressing medi- cation safety issues and problems as well as proactively as- sessing risk.17 In order to ensure overall success, a medica- tion safety leader, preferably a pharmacist, should lead the medication safety efforts throughout the organization. The “ASHP Statement: Role of the Medication Safety Leader” is an important guide.11 A pharmacist position dedicated to medication safety should be developed to ensure that phar- macists are key safety leaders in the organization.

Lastly, the organization must evaluate and adopt tech- nologies that will help reduce the risk of medication errors and help prevent patient harm.18,19 Pharmacists must be in- volved in technology decisions to ensure the safety and ef- fectiveness of technology that impacts the medication-use process.20 The application of individual technologies will be discussed in subsequent sections.

Risk Assessment. The process of completing a medication safety self-assessment will help a health-system organiza-

tion identify medication safety risks within its system so that it can prioritize and plan for improvements. Proactive risk assessment tools, such as assessments available from the Institute for Safe Medication Practices (ISMP) (www. ismp.org/selfassessments/default.asp), may be used to iden- tify opportunities for improvement through a gap analysis.21 ISMP also offers other risk assessment and best-practice tools that focus on specific areas, such as automated dis- pensing cabinets (ADCs) and anticoagulation.22 ASHP also publishes policy positions and guidelines that are national best practices (www.ashp.org/Pharmacy-Practice/Policy- Positions-and-Guidelines). A failure modes and effects analysis (FMEA) and a gap analysis are other methods that can be used to complete a risk assessment. These proactive tools are used to identify the risk of failure before it occurs so that systems can be designed to minimize risk. Examples of where these tools can be applied include when evaluating high-alert medication processes as well as medication–re- lated equipment (Appendix B).8,23

Reducing the Risk of Errors. Organizations should pro- spectively design and implement strategies to reduce cer- tain types of errors in order to prevent patient harm. Areas that must be addressed are high-risk populations, high-risk processes, high-alert medications, and easily confused drug names, also known as “look-alike/sound-alike” (LASA) medications.

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).

Medication Safety–Guidelines 269

Two areas of focus are addressed below. High-alert medications are medications that have an increased risk of causing serious patient harm when used in error. A hospital- specific list of high-alert medications may be developed using the ISMP list of high-alert drugs in conjunction with the hospital’s patterns of medication use and harm events.24 Risk-reduction strategies should be implemented that will (1) prevent errors, (2) make errors visible, and (3) mitigate the harm if an error occurs.25 Strategies will be successful if they effectively address the underlying cause of error and impact as many steps of the medication-use process as possi- ble; a single risk-reduction strategy should not be depended on in most cases. When developing strategies, the literature should be used to identify risk-reduction strategies that have been proven effective, recommended by experts, or imple- mented successfully elsewhere (Appendix A).26

Examples of safety strategies include but are not lim- ited to

• Using oral syringes that cannot be connected to i.v. tubing ports along with education on the existence of oral syringes and safe use.

• Using epidural tubing without ports. • Using smart infusion pumps. • Using electronic prescribing systems with clinical de-

cision support. • Implementing barcode technology for the preparation,

dispensing, and administration of medications. • Employing evidence-based standard order sets and

protocols. • Standardizing concentrations, diluents, and container

sizes. • Using scales that only weigh patients in kilograms and

documenting weight only in kilograms. • Using commercially available products instead of

compounding. • Dispensing oral and parenteral medications in the

most ready-to-administer form. • Using oral measuring devices only in metric scale. • Performing independent double checks on dosing, in-

fusion pump programming, and concentrations when appropriate.

• Utilizing auxiliary labels when appropriate. • Improving readability of labels.

Medications that are commonly confused due to similarities in name, dosage form, or packaging should also be proac- tively addressed. Medications that are at risk of error can be identified by reviewing local data on errors and the list of confused drug names published by ISMP.27 Strategies should be implemented that address LASA medication risks. LASA error prevention strategies include differentiation, improved access to information, reminders, limiting access or use, and redundancies.28

Strategies for handling LASA medications include

• Using both brand and generic names when appropri- ate.

• Using tall-man lettering, color, or font to differenti- ate.29

• Including the indication for use on orders. • Limiting the use of verbal orders.

• Using read-back processes to minimize errors by spelling the medication name and stating the intended purpose.

• Implementing barcode technology and/or radio fre- quency identification (RFID) for the preparation, dis- pensing, and administration of medications.

• Avoiding abbreviating drug names if possible.

Product packaging is another source of look-alike drug er- rors. Strategies to minimize the risk of error include making items look different by purchasing products from different manufacturers, purchasing different-size containers, storing drugs in separate areas, and using alerts on the product and in the storage area.28

The practice of performing independent double checks has been widely promoted in healthcare to identify potential errors before they reach patients.30 However, misuse and im- proper execution of this practice could jeopardize medica- tion safety. Independent double checks should be selectively applied to certain medications after careful consideration to avoid excessive use and maximize its intent as an inde- pendently performed task. An independent double check requires 2 people and must be conducted independently by the second person to reduce bias and increase effectiveness. Avoid using independent double checks as a sole-reliance strategy. Independent double checks should be implemented in combination with other risk-reduction strategies to reduce the frequency of errors.

Pharmacists should be familiar with which medica- tions are managed via a risk evaluation and mitigation strat- egy (REMS). REMS is a Food and Drug Administration (FDA)-mandated program that seeks to manage the safe use of a medication with known or potential serious risks. The REMS may include a medication guide, patient pack- age insert, communication plan, elements to ensure safe use, and an implementation system. Requirements of REMS pro- grams are not identical among different medications; thus, it is important for pharmacists to understand the unique as- pects that may exist.31

Selection and Procurement

Selection and procurement of medications involve appro- priately selecting which medications will be stocked in the institution (the formulary) and then safely and effectively obtaining the medications from manufacturers and whole- salers. Best practices for decreasing the risk of errors during selection and procurement can generally be divided into 5 categories: (1) formulary assessment and management, (2) standard concentrations, (3) safety-alert monitoring, (4) safe procurement, and (5) medication shortage management.

Formulary Assessment and Management. A well-designed formulary system will guide clinicians to prescribe the safest and most cost-effective agent for treating a particular disease state or medical issue.32 Formularies limit the selection of medications available so that clinicians become proficient with the dosing, preparation, and administration practices of a selected number of medications. A streamlined formulary can also help to standardize the content of EHRs, pharmacy information systems, and infusion pump settings/medication libraries. Formularies should be designed to enhance the safe use of medications and not simply as a cost-saving measure.

270 Medication Safety–Guidelines

The “ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System” pro- vide detailed guidance on formularies and medication evalu- ation documents (i.e., monographs) and should be consulted for more information.32 In particular, when preparing an evidence-based formulary review document for a medica- tion, a section should be devoted to medication safety as- sessment and recommendations. In short, the pharmacist should consider whether the medication being reviewed for addition to the formulary has potential safety issues, such as a complicated admixture or administration process, a similarity in sound or appearance to another medication (i.e., LASA medication), dosing or duration limitations, a REMS program, admixture or administration handling pre- cautions, specific requirements on storage or waste, extrava- sation management, and significant serious adverse effects that should be monitored. This assessment should include a relevant literature search, including published studies and case reports, manufacturer information, and profes- sional organization and agency websites such as those of ISMP, FDA (e.g., MedWatch reports), accreditation agen- cies (e.g., Joint Commission), Centers for Disease Control and Prevention (i.e., occupational safe handling—National Institute of Occupational Safety’s List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings), and the Environmental Protection Agency (e.g., waste precautions). Health-system pharmacists may choose to develop and use a standard checklist for medication safety review of formulary additions; there are examples on the ASHP Medication-Use Safety Resource Center.33 If the medication is new and lim- ited information is available, pharmacists need to consider what potential medication safety issues could arise.

When medications with heightened error potential are added to the formulary, strategies to prevent medication er- rors should be considered. Preferably, these safety enhance- ments are established and implemented before the initial use of the medication and should be reevaluated as needed.

When planning for formulary additions and changes, the medication’s integration into technology should be care- fully coordinated. Dosage forms, concentrations, and order- ing options should be limited and standardized.

Questions to ask when integrating new formulary medications into technology include the following:

• Should the routes of administration available for selec- tion be limited?

• Are tall-man letters needed to distinguish from other medications?

• Are there significant medication interaction alerts that should be tested for appropriate firing?

• Are additional alerts or warnings needed for labora- tory monitoring requirements, pregnancy contraindi- cations, formulary restrictions, or other issues?

• Can appropriate and important lab results be displayed during order entry or verification?

• Are dose range–checking and smart pump–dosing recommendations integrated into the computer system and pumps? Are they correct?

• Should an order set be created to ease prescribing and monitoring requirements?

• Should the item be stored in ADCs? • Should the medication be able to be overridden in

ADCs?

• Are there additional alerts or warnings needed when withdrawing the medication from the ADC?

Standard Concentrations. Hospitals should standardize and limit the number of medication concentrations available; in- deed, many regulatory agencies require the use of standard- ized concentrations. Standardization may help avoid error- prone calculations, reduce waste, streamline inventory, and facilitate the use of premixed i.v. solutions. The “rule of 6” should not be used, as this method for calculating concentra- tions of continuous infusions led to calculation errors and waste.34 When more than 1 concentration is needed for med- ications, the institution should use consistent terminology (e.g., double strength, maximum concentration) and con- sider additional labeling to distinguish between concentra- tions (e.g., label comments, auxiliary labels). Furthermore, all needed concentrations should be available in the phar- macy verification system; conversely, rarely used or nonfor- mulary concentrations should be removed.

National standardized concentrations should be used when they are available and are therapeutically appropriate. Standardize 4 Safety is a national initiative between ASHP and FDA to develop and implement national standardized concentrations for i.v. and oral liquid medications, both adult and pediatric. These standardized concentrations, as developed, will be available on the Standardize 4 Safety website.35,36

Safety-Alert Monitoring. Medication safety evaluation does not end when a medication is added to the formulary. The pharmacy department should continue to monitor the litera- ture for new medication safety warnings, in addition to the review and analysis of the institution’s medication error re- porting data. Analyses and recommendations for handling safety alerts that impact the institution should be managed via the medication safety committee or the pharmacy and therapeutics committee.

Every institution or hospital system should have an ongoing mechanism to react to medication safety updates. ISMP’s website and newsletters are unique resources and provide communication about medication errors and strate- gies to prevent their reoccurrence.37 The ISMP website of- fers much of its content free of charge.

FDA also provides numerous methods to keep up- to-date with medication information. By signing up for the MedWatch E-list (email), clinicians will be notified when MedWatch alerts are released.

The National Alert Network (NAN) should be moni- tored for urgent advisories about serious errors or informa- tion requiring immediate attention. These alerts are distrib- uted via ASHP and ISMP.38 NAN alerts are incident driven and reach healthcare providers through several national dis- tribution channels.

Safe Procurement. The pharmacy department must be re- sponsible for all procurement of medications within the or- ganization, including less-obvious patient care areas (e.g., diagnostic imaging, procedural areas).39 Medications should not be brought in from outside sources without collabora- tion with the pharmacy department (e.g., samples, transfers from other institutions). The “ASHP Guidelines: Minimum Standard for Pharmacies in Hospitals” has a section on medication procurement that includes several safety recom-

Medication Safety–Guidelines 271

mendations, including how to handle medication samples and patients’ home medication use in the hospital.39 In short, samples should not be used for inpatient treatment and only used for outpatient treatment with appropriate policies and procedures in place (e.g., maintenance of records, proper storage). Likewise, a patient’s own medications should only be used after prescriber order and pharmacist identification.

Pharmacists should be actively involved in the evalu- ation of all medication device purchasing and replacement decisions (e.g., pumps) and included in discussions related to devices that utilize medications for operational require- ments (e.g., dialysis machines). In addition, patients may be admitted to hospitals with indwelling pumps, such as pain management or insulin pumps, and policy and procedures must be established to ensure safety and continuity of care with these unique medication delivery systems.

The pharmacy department should take a lead role in coordination of outsourcing services and should consult the “ASHP Guidelines on Outsourcing Pharmaceutical Services”40 and the “ASHP Guidelines on Outsourcing Sterile Compounding Services.”41

Medication Shortages Management. Hospitals, via the pharmacy department, should have a process to communi- cate medication shortages, including alternatives and substi- tution protocols, to prescribers and other clinical staff. The “ASHP Guidelines on Managing Drug Product Shortages in Hospitals and Health Systems” provides detailed guidance.42 The pharmacy department should take a lead role in devel- oping and managing a contingency plan in close collabora- tion with affected physicians and health-system committees when faced with severe shortages. Just as when considering the use of a new medication, alternative products should be examined for possible medication safety issues. Oftentimes with shortages, the medication may continue to be available but in a different size, dosage form, or concentration, so medication shortage action plans must examine the implica- tions of these product changes for frontline staff, dispensing system automation, and EHRs. Furthermore, once a shortage is resolved, all system changes that have been made to ad- dress the shortage need to be reversed and corrected.

Storage

Careful arrangement of medication storage in the pharmacy and throughout the hospital can help reduce the risk of medi- cation errors. In the pharmacy, product arrangement should minimize unintended selection of the wrong product or dos- age form.43,44 Steps to minimize selection of the wrong prod- uct or dosage form in the pharmacy include the following:

• Use barcode or RFID scanning in the pharmacy to en- sure correct products are dispensed.

• Provide adequate space for each medication and strength.

• Ensure labels on bottles face forward. • Designate separate areas for each dosage form or route

of administration. • Separate frequently confused pairs. • Segregate high-alert medications and LASA medica-

tions. • Use labeling and alerts when appropriate.

Ambiguous nomenclature should be avoided. The same drug nomenclature should be used in all databases used through- out the entire medication-use process (e.g., EHRs, pharmacy information system, infusion pumps, ADCs), using differ- entiation and screen alerts for medications that may pose a risk for potential errors, such as LASA medications, medica- tions that should not be crushed, and high-alert medications. Wherever possible, generic names of medications should be used, unless the product is a combination product.

Pharmacy inventory should be managed to reduce the risk of errors associated with drug shortages and expired medications. A system for rotating stock should be estab- lished, and all areas should be monitored for expired medi- cations and storage at appropriate temperatures. Because managing expired medications can be challenging, a sched- ule assigning staff to regularly inspect and remove expired medications should be implemented. A process should also be implemented to ensure medications are not used passed the beyond-use date (i.e., reconstituted bulk bottles).

All medications should be stored securely; access to secured medication areas should be limited to authorized personnel.44

Medications that should not be stored outside of the pharmacy include

• Concentrated electrolytes (i.e., potassium chloride, 3% sodium chloride)

• Concentrated oral opioid solutions • Concentrated insulin U-500 • Sterile water in bags • Concentrated epinephrine multidose vials • Neuromuscular blocking agents28

The use of ADCs on nursing units can reduce the fre- quency of certain medication errors.25,43,45,46 The ISMP guidance document can be consulted for ensuring safe use of an ADC.25,43,45-47 Medications and the quantity that will be stocked in the ADC should be carefully selected. Medications should be in ready-to-use, unit dose, or unit-of- use containers. Avoid medications that are in bulk supply or those that are multidose vials. Do not stock medications that require extensive dilutions or calculations. Barcoding should be used to assist in stocking and restocking the correct medi- cation. Medications should not be removed from storage until immediately before administration, and any doses that are not administered should be returned to controlled stor- age promptly. Nurses should not return medications to the ADC, returning them only to the ADC return bin. When configuring storage within the ADC, the use of individual, locked, locked-lidded compartments that open when the product is selected is preferred for all medications, if pos- sible, but at a minimum for high-alert medications, reversal agents, and drugs prone to diversion. If matrix bins are used, each medication and strength must have a separate bin. Steps should be taken to differentiate LASA medications within the ADC. This may include a more-secured configuration of lidded drawers or locked-lidded drawers to separate these medications or make the bins more distinctive. Systematic inventory audits should be performed to identify and remove expired and low-usage products. The ADC functionality al- lows for medications to be vended from the machine after medication order review and verification by the pharmacist, which is the safest scenario. Functionality of override exists

272 Medication Safety–Guidelines

for emergency situations, which bypasses the pharmacist’s review before nurse vending of the medication. The institu- tion must define and approve the specific criteria to allow for medication overrides in emergency situations and specify which specific medication overrides should be allowed.

Patient Admission

Prescribing errors commonly occur during hospital ad

Collepals.com Plagiarism Free Papers

Are you looking for custom essay writing service or even dissertation writing services? Just request for our write my paper service, and we'll match you with the best essay writer in your subject! With an exceptional team of professional academic experts in a wide range of subjects, we can guarantee you an unrivaled quality of custom-written papers.

Get ZERO PLAGIARISM, HUMAN WRITTEN ESSAYS

Why Hire Collepals.com writers to do your paper?

Quality- We are experienced and have access to ample research materials.

We write plagiarism Free Content

Confidential- We never share or sell your personal information to third parties.

Support-Chat with us today! We are always waiting to answer all your questions.