Formulary decisions may need to be reassessed based on relevant new information or in light of newly marketed drugs or dosage forms. New data on safety, efficacy, stability, methods of administration, cost, or pharmacoeconomics may warrant a reevaluation of the drug or dosage strengths or formulations stocked by the health system.Complete Information
Healthcare organizations routinely use performance improvement methods to improve safety, efficacy, quality, and efficiency in patient care. One performance improvement framework that aligns with the MUE process is FOCUS-PDCA model.Complete Information
The occurrence of certain events in a stage of the medication-use process may indicate opportunities to improve medication use and justify undertaking an MUE.Complete Information
The indicators described in the MUE indicators section may reveal specific medications or medication-use processes that should be evaluated in an MUE.Complete Information
While the specific approach varies with the practice setting and patient population being served, many steps common to MUE fall within the FOCUS-PDCA model framework for process improvement.Complete Information
The roles of pharmacists and other healthcare professionals in MUE may vary according to practice setting, organizational goals, and available resources.Complete Information
Common problems and pitfalls to avoid in performing MUE activities often involve lack of interdisciplinary involvement, including authoritative medical staff; poor documentation and communication of the MUE process; and inadequate education of affected staff regarding outcomes of the MUE and improvements to the medication-use system.Complete Information
Key Issues to Address
Formulary decisions may need to be reassessed based on relevant new information or in light of newly marketed drugs or dosage forms. New data on safety, efficacy, stability, methods of administration, cost, orpharmacoeconomicsmay warrant a reevaluation of the drug or dosage strengths or formulations stocked by the health system. An addendum to the original monograph summarizing the new information should be developed for evaluation by the P&T committee. The P&T committee may want to establish reassessment dates at the time of formulary review so that the committee can reassess the effect of a formulary decision on quality or cost of care.
The medication-use evaluation(MUE) is a systematic and interdisciplinary performance improvement method with an overarching goal of optimizing patient outcomes via ongoing evaluation and improvement of medication utilization. When developing a MUE, clinicians should also take into consideration its focus. For example, a MUE may focus on patient-centered therapeutic outcomes (e.g., clinical events, quality of life) or on process elements related to appropriate medication usage (e.g., prescribing, dispensing). In this way, an initial MUE may identify suboptimal therapeutic outcomes experienced by patients, which may trigger a separate MUE focused on aspects of the medication use process and vice-versa (i.e., therapeutic or process outcomes). Specific objectives, examples of MUE designs, and their foci are presented in Table 1.
|Common MUE objectives, example MUEs, and type of outcome (therapeutic or process)|
|Objective||Example MUE||Therapeutic or Process Outcome|
|Promoting optimal medication therapy||Compare efficacy before and after introduction of a biosimilar therapeutic substitution policy||Therapeutic|
|Evaluate the frequency of patients who qualified, but did not receive, an approved therapeutic substitution||Process|
|Improve patient safety||Evaluate the incidence of major bleeding in patients treated with thrombolytic therapy||Therapeutic|
|Evaluate the frequency of use of thrombolytic therapy in inappropriate candidates||Process|
|Standardize to reduce unnecessary variation||Compare rates of adverse events in patients receiving standard vs. highly concentrated vasopressor infusions||Therapeutic|
|Evaluate the prescribing frequency of concentrations outside of the standard concentration policy for vasopressors||Process|
|Optimize drug therapy||Determine the time in therapeutic range for patients treated with a medication requiring pharmacokinetic therapeutic drug monitoring||Therapeutic|
|Evaluate the frequency of appropriate dose changes when an interacting medication is introduced||Process|
|Assess value of innovative practices||Compare the rates of blood pressure control in a physician- vs. pharmacist-managed hypertension service||Therapeutic|
|Evaluate the frequency of physician referral to a pharmacist-led hypertension management service||Process|
|Meet quality or regulatory standards||Determine the percentage of patients with heart failure readmitted after discharge||Therapeutic|
|Determine the percentage of patients receiving required medication discharge education||Process|
|Minimize costs||Compare infection cure rates before versus after involvement of an antimicrobial stewardship pharmacist||Therapeutic|
|Compare costs of antimicrobial therapy before versus after involvement of an antimicrobial stewardship pharmacist||Process|
Healthcare organizations routinely use performance improvement methods to improve safety, efficacy, quality, and efficiency in patient care. Many accreditation bodies, such as the Joint Commission, require annual reviews of a hospital formulary along with other quality and safety improvement strategies that would benefit from such a framework. These methods may be applied in the setting of MUE, which can be considered one component of a performance improvement program. One performance improvement framework that aligns withthe MUE process is FOCUS-PDCA (Figure 1).
|Components of the FOCUS-PDCA process improvement model applied to MUE.|
These steps include:
- Find the process to be targeted for improvement
- Organize the team that knows the process
- Clarify current knowledge of the process
- Understand causes of process variation
- Select process improvement
- Plan: develop a solution
- Do: implement improvements
- Check:evaluate the results
- Act: determine what changes are needed moving forward and implement those changes.
The steps in the FOCUS-PDCA model may need to be repeated in an ongoing, systematic manner.
The occurrence of certain events in a stage of the medication-use process may indicate opportunities to improve medication use and justify undertaking an MUE. Generally, these events may represent trends or deviations in medication use within a health system, availability or discontinuation of drugs, or new knowledge regarding drug therapy (see Table 2).
|Indicators of need for MUE at different steps in the medication-use process*|
|Prescribing||Market entry or withdrawal of approved drug products Regulatory actions such as drug recalls, market withdrawals, or safety alerts Publication of guidelines or high-impact studies that may change treatment patterns New organizational interventions to improve medication therapy, such as changes to protocols or formularies Changes in use of, or requests for, nonformulary medications Changes to pharmacy clinical services to improve medication therapy Introduction of or changes in quality indicators, such as those published by the Centers for Medicare & Medicaid Services, or other regulatory or accrediting bodies|
|Dispensing||Signs of process failures, such as wasted medication or delayed medication delivery Incorrect medication preparation Dosing that requires clinician preparation or compounding Ensuring compliance with regulatory requirements (e.g., United States Pharmacopeia Chapters 795, 797, 800)/td>|
|Administration||Medication misadventures related to medication delivery systems Multiple medication concentrations, units of measure, or infusion rates|
|Monitoring||Adverse events, including medication errors, preventable adverse drug reactions, and toxicity Signs of treatment failures, such as unexpected readmissions and bacterial resistance to anti-infective therapy Patient dissatisfaction or deterioration in quality of life attributable to drug therapy|
|Systems Management and Control||Procurement requirements, specialty pharmacy requirements, Risk Evaluation and Mitigation Strategy (REMS) programs, restricted distribution channels, or other access challenges Drug shortages requiring replacement or therapeutic substitution Diversion of controlled substances Lack of standardization or confusion within the medication use process Changes in contracts, cost or spending on drugs Organizational priorities such as budget constraints or cost saving initiatives|
*This table does not provide an exhaustive list of characteristics
The indicators described in the MUE indicators section may reveal specific medications or medication-use processes that should be evaluated in an MUE. The following partial list of characteristics may help prioritize the selection of a particular medication or medication-use process, based on its magnitude or severity of effect on patients or the medication-use system. Other characteristics will likely emerge with the introduction of new medications and technologies.
- The medication is known or suspected to cause adverse events or is used in the treatment of patients who may be at high risk for adverse events.
- The medication interacts with another medication, food, or diagnostic procedure in a way that presents a significant health risk.
- The medication or process affects many patients, or the medication is frequently prescribed.
- The medication or process is a critical component of care for a specific disease, condition, or procedure.
- The medication is potentially toxic or causes discomfort at normal doses.
- The medication is most effective when used in a specific way.
- The medication is under consideration for formulary retention, addition, or deletion.
- The medication has been the subject of a Food and Drug Administration (FDA) recall, safety alert, or market withdrawal.
- The medication has not been approved by the FDA.
- The medication has not been evaluated in a high-risk population (pregnancy, pediatrics, obesity, etc.).
- The medication or process is one for which its use would have a negative effect or no therapeutic impact on patient outcomes.
- The process is an innovative or newly initiated practice and its effects on patient care are unknown.
- Use of the medication or medication process is considered expensive and the cost benefit is unknown.
- To determine if clinicians are complying with medication formulary restrictions or facility guidelines for use.
- To evaluate pharmacist-directed collaborative practices, such as dosing protocols or algorithms (pharmacy per protocol or pharmacy to dose) to verify appropriate action steps.
- Analytic tools (failure mode and effects analysis, risk priority numbers, cause and effect diagrams, control chart) or scoring systems (harm criteria) suggest the need for intervention.
While the specific approach varies with the practice setting and patient population being served, many steps common to MUE fall within the FOCUS-PDCA model framework for process improvement. See how there are common steps that often occur in an ongoing MUE by using the FOCUS-PDCA process improvement model applied to an MUE (Figure 1).
|Components of the FOCUS-PDCA process improvement model applied to MUE.|
The roles of pharmacists and other healthcare professionals in MUE may vary according to practice setting, organizational goals, and available resources. The organizational body (e.g., quality management or QI committee, pharmacy and therapeutics committee) responsible for the MUE process should have, at a minimum, a prescriber (most commonly a physician), pharmacist, nurse, and an administrator or health-system representative. Pharmacist extenders, including pharmacy technicians, student pharmacists, and pharmacy residents should also participate in conducting MUEs in facilities and healthcare systems where allowed. Other healthcare professionals and subject matter experts should contribute their unique perspectives when the evaluation and improvement processes address their areas of expertise and responsibility. Ad hoc committees or temporary working groups, which include at a minimum a pharmacist as the MUE lead and subject matter expert(s), can be assigned to develop MUEs for specific QI efforts. Best practices should be established in settings whenever possible to enhance the structure around how MUE committees conduct, report, implement, and complete evaluations. In addition, systematic evaluations should be conducted when possible to assess the attributes of the interdisciplinary team regarding subject matter expertise, leadership in the program or healthcare system, and overall ability to implement and sustain the MUE findings. In settings in which only a small number of healthcare professionals are available (e.g., some community hospitals, rural hospitals, or clinics), extensive MUEs conducted by a large interdisciplinary team may not be an option. In such instances, the pharmacist at the smaller facility may be responsible for the design, conduct, analysis, and reporting of an MUE. Implementation of findings from the MUE may require assistance from the hospital administration in such facilities.
QI programs with a high degree of interdisciplinary participation provide an optimal mechanism to conduct MUEs. Although other disciplines should be encouraged to assist in development of MUEs, pharmacists, by virtue of their expertise and mission to ensure appropriate medication use, remain the primary healthcare professional responsible for the development and coordination of MUEs. Pharmacists should continue to exert leadership and work collaboratively with other members of the healthcare team in the ongoing MUE process. The responsibilities of pharmacists (with the assistance of pharmacist extenders such as pharmacy technicians, student pharmacists, and pharmacy residents) in the MUE process should include:
- Developing an operational plan for MUE programs and processes that is consistent with the health system’s overall goals and resource capabilities.
- Working collaboratively with prescribers, subject matter expert(s), and others to develop criteria for specific medications and to design effective medication-use processes and assessments.
- Ensuring optimal input from subject matter expert(s) and interdisciplinary groups in the design of the MUE efforts, when possible.
- Reviewing individual medication utilization against medication-use criteria and consulting with prescribers and others in the process as needed.
- Collecting, analyzing, and evaluating patient-specific data to identify, resolve, and prevent medication-related problems, enhance medication effectiveness, and improve patient outcomes.
- Ensuring the integrity of the collected data.
- Interpreting and reporting MUE findings, as well as recommending and facilitating changes in medication-use processes.
- Providing information and education based on MUE findings.
- Assisting in implementation of optimal findings in the facility or healthcare system.
- Evaluating the outcomes of implemented MUE findings when appropriate and assessing the effect on the facility or healthcare system.
- Ensuring that systems are in place to sustain the implemented MUE findings in the facility or healthcare system whenever possible.
- Ensuring that MUEs emphasize QI versus research.
Common problems and pitfalls to avoid in performing MUE activities often involve lack of interdisciplinary involvement, including authoritative medical staff; poor documentation and communication of the MUE process; and inadequate education of affected staff regarding outcomes of the MUE and improvements to the medication-use system (see Table 3).
|Problems, pitfalls, and barriers to completing a successful MUE|
|Lack of authority||An MUE process that does not involve the medical staff is likely to be ineffective. Authoritative medical staff support and formal organizational recognition of the MUE process are necessary to support changes and incorporate best practices.|
|Lack of organization, structure, or leadership||Without a clear definition of the roles, responsibilities, and accountabilities of individuals involved to complete tasks and reach milestones, an MUE process may not succeed.|
|Poor communication||Everyone included in the MUE process should understand its importance to the health system, its goals, and its procedures. The pharmacist should manage the MUE process and have the responsibility and authority to ensure timely communication among all professionals involved in the MUE process. Criteria for medication use should be communicated to all affected professionals prior to the evaluation of care. MUE activity should be a standing agenda item for appropriate quality-of-care committees responsible for aspects of medication use.|
|Poor documentation||MUE activities should be well documented, including summaries of MUE actions with respect to individual medication orders and the findings and conclusions from collective evaluations. Documentation should address recommendations made and follow-up actions.|
|Lack of involvement||The MUE process is not a one-person task, nor is it the responsibility of a single department or professional group. Medication-use criteria should be developed through an interdisciplinary consensus process. Lack of administrative support can severely limit the effectiveness of MUE. The benefits of MUE should be conveyed in terms of improving patient outcomes and minimizing health-system costs.|
|Data integrity||Data collection efforts are often interdisciplinary and can involve student pharmacists, pharmacy interns, pharmacy residents, and others. Data are often found in different medical record locations and can be interpreted differently, often resulting in discrepancies. Teams should agree on sources and interpretation before data collection begins.|
|Lack of follow-through||A one-time study or evaluation independent of the overall MUE process will have limited success in improving patient outcomes. The effectiveness of initial actions must be assessed and the action plan adjusted if necessary. It is important not to lose sight of the improvement goals.|