EDITORIAL Medication Use Evaluations as a Research Tool Daryl S. Schiller Nyack Hospital, Nyack, New York
Key Words: medication use evaluation, study design, case-control study, research. (Pharmacotherapy 2014;34(12 Pt 2):3S–4S) doi: 10.1002/phar.1515 An important tool for understanding how medications are being used is the medication use evaluation (MUE). An MUE is sometimes referred to as a drug utilization evaluation (DUE) or drug utilization review (DUR). Different organizations have used distinctive names, but they all refer to the same process. The goals of an MUE are to evaluate a medication process, practice, or change within an organization, but large-scale evaluations or controlled research studies can often have a greater impact on advancing pharmacy practice and patient care. Multidisciplinary collaborations can help to ensure the universality of the results, and input from other health care providers should be an essential part of the MUE process. Use of the MUE as a pharmacy-based, quality improvement tool is a relatively new concept. Early MUEs in the 1960s and 1970s commonly focused on evaluating distributive- or clinicalbased models of pharmacy services.1, 2 In the 1980s, the Joint Commission started to focus on a structured, pharmacy-based, Pharmacy and Therapeutics (P&T) committee–approved process for reviewing antibiotic use. As medication costs and regimen complexities increased, this evolved into a requirement for hospitals to also review other classes of medications to receive
At the time of writing, Daryl S. Schiller was Assistant Director of Clinical Pharmacy Services and PGY-1 Residency Program Director at Saint Barnabas Medical Center, Livingston, NJ. *Address for correspondence: Daryl S. Schiller, Nyack Hospital, 160 N. Midland Ave, Nyack, NY 10960; e-mail: [email protected]. Ó 2014 Pharmacotherapy Publications, Inc.
accreditation. In addition, the Omnibus Budget Reconciliation Act of 1990 extended the requirement to perform DURs in the retail setting. Today, many organizations and regulatory bodies such as the Academy of Managed Care Pharmacy, the National Committee for Quality Assurance, and the Centers for Medicare and Medicaid Services have adopted a requirement or a process for conducting a review of medication use.3 Reviewing how a medication, or a medication class, is being used in a health care setting can help to determine if it is being used correctly, if the expected outcomes are occurring, or if opportunities exist to improve the medication use process. Although the MUE is traditionally designed as an observational or cross-sectional study, an opportunity exists for pharmacists to contribute to evidence-based literature with wellplanned, comprehensive evaluations. This should include the use of hypothesis-driven designs, such as a case-control study, with an appropriate epidemiologic or biostatistical analysis. In this supplement, the article by John Fanikos and colleagues describes the steps in planning and conducting an MUE, with a focus on identifying the current state of practice, making a change, and then restudying.4 The restudying part of an MUE is an often-overlooked step. Once an opportunity to improve a medication use process is identified, an intervention, such as a formulary or policy change, an enhanced restriction, or targeted education to improve the process should be implemented. A repeat evaluation should then be conducted to determine if this intervention was successful. Rather than repeat the same MUE, however, a hypothesis-driven, controlled
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Supplement to PHARMACOTHERAPY Volume 34, Number 12, 2014
study should be the next step. This will help strengthen the findings and contribute to evidence-based practice. The American College of Clinical Pharmacy recently published “Standards of Practice for Clinical Pharmacists” and indicates the need for clinical pharmacists to contribute to the evolving literature in evidence-based pharmacotherapy.5 In addition, the American Society of Health-System Pharmacists’ Pharmacy Practice Model Initiative recommends that clinical pharmacists should advance practice, education, and research activities.6 Pharmacist-based research on medication outcomes or quality improvement processes is an essential component of pharmacy practice and optimal patient care. There are numerous reasons for conducting an MUE. The article by Fanikos and colleagues4 describes many of them, but most MUEs generally fall into two categories: MUEs that determine the basis for using a medication or MUEs that determine if a formulary change, order set, or some kind intervention had an impact on an outcome. Determining the basis for using a medication may include identifying where a medication is being used, who is using the medication, or how it is being used. Although these types of evaluations will often be observational in design, evaluating the outcomes from a change or intervention is apposite for a hypothesis-driven study. A cross-sectional study is used when a “snapshot” is needed to get an idea of what is going on. Outcomes and exposures are assessed at the same time, and these studies can often be hypothesis generating. An example of this would be an analysis of in-house vancomycin dosing practices or an assessment of the prevalence of nephrotoxicity or therapeutic serum trough levels with the current vancomycin dosing practice. A case-control study is used to identify factors that contribute to a desired outcome—that is, whether the presence or absence of a particular risk factor increased the chance of an outcome from occurring. This can be an advanced MUE that requires careful planning to identify, and often match, suitable patients to serve as a control group to validate the risk factor’s role in the outcome. In addition, biostatistical methods for hypothesis testing, such as a Student t test or a v2 test, are often necessary.7 An example of this would be determining if instituting a pharmacokinetic dosing service improved the ability to achieve therapeutic vancomycin trough levels. The outcome would be the presence of a therapeutic serum vancomycin trough level, and the factor that contributes to this would be whether
the patient’s dosing was guided by the pharmacokinetic service or the standard of care. Although the former example of a cross-sectional–based MUE can be helpful with internal policies or identification of unexpected physician practices, the latter example of a case-control study can substantiate the value of a specific intervention that can be replicated elsewhere to improve patient care. Regardless of the type of MUE that will be conducted, the importance of a multidisciplinary review of the proposal before starting the MUE is imperative. To move beyond the concept of a pharmacy-centric MUE, the input from other health care providers or administrators who may be interested in the impact of a particular medication on patient care should be elicited. This may require collaborating with nurses who will be affected by a process change or physician specialists who use a high-cost or high-risk medication. The data that will be obtained should be helpful for all stakeholders. To ensure that the results of the evaluation are useful to all health care providers, it may be necessary to restructure the goal from observational to hypothesis testing with the use of a control group to validate the results. Pharmacists who do not have the training in designing these types of studies should seek guidance from their P&T or institutional review board committees or pursue further education in research courses. In addition, specialized training in research design and biostatistical and epidemiologic analysis should be considered an essential component of residency training. An MUE does not have to be useful only for the person asking the question; it should generate results that can be universally appreciated among all those who have a role in the care of a patient. References 1. Petrick RJ, Kleinmann K. Evaluation of a drug distribution system using the physician’s original order. Am J Hosp Pharm 1965;22:512. 2. McKenny JM, Slining JM, Henderson HR, et al. The effect of clinical pharmacy services on patients with essential hypertension. Circulation 1973;48:1104. 3. Peterson AM. Drug use evaluation. In: Peterson AM, Kelly WN, eds. Managing pharmacy practice: principles, strategies, and systems, 1st ed. London, UK: CRC Press, 2004: 195–203. 4. Fanikos J, Jenkins KL, Piazza G, et al. Medication use evaluation: pharmacist rubric for performance improvement. Pharmacotherapy 2014; 5S–14S. 5. ACCP. Standards of Practice for Clinical Pharmacists. Pharmacotherapy 2014;34:794. 6. ASHP. The Consensus of the Pharmacy Practice Model Summit. Am J Health-Syst Pharm. 2011;68:110. 7. DiPetro NA. Methods in epidemiology: observational study designs. Pharmacotherapy 2010;30:973.
Copyright of Pharmacotherapy is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Key Words: medication use evaluation, study design, case-control study, research. (Pharmacotherapy 2014;34(12 Pt 2):3S–4S) doi: 10.1002/phar.1515 An important tool for understanding how medications are being used is the medication use evaluation (MUE). An MUE is sometimes referred to as a drug utilization evaluation (DUE) or drug utilization review (DUR). Different organizations have used distinctive names, but they all refer to the same process. The goals of an MUE are to evaluate a medication process, practice, or change within an organization, but large-scale evaluations or controlled research studies can often have a greater impact on advancing pharmacy practice and patient care. Multidisciplinary collaborations can help to ensure the universality of the results, and input from other health care providers should be an essential part of the MUE process. Use of the MUE as a pharmacy-based, quality improvement tool is a relatively new concept. Early MUEs in the 1960s and 1970s commonly focused on evaluating distributive- or clinicalbased models of pharmacy services.1, 2 In the 1980s, the Joint Commission started to focus on a structured, pharmacy-based, Pharmacy and Therapeutics (P&T) committee–approved process for reviewing antibiotic use. As medication costs and regimen complexities increased, this evolved into a requirement for hospitals to also review other classes of medications to receive
At the time of writing, Daryl S. Schiller was Assistant Director of Clinical Pharmacy Services and PGY-1 Residency Program Director at Saint Barnabas Medical Center, Livingston, NJ. *Address for correspondence: Daryl S. Schiller, Nyack Hospital, 160 N. Midland Ave, Nyack, NY 10960; e-mail: [email protected]. Ó 2014 Pharmacotherapy Publications, Inc.
accreditation. In addition, the Omnibus Budget Reconciliation Act of 1990 extended the requirement to perform DURs in the retail setting. Today, many organizations and regulatory bodies such as the Academy of Managed Care Pharmacy, the National Committee for Quality Assurance, and the Centers for Medicare and Medicaid Services have adopted a requirement or a process for conducting a review of medication use.3 Reviewing how a medication, or a medication class, is being used in a health care setting can help to determine if it is being used correctly, if the expected outcomes are occurring, or if opportunities exist to improve the medication use process. Although the MUE is traditionally designed as an observational or cross-sectional study, an opportunity exists for pharmacists to contribute to evidence-based literature with wellplanned, comprehensive evaluations. This should include the use of hypothesis-driven designs, such as a case-control study, with an appropriate epidemiologic or biostatistical analysis. In this supplement, the article by John Fanikos and colleagues describes the steps in planning and conducting an MUE, with a focus on identifying the current state of practice, making a change, and then restudying.4 The restudying part of an MUE is an often-overlooked step. Once an opportunity to improve a medication use process is identified, an intervention, such as a formulary or policy change, an enhanced restriction, or targeted education to improve the process should be implemented. A repeat evaluation should then be conducted to determine if this intervention was successful. Rather than repeat the same MUE, however, a hypothesis-driven, controlled
4S
Supplement to PHARMACOTHERAPY Volume 34, Number 12, 2014
study should be the next step. This will help strengthen the findings and contribute to evidence-based practice. The American College of Clinical Pharmacy recently published “Standards of Practice for Clinical Pharmacists” and indicates the need for clinical pharmacists to contribute to the evolving literature in evidence-based pharmacotherapy.5 In addition, the American Society of Health-System Pharmacists’ Pharmacy Practice Model Initiative recommends that clinical pharmacists should advance practice, education, and research activities.6 Pharmacist-based research on medication outcomes or quality improvement processes is an essential component of pharmacy practice and optimal patient care. There are numerous reasons for conducting an MUE. The article by Fanikos and colleagues4 describes many of them, but most MUEs generally fall into two categories: MUEs that determine the basis for using a medication or MUEs that determine if a formulary change, order set, or some kind intervention had an impact on an outcome. Determining the basis for using a medication may include identifying where a medication is being used, who is using the medication, or how it is being used. Although these types of evaluations will often be observational in design, evaluating the outcomes from a change or intervention is apposite for a hypothesis-driven study. A cross-sectional study is used when a “snapshot” is needed to get an idea of what is going on. Outcomes and exposures are assessed at the same time, and these studies can often be hypothesis generating. An example of this would be an analysis of in-house vancomycin dosing practices or an assessment of the prevalence of nephrotoxicity or therapeutic serum trough levels with the current vancomycin dosing practice. A case-control study is used to identify factors that contribute to a desired outcome—that is, whether the presence or absence of a particular risk factor increased the chance of an outcome from occurring. This can be an advanced MUE that requires careful planning to identify, and often match, suitable patients to serve as a control group to validate the risk factor’s role in the outcome. In addition, biostatistical methods for hypothesis testing, such as a Student t test or a v2 test, are often necessary.7 An example of this would be determining if instituting a pharmacokinetic dosing service improved the ability to achieve therapeutic vancomycin trough levels. The outcome would be the presence of a therapeutic serum vancomycin trough level, and the factor that contributes to this would be whether
the patient’s dosing was guided by the pharmacokinetic service or the standard of care. Although the former example of a cross-sectional–based MUE can be helpful with internal policies or identification of unexpected physician practices, the latter example of a case-control study can substantiate the value of a specific intervention that can be replicated elsewhere to improve patient care. Regardless of the type of MUE that will be conducted, the importance of a multidisciplinary review of the proposal before starting the MUE is imperative. To move beyond the concept of a pharmacy-centric MUE, the input from other health care providers or administrators who may be interested in the impact of a particular medication on patient care should be elicited. This may require collaborating with nurses who will be affected by a process change or physician specialists who use a high-cost or high-risk medication. The data that will be obtained should be helpful for all stakeholders. To ensure that the results of the evaluation are useful to all health care providers, it may be necessary to restructure the goal from observational to hypothesis testing with the use of a control group to validate the results. Pharmacists who do not have the training in designing these types of studies should seek guidance from their P&T or institutional review board committees or pursue further education in research courses. In addition, specialized training in research design and biostatistical and epidemiologic analysis should be considered an essential component of residency training. An MUE does not have to be useful only for the person asking the question; it should generate results that can be universally appreciated among all those who have a role in the care of a patient. References 1. Petrick RJ, Kleinmann K. Evaluation of a drug distribution system using the physician’s original order. Am J Hosp Pharm 1965;22:512. 2. McKenny JM, Slining JM, Henderson HR, et al. The effect of clinical pharmacy services on patients with essential hypertension. Circulation 1973;48:1104. 3. Peterson AM. Drug use evaluation. In: Peterson AM, Kelly WN, eds. Managing pharmacy practice: principles, strategies, and systems, 1st ed. London, UK: CRC Press, 2004: 195–203. 4. Fanikos J, Jenkins KL, Piazza G, et al. Medication use evaluation: pharmacist rubric for performance improvement. Pharmacotherapy 2014; 5S–14S. 5. ACCP. Standards of Practice for Clinical Pharmacists. Pharmacotherapy 2014;34:794. 6. ASHP. The Consensus of the Pharmacy Practice Model Summit. Am J Health-Syst Pharm. 2011;68:110. 7. DiPetro NA. Methods in epidemiology: observational study designs. Pharmacotherapy 2010;30:973.
Copyright of Pharmacotherapy is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
