Chapter 8. Ensuring Quality in Pharmacy Operations

Dr. Warholak is assistant professor at the University of Arizona College of Pharmacy. She earned a B.S. in pharmacy and an M.S. and Ph.D. in pharmacy administration from Purdue University. Her professional experience encompasses practice in both hospital and community pharmacies, including 5 years as a commissioned officer in the U.S. Public Health Service (Indian Health Service). In addition, she completed a short tour of duty with the Food and Drug Administration (FDA). Dr. Warholak has been recognized as winner of the American Association of Colleges of Pharmacy Council of Faculties Innovations in Teaching Competition for her work titled “Application of Quality Assurance Principles: Reducing Medication Errors in 30 Pharmacy Practice Settings.” This work formed the basis of a national quality improvement educational program for students and pharmacists. Dr. Warholak's teaching and research interests include medication error reduction, health information technology evaluation, questionnaire development, and bringing pharmaceutical care to underserved populations. As such, she has substantial experience collaborating with pharmacists and other health care providers. She has participated in studies evaluating the quality of patient care, techniques for reducing medication errors, and health information technology assessment.

After completing this chapter, reader should be able to

1. Discuss the importance of quality in pharmacy practice.

2. Describe how quality is measured in pharmacy practice.

3. Justify the use of successful quality practices employed by other industries in pharmacy practice.

4. Explain the differences between quality assurance, quality control, and continuous quality improvement.

5. List three methods for ensuring quality in pharmacy practice.

6. Outline the steps necessary for a successful continuous quality improvement plan.

7. Prioritize areas/functions most suitable for conducting a quality analysis.

8. Identify sources for additional information about quality assessment and improvement.

Anita Katz was promoted to “pharmacy manager” at a community pharmacy last week. She was excited and wanted to make some positive changes. Among the charges assigned her was to implement quality improvement programs in the pharmacy to decrease errors, increase efficiency, and improve store performance on pharmacy quality measures so as to maximize service, avoid mistakes that had cost the pharmacy in the past, and also to more easily pass accreditation processes. However, she was overwhelmed and did not know where to start the quality improvement process. Some questions she asked herself were: How should I begin? Who should I involve? How should I decide which quality issue to address first? What type of interventions have been successful in the past? Are there quality improvement programs available that I could use? What stakeholders do I need buy-in from? Anita began to do researching on the Internet but also began to recall key concepts from her Quality Improvement and Medication Error Reduction class in pharmacy school. Armed with this information, she began the planning that would make her pharmacy truly exceptional.

1. How is quality defined within the context of pharmacy practice?

2. Define health care quality in layperson's terms.

3. How can the need for quality improvement be justified to decision makers?

4. How can quality be measured?

5. What can pharmacy organizations learn from other industries concerning quality?

6. List the steps of a continuous quality improvement (CQI) model.

7. List four practical CQI suggestions for the pharmacist.

Quality may appear to be a nebulous term. We know what quality is when we see it, but its definition might be subjective. In fact, there are quite a few definitions of quality. For example, Webster's Dictionary defines quality as a “degree of excellence” (Merriam-Webster, 2003). While this definition provides a framework for quality in general, it is also helpful to examine the definitions of quality specific to health care.

The U.S. Office of Technology Assessment (OTA) has defined the quality of medical care as “evaluation of the performance of medical providers according to the degree to which the process of care increases the probability of outcomes desired by patients and reduces the probability of undesired outcomes, given the state of medical knowledge” (Congress of the United States, Office of Technology Assessment, 1988).

The Institute of Medicine (IOM), in a report entitled, “Medicare: A Strategy for Quality Assurance,” stated that “quality of care is the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge” (Lohr, 1990a), whereas Ovretveit (1992) simply states, “A quality health service/system gives patients what they want and need.”

An amalgamation of these definitions may provide the best explanation of the concept of quality in health care. The OTA definition implies that the care offered to patients should increase the probability of positive outcomes (e.g., getting rid of an infection) and decrease negative outcomes of care (e.g., death). The care offered to patients should be the most current. While the broadened perspective from Ovretveit has merit, patients may not be the best judges of the quality of medical care because even though they may know what they want from medical care, they may not have well-defined notions of what they need from medical care. Thus, it is up to the medical provider to offer quality care to benefit the patient even when the patient does not know what he or she needs. While this may appear paternalistic, it seems reasonable that any person who is not an expert in a field may not know all the best alternatives.

So what is quality in pharmacy practice? Extrapolating from the preceding discussion, it can be said that quality in pharmacy practice

• Represents a degree of excellence
• Increases the probability of positive outcomes
• Decreases the probability of negative outcomes
• Corresponds with current medical knowledge
• Offers the patient what he or she wants
• Provides the patient with what he or she needs

Understanding these aspects of quality will help Anita explain pharmacy quality to patients and will serve as the basis for pharmacy improvement.

Historically, pharmacy practice quality has been measured by assessing its structure, process, and outcomes (Donabedian, 1969, 1991). Simply put, for a good or service,

• Structure refers to the raw materials needed for production.
• Process is the method or procedure used.
• Outcomes are the end result.

Each of the preceding (i.e., structure, process, and outcomes) has been used to measure quality. Traditionally, quality in pharmacy practice has been measured by structure and process methods. This relies on a premise that a quality outcome is not possible without appropriate structure or process. Moreover, it is much simpler and less controversial to measure structure and process than it is to measure outcomes. Recently, however, outcomes quality measurement has become more prevalent.

In the realm of pharmacy, the raw materials or structure necessary for quality care are many and varied. Examples include number of pharmacists per shift, counter space, pharmacist credentials or licensing, pharmacy square footage, medication reference books, medication stock, and counseling facilities.

Because pharmacists are responsible for all phases of medication use, processes in the pharmacy can refer to any phase of the medication use process (e.g., prescribing, dispensing, administering, or monitoring). Examples of process measures include, but are not limited to, adherence to clinical guidelines or pathways, percent of prescriptions assessed for appropriateness, and percent of patients counseled.

Outcomes are the driving force behind medication therapy management, which has pharmacists participating in patient education, medication review, and disease management. Through such activities, pharmacists have been able to improve patient care by (1) increasing patients' control of their medical conditions (Clifford et al., 2005; Cranor et al., 2003; Garrett and Bluml, 2005; Kiel and McCord, 2005; Leal and Herrier, 2004; Ragucci et al., 2005; Sadik et al., 2005; Scott et al., 2006; Schnipper et al., 2006; Sookaneknun et al., 2004); (2) decreasing use of health care resources (Cordina et al., 2001; Dedden et al., 1997; Garrett and Bluml, 2005; Rupp et al., 1997); (3) increasing patients' knowledge of their conditions, treatments, and medications (Mangiapane et al., 2005; Schulz et al., 2001); (4) increasing adherence to and persistence with medication regimens (Krass et al., 2005; Lee et al., 2006; Mangiapane et al., 2005; Sookaneknun et al., 2004; Vrijens et al., 2006); (5) increasing patients' satisfaction with their care (Cranor et al., 2003; Garrett and Bluml, 2005; Weinberger et al., 2002), (6) saving payers money (Cranor et al., 2003; Fertleman et al., 2005; Garrett and Bluml, 2005; Ragucci et al., 2005); and (7) improving patients' quality of life (Cordina et al., 2001; Mangiapane et al., 2005; Rupp et al., 1997; Sadik et al., 2005; Scott et al., 2006; Schulz et al., 2001).

The systems engineering for patient safety (SEIPS) model expands Donabedian's process concept from direct patient care to processes that support patient care (i.e., housekeeping) and indicates that these processes must also be designed to support safety. SEIPS is a multidisciplinary initiative applying systems engineering, human factors engineering, and quality engineering approaches. The research supporting this model examines systems design, quality management, job design, and technology implementations that affect safety-related patient and organizational and/or staff outcomes (Carayon et al., 2006).

Pharmacists' ability to identify, resolve, and prevent medication-related problems, as well as take responsibility in disease management, is well documented (Bluml et al., 2000; Cranor et al., 2003; Fertleman et al., 2005; Hansen et al., 2006; Nolan, 2000; Schnipper et al., 2006). Thus, outcomes describe the ultimate goal of the care or therapy and answer the question, “What are we trying to accomplish?”

There are different ways to look at outcomes. One method, the ECHO model, purports three basic types of outcomes: economic, clinical, and humanistic (Kozma et al., 1993). Economic outcomes include direct costs and consequences, both medical and nonmedical, and indirect costs and consequences. For example, when assessing outcomes from a patient perspective, a medication co-payment would be a direct medication cost, whereas gas money to pick up the medication from the pharmacy would represent a nonmedical direct cost. Lost wages from missed work could be regarded as an indirect cost.

Clinical outcomes measures can include morbidity and mortality, event rates, and symptom resolution (Ovretveit, 2001). These measures are a direct measure of quality but may be difficult to assess, especially in pharmacy, where their onset could be years following a treatment or intervention (Chassin and Galvin, 1998; Shane and Gouveia, 2000). In these cases, indicators or markers can be used to assess outcomes. These indicators can be condition-specific (e.g., HgA1c) or procedure-specific (e.g., rate of postoperative infection after hip surgery) or address an important issue of patient care. For example, blood pressure may be used as a marker to assess susceptibility to stroke because it is not practical, safe, or ethical to wait and measure the occurrence of stroke.

Humanistic outcomes include measures of the “human” aspects of care. Specific types of humanistic outcomes include patient satisfaction and health-related quality of life (HRQoL). For example, a survey concerning patient satisfaction with pharmacy care services could be used to assess humanistic outcomes for patients receiving these services. Alternatively, an HRQoL assessment may be useful to assess the impact medication therapy has on the patient's life as a whole.

Measuring outcomes can seem to be a daunting task. Thus, the remainder of this chapter will present these concepts in an easy-to-understand manner and will include simple implementation tips.

Health care traditionally has lagged behind other industries in quality improvement. It has been suggested that medicine should follow the lead of the airline and other industries by using quality management to decrease unnecessary variation and improve quality (Leape, 1994). An IOM report supported this contention when the authors suggested that the American health care system can improve the quality of care by borrowing techniques used in other industries to standardize processes (Kohn, 2000). Many of these techniques are based on systems theory.

Systems theory, developed by von Bertalanffy (1968), has been used in engineering, medicine, and education (Nagel, 1988; Sheridan, 1988). A systems approach involves defining the purpose and performance expectations of the system, examining the characteristics of the input, considering alternative mechanisms for achieving the stated goals, implementing the system, and adjusting the system based on feedback (Park, 1997; Sheridan, 1988).

Various organizations and regulators have turned to a systems view of quality improvement termed human factors principles (FAA, 1993; Leape et al., 1998a). The human factors view of quality focuses on the relationship between quality problems and the system in which they occur (Rasmussen et al., 1994). “Human factors principles are concepts about the design of work that take advantage of the strengths and weakness of the human mind and compensate for its limitations” (Leape et al., 1998a). Human factors principles include (1) reducing reliance on memory, (2) simplifying and standardizing, (3) using protocols and checklists, (4) using mechanisms to physically prevent error (constraints and forcing functions), (5) improving access to information, (6) decreasing reliance on vigilance, (7) differentiating, and (8) implementing automation (Kohn, 2000; Leape et al., 1998a).

In pharmacy practice, decreased reliance on memory can be accomplished by using decision-support systems. Most community pharmacies now use in-store computer systems to assist with Omnibus Budget Reconciliation Act of 1990-mandated (OBRA 90–mandated) prospective drug utilization review (DUR). However, decision-support systems should be used wisely because they are not intended to supplant the pharmacist's clinical decision-making skills (Leape et al., 1998a; Nolan, 2000).

Standardization is thought to be one of the most powerful tools for improving quality (Leape et al., 1998b). If a person does something the same way every time, the chances that he or she will perform the activity incorrectly are greatly reduced (Leape et al., 1998b). Industry has long known that quality and variation are inversely related; quality improves as variation is reduced (Deming, 1986). In pharmacy, standardization is the simplest, most broadly applicable, and most effective method for quality improvement (Leape et al., 1998b). In fact, the move to standardization has created the impetus for critical pathways that focus not only on error prevention but also on optimization of outcomes, cost reduction, and satisfaction (Clearinghouse, 2000; American Pharmacists Association, 2003). These decision support systems can also be used to decrease reliance on vigilance through alerting the pharmacist of potential problems.

Another mechanism for decreasing reliance on memory and reducing variation is the use of protocols and checklists. Protocols and checklists serve as reminders of critical tasks, especially when an omission can have serious consequences, and are often recommended as mechanisms for increasing quality (Boeing, 1993). Policies and protocols decrease confusion, thus improving overall dispensing quality (Agency for Healthcare Research and Quality, 2001). A constraint that “prevents further action until some condition is met” (Leape et al., 1998a) can also be written into protocols to provide a quality check in a system. For example, protocols usually preclude prescriptions from being dispensed until they are approved by the pharmacist's final check.

Improving access to information leads to improved quality (Abelson and Levi, 1985; Weinstein and Fineberg, 1980). One study indicated that pharmacists make more appropriate prospective DUR decisions when they have access to more complete patient information, such as medication profiles, allergy information, patient age, and diagnosis (Warholak-Juarez et al., 2000). Therefore, medication orders should not be processed without the pharmacist considering these and similar pieces of information.

Moreover, improved quality produces a corresponding increase in productivity because less rework is needed and less waste is produced (Deming, 1986). In pharmacy, quality improvements may produce improved clinical and humanistic outcomes such as improved QoL and customer satisfaction. Improved customer satisfaction can help make the workplace more pleasant and may produce a corresponding increase in employee satisfaction. This ultimately may lead to the pharmacy having a competitive edge and an image as a provider of high-quality pharmaceutical care and may allow the business to recruit and maintain the most highly qualified and desired personnel.

Quality Assurance

Quality assurance (QA) has been defined as “the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met” (Merriam-Webster, 2003). Basically, a check is performed to ensure that a good or service meets a certain quality standard. Problems are addressed after they occur (Godwin and Sanborn, 1995).

Quality Control

Quality control (QC), as defined by Webster's Dictionary, is “an aggregate of activities (as design analysis and inspection for defects) designed to ensure adequate quality” (Merriam-Webster, 2003). Quality control improves product or service design to improve the level of quality; it can be thought of as defect prevention.

Continuous Quality Improvement

Continuous quality improvement (CQI) is “a philosophy of continual improvement of the processes associated with providing a good or service that meets or exceeds customer expectations” (Shortell et al., 1998). CQI has been referred to as quality improvement process, total quality management, and total quality control (Lohr, 1990b).

CQI introduced two important ideas that transcend QA and QC. First, CQI represents a total systems perspective concerning quality; all workers within the health care system are interconnected (Godwin and Sanborn, 1995). When examined from a systems perspective, every action of the health care professional is performed to benefit the patient (Shortell et al., 1998). Therefore, all actions must be planned to improve care and should not focus on correcting individual mistakes after the fact (Godwin and Sanborn, 1995; Shortell et al., 1998). Thus, quality problems are not examined (or blamed) on an individual level (Blumenthal and Kilo, 1998). CQI promotes identification of the cause of problems via “fact-based management and scientific methodology, which make it culturally compatible with the values of health care professionals” (Shortell et al., 1998, p. 605).

Second, CQI demands that the quality improvement process is continuous or never-ending (Blumenthal and Kilo, 1998). Improvement occurs by integrating information concerning quality into the cyclic redesign and improvement of care (Godwin and Sanborn, 1995). The changes can be quick and on a small scale but should be occurring constantly. In this manner, CQI empowers health care providers to improve quality on a daily basis (Shortell et al., 1998).

CQI is more than looking for things that could be wrong; it is a systematic process for continuously improving the quality of every aspect of a pharmacy practice setting from patient care to managerial responsiveness. In this manner, CQI is a much more positive process than QA or QC because the focus is on constantly making things better for all who work in and have contact with the practice. CQI is a method for constantly striving for improvement in every facet, every portion of the medication use system.

Many CQI models exist. Examples of specific models include the plan, do, check, and act (PDCA) model and the find, organize, clarify, understand, select, plan, do, check, and act (FOCUS-PDCA) model and six sigma (Lazarus and Butler, 2001; Lazarus and Stamps, 2002). Most models include elements that reflect the following core concepts: (1) plan, (2) design, (3) measure, (4) assess, and (5) improve (Coe, 1998a).

CQI has been described as a practical application of the scientific method (Blumenthal and Kilo, 1998). Planning in both processes is similar. In this manner, one can think of the steps in the CQI cycle as parallel to the sections of a scientific article: background, methods, results, conclusions, and recommendations. Considering CQI in this manner diminishes the need to memorize additional terminology. See Fig. 8-1 for a flowchart representation of the process.

The steps to CQI discussed in this chapter are included in the CQI Cycle Checklist and Planning Worksheets in Appendices 8A and 8B, respectively. The CQI Cycle Checklist includes an abbreviated list of the actions needed for a successful CQI cycle. The Planning Worksheets are more detailed forms to assist in CQI cycle implementation. Worksheet 1 is intended for use during the first team meeting, Worksheet 2 should be used for the second meeting through completion of data collection, and Worksheet 3 begins with data analysis and guides the user through the remainder of the CQI cycle.

Recruiting the CQI Team

The planning phase of quality improvement is essential. The first step in developing a cohesive plan is to assemble an expert panel. This panel should be interdisciplinary and include representatives of those who are part of or will be affected by the quality plan. The team also should include subject matter experts, decision makers, and frontline personnel. In a pharmacy setting, the entire staff should be invited to participate. This will stress the importance of the quality process and help to get staff support for the quality improvement project. It is important to note that while buy-in will be increased by inviting staff participation and opinions, this effect will be lost quickly if staff members do not perceive that their participation is beneficial.

CQI Cycle Background

Focus Selection

The CQI cycle begins with the selection of a quality improvement focus. Selection may be based on mandate, or the choice may be left to the team. If the team is given the latitude to choose, one of several processes may be used to facilitate this decision. The team could brainstorm possible areas for study. In this case, all team members should provide ideas freely, and each idea should be recorded. Ideas then may be ranked, and team consensus can be used for system selection. Examples of systems that have been shown to provide quality improvement opportunities in health care settings include identifying and measuring the incidence of medication errors, implementing methods to reduce medication errors, measuring medication filling time, analyzing satisfaction with pharmacy services, evaluating the effect of pharmacists' interventions, analyzing adherence to requirements for documentation, documenting the incidence of medication allergy, auditing patient-controlled analgesia pumps, assessing patient-specific medication errors in cart filling, and analyzing hypertension control and guidelines compliance.

Alternatively, processes such as failure mode and effects analysis or root cause analysis can be used to identify systems ripe for quality improvement activities. Failure mode and effects analysis is a prospective procedure used to identify areas for quality improvement before they become a problem (Cohen et al., 1994; DeRosier et al., 2002; NCPS, 2011a). Once possible areas are identified, the investigators decide if the results will be tolerable or intolerable (Cohen et al., 1994).

Root cause analysis is a systematic process used to identify the exact or root cause of a problem (Coe, 1998b). It is used after a quality problem has been discovered (a retrospective procedure) to prevent recurrence (Coe, 1998c; NCPS, 2011b). The process begins with “triage questions” that help the team decide what issues (e.g., staff training, competency, human factors, equipment, and information) could have contributed to the quality problem (Gosbee and Anderson, 2003). Once these questions are answered, more detailed, specific questions are considered in order to identify ways to improve systems to reduce the chance of it recurring. The investigators create an action plan for implementing system improvements and improvements evaluation (Anonymous, 2002; Bagian et al., 2001). A more detailed account of these two processes is included in Table 8-1.

Focus Description

After the focus for quality improvement has been chosen, it is important to make sure that it is clear to each team member. This can be accomplished by providing a detailed description of the area chosen for study, the setting in which the focus occurs, the portion of the medication use process affected, and baseline data, if applicable.

Flowcharts that explicitly represent all portions of the process can be helpful for system description. Flowcharts use standard symbols that represent all process steps (represented as rectangles), as well as decision points (represented by diamond shapes) and the direction of progression from one subprocess to the other (Coe, 1998a). Flowcharts are also useful because they can help the team recognize if the process chosen is too broad (i.e., represented by an unwieldy flowchart). An example of a flowchart is given in Fig. 8-1.

Focus Importance

Next, the team should state why the focus is important. The selected focus should be important to the organization and have the potential to lead to improvement. It should be considered high priority, high volume, high cost, or high risk. For example, a community pharmacy may choose to focus on prescription order-entry error if anecdotal evidence suggests that this may be an error-prone step in its dispensing process.

Literature Review

Relate the focus to the literature by investigating what is known and not known about similar situations. This step can save the team an enormous amount of time in the long run. A brief literature search will help the team to discover techniques, interventions, and other tools that have been successful in improving quality in similar situations.

Goals

Once the focus (i.e., process or problem) is chosen, the team should determine the overall goal (Leape et al., 1998c). Common overall goals include (1) discovery, (2) frequency estimation, and (3) measuring a change (Leape et al., 1998c). For example, after a pharmacy's CQI team has decided that it wants to focus on prescription order-entry error, team members must then decide what they want to know about it. They may decide that since this is their first CQI cycle, they will focus on frequency estimation of the problem. This will serve as baseline data for the assessment of improvements. The overall goal can be used to choose specific goals for the cycle (Leape et al., 1998c). Note that it is important to assess the practicality of the specific goal. The CQI team should examine the specific goal carefully to determine whether it is realistic. If the goal is not realistic, then it may need to be scaled back (Leape et al., 1998c). Choosing something reasonable for the first CQI cycle will provide the team with experience, improve its chances for success, and thus bolster team members' confidence for the next cycle.

CQI Cycle Methods

Intervention

Interventions discovered through a literature review should be included on a list of possible interventions. These may include quality improvement techniques such as reducing reliance on memory, simplifying, standardizing, or automating processes.

Process and Outcomes Measured

Next, the CQI team must determine how progress will be measured (Leape et al., 1998c). Team members should list process and/or outcome measures necessary to determine if the goals were met. Usually, a mix of process and outcome measures is recommended (Leape et al., 1998c). Many measures have been developed, so keep the following in mind: Do not invent a new measure if a good one exists; measure what is important—not easy; and do not measure things you cannot change or interpret (Ovretveit, 2001). Table 8-2 provides additional resources on selecting and developing measures.

Data-Collection Procedures

If the required data are not already being collected, the CQI team should devise a plan to collect the appropriate data. The team can choose from several different data-collection methods (Leape et al., 1998c), including inspection points, focus groups, monitoring for markers, and observation.

Data-Analysis Plan

The planned statistical analysis should be thought out in detail to make sure that all necessary information will be gathered. It can be frustrating and time-consuming to gather forgotten data at a moment's notice. This seems self-evident but is a mistake that many people make.

CQI Cycle Results

Analyze Data

Most descriptive statistics (e.g., mean, median, and percentages) often suffice for data analysis. Some analyses can be performed simply by plotting data onto charts or graphs. Which can help to determine patterns and trends. For more sophisticated analysis or hypothesis testing, outside assistance may be required. If there is not a statistician on the CQI team, it may be beneficial to refer to statistics books to make sure that the chosen analysis is appropriate. Asking for outside help is also an option; the team should not hesitate to call the local college of pharmacy for a referral.

CQI Cycle Conclusions, Implications, and Recommendations

The final section in the process is describing the conclusions, implications, and recommendations that the team reached after examining the results. Since this is the “bottom line” of the process, it is important that this section be understandable to those outside the CQI team. This section should concisely explain the conclusions and detail the actions that need to take place. The CQI process is iterative; thus, the team's recommendations for this CQI cycle and for the next CQI cycle must be included (Leape et al., 1998b). This will be good news to pharmacist Pat. Because CQI is a continuous improvement process, an understanding of the iterative nature of the process will take the pressure off him to “fix” all pharmacy system problems at once.

Often quality improvement activities are necessary for accreditation. Earning accreditation indicates that an organization has met predefined standards. The accreditation process provides a framework to help organizations focus on providing safe, high-quality service and requires that the organization demonstrate to outside reviewers its commitment to continuous improvement (Ovretveit, 2001).

The Joint Commission

The Joint Commission is a nonprofit organization founded in 1951 by the American Medical Association and the American College of Surgeons (O'Malley, 1997). The Joint Commission was established to “continuously improve the safety and quality of health care provided to the public through the provision of health care accreditation and related services that support performance improvement in health care organizations” (Joint Commission on Accreditation of Healthcare Organizations Web site a). The Joint Commission's focus is organization-wide (O'Malley, 1997).

The Joint Commission survey process is largely process-oriented but gradually is moving toward more of an outcomes measurement model in an effort to provide organizations with information they can use to improve patient care (Anonymous, 2003b). Although Joint Commission compliance is voluntary, many organizations view it as mandatory (O'Malley, 1997). Not obtaining Joint Commission accreditation can adversely affect an organization's prestige and reimbursement status (Coe, 1998c; O'Malley, 1997). Key dimensions of performance evaluation include efficacy, appropriateness, availability, timeliness, effectiveness, continuity, safety, efficiency, respect, and caring (Coe, 1998a).

The Joint Commission's annual safety goals often involve medication use and thus pharmacists can use these goals to help improve the quality of medication use throughout the health care system. For example, one of the Hospital National Patient Safety Goals for 2011 is “Check Patient Medications” which includes identifying the patient's home medications, making sure new medications are appropriate to add the patient's regimen, providing a medication list to the patient's next caregiver during their health system stay, and then providing the medication to the patient's regular physician and the patient upon discharge. The medication list should be explained to the patient (Joint Commission on Accreditation of Healthcare Organizations Web site 2011b). These are roles the pharmacist is uniquely suited for and a pharmacist who can contribute in this way to the health system will not only improve the quality of patient care but will also help better integrate him- or herself into the interprofessional medical team.

National Committee for Quality Assurance

The National Committee for Quality Assurance (NCQA, 2011) is a nonprofit organization established in 1979 by a managed-care trade association in response to a perceived need to provide standardized quality measurement and reporting (NCQA, 2003). The NCQA reviews and accredits all types of managed health care organizations (NCQA, 2007).

Quality Measurement

While health care accreditation organizations have existed for quite a while, quality data were not readily available to the general public until recently. These quality measurements (sometimes called “report cards”) make health care quality indicators readily available to the public. This encourages health care organizations to compete on the basis of quality and creates markets where quality, not just cost containment, is rewarded (Blumenthal and Kilo, 1998; O'Malley, 1997).

HEDIS

The Health Plan Employer Data and Information Set (HEDIS) is a health care report card created by NCQA that is used by more than 90 percent of America's health plans to measure performance (NCQA Web site). HEDIS standardizes health plan performance data and disseminates this information publicly so plans can be compared (O'Malley, 1997). This allows health care purchasers and consumers to compare plans and make informed decisions and provides plans with data on where they could focus to improve quality. HEDIS's performance domains include effectiveness of care, access and availability of care, health plan stability, use of services, cost of care, informed health care choices, satisfaction with the experience of care, and health plan descriptive information. Many HEDIS measures involve medication management thus providing an opportunity for pharmacists to help improve the quality of patient care.

Leapfrog Group

The Leapfrog Group was formed by a coalition of Fortune 500 companies and leading health care purchase organizations (Leapfrog, 2003). The Leapfrog Group was developed to create a market that rewards quality, not just the lowest-cost provider, by providing quality information to consumers (Leapfrog, 2003). The Leapfrog survey includes process and outcome measures (Leapfrog Web site).

Deciphering Quality Measures

Quality measures such as those just mentioned are developed for consumer use. However, many patients have difficulty understanding these measures and reports well enough to use them for rational health care decision making. Patients and health care providers can get assistance from a U.S. government Web site called TalkingQuality. (www.talkingquality.ahrq.gov/default.aspx). TalkingQuality was developed to help patients understand the concept of health care quality and to give practical suggestions for choosing health care coverage and providers (Anonymous, 2003a). Sites such as this one are also useful for pharmacists who want to better understand quality improvement in health care.

The Future

Since establishment of the Joint Commission, the scope of health care organizations that are eligible for accreditation has widened from hospitals to encompass health systems and now even pharmacy benefit managers (URAC, 2007). In some countries, such as Australia, pharmacies are accredited (Pharmacy Guild of Australia, 2011). The National Association of Boards of Pharmacy (NABP) has announced a plan to develop and implement a community pharmacy accreditation program. The program would focus on issues such as patient counseling, patient medication adherence, and patient safety. As part of the proposed program, pharmacies would have to implement and maintain continuous quality improvement programs (NABP 2010).

Groups such as the Pharmacy Quality Alliance (PQA) are developing pharmacy-specific quality indicators (PQA, 2011a). These measures assess gaps in patient medication therapy, dosing for specific conditions such as diabetes, suboptimal treatment of conditions such as hypertension, drug–drug interactions, and inappropriate medication use in the elderly (PQA, 2011b). PQA has sponsored demonstration projects to test measures and measure reporting to pharmacists (report cards). PQA is also active in helping pharmacists learn how to improve quality. They have sponsored several educational programs including the self-contained, three-credit QI class titled Educating Pharmacy Students and Pharmacists to Improve Quality (EPIQ) that is available upon request to pharmacists and pharmacy schools (PQA, 2011c).

In the future, the quality improvement process may become more focused on outcomes measurement. Eventually, health care report cards may be more accessible and easy to understand, thus helping to produce a market for quality. Some discussion of adjusting co-payments to encourage patients to use providers that meet the standards purchasers have set has already occurred (Lovern, 2001). In some cases, pharmacy quality improvement may be mandated by state and local governments. For example, a new law in the state of Arizona requires that every pharmacy participate in a CQI program, although the State Board of Pharmacy rules have yet to be implemented (Arizona Revised Statutes, 2007).

So what does this mean for pharmacy practice? More pharmacists must understand continuous quality improvement and be able to develop, implement, and measure the outcomes of such a plan. This could provide an opportunity for a community pharmacy report card (quality measurement) system on which pharmacies can compete on the basis of quality. Such a system may provide a great opportunity for pharmacies to advertise quality outcomes to payers and patients. If such a system is successful, quality could drive patient choices and payer decisions. Ultimately, the pharmacies with the highest quality may get more market share or obtain higher reimbursement rates for certain services (pay-for-performance).

There are several things that Anita can do to improve quality in her pharmacy. First, she can promote a “systems view” of errors within their organization (Hume, 1999). Systems changes should be implemented only when the organization is ready for change and has capable leadership that supports a systems view of “no finger-pointing” (Shortell et al., 1994). Everyone in the organization should be informed of and invited to participate in any quality systems changes (i.e., the quality team). Personnel evaluations (i.e., performance appraisals) should comprise a quality improvement component so that employees are rewarded for their efforts in such matters (Shortell et al., 1994).

Second, Anita and the quality improvement team she creates should focus on high-leverage important systems changes (Hume, 1999; Shortell et al., 1994). For medication safety, this could involve focusing on high-alert medications (e.g., fast movers, narrow-therapeutic-index medications, and medications that are available in multiple strengths), high-risk populations (e.g., pediatrics or geriatrics), or problem processes (e.g., e-prescribing). Significant opportunities for improvement can be gleaned from an analysis of intervention data, medication errors that get identified before they leave the pharmacy (near misses); medication error incident reports, patient comments, or employee feedback (Johnson et al., 2002; Rogers, 1997).

Third, Anita and her team should implement small changes in quick improvement cycles (Hume, 1999). The quality improvement team should be given the opportunity to learn about quality by attempting small changes; it may be too frustrating to take on a large project for the first cycle. Team members should be allowed to experience a success and see how much improvement can be made with a relatively small change; then their enthusiasm will redouble.

Fourth, Anita and her quality improvement team should implement interventions that have worked elsewhere (Hume, 1999). This improves the likelihood of success and reduces the amount of effort required in the process. It is worth noting that the most successful interventions changed systems, not people (Nolan, 2000; van Bokhoven et al., 2003).

If Anita's pharmacy organization does not want to develop its own CQI plan, help is available. Pharmacy Quality Commitment (PQC) has developed the Sentinel System for community pharmacies. This system, which incorporates best practices, risk-management techniques, and systematic procedures to increase quality, is ready to use and is available from the National Alliance of State Pharmacy Associations at www.pqc.net.

It is important to remember that quality improvement in pharmacy is far reaching and that quality improvement projects may take many shapes. That is, the pharmacist can be involved in many different type of quality improvement projects such as the following: decreasing prescribing errors by educating physicians on principles of safe prescribing; improving patient medication compliance by providing a lower-cost alternative; decreasing mortality by helping prescribers select appropriate antibiotics; decreasing medication dispensing errors by implementing dispensing technology; improving the identification of e-prescribing drop down menu selection errors by having prescribers transmit the diagnosis with prescriptions; helping patients better adhere to anticoagulant therapy by providing education; using “show and tell” patient counseling as a method to identify medication errors before they leave the pharmacy; or improving quality of medication use by adding pharmacist-performed medication reconciliation to an accountable care organization. The list—and the ways in which pharmacists can improve the quality of patient care—is endless.

Quality is an essential component of competent, professional pharmacy practice. Increasing quality can have many beneficial effects on any practice, such as minimizing rework and increasing productivity. Many quality improvement changes are simple and can be implemented quickly but may have a large impact on the quality of patient care.

Health care quality finally has achieved a position of high visibility on the national agenda. Thus pharmacists will be called on increasingly to ensure quality in all portions of the medication use system.

Anita has begun to address quality in her pharmacy practice setting.

1. What other steps should she take?

2. How can a quality improvement plan be sustained continuously?

3. How can the pharmacy use the quality improvement plan for marketing?

4. Where can Anita go for additional information about quality improvement?

I would like to thank Dr. Tom Reutzel for his guidance and support in helping to write this chapter.