Importance of a CQI program in ambulatory practice

www.pharmacist.com NOVEMBER 2016 • PharmacyToday 63

Abstract

Objectives: To review the use of a continuous quality improvement (CQI) pro-gram by pharmacy teams to reduce medication errors and to identify strategies for preventing future errors.

Data sources: Institute for Safe Medication Practices community pharmacy safety tools, the National Association of Boards of Pharmacy Model Act and Sur-vey of Pharmacy Law, and CQI information supplemented from select PubMed sources where appropriate.

Study selection: At the author’s discretion based on relevance of the information presented.

Summary: The purpose of a CQI program is to detect, document, and assess prescription errors to determine their cause, develop an appropriate response, and prevent future errors. Through analysis and investigation of root causes and con-tributing factors of error events, strategies to improve the medication-use process and prevent future events can be identified and implemented.

Conclusion: Pharmacists who are well informed about CQI process will iden-tify strategies to improve the medication-use process and prevent future events.

Pharm Today. 2016;22(11):63–75

Introduction

CPE

Importance of a CQI program in ambulatory practiceDonna Horn

Donna Horn, PharmD, Director, Patient Safety–Community Pharmacy, Institute for Safe Medication Practices (ISMP), Horsham, PA

Correspondence: Donna Horn, Director, Patient Safety–Community Pharmacy, ISMP, 200 Lakeside Dr., Ste. 200, Horsham, PA 19044; [email protected]

Learning objectivesAfter participating in this activity, participants will be able to

■ Describe the basic principles of con-tinuous quality improvement (CQI).

■ Explain system-based causes of error. ■ Develop appropriate responses to pos-

sible medication error scenarios using the established guidelines.

■ Specify the board(s) of pharmacy regu-lation requirements for a CQI program.

■ Outline the steps in a CQI program.

The American Pharmacists Association (APhA) is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). The ACPE Universal Activity Number assigned to this activity by the accredited provider is 0202-0000-16-194-H05-P.

Advisory board: Karen M. Ryle, BSPharm, MS, Associate Chief of Pharmacy for Ambulatory Care/Pharmacy, Massachusetts General Hospital, Boston

Disclosures: Donna Horn, PharmD; Karen M. Ryle, BSPharm, MS; and APhA’s editorial staff declare no conflicts of interest, real or apparent, and no financial interests in any company, prod-uct, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures, please see the APhA Accreditation Information section at www.pharmacist.com/education.

Development: This home-study CPE activity was developed by APhA.

Accreditation informationProvider: American Pharmacists AssociationTarget audience: PharmacistsRelease date: November 1, 2016Expiration date: November 1, 2019Learning level: 2

ACPE number: 0202-0000-16-194-H05-PCPE credit: 2 hours (0.2 CEUs)Fee: There is no fee associated with this activity for members of the American Pharmacists As-sociation. There is a $25 fee for nonmembers.

www.pharmacytoday.org64 PharmacyToday • NOVEMBER 2016

CPE cqi in ambulatory practice

Quality improvement is defined “as systematic, data-guided activities designed to bring about immediate improvement in health care delivery in particular settings.1 In health care, the continuous quality improvement (CQI) model is an orga-nizational approach involving organizational management, teamwork, defined processes, systems thinking, and change

to create an environment for improvement. This approach incorporates the view that the entire organization must be committed to quality and improvement to achieve the best results.2

According to the 2015 Survey of Pharmacy Law, published by the National Association of Boards of Pharmacy (NABP), at least 25 states regulate, require, or recommend a CQI pro-gram to monitor and prevent quality-related events (QREs).3

BackgroundConsequences of medication errors can be devastating for both patients and pharmacists. Pharmacists who practice in community pharmacies have numerous demands placed on their attention and cognitive processing ability, which can contribute to the occurrence of an error. Many pharmacy li-censing and accreditation bodies require CQI programs, as well as a root cause analysis (RCA), if a sentinel event occurs (described as an unexpected occurrence involving death or serious physical or psychological injury or risk thereof).4 However, a process for meeting these requirements in phar-macies is still lacking.

Data from the Institute for Safe Medication Practices (ISMP) National Medication Errors Reporting Program ([MERP] www.ismp.org/errorReporting/reportErrortoISMP.aspx) reveal that medication-related problems are repetitive: an incident of misuse in one setting is likely to repeat itself in another if the same system issues exist. Most importantly, the system changes necessary to prevent errors may be similar, and a growing body of literature is available to guide these efforts. Tragically, too many pharmacy organizations and in-dividual providers do not believe that similar incidents can happen to them. They fail to use information about errors occurring elsewhere as a roadmap for improvement in their own pharmacy practice. It is not until a serious error hits home that aggressive prevention efforts are implemented. With so much evidence-based information about error pre-vention at hand, there is little excuse for reacting to errors after they happen instead of preventing them.

The purpose of a CQI program is to detect, document, and assess prescription errors in order to determine the cause, develop an appropriate response, and prevent future errors. It is only through analysis and investigation of root causes and contributing factors of error events that strategies to improve the medication-use process and prevent future events will be identified and implemented.

Development and implementation of CQI efforts should be the highest priority in all pharmacies. Such efforts must be aimed specifically at preventing well-known and repetitive dispensing error categories. Some accreditation programs require pharmacies to seek external medication safety infor-mation and use it proactively to prevent medication errors. At the same time, safety issues recognized internally and re-ported by patients must be documented and analyzed, and a process must be established to determine the best strategies to prevent future problems and ensure implementation. An

Preassessment questionsBefore participating in this activity, test your knowledge by answer-ing the following questions. These questions will also be part of the CPE assessment.

1. Latent system failures includea. A pharmacy storing products with look-alike packaging close

together on a shelfb. Making a math error while calculating the patient’s dose of

medicationc. Staff who bypass barcode scanning during product verifica-

tion because they are too busyd. Overriding a computer alert without fully considering its

importance

2. When describing a continuous quality improvement (CQI) program in community pharmacies, which of the following statements are true?a. CQI can be defined as a system of standards and procedures

to identify pharmacists who make frequent errors so their performance can be evaluated by a peer review committee.

b. CQI can be defined as a system of standards and procedures to identify and evaluate quality-related events and improve patient care.

c. A CQI program is designed to find incompetent staff so they can be retrained

d. A CQI program is designed to provide consumers with a method to report errors to the pharmacy owner/leadership

3. Factors that should be analyzed for each event and then com-pared and contrasted with similar events includea. Staff member(s) involved in the events to see if there is a

patternb. Staffing during the event versus typical, budgeted staffingc. Volume of prescriptions filled at the store versus other storesd. Training level of staff involved in the QRE(s)

4. After an error has occurred, asking the staff to read and review prescription verification policies and procedures is considered to be which type of error-reduction strategy?a. Simplificationb. Educationc. Reminders and checklists d. Redundancy

5. A medication system worksheet designed to assist pharma-cists and pharmacy operators with error report investigations is which of the following?a. Med-ERR toolb. Assess-ERR toolc. ISMP-CQI toold. System-Analysis tool



annual survey to assess consumer perceptions of the quality of dispensed medications and professional services might also be required to supply additional information upon which to base improvement strategies.

Informational tools such as the ISMP Medication Safe-ty Alert! publication5 or ISMP’s Action Agenda6 (a readily available list of medication problems compiled from ISMP’s national reporting program) can be a backbone of any CQI effort. Like any safety reporting program and the expert rec-ommendations that stem from it, the purpose of ISMP MERP is to guide the implementation of quality improvement ini-tiatives by practitioners and pharmacy organizations.

It is important that information that is part of the CQI proceedings and records of review be protected from dis-covery. Patient safety organizations (PSOs) are organizations that share the goal of improving the quality and safety of health care delivery. The Agency for Healthcare Research and Quality (AHRQ) defines patient safety work product (PSWP) as the information protected by the privilege and confidentiality protections of the Patient Safety Act and Pa-tient Safety Rule. AHRQ further explains that PSOs serve as independent, external experts who can collect, analyze, and aggregate PSWP locally, regionally, and nationally to develop insights into the underlying causes of patient safety events, improving quality by identifying and reducing the risks and hazards associated with patient care. These protec-tions were enacted to allow communications with PSOs and to allay fears of increased risk of liability because of collec-tion and analysis of patient safety events.

For more information on PSOs, go to www.pso.ahrq.gov/faq#PSOGeneralInformation.

Assume that errors will occurMany factors, latent and active, must be present and in proper alignment for an error to occur. Latent factors refer to less apparent failures in the design of organizational sys-tems, the environment, or equipment that are often hidden until they contribute to the occurrence of errors or allow er-rors to go unrecognized until they harm patients. An active failure (human error), such as bypassing barcode scanning during product verification, may be an obvious cause in the aftermath of an event, whereas a latent failure, such as the manufacturer providing a stock bottle with a barcode that is difficult to scan, is a less-obvious condition that makes er-rors more likely. Thus, latent failures are accidents waiting to happen.

Adverse events often occur when multiple latent failures align perfectly, like the holes of several unique slices of Swiss cheese, allowing errors to reach patients. The Swiss cheese model, proposed by patient safety expert James Reason, sug-gests that a system is analogous to a stack of Swiss cheese slices; each slice represents a part of the system that defends against errors.7 A hole in one slice of cheese, or part of the system, may allow an error to get through a single layer, but in the subsequent layers, if the holes are not aligned correctly,

the error may be stopped. For an adverse event to occur, the holes need to align perfectly for the error to get through the many layers of the system.

‘There seems to be a mistake with my prescription’When patients report medication errors to ISMP, they are usually more upset about the response, or lack of response, they receive from the pharmacist or pharmacy management than with the actual error itself. All too often, pharmacists, technicians, and management (including corporate), have not been educated or prepared on how to respond to an error.

Following are a few examples reported to ISMP:

I filled a prescription for amoxicillin for my daughter. The dos-age was 5 mL twice a day for 10 days. I gave my daughter 5 mL twice a day. Eight and a half days later, the medication was gone. When I called the pharmacy, they repeatedly told me I was given a 10-day supply and I couldn’t possibly be out. Then I was told it could take days to get my doctor to approve more to finish the cycle. Only when I pointed out that stopping a course of antibiotics before the prescribed timeframe was what causes super bugs did they change their minds and decide my doctor could approve it the same day. I am very displeased with this pharmacy. I won’t be using them again!

Amitriptyline 20 mg was the drug my daughter should have been given. Instead the pharmacy gave her [amitriptyline] 200 mg. She thought this was just a change in the way it looked because it was generic. She has taken this medication for years for migraine prevention. She took this and hallucinated and talked out of her head all night. Her husband put her in the car at one point to take her to the ER, but then she thought she would be ok to sleep it off. The next day she was not able to function and slept most of the day. She called the pharmacy and told them. She said the pharmacist was not very apologetic and did not want to tell her what he had given her. He said he had filled this prescription himself. He told her to bring it in and he would exchange it. She is having her prescription transferred to another pharmacy. We know things can happen, but his lack of concern was the biggest issue.

A rheumatology office faxed my prescription for methotrexate 2.5 mg with dose of eight tablets per week. My prescription was dispensed with directions for me to take six tablets every week. I called the pharmacy questioning the label directions because I had been told by the rheumatologist that the dose was eight tablets per week. I had to return to the pharmacy, and then my physician was contacted to clarify. My physician’s office checked my records and confirmed the dose as eight tablets per week. The pharmacist told me that due to fax machine blur, the dose was read by the pharmacy staff as six tablets per week.

I had a prescription filled (meperidine 50 mg). I did not count the pills onsite, but the next morning I seemed to be missing two pills. I blamed myself, thinking maybe I took them but didn’t re-



member. [A few days later] I went back to the pharmacy to fill an-other prescription for meperidine 50 mg. These pills were for gum pain after dental surgery. Again I didn’t count the pills onsite but did as soon as I got home. I had two pills missing. I called the phar-macy due to my concern. I was asked why I came back there if I had two pills missing from my first prescription? The same pharmacist had filled both scripts, and that is who I was talking to.

I have been receiving phone calls for the past few days from a

pharmacy regarding a prescription that was supposedly placed on my behalf. Curious, I called them back and got the name of the doc-tor’s office, which turned out to be a woman’s health center. I was worried that someone was trying to use my identity, as there is no possible way I placed this order. Both facilities were able to look [up] my name and birth date in their system; however, the person they were trying to reach had a different middle name and social security number. The pharmacy informed me that they send their medica-tion refill requests electronically, so the name would have appeared correct as it was inputted into their system. The pharmacy had originally filled the prescription under my name incorrectly and was contacting me to pick up a prescription for a different person. It wasn’t until the doctor’s office called the pharmacy themselves to inform them they had made an error that they called me to formally apologize for the mix-up. I had contacted them previously regarding the matter, and they nonchalantly informed me that the medication must have been placed under the wrong name, as if this happens all the time and it wasn’t a big deal.

Sound familiar? Certainly these are not unusual stories. In fact, something similar may have happened at your phar-macy. When a patient or caregiver thinks a mistake has been made and brings it to your attention, what do you do? How do you respond? Does your pharmacy have a policy on how to handle these situations? Do you have a CQI program?

All alleged errors or incidents should be handled by a pharmacist with professionalism, courtesy, and empathy. Handling an incident requires positive awareness, sincerity, and concern while addressing the patient or caregiver. The following recommendations will help the pharmacist remain calm and reassured when dealing with a possible incident.

How to respond when a medication error occursEvery pharmacy should have written procedures for handling medication errors, and more importantly, every member of the pharmacy team needs to see, read, and understand these procedures. The procedures should contain guidance about what to say and do and what not to say or do. General prin-ciples to have in any written procedures on how to respond to an error include the following:

■ Define staff roles in response to a possible or actual medi-cation error, including a description of how staff should re-spond to a patient’s questions about what he or she may as-sume is a dispensing error. Also define how management should respond and investigate the cause of the error.

■ Have a written policy on disclosure to the patient that is agreed upon and followed by management and staff.

■ Define when others (e.g., prescriber) should be notified of an error.

■ Respond to the reporter immediately with concern. As-sure the patient reporting a potential or actual error that it is important and a priority.

■ Whether the error is obvious or still a remote possibility, respond to the discrepancy immediately.

■ Remedy the immediate situation with truth and hon-esty. Be direct and open with the patient reporting the error. The goal is to minimize any negative impact to the patient.

■ Consider teaching everyone who is involved in respond-ing to an error to use statements such as, “Please let me explain what we believed happened and how we plan to fix it” or “At this point I can’t answer how this happened, but I promise you I will look into it and get back to you.”

■ Document and report the event, the response made to the patient, and any follow-up needed. Some specific ac-tions to consider include 1) documenting the date, time, and specifics of the event; 2) reporting the event using the pharmacy’s internal reporting system; 3) notifying supervisors, risk management, and the prescriber when necessary; 4) making a note in the patient’s profile so that staff are aware, especially when the patient returns to the pharmacy; and 5) reporting the event confidentially to ISMP, when appropriate, to warn others outside of your pharmacy organization of a possible error that may have been prevented.

■ Establish a CQI program. ■ Follow up and alert staff to the situation. Share and dis-

cuss event details, possible contributing factors, tempo-rary and subsequent prevention strategies, and proce-dural changes.

■ Support staff involved in the incident. Offer access to em-ployee assistance programs to those involved with the error. Offering support and providing opportunities for counseling will help the person transition back to work in a supportive, confident way.

■ Practice and role-play possible scenarios using the estab-lished guidelines. Discuss how you might respond to the following incidents: 1) After just paying for his prescrip-tion, a patient returns to the pharmacy counter with a torn bag and open vial and says, “This does not look like what I got last month!” and 2) while counseling a patient on a warfarin dose change, you discover that the strength on the label and the tablets in the vial don’t match.When communicating with a patient who may have been

involved in an incident, remember to give the situation your undivided attention, introduce yourself to the patient or caregiver, and speak slowly and calmly. And remember that you can offer a sincere apology for the distress they are expe-riencing about the accuracy of their prescription without ad-mitting fault. Let them know your pharmacy has a CQI com-



mittee that reviews all incidents for causes and prevention.

Developing a CQI program

What is CQI?Patient safety is a fundamental and integral component of quality assurance and quality care. Therefore, standardized CQI programs are needed to identify and evaluate quality-related events (QRE) and improve patient care. CQI is a quality assurance program that engages a cyclical perpetual process involving the discovery, analysis, and resolution of a medication error. It reduces errors, improves systems while focusing on learning, and is aimed specifically at preventing well-known and repetitive dispensing error categories.

Why should pharmacies use CQI instead of discipline?Most boards of pharmacy have missions similar to that of Massachusetts’ Board of Registration in Pharmacy: to “set standards of quality assurance and best practices to promote, preserve, and protect the public health, safety, and welfare by fostering the provision of quality pharmacists care through the regulation of the practice of pharmacy, the operation of pharmacies, and the distribution of prescription drugs in the public interest.”7

Quality assurance should be a learning experience, not a punitive process, because the goal is to reduce errors, not punish the staff member involved in the error. Staff need to want to report errors so that they can learn from them. Data are the key to prevention, and prevention is the key to safety.

CQI does not eliminate all error. Instead, it leads to pre-vention by incorporating safety during dispensing. The focus is shifted from blame to analysis. The objective is to work on preventing the next error, not punishing the last er-ror. CQI’s goal is to produce a culture change geared toward safety and education. Pharmacy staff need a method to learn from mistakes, and CQI programs can provide that method. In other words, CQI encourages staff to investigate by asking: What happened? What can we learn? What can we do now?

Whether it is implemented to comply with board regula-tions or a company’s internal program, CQI should not be used against the pharmacist for job performance. It should not be a method to find incompetent staff. Staff should be re-warded for reporting errors, not punished or held to ridicule.

What is a QRE in terms of CQI programs and boards of pharmacy?10

A QRE is the incorrect dispensing of a prescribed medication received by a patient, including the following:

■ Variation from the prescription order ■ Incorrect drug ■ Incorrect drug strength ■ Incorrect dosage form ■ Dispensing the drug to the wrong patient ■ Providing inadequate or incorrect packaging, labeling, or

directions

A QRE is further defined as a failure to identify and manage ■ Overutilization ■ Therapeutic duplication ■ Drug–disease contraindications ■ Drug–drug interactions ■ Incorrect drug dosage or duration of drug treatment ■ Drug–allergy interactions ■ Clinical abuse or misuse

What do typical state board of pharmacy regulations require for CQI programs? Boards of pharmacy determined that CQI program efforts should be prioritized, funded, and incorporated into each pharmacy business. Because many pharmacies did not do it on their own, boards felt compelled to mandate implementa-tion CQI programs in each pharmacy—but how?

NABP is an impartial professional organization that sup-ports state boards of pharmacy in protecting public health. The Model State Pharmacy Act and Model Rules of the Na-tional Association of Boards of Pharmacy (Model Act) pro-vides boards of pharmacy with model language that may be used when developing state laws or board rules. Per the Model Act, the definition of a CQI program is “a system of standards and procedures to identify and evaluate quality-related events, and to constantly enhance the efficiency and effectiveness of the structures and processes of a pharmacy system that determine the outcomes of medication use. All information, communications, or data maintained as a com-ponent of such a system shall be privileged and confidential and not subject to discovery in civil litigation.”10

The Model Act goes on to say: “States should continue efforts to develop and implement requirements for CQI Programs in pharmacies, recognizing that CQI Programs enhance patient safety and operate most effectively when privilege of discovery laws and/or regulations protecting CQI data and information are enacted and included as a component of the CQI process” (see sidebar).

NABP Model Act Section 7. Continuous Quality Improvement Program

(1) Compliance with this section may be considered by the Board as a mitigating factor in the investigation and evaluation of a Quality-Related Event (QRE).

(2) Each Pharmacy shall establish a Continuous Quality Improvement (CQI) Program for the purpose of detecting, document-ing, assessing, and preventing QREs. At a minimum, a CQI Program shall include provisions to:

(i) designate an individual or individuals responsible for implementing, maintaining, and monitoring the CQI Program, which is managed in accordance with written policies and procedures maintained in the pharmacy in an immediately retrievable form;

(ii) initiate documentation of QREs as soon as possible, but no more than three days, after determining their occurrence;

(iii) analyze data collected in response to QREs to assess causes and any contributing factors such as staffing levels, workflow, and technological support;

(iv) use the findings of the analysis to formulate an appropriate response and develop pharmacy systems and workflow processes



designed to prevent QREs and increase good outcomes for patients;(v) provide ongoing CQI education at least annually to all phar-

macy personnel;(vi) for those Persons utilizing a Drug formulary, a periodic

review of such formulary shall be undertaken to ensure that ap-propriate medications are being offered/selected in the best interest of patients.

(3) As a component of its CQI Program, each Pharmacy shall ensure that periodic meetings are held, at least annually, by staff members of the Pharmacy to consider the effects on quality of the Pharmacy system due to staffing levels, workflow, and technological support. Such meetings shall review data showing evidence of the quality of care for patients served by the Pharmacy and shall develop plans for improvements in the system of Pharmacy Practice so as to increase good outcomes for patients

(4) Appropriately-blinded incidents of QREs shall be reported to a nationally recognized error reporting program designated by the Board.

(5) Quality Self-AuditEach Pharmacy shall conduct a Quality Self-Audit at least

quarterly to determine whether the occurrence of QREs has de-creased and whether there has been compliance with preventative procedures, and to develop a plan for improved adherence with the CQI Program in the future. Each pharmacy shall conduct a Quality Self-Audit upon change of Pharmacist-in-Charge to familiarize that Person with the Pharmacy’s CQI Program.

(6) Consumer SurveyAs a component of its CQI Program each Pharmacy should

conduct a Consumer Survey of patients who receive pharmaceutical products and services at the Pharmacy. A Consumer Survey should be conducted at least once per year. A statistically valid sampling technique may be used in lieu of surveying every patient. Each Phar-macy should use the results of its Consumer Survey to evaluate its own performance at a particular time and over a period of time.

(7) Protection from DiscoveryAll information, communications, or data maintained as a com-

ponent of a pharmacy CQI Program are privileged and confidential. This shall not prevent review of a pharmacy’s CQI Program and records maintained as part of a system by the Board, pursuant to subpoena, as necessary to protect the public health and safety. All information, communications, or data furnished to any Peer Review Committee, and any findings, conclusions, or recommendations resulting from the proceedings of such committee, board, or entity are privileged. The records and proceedings of any Peer Review Committee are confidential and shall be used by such committee, and the members thereof, only in the exercise of the proper functions of the committee and shall not be public records nor be available for court subpoena or for discovery proceedings. The disclosure of confidential, privileged Peer Review Committee information during advocacy, or as a report to the Board of Pharmacy, or to the affected Pharmacist or Pharmacy auxiliary personnel under review does not constitute a waiver of either confidentiality or privilege.

(8) Compliance with SubpoenaAll persons shall comply fully with a subpoena issued by the

Board for documents or information as otherwise authorized by law. The disclosure of documents or information under subpoena does not constitute a waiver of the privilege associated with a CQI Pro-gram. Failure to comply with the subpoena is grounds for disciplin-ary action against the Person by the appropriate licensing board.

Pharmacies should consider incorporating NABP model regulations into workable, compliant CQI programs. CQI

programs should include provisions to ■ Designate an individual or individuals responsible for

monitoring CQI program compliance ■ Identify and document medication errors ■ Minimize impact of medication errors on patients ■ Analyze data collected in response to medication errors

to assess causes and any contributing factors ■ Use the findings of the analysis to formulate an appropri-

ate response and develop pharmacy systems and work-flow processes designed to prevent medication errors

■ Conduct a consumer survey at least annually ■ Provide pharmacy personnel ongoing CQI education at

least annually

Peer reviewPeer review—outcomes-based CQI—is an important compo-nent of the CQI process. Peer view components include re-evaluating standards of quality for the pharmacy operation, collecting data when standards are not being met to evaluate reasons for deficiency, and providing an objective review of data to make recommendations for quality improvement. Most importantly, peer review provides a feedback mecha-nism to ensure that processes continually improve the qual-ity of care.

The NABP Model Act defines peer review committee as “a committee that is authorized to evaluate the quality of pharmacy services or the competence of pharmacists and suggest improvements in pharmacy systems to enhance pa-tient care; or a committee established by a person who owns a pharmacy or employs pharmacists that is authorized to evaluate the quality of pharmacy services or the competence of pharmacists and suggest improvements in pharmacy sys-tems to enhance patient care,” and goes on to state that a peer review committee “may be established to evaluate the qual-ity of Pharmacy services or the competence of pharmacists and suggest improvements in Pharmacy systems to enhance patient care. Peer Review Committees may review docu-mentation of quality-related activities in a pharmacy, assess system failures and personnel deficiencies, determine facts, and make recommendations or issue decisions in a written report that can be used for Continuous Quality Improve-ment purposes. A Peer Review Committee may include the members, employees, and agents of the committee, including assistants, investigators, attorneys, and any other agents that serve the committee in any capacity.”8

In retail pharmacy, most CQI components and risk as-sessments are not implemented at individual stores but through committees of practicing pharmacists who review aggregate data from internal incident reports as well as ex-ternal reports. These peer review committees are established by pharmacy owners or managers to reduce occurrence of errors by suggesting improvements to systems, assessing system failures, and making recommendations for quality improvement purposes.

Peer review committees have been recognized as an im-



portant component in any system that is designed to identify and eradicate the causes of medical errors. This self-analysis is vital in the development of new procedures that will help all providers learn from these events so that similar errors are not repeated.

Following are steps to implement a peer review committee. Step 1: Designate an individual or individuals respon-

sible for monitoring CQI program compliance, and develop a committee of peer pharmacists who are familiar with the practice and work environment. The committee members must also be familiar with CQI as well as the causes and pre-vention of QREs.

A community pharmacy’s CQI peer review committee can also include technicians, interns, consumers, attorneys, and other health professionals. Why consumers? They can give insight on such factors as how private the consultation area is or how accessible the pharmacist is either in person or over the phone. Why attorneys? They represent the company in litigation and board hearings, and therefore need to know suggested error-prevention strategies. In addition, they can help with issues surrounding laws such as HIPAA. Why oth-er health professionals? They are the source of prescriptions that are called in, written, or sent electronically and can give insight on communication issues.

Step 2: Set quality standards and indicators. Each phar-macy organization needs to develop standards that measure quality to determine if quality is being achieved and if ser-vices are improving or declining. After identifying quality standards, the pharmacy then needs to develop indicators/metrics for measurement. Some examples of metrics include Number of QREs vs. prescriptions dispensed, QRE by event type, or QRE per time of day (shift). Note that standards and indicators/metrics will continually evolve.

Step 3: Identify and document medication errors. Docu-mentation is key to proving that CQI is being done. Pharma-cies need to develop clear and concise reporting procedures and forms that are preferably electronic. Details of what, when, how, and why—but not WHO—need to be document-ed. The report should record the name of the person docu-menting the information, not the name of the person who made the error.

Data collected during an investigation of a QRE should permit evaluation of quality performance over time. Data should point out how the system failed, compare what ac-tually occurred to standards in place, and measure quality or lack of quality. Factors that should be analyzed for each event and then compared and contrasted with similar events include the following:

■ Time of day the event occurred ■ Staffing during the event versus typical, budgeted staff-

ing ■ Volume of prescriptions that day ■ Whether prescription involved was new or refill ■ Severity of event or worst-case scenario if close call (near-

miss)

■ Probability of event based on frequency of happening in the pharmacy

■ Any other unique details about the eventHaving the peer review committee compare and contrast

errors that occurred in a particular time period can help the committee determine why this many of these particu-lar types of errors occurred. The goal is to discover common causes and changes that can be made.

Step 4: Analyze data collected in response to QREs to as-sess causes and any contributing factors. Submitted reports, properly interpreted, can provide important new knowledge about the function of systems and the latent causes of error. To have a positive impact on patient safety, priority should be given to the reporting and analysis of preventable adverse events or hazardous situations that have the most significant potential to cause harm, or that have actually caused patient harm. The committee may decide not to review all incident reports but instead to develop priorities for improvement and review incident reports that relate to those priorities. For example, a committee could evaluate the following elements against the standard:

■ Occur frequently or affect a large number of patients (high volume)

■ Place patients at risk or are a potential sentinel event ■ Produce problems for patients or staff (problem prone)

Putting QREs into categories during the analysis phase can help the committee determine how to prioritize its efforts.

Step 5: Use the findings of the analysis to formulate an appropriate response, and develop pharmacy systems and workflow processes designed to prevent medication errors. Because CQI is a fluid and evolving process, committee members must receive initial and ongoing education on the need for improvements so that a culture is established to in-tegrate recommendations into practice.

Choosing the right strategy for error preventionInvestigation of an event sometimes ends when “human error” has been identified as the cause. However, a human error investigation should always occur to uncover any pre-existing performance shaping factors (e.g., task complexity, workflow, time availability/urgency, process design, experi-ence, training, fatigue, stress) or other environmental condi-tions, system weaknesses, or equipment design flaws that allowed the error to happen and reach the patient. The in-vestigation is incomplete if it ends with human error as the root cause because it fails to uncover how human errors get through the system and reach patients—information that is critical when planning the redesign of systems.

The most effective risk-reduction strategies involve re-designing systems to make them more resistant to human error and enabling staff to make safe behavioral choices by removing the system- and cultural-based incentives for cut-ting corners. Yet, developing new rules and educating staff—considerably weak interventions—are among the most com-



mon risk-reduction strategies found in root cause analysis (RCA). Next in line is often a manual downstream double-check that does little to prevent errors upstream. Strategies that rely heavily on human memory and vigilance are much weaker than those that prevent staff from carrying out tasks the wrong way, “force” them to carry out tasks the correct way, or involve automation to provide just-in-time decision support, verify accuracy, and halt progress when errors are made. Layering action plans with multiple strategies also helps ensure success.

In theory, choosing a “fix” for recognized contributing factors that arise with the dispensing process should be a relatively easy task, yet ISMP continues to receive medication error reports from pharmacies that have not been successful in developing a plan and sustaining their medication safety goals. Some pharmacies are less successful in creating sus-tainable medication safety change because their cultures are punitive. In this environment, finger-pointing and individual blame still occur, and the unexpected outcome is looked at as the “problem” of the individual pharmacists and/or techni-cians involved. Other pharmacies are unsuccessful because they do not consider the human and environmental factors that influence the work (e.g., fatigue, inadequate staffing, excessive agency staff use, poor environmental conditions, overcrowding of medications) or understand how these fac-tors impact the system’s ability to be reliable. In addition, it is rare to find pharmacy staff that have had formal training around medication risk-reduction principles or how to apply these principles to maximize safety efforts.

Medication safety efforts are best supported with three goals: 1) eliminating error, 2) identifying errors early before they reach the patient, and 3) mitigating harm if an error does occur. For these goals to be achieved, a variety of medi-cation safety strategies need to be implemented at both the corporate level and individual pharmacy practice sites.

As many pharmacies are still rules driven, the strate-gies most commonly selected after an error has occurred are writing a new policy “so the problem is eliminated” and “educating the staff” to help them “be more careful.” While writing new policies and providing education are necessary, when selected as the only strategies for safety improvement, they are not highly effective or sustainable over time, as they require a great deal of human interaction and individual practitioner vigilance to be successful. Thus, reliable systems cannot be built solely on these strategies alone. As an alter-native approach, use a combination of the following safety principles as a guide toward developing a solid safety plan.

Fail-safes and forcing functions. Fail-safe principles prevent the malfunctioning or unintentional operation of a device by having a feature that automatically reverts to the predetermined safe state if failure were to occur. An example is a cash register, which is tied into the pharmacy computer system, locking up to prevent a sale if the prescription has not gone through final verification by a pharmacist. Forcing functions are similar in that they also prevent something

from happening unless certain conditions are met; this is often described as a “lock and key design.” Pharmacy com-puter systems that prevent dispensing unless patient allergy information is entered in the patient’s profile is an example of a forcing function.

Standardization. Standardization of complex medica-tion processes assists individuals in preventing error by eliminating variation. It can also make errors visible because staff become extremely knowledgeable about the standard protocol and therefore can easily identify a practice that oc-curs outside of the norm. An example would be to create a standardized process for receiving a telephone prescription order, which always includes asking for patient’s date of birth, indication of the medication being ordered, and aller-gies, and completing the call by reading back the transcribed order (i.e., using the read-back method).

Simplification. Medication use is an extremely complex process, with many steps and handoffs necessary between many individuals. Thus, the more that medication-use pro-cesses are streamlined and simplified without eliminating critical redundancies, the safer the process will be. Pharma-cies that have both “in” and “out” windows and a linear pro-cess between the two for entering and dispensing medica-tions have simplified what could be a convoluted process.

Critical redundancies. Use of checklists, templates, and independent double-checks fall into this type of strategy. Although pharmacists may consider the double-check a dif-ficult strategy to employ, an independent double-check has been shown to improve the likelihood of catching an error at the time of drug dispensing. Enhance the chance of com-pliance with this strategy by performing double-checks with emphasis placed on specific high-alert, look-alike, or sound-alike medications. Use two different pharmacy staff (tech-nicians included where and when feasible) and the patient or caregiver to double-check the prescription for the correct drug, dose, frequency, and route. Dispensing errors have of-ten been averted when patients are counseled about the med-ication, reason for use, dose, route, and directions for taking the drug. This offers patients an opportunity to speak up if any information does not match their expectation.

Differentiation. This strategy entails modifying medica-tion packages, labels, and the pharmacy computer entry sys-tem screen to distinguish look-alike drug names. This strat-egy can be accomplished by adding auxiliary labels to stock bottles, placing these stock bottles in an outer wrap with an auxiliary label, or storing them behind shelf talkers and us-ing “tall man” letters on drug selection screens.

When choosing error-reduction strategies, use a mix of higher- and lower-leverage strategies that focus on system is-sues and address human factors issues for those who work within that system. Ideally, choose as many strategies from the list as possible, concentrating efforts on the high-lever-age strategies from the top of the list. These strategies may include using automated alerts; standardizing the prescrib-ing, storage, dispensing, and administration of these prod-



ucts; using redundancies such as automated or independent double-checks when necessary; and instituting mandatory patient education for high-alert medications. Since an indi-vidual cannot be expected to compensate for weak systems, routinely evaluate the error prevention strategies being used in your organization.

So which strategies should we choose? Some error-reduc-tion strategies are considered stronger or “high leverage” be-cause of their ability to consistently impact safety. Strategies at the top of the list (Figure 1) are considered high leverage because they do not depend on human vigilance to be suc-cessful. Strategies toward the bottom of the list are necessary for building a solid safety net or system but are not as strong as those at the top of the list because they rely on human memory and behavior to be effective. Thus, these strategies are considered “low leverage” because they are wholly de-pendent on individuals remembering to do the right thing each time. Since human beings are wired to make mistakes, this is an unrealistic expectation.

After evaluating QREs against quality standards, make recommendations and maintain records. Some recommen-dations made by the committee may require involvement of another department in the parent organization (i.e., entities with authority to make changes, such as the IT department or the training department). Of course, leadership/manage-ment must agree with the recommendations, which is why it is necessary to have clear and concise documentation of the QREs and their contributing factors.

Step 6: An essential component of any CQI program is to periodically evaluate how good peer review is working to improve quality. Conduct quarterly self-audits to determine whether QREs have decreased and whether there has been compliance with preventive procedures and to develop a plan for improved adherence with the CQI program in the future.

Ask these questions:

■ Are the quality standards being met? ■ Are the quality standards adequate? ■ Are the quality standards appropriate? ■ Do the results over time show an improvement in quality

for the pharmacy?Development of actions is important within an institu-

tion; it is as important to establish outcome measures to de-termine the effectiveness of the action plan over time. For example, after implementing barcode scanning technology for product verification because of many “wrong drug” re-ports, have the managers periodically run barcode scanning reports (scanning rates, measure bypass reports, and wrong scan reports). This is a source of measurement to see how well or how poorly the actions have actually been imple-mented. Evaluating the results and making appropriate ad-justments to the standards or process will provide feedback to the entire peer review system.

Conduct a consumer survey at least once per year by phone, by mail, electronically, or in person. Use a statistically valid sampling technique. The survey does not need to be limited to patients. It could include physicians, nurses, and others. Solicit input on a wide variety of quality-related mat-ters. Use the results of the consumer survey to evaluate the pharmacy’s own performance at a particular time and over a period of time.

Step 7: Provide ongoing CQI education at least annually to pharmacy personnel. Errors cannot be prevented in the field unless pharmacy staff hear about and learn from the safe practice recommendations that result from analysis of errors, including close calls. For that reason, communica-tion is a powerful and necessary component of an effective CQI program. Conduct periodic staff CQI meetings. Before the staff meeting, prepare an agenda. During the meeting, review all QREs since the last meeting. Share the reports and include facts about the events, including facts about environ-mental, staffing, workflow, and communication issues. Re-view data showing evidence of the quality of care provided to patients served by the pharmacy. Document the meeting date, time, and attendance. Review any CQI tools that have been completed since the last meeting (see below for the CQI tools that are available through ISMP).

Rapid dissemination of accurate, valid, and peer-re-viewed information also provides credible evidence that the information is being used appropriately and effectively, which in turn stimulates further reporting.

ISMP tools for CQI programs

Assess-ERRAssess-ERR (www.ismp.org/Tools/Community_AssessERR/default.asp) is one documentation model that can be modi-fied to meet a pharmacy’s particular needs. This medica-tion system worksheet is designed to assist pharmacists and pharmacy operators with error report investigations. Phar-macies can use the Assess-ERR tool to record errors (includ-

Figure 1. Rank order of error reduction strategies

Fail-safes and constraints High Leverage

Forcing functions

Automation and computerization

Standardization

Redundancies

Reminders and checklists

Rules and policies

Education and information Low LeverageNote: Items at the top of the list, such as fail-safes, forcing functions, and auto-mation, are more powerful strategies because they focus on systems. The tools in the middle attempt to fix the system yet rely in some part on human vigilance and memory. Items at the bottom, such as education, are old, familiar tools that focus on individual performance and therefore are weak and ineffective when used alone.



ing close calls) and/or hazardous conditions. Examples of errors to address with Assess-ERR include dispensing the wrong drug, strength, or dose; look-alike/sound-alike errors; calculation or preparation errors; misuse of devices; and er-rors in prescribing, transcribing, dispensing, and/or moni-toring of medications.

The Assess-ERR medication worksheet asks questions about the possible contributing factors based on ISMP’s Key Elements of the Medication Use System.9 These are the fac-tors that most significantly influence the medication use pro-cess and safe medication use. The interrelationships among these key elements form the structure within which medica-tions are used.

The 10 key elements listed, with some common contrib-uting factors, are as follows:

■ Patient information (e.g., essential patient information is missing, such as allergies and reaction, date of birth, and comorbid conditions)

■ Drug information (e.g., drug references not readily avail-able, lack of dose range checks in the pharmacy computer system)

■ Communication of drug orders and other drug informa-tion (e.g., illegible written prescriptions, misheard tele-phone prescription orders, confusing abbreviations and dosages, electronic prescriptions with conflicting direc-tions in the note/comment field)

■ Drug labeling, packaging, and nomenclature (e.g., look-alike/sound-alike medications, pertinent information missing from pharmacy prescription labels, warning la-bels concealed or missing)

■ Drug standardization, storage, and distribution (e.g., medication-crowded storage shelves, misplaced medica-tions, look-alike/sound-alike products stored consecu-tively)

■ Medication device acquisition, use, and monitoring (e.g., oral measuring devices not dispensed, lack of mainte-nance of dispensing devices)

■ Environmental factors, workflow, and staffing patterns (e.g., dim lighting, inefficient workflow, no breaks during work)

■ Staff competency and education (e.g., insufficient train-ing during orientation, updated or new information on medications or policies not provided)

■ Patient education (e.g., no encouragement for patients to ask questions, patient noncompliance of medications not addressed, no offer to counsel)

■ Quality processes and risk management (e.g., no inde-pendent double-checks, punitive culture for error report-ing, causes of errors not analyzed)Using the Assess-ERR can help a pharmacy convert a

negative error experience into a positive learning experience that enhances the overall future safety of that pharmacy’s practice. The tool aids in the development of a standardized approach to documenting and categorizing error incidents and helps to reveal the underlying system deficiencies that may have caused or contributed to QREs. In addition, the tool can help raise awareness of issues that have become so famil-

iar to pharmacists that they are no longer even recognized as risks.

Root Cause Analysis WorkbookThe Root Cause Analysis (RCA) Workbook for Community/Ambulatory Pharmacy (www.ismp.org/tools/rca/) is de-signed to assist community pharmacy personnel in complet-ing an RCA for a sentinel event that may have occurred in their pharmacy. RCA for sentinel events is required in the Center for Pharmacy Practice Accreditation’s standards, which were developed by NABP, APhA, and the American Society of Health-System Pharmacists, as well as by several boards of pharmacy.

ISMP Action AgendaInformational tools such as the ISMP Action Agenda, a read-ily available list of medication error problems compiled from our national reporting program, can be the backbone of any CQI effort. Each pharmacy needs to accurately assess how susceptible its systems are to errors that have happened in other organizations and acknowledge that the absence of similar errors is not evidence of safety.

A great way to learn about errors that have occurred in other pharmacies is by completing the ISMP Community/Ambulatory Care Action Agenda. Each pharmacy practice site should convene a staff meeting to discuss each item in the Action Agenda. The staff should ask themselves, “Can this error occur at our site?” If the answer is yes, the ISMP recommendations for prevention should be reviewed for ap-plicability at that specific site. If the recommendations are relevant to the practice site, the columns on the Action Agen-da titled ”Organization Assessment” and ”Action Required/Assignment” should be completed, and a reasonable time for completion should be set. The staff should reconvene in 3 months to determine if the proposed recommendation strat-egies have been implemented, if they are still pertinent, and if other strategies have been offered or considered since the initial meeting.

Use of the Action Agenda to review externally reported errors, combined with review and analysis of internally re-ported events, constitutes a feasible and effective CQI pro-gram.

Challenges of a CQI programThe fear of reporting is the biggest challenge pharmacies face when developing and implementing a CQI program. To de-ter this challenge, pharmacies must work toward developing a culture of excellence related directly to quality of service and patient care. Reporting will occur only if practitioners feel safe doing so and it becomes a culturally accepted activ-ity within the health care community. To combat the fear of reporting, the culture must shift from blame to analysis. Un-derreporting takes away the opportunity to better serve pa-tients. To be successful, reporting must come from front-line practitioners, be unrestricted, and include errors that reach the patient, close calls, and hazardous situations. Only front-line practitioners who are involved in the event can provide



the details necessary for effective analysis and selection of strategies to reduce or prevent the likelihood of recurrence.

Encourage error reporting by replacing punishment for reported errors with rewards for participation in reporting and for “bright ideas.” Reporting is perceived to have im-mense value when those who report an error or potentially hazardous situation can readily see that the information is swiftly acted upon and used confidentially and proactively to develop and publish safe-practice recommendations that can prevent errors.

Conclusion Improving medication use and reducing adverse drug events by reducing medication error are essential to providing quality health care. Efforts to improve reporting and imple-ment high-leverage solutions to address the causes of errors identified through reporting efforts are important steps in improving medication use. Systematic assessment of errors to discover the contributing factors is vital to safety. It is not enough for pharmacy practitioners and operators to simply strive to prevent error. To maximize safety, pharmacists at

all levels must also strive to learn from those errors by ask-ing why the event happened and why the pharmacy system didn’t prevent it. The real benefit of CQI comes only when QREs are fully investigated and solutions have been success-fully implemented and continually measured over time for effectiveness.

Key practice points ■ Identify and document QREs. ■ Successful error-reduction strategies depend heavily on

responsible detection and open reporting of errors. ■ Analyze data collected to assess causes and contributing

factors. ■ Use findings from analysis to formulate appropriate responses. ■ Educate all staff on the identified contributing factors to priori-

tize safety changes that should be employed. ■ Use a variety of strategies to reduce error potential. ■ Further develop systems and processes. ■ Provide education from CQI analysis to personnel. ■ Improving patient safety is an ongoing process that demands

continual review and analysis of reported incident data.

CPE informationTo obtain 2.0 contact hours (0.2 CEUs) of CPE credit for this activity, you must complete the online assessment and evaluation. A statement of credit will be awarded for a passing grade of 70% or better on the assessment. You will have two opportunities to successfully complete the as-sessment. Pharmacists who successfully complete this activity before November 1, 2019, can receive CPE credit. Your statement of credit will be available upon successful completion of the assessment and evaluation and will be stored in your My Training Page and on CPE Monitor for future viewing/printing.CPE instructions:1. Log in or create an account at pharmacist.com, and select LEARN from the top of the page; select Continuing Education, then Home Study

CPE to access the Library. 2. Enter the title of this article or the ACPE number to search for the article and click on the title of the article to start the home study. 3. To receive CPE credit, select Enroll Now or Add to Cart from the left navigation and successfully complete the assessment (with randomized

questions) and evaluation. 4. To get your statement of credit, click “Claim” on the right side of the page. You will need to provide your NABP e-profile ID number to obtain

and print your statement of credit.Live step-by-step assistance is available Monday through Friday from 8:30 am to 5:00 pm ET at APhA Member Services at 800-237-APhA (2742) or by e-mailing [email protected].

References1. Lynn J, Baily MA, Bottrell M, et al. The ethics of using quality im-

provement methods in health care. Ann Intern Med. 2007;146:666–73.

2. Hughes RG. Tools and strategies for quality improvements and patient safety. In: Hughes RG, ed. Patient safety and quality: An evidence-based handbook for nurses. Rockville, MD: Agency for Healthcare Research and Quality. http://www.ncbi.nlm.nih.gov/books/NBK2682. Accessed October 4, 2016.

3. National Association of Boards of Pharmacy. NABP survey of phar-macy law 2015. https://nabp.pharmacy/publications-reports/publi-cations/survey-of-pharmacy-law/. Accessed October 4, 2016.

4. The Joint Commission. Sentinel event policy and procedures. https://www.jointcommission.org/sentinel_event_policy_and_pro-cedures/. Accessed September 24, 2016.

5. Institute for Safe Medication Practices. ISMP Medication Safety Alert! Community/Ambulatory Edition. http://www.ismp.org/News-letters/ambulatory/default.aspx. Accessed October 4, 2016.

6. Institute for Safe Medication Practices. ISMP Medication Safety

Alert! Community/Ambulatory Care Edition. The ISMP ambula-tory care action: Learn from others’ mistakes. http://www.ismp.org/newsletters/ambulatory/how-to-use-AA.aspx. Accessed October 4, 2016.

7. Reason J. Human error. Cambridge: Cambridge University Press; 1990.

8. Mass.gov. The official website of the Executive Office of Health and Human Services (EOHHS). Mission Statement. http://www.mass.gov/eohhs/gov/departments/dph/programs/hcq/dhpl/phar-macy/about/about-the-board.html. Accessed October 4, 2016.

9. Institute for Safe Medication Practices. Improving medication safety in community pharmacy: Assessing risk and opportunities for change. https://www.ismp.org/communityRx/aroc/files/ISMP_AROC.pdf. Accessed October 4, 2016.

10. National Association of Boards of Pharmacy. Model state phar-macy act and model rules of the National Association of Boards of Pharmacy 2015. http://www.nabp.net/publications/model-act/.

Accessed October 4, 2016.



CPE assessmentInstructions: This assessment must be taken online; please see “CPE information” sidebar for further instructions. The online system will present these questions in random order to help reinforce the learning opportunity. There is only one correct answer to each question.

1. Latent system failures includea. A pharmacy storing products with look-alike pack-

aging close together on a shelfb. Making a math error while calculating the patient’s

dose of medicationc. Staff who bypass barcode scanning during product

verification because they are too busyd. Overriding a computer alert without fully consider-

ing its importance

2. The way to prevent medication errors is toa. Redesign the systems and processes that lead to er-

rors.b. Focus on correcting the individuals who make er-

rors.c. Discourage practitioners from detecting and report-

ing errors since the practice of reporting assigns blame.

d. Continually update policies and procedures.

3. When describing a CQI program in community phar-macies, which of the following statements are true?a. CQI can be defined as a system of standards and

procedures to identify pharmacists who make fre-quent errors so their performance can be evaluated by a peer review committee.

b. CQI can be defined as a system of standards and procedures to identify and evaluate quality-related events and improve patient care.

c. A CQI program is designed to find incompetent staff so they can be retrained.

d. A CQI program is designed to provide consumers with a method to report errors to the pharmacy owner/leadership.

4. Per the NABP Model Act and boards of pharmacy, which is a requirement for a community pharmacy CQI program?a. To report all QREs to the respective Board of Phar-

macyb. To report all findings of the QRE analysis to the

respective Board of Pharmacyc. To provide ongoing CQI education to pharmacy

personneld. To ensure periodic CQI meetings take place that in-

clude the staff involved in the QRE explaining what they did wrong before they forget

5. A peer review committee should consider which of the following quality standards and indicators to deter-mine if services are improving? a. Number of QREs vs. prescriptions dispensedb. Number of QREs per staffc. Number of QREs at one site vs. anotherd. Number of BSPharm pharmacists vs. PharmD

pharmacists involved in QREs

6. Which of the following correctly describes CQI?a. Eliminates all errorsb. Finds incompetent peoplec. Results in punishmentd. Requires a culture change

7. Which of the following does NOT correctly describe CQI?a. Eliminates all errorsb. Focuses on learningc. Improves systemsd. Incorporates safety as part of the dispensing process

8. Why should pharmacies use CQI instead of disci-pline?a. CQI is a punitive process.b. Staff need a method to learn from mistakes.c. The goal is to reduce errors and punish the pharma-

cists who make them. d. Discipline is the key to prevention.

9. What is a QRE in terms of CQI programs and boards of pharmacy?a. Identifying a patient’s underuse of medicationb. Incorrect dispensing of a prescribed medication c. Success in identifying and managing therapeutic

duplication d. a and b

10. The purpose of a CQI program is toa. Analyze and eliminate QREs.b. Analyze and document QREs.c. Analyze QREs and focus on accountability and

blame. d. Analyze QREs to identify incompetent staff.



11. Why do states mandate CQI programs?a. Many pharmacies were not doing it on their own.b. To find and discipline pharmacists who make mis-

takes.c. So that the board(s) of pharmacy will receive all

medication error reports.d. To compare medication error rates between pharma-

cies.

12. How should a pharmacy respond when a medication error occurs?a. Don’t apologize; your partner made the error, and

the pharmacy holds that person accountable.b. Support staff involved in the error by moving them

to a lower-volume store.c. Inform the patient that the pharmacy takes all inci-

dents seriously and reviews each one for causes and future prevention.

d. To avoid gossip, refrain from discussing event de-tails with staff.

13. Consumer surveys should a. Not use a statistically valid sampling technique

since a survey is for intracompany use onlyb. Be limited to patients and not include physicians,

nurses, or othersc. Be used to compare one pharmacy’s results to an-

other pharmacy’s results d. Be administered at least once per year by phone, by

mail, electronically, or in person

14. Periodically, the peer review committee should a. Determine whether there has been any QREs re-

ported to the respective Board of Pharmacyb. Determine whether QREs have decreased.c. Determine if the CQI program is still needed if error

reporting has decreased.d. Determine which staff need to be retrained

15. Factors that should be analyzed for each event and then compared and contrasted with similar events includea. The staff member(s) involved in the events to see if

there is a patternb. Staffing during the event versus typical, budgeted

staffingc. Volume of prescriptions filled at the store versus

other storesd. Training level of staff involved in the QRE(s)

16. Implementing a system that stops and prevents the clerk from “ringing up” the prescription in the cash register system until documentation of pharmacist final verification has occurred in the pharmacy system is considered to be which type of error-reduction strategy?a. Simplificationb. Automation and computerization c. Fail-safes and forcing functionsd. Standardization

17. After an error has occurred, asking the staff to read and review prescription verification policies and procedures is considered to be which type of error-reduction strategy?a. Simplificationb. Educationc. Reminders and checklists d. Redundancy

18. Using the NABP Model Act as an example, a CQI program should includea. Steps to follow when a quality-related event occursb. How analysis of a QRE can determine staff involved c. How to use the program to evaluate individual staff

performanced. A list of the most effective forms of disciplinary ac-

tion to prevent similar errors

19. A medication system worksheet designed to assist pharmacists and pharmacy operators with error report investigations isa. Med-ERR toolb. Assess-ERR toolc. ISMP-CQI toold. System-Analysis tool

20. A prescription for morphine solution 100 mg/5 mL was input correctly, but morphine 10 mg/5 mL was incorrectly dispensed instead. The pharmacist real-ized the error when returning the incorrect product to the narcotic cabinet, but the delivery had already been sent to the long-term care facility (LTCF). How should the pharmacy staff respond to this error?a. Notify the prescriber and the LTCF immediately to

mitigate patient harm.b. Educate the technician who placed the label on the

wrong medication.c. Discipline the pharmacist who did not catch the er-

ror during verification.d. Send out the correct medication and retrieve the in-

correct medication immediately so that the risk man-agement department does not need to be informed.

Documents

Importance of a CQI program in ambulatory practice