Determinants of medication incident reporting, recovery, and learning in community pharmacies: A conceptual model

Article Outline

• Abstract
• Introduction
• Risk factors of low MI reporting, recovery, and learning
• Pilot study
  • Pilot study methods and analysis
  • Pilot study results
• Proposed model of MI reporting, learning, and recovery
  • Individual self-efficacy
  • Process capability and support
  • Supportive organizational culture
  • Management support
  • Regulatory authority influence
  • MI reporting
  • MI recovery
  • MI learning
  • Future research
• Implications and conclusions
• Acknowledgments
• Appendix. Structural equation modeling latent and manifest variables
• References
• Copyright

Abstract 

Background

Evidence suggests that the underreporting of medication errors and near misses, collectively referred to as medication incidents (MIs), in the community pharmacy setting, is high. Despite the obvious negative implications, MIs present opportunities for pharmacy staff and regulatory authorities to learn from these mistakes and take steps to reduce the likelihood that they reoccur. However, these activities can only take place if such errors are reported and openly discussed.

Objectives

This research proposes a model of factors influencing the reporting, service recovery, and organizational learning resulting from MIs within Canadian community pharmacies.

Methods

The conceptual model is based on a synthesis of the literature and findings from a pilot study conducted among pharmacy management, pharmacists, and pharmacy technicians from 13 community pharmacies in Nova Scotia, Canada. The purpose of the pilot study was to identify various actions that should be taken to improve MI reporting and included staff perceptions of the strengths and weaknesses of their current MI-reporting process, desired characteristics of a new process, and broader external and internal activities that would likely improve reporting. Out of the 109 surveys sent, 72 usable surveys were returned (66.1% response rate). Multivariate analysis of variance found no significant differences among staff type in their perceptions of the current or new desired system but were found for broader initiatives to improve MI reporting. These findings were used for a proposed structural equation model (SEM).

Results

The SEM proposes that individual-perceived self-efficacy, MI process capability, MI process support, organizational culture, management support, and regulatory authority all influence the completeness of MI reporting, which, in turn, influences MI service recovery and learning.

Conclusions

This model may eventually be used to enable pharmacy managers to make better decisions. By identifying risk factors that contribute to low MI reporting, recovery, and learning, it will be possible for regulators to focus their efforts on high-risk sectors and begin to undertake preventative educational interventions rather than relying solely on remedial activities.

Keywords: Medication incidents, Dispensing errors, Community pharmacy, Service quality, Risk management, Service recovery

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Introduction 

It is well known in health care management that medication errors and “near misses,” collectively known as medication incidents (MIs), represent one of the most serious issues impacting patient safety in community pharmacies. Extrapolating current international research¹, ² to the approximately 453 million prescriptions dispensed in Canadian community pharmacies in 2008, it is estimated that as many as 7 million MIs could occur in Canadian community pharmacies in 2009. Yet, despite their implications to both the pharmacy and the public, underreporting of MIs in the community pharmacy setting is high.³, ⁴ Apart from the obvious health risks associated with MIs, when made public, such errors also may lead to a number of negative business implications for community pharmacies, including direct legal and financial costs, tarnished reputations, and decreased customer loyalty.

Given the significant human aspect of their core workflow processes, pharmacy staff will inevitably make mistakes. These mistakes present opportunities for the focal organization and provincial regulator to learn from them and take steps to reduce the likelihood that they reoccur. This research seeks to help pharmacies better learn from MIs by exploring factors that may promote or inhibit MI reporting and subsequent learning activities. More specifically, this research proposes a conceptual model of the determinants of MI reporting, recovery, and learning in Canadian community pharmacies. MI reporting, developed by Ashcroft et al,⁴ gauges the behavioral conditions and patient outcomes under which an error is reported, such as only when the patient is severely impacted by the error and/or dispensing protocols have been violated. MI recovery, developed from the customer service recovery satisfaction (RECOVSAT) construct,⁵ is the effort made to inform pharmacy stakeholders of the MI if it directly impacts them. Such activities may include a phone call to the patient if an error is discovered after prescription pickup or, in the case of a “near miss,” a phone call to the prescribing physician. Learning from the incident,⁶ simply referred to as MI learning for this research, is the extent that the organization has learned from the incident and made internal changes to prevent a similar MI from occurring again. Such activities may include, for example, discussing the MI at a staff meeting, determining the root cause of the error, and revising store-dispensing processes, workflow, or technology.

MIs, although naturally impacting health care service and delivery, are less the domain of health care per se and, increasingly, can be understood as a product of retail practice and management, public and regulatory policy, and risk management and communication. As such, factors influencing MI reporting, recovery, and learning not only originate from the individual staff members but also from community pharmacy as a whole as well as from regional differences and varied approaches used by regulators responsible for developing and enforcing provincial and national pharmacy policy. As a result, this research proposes a holistic model by considering individual pharmacy staff actions and characteristics of the pharmacy and regulatory authority. The need to address such determinants is especially important in Canada given the lack of a national regulatory authority to govern pharmacy practice and no mandatory system for reporting MIs at the national level. In addition, a national shortage of pharmacists, combined with the rapidly expanding scope of pharmacy practice in the country, such as pharmacist prescriptive authority and payment for medication reviews, creates the need for research into MI reporting and learning, especially important and timely.

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Risk factors of low MI reporting, recovery, and learning 

“A key characteristic of high-reliability industries, such as nuclear power, aviation, automobile manufacturing, and chemical processing, is acceptance of the fact that errors will occur, that the impact of errors can be devastating, and that efforts should be made to discover system weaknesses before harm occurs.”⁷ The U.S. Institute of Medicine⁸ issued a report stating that the health care industry is at least 10 years behind the aviation industry in preventing errors. Leape⁹ attributes the difference to the airline industry's focus on safety in design and processes and, as such, supported the creation of a system for reporting medication errors in the health care industry. Evans et al¹⁰ report that 90% of consumers believe that MIs should be reported, and both the UK Department of Health¹¹ and the Australian Council for Safety and Quality in Health Care¹² recommend more open incident reporting to better understand MIs and their causes.

Most of the research on MIs in community pharmacies focus on identifying the causes of MIs. For example, a U.S. Pharmacopeia report¹³ ranks the most commonly reported causes of dispensing errors as performance deficit (38%), policy or procedure not followed (20%), transcription that is inaccurate or omitted (15%), incorrect or insufficient documentation (12%), improper computer entry (11%), knowledge deficit (10%), and lack of communication (10%). The most commonly occurring cause of dispensing errors, performance deficit, refers to a mistake made by the person responsible for administration. This failure could occur for a variety of reasons, which the literature also highlights as causes themselves, including noisy workplace settings, staffing shortages, lack of patient information, poor lighting, and inexperienced staff, among others.¹⁴, ¹⁵, ¹⁶, ¹⁷, ¹⁸

Despite the huge volume of literature on the causes of MIs in community pharmacies,¹⁴, ¹⁵, ¹⁶, ¹⁷, ¹⁸ research on what motivates pharmacy staff to report the MI in the first place and take both short- and long-term steps to reduce the chances of the error, or a similar one, from reoccurring is significantly lacking. In addition, further research is required on organizational learning practices within community pharmacies, with an emphasis on improving existing reporting and feedback systems. Learning from MIs not only has the potential to minimize the chances of similar errors reoccurring but also can make pharmacy staff more aware of their actions and, therefore, improve the likelihood of detecting MIs in the first place.

Studies comparing the MI-detection direct methods of direct observation versus MI reports indicate reduced rates of MI reporting.¹⁹, ²⁰ Varadarajan et al,²⁰ for example, comparing direct observation and incident-reporting methods of MI detection in a high-volume mail service pharmacy, highlight that 16 times more errors were identified through direct observation versus incident reporting. Varadarajan et al²⁰ suggest that differences in error-detection rates between direct observation of pharmacy staff and MI reports is that the latter requires error awareness as a prerequisite to reporting. Similarly, Wiederholt et al²¹ highlight that goal-setting and feedback increase the likelihood of pharmacy staff detecting errors. Specifically, pharmacists with the goal of maintaining their overall performance level detected 22% more MIs than they did before goal-setting. Pharmacists attempting to improve their performance increased their detection of MIs by 103% by becoming more mindful of their actions on the job.

However, the benefits of learning from MIs in the pharmacy can only occur if such errors are, in fact, reported when they occur. Working toward the goal of improved MI reporting and learning, Ashcroft et al²² assess the validity and feasibility of the Manchester Patient Safety Assessment Framework (MaPSAF), a tool to increase awareness of risk management among UK community pharmacies. In their assessment, Ashcroft et al²² generate 5 ascending levels to describe a pharmacy's safety culture, specifically, pathological, reactive, calculative, proactive, and generative. Ashcroft et al²² highlight that UK pharmacies should be striving for the generative culture, where errors are recognized as inevitable, mistakes are deemed as learning opportunities, and knowledge obtained from error reporting is shared among pharmacies to increase overall quality across the health care system. The generative culture integrates risk management in every business process and is considered the greatest manifestation of organizational learning. In reality, however, interviews with pharmacy staff confirm that most of the pharmacies are, instead, at the pathological stage, characterized by avoiding reporting MIs where possible and the lowest of the 5 stages of safety culture development. A pathological culture prevailed because of the threat error reporting poses to a pharmacy's reputation and staff job security. Therefore, error reporting in community pharmacy is seen as something whose benefits do not outweigh its costs.²² The proliferation of the pathological culture in community pharmacies is somewhat indicative of the lack of research on MI reporting and organizational learning and emphasizes the need for best practices, recommendations, and practical advice to assist managers in moving the pharmacy from one that fails to report MIs to one that learns as a whole from such errors.

Given the similarities between the 2 professions, the significant use of manual processes and similar implications to the patient when errors do occur, the literature on MIs in hospitals may also provide potential determinants of MI reporting appropriate within a pharmacy context. For example, Evans et al¹⁰ gauge physician and nurse familiarity with the current system for incident reporting and barriers to reporting health care incidents, with nurses being more familiar with the incident report forms than physicians (99.8% vs 93.6%) and completing incident report forms far more frequently (89.2% vs 64.6%). Additionally, Evans et al¹⁰ identify various self-perceived barriers to reporting. The most common barriers cited, which have also found individual support in other studies,²³, ²⁴, ²⁵ include lack of feedback on action taken as a result of reporting, system design (eg, form takes too long to fill out, not enough time to complete the forms), incident too trivial, delaying filling out a report and ultimately forgetting, and lack of justification for reporting a “near miss.” Additional barriers, albeit less commonly reported, mainly pertained to the workplace culture—a belief that incident reporting is unlikely to lead to system changes, a belief that nothing else needs to be done other than speaking to the person involved, and concern surrounding confidentiality, support of coworkers, and threat of litigation.

In addition to these systems and outcome-oriented determinants, Force et al²⁶ highlight that the culture of the hospital is a major determinant of low MI reporting, citing fear of retribution, punitive actions, and professional humiliation. Through actions, such as reporting confidentiality and efforts focused on improving MI form design and feedback, the culture of blame within the hospital setting was reduced and, as a result, incident reporting significantly increased from an average of 14.3 to 72.5 reports per month. Hartnell²⁷ identifies and categorizes various incentives for, and barriers limiting, MI reporting in Canadian hospitals. Incentives were categorized as patient protection, provider protection, and professional compliance. Barriers were categorized as reporter burden, professional identity, information gap, organizational factors, and fear. Results of interviews and focus groups with hospital pharmacists, nurses, and physicians at 4 hospitals in Atlantic Canada highlight that MI reporting is more likely to occur if the process is quick and comprised of limited effort and if the staff was properly educated on the MI process and received feedback in a timely manner.

The culture of blame is one that seems to be magnified within the community pharmacy context. In the United Kingdom, for example, a dispensing error can be deemed a criminal offense, whereas doctors and nurses are not subjected to the same disciplinary measures.²⁸ For this reason, Nathan²⁸ believes that a “fair blame culture” cannot work in community pharmacy the same way it does in the hospital setting. Ashcroft et al.⁴ discovered that the likelihood of an MI being reported within the pharmacy was, at best, on a level of indifference and occurred primarily when a violation of protocol was made. Reporting any MI to the UK National Patient Safety Agency was rare.

Although different, both the community pharmacy and hospital context share similarities in terms of barriers to MI reporting. Confidentiality of MI reporting is a high priority for staff because of aversion to blame, embarrassment, and humiliation, as well as concerns regarding firm reputation and job security. Feedback and organizational learning are also important determinants for both pharmacies and hospitals in rendering a MI-reporting system worthwhile.⁶, ¹⁰, ²⁶

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Pilot study 

To further explore the issue of MI reporting and learning, a pilot study involving community pharmacies was conducted. Given the lack of complete and well-integrated MI-reporting and learning systems (eg, error reporting and analytic tools, reporting to a national body), this research sought to capture desired characteristics in a new reporting process that would promote its use by staff as well as general initiatives and activities that the staff felt should be undertaken to allow for better reporting and learning from MIs.

Pilot study methods and analysis 

To capture such characteristics and actions, a web-based survey was conducted in 2008 with pharmacy management, pharmacists, and pharmacy technicians from 13 community pharmacies in Nova Scotia, Canada. The questionnaire captured (1) basic descriptive data, such as position, size of pharmacy, pharmacy services offered; (2) activities that may reduce MIs in their pharmacy; (3) current MI-reporting and learning processes in place; (4) factors that may promote or limit their use of a new MI-reporting and learning process; and (5) 2 open-ended questions focused on their current MI-reporting process and activities that should be undertaken to improve MI reporting.

Out of the 109 surveys sent, 72 usable surveys were returned, yielding a response rate of 66.1%. Of these 72 usable surveys, 28 (35.4%) were completed by pharmacists, 18 (22.8%) by pharmacy managers, and 26 (36.1%) by pharmacy technicians. Of the 72 respondents, 36 (50%) worked in an independent pharmacy, 18 (25%) in a corporate pharmacy, 16 (22.2%) in a franchise pharmacy, and 2 (2.8%) declined to answer. To explore the perceptions of the existing MI-learning and reporting processes in community pharmacies, a variety of questions were asked, ranging from the extent that the process is modern and up-to-date to the extent the process treats MIs as a “taboo” subject.

Multivariate analysis of variance (MANOVA) was used to examine the overall difference of means for each group. All calculations were performed using SPSS version (Chicago, IL) 15.0. The MANOVA procedure highlighted no differences in perceptions among pharmacy managers, pharmacists, and pharmacy technicians (Wilks' lambda=0.483, F (26, 94)=1.586, P=.056). Characteristics of the current MI reporting and learning process in place that scored high included impact on day-to-day operations (mean=3.35 on a 5-point Likert-type scale with anchors of strongly disagree [1] to strongly agree [5]), personal support of individual (mean=3.34), and is easy to complete (mean=3.26). Characteristics of the process that were considerably lacking include the extent to which the process is periodically updated (mean=2.31), allows errors to be reported anonymously (mean=2.42), and is reinforced and openly discussed at meetings (mean=2.51). Comments from the open-ended question asking the staff to describe the effectiveness of their current MI-reporting process highlighted 2 important deficiencies, primarily the lack of a formal MI process and insufficient feedback and discussion when an MI does occur:

To explore the desired characteristics of a new MI-reporting and learning process, participants were asked a series of questions regarding items that they felt may influence the success of a new MI-reporting and learning process in their pharmacy. Results of performing MANOVA highlight no mean differences among staff groups (Wilks' lambda=0.295, F (50, 78)=1.311, P=.140). Table 1 presents the complete list of characteristics and their importance based on a 5-point Likert-type scale with anchors of would not (1) to most definitely (5).

Table 1. Desired characteristics in a new reporting/learning process

To examine actions that can be undertaken by the pharmacy or the regulatory authority to increase MI reporting, a wide variety of questions dealing with store, regional, and national initiatives were presented to respondents. Analyzing the data using MANOVA highlighted differences in perceptions of such initiatives among pharmacy managers, pharmacists, and pharmacy technicians (Wilks' lambda=0.544, F (22, 104)=1.684, P=.043). Univariate follow-up indicated a difference among the type of pharmacy staff for mandated reporting to a provincial center (P≤0.05). To further explore this relationship, post hoc analysis was performed using Tukey's test, revealing a difference in perception of mandated reporting to a provincial center between pharmacists (mean=3.58) and pharmacy technicians (mean=2.87). The most critical element for improving MI reporting within community pharmacies is ensuring anonymity to pharmacists and technicians for reporting MIs and sharing “learnings” from errors with colleagues (mean=3.74 on a 5-point Likert-type scale with anchors of would not increase [1] to would definitely increase [5]), and creating a safe reporting environment (mean=3.43). Actions that ranked lower include celebrating the reporting of errors (mean=2.65) and establishing a provincial center of patient safety (mean=2.97). The complete list is presented in Table 2.

Table 2. Actions to improve incident reporting and learning

Comments from an open-ended question asking staff to describe important activities to improve MI reporting reinforce the importance of anonymity in the MI-reporting process and open discussions on the issue of MI reporting:

Pilot study results 

Based on the quantitative and qualitative findings from the pilot study, Fig. 1 synthesizes the different factors that may influence MI reporting, recovery, and learning in Canadian community pharmacies.

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• Fig. 1 

  Risk factors of low MI reporting, recovery, and learning. Potential determinants of MI reporting can be classified as individual, process and technology, management, culture, regulatory, and regional and national. Transposing these groups on a graph highlights those determinants that the pharmacy can individually address and those they cannot.

Based on the results of the pilot study and a review of the pharmacy and broader health care literature, the determinants of MI reporting, recovery, and learning can be grouped into 6 areas: (1) individual pharmacist/technician, (2) process and technology, (3) management, (4) culture, (5) regulatory, and (6) regional and national. The degree to which the pharmacy can address each factor depends on the group. Those factors stemming from pharmacy staff, process and technology, management, and culture are within the ability of the retailer to either reduce or promote. Factors stemming from regulatory, regional, and national issues are outside of the immediate control of the retailer, with responsibility for such factors, instead, falling to government or the regulatory authority. Instead of directly addressing these latter factors, the best a pharmacy can do is to reduce or increase their impact by making changes to internal operations. Internal changes may, however, present new determinants. Therefore, pharmacies need to undergo periodic self-assessments to identify current factors and to develop not only in-store strategies but also collective and regional strategies to address policy and regulatory factors.

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Proposed model of MI reporting, learning, and recovery 

In addition to identifying potential determinants of MI reporting, recovery, and learning, the framework presented in Fig. 1 also helps to illustrate several gaps in the existing body of knowledge concerning MIs in Canadian community pharmacies. First, with the limited research focused on system, outcomes, and organizational culture issues, there is a lack of research addressing how regulatory, regional, and national policies influence MI reporting, recovery, and learning. Furthermore, although the literature from the information systems, innovation diffusion, quality/lean management, and public policy domains presents an extensive list of potential determinants,²⁹, ³⁰, ³¹, ³² a core list of risk and success factors within a Canadian community pharmacy context has not yet been identified and empirically validated. Second, it cannot be assumed that all determinants will influence MI reporting, recovery, and learning equally. Research is needed to identify those determinants that may, for instance, be associated with low MI recovery, but not with low MI learning. Third, to help community pharmacy managers prioritize the determinants they should address first, research is needed to determine the relative influence of each core factor. Fourth, because the regulatory authority is both a source of risk factors and a solution for improving MI reporting, further research is needed to better understand how various characteristics of the regulatory authority influence MI reporting, recovery, and learning. Using Fig. 1 as a starting point, this research takes an initial step in this direction by proposing a model of the core factors influencing MI reporting, recovery, and learning within Canadian community pharmacies, as presented in Fig. 2, with a description of each manifest variable presented in the Appendix.

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• Fig. 2 

  Proposed determinants of MI reporting, recovery, and learning.

Individual self-efficacy 

Given the potential impact to the patient and the potential embarrassment suffered by the pharmacist/technician committing the MI, it is proposed that the ability of the individual to cope with such a challenging and stressful scenario will impact his or her reporting. As such, this research proposes that the individual pharmacist/technician's perceived self-efficacy will impact MI reporting. To identify such broad characteristics, this research applies the perceived self-efficacy construct used to capture an individual's ability to effectively cope with challenging scenarios,³³ such as responding to MIs. To capture this construct, this research adopts the measurement items developed by Jerusalem and Schwarzer.³⁴ This 10-item construct has been shown by previous health care studies to be reliable, with adequate discriminant and convergent validity. The items that comprise the construct address such things as ability to solve difficult problems, ease of remaining focused on goals, ability to cope with unexpected events, resourcefulness, and problem-solving.

Process capability and support 

At the process and technology levels, it is proposed that various characteristics of the store's existing MI-reporting process will impact reporting, including ease of use, degree of confidentiality, and completeness of reporting, among others. Such characteristics are grouped into MI process capability, which are the features and characteristics of the MI process, and MI support, which addresses individual and store support for the MI process. This research proposes that various characteristics of the existing reporting system in the pharmacy will play a significant factor in the extent to which MIs are reported and resulting recovery and learning activities take place. Such characteristics may range from effort and ease of use to capabilities of the technology. However, in addition to the physical characteristics of the process, it is also important to understand the extent to which the MI-reporting process is supported within the pharmacy. For example, is the process in place simply to meet provincial legislation and headquarters' demands, or is it truly supported as a means to better reduce MIs and learn from such mistakes? Subsequently, this research will capture the MI process at the pharmacy using 2 constructs, MI process capability and MI process support.

MI process capability is focused on identifying if the current process is conducive to full MI reporting and effective recovery and learning. This construct will be captured by the extent to which the process is modern and up-to-date, is updated periodically, is easy to complete, does not take much time to complete, has useful reporting and analysis tools, permits the reporting of errors anonymously, is seamlessly integrated into the day-to-day operations of the pharmacy, and is cost effective. MI process support is the extent to which the members of the pharmacy support this process. This construct is captured by the extent to which the current MI process has the support of the individual pharmacist/technician and his or her colleagues; celebrates successful learning; feels like it is their own process; encourages members to make continuous improvements; poses low risk to business operations, such as meeting regulatory compliance and reducing legal risk; treats MIs as a “taboo” subject (reverse coded); and is reinforced and openly discussed at meetings.

Supportive organizational culture 

It is proposed that the culture of the pharmacy and its parent organization, in the case of a franchise, will impact MI reporting, recovery, and learning. As evident from the literature review, it is expected that the extent to which the inverse of a supportive culture, specifically a blame culture, exists in the pharmacy will negatively impact the extent of MI reporting, recovery, and learning. For example, Ashcroft and Parker⁶ highlight that UK pharmacy staff felt that a “blame culture” was quite strong in the workplace, capture by the following variables: when an event is reported, it feels like the person is being reported, not the problem; staff members feel their mistakes are held against them; there is a blame culture, because of which staff are reluctant to report incidents; staff in the pharmacy is seen as the cause of the incidents, and the solution is retraining and punitive action; investigations aim to assign blame to individuals; incidents; and complaints are “swept under the carpet” if possible.⁶ This research applies Ashcroft and Parker's⁶ culture construct, with each item reverse coded.

Management support 

Responding to MIs in a safe manner will require a high degree of support from pharmacy management. These managers include in-store managers and, for those franchise stores, corporate management. In-store pharmacy managers, who are typically pharmacists themselves, must not only take a proactive role by highlighting their MIs but also be supportive of MI reporting by others and pharmacy-level efforts to learn from such errors. To capture in-store management support, we use a variation of the 6 items developed by Igbaria.³⁵ These items have been used in prior studies³⁶ and show adequate internal consistency and validity. These items include management understanding the benefits of MI reporting, encouraging the reporting of MIs by others in the pharmacy, providing the necessary training on the MI processes, providing the necessary assistance to enable organizational learning from an MI, providing the necessary resources for MI learning to occur, and being interested in having employees satisfied with the entire MI process. In addition to in-store management, respondents will also be asked a number of questions regarding support from corporate headquarters where appropriate, including corporate interest in improved MI reporting, extent of existing corporate support mechanisms to assist with MI reporting and learning, and autonomy granted to the stores to change core processes.

Regulatory authority influence 

It is also proposed that various characteristics and actions of the provincial regulatory body will influence the extent to which MIs are reported and follow-up recovery and learning activities take place. For example, it is expected that a regulatory authority that is supportive of MI reporting will increase the likelihood of complete MI reporting and follow-up. Regulatory efforts to make new pharmacy legislation and practices known to stores may also increase such efforts. For example, a number of Canadian provinces have passed legislation preventing a store-to-patient apology letter from being used in subsequent litigation. As a result, pharmacy staff's knowledge of the latest pharmacy regulations, of which the regulatory authority plays a key role in disseminating, will also impact MI reporting and subsequent activities. For this study, regulatory influence is captured by the extent to which the regulatory authority makes one aware of the latest legislation regarding MIs, punishes mistakes (reverse coded), has one's best interests in mind, understands the challenges one faces in dispensing, is controlling (reverse coded), and is transparent.

MI reporting 

Ashcroft et al⁴ highlight that, when deciding to report an MI, the staff takes into consideration the implications to the patient and the type of behavior associated with the error, such as if normal store or dispensing protocol had been followed by the individual who committed the error. Modifying the types of complaint and non-compliant behaviors identified by Reason, Parker, and Lawton,³⁶ for a pharmacy context, Ashcroft et al⁴ highlight that I, the MI may be associated with an error that is in line with current protocol at the pharmacy, an error resulting from staff not being aware of specific protocol, and an error resulting in a deliberate deviation from current protocol. Each of these behaviors may have 1 of 3 effects on the patient. The first and most desirable is a good outcome, where the error is caught before it reaches the patient or has no impact on them. The second, poor, is an outcome that causes “unavoidable and short-term discomfort” for the patient. The final outcome, bad, implies “more prolonged and serious harm.” MI learning is, therefore, captured by the likeliness that pharmacy staff would report an error under each of these 9 conditions.

MI recovery 

On the discovery of a potentially life-threatening MI, it is expected that the community pharmacy will contact the patient to inform him or her of the error and suggest specific actions. However, service recovery actions need not be limited to cases of life-threatening MIs alone. This research, therefore, also examines what happens after the MI is reported and what factors influence the extent to which service recovery activities occur. To capture service quality, variation of the RECOVSAT service recovery construct is used.⁵ The construct has been used by a number of studies, with good internal consistency and discriminant validity.³⁷, ³⁸ RECOVSAT considers service recovery along 6 dimensions, including communication, empowerment, feedback, atonement, explanation, and tangibles (eg, appearance, equipment, physical environment where complaints are handled). For this research, we are interested in pharmacy staff's assessment of their own in-store recovery activities. Subsequently, the RECOVSAT construct is used as a starting point with changes made to shorten the number of items and better fit the pharmacy and internal assessment context of this study. Modifying a shortened version of the RECOVSAT construct,³⁷ service recovery is captured by the extent to which the pharmacy is honest in its endeavors to inform the patient of the MI: store employees who committed the MI can immediately contact the patient without soliciting management approval to do so; a written letter of apology is offered to the patient, which ensures that the customer was not “out of pocket” for the MI; pharmacy provides feedback to the patient on the efforts being made to address the MI; and the patient is informed of what went wrong and how it will be fixed.

MI learning 

MI learning addresses the extent to which pharmacy staff and other stakeholders learn from MIs and take significant action to reduce the likelihood of a similar error occurring again. To capture MI learning, this research adopts measures from a safety culture survey developed by Ashcroft and Parker.⁶ Specifically, they capture this culture using 7 factors, including learning from the incident, staffing and management, perceptions of the causes of incidents, team working, communication, commitment to patient safety, and education and training. This research applies measures from the “learning from incidents” factor to capture MI learning using the following variables: the effectiveness of any changes made after an incident is evaluated; similar incidents tend not to reoccur; the pharmacy learns and shares information about incidents with staff and other pharmacies; investigations aim to learn from incidents and communicate the findings widely after an incident; there is a real commitment to change throughout the pharmacy; the pharmacy welcomes any outside involvement in investigations; investigations are seen as learning opportunities; and continuous improvement occurs, even without the trigger of an incident.

Future research 

To achieve the research objectives, a positivist research approach involving a survey questionnaire will be used. This approach is chosen over an interpretative approach for 2 reasons. First, many of the model's constructs have already been tested and empirically validated in a number of others studies, and are, therefore, ready to be applied within a Canadian community pharmacy context. Second, this proposed research continues from a pilot study that has already collected data to support the model presented in Fig. 2. Therefore, the next logical step is to test this research model through a large national survey. The sampling frame for this survey will comprise pharmacy staff members (ie, 1 manager, pharmacist, and technician) from 2500 community pharmacies across Canada. To ensure that regulatory issues are adequately addressed, surveys will be administered in all Canadian provinces. Participants will have the option of completing a hardcopy or online version of the survey. MANOVA will be used to identify mean scores and differences based on staff position, region, and store characteristics. Maximum likelihood structural equation modeling will be used to analyze the data and test the proposed model.

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Implications and conclusions 

This research proposes a model of the factors influencing the reporting, service recovery, and organizational learning resulting from MIs within Canadian community pharmacies. Based on a synthesis of the research literature and pilot study, it is proposed that individual-perceived self-efficacy, MI process capability, MI process support, supportive organizational culture, management support, and regulatory influence, all influence the completeness of MI reporting, which in turn, influences MI service recovery and MI learning.

Although its contribution to a healthy population in Canada is an important and expected eventual outcome of this research, other major contributions are found within the Canadian management and regulatory contexts. Within the management context, this study may enable pharmacy managers to make better management decisions by helping them thoroughly understand their internal operations and external environment. With improved MI reporting and learning, managers will better understand what process and workflow, human resources, technology, and management changes are needed to improve overall levels of service quality. For many community pharmacies, especially those independently owned, the pharmacy and customer care component is the core source of revenue. Learning from MIs with the goal of improving overall levels of service quality not only makes good sense from a public safety perspective but also from the business perspective. Insufficient organizational learning allows an error to be repeated again and again, increasing the chances of lost customer trust and store litigation, both of which pose very significant financial consequences. Mistakes will occur within a community pharmacy regardless of its commitment to quality. Committing a mistake the first time is, however, often less of a tragedy than failing as an organization to learn from the mistake and preventing it from happening again.

There are a variety of potential risk factors that are outside the immediate control of the community pharmacy to reduce. Provincial pharmacy regulatory bodies must take the lead in addressing such factors. As such, this proposed research also explores issues surrounding public policy and those regulatory bodies assigned with the execution of such policy. In the absence of information related to various risk factors underlying MIs, provincial regulators are less able to prioritize their inspection and monitoring activities. Once such risk factors have been identified, however, it will be possible for regulators to better focus their efforts on high-risk sectors and also begin to undertake preventative, educational interventions rather than relying solely on remedial activities. Once tested, it is envisioned that the research model will contribute to improved productivity and increased awareness of risk and success factors and unintended consequences among regulatory bodies.

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Acknowledgments 

The authors would like to thank the Social Sciences and Humanities Research Council of Canada for funding the pilot study presented in this article and the Nova Scotia Health Research Foundation for providing funding to allow the testing of the proposed model.

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Appendix. Structural equation modeling latent and manifest variables 

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References 

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