Thomas Mahaffey

Challenges of standardized continuous quality improvement programs in community pharmacies: The case of SafetyNET-Rx

BACKGROUND Research on continuous quality improvement (CQI) in community pharmacies lags in comparison to service, manufacturing, and various health care sectors. As a result, very little is known about the challenges community pharmacies face when implementing CQI programs in general, let alone the challenges of implementing a standardized and technologically sophisticated one. OBJECTIVE This research identifies the initial challenges of implementing a standardized CQI program in community pharmacies and how such challenges were addressed by pharmacy staff. METHODS Through qualitative interviews, a multisite study of the SafetyNET-Rx CQI program involving community pharmacies in Nova Scotia, Canada, was performed to identify such challenges. Interviews were conducted with the CQI facilitator (ie, staff pharmacist or technician) in 55 community pharmacies that adopted the SafetyNET-Rx program. Of these 55 pharmacies, 25 were part of large national corporate chains, 22 were part of banner chains, and 8 were independent pharmacies. A total of 10 different corporate chains and banners were represented among the 55 pharmacies. Thematic content analysis using well-established coding procedures was used to explore the interview data and elicit the key challenges faced. RESULTS Six major challenges were identified, specifically finding time to report, having all pharmacy staff involved in quality-related event (QRE) reporting, reporting apprehensiveness, changing staff relationships, meeting to discuss QREs, and accepting the online technology. Challenges were addressed in a number of ways including developing a manual-online hybrid reporting system, managers paying staff to meet after hours, and pharmacy managers showing visible commitment to QRE reporting and learning. CONCLUSIONS This research identifies key challenges to implementing CQI programs in community pharmacies and also provides a starting point for future research relating to how the challenges of QRE reporting and learning in community pharmacies change over time.

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

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.

Keeping the “continuous” in continuous quality improvement: Exploring perceived outcomes of CQI program use in community pharmacy

BACKGROUND Given the significant potential of continuous quality improvement (CQI) programs in enhancing overall levels of patient safety, community pharmacies in North America are under increasing pressure to have a formal and documented CQI program in place. However, while such initiatives may seem great on paper, in practice the outcomes of such programs to community pharmacy practice remain unclear. OBJECTIVE To explore the perceived outcomes identified by community pharmacies that adopted and actively used a standardized (i.e., common across pharmacies) CQI program for at least 1 year and to develop a framework for how such outcomes were achieved. METHODS A multi-site study of SafetyNET-Rx, a standardized and technologically sophisticated (e.g., online reporting of medication errors to a national database) CQI program, involving community pharmacies in Nova Scotia, Canada, was performed. During the summer and fall of 2011, 22 interviews were conducted with the CQI facilitators in 12 Nova Scotia community pharmacies; equally split between independent/banners and corporate chains. Of the CQI facilitators, 14 were pharmacists, while the remaining eight were pharmacy technicians. Thematic analysis following the procedures presented by Braun and Clarke was adopted to identify and explore the major outcomes. RESULTS Results of the thematic analysis highlighted a number of perceived outcomes from the use of a standardized CQI program in community pharmacies, specifically: (1) perceived reduction in the number of medication errors that were occurring in the pharmacy, (2) increased awareness/confidence of individual actions related to dispensing, (3) increased understanding of the dispensing and related processes/workflow, (4) increased openness to talking about medication errors among pharmacy staff, and (5) quality and safety becoming more entrenched in the workflow (e.g., staff is more aware of their roles and responsibilities in patient safety and confident that the dispensing processes are safe and reliable). In achieving such outcomes, pharmacies had to balance customizing the CQI program to address a number of operational challenges, with ensuring that the core standardized components remained in place. CONCLUSIONS This research identified the perceived outcomes of CQI program use by CQI facilitators. Additionally, the findings are incorporated into a framework for CQI implementation that can be used by pharmacy managers, corporate head offices, and regulatory authorities to leverage greater CQI adoption and success.

Safety implications of standardized continuous quality improvement programs in community pharmacy.

Standardized continuous quality improvement (CQI) programs combine Web-based technologies and standardized improvement processes, tools, and expectations to enable quality-related events (QREs) occurring in individual pharmacies to be shared with pharmacies in other jurisdictions. Because standardized CQI programs are still new to community pharmacy, little is known about how they impact medication safety. This research identifies key aspects of medication safety that change as a result of implementing a standardized CQI program. Fifty-three community pharmacies in Nova Scotia, Canada, adopted the SafetyNET-Rx standardized CQI program in April 2010. The Institute for Safe Medication Practices (ISMP) Canada’s Medication Safety Self-Assessment (MSSA) survey was administered to these pharmacies before and 1 year into their use of the SafetyNET-Rx program. The nonparametric Wilcoxon signed-rank test was used to explore where changes in patient safety occurred as a result of SafetyNETRx use. Significant improvements occurred with quality processes and risk management, staff competence, and education, and communication of drug orders and other information. Patient education, environmental factors, and the use of devices did not show statistically significant changes. As CQI programs are designed to share learning from QREs, it is reassuring to see that the largest improvements are related to quality processes, risk management, staff competence, and education.

Implications of process characteristics on quality-related event reporting in community pharmacy

BACKGROUND The lack of a single pharmacy regulator in Canada has led to a wide variety of processes for reporting and learning from medication errors and near misses, collectively known as quality-related events (QREs). These processes range from completely informal processes, through to primarily manual processes that rely on paper forms and incident reports stored in a binder, all the way to fully computerized processes such as anonymous online reporting to a national database. OBJECTIVES The objective of the study was to develop and test a model of the influence of various QRE reporting process characteristics on levels of QRE reporting process support and QRE reporting in Canadian community pharmacies. METHODS A questionnaire was administered to 427 pharmacy managers, pharmacists, and technicians in Nova Scotia, Canada, in 2010, with 210 questionnaires returned. Partial least squares was performed on a subgroup of the data set (N=121) to test and refine the model. Content analysis of the open-ended data provided additional support for model variables. RESULTS The final model retained all proposed variables except for anonymous reporting. The model highlights that process ease and learning capability both greatly influence the overall support for the QRE process; with these 2 variables explaining 62% of the variance in QRE process support and QRE process support explaining 34% of the variance in overall levels of QRE reporting. CONCLUSIONS The findings have implications for the creation and implementation of successful QRE reporting processes in community pharmacies. Implementing effective QRE reporting tools is paramount to ensuring that pharmacies report and learn from QREs. Dynamic QRE reporting tools that are modern, up to date, integrated into workflow, easy to use, and quick have been shown to be the most effective.

Reflections on the role of the pharmacy regulatory authority in enhancing quality related event reporting in community pharmacies

BACKGROUND Given the demanding nature of providing pharmacy services, coupled with the expanded scope of practice of the professions in jurisdictions around the world, greater commitment to continuous quality improvement through adoption of quality-related event (QRE) reporting is necessary to ensure patient safety. Pharmacy regulatory authorities (PRAs) are in a unique position to enhance QRE reporting and learning through the standardization of expected practice. OBJECTIVE This study was aimed to gain a better understanding of the perceived roles of PRAs in enhancing QRE reporting and learning in community pharmacies, and identifying regulatory best practices to execute such roles. METHODS A purposive case sampling approach was used to identify PRA staff members from two groups (Deputy registrars and pharmacy inspectors) in 10 Canadian jurisdictions to participate in focus groups in the fall of 2011. Focus groups were used to explore perceptions of the role of PRAs in enhancing and promoting QRE reporting and learning, and perceived barriers to effective implementation in practice. Thematic analysis was used to analyze the qualitative data. RESULTS Two focus groups were conducted, one with seven Deputy registrars/Practice managers, and one with nine pharmacy inspectors. Five themes were identified, including (1) defining QRE reporting and compliance, (2) navigating role conflict, (3) educating for enhanced QRE reporting and learning, (4) promoting the positive/removing the fear of QREs, and (5) tailoring QRE reporting and learning consistency. CONCLUSIONS Overall, participants perceived a strong role for PRAs in enhancing QRE reporting and learning and providing education for pharmacies to support their compliance with reporting standards. However, PRAs must navigate the conflict inherent in both educating and promoting a process for achieving a standard while simultaneously inspecting compliance to that standard. Ensuring pharmacies have autonomy in operationalizing standards may help to mitigate this conflict. Finally, greater education for PRAs themselves to better inspect compliance and in order to better communicate the benefits of QRE reporting and learning to pharmacies would be beneficial.

Uptake of Quality-Related Event Standards of Practice by Community Pharmacies.

Quality-related events (QREs), including medication errors and near misses, are an inevitable part of community pharmacy practice. As QREs have significant implications for patient safety, pharmacy regulatory authorities across North America are increasing their expectations regarding QRE reporting and learning. Such expectations, commonly encapsulated as standards of practice (SoP), vary greatly between pharmacy jurisdictions and may range from the simple requirement to document QREs occurring within the pharmacy, all the way to requiring that quality improvement plans have been put in place. This research explores the uptake of QRE reporting and learning SoP and how this uptake varies based on pharmacy characteristics including location, prescription volume, and pharmacy type. Secondary data analysis of 91 community pharmacy assessments in Nova Scotia, Canada, was used to explore uptake of QRE standards. Overall, pharmacies are performing relatively well on reporting QREs. However, despite initial success with basic QRE reporting, community pharmacy uptake of QRE learning activities is lagging.

Regulatory Authority Approaches to Deploying Quality Improvement Standards to Community Pharmacies Insights From the SafetyNET-RX Program

Background: Continuous quality improvement (CQI) programs provide an effective means to improve the safety and quality of community pharmacy practice. The role of formal support processes in ensuring the success of these CQI programs is explored in this research using the SafetyNET-Rx project. Objective: The primary objectives of this research were to determine how knowledge of, and confidence in, mandated CQI standards differs among pharmacies with access to formal support mechanisms and those without and the challenges faced by both. Methods: A survey questionnaire was mailed to 179 community pharmacies in Nova Scotia, Canada, in spring 2011. Quantitative results were analyzed using the Mann-Whitney U test for nonparametric data. Qualitative open-ended responses were analyzed using content analysis. Results: Performing the Mann-Whitney U test indicated that a number of differences exist between the 2 groups with respect to: (1) staff knowledge of reporting quality-related events (QREs) to an anonymous database; (2) conducting annual pharmacy safety self-assessments; (3) confidence in meeting these 2 elements; and (4) documenting changes to address QREs. A number of challenges were identified by respondents through the open-ended questions. Conclusions: This research highlights the value of the active provision of formal support when developing standards related to quality improvement.

Head Office Commitment to Quality-Related Event Reporting in Community Pharmacy

Background: This research explores how perceptions of head office commitment to quality-related event (QRE) reporting differ between pharmacy staff type and between pharmacies with high and low QRE reporting and learning performance. QREs include known, alleged or suspected medication errors that reach the patient as well as medication errors that are intercepted prior to dispensing. Methods: A survey questionnaire was mailed in the spring of 2010 to 427 pharmacy managers, pharmacists and pharmacy technicians in Nova Scotia. Nonparametric statistics were used to determine differences based on pharmacy staff type and pharmacy performance. Content analysis was used to analyze the responses to open-ended survey questions. Results: A total of 210 surveys were returned, for a response rate of 49.2%. However, the current study used only the subgroup of pharmacy staff who self-reported working at a chain pharmacy, for a total of 124 usable questionnaires. The results showed that community pharmacies viewed head office commitment to QRE reporting as an area to improve. In general, high-performing pharmacies ranked head office commitment higher than low-performing pharmacies. Discussion: One possible reason why high-performing pharmacies ranked the variables higher may be that increased levels of head office support for QRE processes have led these pharmacies to adopt and commit to QRE processes and thus increase their performance. Conclusion: Demonstrated commitment to QRE reporting, ongoing encouragement and targeted messages to staff could be important steps for head office to increase QRE reporting and learning in community pharmacies.