Abstract
Background: Quality-related events are defined as medication errors that reach the patient (e.g., incorrect drug, dose and quantity), in addition to medication errors that are intercepted before dispensing (i.e., near misses). The aim of this study is to quantify and characterize such events as reported by community pharmacies in a Canadian province.
Methods: A retrospective analysis was conducted on quality-related events reported to the Community Pharmacy Incident Reporting system from 301 community pharmacies in Nova Scotia between Oct. 1, 2010, and June 30, 2017. We performed a descriptive analysis on these events with respect to the discoverer, patient outcome, medication system stages and type.
Results: We identified 131 031 events reported by community pharmacies in Nova Scotia over the study period, 98 097 of which were quality-related events. Overall, 82.0% (n = 80 488) quality-related events did not reach the patient, and 0.95% (n = 928) were associated with patient harm. Incorrect dose or frequency, incorrect quantity and incorrect drug were the most common types of quality-related events reported. Most of the quality-related events occurred at order entry, followed by preparation and dispensing, and prescribing.
Interpretation: Quality-related events reported by community pharmacies differ from those reported in institutional settings with respect to patient outcome, medication system stages and type. This analysis provides valuable information to guide quality improvement initiatives to strengthen medication safety in community pharmacies.
Community pharmacies in Canada dispense more than 600 million prescriptions each year; however, little is known about the quality-related events associated with this process.1–4 Quality-related events are defined as medication errors that reach the patient, such as incorrect drug, dose or quantity, in addition to medication errors that are intercepted before a drug is dispensed (i.e., near misses).2 These events occur when vulnerable medication-use systems or human factors affect prescribing, transcribing, dispensing, administration, and monitoring practices.5 When an event reaches a patient and causes harm, it is defined as an adverse drug event.6 Adverse drug events are estimated to be responsible for 12% of emergency department visits and 24% of all adverse events that occur in hospitals in Canada.7,8
In an effort to address factors that lead to quality-related events, health care organizations and governments have developed and implemented reporting systems. Aside from providing data for large-scale aggregate analysis, reporting systems enable health care stakeholders to better understand the contributing factors that may have led to quality-related events, and have been associated with improvements in patient safety culture and better organizational learning.9 The implementation of reporting systems in community pharmacies in Canada has been limited, but previous research involving analyses of quality-related events from community pharmacies in Europe showed differences from institutional settings with respect to patient outcome, stage of medication use and type of quality-related event.10,11 The aim of our study was to characterize quality-related events reported to an independent third-party national medication safety organization by community pharmacies in a Canadian province.
Methods
The Nova Scotia College of Pharmacists Standards of Practice for Continuous Quality Assurance require community pharmacies to anonymously report all quality-related events to a national incident data repository at the Institute for Safe Medication Practices Canada through the Community Pharmacy Incident Reporting system.12 The Community Pharmacy Incident Reporting system was developed and validated with community pharmacists in Ontario and Nova Scotia.13 The provincial pharmacy regulatory authority regularly audits and ensures pharmacies’ adherence to these standards.
Study cohort
All community pharmacies in Nova Scotia were included in the study.
Data sources
The quality-related event reporting form was developed in collaboration with Nova Scotia and Ontario community pharmacy professionals; it consists of 7 mandatory fields: (1) date quality-related event occurred, (2) type of event, (3) who the event was discovered by, (4) medication system stages involved, (5) medication(s), (6) patient outcome associated with the event, and (7) a free-text description field (Box 1). All members of the pharmacy team (e.g., owner, manager, pharmacist, technician, assistant) can report a quality-related event through the online Community Pharmacy Incident Reporting system.
Mandatory fields of the Community Pharmacy Incident Reporting system
Date quality-related event occurred
Type of quality-related event*
Incorrect patient
Incorrect prescriber
Incorrect drug
Incorrect dose/frequency
Incorrect strength/concentration
Incorrect dosage form/formulation
Incorrect route of administration
Incorrect duration of treatment
Incorrect quantity
Incorrect storage
Omitted medication/dose
Incorrect third-party billing
Drug therapy problem
Contraindication
Adverse drug reaction
Documented allergy
Drug–drug interaction
Drug–food interaction
Drug–disease interaction
Quality-related event discovered by (i.e., Discoverer)*
Pharmacist
Pharmacy technician/assistant
Pharmacy student
Patient
Patient’s family member/relative
Patient’s caregiver/home aid/assistant
Patient’s friend/visitor
Community Care Access Centre home care coordinator
Physician
Medical student
Paramedic
Nurse
Nursing student
Social worker
Dentist
Midwife
Chiropodist/podiatrist
Respiratory therapist
Dietician
Physiotherapist
Occupational therapist
Veterinarian
Other
Medication system stage involved†
Prescribing
Prescription order entry
Prescription preparation/dispensing
Administration
Monitoring/follow-up
Not applicable
Medications‡
Degree of harm (i.e., patient outcome)*
No error (medication not dispensed/near miss/medication discrepancy) — Circumstances or events that have the capacity to cause harm
No harm (medication dispensed) — No symptoms detected; no treatment required
Mild harm — Symptoms were mild, temporary and short-term; no treatment or minor treatment was required
Moderate harm — Symptoms required additional treatment or an operation; the incident kept the patient in hospital longer than expected; or caused permanent harm or loss of function
Severe harm — Symptoms required major treatment to save the patient’s life; the incident shortened life expectancy; or caused major permanent or long-term harm
Death — There is reason to believe that the incident caused the patient’s death or hastened the patient’s death
Quality-related event description
↵* The reporter may only select 1 option from this field.
↵† The reporter may select more than 1 option from this field.
↵‡ Reporters have the option to report an event that is not medication-related by unchecking “Is this medication related” next to the “Medications” field. The “Medications” field will auto-populate if a drug identification number (DIN) is entered. A DIN is an 8-digit unique identifier located on the label of prescription and over-the-counter drugs that have been approved for sale in Canada.
Reporters may also select the medication from a drop-down menu when the reporter begins typing the medication name, or they may choose to manually enter a free-form medication name.
Statistical analysis
All 7 mandatory fields of reported quality-related events from Nova Scotia community pharmacies that occurred between Oct. 1, 2010, and June 30, 2017, were extracted from the Community Pharmacy Incident Reporting system (by A. Boucher and C. Ho). Single-item and cross-tabulation search statements were developed to further extract relevant data for analysis (by A. Boucher and C. Ho). Descriptive analyses were performed on events with respect to discoverer, patient outcome, medication system stages involved and type (by A. Boucher and C. Ho). All analyses were performed using IBM SPSS version 24.
Ethics approval
This study does not involve human subjects.
Results
A total of 301 community pharmacies (Table 1) in Nova Scotia reported 131 031 events to the Community Pharmacy Incident Reporting system during the study period. Of these events, 98 097 were reported as quality-related events and were included in our analysis. A mean of 14 533 quality-related events were reported annually. The mean number of reported quality-related events for each pharmacy during the study period was 326 (standard deviation [SD] ± 439). We found a large variability between pharmacies, with between 1 and 2806 quality-related events reported per pharmacy during the study period. Furthermore, 10% (n = 30) of the pharmacies accounted for 42.7% (n = 41 926) of all reported quality-related events.
Community pharmacies in Nova Scotia
Most (55.2%; n = 166) of the community pharmacies in Nova Scotia are chain pharmacies, and 48.2% (n = 145) are located in a geographic region with a population of between 5000 and 49 999 (Table 1).
Discoverer
Pharmacists discovered 75.2% (n = 73 739) of quality-related events. Pharmacy technicians or assistants and patients discovered 10.3% (n = 10 094) and 9.9% (n = 9728), respectively. The remaining 4.6% (n = 4536) were discovered primarily by other health care practitioners (Appendix 1, available at www.cmajopen.ca/content/6/4/E651/suppl/DC1).
Patient outcome
Analysis of outcomes showed that 82.0% (n = 80 488) of reported quality-related events did not reach the patient (i.e., near misses), and 0.95% (n = 928) were reported as harm events (Table 2).
Medication system stage
Of all analyzed quality-related events, 17.5% (n = 17 135) were reported as occurring in multiple medication system stages. The medication system stage most frequently associated with quality-related events was prescription order entry (58.7%; n = 69 856), followed by prescription preparation and dispensing (29.3%; n = 34 859) and prescribing (9.0%; n = 10 658) (Table 3). Among harm events, there was a more even distribution across the medication system stages, with prescription preparation and dispensing (38.1%; n = 571) accounting for the largest proportion, followed by order entry (27.4%; n = 411) and administration (15.2%; n = 228). Administration and monitoring or follow-up were associated with the highest potential for patient harm.
Type of quality-related event
The most frequently reported types of quality-related event were incorrect dose or frequency (25.6%; n = 25 089), followed by incorrect quantity (20.0%; n = 19 619) and incorrect drug (14.2%; n = 13 951) (Table 4). For harm events, the highest number of quality-related events was associated with incorrect dose or frequency (27.4%; n = 254), followed by incorrect strength or concentration (20.2%; n = 187) and incorrect drug (19.9%; n = 185). Adverse drug reactions were associated with the highest potential for patient harm.
Interpretation
We identified 98 097 quality-related events reported during the study period. Despite variability in reporting between pharmacies, 100% of community pharmacies in Nova Scotia (n = 301) reported at least 1 such event during the study period, suggesting universal compliance with the reporting program.
Most of the events were discovered by a pharmacist and did not reach the patient. Quality-related events most frequently occurred in the order entry stage and were most commonly categorized as incorrect dose or frequency, or incorrect quantity. Most of the events reported were caught by pharmacy staff and did not reach the patient. This result is in contrast to previous analyses of reported events from community pharmacies and hospitals where, in general, less than 60% of quality-related events did not reach the patient.10 This discrepancy may be due to several factors. First, in addition to anonymous reporting, the Nova Scotia Continuous Quality Assurance program also requires community pharmacies to perform an annual medication safety self-assessment and conduct quarterly staff meetings to implement and monitor ongoing quality improvement initiatives.12 These additional quality improvement components help facilitate quality-related event reporting by addressing several common barriers to incident reporting, including lack of feedback on action taken as a result of reporting, insufficient justification for reporting a “near miss” and the belief that reporting is unlikely to lead to system changes.14,15 Second, adherence to all required components of the Standards of Practice for Continuous Quality Assurance are regularly audited and enforced by the provincial pharmacy regulatory authority. As a result, our data and analysis may provide a more representative view of quality-related events and associated outcomes that occur in community pharmacies.
The most common medication system stages involved in the reported quality-related events were prescription order entry and prescription preparation and dispensing. Previous studies in community pharmacies have found similar results,10,11 but studies in hospitals generally report a higher frequency of quality-related events related to prescribing and administration.16–19 In addition, we found that quality-related events that occurred during administration or monitoring and follow-up were more likely to result in patient harm, probably because there are fewer opportunities to catch quality-related events in later stages of the medication-use process, and patients are more likely to identify and report events that cause harm.20 The most frequent types of reported quality-related events (e.g., incorrect dose or frequency, incorrect quantity, incorrect drug) were generally in agreement with results from previous studies conducted in community pharmacies and hospitals.11,16,17,21 However, other types of quality-related events were often reported in different proportions in hospital studies.16,17 We found that adverse drug reactions may convey a higher risk of harm to patients compared with other types of quality-related events, which aligns with previous research that identified adverse drug reactions to be the most common cause for drug-related emergency department visits.7
Limitations
We found significant variability in the reporting rates among community pharmacies. This finding is in line with results from previous research and may imply under-reporting of quality-related events to some extent.10,22 In addition, our findings represent quality-related events reported from a single reporting system in a single province. Because community pharmacies are largely governed by provincial pharmacy regulatory authorities, our results may not be generalizable to the rest of Canada. Nonetheless, our findings will provide important comparative data for other provincial pharmacy regulatory authorities in Canada, which are mandating quality-related event reporting in the coming years.23,24
Conclusion
We aimed to characterize quality-related events reported from community pharmacies in Nova Scotia. We found that these events differ from those reported in institutional settings with respect to patient outcome, medication system stages and types of event. Although our findings provide an important first step in describing quality-related events in community pharmacies, they are unable to provide insight into the various factors that may contribute to these events. Future research should focus on the medications involved and qualitative analysis of the event description to better understand the potential contributing factors associated with quality-related events in community pharmacy practice. Combined with quantitative analysis, such research will provide a comprehensive view of key safety risks and trends, thus allowing for the development of recommendations to improve medication safety.
Acknowledgements
The authors acknowledge the Institute for Safe Medication Practices Canada for providing access to the anonymously reported quality-related events by Nova Scotia community pharmacies that made this study possible; and the SafetyNET-Rx Participating Investigators who contributed to the review and editing of the manuscript.
Footnotes
Competing interests: None declared.
This article has been peer reviewed.
Contributors: Adrian Boucher and Certina Ho contributed substantially to the conception and design, acquisition of data, analysis and interpretation of data, drafted the article, and revised it critically for important intellectual content. Neil MacKinnon, Todd Boyle and Andrea Bishop contributed substantially to the conception and design, and the analysis and interpretation of data, and revised the manuscript critically for important intellectual content. Paola Gonzalez, Christopher Hartt and James Barker contributed substantially to the analysis and interpretation of data, and revised the manuscript critically for important intellectual content. All of the authors gave final approval of the version to be published and agreed to act as guarantors of the work.
Funding: This study was funded by The Kenneth C. Rowe Gift, Rowe School of Business, Dalhousie University, Halifax, NS.
Supplemental information: For reviewer comments and the original submission of this manuscript, please see www.cmajopen.ca/content/6/4/E651/suppl/DC1.
References
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