Assessing pharmacists’ knowledge and compliance with narcotic inventory management using a computer-based educational platform

Abstract

Objectives

Pharmacy professionals are required to take all necessary steps to protect commonly misused drugs such as opioids at their pharmacies to minimize the risk of diversion. The aim of this study is to assess Canadian pharmacy professionals’ knowledge and compliance with federal and provincial regulations using the computer-based educational platform Pharmacy5in5.

Methods

A Narcotic Inventory module was created and reviewed by experts representing provincial and federal regulators. Descriptive statistics were used to analyze users’ performance in quizzes. Binomial regression and logistic regression models were used to investigate the effect of demographic factors on users’ performance. P-values less than 0.05 were considered statistically significant.

Key findings

The analysis included data collected over a period of three months. A total of 792 users accessed the Narcotic Inventory module on the Pharmacy5in5 website between July 2019 and November 2019. Most of the users were licenced pharmacists (64%), female (72%), received their training in Canada (68%), and were practising in Ontario (80%). Users performed best on the quiz addressing the steps for reconciliation of inventory (93%), and worst on the quiz reviewing how to prepare for a Health Canada visit (66%).

Conclusions

Overall, pharmacy professionals showed adequate knowledge of the CDSA and provincial/territorial regulations regarding opioids inventory management. Conversely, the study highlighted poor compliance with the reporting of losses and theft of controlled substances by pharmacy professionals. Innovative approaches are needed to influence pharmacy professionals’ behaviours to improve their compliance with best practices concerning inventory management to reduce drug diversion.

Introduction

The misuse of prescription drugs is a common issue worldwide, with particular dangers identified related to opioids, benzodiazepines, and stimulants.^[1] In 2017 in the United States, for example, two-thirds of the 70 000 drug overdoses that year were related to opioids, many of which also involved benzodiazepines, and 10% were related to stimulants such as methamphetamines.^[2] Over 16 000 Canadians have died from misuse of opioids since 2016, most of these deaths also involving a benzodiazepine.^{[3, 4]} In Europe, as in Northern America, misuse of opioids poses a growing health threat with a total of 16 931 opioid-related overdose deaths estimated to have occurred between 2012 and 2016.^[5]

Pharmacists play an important role in tackling the opioid crisis and misuse of drugs through harm reduction. For example, community pharmacies have become a major access point for opioid agonist therapies such as methadone and buprenorphine across several countries including Australia, Ireland, New Zealand, Canada and the UK.^[6–8] However, there has also been an alarming increase in the quantity of opioids and controlled drugs going missing from pharmacies due to drug diversion, including theft by pharmacy staff or robbery.^[9–12] In Canada alone, the loss of drugs such as opioids and benzodiazepines has increased almost 8-fold over the last 5 years, with 90% of losses originating in pharmacies.^[9]

In Canada, opioids, benzodiazepines and stimulants are generally classified as ‘controlled drugs and substances’ under a federal law-the Controlled Drugs and Substances Act (CDSA), enacted in 1996.^[13] In addition, each province or territorial jurisdiction has its own laws, regulations and standards of practice for pharmacists that can add a layer of complexity to daily practice. As the opioid crisis has grown, it has become clear that a unified approach is needed. In particular, in response to the alarming increase in drug diversion in community pharmacies in 2015 Health Canada started the Community Pharmacy Inspection Program to assess pharmacy compliance with the CDSA and to focus on universal principles of inventory management and loss and theft reporting. The inspection program has consistently identified that compliance with the CDSA is suboptimal across the country. For example, inspections of randomly selected community pharmacies in 2015 and 2016 found that up to 75% of stores had inadequate documentation related to opioids, including incomplete inventory records, and opioid prescriptions misfiled with regular prescriptions.^{[14, 15]} In 2018, random inspections found that 10% of Canadian pharmacies were non-compliant with the regulations, as were 18% of pharmacies targeted for inspection, due to serious issues such as unreported losses, thefts or large unexplained losses.^[16] Given concerns about drug diversion to the illicit market and its contribution to the ongoing opioid crisis,^[17] new approaches to enhance pharmacy professionals’ compliance with the CDSA is needed. While contributing factors to poor compliance among pharmacy professionals are not well documented, this study aims to determine knowledge gaps regarding the existing regulations which could explain poor compliance. In light of the opioid crisis, there has been very limited attention to how pharmacists manage controlled drugs. To address this, we developed an educational module on inventory management of opioids and other controlled drugs inventory management using the Pharmacy5in5.ca online learning platform.

Pharmacy5in5 is a freely available computer-based education platform that aims to help Canadian pharmacy professionals build their knowledge and skills by simplifying complex topics into short 5-min lessons. This module targets pharmacists and pharmacy technicians, as both are regulated professionals in Canada who actively participate in medication inventory management. The primary objective of this study was to use the data generated by the Pharmacy5in5 platform to identify knowledge gaps related to managing opioid records in pharmacies and to assess pharmacy professionals’ self-reported compliance with the CDSA and provincial regulations. Secondary objectives included an gaining understanding of the impact of various demographic factors on pharmacy professionals’ knowledge and compliance with regulations.

Methods

All users of the platform provide their demographic information along with the consent to use their de-identified data for research purposes during registration. Ethics approval has been obtained from the University of Waterloo Ethics Committee (ORE#22642) for secondary use of the data for analysis. The analysis included data collected from the module launch date on 29 July 2019–21 November 2019.

Development and validation of the module

The design of the Pharmacy5in5 platform is described elsewhere.^[18] Briefly, it is a computer-based educational platform designed to regularly release modules that cover five take-home messages related to the scopes of pharmacy practice. Each module has the following design components: one fast fact quiz, six case-based quizzes, immediate and delayed feedback, multimedia resources, peer comparison, and six self-reflection questions. The platform data includes the results of the fast fact quiz and the six case-based quizzes which are used to assess pharmacy professionals’ knowledge, and the six self-reflection questions which are used to assess pharmacy professionals’ compliance or experience. The case-based quizzes describe a fictional pharmacist ‘persona’ in a typical practice situation relevant to the module topic.

The Narcotic Inventory module is one of many available on Pharmacy5in5. To create the Narcotic Inventory module, we started by drafting learning objectives with input from the staff from the Ontario College of Pharmacists, a provincial regulatory authority, and the Health Canada Office of Controlled Substances. Next, we used the learning objectives to develop an educational infographic, two short animated videos, and five flashcards. We also developed fast facts immediate feedback quiz and six case-based delayed feedback quizzes to address all the learning objectives. For the fast facts quiz and the last case-based quiz (five questions each), each question addressed one learning objective. The rest of the case-based quizzes, each composed of five questions, address one specific objective. The case-based quizzes use a delayed-feedback approach to promote comprehension and application of knowledge.^[19] Users have the freedom to access all module components in any order they choose. All module components were reviewed by a panel of six experts representing provincial and federal regulators to assess for comprehensiveness and clarity. In the first round, the module content was shared with the panel via email to gather comments and critiques for each question and all multimedia resources, and modifications were made accordingly. One quiz question was deleted and the infographic was clarified based on panel members’ feedback. During the second round, the revised full interactive module was shared, with no further comments received from panel members. Before launching the module nationally, it was shared with pharmacy regulatory authorities across Canada and four practising pharmacists to identify any final changes. Once complete, the module was made freely available to all pharmacy professionals in Canada.

Population and recruitment

All registered users of the Pharmacy5in5.ca online learning platform were invited to complete the module via email. Registered users include pharmacist, pharmacy technicians, pharmacy students, pharmacy technician students and unlicensed pharmacists. The resources were also shared via social media and regulatory authority promotions.

Study procedure

A de-identified dataset was downloaded from the platform and cleaned to remove duplicate data and test accounts. The dataset included users demographic data including age, gender, years in practice, user type (pharmacist, technician, pharmacy student and technician student), geographic region, main practice location (primary care, hospital, independent community, large chain community, small chain/banner community and university/academic), and place of training (domestic, international and both). The dataset also included user response data for all quizzes attempted and reflection question responses.

Statistical analysis

Categorical data were expressed as frequencies and percentages (%). Continuous data were expressed as mean ± standard deviation (SD), median and range. Knowledge was measured by the overall quiz score mean, with each quiz having a raw score out of five. A binomial regression model was used to understand the impact of various demographic factors on user performance. A logistic regression model was used to understand the impact of demographic factors on the respondents’ answers to the reflection questions. The stepwise selection technique was applied to select the most reasonable set of factors that have an impact on users’ performance based on the Akaike Information Criterion (AIC). Both Hosmer-Lemeshow and Stukel tests were used to check the goodness-of-fit of the resulting model at significance level = 0.05. P-values less than 0.05 were considered statistically significant.

Results

Overall, 792 users accessed the Narcotic Inventory online module during this time period, with 429 users (54%) completing the entire module, and 778 users (98%) completing at least one quiz in the module, resulting in a total of 4550 quiz responses. On average, 73% of quizzes were completed on the first attempt. A total of 24% of users attempted at least one quiz multiple times (1–5 times).

The demographics of Pharmacy5in5 users who answered the quizzes of the Narcotic Inventory module are shown in Table 1. Most users were female (72%), received their training in Canada (68%), were licensed pharmacists (64%), and were practising in the province of Ontario (80%). The most common practice sites for users included independent pharmacies (32%) and large chain pharmacies (25%).

Table 1

Demographics of the users of the narcotic inventory module (n = 792)

Demographics	n (range or %)
Birth year	1977 (1942–2001)
Year started practicing	2005 (1969–2019)
Gender
Female	574 (72%)
Male	218 (28%)
Other	0 (0%)
Location of training
Canada	537 (68%)
Outside of Canada	204 (26%)
Both	51 (6%)
Highest level of education
Bachelor	444 (56%)
Entry level PharmD	47 (6%)
Masters	45 (6%)
Post graduate PharmD	33 (4%)
PhD	7 (1%)
Job title
Licensed pharmacist	507 (64%)
Unlicensed pharmacist	64 (8%)
Pharmacy student	45 (6%)
Pharmacy technician	104 (13%)
Pharmacy technician student	53 (7%)
Other	19 (2%)
Type of pharmacy practice
Independent pharmacy	250 (32%)
Small chain or banner pharmacy	137 (17%)
Large chain pharmacy	200 (25%)
Hospital	89 (11%)
University	7 (1%)
Primary care	5 (1%)
Long term care	15 (2%)
Other	89 (11%)
Province of practice
Alberta	63 (8%)
Ontario	632 (80%)
British Columbia	14 (2%)
Saskatchewan	9 (1%)
Manitoba	15 (2%)
Quebec	6 (1%)
Newfoundland	6 (1%)
Nova Scotia	18 (2%)
New Brunswick	20 (3%)
Prince Edward Island	6 (1%)
Nunavut	0 (0%)
Northwest Territories	1 (0%)
Yukon	0 (0%)

Table 2 shows the mean user performance on each quiz on their first attempt. We refer to each quiz by the name of the fictional pharmacist’s persona assigned to that quiz (e.g., quiz 2 Josh reporting; quiz 3 Nancy fills the form). The quiz ‘Quan Reconciles’, which addressed the steps for inventory reconciliation, had the best performance (93%). In comparison, the quiz ‘Health Canada Visits Sasha’, which reviews how to prepare for a Health Canada visit, had the worst performance (66%). In terms of individual questions, the question regarding the planning for the actual physical count of opioids and controlled drug inventory had the worst performance (25%), followed by a question about whether the loss of all opioids and controlled drugs should be reported to the police immediately (39%), and a question about what should be included in an incident report in case of unreportable losses (40%).

Table 2

Summary of quiz (score out of five) performance by a quiz and addressed learning objective(s)¹

Quiz name	Learning objective(s) addressed	Mean Score/5	Users completing quiz
Fast facts	• Recognize when the loss of a controlled substance should be reported • Follow the steps required to report the loss of a controlled substance • Develop a policy/procedure to manage controlled substances inventory in the pharmacy • Identify appropriate approaches to manage shortage in narcotic reconciliation • Prepare for a Health Canada assessment/inspection.	4.05/5	869
Josh and reporting	• Recognize when the loss of a controlled substance should be reported	3.85/5	742
Nancy fills the form	• Follow the steps required to report the loss of a controlled substance	4.15/5	576
Pradeep and the policy	• Develop a policy/procedure to manage controlled substances inventory in the pharmacy	3.85/5	502
Quan reconciles	• Identify appropriate approaches to manage shortage in narcotic reconciliation	4.65/5	481
Health Canada visits Sasha	• Prepare for a Health Canada assessment/inspection.	3.3/5	450
Nadia and the records	• Recognize when the loss of a controlled substance should be reported • Follow the steps required to report the loss of a controlled substance • Develop a policy/procedure to manage controlled substances inventory in the pharmacy • Identify appropriate approaches to manage shortage in narcotic reconciliation • Prepare for a Health Canada assessment/inspection.	3.65/5	447

¹_{User performance on each quiz on their first attempt.}

We investigated the impact of various demographic factors on user performance. We considered gender, birth year, job title, the year started practising, location of pharmacy training and type of pharmacy. Based on the resulting binomial regression model, licensed pharmacists performed significantly better than pharmacy technicians (β= −0.21, t(4540) = −3.82, P < 0.001), and pharmacy technician students (β = −0.45, t(4052) = −7.15, P < 0.001) and users with other titles (β = −0.37, t(4052) = −3.53, P < 0.001). That said, the median scores for the different groups were very similar, suggesting that the difference is not meaningful. Users who received their training both within and outside Canada performed worse than those who received their training in Canada only (β = −0.2, t (4052) = −2.65, P = 0.01). As above, the difference in scores was very small.

Reflection questions

Users who completed the case-based quizzes were asked to answer a reflection question at the end of each quiz. As shown in Table 3, most pharmacists reported that in the last six months they had performed an actual physical count (92%) and a full reconciliation (85%). They also felt prepared for a Health Canada visit (90%). However, only half (50%) of pharmacists and less than a quarter (21%) of technicians had ever been involved in completing or submitting a loss and theft reporting form.

Table 3

Percentages of pharmacists and pharmacy technicians’ responses to the reflection questions by type of quiz

Reflection questions	Pharmacists’ response (%)	Pharmacy technicians’ response (%)
(1) Have completed and submitted a loss and theft reporting form to Health Canada	Yes 264/530 (50%)	Yes 24/114 (21%)
(2) Who was notified about a loss, theft or forgery:
Health Canada	127/290 (44%)	17/47 (36%)
Police	30/290 (10%)	6/47 (13%)
Both	98/290 (34%)	16/47 (34%)
Neither	35/290 (12%)	8/47 (17%)
(3) Have performed an actual physical count in the last 6 months	Yes 292/316 (92%)	Yes 65/69 (94%)
(4) Have performed a full reconciliation in the last 6 months	Yes 248/291 (85%)	Yes 53/65 (82%)
(5) Do you have a strategy to prepare for a Health Canada inspection?	Yes 80/269 (30%)	Yes 19/48 (40%)
(6) If you had a Health Canada audit tomorrow, how would you feel?
Not at all prepared	28/268 (10%)	3/59 (5%)
Somewhat unprepared	46/268 (17%)	7/59 (12%)
Somewhat prepared	91/268 (34%)	15/59 (25%)
Very well prepared	73/268 (27%)	28/59 (47%)
Cannot judge/do not know	30/268 (11%)	6/59 (10%)

Based on the resulting logistic regression model, we found that users who were trained in Canada were less likely to answer positively to the reflection questions than users who were trained outside Canada (β = 0.338, t(2344) = 2.5, P = 0.01). We also found that users who work in hospitals were less likely to answer positively to the reflection questions than users who work in large chain pharmacies (β = 0.474, t(2344) = 2.26, P = 0.02).

Discussion

Overall, our study showed that pharmacy professionals have adequate knowledge of controlled drug inventory management, in particular, knowledge of regulations concerning reporting losses of controlled substances. Additionally, findings showed adequate knowledge of the controlled drug reconciliation procedure including how to investigate shortages and overages. However, pharmacy professionals showed inadequate knowledge of preparation for regulatory inspection visits, which highlights how different components to inventory management may be less obvious than others. The most remarkable result was that the majority of pharmacy professionals were routinely doing inventory counts of higher risk substances such as opioids, but only half had experience reporting actual losses and only a third had a strategy to prepare for the routine regulatory inspections. Internationally trained pharmacists and those working in large chain store pharmacies reported higher compliance with the regulations.

Strengths of this research include the large sample size and the recruitment of pharmacy professionals from across Canada to improve generalizability. A potential limitation was the use of reflection questions to capture self-reported past behaviour, due to higher flexibility and ease of use compared to other methods, such as direct observation. However, self-reported behaviours are prone to recall and social desirability bias, which can lead to inaccurate estimation of the actual behaviours.^{[20, 21]} Thus, pharmacists may have over-estimated how often they do reconciliation for opioids and other commonly misused drugs, for example. Another limitation was that only 54% of users completed the entire module. Further research is needed on how to incentivize pharmacy professionals to improve their completion rate. Future research could also benefit from measuring the effect of our module on the knowledge and behaviours of pharmacy professionals by conducting appropriate trials.

From an international perspective, there is very little written on the topic of inventory management for commonly misused prescription drugs in community pharmacies. With the rapid escalation of the opioid crisis in Western countries, this is a key skill needed by pharmacists that may be underrecognized. One of our key findings was that pharmacy professionals may have more knowledge and experience with routine audits and reconciliations, but less experience and skill with problem-solving and troubleshooting apparent losses. The study highlighted the difference between what pharmacists know and what they are doing in practice. In particular, our findings indicate that pharmacists can understand the regulations but they don’t have sufficient skills to apply them and have trouble putting them into action, indicating a need for more practice and training. This is consistent with inspection reports from the federal regulator in Canada, which has identified that unsubmitted loss and theft reports have been a major challenge.^{[14, 15]} Similarly, in the UK, the 2019 Care Quality Commission’s annual report on the safer management of controlled drugs reported inconsistency in reporting theft or loss incidents due to confusion on who to report to and what needs to be reported.^[22] This is a major problem when a federal regulator, for example, uses loss and theft reports to track diversions. Thus, there is great value in providing pharmacy staff with reliable and enjoyable training opportunities to build their competence and confidence in troubleshooting and reporting requirements.^{[23, 24]}

Conclusion

Pharmacy professionals dispense commonly misused drugs such as opioids, benzodiazepines, and stimulants in practice daily and have a crucial role in managing and protecting inventory. This study found that pharmacy professionals across Canada have shown adequate knowledge of the laws governing these drugs in Canada, but poor compliance with reporting of losses and theft of commonly misused drugs. This indicates that the problem behind the poor compliance is probably not related to a knowledge gap. Our results suggest that further training and practice opportunities are required to support pharmacists in managing inventories of controlled drugs. Further research is needed to identify other ways to address poor compliance among pharmacy professionals

Author Contributions

RH: contributed to the design of the study, contributed to the data analysis, and led the writing of the paper. ZH: contributed to the design of the study, led the data analysis, reviewed results, and contributed to the writing of the manuscript. RK: contributed to the design of the study, contributed to the data analysis, reviewed results, and contributed to the writing of the manuscript. KG: contributed to the design of the study, contributed to the data analysis, reviewed results, and contributed to the writing of the manuscript. All authors reviewed various drafts of the manuscript and approved the final manuscript.

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors.

Conflict of Interest

The authors declare that they have no conflict of interests.