Drug diversion is the term used to describe the transfer of medications, like opioids, from legitimate medical use to non-medical uses. In Canada, there were over 64,000 cases of opioid loss between January 2012 and September 2017. Researchers from North York General Hospital, the Institute for Safe Medication Practices Canada, and the University of Toronto have been investigating the prevalence and cause of drug diversion in Canadian health facilities. By drawing greater awareness to this issue, they hope that new safeguards can be implemented to increase the security of controlled drugs.
In Canada, opioid overdoses were responsible for 1,628 deaths between April and June 2020, representing the highest quarterly count since national surveillance began in 2016. This figure provides a sobering reminder of the impact that the opioid crisis still has in North America. The burden of opioid-related deaths may be intensified by the loss of controlled drugs from healthcare facilities in a process known as drug diversion.
Drug diversion is the term used to describe the transfer of medications, like opioids, from legitimate medical use to non-medical uses. Diversion can take many forms, ranging from robberies in community pharmacies to the theft of drugs by healthcare workers in hospitals. However, a large proportion of reported drug losses are ‘unexplained’, making it more difficult to identify the underlying causes and thus prevent diversion.
Mark Fan, Maaike de Vries and Patricia Trbovich of HumanEra, a research team based at North York General Hospital and the University of Toronto’s Institute of Health Policy, Management and Evaluation have been collaborating with Dorothy Tscheng and Michael Hamilton at the Institute for Safe Medication Practices Canada to investigate the main causes of drug diversion in Canada and safeguards healthcare facilities can put in place to prevent these acts.
What is known about diversion?
By analysing data from Health Canada, their study found that there were over 64,000 cases of loss of five common opioids: codeine, fentanyl, hydromorphone, morphine and oxycodone, between January 2012 and September 2017. The wholesale cost of these losses totalled almost $9 million CDN, and the estimated street resale value over $130 million CDN.
The predominant reason for losses varied between the type of facility. In community pharmacies, armed robbery was responsible for the majority of opioid losses, whilst in hospitals, the main cause was theft by healthcare workers. However, each type of facility, including manufacturing companies, also reported relatively large proportions of unexplained losses. In hospitals, over 33% of reported losses were categorised as unexplained, suggesting a general weakness in the ability of healthcare facilities to properly track and secure controlled substances, as well as implying shortcomings in the ability to investigate and analyse instances of drug loss. The prominence of unexplained losses also raises questions about the number of losses that may have gone undetected.
To complicate matters further, any organisation licensed to produce, package, sell or transport opioids is required to report any losses to Health Canada within ten days. However, inconsistent monitoring or enforcement of this mandate, alongside ambiguous options within the reporting form at the time this research was conducted, can lead to variable reporting amongst facilities. This variability can obscure the true quantity or value of the lost opioid. There is also no mandate to report losses to the police or insurance companies and as such, they are often not made aware of the losses.
News media and government reports describing diversion have typically reported losses in terms of ‘dosage units’ or ‘incidents of loss’, both of which have significant flaws. Dosage units report the loss in terms of quantities; however, these quantities are indiscriminate, e.g., the loss of one pill can be counted as the same as the loss of one whole bottle of pills. Incidents of loss ignores quantity and can be affected by the frequency with which reports are made, e.g., four losses noted in one report count as one incident, as opposed to the four incidents that would be logged if they were reported separately.
To counter the reporting limitations above and deepen the understanding of the scale of opioid losses in Canada, the research team instead counted the milligrams lost as reported in the Health Canada data to estimate the losses of the five opioids. This provides a complementary metric by which to grasp the true magnitude and economic impact of drug diversion. The analysis suggested that the lower bound for the average annual loss of the five opioids was almost 20 kilograms.
As the greatest drug losses were from community pharmacies over the study period, the research team suggested that introducing safeguards in these settings should be prioritised. Analysis of regional differences could provide helpful insight into practices that could be adopted nationally. For example, pharmacies in British Columbia showed a reduction over time in losses from robberies compared to pharmacies in the rest of Canada; this may be due to their use of time-delay safes to store controlled drugs.
Identifying diversion vulnerabilities in hospitals
Whilst community pharmacies may be inspected by Health Canada to assess compliance with reporting regulations, hospital inspections are not standardised between provinces. For example, Ontario and British Columbia have a pharmacy regulatory body that inspects hospital pharmacies, but this is not a requirement in all provinces and territories. As such, many hospitals in Canada may not have the necessary safeguards needed to detect drug diversion.
The research team also conducted a review of the literature surrounding drug diversions in hospitals and identified two key areas of weakness. The first was the falsification of clinical or inventory documentation, which gives the appearance of legitimate transactions and obscures diversion. Whilst this can be an active process – a healthcare worker may falsely report the amount of drug given to a patient – it is not always. For example, an automated drug dispensing system may continue to allow drug withdrawals for patients after they’ve been discharged. The second key area of weakness was a failure to maintain physical security of controlled substances, such as leaving drugs unattended or failing to restrict access to secure areas.
By recognising these weaknesses, the team was able to suggest appropriate countermeasures to restrict unauthorised access to controlled drugs. These included reducing delays to documentation updates, improving verification of transactions, using tamper-evident packaging and limiting the amount of controlled drug that can be accessed in the first place. Most important, these countermeasures need to be reinforced by an organisational culture that supports awareness that diversion occurs, and does not stigmatise, but rather assists healthcare workers who may be struggling with substance use disorder.
These are, however, by no means the only weaknesses that need to be addressed. Maaike DeVries, a PhD student with the team, led observations in two hospital in-patient pharmacies, two emergency departments, and a critical care unit to look for ways in which the management of controlled drugs may be vulnerable for diversion. The team identified vulnerabilities stemming from several system factors, including the tools and technologies being used, the ways in which tasks are conducted, and policies and practices of the hospital. These vulnerabilities either compromise the integrity of documentation or allow workers to inappropriately gain access to controlled drugs throughout the medication-use process. This includes steps from procurement and preparation in the pharmacy, to distribution to patient care areas, and finally dispensation and administration to patients, or disposal. This research provides the first comprehensive description of system-based weaknesses, highlighting where additional countermeasures are needed to guard against diversion.
The impact of hospital diversion
Drug diversion can have many implications beyond the loss of the drug itself. For example, if a healthcare worker self-injects an opioid, and replaces the dose with saline solution, not only are they providing care in an impaired state and risking patient safety, but the patient receives insufficient pain relief, and the use of contaminated syringes risks bacterial or viral outbreaks in the hospital. The implications for healthcare workers who divert are not only those associated with drug use, such as overdose and death, but also the loss of employment or license to practice and criminal prosecution. Furthermore, the burden of follow-up care for affected patients, internal investigations, the cost of the lost drugs, and compromised reputation falls upon the hospital. All of these implications add up and present public relations challenges, as well as risking an overall loss of public trust in the healthcare system.
To further Canadian hospitals’ understanding of their own vulnerabilities, HumanEra is partnering with the Canadian Society of Hospital Pharmacists Ontario Branch and the Institute for Safe Medication Practices Canada to develop an online platform that would allow Ontario hospitals to assess themselves on best practice to prevent diversions. They aim to make this available in 2021.
With the opioid crisis still as prevalent as ever in North America, elucidating the causes of drug diversion is crucial. This step informs the development and implementation of appropriate safeguards. Successful control of drugs not only reduces the burden of opioid morbidity and mortality, but also improves patient and health system safety.
The authors of this study would like to acknowledge BD-Canada Inc. and the Canadian Institutes of Health Research and thank them for their funding.
- de Vries, M. et al. (2020). Vulnerabilities for Drug Diversion in the Handling, Data Entry, and Verification Tasks of 2 Inpatient Hospital Pharmacies: Clinical Observations and Healthcare Failure Mode and Effect Analysis. Journal of Patient Safety [Online]. Volume Published online ahead of print. doi: 10.1097/PTS.0000000000000744
- Fan, M. et al. (2020). Opioid losses in terms of dosage and value, January 2012 to September 2017: a retrospective analysis of Health Canada data. CMAJ Open. 8(1), pp. E113-E119. http://cmajopen.ca/content/8/1/E113.full
- Fan, M. et al. (2019). Diversion of Controlled Drugs in Hospitals: A Scoping Review of Contributors and Safeguards. Journal of Hospital Medicine. 14(7), pp. 419-428. doi:10.12788/jhm.3228
- de Vries, M. et al. (2019). Clinical observations and a Healthcare Failure Mode and Effect Analysis to identify vulnerabilities in the security and accounting of medications in Ontario hospitals: a study protocol. BMJ Open [Online]. 9(6). https://bmjopen.bmj.com/content/9/6/e027629
Research led by North York General Hospital aims to understand the contributors to and safeguards against diversion of controlled drugs in hospitals, with a view to helping Canadian hospitals understand their vulnerabilities.
Canadian Institutes of Health Research
Mark Fan is the Research Manager of HumanEra, an applied human factors research team based at North York General Hospital and the University of Toronto.
Maaike de Vries is a PhD candidate in the Health Services Research program at the University of Toronto’s Institute of Health Policy, Management and Evaluation. Working with the HumanEra team at North York General Hospital, Maaike is studying vulnerabilities in the security and accounting of controlled substances in Ontario hospitals.
Dorothy Tscheng is the Director, Practitioner & Consumer Reporting & Learning at the Institute for Safe Medication Practices Canada. Dorothy oversees the analysis processes for both practitioner and consumer reporting programmes and is the editor of the ISMP Canada Safety Bulletins and SafeMedicationUse.ca consumer newsletters, both which share learning from analyses of medication errors.
Dr Michael Hamilton is the Medical Director at the Institute for Safe Medication Practices Canada. His work involves researching contributing factors to medication errors, with the goal of reducing preventable harm due to medications. He advises health care providers, administrators, policymakers, and legislators about issues in medication safety.
Patricia Trbovich is an Associate Professor in the Institute of Health Policy, Management and Evaluation at the University of Toronto and holds the Badeau Family Research Chair in Patient Safety and Quality Improvement at North York General Hospital. Patricia leads HumanEra, a group of human factors researchers dedicated to improving healthcare safety.