Proactive risk assessment of vulnerabilities for diversion of controlled substances in Ontario hospitals
Event Type
Oral Presentations
TimeWednesday, April 143:30pm - 3:50pm EDT
LocationHospital Environments
A growing number of controlled substances (CS) (i.e., opioids and other drugs with higher-than-average potential for abuse or addiction) are going missing or being stolen from Canadian hospitals. The theft of medications for personal substance use or trafficking is described as ‘diversion’, as drugs are diverted from legitimate medical use to non-medical use. It is increasingly recognized that hospitals lack robust processes, tools and technologies to detect and investigate incidents of diversion. However, few studies have explored the hospital medication-use processes (MUPs; e.g., procurement, storage, preparation, prescription, dispensing, administration, reconciliation, waste, return, removal) to identify the specific vulnerabilities that increase the potential for diversion.

Improving diversion prevention and detection is important because of the harm diversion causes to hospitals, patients and individuals who divert. The impact of diversion on hospitals includes the costs of lost drug and internal investigations and loss of public trust. Diversion impacts patients by putting them at risk of receiving inadequate care (e.g., does not receive analgesia because saline is substituted for an opioid) or causing harm (e.g., contracts a viral infection from a syringe compromised due to tampering). The individual who diverts can be subject to the harms of a substance use disorder, and access to CS increases their risk of morbidity and mortality associated with drug use. Other repercussions may include losing their job, having their license suspended or being criminally charged.

Hospitals have a responsibility to ensure the safe management of CS. There are several system factors (e.g., task/procedural, organizational, environmental, technological) which can increase or decrease the risk of diversion in a hospital. Human factors embraces this system complexity and provides a framework and methodology for studying diversion from a system perspective. Further research into the vulnerabilities in MUPs is needed to better understand hospital diversion and inform efforts to safeguard against it.

Study Objectives
The objectives of this study are to 1) understand the security and accounting of controlled substances throughout hospital medication-use processes, 2) identify vulnerabilities and existing safeguards, and 3) proactively identify opportunities for improvement.

Study Methods
We conducted a qualitative descriptive study comprised of two parts: Clinical observations and a Healthcare Failure Mode and Effect Analysis (HFMEA).

Clinical observations: The purpose of the observations was to obtain a detailed understanding of the typical tasks and responsibilities of hospital workers, as well as technologies and procedures related to MUPs. We conducted clinical observations in five units (one intensive care unit, two emergency departments, and two inpatient pharmacies) within two large hospitals in Toronto, Ontario. We recruited participants who had a role in at least one component of a MUP. The observations consisted of following participants as they carried out their daily activities. Observers took free-form notes and photographs of the environment, technology and supplies. Recruitment of participants and observations continued until the main tasks in the unit were observed and the work environment was suitably described. We transcribed notes from 223 hours of observations (41 participants) and uploaded them into MAXQDA© data management software, where they were organized and coded to be used as inputs for conducting the HFMEA.

HFMEA: The purpose of the HFMEA was to proactively identify and evaluate failure modes in MUPs and identify opportunities for improvement to the accounting and security of CS. We followed the standard HFMEA approach described by deRosier et al (2002). We used information from the observations to map process flow diagrams for each MUP task observed in the clinical units. We brainstormed potential methods of CS loss (i.e., failure modes) and scored them according to their probability and severity (i.e., hazard score). We then used the HFMEA decision tree to identify a priority set of critical failure modes (CFMs). CFMs from each unit were organized according to hospital site and MUP task from which they were identified. We looked for similarities and differences in CFMs within and between the sites, as well as identified common characteristics.

Preliminary Findings
In this proposal, we outline preliminary results from the inpatient pharmacies and emergency departments. For the HFES meeting in April 2021, we will present results from all of the observed units.

Emergency departments: We identified 28 CFMs from six MUPs: ordering CS for patients, dispensing CS from ADCs, preparing CS for administration, administering CS to patients, wasting unused CS, and returning unopened and unused CS. We categorized CFMs by their effect on diversion risk: a) gaining or increasing access to CS, b) compromising the integrity of documentation, c) or both. Twenty-nine per cent (8/28) of CFMs are failures that enable individuals to gain access to CS or access to an increased amount of CS which could be pilfered (e.g., dispensing a larger quantity of CS or substituting CS with saline before administering). Forty-three per cent (12/28) are failures that compromise the integrity of documentation which impairs the ability to trace the inventory or chain of custody of CS and obscures the detection or investigation of diversion incidents (e.g., forging CS orders or falsifying the amount of CS administered). The remaining twenty-nine percent (8/28) are CFMs that impact both access to CS and compromise documentation.

Inpatient pharmacies: We identified 34 CFMs within four MUPs: procurement of CS, receiving CS deliveries to the pharmacy, unit-dose packaging CS oral solids, and distribution of CS to patient care areas. Three categories of failure modes emerged while analyzing the CFMs. Eight (24%) CFMs in the pharmacies were related to handling tasks. Handling tasks are those where CS are being transported or left in holding areas until the next task takes place, which leaves the CS vulnerable to theft, tampering or substitution. Thirteen (38%) of CFMs were related to data entry tasks. Data entry tasks are those that involve entering or programming information electronically or recording information manually, which creates opportunities for forgery or hiding discrepancies in inventory. The remaining 13 (38%) of CFMs were related to verifying tasks. Verifying tasks involve having a second individual or using a technology to verify the work of another staff member, and if not conducted properly, can impact the integrity of the medication and accuracy of documentation.

Significance and Value
Clinicians should be aware of the threat of diversion within the hospital and their care areas, particularly of the possibility of impaired health care workers treating patients or of patients not receiving medications as ordered. We provide a prioritized set of vulnerabilities that hospitals should address to prevent diversion and mitigate its harmful impact on patients, healthcare workers and the hospital.

The study furthers our understanding of diversion as a systems issue, whereby vulnerabilities stem from failures not only by individual actions, but in the interaction between system factors. This understanding provides a framework for Canadian hospitals and regulating bodies who require guidance on how to configure tasks, technologies, environments, policies and staff training to prevent and detect diversion.

The novelty of our study approach will be of interest to researchers, given our application of HFMEA across multiple sites, as well as its use to identify failure modes in a process where individuals intentionally behave in ways that increase the risk of the failure (i.e., diversion of CS).