The far-reaching impact of the opioid epidemic has become a major challenge for health systems across the nation. Due to the stressful nature of health care workers’ job responsibilities, as well as their extensive access to controlled substances, they may be more likely to misuse medications than the general public. It is estimated that 10% to 15% of health care workers will misuse alcohol or drugs at some point in their careers, and they are more likely to use opiates and benzodiazepines compared with other medications1 (see the SIDEBAR for information about the serious repercussions of diversion2).

Diversion by health care workers is an ever-present reality in health systems, and as such, prompts intense regulatory scrutiny. For example, diversion has spawned multiple DEA audits, which have resulted in significant fines and detailed corrective action plans to remedy inadequate monitoring and oversight of controlled substances.

To prevent diversion, health systems must invest in detection strategies, technologies, and automation. The Brigham and Women’s Hospital (BWH) pharmacy is continuously seeking to improve current processes to manage controlled substance diversion and monitoring; one recent improvement was the implementation of an electronic inventory management system in the hospital’s outpatient pharmacies.

Because diversion schemes are often complex, an investment in robust technology and automation is necessary to detect and address health-system diversion. While many health systems have focused their energies on identifying and preventing diversion in inpatient areas, equal diversion-prevention efforts must take place in the outpatient environment. It is important to recognize that preventing diversion in the outpatient setting oftentimes requires unique considerations compared with the inpatient areas.

Challenges with a Manual System

BWH, an 800-bed tertiary academic medical center affiliated with Harvard Medical School, operates an inpatient pharmacy as well as three outpatient pharmacies, which dispense prescriptions to discharged patients, hospital outpatients, and BWH employees. The BWH outpatient pharmacies dispense more than 120,000 prescriptions annually; approximately 10% of these are controlled substances.

State regulations require that a perpetual controlled substance inventory be kept on a weekly basis. Historically, the outpatient pharmacies employed a paper log to track controlled substances. However, dispensing and managing inventory manually was time consuming, made it difficult to locate information during investigations, and was rife with the potential for human error. Moreover, tracking miscounts, illegible handwriting, and forgotten paperwork made it increasingly difficult to investigate potential diversion.

With a heightened awareness of the opioid epidemic, as well as the risk of health care worker diversion, it became critical to implement an automated system to track all the transactions associated with controlled substances within the outpatient setting. Such a system could reduce the risk of diversion by centralizing transactional data across our pharmacies. In addition, automated oversight provides a comprehensive audit trail and full accountability of drug movement by user through patient-specific dispenses.

An Automated Solution

Since 2013, BWH has utilized an automated controlled substance manager (CSM) for all distribution of controlled substances in the inpatient pharmacy. The inpatient CSM allows for the track and trace of all controlled substance transactions as they are removed from the pharmacy inventory and moved to other areas of the hospital, such as the automated dispensing cabinets, clinics, provider offices, and satellite pharmacies. This provides a closed-loop system, which increases the accountability and adjudication of controlled substances. The expansion of the electronic inventory management system in the outpatient pharmacies in 2016 required minimal vendor involvement, as we were already familiar with the CSM processes in the inpatient setting. The outpatient and inpatient pharmacy teams collaborated to determine cabinet configuration and par levels and to establish staff training, which was based on newly developed policies and procedures.

Cabinet Configuration and Par Levels

Once the appropriate locations were determined for the CSM cabinets in each of the three outpatient pharmacies, the next step was to establish cabinet configuration. Current outpatient purchase histories were reviewed along with dispensing reports to first determine appropriate par levels, and then plan the specific configurations within each cabinet.

Careful review of fast-moving items helped govern where medications would be located within the cabinet to streamline daily workflow. The inpatient electronic database was used to create and map out current outpatient inventories. We also conducted a physical count of inventory on hand to confirm the counts on the paper logs.

Control level also impacted physical location assignment. CII federally controlled substances were located in separate sections within the cabinet from the CIII-CV medications. With this configuration, access can be limited within the system by user type; we also limit user access by site.

Staff Training

To underscore the importance of staff training, users are not permitted to access the CSM until their training is completed.

As part of the CSM rollout, a policy and procedure document was developed. Staff members are required to view the document and then are shadowed by a manager or a superuser to ensure they understand how to manage the inventory and utilize the CSM correctly. We also created a training checklist that all users are required to complete prior to being granted CSM access. To maintain tight inventory control and limit the number of users overseeing controlled substances, a single pharmacy team member is assigned the task of managing controlled substances. This team member varies based on satellite location and could be a pharmacist, certified pharmacy technician, or a registered pharmacy intern.

The Outpatient Setting

Because the retail setting differs substantially from inpatient operations, there were several unique factors we had to consider in automating controlled substance management in the outpatient pharmacies.

For example, we needed to create manual generic sequence numbers. The entries in the CSM are based on a generic sequence number (GSN) that is linked to our EHR. In the outpatient setting, both brand and generic drugs are linked to the same GSN. Because the CSM only allows one entry per GSN, this results in both brands and generics and all manufacturers being linked under a single entry. To separate the products, we created manual GSNs for each entry in the CSM.

In addition, we required a strategy for adding new and missing items into the CSM. After the initial configuration was established, we conducted a review for any items that were missed. Any missing medications or medications that are new to the market, but are not used in the inpatient setting, required an EHR build so the medications could be added to the CSM. This process required approximately 1 week to complete.

The addition of the CSM requires that approved pharmacy staff sign into the cabinet before verifying inventory. In addition, two users cannot simultaneously fill a prescription, which can increase turnaround time. However, we firmly believe that the increased turnaround time is justified by the better reporting and tighter security provided by the CSM.

Finally, be sure to allocate sufficient space for the CSM. BWH chose to maximize cabinet size to account for future growth. To accommodate the larger footprint of the CSM system (height 77.5 inches x width 76.5 inches x depth 27 inches), the outpatient pharmacy was reconstructed. Also, remember to include space for installation of a computer terminal and printer dedicated to the CSM.

Results

With an automated system for managing controlled substances in the outpatient setting, BWH now has robust oversight of controlled substances, improved reporting capacity, accurate inventory management, and efficient auditing.

Because the system is used at all three outpatient pharmacies, we are able to maintain centralized oversight of controlled substances throughout the health system. Every action a user takes is tracked in the CSM, resulting in increased accountability. Moreover, a manager can run reports remotely based on a variety of factors over a wide date range and convert this information into a spreadsheet to facilitate review. The improved reporting also allows for effective inventory management. Each GSN has a set minimum and maximum quantity on hand and the purchaser receives a biweekly report with a recommended purchase order based on these numbers. As medication demands fluctuate, the manager can run a report to identify usage changes and then adjust the par levels to ensure the correct quantities are ordered.

In addition, the CSM eliminates the possibility of an inventory counting error. When a user fills a prescription, the CSM prompts the user to provide the quantity on hand, which is automatically calculated. If the user dispensed the wrong number of pills, this discrepancy will be identified at the next fill, rather than have the error persist in the manual paper log.

In the event of a discrepancy or audit, the pharmacy may be required to refer back to its biennial inventory to account for all transactions. The BWH pharmacy has a team of technicians dedicated to controlled substance auditing. Utilizing the CSM allows the team to audit efficiently without having to reconcile paper records and separate by type of transaction.

Overall, BWH is quite satisfied with the security and maintenance of controlled substances as provided by our CSM. Further integration between the internal outpatient pharmacy software systems would enhance the closed-loop system.

References

1. Baldisseri MR. Impaired healthcare professional. Crit Care Med. 2007;35(2 suppl):S106-S116.
2. Schaefer MK, Perz JF. Outbreaks of infections associated with drug diversion by US health care personnel. Mayo Clin Proc. 2014;89(7):878-887.

Amrita Chabria Shahani, PharmD, MS, is the manager of the outpatient pharmacies at Brigham and Women’s Hospital (BWH) in Boston, Massachusetts. She received her PharmD from Northeastern University, an MS from University of Houston, and completed residency training at St. Luke’s Episcopal Hospital in Houston, Texas.

Angela Triggs, RPh, has worked at BWH for 29 years in various roles, including perioperative staff pharmacist and supervisor, as well as her current role as the operations manager for central pharmacy distribution. She is responsible for controlled substances and automated dispensing cabinet operations. Angela received her BS in pharmacy from the Massachusetts College of Pharmacy in 1991.

Caryn Belisle, BS Pharm, RPh, MBA, is the director of pharmacy regulatory compliance, quality, and safety at BWH. She has served as president of the Massachusetts Society of Health-System Pharmacists (MSHP), and presently serves on the House of Delegates for the American Society of Health-System Pharmacists.