Every hospital is a potential target for drug diversion due to the number of controlled substances prescribed on a daily basis. As such, the pharmacy should look to implement a comprehensive controlled substances compliance program, driven by useful automation and technology solutions, to curb medication abuse. No less important is assigning an individual to oversee the program and to make sense of the data provided by the systems in place.
University of North Carolina Medical Center (UNCMC) is an 803-bed, highly automated facility that is part of the UNC not-for-profit, integrated health care system. Prior to 2012, UNCMC utilized a variety of tools to analyze discrepancy data and detect possible diversion, including an EHR; an ADC Web-based data management system; desktop databases; a controlled substance safe; an analytic platform; admission, discharge, and transfer software; and software that creates an integrated platform for pharmacy systems, but centralized management of controlled substance tools was lacking. While robust technology and automation are useful to monitor controlled substances and detect diversion, these tools cannot interpret data and enact process improvements. In an effort to achieve a safer, more accountable, and better regulated environment for patients and employees handling these products, the UNCMC pharmacy department implemented a controlled substances coordinator (CS coordinator) position in 2012 to ensure a comprehensive approach to managing these products hospital-wide.
Developing the CS Coordinator Position
Initially, the coordinator responsibilities were assigned to a sterile products pharmacist who devoted only 25% of work time to controlled substances duties. The need for an FTE devoted exclusively to controlled substances analytics was realized by the end of the fiscal year. A full-time CS coordinator position was justified and then recruited from inside the organization. The coordinator now reports directly to the assistant director of acute-care operations, who oversees automation and technology, controlled substances, and inpatient pharmacy operations. The CS coordinator additionally serves a wide range of pharmacy divisions, including business intelligence, medication safety, and regulation and compliance. The regular activities of the CS coordinator vary from day to day, but the core responsibilities remain constant and include:
- Evaluating unresolved discrepancies (including those outstanding after 12 hours)
- Auditing controlled substance systems
- Assuring compliance with established policies and procedures (P&Ps) in all areas of controlled substance distribution and administration
- Assisting clinical managers in identifying expectations with controlled substances
- Preparing monthly compliance and trend reports
- Proactively monitoring for drug diversion
- Assisting with investigation of suspected cases of controlled substance diversion
- Developing routine and ad hoc audits and interactions with nursing and anesthesia departments
(See SIDEBAR for characteristics of an ideal CS coordinator and TABLE 1 for tips for novice CS coordinators.)
Evaluating Controlled Substances Discrepancies
All ADC discrepancies involving controlled substances must be resolved by the user within 12 hours of shift time for individuals or business hours for clinics. If a discrepancy on the inpatient floors is not resolved within this time frame, the nurse manager is responsible for filing a case against the user(s) involved. Once a case is filed, the hospital police compose an investigational report comprising the details of the discrepancy as described by the nurse manager and staff involved. There are approximately 40 discrepancies weekly, with only one or two remaining unresolved outside the 12-hour requirement.
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Both ADC and EHR activities, as well as the investigational report, are then reviewed and verified by the CS coordinator. Data should be validated on an individual basis for each discrepancy to ensure accurate records. Discrepancies may be due to errors in the ADC data entry system or to the way the data are accessed by the user; regardless, all discrepancies should receive full and careful attention. Consider the situation wherein two orders of as-needed oxycodone (for two different conditions) appear in the patient’s ADC profile. A discrepancy will be created if the nurse does not document on the order the correct condition for which the oxycodone was vended from the ADC. In this scenario, conducting a history and trend analysis on the user and their medication usage is the only way to identify or resolve a true discrepancy.
If no evidence of diversion exists in the ADC or EHR data, the case is closed. If incriminating evidence is found, the CS coordinator and nurse manager pursue the matter further by performing a more detailed analysis, ie, exploring the behavior patterns of the suspected diverter. In addition, the hospital police may decide, based on the available evidence, to investigate the matter further. Depending on the severity of the offense, the assistant pharmacy director also may become involved in the investigation.
It is imperative to communicate the circumstances of the investigation to police, as they may be able to provide helpful information from previous cases involving the user under investigation. Keep in mind that patient information may be provided to the police as long as it conforms to the Health Insurance Portability and Accountability Act (HIPAA) and organizational policies.
Controlled Substance Audits
Controlled substance audits are conducted in areas as diverse as inpatient acute care units, operating rooms, and clinic procedure areas; thus, a thorough understanding of all controlled substance systems in the clinical areas that dispense and administer these products is critical. The CS coordinator completes routine audits, including surveillance of inpatient and outpatient controlled substance management systems, as well as ADC and EHR transactions (see TABLE 2). UNCMC has approximately 50 ADCs in ambulatory clinics, 180 in inpatient settings, and three controlled substance management systems. The CS coordinator completes audits of (1) controlled substance management system transactions, (2) controlled substance management system vs ADC transactions, (3) ADC-specific transactions, and (4) ADC vs EHR MAR transactions.
- Controlled substance management system transactions include transactions of controlled substances that are dispensed with a receipt (patient-specific or compounded controlled substances), items pre-packed to unit dose from bulk bottles, or those dispensed for non-ADC locations
- Controlled substance management system transactions are reconciled to ADC transactions on a daily basis. Some circumstances mandate that transactions be reconciled manually on a monthly basis, ie, unscannable bar codes, missing patient information, and misplaced delivery sheets
- Using standard deviation reports, ADC-specific transactions are audited and monitored at least monthly for anomalous usage. If issues arise during surveillance, the CS coordinator is responsible for following up with appropriate nurses, pharmacists, safety officers, or managers
- ADC-EHR reconciliation is a more difficult undertaking that requires spreadsheet manipulation. Cycled ADC-EHR reconciliation audits for specific areas are performed quarterly on ADCs by comparing EHR documentation, entries into automated controlled substances (eg, vends, transfers, wastes, etc), and manual accounting records for scheduled drugs
Gaining Multidisciplinary Support
When the CS coordinator position was first implemented at UNCMC, the clinical manager of controlled substances and sterile products introduced pharmacy and nursing managers to the coordinator and presented a framework for the audits along with expected timelines. To gain hospital-wide buy-in, it is vital to create awareness about the importance of effective diversion prevention and the necessity of following federal, state, and organizational rules and regulations. Formal meetings with medical and pharmacy representatives and nurse directors and managers may be necessary to accomplish this task. Offering useful reports may make attending such meetings more palatable for department representatives. For example, at UNCMC, the CS coordinator prepares a usage trend report that identifies possible drug diversion, demonstrating the overall performance and benefit of the controlled substance systems for nursing and pharmacy leadership. Maintaining Compliance
An understanding of organizational requirements and federal and state laws is essential, as these regulations form the basis for maintaining compliance. Moreover, a robust understanding of compliance requirements is necessary for developing effective P&Ps. UNCMC controlled substance-related P&Ps were developed by the CS coordinator in collaboration with the clinical manager of controlled substances. Although a designated pharmacy compliance specialist typically manages P&Ps, the process for updating them involves the area clinical manager, CS coordinator, and the pharmacy compliance specialist. Establishing a streamlined working relationship between all members of the quality, regulatory, and compliance team is fundamental to maintaining compliance with P&Ps.
Tools for Identifying Diversion
When analyzing discrepancy data, it is important to not rely on a single source for diversion information, but rather to compile data from a variety of tools. The ADC data management system has become the foundational tool for controlled substance diversion reporting at UNCMC. We find the detailed transaction and diversion watch list reports most useful, and they have been modified to include appropriate site-specific adjustments, such as stratifying practice sites into profiled ADC, non-profiled ADC, and automated anesthesia carts within the ORs. With this tool as the backbone of our diversion-detection efforts, we added a controlled substances safe that is integrated with our ADC Web-based data management system. Custom reporting is an important tool we have explored; however, it requires significant maintenance and is subject to disruption, as access to data sources can be altered when software upgrades are required. Thus, vigilance is necessary to ensure that reporting tools capture the correct data.
One of UNCMC’s projects in development is a novel effort to integrate ADC, EHR, purchasing, and accounting data feeds into a single enterprise data warehouse. This innovative approach will allow us to develop, further automate, and schedule diversion detection analytic techniques through our analytic platform, thus assisting in identifying discrepancies across these systems and throughout the medication-use process. A first-use for this software will be reconciling anesthesia intra-operative, EHR-based administration data with ADC vend transactions.
Although the CS coordinator position has been well received, there is room for improvement. Moving forward we plan to develop more automated, routine audits for acute and ambulatory care; better utilize software that has the ability to pull data from the entire medication-use process; and improve our capacity to provide regular, structured, high-level reports with meaningful dashboards and score cards. Finally, as UNCHC has grown to eight hospitals, we aim to continue to build relationships with supply chain, operational, and clinical managers across the UNC health system to optimize drug diversion analytics facility-wide.
Adam S. Wolfe, PharmD, MS, BCPS, is the pharmacy business intelligence and data analytics coordinator at the University of North Carolina Medical Center (UNCMC). He received his Doctor of Pharmacy from the University of Utah College of Pharmacy and his MS in health-system pharmacy administration from the University of North Carolina Eshelman School of Pharmacy.
Srilaxmi Musunuri, BS Pharm, MS, is the controlled substances coordinator at UNCMC. She received her BS Pharm from Dr. MGR Medical University, Chennai, India, and an MS in cell biology and biotechnology from University of the Sciences in Philadelphia.
Daniel P. O’Neil, PharmD, BCPS, is a PGY2 health-system pharmacy administration resident at UNCMC and is currently completing his MS in health-system pharmacy administration at the University of North Carolina Eshelman School of Pharmacy. He received his Doctor of Pharmacy from Lake Erie College of Osteopathic Medicine.
Chad J. Hatfield, PharmD, MHA, BCPS, is the assistant director of acute care operations at UNCMC. He received his Doctor of Pharmacy from Oregon State University and his Masters in Health Administration from Simmons School of Management.
The CS Coordinator Position
Ideally, the CS coordinator should have experience and an interest in medication and patient safety, pharmacy regulation and compliance, and pharmacy analytics. Success as a CS coordinator is contingent on being open to new technology, willing to accept change, and able to create process improvements. In addition:
- Because data must be presented to diverse audiences, such as security personnel, nurses, managers, pharmacists, and physicians, the ability to build a network and communicate effectively cannot be underestimated.
- Depending on the reporting structure of the CS coordinator position, presentation skills may be necessary to address audiences ranging from staff to high-level hospital executives.
- In addition to running detailed, analytical reports through various hospital information technology systems, the coordinator also must possess strong analytical skills.
- Understanding the workflow of nurses and pharmacy technicians is essential to identifying false positives and negatives during the auditing process.
- Organizational skills are essential to conduct continuous controlled substances audits, as the CS coordinator at UNCMC is responsible for coordinating with five pharmacy department employees involved in controlled substance monitoring.
- A successful CS coordinator should be able to interact with, manage, and utilize other pharmacy department resources to achieve a safer environment for the patients and employees handling these products.
Case Example of Diversion Investigation
A user was flagged during a quarterly audit for vending large doses of morphine from the ADC in an outpatient clinic. These vends were not consistent with nursing administration from the EHR. The CS coordinator provided this information to the charge nurse, who determined that the nurse was caring for a patient with sickle cell anemia, and the nurse did not record waste correctly.
This experience demonstrates the need for clear, direct interdisciplinary communication and effective training. The charge nurse addressed this issue by reviewing the policies and procedures with staff.
The Systems Scoop
Technologies and automation solutions used at UNCMC for diversion monitoring include:
- Epic Systems Corporation’s MAR
- Epic Systems Corporation’s EHR Reporting Workbench
- CareFusion’s Knowledge Portal
- Microsoft Access
- Microsoft Excel
- CareFusion Corporation’s CII Safe System
- SAP AG’s BusinessObjects
- ALERT Life Sciences Computing’s Admission Discharge and Transfer (ADT)
- AmerisourceBergen Technology Group’s RxWorks
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
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