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October 31, 2006 |
JHQ 152 - Diversion of Controlled Substances: A Catalyst for Change
Kathy Hulse, BSN RN CPHQ; Liz Edmundson, BSN RN; Robin Carroll, MS RD LD
Keywords:
Impaired professional, Narcotic diversion, Patient safety, Quality of healthcare
September/October 2004
| A quality improvement team was formed in response to a controlled substance diversion by an employee. The team’s objectives were to track controlled substances throughout the institution and to design a system that would eliminate inappropriate access to controlled substances without negatively affecting patient care. The team utilized flow charts, staff interviews, and auditing tools to identify weaknesses within the current system. Subcommittees were formed to evaluate access and to develop an education campaign. It is the institution’s responsibility to keep patients and staff safe by designing, implementing, and monitoring systems to appropriately control access to controlled substances. |
Controlled substance diversion by healthcare professionals is an event many healthcare professionals believe could never happen in their institution. Most employees believe they know coworkers well enough and would be able to identify a substance abuser. Employees in pediatric settings appear especially naïve because of the misconception that a coworker would never intentionally withhold a child’s pain medication for personal use. However, drug diversion is more common than most people know. Approximately 15% of healthcare professionals will struggle with chemical dependency during their career (National Council of State Boards of Nursing [NCSBN], 2001). Nearly 30% of addiction problems begin with the abuse of a prescription drug (Briefings on Patient Safety, 2002). Stress and chronic illnesses, including migraine headaches, surgery, and back injury, are two of the main reasons why narcotics are diverted (Hospital Security and Safety Management, 1997).
Background
A well-respected employee was discovered diverting a controlled substance from a patient care area, so the hospital initiated an examination of its process of securing controlled substances, along with scrutinizing access hospitalwide. While these efforts were under way, the hospital was surveyed by the Joint Commission on Accreditation of Healthcare Organizations and received a recommendation related to the medication use standards. The following is an account of the corrective actions taken by the institution and the process used to implement these actions.
Children’s Mercy Hospitals and Clinics is a 241-bed tertiary care teaching facility with a 34-bed satellite hospital, outpatient clinics, and an affiliated home healthcare program. The hospital utilizes the Pyxis™ automated medication cabinet for dispensing controlled substances, and pharmacy services are available 24 hours a day at both campuses.
Multidisciplinary Team
A multidisciplinary, quality improvement team was formed to evaluate the security of controlled substances across all disciplines throughout the hospital system. The team included two representatives from the clinical medical staff, three nurse managers representing medical/surgical units, the surgery department, pain management services, director of pharmacy, and the chief information officer. The team was led by the senior vice president of patient care services, who also co-chairs the hospital’s Clinical Safety Program. Ad hoc members from risk management, human resources, education, and additional pharmacy staff served as team consultants. Two process improvement facilitators were assigned to the team, to assist with flow charting, data collection and management, and rapid team facilitation.
The team was given the task of evaluating areas in the hospital where controlled substances were stored, dispensed, or administered to determine current processes and identify any practice variations. In addition, the team’s mission was to design a system to eliminate inappropriate access to controlled substances without negatively affecting the quality of patient care. Because unsecured narcotics can be a danger to staff, patients, and their families, staff tracked the flow of narcotics through the following areas:
- pharmacy
- anesthesiology
- hematology/oncology
- clinic/dialysis
- toxicology
- research laboratory
- same day surgery
- operating room
- emergency department
- pediatric intensive care unit
- neonatal intensive care unit
- all medical/surgical units
- Children’s Mercy South Inpatient Unit
- home healthcare.
The team defined “controlled substances” as any drug with the potential for abuse, which included all Schedule II, III, and IV medications within the organization.
Flow Charting
To gain a better understanding of the movement of controlled substances throughout the institution, staff from identified areas were interviewed and flow charts developed (Table 1). Staff members were asked to identify examples of breaks in the current system of access to controlled substances. The interviews confirmed the team’s suspicions that the institution’s policies and practices regarding access to medication needed re-evaluation and strengthening. The flow-charting process identified areas where controlled substances were not controlled rigorously.
Medication Processes
A subgroup was formed to evaluate staff access to the Pyxis system and ensure accountability and security of individuals with access. The subgroup evaluated Pyxis access by job code and compared those data with current usage data. Following this evaluation, standard templates were developed by job code to ensure appropriate access was granted to new and current employees. This evaluation reduced Pyxis access from 1,800 to 1,120 employees. Physician access was restricted to medical staff in anesthesiology, emergency medicine, and medical residents during their rotation in the emergency department. Employees who require access to the Pyxis outside of the standard templates must submit a written request to their manager. The manager would then forward the request for consideration to the director of pharmacy. Access could not be changed until the manager and director of pharmacy approved the request.
Information systems staff assisted with restructuring Pyxis features to facilitate increased security. As a result, charge nurses no longer have the authority to refill narcotics without a second licensed provider as witness. Other changes to the system’s functionality included the following:
- Controlled substances too large for the return bin must be returned directly to the original Pyxis drawer with a witness.
- The automatic log-off time was decreased to 30 seconds systemwide to avoid employees obtaining access under a coworkers password after that coworker had left the room.
The Pyxis and medication process policies were revised to reflect the aforementioned changes and to provide standardization to the medication administration process. All nursing and pharmacy staff received education regarding the policy revisions. Patterson (2002) noted that it is key that institutions, when using Pyxis, remember that the machine is not a complete medication control system but rather a tool that is merely a part of that system.
Employee Tracking Mechanism
A system was developed with human resources, information systems, and security to facilitate timely notification of an employee termination or departmental transfer so that access to the Pyxis may be deleted or modified. The goal of this system is to ensure that only active employees, whose job code requires access to a specific Pyxis, have such access. Bogardus (Hospital Security and Safety Management, 2000) reports the most common problem, when automated dispensing systems are used, is failure to delete unauthorized users. Such an incident occurred at a major hospital where a nurse, terminated for drug diversion, returned 6 weeks later in a hospital uniform with identification badge and successfully obtained narcotics from a dispensing machine.
Most drugs are packaged for adults; therefore, there is almost always waste in pediatric drug dispensing (Hospital Security and Safety Management, 2000). The process of wasting controlled substances consumes time and resources. Most practitioners would agree that verifying the dose of a controlled substance prior to administration is a practice standard that should be upheld. But the second part of verification—verifying the remainder of the vial, ampoule, or syringe to be wasted—is a step identified as cumbersome and easily neglected by practitioners if they are too busy.
Controlled Substances in the Operating Room
An area of particular vulnerability in the institution, because of the large number of controlled substances administered daily, was within the department of anesthesiology. Although there was no known diversion or problem, the need to better secure controlled substances in the operating room was realized. A provider-specific lockbox system was developed and implemented. The box contains controlled substances, a beginning and ending inventory card, a place for storing remnant syringes to return to the pharmacy, and a log for tracking patient specific use of controlled substances.
At the beginning of each shift the anesthesiologist or certified registered nurse anesthetist checks out a lockbox—with a day’s supply of controlled substances—from the pharmacy. Patient stickers are applied to the inventory card, along with type and amount of medication administered and the amount of waste. The syringe is included in the lockbox. The lockbox is returned to the pharmacy where a pharmacist audits and validates waste and its contents. This new process was incorporated into the management of controlled substances in anesthesia policy by members of the department of pharmacy and anesthesiology.
Medical Record Audits
The nursing controlled substance audit (Table 2) was developed from the medication process policy as a means to measure current practice. Originally, the team was searching for a pattern of diversion similar to the method used by the aforementioned nurse. It became clear that the current practice for documentation of waste, which included a second registered nurse’s signature and the exact amount administered, was not consistent with the institution’s standards, nor did it meet Joint Commission standards.
The initial audit evaluated documentation of controlled substances administered for a 2-month period for all inpatient units. To preserve confidentiality, a unique identifier was assigned to each nurse, which was not blinded only to the individual conducting the audit. Each dose that was removed from the Pyxis was compared to the medication administration record to validate that the medication was ordered for the patient and that the medication was documented as given. No evidence of diversion was found. However, the results of the initial audit demonstrated a need to update the institution’s policy and improve documentation practices.
This audit was repeated 6 months after the initial audit for 4 random days on a unit where controlled substances were used on a moderate basis. A total of 335 doses of controlled substances were evaluated. Of the 335 doses evaluated, 44 doses were removed from Pyxis by a nurse other than the nurse assigned to the patient. All doses were appropriately documented with the exception of one, which was not evaluated because the medical record was not available.
This audit tool has now been incorporated into the nursing quality improvement program. Originally the nurse managers were asked to perform this audit four times a month; however, the team found that this process was too labor intensive. The current expectation is that an audit will be performed once a month for a 24-hour period. Criteria were developed for the selection of days to audit to ensure a random audit. The team believed it was important that the nurse manager perform the audit rather than a staff nurse who administers controlled substances. Data obtained from the audit are forwarded to the quality improvement department for input into a database for evaluating trends, and reports are sent to the department managers for evaluation.
General Anesthesia
An additional audit to monitor the newly developed anesthesia process was performed. The remnant syringe waste evaluation process began with the initiation of the controlled
substances lockbox exchange. A pharmacist verifies beginning-of-the-shift controlled substances inventory with the ending inventory and any remnant waste syringes. In the first quarter, following the new process, a total of 11 out of 2,056 cases, or less than 1% of remnant syringes, had a noted discrepancy. All the lockbox discrepancies were witnessed either by another anesthesia provider, a nurse, or
a pharmacist. There were no unresolved discrepancies. For this reason the department of anesthesiology has modified the audit process, eliminating the evaluation of remnant waste.
Any audit is limited in that it will only identify one of many methods used to divert controlled substances. In addition, it is essential not to inform the staff about the nature of the audit. A clever diverter could quickly change the method of diversion to avoid detection. Bogardus (Briefings on Patient Safety, 2002) recommends frequently auditing drug-tracking systems before a problem is identified. Important points to look for while conducting an audit include the following:
- Verify that the physician ordered any drugs that were “administered” to a patient.
- Ensure that the nurse noted an injection if a drug was ordered.
- Understand that manual charting systems are easier to tamper with than automated systems.
- Look for inconsistencies.
- Beware of who administers pain medications. Problems may result, if a single clinician administers all the medications.
Education
Manager
As with any change process, writing policies and procedures, to identify optimal behaviors is the easy part. Educating staff about changes in policies and procedures and then ensuring the policies and procedures are put into practice as written is the challenge. Team members met with inpatient and outpatient managers to keep them informed and solicit comments. The results of chart audits, changes in the termination clearance form, and the grand rounds education were discussed. Policy changes were reviewed with the managers who then were asked to discuss them with staff. A video was purchased as a resource, to aid patient care managers in achieving staff compliance (NCSBN, 2001).
Staff
A second subgroup was formed to develop a hospitalwide education campaign to educate employees about the signs of substance abuse and resources available for treatment. Staff ability to recognize and report suspicions about a coworker’s addictive behaviors is key to early detection, treatment, and rehabilitation for the employee (Briefings on Patient Safety, 2002). The goal of the education program on chemical dependency was to reach the entire spectrum of hospital employees, recognizing that chemical dependency in any employee could affect the quality of care provided to patients.
A special summer grand rounds presentation was developed as a three-part series featuring well-respected institution leaders, The Professional Renewal Center, Missouri Physicians Health Program, and New Directions: An Employee Assistance Program. The foundation for the education program was modeled after material published by the National Council for State Boards of Nursing. Caring, understanding, and a deep desire to rehabilitate and retain the employee was the overall message.
The subgroup anticipated that low employee attendance could be a problem. Several proactive steps were implemented to encourage attendance by employees including the following:
- involvement of leadership personnel including senior vice president of patient care services, director of medical services/medical staff compliance, vice president/general counsel, and the employee relations manager
- strategically placed signs advertising the program
- hospitalwide e-mails announcing the content of the program
- continuing education credit offered.
As a result, sessions were well attended. A total of 421 staff attended the grand rounds presentations during the 3 days they were offered. All sessions were videotaped for the future development of an online tutorial on chemical dependency and for use in leadership development classes to educate managers and supervisors on how to assist a chemically dependent employee. A personal disclosure by a current member of the medical staff regarding his previous struggle with substance abuse during the grand rounds presentation was of particular value. It made it clear to staff that, with professional help, employees may continue to contribute to the professional careers that they have worked so hard to develop.
Supportive Environment
The quality improvement team believed that the institution’s best line of defense for preventing controlled substance diversion is an educated employee who is aware of the signs of addiction, and who is not afraid to approach a fellow employee in need of help, or who reports his or her suspicions to a manager. The overall message of the education campaign was to convey concern for the impaired health professional and to identify available resources for treatment. The team’s goal was to prevent a tragic event while retaining quality professionals. This pro-treatment approach is often more successful in the recovery of an employee than termination. A punitive system may create barriers to disclosure and keep staff from seeking help for treatable medical conditions. Early detection of an addiction may improve treatment outcome (Briefings on Patient Safety, 2002).
Four months after the grand rounds presentations, an additional educational effort was published in the hospital’s newsletter. The article reiterated the warning signs of substance abuse including the content contained in the three-part educational program and resources available for employees.
This hospital promotes a culture of caring and even offers an employee assistance program to help employees handle a wide range of challenges including chemical dependency. In 2001–2002, 8%–9% of staff sought help with only two of the cases related to drugs or alcohol. Interestingly, in the 3-month period that included the grand rounds program, utilization of the employee assistance program increased and included three alcohol-related cases (New Directions Employee Assistance Program, 2003).
Conclusion
This hospital will continue to make efforts to design and monitor systems to appropriately control employee access to controlled substances. One way of ensuring success is to identify ownership of the monitoring process. The continued surveillance of Pyxis access and auditing Pyxis activity has been incorporated into the quality improvement coordinator’s responsibilities. The chief of anesthesiology and the director of pharmacy are responsible for monitoring the lockbox process and evaluation of remnant syringes. Unfortunately, the theft of controlled substances will not be completely eliminated and impaired staff will adapt diversion techniques as various processes to restrict access to controlled substances are implemented. However, institutions must remain diligent at finding system pitfalls that allow diversion. It is the institution’s responsibility to keep patients and staff safe by designing, implementing, and monitoring systems to appropriately control access to controlled substances.
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Author's Biography
Kathy Hulse is a quality improvement coordinator at Children’s Mercy Hospitals and Clinics in Kansas City, MO.
Liz Edmundson is the nurse manager for Sedation and Pain Management Services at Children’s Mercy Hospitals and Clinics in Kansas City, MO.
Robin Carroll is the director of nutrition services and research at Children’s Mercy Hospitals and Clinics in Kansas City, MO.
For more information on this article, contact Kathy Hulse by phone at 816/802-1278 or by e-mail at khulse@cmh.edu.
References
An interview with Donald E. Bogardus on dangerous new trends in drug diversion. (1997, May). Hospital Security and Safety Management, 18(1), 12–14.
Briefings on patient safety. (2002). Marblehead, MA: Opus Communications.
Hospital security and safety management. (2002). Washington, DC: Rusting Publications.
National Council of State Boards of Nursing (NCSBN) (Producer). (2001). Breaking the habit: When your colleague is chemically dependent [Motion picture]. (Available from the National Council of State Boards of Nursing, Inc., 676 N. St. Clair Street, Chicago, IL 60611).
New Directions Employee Assistance Program. (2003). Children’s Mercy Hospital/EAP utilization report. (For period starting 05/01/2002–04/30/2003). Kansas City, MO: Author.
Patterson, C. (2002). How must we secure anesthesia drugs? QR Manager, 18(1), 26.
Objectives
Core CPHQ Examination Content Areas
I. Management and Leadership
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