Click here to download Sample Policies and Procedures for the INVESTIGATION AND REPORTING OF DRUG DIVERSION
Regulatory agencies surveying hospitals have high expectations of pharmacy departments when it comes to monitoring the use, and potential diversion of, controlled substances. To meet those expectations, facilities should require internal audits to help identify clinicians with unusual dispensing patterns that might be indicative of diverting controlled substances. When unusual patterns are identified the challenging work begins—investigation, and in cases of proven diversion, confronting the diverter and reporting these events to the appropriate agencies.
Palomar Pomerado Health is a public hospital district in northern San Diego County, California, that includes the 319-bed Palomar Medical Center in Escondido and the 107-bed Pomerado Hospital in Poway, as well as two long-term care facilities. The hospital district has had a very clear policy regarding the inappropriate use, possession, and/or sale of alcohol, drugs, and other substances that can adversely affect an employee’s job performance and patient safety. However, a policy defining the procedure for monitoring controlled substance medication use, and the process for investigation and reporting of proven incidents of diversion, was not in place. Pharmacy leadership’s concerns about the absence of a clear policy and procedure (P&P) were amplified by a mock regulatory surveyor’s comments that such a process was lacking and should be developed immediately.
Reinforcing this idea, an alarming incident occurred in one of our hospitals in which nursing management pursued an investigation of a suspected nurse diverter on their own without consulting the pharmacy until near the conclusion of the analysis. Leading up to the inquiry, pharmacy had been auditing the nurse’s unusual activity and reporting it to nursing management, but this sharing of information was not reciprocal, and pharmacy was left out of the ensuing investigation. Diversion is a significant employee and patient safety concern, and cannot be handled in a vague or unclear manner. To remedy this, we sought to develop a definitive, guiding P&P protocol to ensure all staff members are aware of the steps that should be taken when diversion is suspected.
Developing a Hospital-wide Policy and Procedure
The pharmacy leadership group initially struggled to define the best approach to developing comprehensive P&Ps. Anticipating a political maelstrom trying to obtain other disciplines’ buy-in, we sought the involvement of the district’s corporate compliance officer, who is responsible for ensuring compliance with state and federal law. Initially our medication safety pharmacist contacted other hospitals in the area to see if they would be willing to share their drug diversion P&Ps for reference. The pharmacy department used the responses to help create a template for the initial draft of the drug diversion protocol. Our lead automated dispensing cabinet (ADC) technician, who is an expert on ADC functionality, was instrumental in outlining the auditing process for the initial draft.
Once this draft was created, a multidisciplinary group was formed to edit and revise the document. This group included individuals from a variety of departments, including the corporate compliance officer, the medical staff manager, a chief nursing executive, a human resources representative, the managers of both our pharmacy departments, and the medication safety specialist. One of the challenges in creating the document was that the group was tasked with encompassing not just nursing, but the management of diversion in all departments of both of our hospitals, as well as our two long-term care facilities. The templates we received from other hospitals typically covered audits for the nursing department only, so we spent a significant amount of time researching how to make our P&Ps appropriate for all areas in all our facilities. After receiving initial feedback from the group, pharmacy worked on the draft protocol for several months through completion. The document that was ultimately created describes how diversion can be mitigated through the auditing of pharmacists, pharmacy technicians, physicians, and nursing, as well as staff in our long-term care facilities. (To view a sample of the P&P, see page 10.)
This new P&P outlined the steps pharmacy should take to monitor diversion, who should be contacted when diversion is suspected, and what outside agencies need to be notified when diversion is confirmed. The pharmacy department prints a report that compares ADC activity versus controlled substances safe activity at least every three days, looking for any suspicious patterns. This report allows the auditor to compare the narcotics removed from the narcotics safe to those delivered to the ADC stations, as well as other medications that have been returned or expired. If discrepancies are discovered and cannot be resolved, the pharmacy manager or supervisor is notified.
Managing Diversion in Specific Hospital Departments
Diversion monitoring in the OR requires a distinctive process. To monitor anesthesiologists, pharmacy runs an ADC charge/credit report at least weekly to investigate discrepancies between narcotics pulled from the OR ADC and the anesthesia records for an individual anesthesiologist. The auditor reviews actions that include the removal of anesthesia bags, any additional removal of narcotics from the ADC, and documentation of narcotics administered and wasted. When discrepancies are identified, the pharmacy designee contacts the individual anesthesiologist(s) to resolve them. If discrepancies cannot be resolved in this manner or a concern is raised about possible impairment or diversion, the chair of the department of anesthesia is contacted in writing.
To monitor for nursing diversion, pharmacy runs a proactive diversion report out of the controlled substances safe or an anomalous usage report out of our dispensing analytics system at least monthly. These reports allow the auditor to identify ADC users that have removed larger than normal quantities of controlled substances. The reports are populated according to nursing unit, so the nurses that are compared are ones caring for patients of the same acuity, and thus should be administering about the same amount of controlled substances. If an ADC user has been statistically identified as being three standard deviations above the mean for narcotic withdrawals, an ADC transaction report will be reviewed for that individual. A manager also may request such reports at any time in the event of questionable employee behavior or other indices of suspicion. When reviewing these reports, the auditor focuses on key points, such as excessive discrepancies, excess or lack of waste with the same witness, removals from multiple ADCs, and anything else that seems unusual. After pharmacy review, the reports are sent with a cover letter to the appropriate manager with a brief assessment of any findings the pharmacy has identified. Our policy is to allow 10 days to review the materials and reply back to pharmacy. To ensure follow-up, a copy of the cover letter is kept in the pharmacy.
The nurse managers can respond in one of two ways. They can sign and return the cover letter, which would mean that their review did not lead them to believe the individual was diverting. They also can request, in writing, additional time or reports to further monitor the individual in question. In this situation, pharmacy would consider this an ongoing investigation and a pharmacy designee and the nursing manager would continue to monitor the individual with closer scrutiny until the individual is cleared or there is enough information to confirm diversion. If diversion is identified, the nursing manager must notify pharmacy of the names of the diverted drugs and the number of doses known or suspected to be diverted. The manager also should include any pertinent information on how the diversion occurred.
In our long-term care facilities, any controlled substance count discrepancies are immediately reported to the director of nursing, whose responsibility it is to investigate and attempt to reconcile all reported variances while the nurse in question remains on duty. The director of nursing documents irreconcilable discrepancies in a report to the administrator; any apparent criminal activity must be reported to the pharmacy manager with oversight of the respective facility, the administrator, and the consultant pharmacist.
Steps Taken When Diversion is Suspected
When diversion is suspected, the multidisciplinary group outlined in the P&Ps is contacted to help facilitate the investigation. The investigative team understands that the risk resulting from diversion is very high, both to patients and staff, and thus ultimately to the entire district. The institution’s risk manager is notified right away, through a quality review report, when there is potential impact on patient care. Human resources is also contacted to guide the proper flow of investigation and to protect the employee’s rights. The pharmacy manager also may decide to revoke the individual’s access to ADCs when appropriate. If a physician is suspected of diversion, the chair of the physician’s department is notified. Last of all, the pharmacy billing technician needs to rectify any billing issues related to drug loss or theft if a patient was charged for a medication that he or she did not receive.
Interviewing the Suspected Diverter
When investigating suspected diversion, at some point the employee must be interviewed about their unusual controlled substance usage patterns. Their reactions to questioning can vary widely. An initial inquiry before conclusive evidence is addressed offers an opportunity for the employee to present their side of the story. In our facility, we listen to our employees carefully and keep an open mind regarding possible diversion, but concern also needs to be expressed when an employee’s usage patterns are suspicious. Sometimes it turns out there is a good reason for odd usage patterns, and the employee should be given the opportunity to refute the possibility of diversion.
However, if the diversion evidence is more conclusive, our experience has been that employees respond in one of two ways: they admit they have a problem and ask for help, or they quit their jobs. Our hospital culture supports helping those that admit they have a problem, so these employees are typically directed to our employee assistance program, which usually refers them to a rehab program. Employees are given the opportunity to self-report to the state board of their profession; however, the investigative team follows up to ensure that this happens.
Reporting Diversion to Outside Agencies
Once diversion has been confirmed, a number of agencies are contacted and made aware of the case. At our facility, the corporate compliance officer, the pharmacy department, and the investigating manager are all involved at this stage. The investigating manager is responsible for making sure a report is filed with the individual’s licensing board (ie, nursing, medical, or pharmacy). Pharmacy is tasked with reporting to the Drug Enforcement Administration and to the pharmacy director and chief executive officer, per policy. Pharmacy is also responsible for reporting to local authorities, if appropriate. Whether to include law enforcement is always a tough decision faced by our team. If the employee refuses to admit that he or she has a problem or if the diverter was found to be selling controlled substances to others, we are more likely to report the diversion to law enforcement.
Maintaining Diversion P&Ps
To help enforce the drug diversion P&Ps, the pharmacy department works closely with nurses and anesthesiologists to help them understand and best manage the monitoring process for controlled substances. Pharmacy provides in-services for nursing staff to help them recognize the danger to patients introduced by employee controlled-substance diversion. Pharmacy managers educate nurse managers and anesthesiology leaders, and present the results of audits, including compliance percentages, at their leadership and section meetings.
One policy that has been difficult to enforce has been the 10-day turnaround time for follow-up with nurses having greater than three standard deviations above the mean for narcotic removals. As further proof of the problem, an external auditor validated poor compliance with the 10-day turnaround window. To remedy the situation, the pharmacy shared these results with nurse leaders and managers. Education has improved compliance with the 10-day window, but continual reinforcement remains necessary.
Due to the inherent dangers that employees misusing or abusing prescription drugs bring to patients, facilities, and themselves, hospitals need to have clear, well-defined P&Ps in place to manage these difficult situations. The document should not only include steps for uncovering diversion, it also should contain steps to take after a case of diversion has been verified. A multidisciplinary, investigative team approach is critical to promoting ideal communication among departments when diversion is suspected or validated. Ultimately, the safety of the patient is paramount, and this principle should guide all investigations and actions taken when responding to possible drug diversion.
Ashley Tortorici, PharmD, is the medication safety specialist at Palomar Pomerado Health in San Diego, CA. She earned her doctorate of pharmacy from the University of Pittsburgh in 2007.
Bill Turner, RPh, is the pharmacy manager at Pomerado Hospital. He has served as a pharmacist for 30 years, 16 of which have been spent in both clinical and operational management. He obtained a BS in pharmacy from the University of Wisconsin-Madison.
One Approach to Uncovering Diversion
One successful technique pharmacy employed recently to thwart a diverter was to visit a patient who had just been given a controlled substance medication and qualitatively gauge pain relief. The nurse suspected of diverting had signed out two oral pain medications for a patient, but as a result of pharmacy’s discussion with this patient, it was discovered that he had not received any oral medications for pain. The patient did not, however, complain of pain, since he had recently received a parenteral dose of pain medication.
This fact sparked our interest and we consequently learned a trick this diverter had used: his usage patterns of parenteral medications for his patients were higher than average, and it was discovered that he treated his patients with those medications and then signed out potent oral pain medications for that same patient to divert for himself. He most likely justified his actions to himself by attending to his patients with potent injectable medications, believing then that it would pose no observable danger to the patient to divert the oral drugs prescribed for them—obviously a dangerous and unacceptable practice. When confronted with the evidence, he admitted to having a problem and was referred to rehab for treatment.
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Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
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