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Tools to Effectively Manage Controlled Substances
January 2011 - Vol. 8 No. 1 - Page #8
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St. Joseph’s Hospital is an 886-bed community hospital located in Tampa, Florida. Part of BayCare Health System, St. Joseph’s has been using automated dispensing cabinets (ADCs) since October 1998 to manage the distribution and storage of medications, including controlled substances. Regardless of its distribution model, any hospital can be a target for diversion of controlled substances. Realizing mechanical controls alone were not sufficient to manage CII through CV inventory, St. Joseph’s implemented a computerized ADC reporting application in October 2005 to better monitor the flow of medications through our distribution process.

By automating ADC reporting, we have improved the tracking of CII-CV inventory through all aspects of the medication use system. To begin with, detailed reports on all controlled substance distributions help us identify any issues with the storage and/or delivery of those drugs from the pharmacy department. The application also provides a formal method for monitoring discrepancies at any ADC in the network, which is a default means to monitor for diversion. During the course of monitoring for discrepancies, it may become apparent a staff member is diverting, and may be working while impaired. In addition to fiscal and litigious risks for the institution, not to mention the criminal nature of diversion, impaired staff members can cause harm to patients, other staff, or themselves.

It is important to also consider the ramifications of diversion outside the work environment. After leaving work, an impaired staff member puts the general public at risk if operating a vehicle. Keep in mind that other than diverting for personal use, a staff member may divert to sell controlled substances illicitly. Not to be overlooked in light of public safety and patient care concerns, the loss of medications to diversion is a net financial loss for the pharmacy and the institution. Our computerized reporting application has allowed St. Joseph’s to improve oversight and accountability for controlled substances.

Reports for Discrepancy Management
Human beings are a clever and curious species. One of our defining characteristics is not only finding mechanisms and automation to perform tasks for us, but also discovering ways to defeat, and ideally, improve on such systems. Due to this, simply having automated systems for controlled or otherwise dangerous substances is not enough. St. Joseph’s found the combination of such systems with detailed reporting (not to mention personal, face-to-face contact and communication with staff) provides more thorough oversight and accountability. The number of reports available to screen for discrepancies allows the pharmacy department to closely monitor usage and access and track all distribution details for controlled substances. The following are examples of the reports St. Joseph’s generates:

Daily Reports

  • A cumulative ADC console and station activity report is printed to look for any team members who have been entered as a temporary user by another team member
  • An error report sent from all ADCs to the hospital information system is reviewed to see if any staff are adding patients to an ADC inappropriately, or are selecting incorrect patients to access medications
  • The pharmacy department reviews the ADC-to-CII safe report to ensure medications leaving the pharmacy are correctly delivered to the proper nursing unit ADCs
  • A termination report is supplied by the human resources department so the pharmacy can remove access for staff members who have left the organization
  • A cumulative ADC profile override report is reviewed for overrides of controlled substances. Pharmacists reconcile overridden medications with the patient profiles to ensure appropriate use
  • A cumulative ADC all-discrepancies report for the CII-CV inventory is reviewed for any discrepancies that are either unresolved for greater than the prior 24 hours or where the resolution reason does not fully make sense. The reasons to make this determination are as follows:
  • Incorrect medication found in pocket
  • Loss of liquid medication due to inaccuracy of container
  • Overage of liquid medication due to inaccuracy of container
  • Prior user did not enter the correct beginning count
  • Prior user removed a refrigerator medication without using the ADC
  • Prior user returned medication to return bin instead of pocket
  • Unresolvable: Follow-up required with an incident report
  • User with prior access cancelled removal but withdrew medication
  • User with prior access closed drawer before removing medication
  • User with prior access entered mg dose instead of quantity
  • User with prior access selected one, actually withdrew two
  • User with prior access selected two, actually withdrew one

If any of the above reasons are chosen, but do not make sense in explaining the discrepancy, a copy of the ADC report is sent to the nurse manager for further investigation. For unresolved discrepancies, an e-mail is sent to the nurse manager the following day as a reminder. This has proven successful over time to ensure resolutions are performed in a timely manner. With more than 85 ADCs in use, this has been shown to be an effective process for follow up at St. Joseph’s. 

Weekly Report

  • All CII-CV medications in each ADC are manually counted once a week. This is in addition to counting upon each patient removal. The once-a-week count ensures accurate counts for medications used infrequently.

Using an Online Data Management System
To help manage long-term oversight, St. Joseph’s moved to an online data capture and analysis application. The daily archives of actions performed at ADCs are automatically uploaded to a server to ensure files are current. While many years of data can be stored, St. Joseph’s has elected to retain the prior 365 days in an electronic folder to use for convenient reporting.


A bimonthly anomalous usage report is printed and sorted by facility and individual ADC. The dual report is analyzed to identify ADC users who remove significant quantities of controlled substances compared to hospital-wide users, and compared to team members working in the same patient care area. If a particular user stands out above an expected or reasonable number of removals, the individual’s manager is contacted to review patient records. If this review demonstrates actions above and beyond the course of proper protocol, the human resources department is contacted.


In addition to routine reports, the online data management system is also useful for examining a specific employee’s use of ADCs. If a team member exhibits warning signs of impairment (see sidebar on page 8) a report is run immediately.


Online data management can also provide key assistance with managing non-controlled medications stored in ADCs. Analyzing various components of the distribution process—removals, par levels, stockouts, refills, etc—can help optimize inventory management. From a cost standpoint, more than a third of the pharmacy inventory at St. Joseph’s is stored in ADCs. With such a significant amount of drug inventory held in these satellite units, the reporting capabilities of an online data management system have improved St. Joseph’s ability to automate inventory management and optimize the storage and monitoring of non-controlled substances in ADCs. 


Conclusion
By taking a collaborative approach, the nursing and pharmacy departments can effectively manage controlled substance inventory, distribution, and administration, and the documentation of waste. The vast majority of health care employees come to work every day and perform their duties in a professional, accurate, and honest manner. However, it is essential for all organizations to have oversight and safeguards in place to ensure controlled substances are used and tracked appropriately.

See St. Joseph’s policy for controlled substance management (at the end of the article).


Ira Kurland, RPh, has been coordinator of automated patient medication systems in the department of pharmacy at St. Joseph’s Hospital in Tampa, Florida for the past 13 years. Ira received a BS in pharmacy from St. John’s University in Jamaica, New York.

Tim L’Hommedieu, PharmD, MS, is pharmacy manager at St. Joseph’s Hospital. He completed a PGY1 and PGY2 residency in health system
pharmacy administration at Nationwide Children’s Hospital and received a PharmD and MS from The Ohio State University.

 


Possible Diversion Warning Signs
Diversion is an issue at every hospital; therefore, the pharmacy department should work closely with nursing managers to identify significant changes in job performance, personality, or work schedule. Such changes often can supplement the discovery of discrepancies in identifying diversion, and to properly monitor staff, managers must be aware of the possible warning signs. Consider the following behaviors or conditions when reviewing groups or individual staff members in departments where diversion has either been identified, or is suspected.
 

Job Performance

  • Increased use of sick time, especially following days off
  • Absence without prior notification or last-minute requests for time off
  • Longer than usual breaks
  • Frequent or unexplained disappearances from the department
  • Increase in doing only the minimum work necessary
  • Increasing difficulty meeting schedules or deadlines
  • Sloppy or senseless documentation
  • Excessive mistakes, ie, frequent medication errors or errors of judgment in patient care
  • Smell of alcohol on breath
  • Excessive use of mouthwash, breath mints, or chewing gum
  • Elaborate excuses for behavior


Personality or Mental Status

  • Unusually quiet or irritable or has frequent mood swings
  • Inappropriate verbal or emotional responses such as snapping at colleagues, uncontrolled anger, or crying
  • Changes in alertness (perhaps appearing dazed or preoccupied), or frequent memory lapses
  • Increased isolation from coworkers

 

Other Signs of Potential Diversion

  • Consistently volunteering to be the “medication nurse”
  • Signs out more controlled drugs than coworkers
  • Frequently reports medication spills or other waste
  • Fails to obtain cosignatures
  • Produces reports that reflect excessive use of PRN medications
  • Discrepancies in end-of-shift counts
  • Drug containers show evidence of tampering
  • Waiting until alone to access ADCs, or disappearing after doing so
  • An increase in patient complaints of unrelieved pain
  • Defensiveness when questioned
  • about medication errors
  • Consistently coming to work early or staying late
  • Volunteering to work with patients who receive large amounts of pain medications
  • Requests transfer to an off-peak shift

 


St. Joseph’s Policy for Controlled Substance Management

The purpose of this policy is to provide a written process to facilitate the management of controlled substances in our ADCs and to prevent unauthorized use.*

ADC Access

  1. Initial access is granted by pharmacy upon receipt of the “ADC User Authorization Form” signed by the nurse manager or educator. 
  2. The initial password is set by pharmacy and converted to BioID by the authorized user on first use. If BioID is unsuccessful, notify the pharmacy for a password.
  3. The charge nurse or educator may grant shift access to the ADC system when a nurse floats from another unit by using the activate function.
  4. Access to the ADCs on multiple nursing units may be granted under certain circumstances (eg, float team), when approved by the department manager and pharmacy.
  5. Temporary ADC shift access may be used in rare situations but requires manager or AOD approval and setup.
  6. Access to ADCs is removed by pharmacy upon team member termination or loss of authorized user status.

OVERRIDE

1. The override process inherently bypasses an important safety step in the medication use process and should be utilized only in an urgent/emergent situation in which the care of the patient would be compromised if the medication were not administered immediately.

2. If a patient is not yet in the ADC system (eg, a new patient), an override may be avoided by writing the patient name, account number, and room number on the physician order sheet and scanning to pharmacy.

WASTE

  1. The process for wasting controlled medications, such as narcotics, requires a witness and includes the following:
  • Two authorized users are required. One user will be designated as witness to the wasting process. Those authorized with access to the automated system, whose job description or licensing allows the handling of controlled substances, may serve as a witness in the absence of a second nurse.
  • The witness must enter their BioID or password into the ADC.
  • The witness must view the vial, syringe, tablet, etc, that is used to prepare the medication dose.
  • The witness is required to visualize the solution vial, syringe, tablet, etc, to verify the medication being wasted. The witness must watch the solution ejected from the syringe (preferably in a solid waste/trash receptacle) or watch the destruction of the unused portion (eg, the tablet).
  • The wasting process should be done when the medication is removed from the ADC, unless incremental dosing is utilized (eg, PACU). When incremental dosing is performed, any medication remaining unused after ADC removal shall be wasted at that time using the procedure described above.
  • Unplanned wasting (eg, patient refusal of medication) must be witnessed when the medication is actually wasted using the procedure described above.

RECONCILIATION
Daily: At the end of each shift the charge nurse or their designee will check the ADC for a discrepancy icon.

  • If no icon is present, sign the controlled substance log.
  • If a discrepancy icon is present, the discrepancy must be reconciled as soon as possible.

ADC Reconciliation Process

  1. Touch the document discrepancy icon to obtain current user information. 
  2. Read information on screen. The charge nurse can print a “Discrepancies All” report. Find a witness to help with next steps.
  3. Touch “Inventory,” select by medication, type in name of medicine, and select.
  4. Press “Inventory Selection” and accept.
  5. Witness signs on to the ADC.
  6. Two authorized users perform an inventory and correct the count as needed. In most cases this will produce a second discrepancy in the count.
  7. Go back to the Main Menu and select the document discrepancy icon again.
  8. This time highlight the discrepancy in blue by touching the description.
  9. Witness signs on to the ADC.
  10. Select most appropriate reason that appears and touch accept.
  11. If appropriate reason is not listed, select “Other,” type in free-form explanation.

Weekly: Two nurses perform inventory and document completion
of the inventory by signing the controlled substances log.

OVERSIGHT
The unit/department manager is responsible for the oversight process, by:

  • Ensuring the completion of the daily Reconciliation and weekly Inventory Form for controlled substances in the ADC.
  • Performing the Proactive Evaluation Process as requested by pharmacy.

Proactive Evaluation Process
Level 1: Evaluate the proactive diversion report sent from pharmacy when a concern is noted in the initial pharmacy screening.

  1. If no further investigation is warranted, the manager will notify the pharmacy coordinator or manager.
  2. If further investigation is warranted, proceed to Level 2.

(Note: If a staff member exhibits behavioral signs and symptoms of possible diversion, the manager should also initiate a Level 2 investigation).
Level 2: Investigation will include pharmacy and manager review of detail reports for inconsistencies, trends, and/or suspicious events. If found, proceed to Level 3.
Level 3: Notify Team Resources.
The Level 3 investigation may include manager review of medication-
related documentation on a sample of 8 to 12 charts (physician orders, MAR, nursing notes, pain scores, etc). Reasonable suspicion indicators may include medications withdrawn from ADC without documentation on MAR or lack of correlation between MAR and nurse’s notes. If found, proceed to Reasonable Suspicion Investigation.
Level 4: Reasonable Suspicion.
If Reasonable Suspicion is found, convene Team Resources and HR for next steps.

What is the size of your Facility?
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