Improving controlled substance oversight in surgical areas

An effective drug diversion monitoring program should include controls to monitor controlled substance security in high-risk areas. High-risk locations can be identified by understanding what areas of your organization have a large volume of controlled substances (e.g., intensive care units, pain clinics, recovery room) and complex workflows. Operating rooms are often a high-risk area in most organizations due to the complexity of the workflow, which results in a challenging landscape to monitor. 

Organizations should focus their drug diversion efforts to include oversight of surgical areas. But where should you begin? Following are suggested workflow enhancements to minimize controlled substance-related risks in surgical areas and examples of common risks to look out for. 

Analyze controlled substance workflow  

• Meet with operating room staff to walk through the current process for administering and wasting controlled substances. 
• Understand if there are any manual processes in the organization’s surgical areas, including the following: 
• Paper documentation of medication administration and waste. 
• Manual kits/trays versus anesthesia workstations/automated dispensing machine for the storage and dispensing of medications administered by anesthesia providers. 
• Manual reconciliation of controlled substances dispensed compared to administered. 
• Observe how controlled substances are stored and secured in operating rooms/procedural areas to confirm there are processes in place to guard against theft and diversion of controlled substances.  
• Observe operating rooms/procedural areas for appropriate controlled substance waste receptacles.   

Common controlled substance risks to consider in surgical areas   

Storage/security  

• Controlled substances are not appropriately labeled once drawn up into a syringe. 
• Controlled substances are left unsecured in the operating room/procedural areas. 
• Personal backpacks are located within the operating room/procedural area. 
• Controlled substances are returned to the stock location without a witness. 
• Controlled substance overrides are not reconciled to a valid physician order and/or medication administration documentation on a routine basis. 
• Pharmacy staff deliver controlled substances unsecured on top of an open cart to the operating rooms/procedural areas. 
• Controlled substance storage areas are not secured (i.e., the code of storage area was not changed on a routine basis and controlled substances that require refrigeration are not securely fastened within a refrigeration unit).  

Waste  

• Controlled substance waste is not discarded in an unrecoverable, non-retrievable, and unusable pharmaceutical waste container. 
• IV tubing containing controlled substances is not being properly emptied and wasted in a non-retrievable container. 
• Controlled substance waste documentation is not accurate or is missing.  
• Controlled substance waste is not witnessed.  

Medication administration documentation  

• Controlled substance dispensations are not fully supported by administration/waste data in the EMR. 
• Providers are inconsistent in their documentation in the EMR of controlled substance administration (e.g., anesthesia record, anesthesia note, medication administration record).  

Chain of custody 

• Chain of custody is not maintained throughout the controlled substance removal, administration, and waste processes.   

ADM discrepancy  

• Controlled substance inventory discrepancies in the operating room ADMs are not resolved timely. 
• Questionable discrepancy resolution reasons are not communicated to leadership.  

ADM system access 

• Inactive employees have access to the operating room ADMs. 
• A formal process to validate that only active employees have access to the ADMs is not in place. 

Controlled substance diversion monitoring elements to consider   

• Reviewing controlled substance security and storage controls on a routine basis to confirm preventive and detective controls are in place and working as intended. 
• Reconciling controlled substance waste documentation based on the quantity/strength dispensed and the administered amount. 
• Reviewing full unit waste transactions of controlled substances on a routine basis to trend and report outlier activity compared to peers. 
• Monitoring to make sure controlled substances dispensed from the ADM are documented as administered in the EMR or returned/wasted in the ADM for every removal. 
• Monitoring controlled substance dispenses that have a different user documenting the administration and/or waste compared to the user who dispensed the drug (lack of chain of custody). 
• Reviewing ADM discrepancies on a routine basis for timely resolution and questionable resolution reason. 
• Reviewing employee ADM access for controlled substances on a routine basis to confirm only eligible users have access to controlled substances. 

As drug diversion continues to be a top risk in today’s healthcare organizations, monitoring controlled substance security, including in your organization’s high-risk areas like operating rooms, is essential. Kodiak’s experienced pharmacy risk team is available to help you streamline your drug diversion monitoring program and assist you with other compliance needs.