Kingman Regional Medical Center
Pharmacy Purchasing & Products: What are the challenges of addressing diversion in the operating room (OR) environment?
Patrick Lord, PharmD: ORs and procedural areas carry an inherently high risk for diversion due to the significant abuse potential of the medications used therein, coupled with the staff’s easy access to these medications. ORs are often crowded and hectic; when a number of people work together in a confined space, it can be easy to divert a medication without others noticing.
The most substantial cause of concern related to diversion in the OR is the risk to patient safety. Health care organizations are responsible for providing service to patients consistent with the phrase: First, do no harm. Whether a diverter uses the medication immediately or not, the potential for an intoxicated staff member to cause harm is elevated. Moreover, the legal ramifications of diversion must be taken seriously, as diversion creates the opportunity for a lawsuit. Key to preventing diversion is establishing appropriate documentation and waste procedures. Documentation ensures that items recorded as administered were reduced from inventory correctly. When diversion occurs, it should be impossible to document that the patient received the intended dose. The risk for diversion is high when medications are wasted; while requiring a witness is essential to ensure the medication is wasted as intended, it is not a fail-proof method. Fortunately, a variety of devices, systems, and services are available to ensure safe, effective wasting procedures.
PP&P: What information should be included in policies and procedures (P&Ps) to manage controlled substances in the OR?
Lord: P&Ps for controlled substances should be all-inclusive, comprising not only hospital-specific policies, but also state and federal requirements. Several important issues to keep in mind when developing P&Ps include:
- Hold Staff Accountable. Once tangible metrics are established, documentation practices can be leveraged to ensure accountability. For example, build specific metrics into P&Ps (eg, a patient record audit) to hold staff accountable for documenting medication removals and ensuring that the anesthesia record matches what was removed from inventory. Automation can show if the medications are documented (use and waste) correctly and provided to the correct patient.
- Specify Wasting Procedures. Mechanisms for wasting controlled substances in the OR, as well as in all other hospital areas, must be delineated in P&Ps.
- Standardize Inventory in All ORs. Anesthesia and pharmacy should collaborate to determine what medications must be included for use by the anesthetist. Once agreed upon, all ORs and procedural areas should be stocked identically, and a P&P should be written and approved by both departments. The P&P should specify which medications and quantities are to be stocked in the ORs.
- Stipulate What Data Must Be Tracked and Addressed. Auditing records is critical to identifying patterns. Therefore, P&Ps should be specific regarding what data must be gathered and how anomalies are to be addressed. When diversion is suspected, addressing the issue within the proper time frame is critical; waiting too long provides an opportunity for further diversion, but acting too soon might lead to unnecessary tension with staff. Each institution must define the appropriate time to act. It is important to routinely contact the anesthesia provider for clarification on each incorrect record to facilitate accurate tracking and trending. If incomplete or inaccurate records continue to occur, even after discussion with the provider, it is appropriate to take further action.
- Detail Staff Training Practices and Interdepartmental Collaboration. Staff training and effective collaboration among departments are critical to identifying and preventing diversion in the ORs. This can be fostered through continuing education and regular staff meetings.
- Request P&Ps from Outside Vendors. Organizations that contract management of the anesthesia department with an outside vendor should request that company’s P&Ps on controlled substances and maintain them on file in the hospital.
PP&P: What are some best practices for detecting diversion in the OR?
Lord: Utilizing a diversion-prevention software program in tandem with automated anesthesia carts is a particularly effective strategy to monitor for and prevent diversion, as this software can help detect patterns outside of the norm by individual staff members as well as by specific medications. The data reporting capabilities of the software can also help pharmacy identify areas and practices that require improvement.
User IDs and passwords serve as the first line of defense. Assuming employees do not share their passwords with one another, having such technology significantly enhances the auditing process. During the orientation process for all employees, it is critical to affirm that each person is responsible for all transactions completed under their name, even if they do not make the transaction themselves. Once employees understand that the organization presumes this level of responsibility and that there is a paper trail documenting all medication access, they typically develop a respect for the process and protect their passwords, which can help reduce the incidence of diversion.
Anesthesia carts utilize locked, lidded drawers, which contain only one drug each. Allowing access to only the requested medication promotes proper inventory control. Implementing blind counts, whereby staff (typically anesthesia or pharmacy personnel) count the remaining inventory of the drawer they have accessed and enter it into the automated anesthesia cart, is crucial to ensuring accuracy. After two incorrect counts, a discrepancy is created, and the provider is alerted.
Another best practice is to conduct random patient audits. Even when automation and software are used in the OR, patient chart audits are crucial. Be sure that all documentation is in order, which will simplify recordkeeping and auditing. Auditing procedures should be built into P&Ps for each area of the hospital where medications are used. If automated anesthesia carts and diversion-monitoring software are utilized, compare the anesthesia record with the cart data. This information shows which drugs were signed out, who signed them out, at what time, and if waste was recorded. In organizations where providers input orders prior to removal, running a simple report on the patient can make comparing the anesthesia record to the patient report easier. When comparing records, it might be worthwhile to investigate when the order was discontinued, or when surgery was completed and the patient left the PACU. Controlled substances are normally reserved for OR use; indication of use outside of surgery time or after the order has been discontinued can aid in a diversion investigation.
In organizations with more than one OR suite, standardizing the contents across each suite is important. All the automated anesthesia carts should be stocked with the same medications, in the same quantities, and placed in the same locations within the cart. This allows pharmacy to readily identify potential inventory gaps that might be instances of diversion. It also allows the anesthesia team the ability to quickly locate medications within the carts.
PP&P: What reports are useful to help manage diversion in the OR?
Lord: The capacity to run reports from the automated anesthesia carts is particularly useful, especially during an audit. Of specific importance is the transaction report, organized by user or by drug, which shows every transaction made. Other reports that should be regularly reviewed include the usage report (to gauge which items are being used most frequently and to establish par levels) and the waste report (to ensure that unused narcotics are wasted according to hospital P&Ps and in compliance with all state and federal regulations). The waste report can be reviewed against the provider’s order to verify that a correct dose was registered. Most importantly, the anesthesia record must be reviewed. Usually a permanent attribute of the patient chart, the anesthesia record should document all medications given, including the dose and frequency. This record can then be compared to the usage and waste records to ensure regulatory compliance.
More often than not, regulatory bodies will request documentation of the full life cycle of a controlled substance order, from the time it is ordered by the provider through the waste process (if applicable). Documentation on the anesthesia record and the automated reports can readily provide that information for the auditor.
PP&P: How should controlled substances be wasted in the OR?
Lord: In keeping with best practice, to safeguard the organization and meet regulatory requirements, several steps should be taken when wasting controlled substances. For example, a witness should always be present. Never assume a staff member will physically waste the medication—watch them do it. Whether using a paper or an electronic record, proper documentation must occur. If using a paper system, double signatures should be required. If using automation to document waste, the machine will require a witness to verify, which provides documentation should an audit occur or if questions arise.
In the past, wasting medication in the sink was acceptable practice. More recently, companies have developed wasting mechanisms that are safer and more environmentally sound. There are several products available on the market that can be employed. Typically, these systems mix the medication with a dissolving solution. Once the medication combines with the destroying agent, the controlled substance is no longer active. Using such systems not only ensures compliance, but also protects the staff members performing the wasting and prevents others from being able to retrieve an active drug after disposal.
PP&P: How should pharmacy collaborate with anesthesiology to prevent diversion in the OR and create a culture of accountability?
Lord: Pharmacy and anesthesiology should work closely together to determine expectations for each department in preventing diversion; a defined, simple process for control and waste should be in place. Anesthesia should be involved in identifying their medication needs and should provide input as to how medications are stored and supplied. P&Ps must be developed and reviewed collaboratively to ensure all stakeholders understand their roles; encourage both departments to air concerns and provide input. Collaboration is especially critical during the auditing process, so be sure to involve anesthesiology. As concerns arise, discuss them openly and work together to develop a resolution.
Accountability in the OR must work two ways: Pharmacy and anesthesiology both play essential roles in creating a culture of safety and a positive work environment. Regular interdepartmental staff meetings to discuss diversion issues are helpful to identify mutually agreeable solutions.
Patrick Lord, PharmD, is the operations manager for pharmacy services at Kingman Regional Medical Center in Kingman, Arizona. He received his pharmacy degree from the University of Iowa in Iowa City.
Part 1 of a 2-Part Series: Elements of a USP <800> Compliant Cleaning Program
Conduct a Drug Diversion Investigation
Special PP&P Buyer's Guide: Temperature Monitoring
Develop a Pneumococcal Vaccination Program
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