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Standardization Drives OR Medication Safety
May 2013 - Vol. 10 No. 5 - Page #10

The operating room (OR) environment has historically been fraught with the potential for serious medication errors. Syringe swaps, incorrect labeling, look-alike/sound-alike vials and ampules, incorrect injection sites, and infusion pump programming errors have continued to be reported in recent years. Proper management of these often dangerous medications is vital to ensuring safety in the perioperative environment, and utilizing an OR pharmacy to provide specialized pharmacy services to patients undergoing surgical procedures can increase medication oversight and improve safety. Moreover, outsourcing certain medications, including OR syringes, enables pharmacy to provide standardized medications in a unit-of-use format.

The OR pharmacy at the University of Illinois Hospital (UIH) & Health Sciences System is one of the oldest in the country, having been established in 1980. Our OR has 17 suites serving approximately 60 cases daily from Monday through Friday; surgical cases are not scheduled on weekends, although emergency cases are performed. The OR pharmacy is open from 6am to 4pm, and pharmacy coverage of the OR occurs out of our central pharmacy after hours and on weekends. The OR pharmacy is currently staffed with 1.2 FTE clinical staff pharmacists and 1.2 FTE pharmacy technicians; in addition, there is a clinical pharmacist assigned to the perioperative setting, a position that is co-funded by the departments of pharmacy and anesthesiology. 

Goals of the OR Pharmacy
One of the driving forces behind the many services provided by our OR pharmacy staff is the ongoing goal of improving patient medication safety. Therefore, we consider our OR pharmacists as the medication safety officers for the perioperative setting. One of the principle benefits of utilizing an OR pharmacy is that we are able to provide the majority of medications in a ready-to-use form. This is in line with two of the consensus recommendations from the recent Anesthesia Patient Safety Foundation’s (APSF) medication safety conference, which state that routine provider-prepared medications should be discontinued whenever possible and that high-alert drugs should be prepared by pharmacy in a ready-to-use form. During OR pharmacy hours, virtually all medications are dispensed from the pharmacy, which allows the pharmacist to monitor medication use for surgical procedures and have medications compounded for immediate use by a pharmacy technician in a laminar flow hood. 

Continual standardization is a high priority of the OR pharmacy staff, who work closely with other health care providers in the perioperative setting to standardize preparations and concentrations—such as critical care infusions, anesthesia-related syringes, and irrigation solutions—whenever possible. This activity is supported by another consensus recommendation from the APSF’s medication safety conference, which states that concentrations/diluents of high-alert drugs should be standardized in an effort to prevent medication errors in the surgical setting. To ensure continual improvement, OR pharmacists periodically meet with the various disciplines practicing in the OR to review their medication use and identify additional standardization opportunities. 

Outsourcing Anesthesia Syringes
Since anesthesiologists administer the majority of OR medications, pharmacy focuses on developing strategies that will allow safe and efficient administration of anesthesia medications in a cost-effective manner. One strategy is to outsource select anesthesia-related medications. Outsourcing anesthesia syringes allows pharmacy to provide a preparation in a ready-to-administer format and facilitates standardization to one concentration and size. The OR clinical pharmacist and the assistant director for specialty and support services work closely with key attending anesthesiologists to identify products for standardization, along with desired concentrations and sizes. Medications targeted are generally those that are not commercially available in the dosage form desired, those that are challenging to prepare in-house (eg, excessive waste, workload, record keeping, regulatory compliance), or those not available due to drug shortages. 

The majority of the products that we outsource at UIH are OR-related (see Table 1); expenditures for these medications account for approximately 2% of our overall drug budget.



Cost Comparison
To evaluate the fiscal prudence of outsourcing OR syringe preparation, conduct a financial analysis comparing the in-house costs versus those associated with outsourcing. Keep in mind that when using a simple comparison of pharmacy’s cost for the medication versus the outsourcer’s price, the outsourced product will always appear to be more expensive. To ensure an accurate comparison, additional factors must be considered including the costs related to labor, waste, testing (eg, to establish beyond-use-dating [BUD]), supplies, and equipment, as well as any costs resulting from medication errors. One analysis at the Medical University of South Carolina demonstrated a total waste reduction of 61% with the use of outsourced prefilled OR syringes.

Waste Reduction
Minimizing waste is a cost-reduction strategy that does not impact the clinician’s medication selection. When using outsourced medications, it is important that health care providers work to reduce waste of these products wherever possible. For example, discourage the preemptive removal of packaging, spiking in anticipation of use, or removal of tamper-evident packaging from outsourced syringes until necessary. This will allow unused products to be recycled when appropriate, thus taking advantage of their extended BUD.

OR pharmacy staff provides periodic reminders to our anesthesia residents to ensure compliance on these activities. In addition, we periodically assess wastage by asking our anesthesia residents and anesthesia technicians to return all outsourced medications at the end of each case for a specified period of time. Our anesthesiology department has partnered closely with pharmacy to keep anesthesia-related medication costs as low as possible.  

Syringe Labeling
One of the strengths of outsourcing OR syringes is the availability of robust labeling. Appropriate labeling of medications used in the perioperative setting has positive safety and compliance implications, yet The Joint Commission’s National Patient Safety Goal (NPSG) 03.04.01 often can be a problematic standard for institutions to comply with. 

At UIH, products that are compounded in our pharmacy are labeled in a manner that complies with NPSG 03.04.01. For those syringes drawn up by our anesthesiologists, OR pharmacists facilitate appropriate labeling to the greatest extent possible. Customized label tape that lists the drug name and concentration (see Figure 1) is used to properly identify each medication. For those drugs where more than one concentration is necessary (eg, lidocaine), the anesthesiologist is required to write the concentration on the tape; however, multi-concentration medications are limited to as few as possible. All our label tape follows the ASTM color-coding standards and we do not require expiration dating to be placed on these syringes, as they are discarded at the end of the case. Our outsourcing partner has done an excellent job of developing a label that is easy to read from any vantage point, uses tall man lettering when appropriate, and clearly states the BUD. To best ensure safety, whenever possible we purchase OR syringes from a single compounding company to minimize any look-alike/sound-alike labeling confusion that may occur if syringes from multiple compounding companies are used simultaneously. 



Choosing an Outsourcing Partner
Performing due diligence is requisite when considering purchasing outsourced products from a compounding company, as The Joint Commission holds institutions responsible for ensuring the integrity of all the products it brings into the facility for administration to patients. Therefore, performing a site visit to the compounder to observe the processes used in making the various products that you are considering purchasing is most advantageous. A site visit also allows you to view the general cleanliness and quality of the facility. While visiting, ask to see the standard operating procedures (SOPs) for the production of the products you wish to purchase. If you decide to outsource additional products in the future, the SOPs for these also should be requested. The ASHP Research and Education Foundation has developed a tool that can be used to assess the quality of compounding companies; Table 2 lists the various areas assessed by it.2 This tool provides a final score once completed, with 90% to 100% considered excellent, 80% to 89% considered good, 70% to 79% suggesting that other options should be considered, and ≤69% indicating that the vendor should be disqualified as unacceptable. 

Click here to view a larger version of this Table

In addition, review your compounding company’s quality assurance report on an ongoing basis. This report should be sent to you regularly or be available on the company’s Web site. Particular attention should be given to the results of end product testing (eg, sterility testing). Other metrics that should be evaluated include media fill testing, hood air/hood surface testing, gloved fingertip testing, temperature testing (eg, cleanroom, warehouse, refrigerator, freezer), and product/service inquiries. When the product is received from the compounding company, inspect it prior to dispensing it for use as you would for a product prepared in-house. 

Drug Shortages
The extensive drug shortages in recent years are one of the drivers for outsourcing medications at UIH, and drug shortages continue to be a challenge in the perioperative setting because there are insufficient alternatives for the drugs used in this setting when first-line medications are in short supply. Shortages clearly impact patient care, as evidenced by the results of an American Society of Anesthesiologists survey on drug shortages reported in March 2012. Ninety-seven percent of the anesthesiologists surveyed reported a shortage of at least one medication. Table 3 lists the drugs reported most often in short supply, the impact of shortages on patient outcome, and the impact on the anesthesiologists’ practices. Tragically, six deaths were attributed to drug shortages.3 



Our OR clinical pharmacist works closely with anesthesiologists and other members of the pharmacy department to develop strategies to mitigate the consequences of shortages. For example, we developed guidelines for the use of propofol for sedation in our intensive care units to ensure that we would continue to have propofol available in the OR. We are also proactive in communicating with our anesthesiologists to make them aware when we must change concentrations or substitute an alternative drug due to a shortage. This information is shared verbally with our anesthesiologists at their morning conferences; in addition, we have developed a drug shortages bulletin board that is located outside the OR pharmacy. This is an effective way to communicate shortage information, since our anesthesiology residents can review this information while they are in line at our pick-up window to receive their medications. In those instances when we are not able to obtain required drugs through usual distribution channels, we inquire with our compounding company to see if they have product available. 

Conclusion
UIH has found outsourcing select medications in the perioperative setting to be a viable option for the safe procurement and provision of quality CSPs, and we currently outsource several OR syringes, as well as other anesthesia-related products. Work closely with your anesthesiologists to identify medications that make sense to outsource; it is always prudent to perform a financial analysis to identify how outsourcing may impact the pharmacy department’s budget. Given the recent safety problems with compounding companies, prior to purchasing products, it is imperative to conduct a site visit to the compounding company being considered. While there, ask for SOPs for all products that will be purchased, and review the company’s quality assurance report.

Reference

  1. Fortier CR. Outsourced pre-filled syringe system conversion. Anest Analg. 2012;114:S-124.
  2. ASHP Foundation. Outsourcing sterile products preparation: contractor assessment tool. http://www.ashpfoundation.org/sterileproductstool. Accessed March 5, 2013.
  3. American Society of Anesthesiologists. March 2012 Drug Shortages Survey.http://www.asahq.org/For-Members/Advocacy/Federal-Legislative-and-Regulatory-Activities/Drug-Shortages.aspx. Accessed March 1, 2013.

Andrew J. Donnelly, PharmD, MBA, FASHP, is director of pharmacy, University of Illinois Hospital & Health Sciences System, and clinical professor of pharmacy practice, University of Illinois at Chicago College of Pharmacy. He received his BS and PharmD degrees from the University of Illinois College of Pharmacy and his MBA degree from the University of Illinois College of Business Administration. Andrew’s professional interests include pharmacy administration, technology and automation as it relates to the medication use process, and anesthesiology/operating room pharmacy. 

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