Avoid Compounding in the OR

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Start small to stop drug preparations that can lead to errors and sterility issues.


A BETTER WAY Sanford Medical Center Fargo (N.D.) standardized its irrigation protocol to reduce compounding and the number of solutions surgeons could request.

Doing away with compounding in the OR will improve patient safety and case efficiencies. It will also make sure your facility complies with USP 797, which governs a wide range of factors that ensure compounded drugs are prepared in a dedicated space by specially trained pharmacists who follow strict quality controls and do all their mixing under a laminar air flow hood.

Perhaps you're looking to stop compounding in the OR, but feel overwhelmed at the prospect of overhauling a practice that's become a cornerstone of your day-to-day procedures. Sure, you can outsource anything you mix in-house to a compounding pharmacy (see "5 Questions to Ask Your Compounding Pharmacist"). But if your facility has safety or cost concerns, or simply doesn't have the time or resources to properly vet an outside compounder, there's another option. You can start small by focusing on a specific medication or solution you want to stop mixing in the OR and break down the process step by step until you find a better way.

That's what Sanford Medical Center Fargo (N.D.) did recently. The facility used to rely on a variety of irrigation solutions, which were often compounded or mixed by a circulator right in its ORs. When the Joint Commission raised concerns about the safety of such an approach, Sanford took the following steps to do away with its irrigation compounding practices, according to Laci R. Soper, BSN, RN, the facility's operating room educator.

  • Standardized the options. Sanford's first course of action was a detailed analysis of 50 surgeon preference cards. Throughout the analysis, certain solutions — such as a combination gentamicin-saline solution — were eliminated as Sanford attempted to standardize the solutions surgeons used.

"You need to first find out what your surgeons are willing to part with, and then go from there," says Ms. Soper.

With the help of the surgeons and clinical leaders, she gradually began eliminating the irrigation solutions Sanford surgeons could do without. In the end, the facility reduced its broad list of irrigation solutions to just three main options: A commercially available low-concentration 0.05% CHG jet lavage system, a saline solution and a pharmacy-produced antibiotic solution created in compliance with USP 797.

  • Made education the priority. If you're planning on greatly reducing or eliminating a formerly compounding-heavy approach to medication distribution, you can't afford to cut any corners with the staff education component. When Sanford's standardized irrigation protocol went into effect, every member of the OR staff received comprehensive training on the change. "We make the details of our available irrigation options a focus of our education for new orientees," says Ms. Soper. "It's now one of the skills competencies we measure."

SHOPPING FOR SAFETY
5 Questions to Ask Your Compounding Pharmacist
SAFTY FIRST If you do opt to use a compounding pharmacy, ask whether they have the equipment and resources to comply with USP 797 and 800 standards.   |  Pamela Bevelhymer, RN, BSN, CNOR

You've made the decision to enlist the services of a compounding pharmacy. Now what? Start by asking the potential compounding pharmacist the types of questions that are guaranteed to get to the heart of how dependable and safe they are. Here are five must-ask questions courtesy of Christopher Smalley, RPh, MS, MBA, a pharmaceutical and compounding pharmacy consultant with ValSource in Suburban Philadelphia.

1. What makes you qualified? Any compounding pharmacy should provide very specific examples of why they're qualified to mix medications. A compounder should be able to point to specific additional training they received in the area of compounding, or be a part of an organization or association that is contributing to the advancement of compounding. (You can find a listing of such associations here: osmag.net/tF6oWU.)

2. Are you in compliance with USP <797> and <800> standards? The easiest way to guarantee this level of compliance is by opting for a compounder that's registered as a 503(b) facility, a classification that ensures the pharmacy is held to the same standard operating procedures as large pharmaceutical manufacturers. This means the facility is required to comply with current good manufacturing requirements, report adverse events to the FDA and perform proper labeling practices in accordance with the Drug Quality and Security Act (DQSA).

3. How do guarantee the sterility? Confirm the pharmacy adds preservatives to compounded medications to ensure sterility. For example, compounders that make wound creams typically include methylparaben or propylparaben preservatives.

4. Do you perform appropriate checks? After a staff member draws up the medication, does a second person perform a double-check? Then, does a third person come back and check the label of the compounded medication? The importance of this three-level oversight can't be overstated, and there are facilities that will skip the critical steps because of issues like staffing availability. However, all levels are needed to ensure the right dose of the right drug are prepared for the right patient.

5. Do you have the right culture? You can phrase this question in any way that helps you get at whether the facility takes ownership for a compounding issue. You're looking for any type of response from a compounder that showcases accountability, not plausible deniability.

— Jared Bilski

Slow and steady

In many cases, such a small-scale approach is the best way to make big change happen. "Everyone can't afford to do a complete overhaul of their compounding practices," says Christopher Smalley, RPh, MS, MBA, a pharmaceutical and compounding pharmacy consultant with ValSource in Suburban Philadelphia.

"People are generally resistant to change, so it's best to start a pilot program, make small changes in your processes and find glitches in the system."

Indeed, Sanford's approach to reducing OR compounding offers a blueprint on the effectiveness of smaller, more specific changes. The facility is using the same plan to reduce the mixing of local anesthetics such as lidocaine + epinephrine and bupivacaine + lidocaine.

Sanford's elimination of compounded irrigation solutions not only reduced the potential for medication errors, it's also been a major time-saver. Now that the circulator and other OR staff members don't have to gather sterile supplies, and dilute, mix, dispense and label each of the irrigation agents, the facility saves approximately seven minutes per case. Summing up the benefits of new protocol, Ms. Soper says, "Safety drove the change, and the time-savings helped push it through." OSM

Slow and steady

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