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CLEAR ADVANTAGE Pre-filled syringes offer consistent, legible, standardized labeling, making readability errors much less likely.Can pre-filled syringes reduce the many medication errors that can occur during surgery? When you consider all the factors involved in getting things right, it seems likely. Here are 12 advantages of using pre-filled syringes in the OR.
1. They prevent labeling errors. With consistent, legible, standardized labeling on every syringe, readability errors are much less likely. Compounders also use 'tall man' lettering, standard color-coding, bar coding or RFID technology and tamper-evident caps.
2. They extend shelf lives. Traditional succinylcholine, once removed from the refrigerator, has to be used or discarded after 14 days. Preloaded syringes containing succinylcholine can maintain their potency for 90 days.
3. They prevent mixing errors. Phenylephrine is packaged in concentrations that are 100 times stronger than what's needed for a typical dose. So to get it into a useable range, you need to do a double dilution. In other words, you draw up the contents, dilute it down to 10 ccs, and then squirt out 9 of those ccs. And then you draw up another 10 ccs. But there's a lot of production pressure in ORs, and doing dilution on the fly is risky. I can guarantee people occasionally fail to do the double dilution. I can also guarantee that it's a mistake that's way under-reported. Thankfully, pre-filled syringes that are already 100-fold diluted, which are what we use in my hospital system, eliminate the potential for that human error.
4. They reduce direct drug contamination. Accessing vials through a rubber lid while mixing in an open room is inherently riskier than mixing them under a hood in a clean room.
5. They reduce cross-contamination. Anesthesia providers often add drugs like phenylephrine and epinephrine to bags of saline to use as a dispensary over the course of the day, because it's so much easier that way. But what happens if someone gets confused and violates that supply bag with a syringe that was already used with another patient? That's much less likely with pre-filled single-use syringes.
6. They maintain consistent quality standards for safety and potency. Assuming, that is, you're using an FDA-approved 503B provider (see 'Compounders are Stepping Up, Achieving Impressive Safety').
7. They can save money. They don't always, of course, but by decreasing waste caused by excess quantity in traditional vials, and reducing soft costs — like nursing time and anesthesia time — pre-filled meds often turn out to be less expensive overall. And on occasion they're less expensive, regardless of whether you consider waste and time factors.
MEDICATION ERRORS
Pre-Filled Syringes Shine in Safety Studies
RIGHT STUFF? In a landmark recent study, observers documented 20 medication errors per every 1,000 medication administrations in the OR.How many medication errors are being made every week at your facility? I'd bet that it's more than you realize. I'd also bet that using pre-packaged, pre-filled syringes has the potential to reduce the number — maybe dramatically.
Getting back to the question: If you're typical and if you assume that self-reported data is accurate, you might be looking at a relatively small (but still concerning) number of errors. Studies in South Africa, China and the United Kingdom have pegged the average numbers of medication errors at 4 per 1,000 drug administrations, 7 per 1,000, and 8 per 1,000, respectively. But a landmark recent study (osmag.net/ydEHH2) in the United States pegged the number at an eye-opening 20 errors per 1,000 administrations. Why so much higher? Maybe because the U.S. study used third-party observation, rather than self-reporting.
Of course, that can work both ways. In the U.S. study, which was done at a large academic hospital, people knew they were being watched, so they might have been nervous and more likely to make mistakes. Then again, they were also probably trying to be extra careful. Either way, the fact is that over the course of 277 operations and 3,671 medication administrations, 193 errors were observed. Of those, 153 were considered preventable, and of those, 99 were considered serious, 51 were considered significant and 3 were classified as life-threatening.
Scary, right? Another very recent study (osmag.net/KGvJ2q) compared pre-filled syringes to traditional 'self-filled syringes' and found that pre-filled have the 'potential to improve system safety and work efficiency.'
8. They can help mitigate supply-chain issues. Some compounders are able to guarantee reserve supplies for their clients when shortages occur.
9. They promote environmental stewardship. By cutting down on incinerated drug waste, pre-filled syringes reduce greenhouse gases and environmental pollution.
THUMBS UP
Compounders Are Stepping Up, Achieving Impressive Safety
ON POINT It's doubtful that any surgical facility can match the levels of control, sterility and competence that FDA-approved 503B compounders offer.As a pharmacy and safe medication consultant to ambulatory surgery centers, I can honestly say that once you understand the myriad benefits of using pre-packaged, pre-filled syringes, there's really no more discussion to be had. I'd give them 3 thumbs up, if I had 3 thumbs.
Unfortunately, largely as a result of the 2012 meningitis outbreak, which was linked to the New England Compounding Center (NECC) (osmag.net/Gb3xHT), there's a lingering temptation to put all compounders into a bucket of hesitation. That bucket says they're not as good, or as safe, as pharmaceutical manufacturers. Here's what people need to understand: As a result of the NECC fiasco, the FDA stepped up — and quickly — by, among other things, developing categories of compounders. The resultant 503B compounders — those qualified to dispense not just to a single patient, but also to provide broader distribution to healthcare providers — represent a big step forward. I've collaborated with this select group. They're well aware of provider concerns, are clearly focused on excellence and are achieving exceptional results. In fact, they appear to be achieving a recall rate that equals or surpasses that of pharmaceutical manufacturers.
But there's one caveat. Your pharmacy consultant needs to help facilities in the due diligence of provider selection, because registering with the FDA as a 503B is just the first step. An ensuing FDA inspection is an integral part of the process. I urge my clients not to do business with a 503B compounder until after the FDA has visited the facility and provided its formal assessment.
But once that hurdle is cleared, it should be smooth sailing in terms of regulatory compliance and quality. No surgical facility preparing syringes on as-needed basis can match the levels of control, sterility and competence that FDA-approved 503B compounders achieve.
If you're on the fence because you're concerned about costs, I recommend you work with your pharmacy consultant to develop an accurate cost analysis, based on what you're doing now vs. what you might consider going forward. That means looking at more than just the obvious. For example, now you have to buy drugs, you have to buy needles and syringes, you have to buy labels, and you probably have to buy small IV bags to put drugs in. And then there are the costs related to extra time — with both nurses and anesthesia providers. Those may not be as easily identifiable, but they're interrupters. Consider also the temptation that exists to bend the rules. A busy facility may decide to mix drugs well in advance, instead of doing so on an as-needed basis, as close to administration time as possible. It pays to eliminate that temptation.
Ultimately, when you look at all of those costs, and consider, too, that some compounders' prices may be negotiable and have group purchasing structures, the price gap may really narrow. Pre-filled meds may still be a little more expensive, but there are more factors to consider — the cost of having something go wrong in terms of patient and family impact, legal costs, costs to your reputation or maybe the cost of an injured staff member. That may be all the discussion you need before deciding on this extremely important quality-assurance measure.
Mr. Sones ([email protected]) is a pharmacy and safe medication consultant to surgical centers, and a member of the Outpatient Surgery Magazine editorial board.
10. They improve compliance. Many accreditation bodies recognize the added safety of single-use pre-filled syringes. Facilities that use them are less likely to be cited for non-compliance with labeling standards (date drawn, preparer's initials, etc.) or sub-optimal practice standards (like risking using single-use vials for multiple patients).
11. They eliminate billing fraud. You can't accidentally charge 2 patients for a drug that was drawn from a single vial, which is fraud, plain and simple.
12. They improve staff safety. Pre-filled syringes are a needle-free system. That means fewer accidental needlesticks when preparing medications.
Not perfect
Of course there are some minor disadvantages, too. As noted, pre-filled, pre-packaged drugs can be more expensive, even when you consider the time and waste they save. They can also take up more space in storage — an issue for facilities dealing with tight quarters. Additionally, you may not be able to — or want to — get every drug you need from an FDA-inspected 503B compounder. Some compounder drugs — like propofol — have much shorter shelf lives than the drugs you get from pharmaceutical providers. But when you consider all the factors, including, by the way, the vast improvement in FDA oversight of compounders that's come about in the last few years, pre-filled and pre-packaged meds are clearly an idea whose time has come. OSM
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