COST OF CONVENIENCE What's it worth to have your medications already drawn up and labeled?

For a small physician-owned surgical hospital like ours, prefilled syringes make perfect sense. They might for your facility, too. First, though, you'll have to figure out the math. Because you'll almost always pay more when you buy drugs in premixed, prelabeled syringes, compared with traditional vials. For those who can't see past the price tag, this is where the conversation ends. But if you step back and consider the many benefits you'll receive in exchange, prefilled syringes might seem like quite the bargain.

Convenience. For starters, there's the convenience and time savings of having your medications already drawn up and diluted to the concentration you specify, and already labeled with name, date of expiration, concentration of drug and total amount of drug. It can easily take 45 minutes to draw up and label syringes from multidose vials. We're the only full-time pharmacy employees at our hospital, so not having to spend time drawing and diluting the drugs, and signing and affixing the labels, frees us up to focus on our many other responsibilities.

Safety. Then there's safety. Many medication errors occur at the point of drawing up medication from identical-looking vials. Because the medication is already premeasured and drawn up and ready to go, you'll drastically reduce the potential for human errors in calculating dose and concentration. You'll also remove the possibility of vial splitting and cross-contamination. You don't want your docs to use a single-dose vial for multiple vials, but we all know that physicians routinely split vials rather than waste expensive drugs. We once knew a doctor who would draw up 10 mL of neostigmine and put it in his pocket (unlabeled!). He'd give 3 mL to Patient A, go get a snack in the cafeteria and then pull the same syringe out of his pocket and give Patient B the same medication.

A simulation study published online last June in the Journal of Patient Safety found that medication error rates as high as 75% fell to the single digits when nurses used prefilled syringes vs. vial-and-syringe methods. "Having the medication predrawn in a prelabeled syringe goes a long way to reducing the chance that someone will make a mistake," say researchers.

Reduced waste. There's less wasting of medications with prefilled syringes because they're measured out in their common dosage amounts. If a medication comes in a 10-mL vial and the doctor administers 3 mL to the patient, you're wasting 7 mL (or at least you should be!). Because prefilled syringes come in the dose you most often need, there's little, if any, waste.

Compliance. The Joint Commission's National Patient Safety Goals stipulate that any drug that's drawn up in a syringe and not immediately administered must be labeled with the name of the drug, the concentration or amount and the expiration date if it's not going to be administered in the next 24 hours. Prefilled, pre-labeled syringes can help your facility comply with such rules while also saving time and labor.

Surgeon satisfaction. A doc who comes in one Thursday a month requests a ropivacaine pain ball for each of his cases. We kept 1 pain ball in inventory for him, but inevitably we'd run into trouble. Either he wouldn't show one month and the pain ball would expire, or he'd surprise us with 3 cases and we'd be out of stock. We considered training the nurse circulator to draw that medicine up on the sterile field in the OR, but that would have created a delay for the doctor. Instead we turned to our compounder. Each month, we order precisely the number of pain balls he'll need so we don't carry extras on the shelves and risk having them expire. We tell all of our docs that if they need something that we don't carry, give us 48 hours to order from our compounder and we'll have it here for you. If need be, we can arrange for overnight delivery. That $35 FedEx Express delivery fee is well worth it to please our surgeons.

NO WASTE To ease usage and avoid waste, syringes are filled with the most common dosages of each particular drug.

Overcoming sticker shock
Do the built-in safety, waste reduction and time savings justify the higher costs you'll pay for prefilled syringes? Let's use neostigmine as an example. Our contract price with the manufacturer for a 10-mL vial of the neuromuscular block reversal drug is $55. That's $5.50 per mL. We pay $30 for a 3-mL prefilled vial of neostigmine from our compounding lab. That's $10 per mL. Why would we pay nearly twice as much per mL to outsource that item? Glad you asked.

When you do the math, you'll discover that we're actually saving money by using ready-to-use syringe medications. The equation is simple: spend more, but waste less. We waste not a drop of neostigmine when we administer a 3-mL, $30 syringe. We waste 7 mL when we administer a 10-mL, $55 syringe. Something's wrong when the drain gets more medication than the patient. You'll ease your sticker shock when you take cost per mL, waste and staff time into account.

A longer shelf life is another advantage of prefilled syringes. We order the paralytic succinylcholine in 5-mL prefilled syringes, the appropriate dose for adults. Succinylcholine from the manufacturer comes in 10-mL or 20-mL vials that you must refrigerate. Once you take succinylcholine out of the refrigerator and place it in the automated dispensing machine, the drug will lose its stability before the 14-day expiration date. If a compounder draws succinylcholine up, the drugs will remain stable for 6 weeks.

That 6-week stability also helps us manage our drug inventory with greater precision. Let's say we order 25 prefilled syringes of succinylcholine and we use 14 syringes in 15 days. We order 25 more, which arrive 3 days later, leaving us with 36 syringes: 11 expiring in 2 to 4 weeks, and the rest expiring on their "beyond-use date" in 4 to 6 weeks. With our system of just-in-time inventory, we're never caught shorthanded without needed medications and, just as important, our drugs never expire on the shelves. If a compounder can show a drug is stable for 45 days, it can label the drug with a 40-day expiration date.

IF/THEN
When to Go Prefilled

GOOD DEAL You may find that the higher per-syringe cost is worth the investment due to the time and labor it saves.

When does it make the most sense to buy prefilled syringes? Here are 4 instances when it's wise to consider doing so.

1. If you draw it up 10 times a day. If you use a high volume of inventory and turn it over quickly, go prefilled. As a rule of thumb, we'd say it makes sense to use prefilled syringes if you administer the same drug 10 times a day. This creates a convenience for the OR team. They won't have to draw the drug up, label it properly and put it on the field.

2. If you're wasting a lot. If you're wasting a significant amount from the manufacturer's vials, go prefilled. In other words, if a drug comes in a 10-mL vial and you're using 3 mL at a time, you'll save money using a compounder. Neostigmine and ephedrine are among both the most expensive anesthetics and the most likely to not be completely used.

3. If there's a lot of math involved. If your doctors use a different concentration than what the manufacturer supplies, go prefilled. There's a greater chance of an error occurring if your docs have to draw the medicine up and then dilute with saline and perform a calculation.

4. If shelf life will be longer. If the prefilled manufacturer's beyond-use date (BUD) for a refrigerated item is significantly longer than the manufacturer's expiration date, go prefilled. If a manufacturer's BUD is 14 days and the compounder's is 6 weeks, you have 4 extra weeks of stability during which you can use that product.

— Joshua Montney, PharmD, MBA, BCPS,
and Johnathan E. Stinnett, CPht

Getting started
Many perioperative drugs are available in prefilled syringes, including anticoagulants, some antibiotics, pain relievers (both opioids and non-opioids), heparin flushes and saline flushes. You may also be able to order customized prefilled doses of medications from your compounder.

About a month after our hospital opened, in 2013, we started buying 5 commonly used medications in premixed ready-to-use syringes from a compounding pharmacy: neostigmine, succinylcholine, phenylephrine, prediluted ephedrine and rocuronium. We didn't have a clean room to prepare IV medications and we wanted to reduce the possibility of medication errors. Plus, our anesthesiologists were requesting specific concentrations of drugs. We didn't want them distracted with dilutions and calculations in order to draw up medications in the OR when they should be monitoring patients — especially the anesthesiologist who told us, "I'm not good at math."

We foresaw several problems with anesthesiologists mixing drugs that could have led to patient harm. For example, we didn't want anesthesia providers prescribing, preparing and administering medications with no double-check. We also didn't want to risk incomplete syringe labels — the anesthetist might have included the drug name, but not necessarily other important details, such as drug concentration or expiration date. And then there was the problem of what to do if the drugs the anesthesiologists prepared were not administered during the case? Take atropine, for example, which is often prepared for emergent situations. If it wasn't used, it would either be discarded or inappropriately kept beyond the expiration for use on subsequent cases.

If you decide to buy prefilled syringes, we strongly encourage you to visit the manufacturer. Our vendor invited us to tour their factory in Houston. The 4-hour drive was well worth it. We came away thoroughly impressed and convinced that there was no way we could achieve their level of cleanliness and automation. The machines and testing equipment, the UV lights, temperature and humidity controls, HEPA-filtered rooms — it assured us that we weren't going with another NECC (New England Compounding Center). They also let us watch them preparing a batch of drugs online. We were able to see the whole manufacturing process from start to finish: from receiving and distribution to dilution to labeling.

In praise of prefilled
Retail pharmacists love the convenience of prefilled syringes when giving flu vaccinations. You just screw on the needle and give the shot. The same applies in the OR. Staff simply select the correct medication and dosage, open up the package and administer the drugs immediately rather than drawing up medications and labeling syringes manually. What could be easier? Or safer? OSM

CONSULTANT'S CORNER
Are You Ready for Prefilled Syringes?

The sterile injectable medication landscape is ever changing. State surveyors continue to issue deficiencies related to noncompliance in the areas of medication administration, in both the hospital and ambulatory care setting; CMS safe injection standards, labeling requirements and vial splitting continue to be areas of focus during surveys. As regulation and federal oversight increase on FDA-registered 503B Outsourcing Facilities, we should all feel comfortable exploring compounding options.

The decision to move toward prefilled syringes begins with the evaluation of medication utilization at your facility. Dilutions are always a good place to start when considering which medications are good candidates for prefilled syringes. Cataract centers could move toward combo items that enhance efficiencies and improve dilation, such as tropicamide 1%, cyclopentolate 1%, phenylephrine 2.5% and ketorolac 0.5% in a single use 0.5-mL dropper syringe. Or you might begin by looking at drugs like succinylcholine, which could allow for longer room-temperature shelf life.

Purchasing prefilled syringes drastically reduces the potential for human errors in calculating dose and concentration, reduces preparation time, decreases turnover time and removes the possibility of vial splitting. CMS has incorporated syringe labeling standards from USP 797, which require hospitals and ambulatory surgical centers to include a considerable amount of information on syringe labels, including the beyond-use date and time. Many centers find it difficult to fit all of the information on the syringe. Prefilled syringes are CMS-labeling compliant. In addition, they come complete with an anti-tamper cap, making diversion increasingly difficult.

Begin with a few frequently used medications. Determine your acquisition cost for each drug and current utilization volume. For example, if you purchase 100 vials of neostigmine a year, that would equate to 100 doses administered per year, since each vial is single-patient use. Compare the cost of 100 vials vs 100 pre-filled syringes to determine the potential for savings. Remember to consider preparation time when calculating savings: drawing the medication, the syringe itself, swabbing, labeling and staff hours all contribute to the cost of preparing that syringe. Once calculated, you can use that figure to perform a cost-benefit analysis for the purchasing of vials compared to prefilled syringes. Be sure to ask your 503B sterile re-packager about contract pricing through your group purchasing organization.

Where to begin when transitioning to prefilled syringes? I suggest starting with a top 3 to 6 common medications — propofol, phenylephrine and succinylcholine, for example — that demonstrate the greatest savings in terms of shelf life by virtue of their stability at room temperature.

— John Karwoski, RPh, MBA

Mr. Karwoski ([email protected]) is the president and founder of JDJ Consulting, a pharmacy consulting company in Wenonah, N.J.