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Is Custom Compounding Right For You?
Find out why using a lab to formulate drugs tailored to your needs is the efficient and economical choice for a growing number of facilities.
Dan O'Connor
Publish Date: April 10, 2011   |  Tags:   Anesthesia

Custom CompoundingBefore the Hunterdon Center for Surgery began using a compounding lab to formulate the drops for its cataract patients, the Flemington, N.J., facility was spending $21 on eye drops per patient. And that figure was just the tip of the iceberg. It neither accounted for all the leftover single-dose or single-use medications that went to waste nor for all the time that it took a nurse to instill 3 sets of 5 drops and wait 15 minutes between each set.

The compounding lab has greatly simplified the process. The lab mixes 1mL of all 5 ophthalmic drops — ofloxacin, phenylephrine 10%, ocufen, tetracaine and mydriacyl — into individually packaged and labeled (expiration date included) 3cc syringes. All your dilating, antibiotics and numbing agents formulated in 1 syringe: That's convenience for patients, each of whom gets his own set of drops, and for nurses, who used to have to open 10 bottles of drops for a day's worth of 20 patients, but now simply instill 1 drop from the compounded syringe every 15 minutes for a total of 3 drops.

"The ease makes the savings immeasurable," says Lisa York, RN, MSN, Hunterdon's nursing director. "Our nurses really like it. And if it's my mother, I'd rather she have her own little syringe of eye drops."

But let's not forget about cost savings. The compounding lab charges $7 per formulated syringe, two-thirds less than what the ASC was spending on drops. (The per-syringe cost was $9.74 before the compounding lab recommended that the ASC replace the fluoroquinolone Zymar, which cost $76.74 per bottle, with generic ofloxacin). Hunter-don hosts cataract cases once a week and averages 20 patients per cataract day. In drops alone, the compounding lab is saving the facility nearly $15,000 per year. It's safe to assume that the savings in staff time are twice that when you consider the time nurses used to spend instilling 15 drops in more than 1,000 patients per year and waiting for them to settle in. Staff are free to perform other patient care duties and patient flow is much improved, says Ms. York.

Safe medication vial practices
USP 797, which governs a wide range of pharmacy policies and procedures, is designed to cut down on infections transmitted to patients through pharmaceutical products. The guideline helped clarify the confusion over the expiration dates of multiple-dose and single-dose vials once they're opened.

USP 797 states, "Opened or needle-punctured single-dose containers shall be used within 1 hour if opened in worse than ISO Class 5 (maximum of 3,520 particles up to 0.5 microns in size per cubic meter of air) air quality, and any remaining contents must be discarded. Single-dose vials exposed to ISO Class 5 or cleaner air may be used up to 6 hours after initial needle puncture. Opened single-dose ampoules shall not be stored for any time period. Multiple-dose containers (e.g., vials) are formulated for removal of portions on multiple occasions because they usually contain antimicrobial preservatives. The beyond-use-date (BUD) after initially entering or opening (e.g., needle-punctured) multiple-dose containers is 28 days unless otherwise specified by the manufacturer."

Remember that $77 bottle of antibiotic? How realistic is it to expect a surgical facility to open 20 of those bottles, use only 3 drops from each one and then pour the rest down the drain?

"Compounding is so wonderful because you're decreasing the risk for any infection and following safe injection guidelines," says Ms. York. "You're using drugs you would use anyway, and they're safe, secure, sterile and stable. And it's less expensive."

In the 3 months Ms. York's facility has been using compounded drugs, there's been no difference in dilation. "No problems at all," she says. Ms. York warns that you'll need to sell your physicians on the idea and get approval from infection control before you partner with a compounding lab. Also make sure you're dealing with a lab responsive to the needs of a surgical facility, she says.

One of Ms. York's high-volume cataract surgeons wasn't pleased when the facility wanted to take his Zymar away in favor of a less expensive generic antibiotic. In the end, the $2.74 per-patient savings won the doctor over. "It was a new thing," she says. "Any time you're introducing a change, you're moving their cheese. It took a little convincing."

Compounding labs can prepare products in various strengths and sizes. Hunterdon also gets its Omnipaque, a contrast agent used in pain management cases, from its compounding lab. Omnipaque comes in 10cc or 20cc from the drug manufacturer, but a neck injection only requires 3cc, so that's what the ASC asked for — and received. Instead of paying $40 for larger vials and throwing the leftovers away, the facility orders 3cc vials for $9. "We're not wasting money, we're not wasting drugs. Why would you not do that? You're saving your bottom line," says Ms. York.

You want it, you got it
For Rae-Jean Trantalis, RN, the clinical director of the Constitution Eye Surgery Center in Waterford, Conn., a compounding lab lets her 2-OR facility cater to its surgeons as if her ASC were a hospital with its own pharmacy. Accommodating the 2 physicians who prefer slightly different strengths and dosages of the same agent? Not a problem. "Our lab will mix these drugs in dosages that we need," she says. "It's nice to know that we have options. Our supplier is not going to mix the agent the dosage or strength we need, but our lab can customize for us."

Her compounding lab has also taken the headache out of preparing epi-Shugarcaine, a buffered lidocaine mixture with epinephrine for cataract surgery. Preparing epi-Shugarcaine yourself is no small feat. The recipe in whole cc quantities is 9cc BSS Plus, 3cc 4% preservative-free lidocaine and 4cc 1:1000 preservative-free, bisulfite-free epinephrine. That's fine if you don't mind breaking 3 ampoules to get 3mL of lidocaine and 4 ampoules to get 4mL of epinephrine. "It just becomes very time consuming for the nurses to mix — and easy to stick an ampoule through your finger," says Ms. Trantalis. Her compounding lab prepares the epi-Shugarcaine and puts it in small single-dose vials for her. "There's less chance of error. You know what you've got," she says. "Plus, there's the glass issue: Nobody likes the ampoules."

Bridging the gap during shortages
Compounding labs can provide a product that is otherwise unavailable due to manufacturer back order or discontinuation. Like many facilities, the Constitution Eye Surgery Center has been hampered by the shortage of Wydase, which, when added to retrobulbar or peribulbar blocks, helps the eye absorb the block. "We couldn't get it from our regular pharmaceutical supplier. It became very hard to find for a very long time," says Ms. Trantalis. "Our compounding lab can make it themselves and it's reasonably priced."

About 75 injectables are currently unavailable from suppliers, says the owner of a compounding lab. During these rolling-blackout-type shortages, compounding labs can bridge the gap for you, providing you with enough vials until the supply issues relieve themselves.

Take the reversing agent neostigmine, for example. Many facilities across the country are reportedly facing shortages of the drug that can dramatically shorten recovery times. Rather than consider canceling cases or using an alternative agent, a better option might be to ask a compounding lab to formulate neostigmine for you, says the lab owner. "People are coming to us for those types of things and asking, 'Can you compound this for us in the short term just so we don't have to cancel cases?'" he says. "This is a fairly common problem."

Epinephrine, a crash cart staple, was also in short supply of late, as was succinylcholine, a paralytic drug used to induce muscle relaxation and short-term paralysis. "We were scared that [surgical facilties] were going to have to cancel cases on that one, but we were able to find small supplies of manufactured product," says the lab owner.

Choosing the right lab
Even though the University of California Davis Medical Center in Sacramento operates its own pharmacy, it occasionally uses a compounding lab. "Compounding is a very specialized field and requires extensive training, record keeping and equipment," says Mark Riggle, PharmD, UC Davis's assistant director of pharmacy. If you're considering working with a compounding lab, Dr. Riggle offers this advice:

  • Make sure the compounding pharmacy is properly licensed with the Board of Pharmacy in your state. If the compounding pharmacy is out of state, make sure they can legally ship to your state.
  • Choose a pharmacy that has been accredited or certified to prepare compounded pharmaceuticals.
  • Ensure the pharmacy receives its chemicals and supplies from reputable sources. Ask questions about the lab's processes and make sure it has written policies and procedures in place. "I always visit a compounding pharmacy before doing business with them to view the facility, observe their operations and meet the staff," says Dr. Riggle.
  • Ask for references and check them.

"If you have patients that need specialized medications," says Dr. Riggle, "I feel more comfortable having them prepared by someone with the experience to do so."

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