
The fungal meningitis outbreak caused by contaminated steroid products from the New England Compounding Center (see "The Latest on the Deadly Meningitis Outbreak" on page 10) has left facilities nationwide questioning the compounding services and pre-loaded drugs that play key roles in their patient care. As a pharmacy consultant, I'd advise them to stay the course, but to prepare for safety. Here's how.
• Should we reconsider our use of compounding pharmacies? I've heard this question a lot lately. Although your immediate response may be to abandon compounded drugs entirely, that emotional reaction fails to acknowledge the long and admirable track record of compounding pharmacists — including cutting-edge corporations and hospital pharmacy departments — that meet or exceed quality and safety standards. These services ably fill surgical facilities' needs at a time when drug shortages and a lack of customized products would otherwise leave them at a severe disadvantage. One bad apple shouldn't give the entire compounding industry a bad name. Major well-known pharmaceutical companies have suffered recalls over the years. The key here is to identify compound pharmacy leaders with track records and accreditation credentials that are impeccable.
• What's the best way to choose a compounding service? The outbreak and its aftermath will lead many facilities to seek other sources or evaluate their current contracts. How can they make an informed decision? The FDA has limited supervision over compounders, and not every potential surgical center can visit the compounding sites or know what to look for. But the International Academy of Compounding Pharmacists (IACP) has developed a checklist of criteria for making a selection (tinyurl.com/96bn9qy), and accreditation by the Pharmacy Compounding Accreditation Board (PCAB) is a mark of excellence. Submit the IACP's questionnaire to any services you're considering.
• How should we safeguard our use? Compounded and prepared pharmaceuticals should be used precisely as directed. In the case of pre-loaded syringes, pre-filled pain pumps or ready-to-use sterile admixtures, no other drugs should be mixed in. Standard rules of injection safety apply: These packages are for single-patient use only and should not be tapped like vials for multiple uses.
• What do you see on the horizon? It seems reasonable to assume that the next surveyors who visit your facility will be more focused than ever before on how you handle sterile products in general, and single-dose vials, multiple-dose vials and compounding in specific. You can expect inquiries about whether and how your facility is prepared to handle drug recalls. Because recalls happen fairly frequently (due sometimes to a risk of patient harm and sometimes simply to labeling adjustments), the lack of a file of recall records may indicate that you don't have a working recall policy. Be sure to have those records ready for your surveyor's review. They should include the notification letter from the FDA or drug manufacturer, an accounting of the affected drugs you had on hand, and any action you took to insulate your facility and alert your patients.
Avella Specialty Pharmacy
www.avella.com
(877) 546-5779
FYI: Formerly known as The Apothecary Shops, Avella Specialty Pharmacy focuses on supplying surgery centers. Avella's clinical pharmaceutical management programs are based on regular communications with providers and stringent safety standards. Over the past 16 years, Avella has grown its national mail-order capacity, community-based branches, sales force and wholesale division in order to provide personal, timely, consistent and cost-effective specialty pharmacy services to thousands of practitioners and patients across the country.
B. Braun Medical
2g Cefazolin in Duplex Drug Delivery System
www.bbraunusa.com
(888) 4-BBRAUN
FYI: B. Braun Medical's 2g Cefazolin for Injection USP and Dextrose Injection USP in the Duplex Drug Delivery System is the first and only FDA-approved, pre-measured drug and diluent doses of the frequently prescribed cephalosporin. The Duplex system, a flexible, 2-compartment IV container, is ready to use wherever and whenever it's needed. Just fold, squeeze and shake the package to mix the contents for fast, convenient, accurate, safe administration with no waste. The product, which has a 9-month shelf life at room temperature, is compliant with the Surgical Care Improvement Project (SCIP), Joint Commission Standards and USP 797.
Baxter
www.baxter.com
(800) 4-BAXTER
FYI: The company that pioneered the commercial production of pre-mixed, ready-to-use IV solutions in glass bottles, then flexible plastic, closed-system IV containers and pharmaceutical partnerships to pre-mix drugs for IV efficiency, remains a leading source for drug and fluid delivery. In addition to IV solutions, Baxter's medical products division provides frozen and shelf-stable ready-to-use pre-mixed drugs that simplify preparation and are bar-coded for automated dispensing, pharmacy compounding services and contract manufacturing of pre-filled syringes and vials.
Central Admixture
Pharmacy Services (CAPS)
www.capspharmacy.com
(800) 853-6498
FYI: CAPS (a B. Braun company), the nation's largest network of outsourcing specialty pharmacies, was founded in 1991 to deliver high-quality admixture services and solutions to the dynamic and challenging healthcare market. State-licensed and FDA-registered, CAPS pharmacies operate 365 days a year and make more than 300,000 local deliveries annually to dispense labeled, patient-specific and anticipatory IV prescriptions to a growing family of customers. Both GPO and custom contracts are available.
Hospira
ADD-Vantage System
www.hospira.com
(877) 9-HOSPIRA
FYI: Hospira's ADD-Vantage System enables fast, convenient, safe and precise preparation of IV medications without needles, syringes or alcohol swabs. Liquid or powdered drugs are supplied in threaded vials that easily mate with the top of flexible diluent containers. The drug and diluent remain separate until an internal stopper is activated to allow mixing. A wide selection of drugs, concentrations, diluents and sizes are available in the specially designed containers, which are latex-free and compatible with automated dispensing systems.