Clinical Pearls - Option Care of Arizona

June 2004

This publication was designed by Option Care with you in mind and will serve as your one source for "hot" topics in home infusion today.

Option Care is The Best Option@...for home infusion therapies and specialty pharmaceuticals.

New Sterile Compounding Regulations

New procedures and requirements for compounding sterile preparations have been established by the U. S. Pharmacopeia. The USP is a non government agency that develops standards promoting the safety and quality of medications USP Chapter 797- Pharmaceutical Compounding Sterile Preparations Regulations pertains directly to pharmacies that provide compounded infusion preparations. These regulations took effect January 1, 2004. These new guidelines will replace the former USP Chapter 1206, Sterile Drug Products For Home Use. The purpose of this new regulation is to ensure the sterility and integrity of all CSP's (Compounded Sterile Preparations), thus ultimately preventing harm to patients.

Some of the key principles of the USP 797 are highlighted below:

● Compounding conditions must meet an ISO Class 8 room, which is equivalent to a Class 100,000 clean room. (This means that there are filters in the room to remove particles from the air and there is regulation of the temperature and humidity)

● All aseptic manipulations must take place in an ISO Class 5 environment, which is equivalent to a Class 100 environment (This means that all compounding must take place in a horizontal or vertical laminar flow hood, or barrier isolator.)

● The new acronym CSP (Compounded Sterile Preparations) was introduced

● A quality assurance program must be in place. (Testing of the staff and the environment must take place. Examples of this are staff process validation, environmental testing, and end product sterility testing.)

● Batch records and lot numbers must be documented (Usually on a compounding worksheet, these are used in the event of a recall.)

● All healthcare professionals need to train patients and caregivers on proper storage of compounded products. (Our nurses and pharmacist are trained to perform this)

● Products should be kept in a temperature-controlled environment, meaning that refrigerated products should not be left in the sun and frozen products should not be allowed to defrost. (Option Care packs patient products to protect them from temperature variations.)

● Pharmacists must have extensive knowledge in beyond-use dating (meaning expiration date).

● Finished product release checks and tests need to be done. This includes visual inspections, reviewing the label, and applying injection port seals on all products.

● Aseptic technique needs to be validated through a training program (didactic, written and hands on).

● Environmental controls, such as strict cleaning procedures and monitoring programs, are performed to ensure a clean environment

Option Care has a history of providing high quality compounded sterile products. We have reviewed USP 797 chapter, attended professional education sessions, and have consulted many other sources in order to update our existing policies and procedures to comply with this new regulation. In January we performed a series of conference calls for our Option Care locations to review these changes in procedure We are very confident that Option Care has always been a leader in the area compounding sterile preparations because of our exacting standard for clean room maintenance, staff competency, and quality assurance. Be confident that your patient is receiving the highest quality infusion preparation (LKL)

Infliximab Maintenance Therapy for Patients
with Crohn's Disease and Fistulas

Infliximab has been used for maintenance therapy in patients with Crohn's disease without fistulas with excellent results. Infliximab is a monoclonal antibody against tumor necrosis factor. In a multicenter, double-blind, randomized, placebo-controlled trial, 282 patients received 5 mg of infliximab ker kg on weeks 0, 2, and 6 and were available for randomization at week 14 to receive placebo or infliximab maintenance. The conclusion was that patients with fistulizing Crohn's disease who have a response to induction therapy with infliximab are more likely to sustain a response for 54 weeks (length of study) if infliximab treatment is given every 8 weeks. Fistulas occur in 17 to 43 percent of patients with Crohn's disease which severely decreases the quality of life and may lead to total colectomies or other complications. Other treatments including antibiotics, immunomodulators, and dietary therapies have not resulted in sustained closure of fistulas in Crohn's disease. Surgical treatments with diversion of the fecal stream by creating a stoma often produces healing but is often undesirable to patients and the benefit of this approach may be minimal once bowel continuity is restored. The findings of this study have important implications for managing patients with fistulizing Crohn's disease. Response to infliximab is rapid and sustained with superior control of disease activity and an improved quality of life. (SP)

Reference: New Eng J Med 2004;350(9):876-885Infliximab Maintenance Therapy for Fistulizing Crohn's Disease

Vancomycin Resistance

A frequent cause of hospital and community acquired infections is Staphylococcus aureus. Development of vancomycin-resistant enterococci in the late 1980's has led the way to vancomycin resistant S Aureus (VRSA). Three isolates of VRSA from patients in the U.S. have been recently identified (Michigan, Pennsylvania, New York). There was a failure to detect this latest VRSA from a patient in a long-term care facility by a commonly used automated antimicrobial susceptibility test. After further testing and analysis by the CDC, it was confirmed to be VRSA susceptible to chloramphenicol, linezolid, minocycline, quinupristin-dalfopristin, rifampin, and trimethoprim-sulfamethoxazole. The goals of the investigation include assessment of infection control practices and whether transmission to other contacts has occurred. The public health response to identification of this VRSA infection is ongoing. Use of preventive infection control measures and early identification are critical to limiting the emergence and spread of antimicrobial-resistant microorganisms. (SP)

Whether it is anti-infectives. TPN, IVIG, or home chemotherapy, Option Care is the right choice. You may call us 24 hours a day, 7 days a week, for all your home infusion and specialty pharmacy needs.

For Patient Care: 800-531-2469 or 928-708-0025
For Customer Care: Contact Risa Little at 928-899-5774
E-Mail at rlittle@optioncareaz.com

And please, visit us online at www.optioncareaz.com

The Best Option@...for home infusion therapies and specialty pharmaceuticals.

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