Drug Topics - January 28, 2008 - (Page 9) www.drugtopics.com JANUARY 28, 2008 DRUG TOPICS 9 Latebreakers In Depth > > > How will revised USP 797 guidelines affect you? Sandra Levy T he United States Pharmacopeia released its revican be totally gowned and gloved and if you do not sion of Chapter , “Pharmaceutical Comavoid touching critical sites and if you do not disinfect pounding—Sterile Preparations,” in December. critical sites prior to injecting anything through them, The new standards become official June 1, 2008. you will contaminate IVs,” said Hernandez. How will the guidelines affect Ken Speidel, Pharm.D., conpharmacists? Eric Kastango, sultant for PharmaCare Rx Inc., R.Ph., CEO of Clinical IQ, applauded the revision for definLLC, Florham Park, N.J., who itively stating that the guidelines served on the Sterile Comapply to all persons who are compounding Expert Committee, pounding sterile preparations. told Drug Topics that the revi“It’s not just pointing to the sion emphasizes training and pharmacist in the home infusion competency of pharmacists and company or the institutional Eric Kastango (l) and Ken Speidel technicians. area. It applies to the ambulatory “Attention has been focused are both proponents of USP’s revised infusion suite, infusion centers, sterile compounding guidelines. on facilities, clean rooms, cleanliand physician suites,” he said. ness, and air classification, but the most important Speidel also praised USP for permitting comfactor that determines whether a product is going to pounded parenteral nutrition to be considered stable be sterile is the person who is compounding the prodfrom a sterility sense when kept in the refrigerator for uct. The chapter is much more employee centric. nine days, instead of seven. There has to be a greater focus on training, competency, and documentation of the training and holding Viable air testing people accountable,” said Kastango. Speidel expressed concern about USP’s viable air testing requirements because the equipment is expensive, Preventing contamination especially for smaller organizations. “We are required Kastango explained that the revision highlights the by USP to test our clean rooms every six months. We importance of finger tip sampling, and surface samhave a company that comes in. We need to push testpling of hoods and other components as well as othing companies to include viable air testing in their er sources of contamination. It also explains the imservice offerings, so that when they come in to test our portance of wiping vials and components before particulates, they will also look for pathogens, bacteusing them, and routinely disinfecting gloves with ria, or fungi that are in the air,” said Speidel. sterile alcohol. Finally, Speidel praised USP, stating, “Oftentimes Kastango added that Chapter is now aligned in home infusion we are asked to prepare certain with existing evidence-based standards such as the chemotherapy products that are used on a pump for a Centers for Disease Control & Prevention’s hand hypatient in the home. To require that these products be giene guidelines. prepared in a negative pressure room would be cost Luis Hernandez, R.Ph., sterile admixtures superviprohibitive to organizations that do a very small volsor at Baptist Hospital Miami, in Florida, said, “Makume. USP said that small organizations can use ing sterile products in a hospital environment has closed-system transfer devices, which aren’t as costly.” been something that everybody has gone about in Meanwhile, the Pharmacy Technician Certification whatever way they thought was best.” Board has revealed that an exam that will give certified Hernandez went on to explain that many people technicians an additional designation in IV admixture haven’t followed guidelines for gowning, cleaning, is on the drawing boards. According to Melissa Murand using aseptic technique. “You have to have some er Corrigan, CEO of PTCB, this additional credential kind of enforcement. Touch contamination is the No. will give technicians new room for moving up the ca1 reason why we have line infections in patients. You reer ladder. DT http://www.drugtopics.com
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