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“USP’s Revised General Chapter Pharmaceutical Compounding-Sterile Preparations <797> Tightens Patient Safety Guidelines”

 Medical Air Solutions, LLC. monitors, daily, all informational sources and details relating to the long awaited changes in the guidelines (now standards) for compounding sterile preparations, (CSP).  USP announced last week the long awaited final revision was to be published today. It was released at noon, Dec 3, 2007. This new release confirms basically what Medical Air Solutions published in June 2006 in our publication “Current Comments in Healthcare  IAQ Issues, Volume 4, No.1”. following the Webinar hosted by USP.  Our document is a condensed eleven (11) page version of the extensive 61 pages of descriptions offered in the now released final Chapter <797> standards document.  We have taken the liberty of attaching both a copy of the USP announcement as well as a copy of the Joint Commission’s (JCAHO) statement regarding their intentions relating to this communication. You can review our Current Comments issue on our Web-site at your convenience at:

 www.medicalairsolutions.com


FOR IMMEDIATE RELEASE                                                                                     CONTACT: Sandra Kim, 301/816-8241; sek@usp.org

USP’s Revised General Chapter Pharmaceutical Compounding – Sterile Preparations <797> Tightens Patient Safety Guidelines

Rockville, Md., November 27, 2007 — The U.S. Pharmacopeia is pleased to announce that changes to General Chapter Pharmaceutical Compounding – Sterile Preparations <797> are final and available online prior to becoming official.  This revision tightens standards and conditions for sterile compounding over the current version of <797>, and will help improve patient safety.

The full chapter will be posted as a Revision Bulletin on USP’s Web site at http://www.usp.org/USPNF/pf/generalChapter797.html as of December 3, 2007.  These revisions will become official on June 1, 2008, and will be included in USP 32–NF 27 and the second edition of the Pharmacists’ Pharmacopeia, which will be published in March 2008.

The revised standards are being published online to give the compounding community time to implement changes before the official date. After June 1, the current version in USP 31–NF 26 will no longer be the official chapter.

“We deeply appreciate the dedication and commitment of the Sterile Compounding Expert Committee, which reviewed more than 500 comments from health care practitioners and organizations in response to the proposed revisions to General Chapter <797>,” said USP’s Diane Cousins, vice president, healthcare quality and information. “General Chapter <797> sets practice standards for compounding sterile preparations to ensure that all patients receive sterile, safe and accurate preparations during treatment. This chapter is one of the most important contributions to patient safety in decades.” The Expert Committee also convened two Advisory Panels and one industry forum to support its work.

USP is providing a variety of ways for practitioners and other interested parties to become familiar with the revised sterile compounding provisions prior to the June 1 official date. The next edition of the Guidebook on USP General Chapter <797> Pharmaceutical Compounding – Sterile Preparation will be available soon. In addition, USP is offering a variety of educational Webinars and workshops. All workshops will be ACPE accredited. For information on availability, pricing, dates and content, please visit www.usp.org after December 3.

For further information, please send an email to mediarelations@usp.org.


(For the full text of this article go to: http://www.drugtopics.com/drugtopics/article/articleDetail.jsp?id=414436)


Infectious Disease Experts Urge Hospitals to Reduce Infections and Protect Patients

Posted on: 04/03/2007

 

NEW YORK -- “Hospital infections affect two million Americans every year, costing 100,000 lives and adding $30.5 billion to the nation’s healthcare tab,” said Betsy McCaughey, PhD, founder and chairman of the Committee to Reduce Infection Deaths (RID). “This issue is especially critical for New York right now,” she said, because infection rates of New York hospitals will be made public beginning in 2008.

McCaughey, legionella expert Janet E. Stout, PhD, of the University of Pittsburgh, and Bruce Farber, MD, chief of infectious diseases at North Shore University Hospital in New York, met with New York-area hospital executives and infection control professionals recently to discuss the latest medical and economic data on infections acquired in the healthcare setting and provide solutions. The seminar, held at the Hilton in Melville, N.Y., was sponsored by RID and the North Shore-Long Island Jewish (LIJ) Health System with an educational grant from Pall Corporation.

McCaughey, a leading national figure in infection prevention and former lieutenant governor of New York, illustrated the cost-effectiveness of infection control. Research shows that eliminating infections can result in a 20-to-1 payback for the hospital within the first year alone, with no or minimal capital outlay. “Good infection control can make the difference between profitability and loss for an individual hospital,” she said.

McCaughey focused on cost-effective measures to curb the alarming rise in methicillin-resistant Staphylococcus aureus (MRSA), one of the deadliest germs responsible for hospital infection and one of the hardest to treat. She presented success stories from hospitals in Virginia, Pennsylvania, and Iowa that realized significant reductions in infection rates through simple screening programs and rigorous enforcement of staff and equipment hygiene procedures.

(For the full text of this article go to: http://www.infectioncontroltoday.com/hotnews/74h37301265390.html)

Source: Committee to Reduce Infection Deaths


Risk Factors for Spread of Respiratory Infections in Hospitals is Identified

Posted on: 03/20/2007

The 2003 severe acute respiratory syndrome (SARS) epidemic in China has lessons to teach hospitals on how to prevent the spread of other respiratory diseases, according to new research appearing in the April 15 issue of Clinical Infectious Diseases, currently available online.

Hospitals were epicenters of SARS transmission in Guangzhou province and Hong Kong in 2003. In hospitals with especially severe outbreaks, the researchers looked at environmental and administrative factors that may have assisted in the transmission of the infection from one patient to another. This new study suggests that hospital beds placed too closely together, hospital staff working while having symptoms of SARS, and the use of oxygen therapy were the most significant risk factors associated with the spread of SARS in 26 hospitals in Guangzhou and Hong Kong.

These findings have implications for controlling other respiratory disease threats, including pandemic influenza, according to senior author Joseph Sung, MD, PhD, of the Chinese University of Hong Kong. "The lesson we learned during the SARS epidemic," he said, "was that the hospital can be a breeding ground for infectious disease. Nosocomial infection can amplify an infectious disease outbreak. It is very important to provide adequate space in hospital wards and implement effective infection control measures in order to avoid cross-contamination in hospitals."

Unfortunately, the authors note, it is a common practice for hospitals to increase the number of hospital beds inside a ward to meet the increasing demand, especially during an epidemic. When the distance between beds is reduced, exhaled droplets can spread from one patient to adjacent patients, spreading infection.

Healthcare staff working while sick are an obvious source of infection. This study found that hospitals could reduce the risk of outbreaks by providing staff with handwashing, showering, and changing facilities.

The use of oxygen therapy, including both the use of high flow rate oxygen masks and bi-level positive airway pressure ventilation, increased the risk of the spread of SARS. The authors hypothesize that these treatments may propel infectious air from these patients farther than without masks or ventilation. Alternatively, they may generate more infectious aerosols.

"There is a gap in the knowledge of how oxygen and ventilation therapy may promote the spread of infection. Future research should include investigating the safety of high flow rate oxygen therapy and positive pressure ventilation in medical facilities and effective ways of ventilating hospitals and clinics to avoid spreading of droplets," said Sung. "These findings are relevant not only for SARS," he concluded, "but also for other infections transmitted by droplets such as influenza."

Source: Infectious Diseases Society of America (IDSA)

Betsy McCaughey, a health-policy analyst and former lieutenant governor of New York, works to reduce infection rates by promoting changes in hospital procedures. "Almost all infections are preventable. We've worked with hospitals that have reduced infections by 90 percent," said Mrs. McCaughey, founder and chairwoman of the nonprofit Committee to Reduce Infection Deaths (RID).

CDC data on the prevalence of hospital infections -- both for the nation and for individual states -- were last published nearly a decade ago. The non-random sample of 270 hospitals showed that the infection rate climbed 36 percent between 1975 and 1996.

But it said tracking infection sites was difficult because postoperative stays were often shorter than the incubation period for Staphylococcus aureus infections.

Late last year, Pennsylvania became the first state to disclose the number of hospital-acquired infections reported by the 168 hospitals in that state. The hospitals reported 19,154 cases in which patients acquired such infections in 2005, a rate of 12.2 per 1,000 cases.

The mortality rate for patients with hospital infections was nearly 13 percent. That compared with a rate of 2.3 percent for patients without a hospital-acquired infection.

Ms. Griffin of IHI said most of the nation's hospitals are participating in initiatives the group has sponsored that are designed to prevent "unnecessary deaths and harm in hospitals."

"Awareness is increasing, but reporting is just beginning," Mrs. McCaughey said. "Meanwhile, these infections are adding $30.5 billion to the nation's health tab."

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