Drug Store Directory Blog
Tuesday, January 31, 2006
  Free Online Daily Business Newsletter for Physician Leaders
 
HealthLeaders Media Launches Free Online Daily Business Newsletter for Physician Leaders - PhysicianLeaders Daily News

PhysicianLeaders Daily News, a new free online publication offering daily updates on top business news of the day for physician leaders, is now available.

Marblehead, MA (PRWEB) January 31, 2006 -- PhysicianLeaders Daily News, a new free online publication offering daily updates on top business news of the day for physician leaders, is now available.  

Physician leaders need timely, accurate and relevant business information every day. Physicians are trained to sift through myriad bits of information to come up with only what is essential. This same philosophy guides our editors—the same team of journalists who bring you HealthLeaders magazine and HealthLeaders Daily News. We look for the national stories that have implications for physician leaders, as well as some of the local and regional issues that could impact their practice.

“Today’s physician leader is being bombarded with information at the same time that the business side of medicine increases in complexity,” says HealthLeaders editor Jim Molpus. “This newsletter is designed to be a streamlined way for physicians to stay current on the business of healthcare.”

Every issue will feature a handful of links to the top news of the day from newspaper Web sites across the country. PhysicianLeaders Daily News also offers quick, action-oriented insight, from new ways to make the practice more efficient, to updates on policy from Washington. Peer insight comes from contributed columns from experts in the medicine. Plus, the PhysicianLeaders Daily News offers abstracts and exclusive bonus content from the physician practice expert newsletters of HCPro, Inc.

PhysicianLeaders Daily News is delivered to a physician’s inbox every day for free, in an easy-to-read format. Readers may go to www.healthleadersmedia.com/subscribe to sign up.

To sponsor PhysicianLeaders Daily News contact Sara Law at 800.639.7477.

About HealthLeaders Media
HealthLeaders Media, a division of HCPro, Inc, is the premier publisher of information resources for senior executives at healthcare organizations. Each month, more than 100,000 healthcare executives and key decision makers nationwide turn to HealthLeaders Media for timely industry information and practical advice on trends and innovations, strategy, case-study solutions, and opinions. As an integrated media company, HealthLeaders Media consists of the monthly HealthLeaders magazine, several healthcare business e-mail publications, live events, and a state-specific healthcare business news service. Advertising vehicles include print ads, online sponsorships, banner ads, e-mails, Webcasts, roundtables and custom publishing products. For more information, visit them online at
www.healthleadersmedia.com.

Contact:
Matt Cann, Group Publisher
Phone: 781-639-1872 ext. 3233

Mark H. Hollister, General Manager
Phone: 888.834.4678

# # #

Press Contact: Matt Cann
Company Name: HCPRO
Email: email protected from spam bots
Phone: 781-639-1872
Website: www.healthleadersmedia.com/subscribe

 
Monday, January 30, 2006
  Cub Pharmacies Help Seniors with Medicare Education Program
Minnesota Cub Pharmacies Help Seniors with Medicare Education Program
 
ST. PAUL, Minn.--(BUSINESS WIRE)--Jan. 30, 2006--Several Cub Pharmacies in Minnesota will host My Medicare Matters(TM), a free, one-on-one educational program to help Medicare participants and their families understand the new Medicare Prescription Drug Coverage. Forty-two million seniors in the U.S. face critical Medicare Part D choices that must be made by May 15, 2006.

The National Council on the Aging (NCOA) and the Access to Benefits Coalition (ABC) have recently launched My Medicare Matters nationwide in an effort to provide much needed impartial educational support for seniors at local events and community centers via computer equipped vans and expertly trained educators. The program is supported by The Minnesota Senior Federation, the primary grassroots organization of seniors in Minnesota. With more than 20,000 members and 100 affiliated organizations, the Federation is dedicated to helping seniors develop leadership skills and work toward positive social change locally, statewide and throughout the nation.

The My Medicare Matters team of educators will meet with individuals, family members and/or caregivers for 10 minutes ... 45 minutes ... or more until each senior's questions and concerns have been addressed.

At the events, seniors can sit down with benefits educators who will provide private, personalized guidance as they learn about the new coverage and their options. The educators will use the latest technology via Web-enabled computers, and use Internet-based tools during counseling sessions to help seniors compare plans and make the enrollment decision that is right for their health and their financial situation.

If and when seniors are ready to join a plan, the My Medicare Matters (TM) educators will also assist them in completing the online enrollment process or advise them about other methods for joining a plan.

My Medicare Matters sessions will be held according to the following schedule. Sessions at each location are always held from 1:00 p.m. to 4:00 p.m.:

-- Thursday, Feb. 2, 2006, Cub Foods, 7555 W. Broadway Ave., Brooklyn Park;

-- Friday, Feb. 3, 2006, Cub Foods, 250 33rd Ave. So., St. Cloud;

-- Wednesday, Mar. 1, 2006, Cub Foods, 2859 26th Ave. So., Minneapolis;

-- Friday, Mar. 3, Cub Foods, 2001 So. Robert St., West St. Paul;

-- Tuesday, Mar. 14, Cub Foods, 15350 Cedar Ave.; Apple Valley;

-- Monday, Mar. 27, Cub Foods, 2197 Old Hudson Rd., St. Paul;

-- Thursday, Mar. 30, Cub Foods, 1440 University Ave., St. Paul;

-- Wednesday, Apr. 5, Cub Foods, 8690 E. Point Douglas Rd., Cottage Grove;

-- Wednesday, April 12, Cub Foods, 701 W. Broadway Ave., Minneapolis;

-- Friday, Apr. 21, Cub Foods, 5397 Nicollet Ave., Minneapolis;

-- Tuesday, Apr. 25, Cub Foods, 7435 179th St., Lakeville;

-- Tuesday, May 2, Cub Foods, 1729 Market Blvd., Hastings;

-- Wednesday, May 10, Cub Foods, 4801 Hwy. 101, Minnetonka;

-- Monday, May 15, Cub Foods, 1059 Meadowlands Dr., White Bear Lake.

The Web site, www.MyMedicareMatters.org, is available for use by Medicare participants, and their families, friends, caregivers, professionals and organizations. The Web site provides educational materials, and Internet tools that can be used to learn about Medicare Part D, and links them to CMS' Medicare Prescription Drug Plan Finder. People who visit www.MyMedicareMatters.org will also be able to enroll online or request extra help from the Social Security Administration.

Nationally, My Medicare Matters has deployed a fleet of 37 mobile education vans that are bringing trained staff and technology to 27 states and the District of Columbia to offer help in 44 metro areas and nearly 300 counties across the country. My Medicare Matters intends to hold informational events in the Twin Cities throughout the Medicare Part D enrollment period which ends on May 15, 2006.

My Medicare Matters is being supported by AstraZeneca Pharmaceuticals LP, fulfilling the company's mission to improve patient health for seniors across the country. "We believe the Medicare Prescription Drug Benefit can make a tremendous contribution to the quality of life for millions of Americans and we commend the NCOA and the ABC for offering this crucial educational program for seniors," said Tony Zook, President and CEO designate.

Additional My Medicare Matters sessions are being scheduled at Cub Pharmacies. Consumers interested in attending should call their local Cub Pharmacy for a schedule of events. Consumers also may contact the Senior Linkage Line at 1-800-333-2433.

Contacts
My Medicare Matters(TM)
Katie Keller, 651-351-7032
or
SUPERVALU/Cub Foods
John Anderson, 612-455-1756
 
  New Discussion Forum About Avian Flu Talk Launches
 
Avian Flu Talk Launches New Discussion Forum

Avian Flu Talk hosts forum for discussions relating to H5N1 bird flu virus.

(PRWEB) January 30, 2006 -- Avian Flu Talk recently announced that it had launched a discussion forum dedicated to discussing issues relating to the H5N1 bird flu virus. Over the last 90 days, this new forum has rapidly grown to be one of the most active forums in the world. The new forum appears to be capturing the public’s attention as people continue to join this community in waves.

“Perhaps the forum is appealing to so many around the world because of the overall caring nature being displayed among the members,” said Ryan Evans, founder of the forum. “The people on this forum also seem to be taking a united stance against the growing pandemic threat, which is also attracting people to the site.”

The new website recently added new informative forums that are designed to help educate the public on pandemic preparedness. “The addition of these new forums will provide a great service to the world,” said Evans, who attributed these latest enhancements to the forum Moderator.

In addition, this forum is a great news source to receive all of the latest information and developments regarding the bird flu as its members share news articles from around the world.

View the forum at www.Avianflutalk.com .

Media Contact:
Ryan Evans
Avian Flu Talk
P.O. Box 1294
Stanton, California 90680
714.965.5950
www.Avianflutalk.com

# # #

Press Contact: Ryan Evans
Company Name: Avian Flu Talk
Email: email protected from spam bots
Phone: 714.965.5950
Website:
www.Avianflutalk.com

 
  Merchandising Software Enhanced By Lawson
Lawson Enhancing Merchandising Software
 
ST. PAUL, Minn.--(BUSINESS WIRE)--Jan. 30, 2006--Lawson Software (Nasdaq:LWSN) announced today that it is working with a consortium of leading grocery customers to develop Lawson's next-generation Merchandising software suite.

"Our ongoing investment in Merchandising reflects our continued commitment to this industry," said Dale Christopherson, director, Retail Product Development, Lawson Software. "Based on the feedback provided by our retail customers, we're focusing our product development resources on Merchandising enhancements that will help save our customers time and help deliver a significantly lower total cost of ownership."

Lawson is updating seven applications within its Merchandising suite, including Category Review, Distribution, Retail Channel Order Management, Costs and Deals, Replenishment, Business Organizer and Reference Maintainer.

Lawson's industry-focused software solutions help retailers integrate the systems they use to run and grow their businesses. Lawson customers include five of the top 10 U.S.-based retailers, eight of the top 20 apparel retailers, seven of the top 25 grocery chains, 23 of the top 100 restaurant chains and 20 of the top 100 specialty chains.

About Lawson Software

Lawson Software provides business application software and consulting services to services organizations in the healthcare, retail, government and education, banking and insurance and other markets. Lawson's software suites include enterprise performance management, distribution, financials, human capital management, procurement, retail operations and service process optimization. With headquarters in St. Paul, Minn., Lawson has offices and affiliates serving North and South America, Europe, and Africa. Lawson Software and Lawson are registered trademarks of Lawson Software, Inc. All rights reserved.

Forward-Looking Statements

This press release contains forward-looking statements that contain risks and uncertainties. These forward-looking statements contain statements of intent, belief or current expectations of Lawson Software, Inc., and its management. Such forward-looking statements are not guarantees of future results and involve risks and uncertainties that may cause actual results to differ materially from the potential results discussed in the forward-looking statements. The company is not obligated to update forward-looking statements based on circumstances or events that occur in the future. Risks and uncertainties that may cause such differences include but are not limited to: uncertainties in the company's ability to realize synergies and revenue opportunities anticipated from the Intentia International acquisition; uncertainties in the software industry; global military conflicts; terrorist attacks in the United States, and any future events in response to these developments; changes in conditions in the company's targeted service industries; increased competition and other risk factors listed in the company's most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission and as included in other documents the company files from time to time with the Commission.

Contacts
Lawson Software, St. Paul
Terry Blake, 651-767-4766
terry.blake@lawson.com
or
Weber Shandwick
Jenny Myers, 217-649-2965
jmyers@webershandwick.com
At A Glance
Lawson Software
Headquarters: Saint Paul, Minnesota
Website: http://www.lawson.com
CEO: Harry Debes
Employees: 1354
Ticker: LWSN  (NASDAQ)
 
  Application for Medicare Deeming Authority Published By Federal Register
 
Federal Register Publishes TÜV Healthcare Specialists’ Application for Medicare Deeming Authority

Healthcare quality firm TÜV Healthcare Specialists (TÜVHS) today announced that its application to the Centers for Medicare & Medicaid Services (CMS) for deeming authority has been published in the Federal Register.

Cincinnati, OH (PRWEB) January 30, 2006 -- Healthcare quality firm TÜV Healthcare Specialists (TÜVHS) today announced that its application to the Centers for Medicare & Medicaid Services (CMS) for deeming authority has been published in the Federal Register.

The CMS request for public comments in the Federal Register is a key administrative milestone in the months-long process to achieve CMS hospital deeming authority for Medicare. TÜVHS completed its formal application for deeming authority in December. Posting in the Federal Register (
http://www.gpoaccess.gov) moves the process into the public domain as a way to inform and involve healthcare leaders and the general public.

“January has been a significant month for us,” says Rebecca Wise, CEO of TÜVHS. “In addition to expanding our ISO 9001 and accreditation teams, we have been undergoing a rigorous evaluation of our operations by CMS. We want to be ready when CMS issues their decision.”

If granted deeming authority, TÜVHS will become the first new option for CMS hospital accreditation in 40 years, and the only service to integrate the ISO 9001 Quality Management System into the accreditation process.

About TÜV Healthcare Specialists

TÜVHS (TÜV America Healthcare Specialists TÜV SUD Group LLC) is an experienced healthcare quality company dedicated to improving safety and patient outcomes in America’s hospitals. TÜVHS is a subsidiary of the international quality management and product testing company TÜV America. TÜV America is a Registrar for the international ISO 9001 Quality Management System. For more information visit: www.tuvhs.com.

# # #

Press Contact: Peter Greer
Company Name: TUV Healthcare Specialists
Email: email protected from spam bots
Phone: 978-462-8042
Website:
www.tuvhs.com

 
  Patient Flow System Integrates with Physician Office Practice Management System
 
MediComm Patient Flow System Integrates with Centricity Physician Office Practice Management System

Visionary Systems announces new Reception Desk Software that integrates its MediComm exam room management system with Centricity’s Patient scheduling module.

(PRWEB) January 30, 2006 -- Visionary Systems announces new Reception Desk Software that integrates its MediComm exam room management system with Centricity’s Patient scheduling module.

Centricity, the industry's leading practice management software, can now forward patient information to Visionary System's MediComm exam room management system.

When the receptionist checks a patient in using Centricity, the patient's name and the name of their physician are automatically sent to the MediComm system. The MediComm system then keeps track of patients as they are assigned to exam rooms, taken to the x-ray suite, or to the lab for blood work. Throughout these movements within the office, the MediComm system maintains the proper priority of the patient relative to other patients.

Norma Morrison, vice president of operations at Foundry Sports Medicine and Fitness in Providence, Rhode Island says “One of our concerns coming to our new office was the communication from the front desk to the patient treatment area. The MediComm system handles this without extra steps or wasted time in walking up front, and eliminates confusion if a medical assistant/x-ray tech is busy and does not hear an overhead page. The MediComm system is foolproof and has exceeded our expectations.”

The heart of the MediComm system is an LCD touch screen mounted at the back nurse's desk. Along with a full floor plan of the exam room status, the MediComm system displays a list of patients in the waiting room. Using the touch screen, a staff member assigns patients an exam room, which alerts the doctor that the patient is ready. Modules outside each exam room display the name of the patient in the room, as well as which room the doctor should go to next. User defined pushbuttons on the modules allow the doctor to call for additional services such as an x-ray, medical assistant, or lab tech.

Morrison added “We no longer use paper charts. But without the chart on the door, the doctors wouldn't have known the name of the patient in the exam room. The MediComm system not only lets the doctor know who is in the room, but also the order of rooms to visit - even if a patient left the exam room for an x-ray, and is now back and awaiting the results. Our staff always knows what to do and where to go next.”

About VISIONARY SYSTEMS and MEDICOMM.
The MediComm is a sophisticated and user-friendly communication system. It allows doctors to request specific staff assistance, and directs doctors to their next patient. It is the ultimate exam room signaling system.

A central display panel gives an overview of the entire office, while modules at each exam room allow quick data entry and focused information display.

MediComm can streamline traffic and information flow in your office. MediComm:

Indicates which rooms are free.

Tells the doctor which room he has patients in – and keeps them in order so he knows which room to go to next.

Allows the doctor to call a particular nurse or tech service with enough detail so that the assistant arrives prepared.

To learn more visit http://visionary-systems.com or call 401-643-1765.

# # #

Press Contact: Marshall Huggins
Company Name: Visionary Systems
Email: email protected from spam bots
Phone: 401-643-1765
Website:
http://visionary-systems.com

 
Sunday, January 29, 2006
  New Trial of Anticancer Drug From Genta
Genta Initiates New Trial of Anticancer Drug
Jan 29, 2006 11:22 AM

Genta Incorporated has entered the first patient into a new clinical study that will evaluate the bioactivity and safety of the company's lead anticancer drug, Genasense Injection, administered by intermittent subcutaneous injection.

The study employs a new formulation of Genasense that is five-fold more concentrated than material currently used in clinical trials. Having completed requisite animal toxicology work, the trial is proceeding pursuant to a separate investigational new drug application that was filed with the FDA.

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced cell death. By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment.

A prolonged subcutaneous infusion method using the existing intravenous formulation of the drug has been studied in patients with advanced non-Hodgkin's lymphoma. In this study the drug showed anti-tumor activity as a single agent and documented down-regulation of Bcl-2.

The new program seeks to extend these initial observations in a formal dose-ranging trial using the new, highly concentrated formulation.

"Genasense has demonstrated synergy with various treatments, such as Tarceva, interferon and radiation, all of which require multi-day schedules," commented Dr Raymond Warrell, Genta's chairman and CEO. "The new method may substantially increase patient convenience and expand the utility of Genasense, particularly in front-line and adjuvant settings."

Other resource sites:
Mesothelioma Lung Cancer
Mesothelioma Search Engine
 
Friday, January 27, 2006
  2006 National Conference for Certified Professionals
 
PMI Announces the 2006 National Conference for Certified Professionals to be held in San Antonio, Texas

Practice Management Institute (PMI), a leading provider of medical office continuing education, today announced its National Conference for Certified Professionals, to be held on May 18 & 19, 2006 on the River Walk in San Antonio.

San Antonio, TX (PRWEB) January 27, 2006 -- Practice Management Institute (PMI), a leading provider of medical office continuing education, today announced its National Conference for Certified Professionals, to be held on May 18 & 19, 2006 on the River Walk in San Antonio.

“This conference is jam-packed with information critical to the physician’s office. Topics such as: ‘EMRs -- Should you Implement a Paperless System?’, ‘Pay For Performance and Consumer Driven Healthcare’ and ‘Making Sense of the New Competitive Acquisition Plan’ will be profiled at this year’s conference,” said Lynn Ballard, Conference Chair and VP of Professional Services for Practice Management Institute. “These sessions will be presented along with 20 other classes highlighting critical administrative issues that impact today’s physicians and their practices.”

PMI’s veteran faculty team will present the program, along with guest presenters, including Stan Luke, Deputy Chief, U.S. District Attorney’s Office, Civil Division, Department of Justice, and Michael Brown, Contributing Editor for Medical Economics. Round table discussions, customized breakout sessions and networking luncheons are planned to promote group interaction with conference participants and faculty members.

Participants are encouraged to register early, as the conference will be capped at 300 participants. This year, PMI celebrates 25 years of coding, reimbursement and practice management training. The federal government recently recognized PMI’s Certified Medical Coder (CMC) program. In 2004, the Centers for Medicare and Medicaid Services (CMS) named PMI’s Certified Medical Coder program as an example coder certification programs that could be utilized to fulfill its coding certification requirement of Medicare Contractors. The requirement stems from implementation guidelines for the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA). This recognition reinforces PMI’s position as a top provider of certification for medical office staff.

PMI training and certification classes are currently presented to physicians and their staffs in 400 of the nation’s leading hospitals, health care systems, colleges and medical societies. For more information, visit
www.pmiMD.com or call 800-259-5562.

###

Press Contact: Nancy Clements
Company Name: PRACTICE MANAGEMENT INSTITUTE
Email: email protected from spam bots
Phone: 210-691-8900
Website:
www.pmimd.com

 
  MD-IT Adds Operations Executive
 
MD-IT Adds Operations Executive

MD-IT, an industry leader in integrating automated tools with medical transcription to assist physicians in documentation of medical care, announced today that Michael Murphy has joined the Company as Vice President of Operations.

Denver, CO (PRWEB) January 27, 2006 -- MD-IT, an industry leader in integrating automated tools with medical transcription to assist physicians in documentation of medical care, announced today that Michael Murphy has joined the Company as Vice President of Operations.

Mr. Murphy brings twenty-five years of leadership and management experience with both start-up and Fortune 500 firms in software and services businesses. He has distinguished himself as an effective leader with a strong customer service orientation. After beginning his career at Verac, Inc. and later Ball Corporation, Mr. Murphy co-founded Colorado-based Requisite Technology and has been a key member of several successful Colorado startup companies. Most recently, Mr. Murphy served as the Vice President and COO of CTEK, a Colorado-based organization that helps entrepreneurs launch and develop new growth businesses.
“I’ve had my eye on MD-IT for the past couple of years,” said Murphy, “and I’m impressed by the cutting-edge technology it has developed and is now deploying to deliver state-of-the-art medical transcription services. I’m excited to be joining the company at this juncture, as it accelerates its growth to apply its medical transcription solutions more widely.”

The addition of Mr. Murphy is an important commitment to ensure timely, world-class customer support and service. MD-IT’s goal is to make it easy for physicians to use twenty-first century technology in their medical practices without complicating their workload or distracting from physician-patient interactions. “Physicians have enough time demands just keeping up with medical advances in their specialty area, much less having time to research and apply the latest advances in information technology,” noted Thomas Carson, president and CEO of MD-IT. “Our business is to integrate new technology seamlessly into the medical transcription process, so that when an individual physician is ready to try a new tool, such as automated voice recognition, we can switch on that function as part of their existing transcription service. The best part is that the more technology is used, the less expensive documentation becomes, so we can actually help a medical practice decrease operating costs over time while creating an electronic record.”

About MD-IT
MD-IT provides Intelligent Transcription services and products to over 300 physicians in 90 clinics and group practices. Intelligent Transcription uses new technology to transform old services by providing a full range of automated tools that enable fast and easy document creation and exchange among physician offices, medical transcriptionists and information systems, while retaining personalized service to support individual physician preferences. Located in Denver, Colorado, the company is financed by equity investments from strategic partners and private investors. Additional information can be found at www.md-it.com.

Intelligent Transcription - New Technology Transforming Old Services

Media Contact
Thomas Carson President and CEO, 720-932-6262 x411

# # #

Press Contact: Thomas Carson
Company Name: MD-IT
Email: email protected from spam bots
Phone: 720-932-6262
Website:
www.md-it.com

 
  Safe Handling of Hazardous Drugs Technical Paper
Technical Paper
 
Safe Handling of Hazardous Drugs
 
Discussions from a scientific advisory board on the impact of USP 797 and the NIOSH Alert for guiding the safe handling of hazardous drugs in healthcare settings. 
Introduction
 
2004 was a year of big change for United States pharmacy IV admixture services. That year, two documents were released with major regulatory implications for pharmacy practice:
 
1. USP Chapter 797. The U.S. Pharmacopoeia (USP) issued USP General Chapter 797, Pharmaceutical compounding sterile preparations in January, 2004. The Joint Commission for Accreditation of Healthcare Organizations (JCAHO) has adopted these standards for their own use as of July 1, 2004, and now includes adherence to the requirements as part of their accreditation audits. The full USP 797 implementation process is a staged series of escalating compliance issues. The entire chapter becomes enforceable in January 2008. In the meantime, numerous individual State Pharmacy Boards are including these standards in their inspections.
 
2. NIOSH Alert. On March 25, 2004, the National Institute for Occupational Safety and Health (NIOSH) issued a long-awaited study, Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Health Care Settings. NIOSH is an arm of the better-known OSHA (Occupational Safety and Health Administration) that will likely consider the Alert in its future regulatory influence on worker safety issues.
 
Experts in the field and other interested professionals assembled in San Antonio, Texas in the fall of 2004 for a scientific advisory board on the advancement of safe practice and the impact of the new regulatory requirements. This paper is a summary of viewpoints shared on the issue of hazardous drug handling from those in attendance. The scientific advisory board was co-sponsored by Baxa Corporation. Attendees included employees from both sponsors, industry thought leaders, participants from the NIOSH Hazardous Drug Safety Working Group, and healthcare practitioners.
 
The Importance of the NIOSH Alert
 
Tom Connor, PhD from the Division of Applied Research and Technology at NIOSH, and a member of the NIOSH Drug Safety Working Group, says there is certainly sufficient scientific evidence to support the Alert. He wants to get more people involved with safe handling issues.
 
We tried to make [the Alert] evidence-based. And, we have an extensive bibliography and cite many studies. So I think we have the support that we need to address some of the issues in the Alert, Connor explains. It's really difficult to get the information out there. We have nurses. We have pharmacists. We have people in home health care. And we've tried to include these people in our working group so that we can get the message out to them. I think the biggest thing is getting the message out to the people who need to have it.
 
Further, Melissa McDiarmid, MD, MPH of the University of Maryland and a fellow member of the NIOSH Drug Safety Working Group noted, the NIOSH Alert is an opportunity for everyone to refresh on what, theoretically, they should have already known and already put in place. But, we know from studies as well as from a lot of walk arounds, walk through rounds, and epidemiology that people were not honoring the OSHA guidelines. And, as the toxicity of anti-cancer drugs and the anti-viral agents gets ever greater, and we talk about different kinds of therapy, there's only going to be a need for increased vigilance.
 
Roger Anderson, D PH, RPh, Senior Vice President and Chief Pharmacist of Medco Health Solutions and former Director of Pharmacy for the MD Anderson Cancer Center was an early supporter of closed-system solutions for safe handling of hazardous drugs. Also a member of the NIOSH Drug Safety Working Group, Roger observed, Pharmacists are now on record as having to do something about environmental contamination. The Alert finalizes what we have been working on for over twenty-five years, and now have well documented, that pharmacists and other healthcare workers must do something to change current practice.
 
The Implications of USP 797
 
According to Professor Graham Sewell, professor UPS 797 and the NIOSH Alert are milestones for US pharmacy practice. Clearly they need to be brought together and can't be taken individually. One document obviously protects the product, and the other is designed to protect the operator. Sewell continues, In actual practice, you can't separate those two issues. So they need to draw together and develop a common approach, in my view.
 
According to Roger Anderson, Chapter 797 addresses sterility issues and the potential for cross-contamination both bacterial and other drugs and offers applications for the PhaSeal products, given that the device maintains a closed system that offers protection against touch contamination in addition to preventing environmental contamination.
 
The guidelines in USP 797, continues Anderson, as they relate to isolators, are a little bit more clear cut as far as the potential microbiological contamination of products. But, the application to the cytotoxic drug exposure to personnel and to the environment, to me, is extremely limited by the use of isolators. I have never believed that the use of isolators has much to do at all with environmental contamination. The exposure still occurs. The environmental aerosolization of drug products still occurs within the isolator environment...Other products that will come out of the isolator, to me, will carry the contamination. And I have never seen a system to definitely clean the products that come out that will then be dispensed to the wards. So to me, they carry out the contamination, Anderson explains.
 
I think the most important thing is that these two alerts NIOSH and USP797 have different points of view, asserts Johan Vandenbroucke, PhD of the University of Ghent in Belgium. ..somehow, we have to combine these two together. The protection of the employee and the protection of the product. And, I think they have an equal importance if you look at the safety of the patient, too. If you look at isolators, if you look at the PhaSeal system, if you look at biological safety cabinets and clean rooms, I think the most important thing is to fit it well into the [heuristic] order of protection, Vandenbroucke explains.
 
Thoughts On Barrier Isolators
 
Barrier isolators are very good at containing cytotoxic contamination, noted Sewell during the discussion. He continued, We have to remember that in that process, they themselves become heavily contaminated on the inside, unless you take steps to prevent or reduce the amount of contamination that's produced during cytotoxic reconstitution. Clearly, devices such as PhaSeal should help enormously in that aspect. And should reduce the amount of internal contamination in an isolator. And that's important because we want to make sure that we reduce the amount of contamination that's transmitted from the isolator onto products; syringes, bags, etc, that actually go to the patient. I think the whole chain of contamination needs to be addressed, and clearly PhaSeal is an approach that should help that. Further, Sewell cautioned, as US pharmacists look at USP 797 compliance, an isolator does not replace the need for a cleanroom. And I think we need to be really clear about that.
 
Regarding isolators, Jorgensen explains, we considered isolators, but you know we looked at isolators [as being] more interchangeable with biological safety cabinets. We really didn't look at isolators as a replacement for PhaSeal. We think that PhaSeal needs to be complementary with either of those two technologies -- barrier isolators or biological safety cabinets. So, for our purposes, the biological safety cabinets still made more sense to us.
 
Jorgensen continued the discussion noting that in the United States there are still a lot of misconceptions about what isolators do and don't do, and, where they should be positioned and how they should be used. I think [isolators] are much more well-established in Europe. They've had a lot more experience than we have using isolators.
 
Thoughts From NIOSH Conference Attendees
 
Following the scientific advisory board, NIOSH kicked off its educational conference on safe handling of hazardous drugs. Participants were interviewed regarding their reasons for participating in the workshop, and their understanding of the requirements for compliance with USP 797 and the NIOSH Alert.
 
I came to the NIOSH Hazardous Drugs conference because I'm an industrial hygienist, stated Erica Stewart, BS of Kaiser Permanente. I'm very concerned about being able to protect workers from hazards associated with potent and hazardous drug use. So that's the number one reason. And secondarily, we're also interested in what's on the forefront for medical surveillance in regards to hazardous drugs, she continued.
 
At Kaiser Permanente we've been working with our pharmacy group to establish what USP 797 means to Kaiser Permanent operations, especially in regards to the way we're built. We're very concerned about being able to meet those standards even if they aren't adopted by the boards of pharmacies in all states. It will still be a de facto standard that the Joint Commission will certainly be looking at when they come in to gauge compliance.
 
Mary Gullatte, RN, of Winship Cancer Institute actually downloaded the preliminary NIOSH guidelines back in March. When I read them and started talking to our team in terms of looking at our current policies and procedures and what may be needed from the new guidelines that have come out. Gullatte added, I thought that we really needed to implement some of these programs because one of the things that we make a point of doing is making sure that patients are safe in terms of compliance with patient safety guidelines from the Institutes of Medicine. But at the same time, we have a responsibility for our staff. To make sure they're safe in terms of these hazardous drugs that they are using day to day in terms of treating patient with chemotherapeutic agents.
 
About Baxa Corporation
 
Baxa Corporation offers the only closed system for safe handling of antineoplastic and other hazardous drugs. This system, PhaSeal, uses dry connections and a built-in expansion chamber to prevent drug aerosol leakage and subsequent transfer into the work environment. As a closed system, it contains hazardous drugs throughout the entire process of drug transfer, preparation, transport, administration and disposal eliminating the risks of environmental and occupational exposure.
 
A leading provider of devices and systems for the preparation, handling, packaging, and administration of liquid medications, Baxa Corporation manufactures and markets a wide range of healthcare products for use in hospitals, critical care units and alternate-site pharmacies. Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in Canada, the United Kingdom; Denmark, and Germany; and distribution partners worldwide. Further information is available at http://www.baxa.com.
 
Additional Resources
 
The full text of the NIOSH Alert can be found at http://www.cdc.gov/niosh/docs/2004-165/.
 
The full text of USP 797 can be found at (http://www.usp.org). Complementary materials on USP 797 are available on the Baxa Corporation Web site (baxa.com/OnlineHelp/Default.asp?ID=4&Item=11), and at the ASHP Web site (ashp.org/SterileCpd/).
 
2005 Baxa Corporation 
 
  Drugs: Environmental Controls for Sterile Compounding
Environmental Controls for Sterile Compounding

Technical Paper

A guidance document on developing sterile preparation areas to meet the USP <797> requirements for low and medium risk compounded sterile Preparations (CSPs).
ABSTRACT

This paper provides clarification and possible alternatives for designing room layouts, engineering controls, and equipment that provide the necessary level of environmental control to satisfy the requirements for compounding sterile preparations in compliance with USP 797. The standard is presented in sections that include: compounding personnel responsibilities, risk level classifications, verification of compounding accuracy/sterility, quality assurance and quality control, event and patient monitoring, training and evaluation, and environmental quality and control. This paper addresses environmental quality and control issues.

INTRODUCTION

USP Chapter <797>, released in January 2004, created a new (US) national standard for sterile preparation. The standard resulted from the efforts of earlier organizations to improve the quality and consistency of sterile preparations. These groups included the National Coordinating Commitee on Large Volume Parenterals (NCCLVP), the American Society for Health-System Pharmacists (ASHP) Guidelines, USP Chapter <1206>, FDA Modernization Act of 1997 (FDAMA) and the National Association of Boards of Pharmacy (NABP). The new standard is intended to describe the current best practice for quality assurance in compounding in an effort to improve patient safety and reduce the number of adverse events related to compounding activities.

There is still debate within the pharmacy profession about what the requirements are to fully comply with this new standard. However, what individuals can agree on is that the practices of the past are going to change, particularly in hospitals. The extent of change necessary to achieve 兎xcellent・results will be determined over time as the Chapter guidelines are interpreted and individual (facility) responses are audited for compliance. Refer to the USP Web site (www.usp.org) and the JCAHO Perspectives newsletter (www.jcaho.org) for current guidance on the regulations.

UNDERSTANDING CLEANROOMS

The International Standards Organization (ISO) defines a cleanroom as, 鄭 room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimize the introduction, generation, and retention of particulates inside the room, and in which other relevant parameters, e.g., temperature, humidity, pressure, are controlled as necessary.・ Control in this context means that a selected parameter is governed by procedure and practice, is routinely measured, and prescribed action is taken if that parameter exceeds predetermined limits.

ISO 14644 classifies nine levels of cleanroom based upon particle counts within one cubic meter of room air. ISO Class 1 is the highest or cleanest rating, with Class 9 being the lowest. A number of third-party vendor offer particle counting services. There are also cleanroom particle counters available for sale that can be used to evaluate the cleanliness of sterile compounding preparation areas. The Cleanrooms (http://cr.pennnet.com /home.cfm) and Cleanroom Technology (http://www.cleanroom-technology.co.uk/) magazine Web sites both offer references and resources for determining current state of environmental control, as well as information on designing and constructing cleanrooms, and purchasing cleanroom equipment.

REQUIREMENTS

USP 797 requires that low- and medium- risk compounded sterile preparations (CSP痴) be prepared in a 壮uitable・area. The document provides guidance for establishing controls over CSP production and processes. It also includes some recommendations for how to meet the requirements.

In a hospital pharmacy context, USP <797> requires the maintenance of ISO Class 5 air quality for the sterile compounding area. This designation, formerly Class 100, allows a maximum of 100 particles per cubic foot. This environmental control is the same level as the typical laminar airflow hood (LAFW) in use in US pharmacies today. The Chapter also allows the use of verified alternative systems in cleanrooms that achieve the same or better level of environmental controls as LAFWs.

In addition to the primary engineering control above, USP 797 requires secondary engineering control that provides a buffer zone around the primary mixing area. This buffer zone should be preceded by an anteroom that is a clean area for putting on personnel barriers such as hair covers, gloves and gowns. The class limit for this buffer zone should be demonstrably better than ambient air, providing at least Class 8 air quality. This class, formerly Class 100,000, allows a maximum of 100,000 particles per cubic foot.

Baseline testing should be performed in these designated areas to determine the current level of environmental contamination before undertaking construction and redesign projects. Implementing basic cleaning and control steps, coupled with a positive pressure air system, mayresult in a room with less than 10,000 particles per cubic foot. Then, the standard of less than 100,000 particles per cubic foot is achievable by following the simple USP 797 physical facility suggestions.However, in practice there are different options regarding the establishment and maintainance of these production and process controls in the pharmacy.

BASIC REQUIREMENTS

There are a number of options for meeting the USP 797 guidelines as they are currently described. Three such options (Good, Better, Best) are detailed in the examples below. This guidance is not intended to dictate how a preparation area for low and medium risk CSP痴 must be laid out, but to provide some options for satisfying the USP requirements.


The elements below are basic production and process controls that are required for all CSP production areas. Please note that these requirements address environmental control for compounding standard sterile preparations for IV administration. There are separate recommendations for safe handling of hazardous drugs that should be reviewed and addressed prior to undertaking a facility redesign.(8)

1. ISO Class 5 Air Quality in the critical area.
Primary environmental control must provide at least ISO Class 5 quality of air to which sterile ingredients and components of CSP痴 are directly exposed.(7)

2. Environmental Controls and Procedures

a. ISO Class 8 air quality in the buffer areas
b. Area entry
c. Materials movement and storage
d. Gowning, hair covers, etc.
e. Hand washing
f. Behavior
g. Area clearance between batches
h. Area exit

3. Housekeeping Procedure

4. Visual Controls

5. Microbial and Particulate Monitoring

"GOOD" STERILE PREPARATION CONTROLS

1. All the Required Items shown above.

2. A Controlled Environment Area of the Pharmacy where CSP痴 are made, ingredients are opened, etc. This area of the pharmacy is not necessarily a separate room, but is isolated and well-marked, using clear visual controls such as floor tape, paint, physical barriers, etc.

3. Laminar Air Flow Workbench(es), Vertical Flow Clean Bench(es), Biological Safety Cabinet(s), or Barrier Isolator(s) certified to provide ISO Class 5 Air Quality. This is where the actual CSP compounding takes place.

"BETTER" STERILE PREPARATION CONTROLS

1. All Required Items shown above.

2. A dedicated Controlled Environment Room. This room is closed off from the rest of the pharmacy by standard structural features such as doors and walls. This 努hite room・is isolated, and accommodates all of the items found in #2 of the Required Items above.

3. Laminar Air Flow Workbench(es), Vertical Flow Clean Bench(es), Biological Safety Cabinet(s), or Barrier Isolator(s) certified to provide ISO Class 5 Air Quality. This is where sterile compounding takes place.

"BEST" STERILE PREPARATION CONTROLS

1. All Required Items shown above.

2. A positive or negative pressure cleanroom with ISO Class 8 air quality.

3. An anteroom for entry from the outside areas.

4. Airlocks or pass throughs for material movement.

5. Hand-washing facilities.

6. Laminar Air Flow Workbench(es), Vertical Flow Clean Bench(es), Biological Safety Cabinet(s), or Barrier Isolator(s) certified to provide ISO Class 5 Air Quality. This is where sterile compounding takes place.

CONCLUSION

Most pharmacies will have significant gaps between the USP 797 requirements and their current facilities and standards of practice. The timelines for compliance have been set forth to allow a reasonable period for gap analysis, evaluation and the development of action plans for remediation. A number of steps can be taken in order to immediately improve the practice of sterile compounding, which would reduce the risks of inaccurate and contaminated compounds. Individual facilities should move to address those requirements that would have the greatest immediate impact on CSP quality, then seek guidance where necessary from qualified (certified) consultants with regards to cleanroom design and environmental control prior to modifying existing facilities.

ADDITIONAL RESOURCES

(1) The ASHP Discussion Guide for Compounding Sterile Preparations. American Society of Health-System Pharmacists. 2004. www.ashp.org.

(2) Cleanroom Design: Fundamentals of Design, Testing, and Operation. Whyte, William. ISBN 0471 942049. Wiley Press.

(3) Control of Particulate Contamination in Healthcare Manufacturing. Barber, Thomas A. ISBN 1-57491-072-8. Interpharm Press.

(4) Frequently Asked Questions About Cleanrooms. Baxa Corporation Technical Paper. Hynes, J. Patrick.

(5) HEPA Corporation. www.hepa.com

(6) ISO-14644 Family of Cleanroom Standards. (8 documents). www.iso.org.

(7) USP, NF, 2004 Chapter 797. United States Pharmaceopeia. www.usp.org.

(8) NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. Department of Health and Human Services. DHHS (NIOSH) Publication Number 2004-165. September 2004.

ゥ 2004 Baxa Corporation
 
Thursday, January 26, 2006
  Safe Handling of Hazardous Drugs
 
“Safe Handling of Hazardous Drugs” Technical Paper from Baxa Corporation Now Posted on PublicRelationsNewsroom.com For Media Access

Discussions from a scientific advisory board on the impact of USP 797 and the NIOSH Alert for guiding the safe handling of hazardous drugs in healthcare settings are the topics of a new technical paper posted at the Public Relations Newsroom Web site. This posting joins a related page at the Expert Information for Journalists Web site (Expert411.com) featuring James Jorgenson, RPh, MS, and Martha Polovich, MN, RN, AOCN, industry experts on the subject of safe handling.

“Safe Handling of Hazardous Drugs” Technical Paper from Baxa Corporation Now Posted on PublicRelationsNewsroom.com For Media Access
Denver, CO, December 22, 2005 --(PR.COM)-- With hazardous drug handling brought to the forefront of public scrutiny by USP 797 and the recent NIOSH Alert, a new technical paper has been posted at http://www.PublicRelationsNewsroom.com for media access. Baxa Corporation manufactures devices and systems for safe handling. packaging and distributing fluid medications.

The new safe handling technical paper is found at: http://publicrelationsnewsroom.com/_wsn/page13.html

The “safe handling of hazardous drugs” expert information page is found at http://www.expert411.com/_wsn/page9.html.

The Journal of Community Oncology article featuring Marty Polovich and detailing hazardous drug handling risks is found at: http://www.communityoncology.net/journal/articles/0203277.pdf

The NIOSH Alert, "Preventing Occupational Exposures to Antineoplastic and other Hazardous Drugs in Healthcare Settings," reflects years of work by physician, nurse, pharmacist and scientific experts in collaboration with members of the broad-based NIOSH Hazardous Drug Safe Handling working group. Among the findings in the Alert are warnings that previous workplace precautions for containing hazardous drugs have been inadequate. Examples include:

* "Sessink and Bos noted that 11 of 12 studies detected cyclophosphamide in the urine of healthcare workers tested, indicating continued exposure despite safety precautions." (page 17)

* "Considering all the data, the weight of the evidence in occupationally exposed cohorts demonstrates an association between exposures to hazardous drugs and increases in various measures of genotoxicity..." (page 19)

* "Recent evidence summarized in this Alert documents that worker exposure to hazardous drugs is a persistent problem. Although most air sampling studies have not demonstrated significant airborne concentrations of these drugs, the methodology employed in the past has come into question...and may not be a good indicator of environmental contamination of the workplace. All studies that examined surface wipe samples have determined that surface contamination of the workplace is common and widespread." (page 41)

The Alert recommends that employers improve environmental and employee protection where hazardous drugs are handled. The specific benefits of closed systems were called out:

* "An investigation conducted in the US demonstrated a reduction in both the percentage of urine samples with measurable levels of cyclophosphamide or ifosfamide present and the concentration of the drugs in the urine following use of a closed-system device for six months..." (page 18)

* "Transfers from primary packaging such as vials to dosing equipment (i.e., infusion bags, bottles or pumps) should be carried out using closed systems whenever possible. Devices that contain the product within a closed system during drug transfers limit the potential for aerosol generation, as well as exposure to sharps." (page 35)

A leading provider of devices and systems for the preparation, handling, packaging, and administration of liquid medications, Baxa Corporation manufactures and markets a wide range of healthcare products for use in hospitals, critical care units and alternate-site pharmacies. Headquartered in Englewood, Colorado, Baxa has subsidiaries and sales offices in Canada, the United Kingdom and Denmark, and distribution partners worldwide. Further information is available at http://www.baxa.com.

Click the following link to view a presentation by Jim Jorgenson, "Using a Closed System Device to Reduce Occupational Exposure to Hazardous Drugs." Jorgenson is Director of Pharmacy for the Huntsman Cancer Institute and Associate Dean for Professional Affairs at the University of Utah:
http://www.isips.org/presentations/PhaSeal/player.html

###

Contacts:
Marian Robinson, Vice President, Marketing
Baxa Corporation: 800.567.2292 ext. 2157 or 303.617.2157
Email: marian.robinson@baxa.com

Maggie Chamberlin Holben, APR
Absolutely Public Relations
303.984.9801, 303.669.3558
Email: maggie@absolutelypr.com
Contact Information
Baxa Corporation
Maggie Chamberlin Holben, APR
303.984.9801 or 303.669.3558
maggie@absolutelypr.com
http://www.baxa.com
 
  Pharmaceutical Compounding - Sterile Preparations
Understanding USP 797
Technical Paper

An overview of USP General Chapter <797>
Pharmaceutical Compounding - Sterile Preparations

By Mike Hurst, RPh, MBA
INTRODUCTION

USP Chapter 797(1), enacted January 1, 2004, presents the first enforceable standards for sterile compounding. Following years of patient safety recommendations and professional guidelines, the intent of USP 797 is to set forth the procedural and practical requirements for safe compounding of sterile preparations. The Chapter's requirements are applicable in all practice settings where sterile preparations are compounded, raising concern among many facilities regarding the cost and difficulty of compliance. That concern has resulted in numerous symposia and journal articles attempting to bring clarity to the requirements.

One article, USP Chapter 797: Establishing a practice standard for compounding sterile preparations in pharmacy・2) published in the September 15, 2004 issue of the American Journal of Health-System Pharmacists provides an excellent historical framework for understanding how USP 797 came about. In addition, the article summarizes the Chapter's major topics and offers 38 references to complete the story. Copies of this article, and many other excellent resource and reference materials are available at the American Society for Health-System Pharmacists・(ASHP) Web site. There, the ASHP Compounding Resource Center(3) brings together information on publications, educational seminars, compliance tools and references regarding USP 797.

While understanding the historical background is important, most hospital pharmacists just want to comply with the basic requirements and get on with the business of patient care. This brief paper is intended to help pharmacies get started in that direction. It also discusses USP 797 from a couple of unique angles not necessarily considered in the initial literature published on the subject.

GETTING INTO THE FLOW OF USP 797

First, it's important to appreciate that USP 797 was written to improve the compounding of sterile products. But, like any change, it has the potential to be misinterpreted, and thus feared. The biggest misconception about USP 797 seems to be that a sophisticated Cleanroom is required. This requirement has been interpreted in many different ways, and is explained in more detail below. For the most part, USP 797 contains many procedural, training and quality assurance requirements that are not unreasonable for a quality IV operation.

In time, USP 797 will be implemented as the US standard for sterile compounding, with ASHP and other industry guidelines following its lead. Once the initial concerns over the cost and difficulty in meeting 797's requirements have passed, patients and staff alike will be better off as a result. Baxa products can be outstanding quality partners in this journey. Our goal is to enable pharmacies to learn how to use Baxa products in compliance with USP 797.

THE US PHARMACOPOEIA

The USP (US Pharmacopoeia) is a private organization formed in 1820. Current members include many members of accredited schools of medicine and pharmacy, state medical and pharmacy associations, government agencies, consumer organizations and other prestigious health organizations.

The standards developed by USP are important for several reasons:

1. The Food, Drug and Cosmetic Act (and thus the FDA) recognizes the USP/NF (National Formulary) as the official compendia of US drug standards. There are hundreds of USP drug standards and all standards numbered less than 1,000 are enforceable by either individual State Boards of Pharmacy, or the FDA. The FDA does not routinely inspect individual pharmacies but may intervene in the case of injuries, a death, or a complaint.

2. USP/NF standards are often used as evidence of national standards in lawsuits.

3. The JCAHO (Joint Commission for Accreditation of Healthcare Organizations) has adopted these standards for use after July 1, 2004. JCAHO accreditation is the most universally recognized standard of US healthcare system quality. JCAHO accreditation is required for reimbursement through the national Medicare program and almost all state Medicaid (welfare) programs.

4. Many State Boards of Pharmacy are adopting USP 797 for their pharmacy inspections.

USP Chapter 797 was published in the 2004 edition of the United States Pharmacopeia 27 ・National Formulary 22 (USP-NF). Copies of the chapter may be purchased through ASHP(4) or USP(5).

USP: WHAT IT IS

Pharmacy rumors abound about USP 797. Clarification on some of the most important topics is below. First, USP 797 is a number of things:

1. Long. It's 18 pages, including 13 using single spacing and a small text font. That's a lot of information to read, but the concepts are not complicated.

2. Paperwork and process intensive. Virtually every significant step of the sterile compounding process is covered in detail. Once again, the major topics are summarized in the September 2004 American Journal of Health-System Pharmacy article.

3. Intended to upgrade pharmacy admixture processes to reasonable precautions. While some pharmacists may disagree with a number of the requirements, the overall tone is proactive, scientific, comprehensive and effective. There is nothing in USP 797 that a pharmacy cannot implement with a reasonable amount of time and resources.

4. Specifies increasing controls based on risk. CSPs (compounded sterile products) are classified into low, medium and high risk categories. Most CSPs prepared with/for Baxa products are in the low and medium risk categories.

USP: WHAT IT ISN'T

But USP 797 is not some of the things that it's rumored to be:

1. USP 797 does not require sophisticated cleanrooms to be installed. What the guideline does require is environmental controls ・specifically, a separate area for compounding that meets a defined level of cleanliness, and monitoring to ensure that control is maintained. A brief explanation of standards clarifies the actual USP 797 cleanroom requirements. First, there are six levels of ISO (International Organization for Standardization) cleanrooms from ISO Class 3 to ISO Class 8. Three of these are:

ISO Class 3 ・equivalent to the former Class 1 designation, allows a maximum of one particle (over 0.5 microns in size for all classes) per cubic foot. This cleanliness level is suitable for the ultimate cleanroom application such as microchip manufacturing, but is not required for pharmaceutical manufacturing or sterile compounding.

ISO Class 5 ・(formerly Class 100), allows a maximum of 100 particles per cubic foot; which is the level for the typical laminar airflow hood that is required by USP 797 for the actual mixing area. Mixing IVs in a hood is nothing new in US pharmacies.

ISO Class 8 ・(formerly Class 100,000), allows a maximum of 100,000 particles per cubic foot. This level is required for an IV preparation area/IV room.

There are other issues recommended in the Chapter, such as an ante room for dressing, etc. but the Class 100,000 mixing area is the primary environmental control requirement. Implementing the most basic steps of straightening up an IV room, coupled with a positive pressure air system, will result in a room with less than 10,000 particles per cubic foot. Getting an IV room to less than 100,000 particles per cubic foot is achievable by following the simple USP 797 physical facility suggestions.

The first step is getting a baseline on your existing facility to determine what remediation steps, or facility and procedural redesign, will be required to meet the environmental controls above. The net result of the USP 797 guidelines is that sterile mixing take place in a properly maintained laminar airflow hood (ISO Class 5) situated in a relatively clean room (ISO Class 8). For most pharmacies, this is neither difficult or unreasonable. In some cases, individual interpretations of this requirement have made it seem more onerous.

2. USP 797 is NOT a radical departure from what most admixture programs are already doing. There are basic steps in quality sterile compounding that many inpatient pharmacies have unfortunately not had the time, or interest, to implement. Regulatory agencies such as the FDA and State Boards of Pharmacy have long recognized this need. USP 797 simply puts the requirements in a format that inspectors can check against.

3. USP 797 cannot be fully met by outsourcing. Legitimate first doses are not covered by USP 797 and other doses can be outsourced. But almost any pharmacy will still need to make many doses such as those subject to change, short-expiration drugs, some antineoplastics etc. that are not candidates for outsourcing. Other expensive and specialized drugs may be hard to outsource, also. Sterile compounding activities can be minimized through an outsource arrangement, but not entirely eliminated. This means that nearly all hospital pharmacies will still have to meet the requirements of USP 797.

4. Isolators alone will not ensure compliance with USP 797. Using an isolator for sterile compounding handles only part of the requirements for USP 797. Issues such as process validation, training, expiration setting, product quality maintenance after the CSP leaves the pharmacy, caregiver training, patient monitoring, QA program, etc. remain the same as for products compounded in standard laminar flow hoods. The special requirements for cleaning the isolator itself and for cleaning materials entering the isolator make this a demanding alternative to standard pharmacy flow hoods. Additionally, many users find isolators physically difficult to work in and inappropriate for medium-to-large institution workloads.

WHAT'S NEXT?

Compliance with USP 797 will be achieved through the completion of steps on a timeline that stretches out to January 2008. The requirements allow pharmacies to plan appropriately for compliance, understanding that changes of this magnitude will not be accomplished overnight. JCAHO surveyors began surveying facilities for compliance with Chapter 797 on July 1, 2004. Many of the requirements are equivalent to current elements of performance of the 2004 Joint Commission standards. Current compliance to these will be evaluated and scored in JCAHO reviews. Other areas of Chapter 797 will be evaluated but not scored.

The October 2004 issue of Joint Commission Perspectives listed the five items that the USP 797 advisory group recommends that organizations focus on for compliance. This list, repeated below, recognizes that the task of developing a comprehensive plan for USP 797 compliance is a daunting one. While all components of the Chapter must be addressed for compliance, these priority activities will allow organizations to make the most significant progress towards achieving its goal of improving the quality of sterile compounded products.

1. Personnel training and evaluation (that is, competence assessment)

2. Beyond-use dating and labeling

3. Verification of automated compounding devices

4. Finished preparation release checks and tests

5. Aseptic technique

USP 797 represents a profound change for the profession of pharmacy. The key is using aseptic technique with the right equipment in an environment that's appropriate. Baxa is working on a number of consultive strategies and tools to help our customers meet the compliance challenges of USP 797 as easily as possible. The company is committed to providing the right equipment, along with the training and assessment tools, to meet patient safety and sterile compounding requirements.

KEY COMPLIANCE DATES AND ACTIVITIES

Summarized below are the key dates and activities for USP 797 compliance. Please refer to full document for details.

Pharmacies should have basic policies for aseptic technique, finished product testing, patient monitoring, and adverse drug reaction (ADR) reporting in place currently. Immediate attention should be paid to high-risk level product sterility.

That said, the most urgent initial task for USP 797 compliance is the completion of a gap analysis. This document details the current state of the pharmacy against the end state, or compliance with USP 797, to identify the differences or gaps. From that analysis, an action plan can be formed to prioritize the gaps and develop options for compliance.

January 2005 ・The Gap analysis and an initial action plan for each section must be completed by January 1, with interim measures for personnel performance training and testing set up. This is the first major milestone for most organizations. Action plans are expected to have realistic timeframes for completion, with the understanding that full compliance will not be accomplished quickly.

Several templates available for performing this gap analysis. The International Journal of Pharmaceutical Compounding offers a reasonably priced gap analysis template on CD.(7) Two additional options are available through the ASHP. The first, the 797 Compliance Advisor is an industry-sponsored tool that offers downloadable checklists.(8) The second is a more comprehensive, Web-based tool that takes users through the step-by-step questions to complete the analysis.(9) Check the sources at the end of this paper for Web links to these templates.

July 2005 ・Renovation plans for physical site must be completed. Equipment and personnel training, and all operational policies and procedures and the quality assurance plan should be in writing. Standard operating procedures (SOPs) for personnel and equipment need to be in place and operational.

January 2006 ・Formal quality assurance plan should be in place and operational.

January 2008 ・Physical site changes should be complete, with sterile compounding fully compliant with USP 797.

SOURCES CITED

(1) USP General Chapter <797> Pharmaceutical Compounding ・Sterile Preparations. United States Pharmacopeia. 2004.

(2) Kastango E. and B. Bradshaw. American Journal of Health-System Pharmacy. Volume 61, Number 18. September 15, 2004.

(3) The ASHP Compounding Resource Center, http://www.ashp.org/SterileCpd/

(4) American Society for Health-System Pharmacists. www.ashp.org.

(5) United States Pharmacopeia. http://store.usp.org).

(6) ASHP 797 Compliance Advisor http://www.797complianceadvisor.com/

(7) International Journal of Pharmaceutical Compounding. http://ijpc.com/products/ProductDescription.cfm?PID=141

(8) http://www.ashpbestpracticessat.com/797.html

ゥ2004 Baxa Corporation

ABOUT THE AUTHOR

Michael Hurst RPh, MBA worked for 18 years at Swedish Medical Center in Seattle, Washington in operational management, including positions as IV Supervisor and Assistant Director of Pharmacy. His implementation of a syringe infusion system in 1984 had national implications. For the next 9 years Mike wrote, spoke, consulted and acted as a reference site for syringe infusion installations across the country.

Mike moved to industry full time in 1994, joining Baxa Corporation as Vice President of Infusion Systems. His job duties have included customer support for syringe infusion system installations, new business and product development roles, and professional services support for various Baxa pharmacy and nursing product lines. Mike is currently consulting with a hospital system in the development of a comprehensive USP 797 compliance template that can be applied in other hospital pharmacies
 
  Healthcare Costs Battle Involves Use of Technology At University of California
 
University of California Uses Technology to Tackle Rising Healthcare Costs

California’s 2nd largest employer selects CompassCare’s Clinical Information System.

Chicago, IL (PRWEB) January 26, 2006 -- The University of California’s (UC’s) Office of the President selects CompassCare’s Clinical Information System, which will be provided to its occupational health clinics on a system wide basis. CompassCare provides software to manage healthcare information and delivery.

“A top priority for UC is to ensure that all employees have access to quality healthcare when they need it. Technological innovation helps us advance the delivery of care while stemming the tide of rising costs,” says Dan Nicholson, Workers’ Compensation Manager, UC Office of the President.

The State of California has seen workers’ compensation (WC) costs more than triple from 1995 to 2003. Total medical treatment costs are estimated to be 50 to 100 percent higher in WC than treatments paid for by private health insurance. Although medical costs have decreased with recent reforms, the overall cost of workers’ compensation in California remains significantly higher than in other states.

“As the 2nd largest employer in California with more than 175,000 faculty and staff, it is important that we take proactive measures to ensure our people’s access to high quality care,” says Nicholson. “CompassCare enhances our ability to monitor and measure performance system wide, increasing our visibility into the entire care process. It will help us standardize clinical documentation electronically, capture information on a real-time basis, transmit appropriate levels of information to the correct parties (e.g., claims administrator), and automate clinical and operational functions using a rules-based engine.”

UC comprises 10 campuses and 5 medical centers. The Office of the President is responsible for UC's system wide activities and programs including the coordination of all workers’ compensation claims made throughout the UC system. The CompassCare system will be used by UC to link together its Occupational Health clinics on a common, electronic platform, creating seamless networking and information flow.

The CompassCare clinical information system integrates practice management, EMR, billing and communication processes on top of a rules engine driven architecture – all accessible from a secure, HIPPA compliant, web-interface.

“Effectively managing the delivery of Occupational Healthcare services is paramount for employers like the University of California who serve a broad patient community. We designed CompassCare with the intent of improving the delivery of care on a massive scale. This is being validated at UC as it is with several other hospital systems that use our software,” said Rick Valentine, CEO of CompassCare Inc.

“The CompassCare system helps hospitals reduce the costs associated with processing claims, ensure compliance with regulations, eliminate redundant data entry, manage the delivery of care, and improve communication flow between key stakeholders such as the healthcare provider, the employer and the insurer, all to ensure the injured worker gets the required treatment quickly and efficiently,” says Valentine.

UC represents Chicago-area CompassCare’s 3rd customer in California, others include Dameron Hospital in Stockton, CA and Sutter Health based in Sacramento, CA.

About University of California
UC’s ten campuses at Berkeley, Davis, Irvine, Los Angeles, Merced, Riverside, San Diego, San Francisco, Santa Cruz and Santa Barbara. The UC’s 5 medical centers and 10 health centers comprise one of the largest health care systems in the state, and one of the most respected in the country. Each year the University provides care to more than 135,000 inpatients, 239,000 emergency room visitors and more than 3.6 million outpatients. In 2004, the UCLA and UCSF medical centers were ranked fifth and sixth, respectively, in the entire by U.S. News and World Report.

About CompassCare
CompassCare Inc. provides occupational healthcare stakeholders (employers, care providers, and TPA/ case managers) an integrated management system that connects all parties together in "real-time” via the Internet. It provides instant access to HIPAA-compliant information on an injured worker so all parties have the tools they need to manage the information and activity associated with workers' compensation. The result is improved quality of care and better financial and operations management. With more than 25 million electronic medical (patient) records accurately processed to date, CompassCare is one of the leading suppliers of healthcare information technology. The following are copyrights of CompassCare: CompassCare, MedTRAK, FasTRAK, ClaimTRAK, CaseTRAK, For more information please visit: www.compass-care.com.

Media Contact:
Stewart Dixon
847.604.9800

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Press Contact: Stewart Dixon
Company Name: CompassCare
Email: email protected from spam bots
Phone: 847-604-9800
Website:
www.compass-care.com

 
  Health Industry News Resource for Medical and Pharma Sectors
 
Wisdomatics Launches Health Industry News - Comprehensive Resource for Medical and Pharma Sectors

Wisdomatics, publishers of the successful consumer health websites BreakThroughDigest.com and Search Cancer.com, announces the launch of a new business information portal for the medical industry: Health Industry News.

Seattle, WA (PRWEB) January 26, 2006 -- Wisdomatics, publishers of the successful consumer health websites BreakThroughDigest.com and Search Cancer.com, announces the launch of a new business information portal for the medical industry: Health Industry News (www.healthindustrynews.com).

"This website is about the business of medicine", says Wisdomatics president and executive producer, Gary Bryant. "There are financial information sources out there that offer highlights of the health industry, and there are consumer health sites that allude to the business side of medicine. But Health Industry News is nothing but Health Industry News."

Wisdomatics is no stranger to the Web and health content in particular. Launched in 2003, their flagship website Breakthrough Digest now receives millions of visitors each year.

"Consider the challenges this industry faces today: drug companies have a public image problem, a deepening health insurance crisis as more and more employers cut health benefits, a nursing shortage, dissatisfaction with the new federal prescription drug plan, and of course, product safety." Says Bryant, "This is a fragmented business sector that screams for visionaries."

One feature to be introduced in April of 2006, Health Industry Leaders, will present editorial content written by the leadership of the industry. Health Industry Leaders will be an opportunity for a company's visionaries to provide high-level perspective on the issues facing the healthcare industry today- a perspective that can only come from a company's unique position in the marketplace.

Other site highlights include daily news updates, interactive event scheduling, a sizeable resource directory and additional features available to registered users. The entire site's offerings are free. Health Industry News can be found on the Web at http://www.healthindustrynews.com

Wisdomatics is a web site publishing enterprise. Since 1994, has created, developed and managed a number of award winning web sites including BreakThroughDigest.com and Search Cancer.com.

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Press Contact: Gary Bryant
Company Name: WISDOMATICS
Email: email protected from spam bots
Phone: 360 547 1339
Website:
http://www.healthindustrynews.com

 
Wednesday, January 25, 2006
  Healthcare IT Solutions For Health Care Delivery At HIMSS Conference
Healthia Consulting to Showcase Healthcare IT Solutions at the 2006 HIMSS Annual Conference & Exhibition
 
HIMSS 2006 Annual Conference
MINNEAPOLIS--(BUSINESS WIRE)--Jan. 25, 2006--The challenges surrounding the pivotal issues of patient safety, security, electronic health record, ambulatory care and clinical systems will be addressed in detail at the upcoming 2006 HIMSS Annual Conference & Exhibition, Feb. 12-16, in San Diego, CA. Healthia Consulting of Minneapolis, MN, will exhibit its healthcare information technology (IT) solutions at the meeting, recognized as one of the premier conferences in the healthcare industry.
Attendees visiting Healthia Consulting at booth #5815 will have the opportunity to learn more about the company's consulting services for improving the effectiveness and quality of healthcare delivery. Healthia Consulting assists customers in assessing their needs and devising and implementing solutions that will meet both current and future needs.

Glenn Galloway, CEO for Healthia Consulting, stated: "The annual HIMSS conference is the place to be for an organization like Healthia Consulting. It brings the key industry players right to us; those who can make the buying decisions and are ready to buy. When they stop by our booth, we can talk one-on-one with them about their needs and how Healthia Consulting can help them meet those needs. We would never be able to see as many high-level decision makers otherwise."

The HIMSS conference attracts more than 22,000 attendees annually, making it one of the largest healthcare IT and management systems conference in the world. Attendees who visit the conference participate in education sessions and networking events, in addition to visiting the exhibits. The 2006 conference takes a knowledge-based focus, with more than 300 education sessions and seven symposia, including five new sessions: Pre-Nursing Informatics, Clinical Engineering, Pay-for-Performance, Pharmacy and RHIO, in addition to the Nursing Informatics and Physician symposia so popular at HIMSS 2005. The Interoperability Showcase returns in 2006 with groundbreaking demonstrations that utilize cutting-edge technology and standards to demonstrate interoperability in an interactive environment. Attendees will be able to create, track and manage virtual electronic health records and experience interoperability advances across both acute and ambulatory care environments.

Among the speakers lined up for the 2006 conference are keynoters secretary of Health and Human Services, Michael Leavitt (invited), national health information technology coordinator, Dr, David Brailer, Virginia Governor, Mark Warner, and Intel board chairman, Craig R. Barrett, as well as a number of leading healthcare IT industry and business speakers.

ABOUT HEALTHIA CONSULTING

Healthia Consulting, Inc. is a privately held national healthcare consulting firm that offers management advisory and solution delivery services for healthcare provider, payer and life sciences organizations. Founded in 1998, the company has three regional offices in Chicago, Minneapolis and Denver and a client roster that includes the nation's most prominent healthcare organizations. For more information, visit www.healthiaconsulting.com.

ABOUT HIMSS

HIMSS (Healthcare Information and Management Systems Society) is the healthcare industry's membership organization exclusively focused on providing leadership for the optimal use of healthcare information technology and management systems for the betterment of human health. Visit www.himss.org for more information.

Contacts
Healthia Consulting, Inc.
Shawna Schueller, 763-923-7909
shawna.schueller@healthiaconsulting.com
At A Glance
StoneBridge Group
Source: via Business Wire
Updated  01/10/2005  by company
Headquarters: Minneapolis, MN
Website: http://www.stonebridgegroup.com
CEO: Glenn Galloway
Employees: 45
Organization: Private
 
  Are Medicare Professionals Served By New Medicare Industry Web Site?
 
Dynamic Healthcare Systems Debuts ManagingMedicare.com

Industry site designed to serve medicare professionals.

Irvine, CA (PRWEB) January 25, 2006 -- Dynamic Healthcare Systems, a provider of innovative solutions for Medicare-focused health plans, today announced the creation of ManagingMedicare.com (http://www.managingmedicare.com), a Medicare industry web site that offers analysis, expertise, current information, discussions and collaboration between professionals who are committed to the success of the ever changing Medicare industry.

“As new guidelines and regulations set forth by the Medicare Modernization Act of 2003 are rolled out for implementation, Medicare-related businesses need a forum for up-to-date analysis and information to help them streamline their transition and adoption of the new rules,” said Ken Stockman, Founder and CEO of Dynamic Healthcare Systems, Inc. “ManagingMedicare.com is a collaborative site that tracks trends, issues, ideas and best practices.”

ManagingMedicare.com has enlisted industry experts and leaders to contribute content on a regular basis. Collaboration between professionals who manage Medicare programs is critical to the success of providing quality health care to the elderly and disabled. ManagingMedicare.com is just one place where cooperation and the exchange of information and ideas can take place.

About Dynamic Healthcare Systems
Dynamic Healthcare Systems, Inc. was founded on delivering comprehensive solutions for Medicare Advantage health plans and MSOs striving to succeed amid new and evolving regulatory requirements. Headquartered in Irvine, California, the company brings world-class innovations to middle market companies serving the Medicare population. Dynamic Healthcare Systems can be reached at (949) 975-1877. www.dynamichealthsys.com.

Contact:
Dynamic Healthcare Systems
Media Relations
Jay Baker
Phone: 805.906.7327
Web: http://www.dynamichealthsys.com

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Press Contact: Jay Baker
Company Name: DYNAMIC HEALTHCARE SYSTEMS INC.
Email: email protected from spam bots
Phone: 805.906.7327
Website:
www.dynamichealthsys.com