Health Law Could Spur Momentum On OSHA Infectious Disease Reg

OSHA’s request for information (RFI) on a possible “infectious diseases” rule is drawing praise from nurses’ groups and unions, but the American Hospital Association is reserving judgment for now while encouraging its members to share their existing caregiver-protection plans with the agency.  (I BET THEY ARE — KEEP THEIR INFECTION RATES A SECRET — SEND THOSE LOBBYISTS OUT THERE!!!)

One union source even called hospital-acquired infections the most “significant” problem in our country, and suggested the new health reform law has created an opportune time for OSHA to address the issue.

The RFI follows OSHA’s announcement last month that it would broaden its initial focus on “airborne infectious diseases.” The expansion drew mixed reactions, with some praising it as an efficient means to address diseases obtained through a variety of exposures, while others cautioned that the broadened focus could potentially lead to a “fractionation of support” (see Inside OSHA, May 4).

The RFI, published in the May 6 Federal Register, provides further explanation for why the agency broadened its focus from airborne exposures, noting that OSHA currently lacks a comprehensive standard that addresses occupational exposure to contact, droplet and airborne transmissible diseases. But the agency also invited stakeholders’ comments on whether OSHA’s deliberations “should focus only on droplet and airborne transmission or if contact transmissible diseases should also be included.”

The RFI also asks stakeholders to comment on existing standards that may apply, including Bloodborne Pathogens, Respiratory Protection, General Personal Protective Equipment and in some cases the general duty clause.

Bill Borwegen, occupational health and safety director of the Service Employees International Union (SEIU), praised OSHA’s broadened approach, citing Centers for Disease Control and Prevention (CDC) statistics to suggest that more than a million infections are acquired in hospitals each year. “Anything we can do to stem this is a step in the right direction,” he said.

“I can’t imagine a more significant problem in our country than hospital-acquired infections,” he said, adding that those who die as result outnumber those killed by “guns and cars combined.” Borwegen called the Bloodborne Pathogens standard “an amazing success” that has reduced infections and curbed needle-sticks by more than half. However unions remain concerned about continued needlestick injuries (see related story).

“Now we need to deal with all these other infections,” Borwegen said – as opposed to conducting rulemaking in “a piecemeal fashion” that could “drag it out for an additional five or 10 or 15 years.”

He added that OSHA’s timing “couldn’t be better,” with healthcare reform being implemented. Borwegen pointed to recent remarks by Centers for Disease Control and Prevention Director Thomas Frieden that hospital infections may trigger up to $33 billion annually in excess medical costs.

Further, Borwegen pointed to California’s ATD standard as a “good model” that was developed using input from both industry and unions. “We don’t have to reinvent the wheel here. A lot of work has already been done,” he said.

Nancy Hughes, director of the Center for Occupational and Environmental Health with the American Nurses Association (ANA), told Inside OSHA that it was important for OSHA to take an “overall look” at caregiver infections, noting that some — such as H1N1 — can be airborne, or spread via droplet.

Hughes said the importance of hierarchy of controls is one point ANA is likely to make in its RFI comments. “Because you don’t want to go right to personal protective equipment,” she said. However, she noted that ANA hadn’t yet had the chance to formulate its formal comments for OSHA.

A source with the National Nurses United (NNU) said the organization would look more closely at the RFI and then decide whether to submit comments to OSHA.

During a speech to the NNU staff nurse assembly on May 11, Labor Secretary Hilda Solis touted OSHA’s effort as one that would protect nurses. “We’ve begun work on a standard that will protect nurses against infectious diseases. Right now OSHA only has a standard that covers bloodborne pathogens,” Solis remarked.

An AHA spokesman said the group is in the process of drafting its comments, and that it would neither support nor oppose a possible rulemaking at this point.

Roslyne Schulman, AHA director of policy development, issued the following statement to Inside OSHA: “The AHA encourages hospitals to respond to the RFI, and to share their plans and actions to protect their caregivers against infectious disease. Hospitals follow Centers for Disease Control and Prevention guidelines and recommendations for protecting caregivers and patients from infectious disease, which are enforced by hospital accrediting and certifying bodies such as The Joint Commission and Centers for Medicare & Medicaid Services.”

The AHA had previously praised OSHA’s announcement that it would issue an RFI for its now-expanded airborne infectious diseases regulation. Plus, the previous announcement had prompted union sources to suggest the federal standard addressing airborne exposures should be modeled after California’s, which took effect last August (see Inside OSHA, Jan. 12 and May 4).

According to the agency’s fall 2010 regulatory agenda, OSHA had planned to issue an RFI in March 2010 for its potential airborne infectious diseases standard. But it announced during a regulatory agenda Web chat in April that it would be expanding the standard to encompass all infectious diseases.

Comments are due to OSHA by Aug. 4. — Kristina Sherry

Will be watching and posting these comments. I expect to see the Hospital Lobbyist for the American Hospital Association and thier Attorneys posting negative comments.  Who will post for the patients — dead and alive?

To Comment:

Information on possible Infectious Diseases Rule, as posted in the Federal Register on May 6, 2010: see http://www.osha.gov/FedReg_osha_pdf/FED20100506.pdf

Your comments must be submitted (postmarked or sent) by August 4, 2010.

You may submit comments and additional materials by any of the following methods:

Electronically: You may submit comments and attachments electronically at  http://www.regulations.gov, which is theFederal eRulemaking Portal.

Fax: If your submissions, including attachments, are not longer than 10 pages, you may fax them to the OSHA Docket Office at (202) 693–1648; or

Mail, hand delivery, express mail, messenger or courier service: Three copies of your comments and attachments to:

OSHA Docket Office, Docket No. OSHA–2010–0003
U.S. Department of Labor, Room N–2625
200 Constitution Avenue, NW.
Washington, DC 20210.

All submissions must include the Agency name and the OSHA docket number for this rulemaking (OSHA Docket No. OSHA–2010–0003).

Submissions, including any personal information you provide, are placed in the public docket without change and may be made available online at http://www.regulations.gov.

Docket: To read or download submissions or other material in the docket, go to http://www.regulations.gov or the OSHA Docket Office at the address above.

Lee Ann Torrans
ltorrans@gmail.com

Is Your State on the List?

Facilities Enrolled in NHSN, by State (total=2456)

CDC currently supports more than 2000 hospitals that are using NHSN and 21 states require hospitals to report HAI’s using NHSN.

The NHSN is a secure, internet-based surveillance system that integrates former CDC surveillance systems, including the National Nosocomial Infections Surveillance System (NNIS), National Surveillance System for Healthcare Workers (NaSH), and the Dialysis Surveillance Network (DSN).

NHSN enables healthcare facilities to collect and use data about healthcare-associated infections, adherence to clinical practices known to prevent healthcare-associated infections, the incidence or prevalence of multidrug-resistant organisms within their organizations, and other adverse events. Some U.S. states utilize NHSN as a means for healthcare facilities to submit data on healthcare-associated infections (HAIs) mandated through their specific state legislation.

Consumer’s Union Not Impressed

Despite efforts to create a national, publicly available, hospital-by-hospital infection reporting system in the recently approved health care reform law, just a stripped-down version of it was enacted, using only a confidential reporting method. The law will impose financial penalties — a 1 percent reduction in Medicare reimbursements — on hospitals with the worst performance on a list of hospital-acquired conditions that include several types of infections.

Read Consumer Reports Results and view video.

“We need a national system that is standardized,” said Lisa McGiffert, campaign director for the Safe Patient Project of Consumers Union, the advocacy arm of Consumer Reports. “We really need a system that shows every hospital’s performance individually and not grouped together as a hospital system, like some reports allow. Individual hospitals in the same system can be very different.”

List of Patient Safety Pending Legislation

Safe Patient Project

http://www.safepatientproject.org/

About Mandatory Reporting

Will facilities in states with mandatory reporting have to submit data twice: once to the state and once to CDC?

No, the state, or entity authorized by the state to collect reports of healthcare associated infections, will view and analyze reports using a special function of the application referred to as “group functionality.” A group is created by a participating facility. Other facilities in the same state could join the group; all facilities would confer rights to the State or entity authorized to view and analyze reports. Facilities within the group cannot see each other’s data; only at the group level can data from the participating facilities be viewed and analyzed, as authorized by each facility. Facilities might collect more data than is required to be reported, and they can limit the authority of the group to view only data that are reportable. For example, a facility might conduct surveillance for surgical site infections associated with several different surgical procedures, but only authorize the group to view data on CABG.

California Hospital Acquired Infection Complaints

Consumers Union charges the State of California is not upholding patient safety laws.

Consumers Union, the publisher of Consumer Reports, is an independent, nonprofit testing and informational organization.  An estimated 240,000 California patients develop infections resulting from their hospitalizations each year, resulting in an estimated 13,500 deaths at a cost of $3.1 billion, Consumers Union says.

Separately, medical errors reportedly kill as many as 10,000 Californians each year and injure 140,000.  These errors include a class of adverse events known as “never-events” because they can be prevented, Consumers Union says in a nine-page report published last month.

Kathleen Billingsley, deputy director of the state Center for Health Care Quality, said the agency was improving the level of care for all Californians after disbanding the legally required Healthcare-Associated Infection Advisory Committee and failing to clearly move forward with a series of other initiatives to reduce hospital- acquired infections.

The Center for Quality Improvement and Patient Safety is a group in the Department of Human Services which recently noted, “These are not people dying because they are ill or injured. These are people dying from an adverse effect of their care … The number is unacceptable.”

Pennsylvania Hospital Acquire Infection Reporting Issues

The Pennsylvania Department of Health will release its first full-year’s worth of hospital-by-hospital data in May of 2010 showing how many bloodstream, urinary tract and other infections patients contracted during hospital stays in 2009.

But even though the state has been collecting similar data since 2005, and anecdotal evidence indicates that at least some hospitals have made significant progress — particularly in the Pittsburgh area — it won’t be possible to say how the state has done over the past half-decade in its nationally celebrated effort to reduce hospital-acquired infections.

That’s because the way infection reporting has been collected and analyzed has changed so much year to year — and agency to agency — that drawing long-term conclusions using the state’s data is impossible, state officials and experts say.

Nationally, the report found rates for three of five major types of serious hospital-related infections had increased in 2007 — the last full year national data was available for analysis — including an 8 percent increase in one of the most fatal infections, bloodstream infections following surgery.

Ms. McGiffert and others said a system like Pennsylvania’s hospital-by-hospital public reporting is still the model, despite the problems that now hobble making long-term conclusions.

From 2005 to 2007, the Pennsylvania Health Care Cost Containment Council issued infection reports before the Health Department took over in 2008 with a vastly different system of reporting.

“It’s just not possible to compare all the information that PHC4 was collecting to what the Department of Health is now getting,” said Mike Doering, executive director of the Pennsylvania Patient Safety Authority, a state agency that uses infection reporting to educate hospitals on best practices and problem areas.

“It’s now a different set of infections that are reported, a different set of patients, even a different set of hospitals. Plus the data is collected in a different way,” he said.

PHC4 collected data directly from all of the state’s 165 acute- care hospitals, first in four infection categories — urinary tract, pneumonia, bloodstream and surgical site — and then two more, gastrointestinal and an “other” category.

The agency also reported on other categories that hospitals took particular issue with: how many people died after contracting infections; the average length of stay for someone with an infection; and how much patients were charged.

“That’s one of the things we liked about PHC4; they collected data that people wanted to see,” said Ms. McGiffert.

The state was lauded nationally for its public reporting, even as the state’s hospitals and their lobbyists roundly criticized PHC4 reports as an unfair, unscientific reflection of their work. They pushed for a new system handled by the Health Department, which was approved in 2007.

“This is a more robust and actionable reporting system, rather than trying to create a system based on an overall hospital visitation rate” like PHC4 was using, said Paula Bussard, senior vice president of policy and regulatory services for the Hospital & Healthsystem Association of Pennsylvania.

“It’s not starting over. It’s moving forward, and you always have to start somewhere,” she said.

Pennsylvania hospitals no longer report directly to the state. Instead, hospitals report to the National Health and Safety Network, a surveillance system managed by the Centers for Disease Control and Prevention. The state pulls its data from that system.

The Health Department reports on nine infection categories, including four that PHC4 did not: eye, ear, nose and throat; lower respiratory tract; reproductive; and skin and soft tissue.

More institutions are included in the Health Department’s reports — 246 in all, 81 more than PHC4 studied — adding mental health hospitals, inpatient rehabilitation facilities, specialty general acute-care hospitals and long-term acute-care hospitals. It also is reporting on more categories of patients, adding those with burn injuries, organ transplants, mental disorders, drug and alcohol disorders, and children younger than 2.

The change in reporting caused so many problems that the first half-year of data collected by the Health Department in 2008 was so replete with mistakes that the department decided not to use it and released information only from the second half of the year.

Although PHC4 has not issued a report on hospital-acquired infections since it released the 2007 data, it still has the authority to do so and may release future reports on infection- related deaths, length of stays and costs that the Health Department is not reporting. PHC4’s board meets in July and will consider then whether to issue any future infection reports.

The Health Department report might not be much help in saying how the state has done in the past, but it is vitally important to hospitals’ futures. That’s because the report on 2009 data will become the base year that the state will use to set infection- reduction goals.

The law that gave the department reporting responsibilities set the first-year goal as a 10 percent reduction in infections for every hospital. The department will set the reduction goals for future years. If those goals are not met, hospitals could face financial penalties.

The Pittsburgh region long has been considered a leader in the infection battle after 33 hospitals here were involved in a successful joint project from 2001 to 2005 that significantly reduced central line bloodstream infections. Most local hospitals have already brought their rates down significantly, and they continue groundbreaking work on infections:

* Allegheny General Hospital has dropped its ventilator- associated infection rate in its trauma intensive care unit by 30 percent over the past two years by closely monitoring how many hours a day patients on ventilators were sitting up, rather than lying down;

* UPMC Montefiore recently began using a SwabCap, a device with a small, alcohol-doused sponge inside an orange cap that is placed on the unused hub of a central line that has been inserted inside a patient to keep the hub clean and prevent a bloodstream infection;

* Excela Health, which runs Latrobe, Frick and Westmoreland hospitals, has instituted a “storytelling” session for staff to try to figure out the source of an infection and reinforce daily hygiene practices.

“The thinking back in 2001 was, ‘Well, if you have a more high- risk population of patients, you’re allowed to have a higher rate,’ ” said Dr. Carlene Muto, UPMC’s medical director for infection control. “We said the hell with that, our goal is zero.”

Dr. Muto showed internal data that demonstrated UPMC’s ongoing effort to drive the most lethal of infections — central line bloodstream infections — down to nearly zero, which is why it is trying novel approaches such as the SwabCap.

Dr. Stephen Ostroff, director of the bureau of epidemiology for the Health Department, said the work that began in the past decade appears to have had ongoing benefits.

“That is clearly seen in our report. Clearly, facilities in the western part of the state look better than the rest of the state,” he said. “One of their challenges is that since they’re so far out in front of others, they’re going to have a hard time bringing it down even more, because ultimately we do want to bring everyone down to zero.”

Lee Ann Torrans
ltorrans@gmail.com

A WSSU Researcher is Working to Fine Tune Ultrasound to Destroy Infectious Bacteria

WINSTON-SALEM, N.C., June 8 — Winston-Salem State University issued the following news release:

A Winston-Salem State University (WSSU) researcher is working to fine tune ultrasound waves to destroy dangerous antibiotic-resistant bacteria that causes open wound infections that claims lives annually.

Bacteria in open wounds are often treated with antibiotics, according to Dr. Teresa Conner-Kerr, WSSU Department of Physical Therapy chair in the School of Health Sciences and author of the study. But antibiotic-resistant forms of bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), are emerging as problems in daycares, sports facilities and homes. They are no longer just a problem in hospitals.

Conner-Kerr and her research team found that very low frequency ultrasound at 35 khz kills bacteria including — MRSA — by puncturing and fracturing the bacterial cell walls and altering the cells’ tendencies to grow in colonies. This study measured the effects of ultrasound on bacterial viability, cell wall structure, colony characteristics and antibiotic sensitivity. The study was conducted on in vitro bacteria samples. The study documented that when exposed to 30 seconds of treatment, antibiotic-resistant forms of bacteria dropped from 106 per milliliter to six per milliliter, an approximate 99 percent drop.

“We are happy to report, based on our study, 35 kHz very low frequency ultrasound is more effective at reducing total bacteria cells in vitro than other frequencies of ultrasound. This is encouraging and timely news because standard therapies are failing and the importance of finding alternative approaches to managing these pathogens are becoming increasingly important,” said Conner-Kerr, “but further study is recommended on this potentially effective therapy.”

In the past, one antibiotic medication, methicillin, has been effective in killing open wound bacteria. But increasing cases of MRSA have become a particular concern in the medical community. This study focused on those bacterial strains.

Conner-Kerr and her research team found very low frequency ultrasound alone and in combination with standard antimicrobial compounds may prove to be beneficial and may provide an alternative strategy for not only treating antibiotic-resistant bacteria including MRSA but also in reversing its resistance to drugs. The ability to resensitize MRSA to methicillin points to a new way of utilizing older antibiotics that have become ineffective by pairing them with low frequency ultrasound when administered to the wound bed. Because low frequency ultrasound penetrates tissue deeply, the entire wound can be treated.

Lee Ann Torrans
ltorrans@gmail.com

Daily Express, London.  I include these real stories in addition to factual information to highlight the fact — this could be YOU.  This could be YOUR FAMILY.  MRSA strikes everyone.

To be told your child might not survive is a parent’s nightmare; Emily Darbyshire was a popular, A-grade student when she was struck down by two life-threatening illnesses. Her mother Gill, 55, describes the family’s struggles over the past few years

EMILY was a typical lively teenager with a social life that required more hours than there are in a day.

She loved being with her friends, going out and shopping. We have photos of her grinning, laden down with bags.

She was doing well academically and played lead trumpet for the Sussex Youth Orchestra. She had received offers to study at music conservatoires and the chance of going to Leeds University.

I’m describing all this in the past tense because everything changed for Emily and all of us one morning. She had come back home to Horsham, West Sussex, from a summer holiday with friends and we put her tiredness down to the late nights they had enjoyed.

On the Monday morning she wandered into our bedroom dragging her duvet, saying she had a horrendous headache and was going to watch TV. Her father Bill and I were getting ready to go to work: he is an executive for a printing ink company and I worked for a finance firm.

I had checked Emily over the night before and meningitis had crossed my mind although she showed none of the classic symptoms. It was the same the following morning but then I noticed a red patch on her foot. It wasn’t a rash but I sensed it was serious and shouted to Bill to call an ambulance. We were lucky to spot it. Had we missed it Emily would be dead now. We didn’t know it then but Emily did have meningitis and worse was to come.

The ambulance came in minutes and we were then caught in a whirlwind of fear and disbelief as our little girl became the centre of a dramatic medical emergency. A doctor told us Emily had meningitis and would be in hospital for four days but when they took her for a CT brain scan she started to go downhill. Her breathing became erratic and her lungs filled up as though she was drowning.

She was whisked into intensive care and then came the moment when a consultant uttered the words: “We are not sure we can save her.” Our world fell apart. We were her parents but were helpless. Her heart stopped but minutes later (it seemed like hours) they stabilised her.

We didn’t leave the hospital for three days while her condition remained critical. She was placed in an induced coma for about a week and then transferred to St George’s Hospital in London. For three weeks she remained in the coma while drugs were administered.

The staff were incredible and we never gave up hope. The following weeks were filled with anxious moments, particularly when she contracted MRSA and became really sick but she was eventually transferred back to our local hospital. She had survived both meningitis and encephalitis but now the fight was on to rebuild her life. We were told that most of her brain was OK although some crucial parts had been damaged.

Our once bubbly girl couldn’t talk and had to convey feelings with her eyes. Gradually she regained enough movement to point to letters on a board to communicate.

She couldn’t move her head and needed physiotherapy to get her muscles moving. To watch Emily in so much pain as she attempted to stand was unbearable but I knew they had to make her do it.

Bill, myself and her elder sister Charlotte, who is 26, would sit with her and bend her fingers to help her regain movement. She used to play the piano and the trumpet and we knew it was important for her to get that movement back. She couldn’t sit up or speak or feed herself but eventually we were told we would have to find alternative care for her.

She was given a 12-week place at a rehabilitation centre for stroke victims in Sussex but it quickly became clear she needed a place better suited to a teenage girl.

Emily’s birthday falls on Christmas Day and we decided we wanted her home to celebrate her 18th as a family. Staff at the centre were not keen and Bill had to fight hard to allow her to leave.

We spent ages sourcing the right equipment and hiring a bed and a hoist. We converted the dining room into her room which upset her because we normally sit in there for Christmas dinner. In the end we ate in the kitchen. We had to cut up food and feed it to Emily but we were so happy to have her back and it was a very emotional time.

As a mother you don’t expect to be back doing so many basic things for your child but I could see the fight in Emily’s eyes and her determination gave us all strength.

Bill and I took time off work to help care for her and I started trawling the internet for places that could offer her the treatment and support she so obviously needed. It was then we learned about the Queen Elizabeth’s Foundation for Disabled People, based in Banstead, Surrey. It was by no means certain Emily would get a residential place but thank God she did. The staff resurrected her life.

The QEF specialises in caring for patients aged 17 to 35 and was the perfect environment for Emily. They taught her so much and helped her regain her independence. She had intensive physiotherapy, speech therapy and skills sessions.

Emily was given her own room, which is so important for a teenage girl. Over the next two-and-a-half years she recovered enough to complete her geography A-level and learn to drive. Her recovery has been remarkable. She is now studying for an HND at Chichester College, where she has her own flat, and is planning for university.

Family life is obviously different now. Emily needs a wheelchair and we’ve adapted the house with wider doors and ramps. We have weepy nights but Emily is positive and her attitude is “the sky’s the limit”.

Being told your child may die is a devastating moment. Meningitis can kill within four hours and we were lucky we picked it up.

The future is a lot different to how we planned it but Emily is still our beautiful, bright daughter and as her confidence grows I know she has a great future.

Lee Ann Torrans
ltorrans@gmail.com

Methicillin-Resistant Staphylococcus aureus; Researchers from Johns Hopkins University, Medical Department detail new studies and findings in the area of methicillin-resistant Staphylococcus aureus

“We found that 72 (6%) of 1,674 PICU patients were colonized with MRSA.

MRSA-colonized patients were more likely to be younger (median age 3 years vs. 5 years; p = 0.02) and African American (p <0.001) and to have been hospitalized within 12 months (p <0.001) than were noncolonized patients.

MRSA isolates from 66 (92%) colonized patients were fingerprinted; 40 (61%) were genotypically Community Acquired -MRSA strains.

Community Acquired – MRSA strains were isolated from 50% of patients who became colonized with MRSA and caused the only hospital-acquired MRSA catheter-associated bloodstream infection in the cohort.

Epidemic Community Acquired – MRSA strains are becoming endemic to Pediatric ICUs, can be transmitted to hospitalized children, and can cause invasive hospital-acquired infections,” wrote A.M. Milstone and colleagues, Johns Hopkins University, Medical Department.

The researchers concluded: “Further appraisal of MRSA control is needed.”

Milstone and colleagues published their study in Emerging Infectious Diseases (Community-associated Methicillin-Resistant Staphylococcus aureus Strains in Pediatric Intensive Care Unit. Emerging Infectious Diseases, 2010;16(4):647-655).

According to recent research from the United States, “Virulent community-associated methicillin-resistant Staphylococcus-aureus (CA-MRSA) strains have spread rapidly in the United States. To characterize the degree to which CA-MRSA strains are imported into and transmitted in pediatric intensive care units (PICU), we performed a retrospective study of children admitted to The Johns Hopkins Hospital PICU, March 1, 2007 May 31, 2008.”

For additional information, contact A.M. Milstone, Johns Hopkins University, School Medical, Dept. of Pediatrics Infectious Disease, 200 N Wolfe St., Rubenstein 3141, Baltimore, MD 21287, US

Medizone International, Inc. (Dually Traded: OTCBB/OTCQB: MZEI)
(http://medizoneint.com)

Medizone International, Inc. is a research and development company engaged in developing its AsepticSure™ System to decontaminate and sterilize hospitals, sports training facilities, schools and other critical infrastructure. A government variant is being developed for bio-terrorism counter measures. Successful decontamination by AsepticSure™ to the 6 log standard or greater has been demonstrated with C.difficile, E coli, Pseudomonas aeruginous, MRSA, VRE and Bacillius subtilis.

Lee Ann Torrans

ltorrans@gmail.com

DRUG-RESISTANT BACTERIA INVADE U.S. HOSPITALS

A surge in drug-resistant strains of Acinetobacter, a dangerous type of bacteria that is becoming increasingly common in U.S. hospitals, has been reported In a study published in the journal Infection Control and Hospital Epidemiology. These infections attack patients in hospital intensive care units while also plaguing soldiers returning home from the Iraqi war. They often appear as severe pneumonias or bloodstream infections, and require strong drugs to be treated, when they can be stopped at all.

Using data from hospitals around the country, researchers at Extending the Cure- a project of the Washington, D.C.-based think tank Resources for the Future – analyzed trends in resistance to imipenem, an antibiotic often reserved as a last-line treatment The study found that in recent years, there has been a more than 300% increase in the proportion of Acinetobacter cases resistant to the drug.

“The findings are troubling because they suggest this bacteria is becoming resistant to nearly everything in our arsenal,” notes principal investigator Ramanan Laxminarayan. ‘There is a lot of attention on MRSA [methiállin-resistant Staphylococcus aureus], but less on infections caused by bacteria like Acinetobacter, for which there are fewer drugs in the development pipeline. While all drug resistance is of concern, it is particularly worrying in the case of bugs for which we have few treatment options.”

Using data from hospitals around the country, researchers at Extending the Cure- a project of the Washington, D.C.-based think tank Resources for the Future – analyzed trends in resistance to imipenem, an antibiotic often reserved as a last-line treatment The study found that in recent years, there has been a more than 300% increase in the proportion of Acinetobacter cases resistant to the drug.

Lee Ann Torrans
ltorrans@gmail.com


Growing dangers of infections ; Overuse of antibiotics is making treatment of diseases more difficult
10 May 2010

Alice M. Brennan was 88, but she didn’t look or act very old.

She lived independently in Lockport, managed her own finances, drove a car and maintained an active social schedule.

Her daughter, Mary Brennan-Taylor, likes to show a photograph of her mother dancing at a family wedding last year.

“She had the spirit of an 18-year-old,” said Brennan-Taylor.

But Alice Brennan’s right leg began to experience pain and swelling in 2009. She was hospitalized briefly, diagnosed with gout and sent to a nursing home for rehabilitation.

Instead of recuperating from the severe form of arthritis, she deteriorated and died six weeks after the initial hospitalization.

Her family contends three infections that Brennan developed led to her death.

“What’s most difficult for me is that this was preventable,” said Brennan-Taylor.

Brennan’s story illustrates a major challenge in health care.

It was once believed that antibiotics would erase bacterial infections. Instead, overuse and misuse of the drugs in medicine and on farms is making treatment of infections more difficult as germs evolve with growing resistance.

An estimated 99,000 deaths associated with infections occur in hospitals alone each year, according to the federal Centers for Disease Control and Prevention. In recent decades, infections became so common that they were considered an unavoidable complication of caring for the sickest patients. Yet many are avoidable.

“We assume that infections are natural, that they emerge out of nowhere because they often occur in people who are already ill. But infections are transmitted. That means they can be prevented and these deaths reduced,” said Ramanan Laxminarayan, the lead investigator for Extending the Cure, a project examining antibiotic resistance based at Resources for the Future, a think tank in Washington, D.C.

Hospitals are trying to improve.

Earlier this year, for instance, a project at more than 100 Michigan intensive-care units reported a 66 percent drop in bloodstream infections from the placement of catheters in veins after adopting a checklist of infection-control practices, including hand-washing, and measuring the results.

But potentially fatal infections like the ones linked to Brennan’s death persist despite the existence of measures to limit the spread of microbes.

In its 2009 quality report to Congress released last month, the Health and Human Services Department found “very little progress” on eliminating health care-acquired infections.

Among five major infections examined, the rate of bloodstream illness following surgery increased 8 percent from 2006 to 2007, while the rate of post-operative urinary tract infections from catheters rose 3.6 percent.

There is debate over the quality report’s conclusion about progress that forthcoming government studies may clarify. But there is little disagreement over the problem of antibiotic resistance and the specter of making once-treatable diseases untreatable, as if the era before antibiotics had returned.

“If we use antibiotics more appropriately we will improve our ability to treat bacterial infections, and if we do a better job of infection control, we will reduce the need for antibiotics,” said Laxminarayan.

In a recent study, he and his colleagues found that two common hospital-acquired infections — pneumonia and sepsis, a bloodstream illness — killed 48,000 people and increased health costs by $8.1 billion in 2006 alone. The research looked at deaths actually caused by infections, whereas the CDC statistic of 99,000 refers to deaths associated with hospital-acquired infections.

Laxminarayan said solutions to the problem will require stronger government leadership to develop new antibiotics, better treatment strategies and community infection-control efforts that go beyond hospitals.

Brennan’s case illustrates how patients and microbes today travel from facility to facility.

She was discharged July 17 from Eastern Niagara Hospital (formerly Lockport Memorial) to the Odd Fellows & Rebekah Rehabilitation and Health Care Center in Lockport for what was supposed to be two weeks of therapy to help with walking.

However, she began to suffer from hallucinations, incontinence and loss of appetite, symptoms her daughter contends resulted from a high dose of a muscle relaxant.

Brennan was readmitted Aug. 3 to Eastern Niagara with dehydration and a few days later sent back to Odd Fellows, where symptoms worsened and grew to include abdominal pain, according to Brennan- Taylor.

She returned to the hospital around Aug. 10 with a urinary tract infection caused by MRSA, a bacterium resistant to common antibiotics, said Brennan-Taylor. Her mother was treated with another antibiotic, vancomycin, but continued to decline. Then tests identified two more bacterial infections — clostridium difficile, which causes diarrhea, and vancomycin-resistant enterococci, which can cause skin wounds.

“My mom fell prey to a fragmented health system and a complacent attitude about infections,” said Brennan-Taylor. “People in health care act as if infections are inevitable, or that this happens all the time, and they can turn it around. It shouldn’t be something they deal with all the time.”

A state Health Department investigation faulted the hospital for not implementing an adequate care plan for isolating the patient. A review of Odd Fellows found no evidence to corroborate Brennan- Taylor’s complaint of inadequate care.

Hospital and nursing home officials declined to discuss the case, citing privacy laws.

In a prepared statement, hospital spokeswoman Carolyn Moore said the hospital maintains an infection-control program that includes surveillance of inpatients. She said Eastern Niagara takes the additional step of screening patients at admission for MRSA, which individuals can carry into a facility. Eugene L. Urban, chief executive officer of Odd Fellows, in a statement, said the nursing home has not been found to be in violation of any infection-control standards.

Much of the focus on infections has centered around staphylococcus aureus, a bacterium commonly carried on the skin or in the nose of healthy people. About 30 percent of healthy individuals in the community have staph living in their nose but aren’t infected.

Staph can cause an infection, usually minor skin ailments, and outbreaks have become more common in locker rooms and schools. But another strain of staph bacteria occurs most frequently in hospitals and nursing homes, where it can cause serious infections in the blood, lungs and surgery sites.

MRSA, or methicillin-resistant staphylococcus aureus, is the type of staph that is resistant to common antibiotics. Of the individuals living with staph in their noses, an estimated 1 percent have the MRSA strain.

The community-acquired strain of MRSA is a growing problem, including in Buffalo.

A study reported this year of Kaleida Health hospitals reflected what is happening across the country. The rate of suspected community-acquired MRSA in patients increased for adults from 56 percent in 2003 to 71 percent in 2006, and for children from 26 percent to 64 percent.

Most MRSA occurs in health care facilities, where the bacteria can enter the body through wounds, catheters and ventilators. Older and weakened patients are especially vulnerable.

“It’s complicated for hospitals because you often can’t differentiate hospital-acquired MRSA from the community variety,” said Dr. Chiu Bin Hsiao, lead author and associate professor of infectious diseases at the University at Buffalo.

MRSA is just one of many antibiotic-resistant pathogens that pose a danger to patients and that can be spread by skin-to-skin contact or by touching contaminated items. Others include acinetobacter, pseudomonas aeruginosa and clostridium difficile.

Cases of clostridium difficile are now more common than MRSA in community hospitals, according to research reported in March at an international conference on health care infections. These bacteria normally live in the large intestine, but taking antibiotics for other infections can wipe out the “good” bacteria in the digestive tract that keep them from proliferating like weeds on a lawn.

Efforts under way to curb infections include financial penalties by Medicare and private insurers for preventable episodes in hospitals, screening of patients for MRSA and hospital-acquired infection reporting by more than half the states.

New York last year began releasing 12 different infection rates for hospitals. No one facility was found to have a high infection rate across the board, but officials say it’s premature to draw conclusions.

“The public perception has been that a patient comes into a hospital and gets an infection. But the problem is much more complex, with different types of infections in different health care settings,” said Rachel Stricof, director of the state’s bureau of health care-associated infections.

One solution is to deny payment to hospitals for some infections, although critics contend it’s impossible to eliminate all infections. They say the penalties don’t account for patients who are extraordinarily ill, or for the way patients routinely move through multiple facilities for care.

Veterans Affairs hospitals began screening patients for MRSA in 2007. The mandated measure resulted in a decline nationally in transmission of MRSA and new infections, although a recent study at the VA Medical Center in Buffalo did not find a similar drop in new infections over the first two years of the program for reasons that remain unclear.

Screening may work against MRSA, but its high cost would impose a huge financial burden on private hospitals with far more patients, said Dr. John Sellick, lead author of the study and the medical center’s epidemiologist.

“There are a lot of other infections to control, and hospitals don’t get reimbursed more for these measures. You have to consider what is the best use of your human and laboratory resources,” he said.

Sellick said hospitals should encourage a culture in which the entire staff buys into a system of infection control.

To Brennan-Taylor, who took her mother’s death hard, what’s needed at a minimum is a change in thinking about the scale of the problem.

“The deaths are isolated, so they don’t get much attention,” she said. “But it’s akin to a jumbo jet crashing every other day.”

e-mail: hdavis@buffnews.com

Caption: Harry Scull Jr./Buffalo News Alice M. Brennan, 88, died six weeks after her initial hospitalization, where she was diagnosed with gout and sent to a nursing home for rehabilitation. Patient safety WNY hospitals with infection rates significantly better or worse than state average [Graphic - see microfilm]

Document BFNW000020100511e65a0001s

Lee Ann Torrans
ltorrans@gmail.com

As science reconstructs deaths of great men in hind sight and we have come to understand Edgar Allen Poe suffered a prolonged and painful death from rabies as opposed to alcohol as believed at the time.  I wonder if Dylan Thomas might have died of a hospital acquired infection rather than alcohol poisoning.  No doubt alcohol was the basis for admission and was a contributing cause of his death but was it the sole cause?

Link Here to Hear Dylan Thomas Reading His Poetry (Caution: is a bit loud now — will edit to lower the sound soon.)

I believe this poem touches on the emotion of mourning.  In this country 99,000 needless deaths occur followed by mourning and grief.

Refusal to Mourn the Death by Fire of a Child in London

Never until the mankind making
Bird beast and flower
Fathering and all humbling darkness
Tells with silence the last light breaking
And the still hour
Is come of the sea tumbling in harness

And I must enter again the round
Zion of the water bead
And the synagogue of the ear of corn
Shall I let pray the shadow of a sound
Or sow my salt seed
In the least valley of sackcloth to mourn

The majesty and burning of the child's death.
I shall not murder
The mankind of her going with a grave truth
Nor blaspheme down the stations of the breath
With any further
Elegy of innocence and youth.

Deep with the first dead lies London's daughter,
Robed in the long friends,
The grains beyond age, the dark veins of her mother,
Secret by the unmourning water
Of the riding Thames.
After the first death, there is no other.

Lee Ann Torrans ltorrans@gmail.com

Congressional Hearing: Subcommittee on Health Antibiotic Resistance and the Threat to Public Health
Hearings – Subcommittee on Health – Wednesday, 28 April 2010 13:02

See Text of hearing:

The hearing explored the phenomenon of antibiotic resistance and the effects it has on human health.  The Subcommittee on Health held a hearing entitled “Antibiotic Resistance and the Threat to Public Health” on Wednesday, April 28, 2010. The hearing explored the phenomenon of antibiotic resistance and the effects it has on human health.

Witnesses

  • Thomas Frieden, M.D., M.P.H., Director, Centers for Disease Control and Prevention
  • Anthony Fauci, M.D., Director, National Institute of Allergy and Infectious Diseases

Documents

Testimony

Video – WMV
Download or Stream

I. INTRODUCTION: BACTERIA, ANTIBIOTICS AND ANTIBIOTIC RESISTANCE

Bacteria are microscopic organisms that are found naturally both inside and outside of our bodies. Sometimes bacteria can be harmless or even beneficial. There are a hundred trillion or so bacteria that live in a person’s gut and can help process food and protect people from unfriendly germs1. At other times, bacteria can be harmful to humans by infecting the body (e.g., strep infections of the throat). Viruses are different from bacteria but are also microscopic organisms that can infect the body (a viral infection of the upper respiratory tract is usually called a cold).

Two Million Patient Infections with 90,000 Deaths Annually in the United States

Each year nearly two million patients in the United States get an infection in a hospital, and about 90,000 die as a result of these infections.10 More than 70% of the bacteria that cause hospital-acquired infections are resistant to at least one of the antibiotics most commonly used to treat them.11 People infected with drug-resistant organisms are more likely to have longer hospital stays and require treatment with other drugs that may be less effective, more toxic, or more expensive.12 Between 5 and 10 percent of all hospital patients develop an infection, leading to an increase of about $5 billion in annual U.S. healthcare costs.13

See:  1 NIAID, Bacterial Infections: Birth of an Intestinal Ecosystem (online at www.niaid.nih.gov/topics/bacterialInfections/pages/intestinalecosystem.aspx) (accessed Apr. 19, 2010). Antibiotics are only useful against bacteria and not viruses. Antiviral drugs can be used against viruses.

Antibiotic resistance is “the ability of bacteria or other microbes to resist the effects of an antibiotic. Antibiotic resistance occurs when bacteria change in some way that reduces or eliminates the effectiveness of drugs, chemicals, or other agents designed to cure or prevent infections.”3 Every time antibiotics are used, sensitive bacteria are killed and resistant forms of the bacteria may survive.4 These resistant bacteria can then flourish and infect others.

The ability for bacteria to be resistant to an antibiotic can be encoded on a single segment of DNA. These DNA segments can be transferred between different strains or even different species of bacteria, and through this gene transfer, bacteria that were never exposed to the antibiotic can acquire the resistance from other bacteria.5 Some DNA segments can even encode resistance to multiple antibiotics, and so when bacteria acquire that single piece of DNA, they can become resistant to many antibiotics.6

The U.S. Centers for Disease Control and Prevention (CDC) observes that “the number of bacteria resistant to antibiotics has increased in the last decade. Many bacterial infections are becoming resistant to the most commonly prescribed antibiotic treatments.” According to the National Institute of Allergy and Infectious Diseases (NIAID), “many infectious diseases are increasingly difficult to treat because of antimicrobial-resistant organisms.”7 This hearing will examine the recent trend in infections that have become more difficult to control.

II. PUBLIC HEALTH IMPACT OF ANTIBIOTIC RESISTANCE

2 CDC, Get Smart: Know When Antibiotics Work—Antibiotic Resistance Questions & Answers (online at www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html) (accessed Apr. 19, 2010).
3 CDC, Get Smart: Know When Antibiotics Work—Antibiotic Resistance Questions & Answers (online at www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html) (accessed Apr. 19, 2010).
4 CDC, “Get Smart: Know When Antibiotics Work—Fast Facts” (online at http://www.cdc.gov/getsmart/antibiotic-use/fast-facts.html) (accessed Apr. 19, 2010).
5 NIAID, “Bacteria Infections” (online at http://www.niaid.nih.gov/topics/bacterialinfections/Pages/default.aspx) (accessed Apr. 19, 2010); NIAID, “Antimicrobial (Drug) Resistance: Causes” (online at http://www.niaid.nih.gov/topics/antimicrobialResistance/Understanding/Pages/causes.aspx) (accessed Apr. 19, 2010).
6 CDC, Get Smart: Know When Antibiotics Work—Antibiotic Resistance Questions & Answers (online at www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html#d) (accessed Apr. 19, 2010).
7 NIAID, Antimicrobial (Drug) Resistance (online at www.niaid.nih.gov/topics/antimicrobialResistance/Understanding/Pages/quickFacts.aspx) (accessed Apr. 19, 2010).

Numerous press reports have highlighted the decreased ability of modern antibiotics to control deadly diseases, and CDC has described antibiotic resistance as “one of the world’s most pressing health problems.”

IMPACT OF SPECIFIC BACTERIA

Some resistant organisms have garnered specific interest. In 2007, CDC experts estimated that methicillin-resistant Staphylococcus aureus (MRSA) was responsible for about 94,000 infections and over 18,000 deaths each year.14 Even young, healthy patients were killed by this infection.

One outbreak in relatively young patients was documented by CDC in 2004, when an outbreak of antibiotic-resistant Acinetobacter baumannii began in veterans returning from Iraq and Kuwait and from Afghanistan.15

8 Rising Threat of Infections Unfazed by Antibiotics, New York Times (Feb. 26, 2010).

9 CDC, Get Smart: Know When Antibiotics Work—Antibiotic Resistance Questions & Answers (online at www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html) (accessed Apr. 19, 2010).

10 CDC, Campaign to Prevent Antimicrobial Resistance in Healthcare Settings (online at www.cdc.gov/drugresistance/healthcare/problem.htm) (accessed Apr. 19, 2010).

11 CDC, Campaign to Prevent Antimicrobial Resistance in Healthcare Settings (online at www.cdc.gov/drugresistance/healthcare/problem.htm) (accessed Apr. 19, 2010).

12 CDC, Campaign to Prevent Antimicrobial Resistance in Healthcare Settings (online at www.cdc.gov/drugresistance/healthcare/problem.htm) (accessed Apr. 19, 2010).

13 NIAID, Antimicrobial (Drug) Resistance: Quick Facts (online at www.niaid.nih.gov/topics/antimicrobialResistance/Understanding/Pages/quickFacts.aspx) (accessed Apr. 19, 2010).

14 Klevens RM, Invasive Methicillin-Resistant Staphylococcus aureus Infections in the United States, Journal of the American Medical Association (Oct. 17, 2007).

15 CDC, Acinetobacter baumannii Infections Among Patients at Military Medical Facilities Treating Injured U.S. Service Members, 2002-2004, MMWR Weekly (Nov. 19, 2004).

Other infections are becoming so resistant that few antibiotics are effective against them. Enterococci bacteria can cause serious infections, especially in people susceptible to infections. There are now strains known as vancomycin-resistant enterococci (also known as VRE) which can be resistant to even the drugs of last resort, leaving very little recourse for treating physicians.16

III. ORIGINS OF ANTIBIOTIC RESISTANCE AND POTENTIAL ROUTES TO ADDRESS THE PROBLEM

According to NIAID, the broader causes for resistance could include the following:

1. Inappropriate use by physicians.
2. Inadequate diagnostics, leading to use of broad spectrum antibiotics when a specific one might be better, or leading to the use of antibiotics to treat viral infections.
3. Hospital use, because of the heavy use and the close contact among sick patients
4. Agricultural use, particularly in animal feed, although NIAID acknowledges there is debate about the public health impact.

CDC states that “widespread use of antibiotics promotes the spread of antibiotic resistance. Smart use of antibiotics is the key to controlling the spread of resistance.” 17 CDC has multiple campaigns to address antibiotic resistance: The “Get Smart: Know When Antibiotics Work” campaign, which focuses on the judicious use of antibiotics by physicians; the “Get Smart: Know When Antibiotics Work on the Farm” campaign, which focuses on use of antibiotics in agricultural settings; and the “Campaign to Prevent Antimicrobial Resistance in Healthcare Settings.”

Others, such as the Institute of Medicine, have suggested the need for additional actions, such as incentives to bring more antibiotics to market, more aggressive policies to prevent healthcare-associated infections, strengthened surveillance, and increased efforts in vaccine development and production.18

IV. WITNESSES

The following witnesses have been invited to testify:

16 NIAID, Antimicrobial (drug) resistance: Vancomycin-resistant enterococci (VRE) (online at www.niaid.nih.gov/topics/antimicrobialResistance/Examples/vre/Pages/default.aspx) (accessed April 19, 2010).
17 CDC, Get Smart: Know When Antibiotics Work—Antibiotic Resistance Questions & Answers (online at www.cdc.gov/getsmart/antibiotic-use/anitbiotic-resistance-faqs.html) (accessed Apr. 19, 2010).
18 Institute of Medicine, Microbial Threats to Health: Emergence, Detection, and Response (2003).

Thomas Frieden, MD, MPH Director Centers for Disease Control and Prevention
Anthony Fauci, MD Director National Institute of Allergy and Infectious Diseases

Lee Ann Torrans

ltorrans@gmail.com

Enanta Pharmaceuticals Begins Phase I Trial of EDP-322, the First MRSA-Active Bicyclolide in April 2010.

In our in vitro studies, EDP-322 demonstrated good potency against both hospital- and community-acquired MRSA, even against highly drug-resistant MRSA strains,” explained Yat Sun Or, Ph.D., Senior Vice President of Research and Development at Enanta. “The potency of EDP-322 against hospital-acquired MRSA, community-acquired MRSA, and other gram-positive pathogens, combined with the convenience of oral administration, has the potential to uniquely position EDP-322 among marketed MRSA drugs in both the hospital and community settings.”

__________________________________

Cubist Pharmaceuticals Inc. enrolled the first subject in its Phase 2 trial of an antibacterial drug candidate for patients with a form of severe and sometimes life-threatening diarrhea. The drug candidate (CB-183,315) targets diarrhea caused by Clostridium difficile, known as C. difficile-associated diarrhea. The trial is expected to enroll 200-plus subjects.

Cubist spent approximately $402.5 million to buy a California company that is developing an antibiotic to fight superbugs.

Cubist, a Lexington therapeutics company, already markets an antibiotic, Cubicin, to battle infections caused by the methicillin- resistant Staphylococcus aureus (MRSA) bacteria. Now it has agreed to pay $92.5 million cash – and as much as $310 million more in future milestone payments – to acquire two-year-old Calixa Therapeutics of San Diego, which is testing an antibiotic called CXA- 201 to treat complicated urinary tract and intra-abdominal infections.

Cubist employs about 600 people worldwide, including 370 in Massachusetts.

Cubist plans to take over management of Calixa’s clinical trials and extend them to treat nosocomial pneumonia, also known as hospital-acquired pneumonia. It plans to file a new drug application for CXA-201 with the Food and Drug Administration by the second half of 2013.

Cubist is also pressing a patent suit against Teva Parenteral Medicines Inc. of Israel, which is developing a generic version of Cubist’s primary drug, Cubicin. A trial has been set for April 25, 2011, four months before the FDA could rule on Teva’s application to sell its generic drug in the United States.

Cubist currently markets the antibiotic Cubicin, for infections by methicillin-resistant Staphylococcus aureus (MRSA) bacteria. The high-profile drug, Cubicin, use to fight MRSA infections is an important asset for Cubist.

April 2010

Lee Ann Torrans

ltorrans@gmail.com

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