Archive for March 17th, 2008

OMNI Postings of 3/17/08

Postings:  646, 653, 654, 650, 656. 

Case report from J Emerg Med.  This patient was seen twice in the ER and sent home before he presented with the ultimate diagnosis.  This last time, he couldn’t be discharged.  Even Helen Keller wearing a blindfold would have no problem figuring it out. Nice X-ray.
http://omniphysicians.com/2008/03/17/necrotizing-fasciitis-as-the-clinical-presentation-of-a-retroperitoneal-abscess/
Three pillars of the community shoot it out outside of an ER.  I wonder why?  #1: Hey man, did you get the script for the Vicodin?”  #2:  No, man.  I thought you did.  # 1:  I ain’t got it.  I was the “patient.”  You were supposed to get it, f–k!   #3:  This is just great!  Now what are we going to do, man?  I’m hurting, bro!  #1:  Well you go back  and be the “patient” this time.  #3:  No, I ain’t.  You do it.  It’s your fault, you ass—–.  #2:  Don’t call me ass—–.  #1:  You’re both ass—–!  #3:  That’s it.  It’s over… Bang!…Bang!… Bang!!!
http://omniphysicians.com/2008/03/17/gunfight-at-the-ok-hospital/
In case you’re interested, here is a summary from McCain, Obama, & Clinton on healthcare reform.   McCain’s idea will have other people lose all their teeth while they can’t afford to see a dentist.  Obama & Clinton’s idea is for you and me to lose our teeth while we wait interminably to get in to see a dentist.
http://omniphysicians.com/2008/03/17/presidential-hopefuls-healthcare/
This kind of study from  CDC keeps popping up every now and again and even though the researchers can’t prove discrimination, the implication is there.  The study says:  The chest pain of Eliot Spitzer will be managed in the ER more quickly than Rev. Farrakhan’s.    The study is superficial in nature, but no matter who gets seen faster, the researchers state that there was no difference in mortality and hospitalization.  Anyway, back to Former Gov. Spitzer:  that chest pain may be related to Silda’s letter opener that is sticking in his left 5th ICS.
http://omniphysicians.com/2008/03/17/white-males-with-chest-pain-get-seen-faster/
Arguably, ERs in Arizona are the worst in the nation for lack of resources and personnel while the patient population continues growing.  This news story presents the human side to this Tucsonian crisis.
http://omniphysicians.com/2008/03/17/er-crisis-in-tucson/

ER Crisis in Tucson

Arizona Daily Star, 3/16/08: 

For eight long, agonizing hours, the young woman sat beside her husband in a Tucson emergency room, terrified as he fought unbearable pain and struggled to breathe.
She begged the people in charge for help. She was told to go sit down. It would be many more hours. There were many people ahead of them who already had waited far longer.

When her husband, 39-year old Rob Sweitzer, was finally summoned to see a doctor — at 2:30 a.m. — it was too late.
His lungs were full of blood. His body was shutting down. His heart stopped twice. They resuscitated him once, but it failed a second time. He died in the ER, most likely of a severe — and untreated — infection.
“I was completely helpless the entire time we were there. There was just nowhere to turn, nowhere to go to get help for Rob,” said his wife, Rachel Sweitzer.
“You go to the emergency room because you need emergency care. But you can’t get it. It’s horrible. It’s broken. And this is the United States.”
Hospital officials have declined to comment specifically on what went wrong that night, saying the case remains under internal review.
But if Rachel Sweitzer’s pleas indeed were ignored that night, that is “totally unacceptable,” said St. Mary’s spokeswoman Letty Ramirez.
“What happened was so incredibly unusual, so sudden and shocking and disturbing to everybody here,” she said.
While this tragedy was unfolding on a recent Saturday night in Tucson, just a few miles away another couple, David and Bette Lou Holstein, packed their belongings, preparing to leave this desert city they had grown to love in the past six years.
They too, have endured six- and eight-hour waits in Tucson ERs. David Holstein has multiple sclerosis but could not find a specialist in that disorder. He has had to wait weeks, sometimes months, to see a neurologist or other specialist, despite acute MS attacks. He was sent instead to the ER. He could not get doctors to answer the phone, to call him back, to even refill a prescription, without begging for days.
The Holsteins finally gave up. They felt unsafe here.
“Why are such bad things happening to us?” asked Bette Lou Holstein, who once saw Tucson as the perfect place to retire with her husband. “Why can’t we access the health-care system when we need it?”
They asked doctors and nurses what they were doing wrong.
“They told us, ‘Nothing.’ They all agreed it’s a mess, but they said you can’t do anything about it,” she said.
“We moved to Tucson from Pennsylvania because the winters are mild and healthy. We met wonderful people, made special friends, life was good. Now, because our world in Arizona seems so unhealthy, so uncaring and in such a shambles, we must go back to the snows of Pennsylvania.
“We don’t want to leave. But this is health care we’re talking about. Why is it not a priority here? It’s very frightening.”
Beyond the tipping point
Strong evidence is mounting that Tucson’s overcrowded, overwhelmed and understaffed ERs have reached crisis level, struggling to safely handle the daily load, unable to handle any new strains at all.
Our emergency physicians are pleading for help. In a letter to the editor printed in the Arizona Daily Star 10 days ago, Dr. Ken Iserson — at University Medical Center — said the current flu outbreak has pushed the city’s ERs, including his own, to the “tipping point,” putting “our lives at risk.”
This, even though we can pretty much predict a flu outbreak, to some degree, every winter. We still can’t handle it, they admit.
Rob Sweitzer died Feb. 10 at a packed ER across town also beyond its tipping point, at St. Mary’s Hospital.
This meltdown of emergency care is happening throughout the United States, for a complex and cascading series of reasons: a severe shortage of surgeons and specialty doctors willing to do ER duty, a shortage of nurses and ER staff, a shortage of inpatient beds to get emergency patients out of the ER and into the hospital, too many uninsured patients with nowhere else to go, long waits for doctors’ appointments that force non-emergency patients to clog the ERs when they’re sick, and a huge and aging baby boomer population now needing more emergency care, to name the worst.
But these problems appear to be significantly more acute in Southern Arizona than elsewhere in the nation — and affect our entire health-care system here — a series of studies, affirmed by patient case histories, shows.
● Arizona tops the nation for long waits in the ER. We wait more hours than anywhere else, a 2006 national survey by USA Today found.
● We are among the worst nine states at providing emergency care, with poor patient access to that care, and extreme shortages of emergency physicians, on-call specialists, nurses and trauma centers, said a 2006 study by the American College of Emergency Physicians.
● During the past five years, outpatient visits to ERs jumped 8 percent across the nation. But in Arizona — one of the fastest-growing states — ER visits soared at six times that rate, by 46 percent, according to the American Medical Association.
● The nursing shortage is significantly worse here. In Arizona, we have only 681 registered nurses per 100,000 population, compared with 825 per 100,000 in the nation as a whole, according to the U.S. Department of Health and Human Services.
● We also are seriously short doctors, with 219 per 100,000 population, compared with 293 per 100,000 nationwide.
● As for our jammed ERs, fully 50 percent of all ER patients are seeking primary care — not emergency care — in Maricopa County hospitals, found a recent survey by Arizona State University. Across the country, primary-care seekers totaled only 14 to 17 percent of ER visits. (No similar survey has been conducted yet in Pima County.)
“These strains are not unique to Tucson and Arizona, but the situation is much worse here,” said Dr. R. Screven Farmer, a Tucson anesthesiologist who was president of the Arizona Medical Association last year.
“What happened to those two families (Sweitzers and Holsteins) rings all too true. That doesn’t surprise me.”
At the root of this problem is the troubled state of primary care in Tucson — the difficulty people have getting in to see their doctors when they need them, Farmer said.
For that, he and others blame the managed-care-insurance system that has dominated Tucson for decades. It is a system designed to control costs, by negotiating contracts with doctors to provide care to groups of patients at a discounted price.
The result is low payments to primary-care doctors, along with extremely high office costs to process the maze of managed-care plans. The twin pressures have forced doctors to squeeze too many patients into too short a day, to maintain income. That makes long waits to get in the norm. It also has discouraged doctors from going into primary care, causing a serious shortage in Southern Arizona.
That shortage is forcing too many people to crowd the ERs for garden-variety medical care.
“Students come out of medical school with a huge debt and they look at the economics of primary care and they can’t do it,” Farmer said.
“My own mother had a heck of a time finding a primary-care doctor when she moved here.”
As longtime Tucson primary-care physician Dr. Michael Hamant — who also is president of the Pima County Medical Society — put it bluntly:
“I can spend 30 minutes in an office visit with a patient — take care of his diabetes or high blood pressure or aches and pains, write prescriptions, do the lab work, make referrals, and do all the paperwork that goes with all that, and I’ll get paid $88 from Medicare or the managed-care plan.
“But if I take my dog to the vet for the same amount of time, I’ll pay twice that.
“Is something wrong here?”
“We’ve got to get out of here”
There is no way to quantify how many people have left Tucson because they cannot get adequate and timely health care.
The Holsteins say they know of four other Tucson couples leaving for the same reasons they are. Most declined to talk on the record about it.
“Many times I think I made a mistake moving here,” said Ken Bolotin, 52, who left the cold and snow of Chicago for desert warmth two years ago.
“When I had visited Tucson, I saw doctors’ offices everywhere and I said, ‘Well, I’ll get great care here.’ I was so wrong.”
Also an MS sufferer, Bolotin has endured the same trials as the Holsteins — weeks waiting to see a doctor, sent to the ER instead, to endure 10-hour waits.
“Here, with so much trouble getting in to see your doctor, going to the ER circumvents the whole system,” he said. “That’s why people try to get in that way.”
The Holsteins are absolutely convinced their health-care horror stories will end when they return to their hometown in the Lehigh Valley of Pennsylvania.
Doctors there are far more likely to have extended hours — into the evening and on Saturdays — meaning patients are less likely to be told to go to the ER instead. And if you do go, many hours of waiting are all but unheard of, they say.
“Calling a doctor day after day after day with no response while David is having an MS attack, or is having trouble with a new drug — that would not happen,” Bette Lou Holstein said.
“In Pennsylvania, the doctor himself would have called you back, the same day, and would have you come in to the office or meet him at the hospital, even at night.”
On one occasion here, the Holsteins waited four days to get a doctor’s response to his worsening symptoms of pneumonia. Finally, they were told, go to the ER. They did, and waited 6 1/2 hours for care.
“This kind of thing happened repeatedly,” said David Holstein, a retired chemist. “We don’t call for every little thing — we don’t panic. If anything, we try to sit it out.
“But after that last incident, we looked at each other and said, ‘We’ve got to get out of here.’ And it’s breaking our hearts.”
Hamant admits few doctors here work after hours, when patients are routinely sent to the ER instead.
“It’s the worst situation, by far,” he said. He described a recent call at 5:15 p.m. from an elderly patient who said her heart was fluttering and she was light-headed.
“I said, ‘You’ve got to go to the ER.’ I’m not going to sit on symptoms like that, and often we don’t have the capability to deal with the situation,” he said.
“But she waited there until 2 a.m, before she was finally admitted to the hospital. Not a good night for her.”
However, there may be a small ray of help on the horizon, at least on this issue. One of Tucson’s largest primary-care practices — the Carondelet Medical Group of 80 primary-care physicians — is planning to expand office hours into the evenings in the near future.
“We did that during this flu outbreak, at the request of the county Health Department, and it worked,” said Ramirez, the St. Mary’s spokeswoman who also is chief planning officer for the Carondelet Health Network.
“It really did help significantly to keep patients out of the ER during this outbreak. We are looking to do that permanently now.”
That will be at least a finger in the dike of our health-care problems in Southern Arizona. But a comprehensive solution will be complex and will take years of effort, a strong political will and no small amount of money. There is no easy fix.
What must be done — says a task force formed in 2006 by Gov. Janet Napolitano to deal with this crisis — includes:
● Expand our medical schools — especially residency programs — to train and keep more doctors in Arizona.
● Use nurse practitioners more effectively to expand access to primary care and reduce the use of ERs.
● Find funding sources to help hospitals pay surgeons and specialists to work in ERs and trauma centers.
● Improve medical liability protection for doctors who provide emergency and trauma services.
● Expand hospital bricks and mortar — add inpatient and ICU beds, expand emergency-care units.
There has been some progress in Tucson on these fronts. The UA College of Medicine just opened a new campus in Phoenix. Several hospitals — UMC, Tucson Medical Center, St. Joseph’s Hospital — now are planning or constructing new bed towers and bigger ERs. St. Mary’s just opened a new, state-of-the-art ER.
But whether Arizona is truly capable of tackling a crisis of this magnitude is a troubling question among those who run our state.
“It is shocking to see a family run out of the state because they can’t get decent care — a fully insured family with social and economic status. That should not be happening,” said state Rep. Phil Lopes, D-Tucson.
“This is sad and embarrassing, that our health-care system has come to this.”

URIs, OM, & Kids under 3

WebMD, 3/14/08:  Kids under age 3 get five colds a year — and 61% of the time, they get ear infections, too.The finding comes from a study of 294 healthy children aged 6 months to 3 years. Each child was followed for one year by Tasnee Chonmaitree, MD, a pediatric infectious disease specialist at the University of Texas Medical Branch at Galveston, and colleagues.

Chonmaitree and colleagues found that day-care kids got more than six colds a year; those cared for at home got five. Children between the ages of 6 and 12 months got about twice as many colds as did children between the ages of age 2 and 3 years.

More than half of children who get colds — 61% – come down with otitis media, infection of the middle ear. About a quarter of the time, this infection has no symptoms, but the child has a buildup of fluid inside the ear.

Fortunately, the risk of getting an ear infection after a cold drops quickly with age.

“For every month older a child gets, she or he has a 4% lower risk of getting otitis media after a cold,” Chonmaitree tells WebMD. “So an 8-month-old child has 8% less chance of otitis media after a cold than that same child had at age 6 months.”

Chonmaitree finds that ear infections are most likely to occur after colds in children aged 6 months to 18 months. She suggests that parents should try to avoid sending children this age to day care.

In an editorial accompanying the study, Pascal Chavanet, MD, of University Hospital, Dijon, France, takes issue with this recommendation.

“The expectation that ill children can be kept out of day care centers or that home care can be provided for children until at least 1 year of age raises very difficult socioeconomic barriers,” Chavanet suggests.

The Chonmaitree study, and the Chavanet editorial, appear in the March 15 issue of Clinical Infectious Diseases.

White males with chest pain get seen faster

HealthDay News, 3/14/08:  White men who arrive in emergency rooms complaining of chest pains get treatments for heart trouble faster than African-Americans or women do, a new U.S. government study finds.Researchers looked at more than 19 million emergency room visits and found that whites who reported angina were 1.6 times more likely than nonwhites to be seen by a medical staff member within 10 minutes, and men were 1.5 times more likely than women to get that quick reaction, said study author Dr. Jing Fang, an epidemiologist with the U.S. Centers for Disease Control and Prevention. He was expected to report the findings at the American Heart Association’s Cardiovascular Disease Epidemiology and Prevention Annual Conference in Colorado Springs.

Those numbers are not clear-cut evidence of discrimination on the basis of race and sex, Fang said, since emergency room responses may be based on evidence that ischemic heart disease — blockage of coronary arteries that causes chest pain — is more common among those who get faster treatment, and that chest pains are more likely to have other causes in nonwhites and women.

“When you see that the percentage of ischemic heart disease is higher among whites than nonwhites and among men than women, maybe the health-care providers who decide who gets treated first are thinking that whites are more likely to have ischemic heart disease, men are more likely to have ischemic heart disease,” she said.

The study found no difference in response time or treatment based on age. Emergency room service was the same for visitors complaining of chest pains who were over 65 and those who were younger.

But treatments were different for the sexes and races. Men were 1.5 times more likely than women to get an electrocardiogram and 1.7 times more likely to be given a beta-blocker heart drug. Whites were 1.8 times more likely than nonwhites to get an electrocardiogram and 1.5 times more likely to be prescribed drugs for chest pain.

The study did not show whether the difference in treatment made a difference in outcomes such as mortality or hospitalization, Fang said. “We were unable to note the outcome, short-term or long-term mortality,” she said. “A follow-up study would be nice.”

Two other reports presented at the same conference showed clear ethnic influences on incidence and awareness of cardiovascular disease in the American population.

A study of Native Americans done at the University of Oklahoma found they had a higher incidence of stroke and were more likely to have a first stroke at an early age than whites and African-Americans. The incidence of stroke among Native Americans in the study was 679 per 100,000 person-years, higher than among other Americans, and the average age when a first stroke occurred was 66.5 years, earlier than in the general population.

And a study of health beliefs done at Columbia University found that members of racial or ethnic minorities were less likely to adopt prevailing views of cardiovascular disease prevention than other Americans. Minorities were more likely to place faith in a higher power than on personal actions to prevent disease, the researchers found. The finding “may represent a unique opportunity for education and early intervention,” they said.

Necrotizing Fasciitis as the Clinical Presentation of a Retroperitoneal Abscess

Journal of Emergency Medicine
Volume 34, Issue 1, January 2008, Pages 37-40  

Introduction

Infections of the retroperitoneum and psoas sheath may present with insidious symptoms and non-specific clinical signs. These infections commonly present with indolent fevers and chills; weight loss; abdominal, flank, groin, or back pain; malaise; and anorexia. Diagnosis is usually delayed, often for months, or confused with other clinical entities ([1] and [2]). Presentations may be dramatic, with the rapid onset of septic shock or other complications after perforation and release of bacterial contents into the peritoneum, thorax, meninges, and thigh ([3], [4], [5], [6] and [7]). Before the age of antibiotics, spread of infection from tuberculous vertebral osteomyelitis to the lower extremities via the psoas fascia was also common. These complications are now rarely seen due to improved diagnostic and therapeutic modalities. We report a case of retroperitoneal abscess whose diagnosis was delayed for weeks before it developed into a lower extremity necrotizing fasciitis.

Case Report

A 45-year-old man presented to the Emergency Department (ED) with the chief complaint of a painful and swollen left thigh. The pain and swelling began 3 days before presentation, worsening until he was unable to walk. He reported having hit his left thigh several days before presentation, and to having ”fallen in the kitchen” a month earlier, with subsequent left flank and hip pain. In the weeks before presentation, he made two visits to community EDs and was evaluated with plain films of the pelvis, lumbar spine, and left hip. He was told he did not have ”hip arthritis,” and discharged with a prescription for a non-steroidal anti-inflammatory drug. Review of systems was notable for intermittent subjective fever, low back pain, and weight loss. He denied abdominal pain, nausea, vomiting, melena, weakness, numbness, or tingling. He had no previous medical history and was not taking medications, but described moderate alcohol consumption and cigarette smoking.

Vital signs included a blood pressure of 123/65 mm Hg, heart rate of 103 beats/min, respiratory rate of 20 breaths/min, and oral temperature of 36°C (97.2°F). He was in no obvious distress or discomfort, and did not appear dehydrated. The breath sounds were clear bilaterally. The abdominal examination was notable for moderate tenderness over the left iliac crest, but he had normal bowel sounds and no peritoneal signs. The rectal examination was unremarkable and negative for occult blood.

The left thigh was diffusely swollen and exquisitely tender to touch, with palpable crepitance. The skin overlying the thigh, and extending from the knee to the left iliac crest, was circumferentially erythematous, shiny, and tense, but not indurated. There were no bullae or vesicles. The left calf was normal in appearance and on palpation, but the range of motion of the left hip and knee was limited secondary to pain. The distal neurovascular examination was normal.

A portable radiograph of the left thigh was quickly obtained, showing air dissecting subcutaneously and along multiple fascial planes.

1 

Blood cultures were sent. The patient was immediately started on piperacillin/tazobactam (Zosyn, Lederle Laboratories, Pearl River, NY) and taken to the operating room (OR) for debridement. Laboratory results were remarkable for a white count of 28,900/μl, with a bandemia of 24%. Serum biochemistry assays were within normal limits, except for a moderately elevated creatinine phosphokinase of 554 U/L (normal < 130 U/L). In the OR, the patient’s left thigh was longitudinally incised and necrotic vastus lateralis muscle débrided. A necrotic tract containing feculent material was found extending superiorly in the subcutaneous tissue. The tract continued lateral to the ilium, where it communicated with a large retroperitoneal abscess overlying the left superior iliac crest as well as an inflamed sigmoid colon diverticulum. A contrast-enhanced spiral computed tomography (CT) scan of the abdomen and pelvis was performed demonstrating the extent of the retroperitoneal abscess and its communication with the sigmoid colon.

Culture of the abscess fluid grew Escherichia Coli, Streptococcus Viridans, and Enterococcus fecalis. Blood and urine cultures were negative. The patient returned to the OR for debridement and sigmoidectomy with colostomy. Over the next 4 weeks, the patient was taken to the OR five more times for multiple irrigations, split thickness skin grafts over the thigh and flank, and removal of the colostomy. Hyperbaric oxygen therapy was not available at the institution, and because the patient’s clinical status was improving, the inpatient surgical team elected not to transfer him. Five weeks after being admitted to the hospital, the patient was discharged home with full left lower extremity function.

Discussion

A rare but life-threatening complication of intra-abdominal infection is extension to the thigh. In the absence of a clear lower extremity origin for soft tissue infection of the thigh, the peritoneum, psoas sheath, and retroperitoneum must be evaluated for occult infection. Historically, retroperitoneal and psoas abscesses were most frequently encountered with tuberculous vertebral osteomyelitis, but cases have been described resulting from appendicitis, ischiorectal abscess, vaginal delivery, pancreatitis, colonic carcinoma, diverticulitis, blunt trauma, hematogenous spread, biliary tract disease, inflammatory bowel disease, perinephric abscess, and acupuncture ([8], [9], [10], [11], [12], [13], [14], [15], [16], [17], [18], [19], [20], [21], [22] and [23]).

Several routes have been described for communication of infection and neoplastic disease to the lower extremities (11). The psoas sheath forms a tough, fibrous, tube-like structure that can carry inflammatory material deep to the inguinal ligament to the proximal femoral shaft under the femoral triangle. Due to the strength of the psoas sheath, infection tracks into the thigh from psoas abscesses more commonly than it ruptures into the peritoneum (24). The femoral sheath and canal, and sacrosciatic notch and obturator foramen also may serve as routes of entry ([9] and [25]). Extravasated air from perforated bowel may travel along these routes as well and contribute to the emphysema produced by bacterial metabolism (25). Neurological, vascular, and lymphatic symptoms may accompany infection and vary according to the anatomical location of the infectious tract.

The location of infection may give some indication as to its route of spread. In one review of thigh abscesses secondary to abdominal infections, the majority were located in the anterior and medial aspects of the thigh, indicating spread via the psoas and femoral sheath, and obturator foramen; but a small number of posterior abscesses were documented as well, indicating spread via the sacrosciatic notch (11). Additionally, infections can be transmitted hematogenously or by direct extension, as in this case, where a necrotizing fasciitis of the subcutaneous tissue rapidly spread from the abdominal wall to the lateral thigh.

This patient presented with a month of left-sided flank pain, for which he had already made two ED visits, and received repeated plain film workups. This delay in diagnosis is typical of retroperitoneal abscess. Patients with retroperitoneal abscesses commonly present with vague complaints of pain in the lower abdomen, flank, back, hip, or thigh, with or without fever, abdominal tenderness, weakness, intestinal distension, and abdominal masses (26). Additional symptoms may include weight loss, malaise, hip and back weakness, chills, scoliosis, and anorexia. The psoas sign has been reported positive in only 20% of all retroperitoneal infections, and 50% of psoas abscesses (27). Ancillary evaluation of retroperitoneal abscesses may reveal leukocytosis, sterile pyuria, abnormal psoas shadows or diaphragmatic elevation on plain films, and urinary obstruction, but are frequently unremarkable (28). The most reliable and sensitive means of diagnosis remains CT scan, with bedside ultrasound as a less desirable alternative for clinically unstable patients (29).

Cellulitis, emphysematous cellulitis, and necrotizing fasciitis form a continuum of soft-tissue infection, ranging from subacute to fulminant disease. A wide range of infectious agents may be responsible, including E. coli, Clostridium, Bacteroides, and polymicrobial combinations of aerobes and anaerobes. Overall, approximately half of all cases of necrotizing fasciitis are gas forming (30). The classical entity of gas gangrene, known also as emphysematous myositis, is best known as a clostridial infection, but in recent reviews most cases of gas-forming myositis and soft-tissue infections have been due to other organisms, including Staphylococcus, Group A Streptococcus, Actinomyces, Aerobacter aerogenes, Proteus, Klebsiella, and Pseudomonas. Group A Streptococcus has been increasingly responsible in recent years for an aggressive monobacterial necrotizing fasciitis that notably does not form gas (30). Penicillin-resistant Streptococcus pneumonia necrotizing fasciitis also has been reported as a cause of monobacterial necrotizing fasciitis (31).

Conclusive definition of whether an infection is emphysematous myositis or necrotizing fasciitis is unnecessary in the emergency setting. Treatment of necrotizing fasciitis/emphysematous cellulitis and emphysematous myositis both rely on aggressive surgical debridement and antibiotics (32). In cases of known clostridial gangrene, penicillin combined with clindamycin is the antibiotic protocol of choice (33). ED management of undifferentiated infection, however, should include an expanded-coverage, penicillinase-resistant penicillin, in combination with an aminoglycoside, imipenem, or metronidazole. This will adequately cover clostridium as well as organisms responsible for necrotizing fasciitis. Intensive care unit admission after surgical intervention is mandatory due to the high incidence of septic shock.

As an adjunct therapy, hyperbaric oxygen increases PO2 in both healthy and infected tissues, and may be useful in treating aerobic as well as clostridial and other anaerobic infections (34). Prospective randomized controlled trials have yet to be performed, but the Undersea and Hyperbaric Medical Society now recommends the use of hyperbaric oxygen for necrotizing soft tissue infections “where risk of morbidity and mortality are high” ([35], [36] and [37]).

Conclusion

Retroperitoneal and psoas abscesses can occur secondary to a range of abdominal pathologies and are an important differential diagnostic consideration in the evaluation of patients with chronic non-specific complaints. The clinician must aggressively obtain imaging studies in patients with suggestive histories, as physical examination and laboratory evaluation are insensitive for these frequently fatal infections. In cases that progress to necrotizing fasciitis or clostridial gangrene, obtaining aggressive surgical intervention and antibiotic coverage are critically important ED interventions, with hyperbaric oxygen as a potentially useful adjunct therapy.

References

1 M. Muttarak and W. Peh, Clinics in diagnostic imaging (71) Left iliopsoas abscess secondary to vertebral osteomyelitis, Singapore Med J 43 (2002), pp. 161–166.

2 C.R. Taylor, A 58-year-old man with a groin mass and septic shock, Medscape Gastroenterology 6 (1) (2004) Available at: http://www.medscape.com/viewarticle/474658. Accessed January 18, 2006.

3 M. Livne, F. Serour, M. Aladjem and I. Vinogard, General peritonitis induced by rectal examination: an unusual complication of primary psoas abscess, Eur J Pediatr Surg 4 (1994), pp. 186–187.

4 M. Alifano, N. Venissac, D. Chevallier and J. Mouroux, Nephrobronchial fistula secondary to xanthogranulomatous pyelonephritis, Ann Thorac Surg 68 (1995), pp. 1836–187l.

5 J.R. van Dellen and N. Buchanan, Meningitis caused by psoas abscess, S Afr Med J 57 (1980), pp. 552–553. 

6 S. Kumar and S. Jain, Peritonitis and fulminant sepsis due to spontaneous rupture of iliopsoas abscess, Indian J Gastroenterol 23 (2004), pp. 222–223.

7 J.E. Peacock Jr, Colonic perforation with thigh abscess: an unusual presentation of tuberculous spondylitis, South Med J 75 (1982), pp. 623–625.

8 J.D. Colmenero, M.E. Jimenez-Mejias and J.M. Reguera et al., Tuberculous vertebral osteomyelitis in the new millennium: still a diagnostic and therapeutic challenge, Eur J Clin Microbiol Infect Dis 23 (2004), pp. 477–483.

9 N.S. El-Masry and N.A. Theodorou, Retroperitoneal perforation of the appendix presenting as right thigh abscess, Int Surg 87 (2002), pp. 61–64.

10 T. Ushiyama, R. Nakajima and T. Maeda et al., Perforated appendicitis causing thigh emphysema, J Orthop Surg 13 (2005), pp. 93–95.

11 O.D. Rotstein, T.L. Pruett and R.L. Simmons, Thigh abscess: an uncommon presentation of intra-abdominal sepsis, Am J Surg 151 (1986), pp. 414–418.

12 S. Shahabi, J.P. Klein and P.F. Rinaudo, Primary psoas abscess complicating a normal vaginal delivery, Obstet Gynecol 99 (2002), pp. 906–909.

13 A. Balaz, P. Lukovich and L. Flautner, [A case of retroperitoneal pancreatic abscess spreading to the femoral region] (Hungarian), Orv Hetil 141 (2000), pp. 241–244.

14 H. Kobayashi, R. Sakurai and M. Shoji et al., Psoas abscess and cellulitis of the right gluteal region resulting from carcinoma of the cecum, J Gastroenterol 36 (2001), pp. 623–628.

15 N. Levi, An unnecessary femoral amputation, J R Coll Surg Edinb 43 (1998), pp. 196–197.

16 D.R. Gutknecht, Retroperitoneal abscess presenting as emphysema of the thigh, J Clin Gastroenterol 25 (1997), pp. 685–687.

17 R. Anderson, D.R. Meyer and D. Banzer, Soft tissue emphysema as a manifestation of perforating diverticulis, Aktuelle Radiol 7 (1997), pp. 202–204.

18 D.D. Sinha, C. Sharma, V. Gupta, V. Chaturvedi and V. Sharma, Post-traumatic retroperitoneal colonic injury presenting as gluteal abscess, Indian J Gastroenterol 23 (2004), pp. 151–152.

19 T.R. Walsh, J.R. Reilly, E. Hanley, M. Webster, A. Peitzman and D.L. Steed, Changing etiology of iliopsoas abscess, Am J Surg 163 (1992), pp. 413–416.

20 R. Kaushik and A.K. Attri, Choleretroperitoneum—an unusual complication of cholelithiasis, Indian J Surg 66 (2004), pp. 358–360.

21 J. Kyle, Psoas abscess in Crohn’s disease, Gastroenterology 61 (1971), p. 149.

22 M. Capitan, S. Tejido and L. Piedra et al., Retroperitoneal abscesses—analysis of a series of 66 cases, Scand J Urol Nephrol 37 (2003), pp. 139–144.

23 Y.P. Cho and H.J. Jang, Retroperitoneal abscess complicated by acupuncture: a case report, J Korean Med Sci 18 (2003), pp. 756–757.

24 K.L. Moore, Clinically oriented anatomy (3rd edn.), Williams & Wilkins, Baltimore, MD (1992).

25 P. Nicell, J. Tabrisky, R. Lindstrom and M. Peter, Thigh emphysema and hip pain secondary to gastrointestinal perforation, Surgery 78 (1975), pp. 555–559.

26 Y.T. Lee, C.M. Lee, C.P. Su, C.P. Liu and T.E. Wang, Psoas abscess: a 10 year review, J Microbiol Immunol Infect 32 (1999), pp. 40–46.

27 E.O. Stevenson and R.S. Ozeran, Retroperitoneal space abscesses, Surg Gynecol Obstet 128 (1969), pp. 1202–1208. 

28 A. Tununguntla, R. Raza and L. Hudgins, Diagnostic and therapeutic difficulties in retroperitoneal abscess, South Med J 97 (2004), pp. 1107–1109.

29 C.H. Chern, S.C. Hu, W.F. Kao, J. Tsai, D. Yen and C.H. Lee, Psoas abscess: making an early diagnosis in the ED, Am J Emerg Med 15 (1997), pp. 83–88.

30 R.R. Samadi, Bacterial skin and soft tissue infections: a systematic approach to diagnosis and treatment, EM Reports 25 (2004), p. 14.

31 G.R. Ballon-Landa, G. Gherardi, B. Beall, S. Krosner and V. Nizet, Necrotizing fasciitis due to penicillin-resistant streptococcus pneumoniae: case report and review of the literature, J Infect 42 (2001), pp. 272–290.

32 J.D. Urschel, Necrotizing soft tissue infections (review), Postgrad Med J 75 (1999), pp. 645–649.

33 E.K. Chapnick and E.I. Abter, Necrotizing soft-tissue infections, Infect Dis Clin North Am 10 (1996), pp. 835–855. 

34 K. Korhonen, Hyperbaric oxygen therapy in acute necrotizing infections, Ann Chir Gynaecol 89 (Suppl 214) (2000), pp. 7–36.

35 N. Jallali, S. Withey and P.E. Butler, Hyperbaric oxygent as adjuvant therapy in the management of necrotizing fasciitis, Am J Surg 189 (2004), pp. 462–466.

36 D.C. Vinh and J.M. Embil, Rapidly progressive soft tissue infections, Lancet Infect Dis 5 (2005), pp. 501–513.

37 Undersea and Hyperbaric Medicine Society Hyperbaric Oxygen Therapy Committee, Indications for hyperbaric oxygen therapy http://www.uhms.org/Indications/indications.htm Accessed July 12, 2006.

Obama & Pay for Performance & Tort Reform

MedPage Today, 3/14/08: 

The top health-policy adviser to Sen. Barack Obama is an ardent supporter of pay for performance for physicians so long as they are comfortable with the standards that are set for them. 

 

In a wide-ranging interview with MedPage Today on the Democratic presidential hopeful’s views on some of the hot-button health issues of the day, David Cutler, Ph.D., dean for the social sciences and a professor of applied economics at Harvard University, conceded that implementing pay for performance is not an easy proposition. 

 

Yet it could reduce wasteful health spending and help physicians provide better care if they have a substantial input in how quality standards are set, said Dr. Cutler. 

 

“The current system financially penalizes physicians who want to spend the time with patients needed to achieve quality outcomes,” said Dr. Cutler. “Pay for performance needn’t be punitive for doctors if we use well-validated measures that doctors feel can work for them. 

 

“If a system is just imposed on doctors, though, it will be a disaster,” Dr. Cutler added. “We want to work with doctors, not just do unto them. We need physician buy-in for reform to work.” 

 

Dr. Cutler served on the Council of Economic Advisers during the Clinton Administration and has advised the presidential campaigns of Bill Bradley and John Kerry. Ironically, he helped draft the Clinton health plan in the 1990s. 

 

“I respect Sen. (Hillary) Clinton very much and have no substantial objections to her current plan,” he said. “I just think Sen. Obama’s plan is better and he can bring all of America along to implement real healthcare reform.” 

 

Dr. Cutler spoke about Medicare policies, how to control health costs, electronic medical records, insurance reform, and other health topics. 

On pay for performance, Dr. Cutler said that “we should increase payments for doing a good job and cut them for providing needless services.” But he acknowledged that pay for performance hasn’t been tried on a large enough scale to know if it can succeed. “It’s where we need to experiment.” 

How might a system work in actual practice? Details are sketchy but as one example, Dr. Cutler favors increasing pay for appropriate long-term care for chronic patients, such as diabetics. Rather than reimburse physicians on the basis of volume alone, he would have plans that provide bonuses if patients get annual eye exams, have blood sugar and cholesterol below certain levels, take aspirin daily, and other evidence-based measures. The system might set up a bonus fund for doctors who follow guidelines or have the best measures of outcomes, and pay less for procedures, drugs, and services that seem discretionary. 

 

The Obama plan would require greater transparency about quality and costs, requiring hospitals and providers to collect and publicly report measures of healthcare costs and quality. These would include data on preventable medical errors, nurse staffing ratios, hospital-acquired infections, and disparities in care. Health plans would also be required to disclose the percentage of premiums that go to patient care as opposed to administrative costs. 

 

Dr. Cutler sees the annual debate over the “sustainable growth rate,” the formula that typically results in planned annual Medicare pay cuts for physicians, as “a reflection of just how bankrupt our health policy is. Of course, it must be reformed but as a part of system reform. That’s not to say the problem should be held hostage to overall reform, but if we just zero in on this one issue without making bigger fixes, no one will be satisfied.” 

 

The Obama plan calls for investment by the government for health information technology and comparative effectiveness research to measure the worth of various treatments. “You have to put the effort in up front,” Cutler says. “The Bush Administration often talks about these measures, but talk is cheap and there’s no serious engagement.” 

 

Investment in electronic health IT can lower costs, he says. Obama would invest $10 billion a year over the next five years to move the system to broad adoption of standards-based electronic health information systems. “Physicians would receive some technical and financial help to implement this,” Cutler says. No decision has been made on how much, or if there will be penalties for those who don’t comply. 

 

The Obama campaign believes that greater efficiency and financial incentives can squeeze out wasteful spending that may account for as much as one-third of the nation’s healthcare bill. “There’s a tremendous amount of spending that doesn’t result in better health,” Dr. Cutler said. “If we’re serious about reform, we can cut spending without rationing or hurting patients. Obama’s plan can save $2,500 a year for a typical family on health insurance costs.” 

 

Dr. Cutler cited the work of John Wennberg, M.D., a healthcare researcher at Dartmouth, who found that areas like Boston and Miami, which spend far more than other communities, don’t achieve any noticeable improvement in mortality. This disparity is a ripe area for cutting costs and improving quality, Dr. Cutler said. 

 

The Obama plan calls for a national insurance exchange that will increase competition among insurers and bar them from “abusing their monopoly power through unjustified price increases.” The plan would force insurers to pay out a reasonable share of their premiums for patient care instead of keeping huge amounts for profits and administration. Like the Hillary Clinton plan, it would prohibit insurers from turning away applicants because of pre-existing conditions. “With a new set of rules that everyone has to follow, insurers will comply,” said Dr. Cutler. 

 

Obama doesn’t favor a national market for health insurance supported by Republican presumptive nominee Sen. John McCain so that patients could buy policies written by companies in another state. “Most of these proposals don’t say that insurers can’t turn away the sick or must charge reasonable premiums,” Dr. Cutler said. “It just isn’t a reform that works.” 

 

Obama also disagrees with McCain on the urgency of tort reform. “The single biggest thing we can do is to reduce medical errors that hurt patients,” said Dr. Cutler. “We need to get better information to doctors. Sen. Obama doesn’t favor mandatory caps on awards for pain and suffering because he believes that penalizes people who’ve been seriously injured.” Obama would strengthen antitrust laws to prevent insurers from overcharging physicians for their malpractice insurance, he adds. 

Severe Menopause: CAD Risk?

HealthDay News, 3/14/08:  Women who have the most severe menopausal symptoms may also be at a higher risk of cardiovascular disease, a new study suggests.

1

Dutch researchers surveyed 5,648 women, aged 46 to 57, about their menopausal complaints and collected data on other health information such as their cholesterol and blood pressure.

Night sweats were reported by 38 percent of women; flushing by 39 percent.

Those with flushing had higher cholesterol levels than those without the symptom. They also had higher blood pressure, higher body mass index (BMI, a ratio of weight to height) and a slightly higher chance of developing heart disease over the next decade. The women with night sweats had comparable results.

The researchers, from the University Medical Center Utrecht, conclude that the connection between severity of symptoms and heart disease risk may be the result of reduced beneficial effects of estrogen on the functioning of blood vessel walls, as estrogen declines during menopause.

The Dutch researchers were scheduled to present their findings Friday at the American Heart Association’s Cardiovascular Disease Epidemiology and Prevention Conference, in Colorado Springs, Colo.

“The implication is the women with the worst symptoms may be at higher risk, clinically, for heart disease,” said Dr. Suzanne Steinbaum, director of women & heart disease, at the Heart & Vascular Institute at Lenox Hill Hospital, in New York City.

But the American Heart Association does not advise postmenopausal women to take hormone therapy to reduce heart disease or stroke risk, due to clinical trials that show the hormones, over time, actually increase cardiovascular risks. Hormone therapy is only recommended to relieve very severe symptoms of menopause, and only for the shortest possible period.

The take-home point from this study for the general population, according to Steinbaum, is to pay close attention to improvement in lifestyle habits before menopause and before estrogen levels decline. “One of the things I talk about is lifestyle management to control high blood pressure, high cholesterol,” she explained.

If women keep in check the risk factors of heart disease, such as high blood pressure and high cholesterol, by eating healthfully and exercising often before menopause, the transition “doesn’t have to be as terrible” as many women fear it will be.

Among her suggestions: Exercise at least 20 to 30 minutes three to five days a week, and eat a diet filled with fiber, vegetables, fruits, multi-grains, legumes and omega-3 fatty acids.

In a second study, also scheduled to be presented Friday at the conference, French researchers found the type of hormone delivery method affects the risk of blood clots in postmenopausal women.

Researchers from Paul Brousse Hospital in Villejuif, France, compared women who did not use hormones with those who used estrogen, taking it either orally or transdermally with a patch. Some women took only estrogen, others took estrogen plus progesterone, pregnane, norpregnane or nortestosterone.

The researchers found that transdermal estrogen alone or in combination with progesterone or pregnane derivatives did not raise the risk for blood clots, while other delivery systems did.

They looked at a population of nearly 86,000 French women — including 984 with blood clots — who were followed for more than 10 years.

“This [study] is one more piece of the puzzle,” said Dr. Jennifer Wu, an obstetrician-gynecologist at Lenox Hill Hospital in New York City. When women take hormones orally, she said, the metabolism involves much more processing through the liver, for instance.

While the study concluded that the patch delivery is less risky when it comes to blood clots, Wu said “the indications remain the same” for hormone therapy. It should be used only for very severe menopausal symptoms interfering with daily life, for the shortest possible time.

Presidential Hopefuls & Healthcare

MedPage Today, 3/15/08:  Should everyone in America have access to health insurance? If so, should you be required to get it?Beneath all the complexities, the presidential health care debate really boils down to those two big questions. And how you feel about the answers might tell you a lot about which candidate you think can solve the nation’s mounting health care problems.

As for question one, Democratic candidates Hillary Clinton and Barack Obama both answer “yes.” Each has a plan leading to “universal health care,” a system in which everyone has medical coverage. For McCain, the answer is both “yes” and “no.”

McCain says everyone should have access to coverage in principle, but his plan doesn’t guarantee it and won’t try to. He believes that market-based forces can work to bring down health care costs so that eventually people can afford to buy it.

But before you think it’s just Clinton and Obama vs. McCain when it comes to health care, think of question two. Clinton says that making sure everyone is covered is a critical ingredient to reforming the way insurance companies cover health care. That’s why she says that everyone should be required to get coverage.

Obama agrees, but only up to a point. He says parents should be required to make sure their kids are covered. Then once insurance reforms help bring down costs, everyone else will eventually have to get coverage too.

Obama has attacked Clinton for calling for an insurance mandate. While that is often a dirty word in politics, Clinton and her advisors say it’s necessary.

“It’s important from the start to make sure that coverage is universal,” says Katherine Hayes, a vice president at Jennings Policy Strategies, which advises Clinton’s campaign on heath issues.

Unless everyone has coverage, insurance companies can still seek out the healthiest people to cover. That leaves older and sicker people — the ones who need coverage the most — out of the loop, Hayes said at a Capitol Hill forum on the candidates’ health plans sponsored by the Alliance for Health Reform.

The practice is called “cherry-picking,” and both Clinton and Obama say it needs to be done away with.

“Both call for individuals to acquire coverage when it becomes affordable,” says Gregg Bloche, a professor of law at Georgetown University and an advisory to Obama’s campaign.

But Obama wants to give reforms time to work before requiring coverage. Both he and Clinton want to form purchasing pools to make insurance cheaper, and to work to decentralize health care from hospitals and traditional clinics so that it’s easier to access.

They both also want to provide tax credits to help small businesses buy coverage for workers, and provide subsidies to help people get coverage if they can’t afford it themselves.

McCain wants to expand coverage, but thinks the best way to do it is by going after cost first. He wants to give individuals more tax incentives to buy coverage on their own instead of through their workplace. He would also push tax credits — $2,500 for individuals and $5,000 for families — to encourage people to buy coverage.

“He doesn’t have to do so at a price that is inordinately high to the taxpayer,” says Raissa Downs, a partner at the Tarplin, Downs, and Young law firm in Washington and a health policy advisor to McCain’s campaign.

Where They Agree

McCain, like Clinton and Obama, favors a stronger role for primary care doctors, and a much bigger emphasis on preventive medicine as a way to improve care and cut costs. And all three say they want to shake up the way Medicare and Medicaid pay for care, by paying more when doctors and hospitals provide good quality care, instead of just paying for every test and treatment the way they do now.

All three also say they want a much bigger role for health information technology like electronic medical records and virtual information sharing between doctors.

Of course, the similarities don’t mean that Democrats and Republicans will start getting along about how to change the $2 trillion-per-year health system. Obama and Clinton are still fighting it out in the primaries, often grappling over their highly similar health plans.

Hayes, who advises Clinton, says Democrats will be united once they choose a nominee.

“Then we can turn our focus to attacking Sen. McCain’s plan,” she said

FDA: 8 Watchdogs in China

Chicago Tribune, 3/15/08:  The U.S. Food and Drug Administration announced plans Friday night to strengthen its regulatory presence in China, a country that has become a major exporter of pharmaceutical ingredients to the U.S. and that has been linked to an investigation of allergic reactions in U.S. blood thinner.

As the FDA investigates what went wrong with heparin blood thinner sourced from China and sold by Baxter International Inc., the agency said it received U.S. State Department approval to establish eight “permanent FDA positions” at U.S. diplomatic posts in China over the next 18 months, pending the Chinese government’s approval. In addition, the FDA will hire five Chinese nationals to work with the new FDA staffers.

“In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory … cooperation, especially on product quality and enforcement matters,” said Dr. Murray Lumpkin, deputy commissioner for international and special programs at the FDA.

The trouble with heparin comes after the U.S. and China appeared to lag in following through on an agreement reached in December to speedily implement plans to cooperate on inspection of drug production in China. The FDA last month acknowledged that a heparin plant in China operated by a Baxter supplier had not been inspected by U.S. or Chinese drug regulators. Friday’s announcement appeared to be a sign of progress.

Earlier Friday, the FDA said it will stop and test all heparin products slated for import into the U.S. as part of its widening investigation into the cause of hundreds of potentially deadly allergic reactions related to the blood thinner sold by Deerfield-based Baxter.

The FDA said it has found a “heparin-like” contaminant in 20 of 28 samples of heparin’s active pharmaceutical ingredient tested in batches made by Baxter’s supplier, Wisconsin-based Scientific Protein Laboratories, from its plant in China. The FDA has described the contaminant as some kind of “biological” product and has not ruled out the possibility that Baxter’s heparin might have been tampered with in the Chinese supply chain leading to Scientific Protein’s factory in Changzhou.

The FDA said it still has not found the cause of the more than 700 allergic reactions that have been linked to at least four deaths. Baxter said it also was unable to determine the cause of the reactions, which led dialysis patients and others receiving dosages before heart surgery and other treatments to experience dramatic drops in blood pressure and racing heartbeats.

“There is now a worldwide testing effort going on,” said Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.

The FDA’s inspection team has visited “consolidators,” who acquire raw heparin produced from the mucous lining of pig intestines, from numerous farms. But inspectors have not visited any farms and do not plan to do so, officials said. Instead, the FDA is asking Chinese authorities to send that country’s agricultural inspectors to the farms.

FDA: More holes than a sieve

NY Times, 3/17/08:  After a contaminated medicine from China was linked to as many as 17 deaths in the United States, members of Congress clamored for changes while regulators defended their actions.The drug was a common antibiotic, and the year was 1999. But in recent weeks, the Food and Drug Administration has faced an almost identical crisis.

Nineteen deaths have been linked to contaminated heparin, a crucial blood thinner manufactured in China. Again the drug agency became aware of the problem only after hundreds were sickened. Again Congress is investigating.

The F.D.A. admitted that it violated its own policies by failing to inspect the China plant, and on Friday it said it had alerted border agents to detain suspect heparin shipments.

“This heparin problem has happened before with other drugs,” said William Hubbard, a former F.D.A. deputy commissioner, “and it’s going to keep happening until Congress fixes this problem.”

The Institute of Medicine, the Government Accountability Office and the F.D.A.’s own Science Board have all issued reports saying poor management and scientific inadequacies make the agency incapable of protecting the country against unsafe drugs, medical devices and food.

Indeed, in the years since the last China drug scandal, the share of drugs coming from that country has soared while the F.D.A.’s inspections of overseas drug plants have dropped. There are 566 plants in China that export drugs to the United States, but the agency inspected just 13 of them last year.

The agency does not have the money to inspect many more, and the Bush administration has no plans to fix this most basic of problems. The administration’s budget calls for a 3 percent increase in allocated funds next year, not enough even to keep up with rising costs.

Congress, though, may finally heed the calls of Mr. Hubbard and others and allocate far more money. The Senate passed a budget resolution on Friday to give the F.D.A. an additional $375 million, a 20 percent increase over this year.

“Congress has a responsibility to close the glaring gaps in food and drug safety that have begun to overwhelm the F.D.A.,” said Senator Edward M. Kennedy, Democrat of Massachusetts, who pushed for the new financing.

Several top legislators in the Senate and House said they supported the increase.

“F.D.A. needs a serious infusion of resources and strong leadership dedicated to reforming the agency,” said Representative Henry A. Waxman, Democrat of California, who is chairman of the House oversight committee.

Representatives John D. Dingell and Bart Stupak, powerful Democrats from Michigan, said they would fight to support the increase in the agency’s budget.

But the new money is far from assured. President Bush has threatened to veto appropriations that go beyond his requests, and there are powerful interests in Congress that are skeptical of increased agency financing.

Among the skeptics is Representative Rosa DeLauro, Democrat of Connecticut, who leads the House appropriations subcommittee with authority over the agency. Ms. DeLauro said that although the F.D.A. was in crisis, “I don’t want to throw money at an agency that doesn’t have the infrastructure to carry out its mission.”

Some top agency officials are simply “incompetent,” she added, and real change can occur only with a new administration.

An F.D.A. spokeswoman, Julie Zawisza, said the agency was “looking at a number of options in addition to more foreign inspections to increase our presence abroad and our ability to detect problems.” For instance, the agency is opening an office in China to conduct audits and inspections.

The uncertain prospects of the increased financing have led many in Congress to consider a user-fee system to pay for foreign inspections. The agency already relies heavily on user fees to pay for new drug reviews. Mr. Stupak said such a system might be the only way to pay for the necessary inspections of an industry rapidly moving to places like China.

“Why should the taxpayer pay for these inspections so that you can close a plant here and open it over there to ship it back?” Mr. Stupak said. “It will be sustainable income so that we don’t have to get into these budget battles every year.”

Eighty percent of the active pharmaceutical ingredients of drugs consumed in the United States are manufactured abroad; 40 percent are made in China and India. Meanwhile, the F.D.A. has cut back on its foreign drug inspections, which declined to 341 in 2006 from 391 in 2000.

Among the only foreign inspections that the F.D.A. still conducts are those done before a drug’s approval. Spot foreign inspections are rare. For logistical reasons, the agency warns foreign plants when its inspectors intend to visit, something not done domestically. All of this needs to change, said Mr. Stupak, who wants the oversight of foreign plants to be as strict as those governing domestic ones.

Dr. Sidney Wolfe, director of Public Citizen’s health research group, said a fee-based inspection system was “a terrible idea” because it would lead the agency to become more lax with those who pay their salaries.

“The F.D.A. is too important to be left to the industry to fund it,” Dr. Wolfe said.

Manufacturers would support a user-fee system in hopes of making medicines safer and competition fairer, said Guy Villax, chief executive of Hovione, a drug maker based in Portugal with plants in Europe, the United States, China and Macao.

Plants in China and India are rarely inspected by Western governments, which can reduce costs dramatically, Mr. Villax said. Even the Chinese did not inspect the plant making contaminated heparin because, regulators there said, everything made at the plant was shipped overseas.

“The globalization of active pharmaceutical ingredients has happened very quickly,” Mr. Villax said, “and the government agencies are very slow at adapting to changing circumstances.”

Fentanyl & the RN

HealthCare Security Weekly, 3/17/08:  Nurse tampers with fentanyl vials A Minnesota hospital has already made some changes to its security procedures after a nurse was caught tampering with its stock of the pain medication fentanyl.

Immanuel St. Joseph’s Mayo Health System in Mankato suspended the nurse and has notified 335 patients they may have received saline solution instead of the intended drug, the Associated Press (AP) reported. The health system’s president and CEO said there is no indication so far that any patients suffered ill effects from the nurse’s actions.

The hospital began an investigation after workers found empty fentanyl vials in a wastebasket February 25, which were not disposed of in the usual way. The hospital said the nurse would open new vials of the drug, withdraw the contents, and replace it with sterile saline solution, the AP reported. The nurse would then self-administer the drug later, said the hospital, which has referred the case to authorities for possible charges.

The hospital issued letters to patients who had procedures involving sedation in the cardiac catheterization lab, endoscopy, and radiology departments during February and early March, who could have received affected medication.

Gunfight at the O.K. Hospital

Healthcare Security Weekly, 3/17/08:  A man was killed in a shooting March 8 in the parking lot outside the entrance to the Coliseum Northside Hospital emergency room in Macon, GA.Police said the fatal shootout stemmed from a verbal altercation between the three men, which left one dead from multiple gun shot wounds and the other two charged with murder, reported Macon.com. Police said the three men got into an argument at the hospital and went out to their cars to retrieve guns. All three were shot in the dispute.

The hospital was on lockdown following the shooting and put extra security in place, the Web site reported.