New Web Training for Clinical Decision Support for Immunization (CDSi)
Did you miss a Clinical Decision Support for Immunization (CDSi) training session or need a refresher? Are you new to CDSi? For technical details as well as background information, see this series of training videos. The 5 new CDSi video presentations mix lecture, real-life examples, and interactive learning with quizzes to test knowledge gained. See the web-based training courses.

New Regulations for Conducting DOT Physicals
The Federal Motor Carrier Safety Administration (FMCSA) has published a new Federal regulation that requires that any provider conducting a Department of Transportation (DOT) physical for a commercial truck or bus driver must be listed on the National Registry of Certified Medical Examiners (NRCME). The compliance date for this regulation is May 2014. The National Registry of Certified Medical Examiners (National Registry) is a Federal program that establishes requirements for healthcare professionals that perform physical qualification examinations for truck and bus drivers. To become a certified medical examiner (ME) and be listed on the National Registry, healthcare professionals must complete training and testing on the Federal Motor Carrier Safety Administration’s (FMCSA) physical qualifications standards and guidelines. Click here to learn more.

Check out the brochure


Register today to become a certified medical examiner at https://nationalregistry.fmcsa.dot.gov.

Untreated Sleep Problems = Depression
People with depression or other mental illnesses often report trouble sleeping, daytime drowsiness and other sleep-related issues. Now a growing body of research is showing that treating sleep problems can dramatically improve psychiatric symptoms in many patients, according to a Scientific American article. See study here.

No Apparent Increase in Shingles Risk for Patients With Rheumatoid Arthritis Who Take Certain Immunosuppressants
Concern that a front-line class of immunosuppressant drugs used to treat rheumatoid arthritis might increase a patient’s risk of developing herpes zoster (shingles) appears to be unfounded, according to research appearing in JAMA. Shingles, caused by a reactivation of the herpes zoster virus in individuals who previously had chickenpox (caused by the same virus), is characterized by a painful rash and can also cause depression and long-term disability. The condition tends to develop in elderly individuals or those who are immunosuppressed. Patients with rheumatoid arthritis, a disease that involves dysregulation of the immune system, are up to 3 times more likely to develop shingles than people without the disease.

Although anti–tumor necrosis factor (anti-TNF) therapy is considered the treatment of first choice for patients first diagnosed with moderate to severe rheumatoid arthritis, the medications’ powerful immunosuppressant effects prompted concerns about whether their use would increase the risk for shingles in such patients. But the JAMA researchers found no increased shingles risk for patients with rheumatoid arthritis and other inflammatory diseases (inflammatory bowel disease, psoriasis, psoriatic arthritis, or ankylosing spondylitis) who started using an anti-TNF drug compared with those who began taking nonbiologic disease-modifying antirheumatic drugs. The findings are based on retrospective analysis of 59 066 new users of these medications between 1998 and 2007.

Lead author Kevin L. Winthrop, M.D., M.P.H., of Oregon Health & Science University in Portland, discusses his team’s findings:

JAMA: Why did you do this study of anti-TNF therapy?

Dr. Winthrop: This class of drugs is widely used in rheumatoid arthritis and for other autoimmune diseases and is known to increase the risk of certain opportunistic infections like tuberculosis, and herpes zoster is a pretty common infection, especially in those with rheumatoid arthritis and other autoimmune diseases. Several studies previously, using different methodologies, came up with conflicting results, with some saying the therapy did increase risk and others saying it didn’t. So we tried to take a formal look at this, using a large cohort that allowed us to do a large study.

JAMA: What did you find?

Dr. Winthrop: We found that patients starting a new anti-TNF drug didn’t have a higher risk of shingles than those starting other disease-modifying medications. It’s reassuring that it didn’t increase risk. We also found that patients who had herpes zoster before were also able to start these therapies without increasing risk. These findings should be comforting to both patients and physicians.

JAMA: You also looked at a synthetic corticosteroid immunosuppressant, prednisone, and its effect on shingles risk in these patients. What were the results?

Dr. Winthrop: Prednisone doubled the risk of herpes zoster, and this finding is another nail in the coffin for using that drug. If you can get people off prednisone, you can do them quite a bit of good for risk reduction of infections.

JAMA: A live vaccine to prevent herpes zoster is approved in the United States for individuals aged 50 years or older. Should this vaccine be given to patients with rheumatoid arthritis?

Dr. Winthrop: While most patients with rheumatoid arthritis are eligible for the vaccine due to their age, those taking an anti-TNF drug don’t get it because the vaccine is contraindicated due to a concern that if you get the vaccine, you’d get the disease. But we’ve published an earlier study showing that certain people who got the vaccine while on the drug didn’t have any adverse events.


News From the Lab: Enzyme From Bacterium Found on Seaweed Probed as Tool for Treating Chronic Sinus Infections
Researchers from Newcastle University in England were researching whether an enzyme isolated from a bacterium found on the surface of seaweed could prove useful in cleaning the hulls of ships. In new studies of this enzyme, however, they explored whether the enzyme’s ability to penetrate microbial biofilms might provide a strategy for tackling biofilms in chronic bacterial sinusitis and help antibiotics clear the infection. The finding appears today in the journal PLOS ONE.

Chronic sinusitis, which typically lasts more than 4 weeks and occurs more than 4 times a year, is one of the more prevalent chronic illnesses in the United States, affecting about 1 in 8 adults annually, resulting in almost 12 million visits to physician offices. Many types of chronic sinusitis are associated with the buildup of microbial biofilms that can make it difficult for antimicrobial drugs to reach the infecting bacteria. Microbes living under biofilms can be up to 1000-fold more resistant to antibiotics than free-living cells of the same species.

Previous studies had demonstrated that the enzyme, extracellular DNase (NucB), produced by marine-derived Bacillus licheniformis, can disperse bacterial biofilms, so the Newcastle researchers decided to see if it worked on bacteria specifically associated with chronic sinusitis. To test their hypothesis, they collected mucous and sinus biopsy samples from 20 different patients, isolating between 2 and 6 different bacterial species from each individual, and cultured 24 different strains on glass surfaces. Of these, 14 strains (58%) were disrupted by treatment with NucB.

“In effect, the enzyme breaks down the extracellular DNA, which is acting like a glue to hold the cells to the surface of the sinuses,” said Nicholas Jakubovics, PhD, a coauthor of the Newcastle study in a release. “In the lab, NucB cleared over half of the organisms we tested.”

The researchers cautioned that their findings were very preliminary. They are currently testing the safety of NucB, with a view to conducting animal and clinical trials.

Walgreens Moves into Dx for Chronic Care
Walgreens became the first retail store chain to expand its healthcare services to include diagnosing and treating patients for chronic conditions such as asthma, diabetes, and high cholesterol. The move is the retail industry's boldest push yet into an area long controlled by physicians, and comes amid continuing concerns about healthcare costs and a potential shortage of primary care doctors. Other retail store clinics, such as those at Walmart, CVS, and Target stores, help customers manage chronic illnesses but generally do so only after they have been diagnosed elsewhere. Walgreens officials say they will have nurse practitioners and physician assistants at more than 300 Take Care Clinics in 18 states and the District of Columbia to do tests and make diagnoses – and also write prescriptions, refer patients for additional tests, and help them manage their conditions.

Equation May Give Wrong LDL Status
The widely used Friedewald equation may be underestimating LDL cholesterol levels in many patients, researchers found. The discrepancy between LDL cholesterol values that were estimated by the Friedewald equation and those that were directly measured was greatest when LDL cholesterol levels were low and triglyceride levels were high, according to Seth Martin, MD, of Johns Hopkins Hospital, and colleagues. Among patients with a Friedewald-estimated value of less than 70 mg/dL, for example, the directly measured level was a median of 9 mg/dL higher when triglycerides were 150 to 199 mg/dL and 18.4 mg/dL higher when triglycerides were 200 to 399 mg/dL, the researchers reported online in the Journal of the American College of Cardiology. Overall, 14.6% of the patients included in the study were placed into different treatment groups by the Friedewald estimates and direct measurements. This discordance was mainly due to "classification in a lower LDL cholesterol treatment group by Friedewald compared with direct LDL cholesterol," which occurred in 11.3% of patients, they noted. The discordance was greatest "when accuracy is most crucial, in patients with LDL cholesterol levels in the high-risk treatment range and concurrent hypertriglyceridemia," Martin and colleagues wrote, noting that because the Friedewald estimates were generally lower than the directly measured values, using the equation could result in undertreatment of high-risk patients.

"This phenomenon warrants consideration in contemporary patient care and clinical practice guidelines," the authors wrote. With the Friedewald equation, LDL cholesterol is estimated by subtracting the HDL cholesterol level and the triglyceride level (divided by 5) from the total cholesterol level. Using the equation avoids the extra time and expense needed to directly measure LDL with ultracentrifugation.Since the equation was introduced in 1972, however, practice guidelines have introduced lower LDL cholesterol targets, and high triglyceride levels have become more common due to the increasing problems of obesity, insulin resistance, and diabetes.

To assess the accuracy of the equation in a contemporary setting, the researchers compared Friedewald estimates with direct measurements performed with vertical density gradient ultracentrifugation by the Vertical Auto Profile (VAP) from 2009 to 2011. After excluding the patients who had a triglyceride level of 400 mg/dL or greater -- in whom there are known limitations of the Friedewald equation -- the researchers examined data from 1,310,440 adults (mean age 59) who underwent lipid screening; 14.6% had a Friedewald-estimated LDL cholesterol level of less than 70 mg/dL, the treatment target for high-risk patients. The median directly measured LDL cholesterol level was 109 mg/dL. Lipid distributions were similar to those seen in the National Health and Nutrition Examination Survey for 2007 to 2008, indicating that the study sample was nationally representative.In general, the Friedewald estimates were lower than the direct measurements of LDL cholesterol, and the discordance was greatest among patients with low LDL cholesterol levels and high triglyceride levels. Of the patients with a Friedewald estimate of less than 70 mg/dL, 23% had a direct measurement that was higher than that. That figure rose to 39% when triglycerides were 150 to 199 mg/dL and 59% when triglycerides were 200 to 399 mg/dL. The findings could have implications for patient care, according to the researchers.

"While we are not suggesting the need for routine clinical measurement of LDL cholesterol by direct assays, it bears mentioning that multiple direct assays beyond the VAP test [used in this study] are available," they wrote."Nevertheless, non-HDL cholesterol and apolipoprotein B are alternative approaches, with potential advantages over any measure of LDL cholesterol, and these measures avoid confusion that arises in defining LDL cholesterol ...," they wrote. "Moreover, in clinical trial patients with LDL cholesterol levels in the high-risk range highlighted in our study, non-HDL cholesterol and apolipoprotein B were stronger markers of residual risk than Friedewald LDL cholesterol." They acknowledged some limitations of the analysis, including the possibility that patients who undergo a VAP test may be a special population and the use of one-time LDL cholesterol measurements. In addition, the researchers did not have access to detailed clinical characteristics of the patients or clinical outcomes or information on statin use and fasting status before the lipid test.

CDC: New Strain of Norovirus has Reached U.S.
A new strain of norovirus has reached the U.S. from Australia. The CDC credits the new strain for 141, or 58%, of the 266 norovirus outbreaks reported since September, with many sources describing the norovirus as a highly contagious "bug." About two-thirds of this season's outbreaks occurred in long-term care institutions and 13 percent involved restaurants, according to the Morbidity and Mortality Weekly Report. For its part, Virginia "has identified six outbreaks caused by GII.4 Sydney this season - four in 2012 and two this month", said Michelle Stoll, a spokeswoman for the state health department.

New Tickborne Pathogen Found in U.S.
An elderly immunocompromised woman who developed meningoencephalitis was most likely infected with Borrelia miyamotoi, which is related to the spirochete that causes Lyme disease and may be an underappreciated cause of disease in locations where Lyme disease is endemic. Real-time PCR testing of cerebrospinal fluid samples confirmed the presence of the Borrelia species in this patient, but ruled out the presence of the Lyme disease pathogen B. burgdorferi, according to Sam R. Telford III, ScD, of Tufts University in North Grafton, Mass., and colleagues.Instead, amplification of two genes specific to B. miyamotoi implicated this organism, a finding that "was confirmed by sequencing and phylogenetic analysis of the 16S rRNA and flagellin genes," and "that definitively place the Borrelia from this patient within the American clade of the B. miyamotoi-like spirochetes," the researchers reported.

The researchers noted that the patient had responded well to a course of treatment suitable for Lyme neuroborreliosis, and suggested that other cases of B. miyamotoi may have been misidentified if patients had received standard Lyme disease treatment and recovered uneventfully.The patient was an 80-year-old resident of rural New Jersey who had been treated with several chemotherapeutic and immunomodulating agents for non-Hodgkin's lymphoma, and who had previously had two episodes of Lyme disease. Over the course of several weeks, she experienced progressive deterioration in mental and physical functioning; oncologic work-up found no cancer recurrence. However, examination of cerebrospinal fluid revealed the presence of spirochetes, and she was treated with intravenous penicillin G for 30 days, by which time her mental status and physical function had returned to normal.

Findings on numerous laboratory tests performed during her hospitalization found low levels of IgM and IgG and negative results for cryptococcal antigen and acid-fast bacilli. Detailed analyses of CSF samples were then undertaken at a reference laboratory. On microscopical and immunofluorescence examinations, coiled spirochetes were identified that belonged to the genus Borrelia. No Treponema spirochetes were found.The motile organisms were notably different in appearance from B. burgdorferi, and no reactivity was seen with exposure to a monoclonal antibody that tests positive for all known U.S. strains of B. burgdorferi. Real-time PCR testing then confirmed the species as being Borrelia rather than Treponema, and eliminated the possibility of B. burgdorferi with an assay that can detect that organism's OspA gene.Detection of the two B. miyamotoi genes strongly supported that organism as the cause of the woman's disease, according to the authors. Borrelia species are known to cause two types of illness -- Lyme disease and various relapsing fevers -- and all are carried by hard or soft ticks.

Borrelia miyamotoi was first identified in 1995 in Japan, and is now found worldwide. It is carried by the same ticks as B. burgdorferi, but with a much lower prevalence. A series of almost 50 cases was reported from Russia in 2011, with clinical manifestations of the relapsing fever form of illness. Those patients showed seroreactivity to testing for the broader, worldwide range of B. burgdorferi species, but DNA analysis of two specific genes identified B. miyamotoi as the most plausible causative pathogen. Recent research has demonstrated seropositivity to B. miyamotoi in up to 3% of individuals residing in the northeastern U.S. where Lyme disease is endemic and numerous types of Borrelia-laden ticks are found. Unlike the Russian cases, the elderly woman had not reacted to antigen testing for B. burgdorferi, even though the organisms are related. This lack of reactivity may have resulted from the patient's immunomodulating treatment with rituximab, according to Telford and colleagues. Misdiagnosis of meningoencephalitis with B. miyamotoi may be particularly likely in elderly patients, in whom the mental changes may be attributed to dementia, they noted. "Immunocompromise in older patients should always prompt a more rigorous laboratory analysis, because such persons may serve as sentinels for poorly recognized or novel pathogens," the researchers concluded.

In a letter in the same issue of NEJM, Peter J. Krause, MD, from Yale University and colleagues reported on 18 patients who showed evidence of antibodies to B. miyamotoi, and three whose titers were sufficiently high to suggest recent infection. Those three patients were symptomatic, with fevers, arthralgias, and sweats, and received antibiotic therapy with amoxicillin or doxycycline. None were immunocompromised. Echoing the observations of Telford and colleagues, Krause's group stated, "B. miyamotoi infection may be prevalent in areas where Lyme disease is endemic in the United States."

Updated Bloodborne Pathogen Exposure Protocols from the CDC available for download for AAUCM members. Log in to your AAUCM Member Center account and go to the Physician Toolbox.

1st Flu Vaccine From Cell Culture Wins FDA Nod
A seasonal influenza vaccine produced in cell culture, rather than chicken eggs, has been approved by the FDA for people 18 and older. To be sold with the brand name Flucelvax, the Novartis product is the first approved flu vaccine to be manufactured this way, the FDA said.

Cell-culture-based manufacturing is expected to shave weeks off the necessary start-up time to produce new vaccine formulations compared with the conventional method using chicken eggs. In a placebo-controlled clinical trial conducted during the 2007-2008 flu season in the U.S., Finland, and Poland, the vaccine showed efficacy of 83.8% in preventing infection -- similar to a conventional flu vaccine -- among adults 18 to 49 years old. A separate study in individuals 65 and older also demonstrated efficacy comparable with a conventional product. Adverse events with Flucelvax were also similar in type and frequency to regular flu vaccines.

The product's approval is especially important because it represents the culmination of U.S. government efforts to encourage production of cell-culture-derived flu vaccines, as preparation for a possible future pandemic, the FDA said. Other types of vaccines are currently manufactured in cell culture, the FDA noted. The government partnered with Novartis to build a $1-billion manufacturing facility in Holly Springs, N.C., to produce the vaccine. However, it is not yet ready for full-scale commercial production, the company said in a statement. Neither the FDA nor Novartis indicated when Flucelvax would be generally available.

Viewpoints: Can primary care safety net handle region's newly insured? Read more here. "Safety Net" and the Affordable Care Act - Urgent Care Centers will continue to grow!

Bird Flu Spreads To Seals, May Threaten Humans
A new strain of flu virus that started in birds and then jumped to harbor seals may pose a threat to human health and wildlife, according to a new study due to be published this week in mBio, an open access online journal of the American Society for Microbiology.

The strain, called H3N8, was found in New England harbor seals. The study authors identified it from a DNA analysis of a virus that was linked to the die-off of 162 New England harbor seals in 2011. The DNA test was done on samples taken during autopsies on 5 of the seals. Analysis reveals the new strain is able to target a protein in the human respiratory tract.

Anne Moscona, a pediatrician who researches emerging viruses at Weill Cornell Medical College in New York City, edited the study report. She told the press: "There is a concern that we have a new mammalian-transmissible virus to which humans haven't been exposed yet. It's a combination we haven't seen in disease before."

The study authors, from Columbia University and the National Oceanic and Atmospheric Administration Outbreaks, and other research centers, point to the importance of monitoring new strains of flu that start in birds and adapt to infect mammals. By studying and following the progress of the virus, scientists stand a better chance of being able to predict any emergent strains that could pose a threat to humans and start a new pandemic.

Cause for Concern
The study authors say we should be concerned about this new strain because it seems to have followed a similar path as the H1N1 "swine flu", that probably came from a reassortment of flu viruses in birds, pigs and humans. It could be the first sighting of a new group of flu viruses with the potential to persist and move between species, they note. The new virus appears to be a close relative of a flu strain that has been circulating in birds in North America since 2002, but adapted to living in mammals. The virus has mutations that are known to make flu viruses more transmissible and cause more severe disease. For instance, it is able to target a receptor called SAα-2,6, a protein found in the human respiratory tract. Scientists have suggested, that should for instance, the bird flu virus H5N1 adapt to human hosts, then the first step is likely to be a switch to bind to human rather than bird cell receptors.

Need to Consider New Routes
Moscana says these findings raise two reasons to be concerned about H5N8. First, it is a new virus that infects mammals, and it may cross the species barrier and pose a threat to humans. Second, the possibility that the threat from bird flu would come through seals has not been widely considered before. She says pandemic flu can emerge unexpectedly via routes we have not thought of, and we need to be ready for that. "Flu could emerge from anywhere and our readiness has to be much better than we previously realized," says Moscona. "We need to be very nimble in our ability to identify and understand the potential risks posed by new viruses emerging from unexpected sources," she adds.

Seal Deaths Not Unusual
It is not unusual for large numbers of seals to die from flu-virus infections. Last year, a report in the Boston Globe highlighted how the past few decades have seen notable seal die-offs in the Northeast of the United States, including a rash of flu deaths in 1979 and 1980. A link to bird flu was suspected then as well, the theory being that the mammals picked up the virus while sunning themselves on rocks covered with bird droppings. In 2006, a morbillivirus (from a family of viruses that includes the one that causes measles in humans) killed hundreds of harbor and gray seals in New England. The same virus was behind the death of 20,000 seals a few years earlier in the United Kingdom. Harbor seals are year-round inhabitants of the coastal waters of eastern Canada and Maine and occur seasonally along the southern New England to New Jersey coasts from September through late May, although a recent report from by the National Marine Fisheries Service, suggests scattered sightings and strandings have been recorded as far south as Florida.

First Quadrivalent Vaccine Against Seasonal Flu Wins FDA Approval
The FDA has approved FluMist Quadrivalent, a vaccine to prevent seasonal influenza in people aged 2 to 49 years. This is the first quadrivalent flu vaccine, that is one that contains four strains of flu virus, the agency has approved. FluMist Quadrivalent, made by MedImmune, contains weakened forms of two influenza A strains and two influenza B strains.

Google Flu Trends
Seasonal influenza epidemics are a major public health concern, causing tens of millions of respiratory illnesses and 250,000 to 500,000 deaths worldwide each year. In addition to seasonal influenza, a new strain of influenza virus against which no previous immunity exists and that demonstrates human-to-human transmission could result in a pandemic with millions of fatalities. Early detection of disease activity, when followed by a rapid response, can reduce the impact of both seasonal and pandemic influenza. One way to improve early detection is to monitor health-seeking behavior.

Google Flu Trends provides near real-time estimates of flu activity based on internet search queries. Google Flu Trends, collects and provides data on search traffic for flu information on a daily basis by detecting and analyzing certain flu-related search terms. Doctors can monitor internet search traffic about the flu to know when to expect a rise in patients coming in complaining of flu-like symptoms or looking for a flu shot.  

Google Flu Trends: http://www.google.org/flutrends/

A Win for Urgent Care!
The American Academy of Urgent Care Medicine, in an Amicus Brief, was successful in striking down a court ruling in the state of Michigan that held that an Urgent Care physician should be held to the same standards of care as that of an Emergency Medicine physician practicing in an emergency department. The original ruling would have had many ramifications for those physicians who operate Urgent Care centers, not only in MI, but also had the potential of spreading this type of doctrine to other states.

The AAUCM wishes recognizes and thank Alexandra Ritucci, ESQ, on this successful accomplishment!

10-Fold Increase Over 2-Year Period In The Use Of Retail Medical Clinics
Use of retail medical clinics located in pharmacies and other retail settings increased 10-fold between 2007 and 2009, according to a new RAND Corporation study. The determining factors in choosing a retail medical clinic over a physician's office were found to be age, health status, income and proximity to the clinic. No link between availability of a primary care physician and retail clinic use was found.

The RAND team used data from a commercially-insured population of 13.3 million to describe trends in retail clinic usage. Of that number, 3.8 million enrollees made at least one clinic visit between 2007 and 2009. During the study period, the rate of utilization increased from a monthly tally of 0.6 visits per 1,000 enrollees in January 2007, to 6.5 visits per 1,000 enrollees in December 2009.

The strongest predictor of retail clinic use was proximity. Other key predictors are gender (females were more likely to visit clinics than males), age (retail clinic patients tended to be between the ages of 18 and 44; those over 65 were excluded from the study), higher income (those from zip codes with median incomes of more than $59,000 were more likely to use retail clinics than lower income groups), and good health (those with a chronic health complaint were less likely to use retail clinics).

"We identified 11 simple acute conditions that can be easily managed at a retail clinic," said J. Scott Ashwood, the study's lead author. "These conditions, which include upper respiratory infection, bronchitis, ear infection, flu, and conjunctivitis, were the most common seen at retail clinics." The researchers found no correlation between retail clinic use and the number of primary care physicians in the community. "It appears that those with a higher income place more value on their time, and will use clinics for convenience if they have a simple health issue such as a sore throat or earache," said Dr. Ateev Mehro

How this trend will affect the rising cost of health care is unclear? Care initiated at retail clinics is 30 percent to 40 percent less expensive than similar care provided at a physician office, and 80 percent less expensive than such care provided in an emergency room. "If the growth in retail clinic visits that we noted represents substitution for other sources of care, then the increase in retail clinic use could lead to lower costs," Ashwood said. "However, if these visits represent new utilization or induced demand -- in other words, patents are seeking care when they would have otherwise stayed home -- then costs could increase. Answering these questions requires additional study."

Finding a Robust Urgent Care EMR – Peer Reviews
In cooperation with the AAUCM, KLAS Research is putting together a comprehensive review of EMR systems for urgent care centers.

Since the key findings from this research will be of interest, all healthcare providers who participate will receive a complimentary summary of the results.

Whether you utilize an EMR today, or are planning to purchase an EMR down the road, would you be willing to share some insight?

Please use this link to contribute your thoughts.  All responses are aggregated and appreciated.

Mosquitoes With West Nile Virus Appearing In Various Parts of the US
The Connecticut Department of Public Health's State Mosquito Management Program has announced that mosquitoes in Bridgeport tested positive for West Nile Virus on June 21st - the first cases identified by CAES (Connecticut Agricultural Experiment Station) in 2011. Tennessee - the state's Public Health Laboratory confirmed WNV in mosquitoes in Memphis, Nashville and Knoxville. State officials urge citizens to use repellants and take other precautions to prevent mosquito and other insect bites. Abelardo C. Moncayo, PhD, director of the Vector-Borne Diseases program for the Tennessee Department of Health, said: "These positive tests tell us that individuals bitten by mosquitoes in Tennessee could be at risk for contracting West Nile Virus. We can help control mosquito populations and lessen the risk of infection by emptying containers with standing water, keeping doors and windows screened, and wearing mosquito repellent when outside." Authorities inform that Tennessee is the 10th state so far in 2011 to show positive tests for WNV in mosquitoes, horses or birds. Officials in South Dakota inform that peak WNV transmission occurs from mid-July through mid-September. There have been over 1,700 human cases reported in the state since 2002, including 26 deaths. Ohio - two mosquito pools in the City of Columbus tested positive for WNV. No human cases have been reported in the state so far. According to the CDC's "2011 West Nile Virus Human Infections in the United States", up to June 28th there has been one human case of WNV infection, reported in Mississippi - a non-neuroinvasive disease case.

AAUCM, AMA, Other Groups Say Proposed Rules for Demonstrating Meaningful Use Are Unrealistic
Medical associations are warning that overly strict meaningful use criteria proposed by the Dept. of Health and Human Services for the next phase of the Medicare and Medicaid electronic medical records incentive program could dissuade physicians from participating. While stage 1 requires that 40% of all permissible prescriptions be transmitted electronically, stage 2 would increase the threshold to 50%. The American Medical Association and 38 other members of organized medicine sent a letter outlining their concerns to the Office of the National Coordinator for Health Information Technology, which is developing the objectives for the program.

States Working to Implement Medicaid Provisions of ACA
Medicaid programs will expand and change significantly over the next few years, largely because of the Affordable Care Act (ACA). An additional 16 million newly eligible people are expected to enroll in Medicaid by 2014. At that point, Medicaid programs also will have implemented a new method to calculate income, as well as new eligibility and enrollment systems that coordinate with the health insurance exchanges that will be established through the ACA. While many of these changes do not take place until 2014, many states already have begun working toward implementation. Given the dire budget situation in many states, however, these implementation efforts have been a challenge. Since 2008, states have confronted declining revenues and been forced to make multiple budget cuts, closing almost $230 billion in budget gaps between fiscal years 2009 and 2011. Because Medicaid is one of the top line items in most state budgets, states have cut funding for those programs for several years. To make the problem worse, Medicaid spending is "countercyclical." As the economy declines, the number of eligible enrollees increases while funding decreases, contributing to the overall budget pressures. While state lawmakers are forced to control Medicaid spending, their options for cutting program costs are somewhat limited by federal requirements. For example, the maintenance of effort requirements tied to the federal stimulus bill and the ACA prohibit states from reducing eligibility levels. As a result, states have implemented other measures, including provider payment cuts. States also have eliminated optional benefits, increased deductibles and/or copayments for certain services, and expanded or created new Medicaid managed care plans. Several states have focused on reducing pharmaceutical costs by implementing formularies, requiring generic substitution or limiting the number of covered prescriptions. The ACA includes several opportunities for states to receive federal funding to explore new Medicaid strategies. For example, the Department of Health and Human Services (HHS) will award state grants for the Medicaid Incentives for Prevention of Chronic Diseases Program, which rewards Medicaid beneficiaries for participating in prevention programs that positively impact their health. HHS also has awarded "early innovator" grants to seven states for designing and implementing the information technology (IT) infrastructure needed to operate the health insurance exchanges, including the means of coordinating with state Medicaid programs. Additionally, the ACA includes several Medicaid demonstration projects that states can pursue, such as pediatric accountable care organizations, the emergency psychiatric care demonstration project and the payment system demonstration project. Federal funding is tied to several of these projects. The ACA also provides grant opportunities or increases in the states' federal medical assistance percentage, or FMAP, for implementing such innovative programs as the community first choice option or home- and community-based services. Recognizing the enormous tasks ahead for the states, HHS and the Centers for Medicare & Medicaid Services (CMS) have signaled their commitment to working with them as they implement the ACA. For example, CMS indicated it will provide an enhanced federal match to states for developing and administering the IT infrastructure for their new eligibility and enrollment systems. In a recent letter to the nation's governors, HHS Secretary Kathleen Sebelius said the Obama administration will work hard to identify cost drivers for the states and offered several suggestions to help states save money, including cutting optional benefits, managing care for high-cost enrollees, controlling pharmaceutical spending and addressing program integrity. States will continue to be the laboratory for innovation. The AMA's Advocacy Resource Center provides tools and resources to state medical societies to support their state legislative and regulatory efforts, including implementation of the ACA. Visit the Advocacy Resource Center website for more information.

Scientists Discover Mutation That Could Cause H1N1 To Spread Faster
Scientists at the Massachusetts Institute of Technology have examined H1N1 and discovered that a single mutation could make the flu more dangerous. They found that the 2009 H1N1 virus, like the first version of the 1918 virus, had a protein structure that did not bind efficiently to cells in the human respiratory tract. In their study in the journal PLoS ONE, the researchers describe how they were able to create a version of H1N1 with a single mutation that greatly increased the virus' binding strength. Moreover, the MIT team noted that further testing showed the mutated version of the virus spread rapidly in ferrets that were used as a model for the human response to influenza.

Study Finds Growing Lack Of Teamwork Between ED, Primary Care Physicians
Coordination between ED physicians and PCPs is often disjointed, according to a study by the Center for Studying Health System Change. Researchers interviewed 21 pairs of ED physicians and PCPs who practiced at the same hospital in 12 communities and found numerous hindrances to teamwork. For example, the availability of more hospitalists and fewer PCPs hinders ED physicians and PCPs from developing close working ties. Moreover, there are technological barriers, with ED physicians and PCPs often using electronic health systems that cannot talk to each other. Lastly, there are financial barriers, such as when follow-up care discussions go unreimbursed and distract both ED physicians and PCPs. The study authors recommend a wide range solutions focusing on better coordination.


Jackson Healthcare is proposing a new federal law in March 2011 to address the high cost of defensive medicine.

This is not a traditional tort reform approach that seeks to limit or “cap” physician liability.  It proposes a no-fault system that benefits physicians in three important ways:

• Prevents anyone from suing physicians personally for medical malpractice.
• Eliminates the hassles of physicians defending themselves against  lawsuits.
• Protects physicians from being personally financially liable and indefinitely tied up in court. 

In essence, this proposal would be similar to the workers’ compensation system.  It would:

• Create a separate administrative agency to oversee malpractice claims,

• Move medical malpractice cases out of civil court system;

• Ensure contested cases are reviewed by a physician panel, rather than a public jury

Here’s how you can help…

STEP 1:  Review the proposal clicking through the next several slides

STEP 2:  Give us your opinion in the survey following the proposal

After you've taken the survey, please pass this onto your colleagues, and encourage them to take the survey.

Click here to begin...

One In Three US Adults May Have Pre-Diabetes, CDC Reports
Approximately one of three American adults may have so-called pre-diabetes, a 39% jump over 2008 estimates, according to a report released by the Centers for Disease Control and Prevention.  According to this new CDC data, half of all Americans over the age of 65 are prediabetic and 27% have diabetes. Minorities are still at higher risk compared with Caucasians: 16 % of American Indians/Alaska Natives, more than 12% of African-Americans and nearly 12% of Hispanic adults now have diabetes, compared with a little more than 8% of Asian-Americans and 7% of non-Hispanic whites. In 2008, the CDC estimated that 23.6 million Americans had diabetes and an additional 57 million adults had prediabetes.

FDA Approves Head Lice Treatment For Children And Adults
The Food and Drug Administration approved Natroba (spinosad) Topical Suspension 0.9% for the treatment of head lice infestation in patients ages 4 years and older. Natroba provides another option for the topical treatment of head lice infestations, which are especially prevalent in the pediatric population. Natroba is a topical drug product and should be applied only to the child's scalp or hair.

Global Fees Reach MA: Urgent Care Centers Are No Longer the Target of This Cost-Reduction Phenomenon
Blue Cross Blue Shield of Massachusetts and the Beth Israel Deaconess Physician Organization have signed an alternative quality contract, thereby covering 40 percent of Blue Cross HMO members under so-called "global payments." The move is a signal that global payments, a system designed to reward doctors for keeping patients healthy and reducing the number of medical procedures, is gaining traction among Massachusetts doctors, reports the Boston Business Journal. The agreement sets a global, or fixed, payment per patient adjusted for age, sex, and health status as well as payments tied to performance on quality measures, health outcomes and patient care experiences. The contract's global payment covers all services received by a patient, including primary, specialty and hospital care, Blue Cross officials said in a statement.   Now, instead of getting paid for every visit, test and procedure, doctors at Beth Israel will receive a budget to care for their Blue Cross HMO patients. If the physicians group goes over-budget, they split the loss with Blue Cross. If they come in under budget, they share the surplus, based on how much they improved the care of patients with certain conditions. If the doctors can't show improvement in patients' conditions or that patients are getting more preventative tests, they don't share the surplus. Beth Israel is the largest physicians group to join the Blue Cross payment system since the insurer started advocating for this contract two years ago. "It's rooted in a group that initially was skeptical," Blue Cross CEO Andrew Dreyfus told WBUR. "It took a long time for the group to come around and I think by the way our discussions with them improved (the contract)." This new way of paying for healthcare already seems "very encouraging," Dreyfus said. "Quality is improving at a faster rate with physicians who are practicing under our new payment model than with physicians who are outside of our payment model."

The Global Fee structure is good for the insurance companies, but not healthy for the public and physicians. The public needs to keep in mind that once an individual is assigned a "fixed dollar amount" to their visit, there is no incentive for a physician or health care system to invest in new diagnostic technologies and/or diagnostic tests, that will not be reimbursed. When purchasing insurance, always ask your insurance company, on what basis will my doctor be reimbursed? Do they endorse Global Fees? If so, walk away. They are only looking at their bottom line. We have not seen any data that shows that health care insurances are reducing premiums with this tactic.

CT Imaging Study May Increase Acute Abdominal Pain Patients' Confidence In Physician's Diagnosis
ED patients who have acute abdominal pain are four times more confident that doctors have correctly diagnosed their conditions when a CT imaging study is used to facilitate diagnosis, according to a study published in the online version of the Annals of Emergency Medicine. Researchers from the University of Medicine and Dentistry of New Jersey surveyed 1,168 patients with non-traumatic abdominal pain and found that 20% were confident in a diagnosis based on patient history and physical exam only. But 90% of patients reported confidence in their diagnosis when the medical evaluations also included blood work and a CT scan.

Will consumer driven algorithms be the next phase vs. as opposed to scientific based processes?

Signs Of Flu Season Upon Us, CDC Officials Announce

The first signs that the flu season is upon us have arrived, says the CDC. In some states, for example Georgia, reported cases of flu have suddenly risen so rapidly that state authorities are referring to a "regional outbreak". It seems that the virus strains identified so far closely match those used in this year's vaccinations, which is good news for those who had the jab.

The CDC has announced December 5 to 11th as National Influenza Vaccination Week. The aim is to stress the importance of vaccinations and to get as many people as possible immunized.

In a communiqué, the CDC wrote:

During the 2010-2011 flu season, three influenza strains are expected to be present. Health authorities say every person aged 6 months or more should be vaccinated. Having the flu jab does not only protect you, but also those around you.

The three flu strains that will be circulating during the current/coming flu season, according to the CDCs' Advisory Committee on Immunization Practices, are:

• An A/H3N2 strain

• A B strain

• The H1N1 (2009) pandemic strain, which for a while was informally termed "swine flu"

The current vaccine protects against these three strains. The CDC says 160 vaccines have been distributed throughout the USA.

Dr. Anne Schuchat, Assistant Surgeon General of the U.S. Public Health Service and CDC's Director of the National Center for Immunization and Respiratory Diseases, said:

"The new vaccination recommendation shows the importance of preventing the flu in everyone. People who do not get vaccinated are taking two risks: first, they are placing themselves at risk for the flu, including a potentially long and serious illness, and second, if they get sick, they are also placing their close contacts at risk for influenza."

Howard K. Koh, M.D., M.P.H.,Assistant Secretary for Health, said:

"The bottom line is, anyone - even healthy people - can get sick from the flu. Lead the way to better health for all by getting your flu shot."

The CDC says that the National Influenza Vaccination Week must engage at-risk audiences - people who have not yet been immunized, individuals who are hesitant or unsure whether having the jab is good for them.

Useful Tool for Docs: http://www.nccc.ucsf.edu/

An Open Letter to the Health Care Insurance Industry

Dear Insurance Carriers:

InQuicker.com, an online ER and Urgent Care check-in system, encourages patients "tired of waiting for hours in the ER waiting room" to check in on the web before they arrive, skipping the hours in the waiting room.  

With story after story of emergency room overcrowding flooding the news ^1,2,3,4,5,6, the question arises as to why this web site – and its participating hospitals – are advocating treatment for non-emergencies? It seems that the emergency medicine community is sending a mixed message; on one hand they purport that the emergency room is intended for life-and-limb treatment, i.e., emergencies, yet they are encouraging patients to come to the emergency room for non-emergency care when perhaps those patients would be better served at an urgent care center.  

Emergency rooms are designed to treat patients suffering from life threatening injuries or serious illnesses. In contrast, urgent care centers are designed to lighten the load on local emergency rooms by treating non-life threatening injuries. The urgent care center is available for any non-life threatening medical illness or injury, providing direct attention without waiting hours for treatment (whether waiting at home or in the emergency room).  

As an insurance carrier, why should you be concerned about this trend? Treating non-emergency cases in an emergency environment will ultimately have a negative effect on your bottom line. Hospitals and their emergency rooms run up bills and then charge you, the insurance provider, emergency room visit fees and facility fees. In contrast, treatment at an urgent care center costs hundreds if not thousands of dollars less.⁷  

By educating consumers to “Know Where to Go” ⁸ and encouraging your participants to utilize urgent care centers for non-emergency care, you will be promoting better health care, helping to solve the health care crisis and helping your bottom line.  

Sincerely,      
Franz Ritucci, M.D.
President, American Academy of Urgent Care Medicine

1. http://www.emergencymedicineexpert.com/index.php/Latest-News/emergency-room-overcrowding-and-the-dangers.html
2. http://aappolicy.aappublications.org/cgi/content/full/pediatrics;114/3/878 
3. http://jama.ama-assn.org/cgi/reprint/276/6/460.pdf
4. http://intqhc.oxfordjournals.org/content/9/3/225.full.pdf 
5. http://www.bizjournals.com/denver/stories/2006/02/13/focus4.html
6. http://rocnow.com/article/living/201010130339 
7. http://www.wisebread.com/cost-comparison-emergency-rooms-vs-urgent-care
8. http://www.aaucm.org/Patients/SelectUrgentCareCenter/default.aspx

InQuicker.com - Online ER and Urgent Care Check-In System
According to the web site InQuicker.com, patients "tired of waiting for hours in the ER waiting room" can check in on the web before they arrive, skipping the hours in the waiting room.

Emergency medicine seems to be sending mixed messages - on one hand they purport that the ED is for emergency/life and limb treatment, yet they want to see patients that  perhaps would be better served at an urgent care center. Are complaints and data of "overcrowding" in the nation's EDs just noise? It's unfathomable that insurance carriers would support this; if a patient pays out of pocket for non-emergency care  appointment using a system such as InQuicker.com, then the insurance company pays a higher rate for treatment and care! Yet the insurance industry wants urgent care centers to accept global fees for their patients!

What are your thoughts on this? Click Here to send comments to the AAUCM.

Cheap Generics Threaten QA Efforts
Four-dollar generic drug programs may boost access to medications but make it tougher to monitor quality of care, researchers warned.Many pharmacies that offer low-cost generics don't submit claims to insurers when patients pay cash, noted Niteesh K. Choudhry, MD, PhD, and William H. Shrank, MD, MSHS, both of Brigham and Women's Hospital and Harvard in Boston. "The consequences of missing these claims is not insignificant," they cautioned in a perspective piece in the Nov. 11 issue of the New England Journal of Medicine.Eight of the 10 largest retail pharmacy chains, including Wal-Mart, Target, and Walgreens, have programs that charge $4 to $9.99 for a one-month supply or $10 to $12 for a three-month supply of some of the most widely used generic medications. As atorvastatin (Lipitor) and clopidogrel (Plavix) go off patent over the next several years, the role of such programs and their impact on public health will only grow, Choudhry and Shrank speculated. "Lower medication costs should have desirable effects on medication use, especially as the patents on more therapies for chronic conditions expire, and these low-cost programs have been a welcome advance for low-income patients," they noted in the article. However, an ironic side effect of the programs' failure to report filling patients' prescriptions when paid in cash is that these patients would be misclassified as nonusers or "nonadherers" to their medication regimen in the pharmacy claims databases that are increasingly used for quality assurance, Choudhry and Shrank wrote. These databases -- used to target interventions to improve adherence, to evaluate effectiveness and safety of medications outside of clinical trials, for pay-for-performance contracts, and to track utilization and expenditure -- "can contribute to long-term improvements in the healthcare system and may thereby directly benefit both current and future patients," Choudhry and Shank explained in their paper. With healthcare reform coming into play, the need to monitor the performance of health systems is even more pressing, they noted. The simplest solution may be to ensure that pharmacists submit all prescription benefit claims regardless of method of payment, which may require providing an incentive to do so without violating conflict-of-interest or kickback regulations, the researchers suggested. Other possibilities would be to use the electronic systems pharmacies use to record transactions and monitor inventory, to use electronic prescribing data instead of prescriptions filled, or to use electronic health records integrated with pharmacy and insurance claims. "Of course, obstacles related to the cost of maintaining these data, privacy concerns, and incentives for data sharing will need to be overcome," Choudhry and Shank wrote. But, they concluded, "we must be certain not to diminish our ability to measure and improve the quality of U.S. healthcare."

Health Care Reform: New Perspectives on Contracting and Partnerships
A nationwide survey of contracting executives in hospitals, health plans and multi-specialty physician groups
http://www.meyerconsultinginc.com/Contracting-Survey-Findings.pdf

Analysis: More Americans Abandoning Prescriptions Due To Price
More Americans are abandoning their prescriptions at pharmacies rather than pay higher prices for them, according to a recent analysis of 80 million pharmacy claims conducted by Wolters Kluwer Pharma Solutions. The data showed that this phenomenon increased by 55% during the second quarter of 2010, compared to 2006 statistics. This finding is crucial because conventional wisdom indicated that prescription drugs were not susceptible to economic downturns since sick people must take medication in order recover, yet, this new evidence suggests that people are in fact deciding whether to pick up prescriptions based on price.  This dovetails with the AAUCM suggestions that Urgent Care centers should provide self dispensing to patients at affordable prices where permitted by state regulations.

Doc Shortage to Worsen After Healthcare Reform
A new estimate from the Association of American Medical Colleges (AAMC) pegs the projected physician shortage at 50% worse than it would have been if healthcare reform hadn't passed. By 2015 -- one year after the majority of the provisions in the Affordable Care Act (ACA) will have taken effect -- the nation will be short 63,000 physicians, a figure that includes both primary care doctors and specialists. Previous estimates put the shortage at 39,600. By 2020, there will be 45,000 too few primary care physicians, and 46,000 too few specialists, according to the AAMC. The Affordable Care Act (ACA) contains several provisions that will add an estimated 3,500 new physicians to the work force over the next 10 years, including primary care grants and reshuffling residency programs. However, the ACA provides insurance coverage for an additional 32 million Americans, so the number of new patients seeking medical care will far outweigh the number of doctors trained to provide it. In addition, the Census Bureau projects a 36% growth in the over-65 population in the next decade, which means an influx of Medicare recipients. Couple that with a projection that nearly one-third of all physicians are expected to retire in the next decade, and the "need for timely access to high-quality care will be greater than ever," the AAMC said in a press release. The AAMC said that although medical school enrollment continues to increase, more residency training slots are needed, and Congress should overturn a 1997 law that put a freeze on Medicare-funded residency positions. "Unless Congress supports at least a 15% increase in residency training slots (adding another 4,000 physicians a year to the pipeline), access to healthcare will be out of reach for many Americans," the group said in its press release. The problem will be most pronounced for people living in rural and underserved areas where finding a doctor can already be a difficult task, according to the report. Urgent Care is poised to fill this need!

Drug Updates

Lamictal
The FDA warned that Lamictal (lamotrigine), approved to treat seizures and bipolar disorder, can cause aseptic meningitis, an inflammation of the meninges that cover the brain and spinal cord not caused by bacterial infection. The agency is working with the drug's manufacturer, GlaxoSmithKline, to update the prescribing information and Patient Medication Guide to include information on this risk. The FDA became aware of the association between Lamictal and aseptic meningitis through routine adverse event monitoring and communications with the drug's manufacturer. Since the drug's approval in December 1994 through November 2009, there were 40 cases of aseptic meningitis identified in patients taking Lamictal. The symptoms were reported to occur within 1-42 days after starting Lamictal. Thirty-five of the 40 patients required hospitalization and in most cases, symptoms ended after Lamictal was discontinued. In 15 cases, symptoms, often more severe, returned when patients restarted the drug. For more information, visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222212.htm .

Cubicin
The FDA is informing patients and healthcare professionals about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin), an intravenous antibacterial drug. In 2007, pulmonary eosinophilia was added to the Adverse Reactions, Post-Marketing Experience section of the Cubicin product label. Since then, the Agency has reviewed published case reports of Cubicin-associated eosinophilic pneumonia, and conducted a review of post-marketing adverse event reports from the FDA's Adverse Event Reporting System (AERS). The FDA's review identified seven cases of eosinophilic pneumonia between 2004 and 2010 that were most likely associated with Cubicin. Based on these reviews, the FDA determined that eosinophilic pneumonia can be associated with Cubicin use and requested that the manufacturer of Cubicin include this information in the Warnings and Precautions and Adverse Reactions, Post-Marketing Experience sections of the drug label. Healthcare professionals should closely monitor patients being treated with Cubicin for eosinophilic pneumonia. Patients receiving Cubicin should immediately contact their healthcare professional if they develop a new or worsening fever, cough, shortness of breath, or difficulty breathing. For more information, visit www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220273.htm.

Simcor
Abbott received FDA approval for two new dosage strengths of Simcor: 40 mg of simvastatin–the most commonly prescribed dose of simvastatin–with either 500 mg or 1,000 mg of niacin extended-release. Simcor is used along with diet in people who cannot control their cholesterol levels by diet and exercise alone. Simcor is approved to raise HDL cholesterol and lower levels of elevated total cholesterol, LDL cholesterol, and triglycerides and is prescribed when treatment with either simvastatin or niacin extended-release alone is not considered adequate. Simcor is already available in the following strengths: 500/20 mg, 750/20 mg and 1,000/20 mg. For more information, visit www.abbott.com.

Influenza Vaccines for 2010-2011 Season
The FDA has announced that it has approved vaccines for the 2010-2011 influenza season in the U.S. Seasonal influenza vaccine protects against three strains of influenza, including the 2009 H1N1 influenza virus, which caused the 2009 pandemic. Because the 2009 H1N1 virus emerged after production began on the seasonal vaccine last year, two separate vaccines were needed to protect against seasonal flu and the 2009 H1N1 pandemic flu virus. This year only one vaccine is necessary. Vaccines for the 2010-2011 seasonal influenza contain the following strains: A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus), A/Perth/16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus. The brand names and manufacturers for the upcoming season's vaccines are Afluria (CSL Limited), Agriflu (Novartis Vaccines and Diagnostics), Fluarix (GlaxoSmithKline Biologicals), FluLaval (ID Biomedical Corporation), FluMist (MedImmune Vaccines Inc.), Fluvirin (Novartis Vaccines and Diagnostics Limited), and Fluzone and Fluzone High-Dose (Sanofi Pasteur Inc.).

Each year, experts from the FDA, WHO, CDC, and other institutions study virus samples and patterns collected worldwide to identify strains likely to cause the most illness during the upcoming season. Based on that information and the recommendations of the FDA's Vaccines and Related Biological Products Advisory Committee, manufacturers included the respective three strains in the 2010-2011 vaccines. The closer the match between the circulating strains and the strains in the vaccine, the better the protection against influenza disease. For more information, visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220718.htm.

Many Emergency Department Visits Could Be Managed At Urgent Care Centers and Retail Clinics
Researchers analyzed samples of patient records and found 13.7% of all ED visits could take place at a retail clinic – 7.9% when hours are restricted – and an additional 13.4% of ED visits could take place at a urgent care center — 8.9% when hours are restricted. That is, a total of 27.1% of all ED visits could be managed at a retail clinic or urgent care center — 16.8%  when hours are restricted. Assuming the smallest of each of these savings and assuming that 16.8% of the 104 million ED visits that did not result in a hospital admission in 2006 could take place in one of these alternative settings, the potential savings to the health care system would be approximately $4.4 billion annually, or 0.2% of national health care spending.

Relationship Between Patient Panel Characteristics and Primary Care Physician Clinical Performance Rankings
An intrinsic assumption underlying physician clinical performance assessment is that the measures represent physician performance. However, the same physician may have higher or lower measured quality scores depending on the panel of patients he or she manages. Researchers looked at data from a large academic primary care network; 125,303 adult patients who had visited any of the nine hospital-affiliated practices or four community health centers [at Massachusetts General Practice] between January 1, 2003, and December 31, 2005 report that the primary care doctors who were rated in the top third of measured quality were more likely to care for older patients with greater comorbidity who made more frequent visits to see a primary care physician. Because older patients with more comorbidities are often seen more frequently, they may have stronger relationships with their physicians, and physicians caring for such patients may have more opportunities to complete process measures. Those physicians were also less likely to care for minority, non–English-speaking, Medicaid, and uninsured patients than the doctors in the bottom third of the rankings.

The FDA has a new pamphlet available for physicians to provide to parents on giving over-the-counter medications to their children. To order FREE copies of this brochure for your clinic, call Sherunda Lister at  301-796-3124.

Dengue Information for Clinicians
Dengue infection is caused by any of four distinct but closely related dengue virus (DENV) serotypes (called DENV-1, -2, -3, and -4).  Dengue viruses are flaviviruses, a family which includes other medically important vector-borne viruses (e.g., West Nile virus, St. Louis encephalitis virus, etc.).  Dengue is currently the most frequent cause of acute febrile illness among returning U.S. travelers from the Caribbean, Central and South America, and Asia.  It is widespread throughout the tropics and sub-tropics and an outbreak was recently identified in Key West, Florida.  The primary method of transmission is through the bite of an infected Aedes aegypti. mosquito.  Dengue may also be transmitted from mother to fetus in utero or to neonate at parturition.  Incubation period is 3-14 days.  Infected persons may be asymptomatic in up to 53-89% of cases.  Clinical presentation in those who become ill can range from a mild non-specific febrile syndrome, to classic dengue fever (DF), or in the most severe forms of the disease (2-4% of cases), dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS).  Early clinical recognition and treatment for those who develop DHF or DSS can save lives.   Dengue should be considered when persons that live in or have traveled to a dengue endemic area in the two weeks prior to symptom onset have fever and two of the following signs and symptoms:

• Ache and pains (headache, retro-orbital pain, myalgia, arthralgia)
• Anorexia and nausea
• Rash
• Positive tourniquet test
• Leucopenia Warning sign for severe disease. 
• Warning signs typically manifest after a two to seven day febrile phase and include abdominal pain or tenderness, persistent vomiting, mucosal bleeding, liver enlargement greater than two centimeters, clinical fluid accumulation, lethargy/restlessness, or laboratory results indicating an increase in hematocrit concurrent with a rapid decrease in platelets.

 

Patients at risk for severe disease:
Previously infected with another dengue virus  
Diabetes mellitus
Pregnant women                                                 
Chronic renal failure Infants                                                              
ObesityElderly

Laboratory testing is necessary to confirm whether local transmission is occurring and to identify circulating virus types (PCR).  Serum samples collected during the first five days post onset should be submitted for PCR testing to DOH Tampa Laboratory.  Most convalescent serum samples (>6 days onset) should be submitted for IgM antibody detection by ELISA at a commercial laboratory.  Either PCR or ELISA samples can be collected in a red or tiger top tube.  Your county health department can provide guidance on how and when to submit samples to DOH Laboratories. The Florida Department of Health is relying on physicians to identify suspect cases of dengue and report them to their county health department.  Please contact your county health department by the next business day if you suspect dengue to ensure prompt mosquito control efforts.

Resources:
CDC guidelines for clinical management of dengue infection http://www.cdc.gov/dengue/clinicallab/clinical.html  
More information on the 2009 Key West dengue outbreak: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5919a1.htm                       

Dengue Clinical Sample Submission Guidelines
When dengue is suspected in a patient, a sample should be promptly submitted to either the Dept. of Health or a commercial laboratory such as Quest or LabCorp.  The following categories will help you determine which laboratory is appropriate:

This Year's Flu Vaccine To Include H1N1, Influenza B, and New Strain H3N2
The swine flu, which nearly caused a national panic last year before collapsing by year's end, remains very low across the US, with no indication it will worsen as the fall flu season nears. However, this year, unlike last year, there will be a single vaccine that will cover H1N1, the seasonal influenza B, and a new strain, H3N2. Also, unlike last year when the federal government paid for the swine flu vaccine and set up special locations, this year, the combined vaccine will be disseminated mostly through commercial facilities, including private doctors' offices, clinics and pharmacies.

More ED Crowding Expected Under New Healthcare Law
EDs may grow even more crowded with longer wait times under the nation's new health law. Even though the new measure may help millions of Americans secure insurance, there is already a shortage of front-line family physicians in some places and experts think that will get worse. What's more, people without insurance aren't the ones filling up the nation's EDs. In fact, the biggest users of ED's by far are Medicaid recipients, and the new health insurance law will increase their ranks by about 16 million.

Number of People Visiting Hospital EDs Climbed In Massachusetts
The number of people visiting EDs has climbed in Massachusetts. After the passage of the insurance law in 2006, officials hoped it would increase access to primary care doctors for the uninsured, which would improve their health and lessen their reliance on EDs for the flu, sprains, and other urgent care. Yet, according to a report from the Division of Health Care Finance and Policy, expanded coverage may have contributed to the rise in ED visits, as newly insured residents entered the healthcare system and could not find a primary care doctor or get a last-minute appointment with their physician. In fact, ED visits rose by 9% from 2004 to 2008, to about 3 million visits a year according to state data.

Infant Tylenol, Motrin And Zyrtec Medications Recalled By Johnson and Johnson
Infant Tylenol, Motrin And Zyrtec Medications Recalled By Johnson And JohnsonJohnson & Johnson's McNeil Consumer Healthcare, in consultation with the FDA, is voluntarily recalling all unexpired lots of certain over-the-counter Children's and Infants' liquid products, including Tylenol, Mocrin, Zyrtec and Benadryl, manufactured in the US and sold in the United States, Canada, Dominican Republic, Dubai, Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. The company says this voluntary recall is being initiated because some of the products may not meet required quality standards. McNeil Consumer Healthcare adds that this recall is not being undertaken on the basis of adverse events.

High-Dose Aspirin May Provide Acute Migraine Relief
High-dose aspirin matched a triptan drug for relief of acute migraine, Oxford researchers found after reviewing 13 studies in which 4,222 people received either aspirin with or without an antiemetic, placebo, or an active comparator, most often sumatriptan 50 mg or 100 mg. A fourth of patients treated with 900 to 1,000 mg of aspirin, with or without an antiemetic, were pain free after two hours, and half of patients had no more than mild residual pain. Results for most outcomes were similar for patients treated with sumatriptan.

Nonsterile Eye and Nose Drops Recalled
The manufacturer of several eye and nasal drops has voluntarily recalled a number of its products due to potentially nonsterile conditions at its manufacturing facilities. Although no adverse events related to the eye and nose drops have been reported, manufacturer US Oftalmi recalled specific lots of eye and nose drops because the nonsterile products may cause eye infections, according to a company statement. Included in the recall are:

• Camolyn Homeopathic, lots #049036 and 087934
• Camolyn Plus, Naphazoline + Chamomile 15 ml, lots #037691 and 097420
• Camolyn Refresh 15 ml, lots #116636 and 107610
• Camolyn-A, Naphazoline + Pheniramine 15 ml, lots #057063, 058962, 106606, and 099487
• Fisiolin Nasal Drops Sodium Chloride Pediatric Uses 15 ml, lot #028659

Over-the-Counter Version of Heartburn Drug Zegerid Approved
The FDA has approved the over-the-counter version the prescription heartburn drug Zegerid. Zegerid OTC (omeprazole 20 mg/sodium bicarbonate 1100 mg capsules) will be marketed by Schering-Plough HealthCare Products, Inc., the consumer healthcare division of Merck & Co. Zegerid OTC, a proton pump inhibitor, treats frequent heartburn by controlling and suppressing acid for a full 24 hours. Zegerid OTC contains a patented dual-ingredient formulation that combines omeprazole with sodium bicarbonate, which protects the omeprazole from acid in the stomach. Zegerid OTC capsules will be available in their original prescription formula, and are expected to be available in the first half of 2010.

Lamictal XR Approved for Epilepsy Therapy
The FDA has approved Lamictal XR (lamotrigine) extended-release tablets as once-a-day, add-on therapy for epilepsy in patients >13 years with primary generalized tonic-clonic seizures. This is an expanded label, as Lamictal XR is already approved for partial onset seizures (with or without secondary generalization) for patients in this age group.

Crestor Approved to Reduce Risk of Stroke, MI
The FDA has approved Crestor (rosuvastatin calcium) to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in individuals without clinically evident coronary heart disease but with an increased risk of cardiovascular disease (CVD) based on age (men >50 and women >60), high-sensitivity C-reactive protein >2 mg/L, and the presence of at least one additional CVD risk factor, such as hypertension, low HDL-C, smoking, or a family history of premature coronary heart disease.

Smartphone Medical Applications Become More Readily Available To Consumers
Medical emergency applications for smartphones are finding their way into the marketplace for consumers. For example, AED Nearby will help users locate the nearest defibrillator when sudden cardiac arrest occurs. A number of members of the American College of Emergency Physicians said they have found some of the consumer applications useful. But, ACEP spokesman Ryan Stanton said, "If you don't know the setting or the background behind the information, sometimes it can be misinterpreted," meaning that "emergent conditions" can go untreated.

Migraine Sufferers May Be Much More Likely To Have a Heart Attack
People who suffer from migraine headaches may be much more likely to have a heart attack as well as a host of risk factors for heart disease, according to a new study published in the Feb. 10 online edition of Neurology. The study, which compared 6,102 people with migraine and 5,243 without the headaches, found a 4.1 percent incidence of heart attacks in the migraine patients, compared with 1.9 percent in those without the debilitating headache. The researchers also found that people with migraine were more likely to have the classic risk factors for heart attack, stroke, and other cardiovascular problems: diabetes (12.6% versus 9.4 %), high blood pressure (33.1% versus 27.5%), and high cholesterol (32.7% versus 25.6%).

Salmonella Montevideo Outbreak
The FDA, along with the CDC and the U.S. Department of Agriculture, is working closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infection associated with certain salami products.

The CDC reports that 202 people have been infected with a matching strain of Salmonella Montevideo in at least 42 states and the District of Columbia. Recently, the CDC and public health officials in multiple states conducted an epidemiologic study by comparing foods eaten by 41 ill and 41 well persons. Preliminary analysis of this study has suggested pepper-coated salami as a possible source of illness.

On Jan. 23, 2010, Daniele International Inc. recalled ready-to-eat varieties of Italian sausage products, including salami. The recalled meat products have an extended shelf life up to one year. Recent test results provided by the Rhode Island Department of Health revealed that an opened container of black pepper used at the salami manufacturing facility of at least some of the recalled products were positive for Salmonella Montevideo and that the DNA fingerprint matched the outbreak strain.

The FDA is actively investigating the supply chain of the black pepper used in the manufacturing of the recalled meat products to see if it poses a risk to consumers. The agency has collected and is currently analyzing black pepper samples. To date, all the samples collected and analyzed by the FDA have tested negative for Salmonella; however, sample collection and analysis continues.

FDA Adds Cardio Warnings to Weight-Loss Drug
The FDA said the weight-loss drug sibutramine (Meridia) should not be taken by patients with history of cardiovascular disease following a review of additional data showing an increased risk of heart attack and stroke among that population.

The agency said the manufacturer, Abbott, has agreed to add the contraindication to its labeling, which will be expanded to include patients with a history of the following:

• Coronary artery disease (i.e., heart attack, angina)
• Stroke or transient ischemic attack
• Heart arrhythmia
• Congestive heart failure
• Peripheral arterial disease
• Uncontrolled hypertension (>145/90 mmHg)

Healthcare professionals should monitor patients for increase in blood pressure and heart rate and should discontinue therapy if either increase is observed. Patients should also discontinue use of sibutramine if they do not lose 5% of their baseline body weight within the first three to six months of treatment, as the drug may not be effective and puts the patient at unnecessary risk.

Measuring Medicine Using Kitchen Spoons May Lead to Under or Overdosing
Individuals using standard spoons from their home kitchen to dispense liquid medications may be pouring too little or too much of the drugs, researchers found after evaluating 195 college students. Participants were told to imagine they were at home and needed to take 5 mL - one teaspoon - of cold and cough medicine.  With that in mind, the subjects were then asked to pour the same 5-mL dose into a 15-mL spoon, and a 45-mL spoon in a randomized order.  Despite the fact that most students had 'above average' confidence that they had poured accurate doses, investigators found that dosages actually varied depending on the size of the spoon. When using the medium-sized tablespoon, the students underdosed by more than eight percent, on average. And when using the larger tablespoon, they overdosed by nearly 12 percent, on average.

Drug-Resistant E. Coli Called Significant Threat
First-line use of carbapenem antibiotics for urinary tract infections may become necessary if the spread of drug-resistant E. coli continues. An E. coli strain expressing a beta-lactamase enzyme known as CTX-M-15 has suddenly emerged in community-acquired infections worldwide, apparently originating in the Indian subcontinent and spread by travelers. In a review published online by Faculty of 1000 Medicine, Pitout suggested this strain is among the most worrisome of a series of recently emerging, community-acquired E. coli clones that express so-called extended spectrum beta-lactamases. These enzymes break down cephalosporin and monobactam antibiotics which have been first-line treatments for urinary tract infections. The bacteria remain susceptible to carbapenems such as meropenem (Merrem) and doripenem (Doribax). But their wider use would be likely to spur the emergence of new bacterial strains resistant to them, further diminishing the available treatment options.

Nitrogen Dioxide, Particulate Matter May be Linked to Increased Pneumonia
According to research published in the American Journal of Respiratory and Critical Care Medicine, two common air pollutants may put patients at risk of severe pneumonia. In a study of 349 patients who had been hospitalized for community-acquired pneumonia and 494 controls, researchers found that both nitrogen dioxide and particulate matter were associated with more than a twofold increased risk of community-acquired pneumonia. Notably, the same relationships were also found when estimating air pollution levels via bicubic spline interpolator and land use regression methods.

Analysis Finds New Mothers Remain at Risk for H1N1
The New England Journal of Medicine has determined that the H1N1 virus is not only dangerous to pregnant women, it's a threat to new mothers, too. This is based on a study involved 94 pregnant women and eight new mothers who were hospitalized during the first four months of the pandemic, before a vaccine became available. As a result of the findings, the Centers for Disease Control and Prevention recently revised its guidelines, recommending that flu drugs be given to women who show signs of the flu soon after they give birth.

FDA Okays New Indication for COPD Inhaler
The FDA has expanded the approved indications for inhaled tiotropium bromide (Spiriva HandiHaler) to include reducing exacerbations of chronic obstructive pulmonary disease (COPD), in addition to its previous approval for COPD maintenance. Tiotropium is a bronchodilator that works by antagonizing acetylcholine receptors in airway tissues. As before, the drug includes several cautions including:

• Tiotropium bromide is contraindicated in patients with an allergy to atropine or its derivatives.
• Patients with an allergy to tiotropium or a past allergy to ipratropium should not take the drug.
• The inhaler is not intended as a rescue therapy and is not indicated for use in treating sudden breathing problems.
• The drug may worsen symptoms in patients with narrow-angle glaucoma, prostatic hyperplasia, or bladder-neck obstruction.
• Patients who experience any hypersensitivity symptoms, such as lip, tongue, or throat swelling or paradoxical bronchospasm, should discontinue inhaler use immediately.

Common side effects include upper respiratory tract infection, dry mouth, sinus infection, and sore throat.

800,000 Doses of Childrens’ H1N1 Vaccine Recalled
Hundreds of thousands of H1N1 shots for children aged 6 months to three years have been recalled because tests indicate the doses lost strength, falling about 12% below the government standard. The shots, made by Sanofi Pasteur, were distributed across the country last month and most have already been used, according to the Centers for Disease Control and Prevention. Tests done before the shots were shipped showed that the vaccines were at the required potency. No potency problem has been detected in the same vaccine packaged in other types of syringes or vials. Experts suspect the antigen may be sticking to the walls of the pre-filled syringes.

FDA Gives Emergency Approval for New Swine Flu Test
The FDA has granted emergency use authorization for an H1N1 influenza virus detection test to be used on the portable GeneSTAT platform. This GeneSTAT "lab in a box" allows point-of-care testing for novel H1N1 and determines infection status in about 50 minutes without need for a technician or pathologist, according to the manufacturer, DxNA. A sample is collected by cheek or nasal swab and put in a closed cartridge that screws into the unit. Because the device is portable, fast, easy to use, and comparatively cheaper than PCR testing done in reference labs, it could be especially useful in rural areas and developing nations.

Amneal Receives FDA Approval For Nizatidine
Oral Solution is pleased to announce that it has received The FDA has approved Amneal Pharmaceuticals to manufacture Nizatidine Oral Solution in 15 mg/mL. It is a therapeutically equivalent alternative to Axid® Oral Solution (a licensed trademark of Braintree Labs). Nizatidine Oral Solution is the first available generic in oral solution form. Nizatidine Oral Solution is an anti-acid indicated in the treatment and prevention of ulcers, the treatment of heartburn and the stomach disorder GERD (gastroesophageal reflux disease) as well as conditions associated with excess acid secretion. Nizatidine belongs to a class of medications known as H2-blockers that inhibit the action of histamine on stomach cells, thus reducing stomach acid production.

New Jersey May Restrict Physician-Industry Relationships
Many states are mulling restrictions on relationships between doctors and industry. This week, New Jersey joined the list of states challenging such relationships, precipitated by a critical report from the state attorney general's office. The New Jersey Attorney General released a report this week recommending that his state impose tough new rules governing physician interactions with drug and device makers, including:

• Banning physicians and their office staff from accepting food from pharmaceutical companies, whether in their office, at facilities or in commercial venues like restaurants.  
• Requiring doctors renewing their licenses to disclose whether they'd accepted more than $200 worth of payments and/or gifts from industry during the prior two years.
• Mandating the state to create a public database of physician disclosures.  
• Restricting the sale of "prescriber-identifiable" prescription data for commercial databases, data now used by pharmaceutical companies to improve sales pitches to doctors.

If these recommendations were to be enacted, New Jersey would have some of the toughest rules in the U.S. The state's doctors are already worried, arguing that they made physicians do extra work and don't slap down the bad actors in industry. For the time being, these are recommendations. What’s next?

Treating Cluster Headaches With High-Flow Oxygen Appears Effective
According to a study in JAMA , patients with a cluster headache, which is characterized by bouts of excruciating pain usually near the eye or temple, were more likely to report being pain-free within 15 minutes of treatment with high-flow oxygen than patients who received a placebo treatment. Cluster headache attacks typically last for 15 minutes to three hours untreated and have a frequency of one every other day for up to eight attacks a day. Attacks usually occur in bouts, or clusters, lasting for weeks or months, separated by remissions lasting months or years, according to background information in the article. The current treatment for acute attacks of cluster headache is injection with the drug sumatriptan, but frequent dosing is not recommended because of adverse effects. Another treatment option is the inhalation of high-dose, high-flow oxygen, but its use may be limited because of the lack of a good quality controlled trial.

Intranasal Monovalent Vaccine Administration Instructions
Administration of the Intranasal Influenza A (H1N1) 2009 Monovalent Vaccine can be confusing, leading to incorrect dosing. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is indicated for the active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus. Dosage and administration instructions for intranasal H1N1 monovalent vaccine is available here.

Senate Affirms Screening Mammography for Women in Their 40s
On Thursday, Senators voted on an amendment that would require insurers to cover mammograms for women ages 40-49, essentially deciding to disregard the U.S. Preventive Services Task Force’s recent recommendation that women under 50 shouldn't undergo routine mammograms. This deals a significant blow to the power and credibility of the USPSTF. The amendment would increase coverage and eliminate copays for more women's preventive services. The USPSTF recommendations on any given procedure are important because the healthcare reform bill that was passed by the House and the bill being considered by the Senate would require insurance companies to cover all medical services that receive a grade of "A" or "B" from the USPSTF. In its recent recommendations, the task force downgraded mammography in women under 50 to a "C" grade, which means there is limited evidence to support its use. That would mean that insurance plans wouldn't be required to cover screening mammography for those women, unless the secretary of Health and Human Services (HHS) used her discretionary power to require plans to cover services with lower grades.

FDA Okays Sixth Seasonal Flu Vaccine
The FDA has approved the seasonal influenza subtype A and B vaccine Agriflu for patients ages 18 and older. The approval was based on a demonstration that the vaccine created levels of antibodies in blood likely to be effective in flu prevention. Side effects in Agriflu's clinical trials included pain, swelling and redness of injection site, headache, muscle ache, and malaise. The drug should not be administered to patients with severe allergies to eggs or any other vaccine ingredient. The new vaccine is not approved for prevention of the 2009 H1N1 virus. seasonal flu. The drug is distributed in single dose, prefilled syringes for single injection in the upper arm. Agriflu is the sixth drug approved for vaccination against the 2009-2010 seasonal influenza virus. The drug was made available through the agency's accelerated approval pathway, which makes devices and products for serious or life-threatening diseases available sooner than usual if they demonstrate safety and efficacy.

CDC Watching H1N1 Mutation
The CDC is keeping a careful eye on a mutation in some strains of the pandemic H1N1 flu that Norwegian researchers isolated from three patients with severe disease. According to Anne Schuchat, MD, director of the CDC's National Center for Immunization and Respiratory Diseases, the mutation has been seen "sporadically" in the U.S. The U.S. mutation has been associated with mild disease although the Norwegians isolated it from the first two patients who died of the disease in that country. The CDC will be watching to see if the mutation spreads and if it is more common in cases of severe disease.

Cell-Based, Egg-Free Method Produces Novel 2009 H1N1 Vaccine Virus
FluGen, an emerging leader in the development, production and delivery of influenza vaccines, announced that its proprietary CHO-cell-based production system has generated novel 2009 H1N1 influenza vaccine virus without the use of eggs during any step of production. Unlike traditional vaccine production methods, FluGen's CHO-based system does not use eggs. The company expects its cell-based, egg-free method to readily transfer to full-scale vaccine production and is in the process of developing a highly-efficient, production-scale system that will be available in the near future. FluGen's system would avoid the costly and time-consuming steps of egg-based production, including propagation of the virus in eggs and production of the vaccine itself in eggs. This egg-based process, by which all influenza vaccines are now produced, can take up to six months to deliver vaccine. The worldwide shortages of seasonal and novel 2009 H1N1 vaccine, exacerbated by this year's influenza pandemic, highlight the need for a quicker, cleaner, egg-free vaccine production methods.

Question: Does controlling systolic blood pressure to lower than 130 mm Hg lead to fewer bad outcomes than controlling it to lower than 140 mm Hg?
Results: In this open-label study of nondiabetic patients with systolic blood pressure (SBP) of at least 150 and at least one other cardiovascular disease risk factor, controlling the SBP to lower than 130 mm Hg reduced more adverse events than controlling the SBP to lower than 140 mm Hg. (LOE = 1b) Reference

Urgent Care Clinic Industry Expanding Again  
It's beginning to look like convenient care is on the rise - and not just in the retail clinic sector. While the retail clinic market expansion has gotten most of the attention, the urgent care industry is seeing some new growth as well.  Recent estimates suggest that the volume of U.S. urgent care clinics has gone from a steady decline to a growth rate of about two clinics a week. While the growth in retail clinics is likely to outstrip that by a considerable margin, it's still worth noting for an industry which had stalled throughout the 90s. Observers note that the growth in urgent care centers compliments, rather than competes with, emerging retail clinics. While urgent care centers see a slightly more acute patient, treating conditions like fractures and sprains, lacerations and abdominal illnesses, retail clinics typically limit themselves to low-complexity treatments for conditions such as strep throat and bladder infections. Retail clinics are actually beginning to refer to urgent care centers, in fact, according to urgent care administrators.

FDA Monitors LASIK Safety and Quality  
The FDA has begun a three-phase, quality-of-life study of patients who have received laser-assisted in situ keratomileusis (LASIK). The joint venture between the FDA, National Eye Institute, and the Department of Defense hopes to identify the frequency and predictors of problems associated with the surgery to determine whether further regulation of the excimer laser in the procedure is necessary. The first phase of the study, which began this July, asked patients to self-report surgery outcomes and postoperative quality of life through an online survey. The second phase will evaluate a select, active-duty population of patients treated at the Navy Refractive Surgery Center. The final phase will consist of a national, multicenter clinical trial studying the impact of quality of life in the general population. The third phase is expected to end in 2012. A decade-long survey that ended this April found that 95.4% of patients were satisfied with the results of LASIK surgery.  In 2008, the FDA announced the surgery was safe and well accepted, but that aggressive marketing of the procedure resulted in inappropriate clinical decision-making.  The FDA issued warning letters to 17 ambulatory surgical centers for inadequate adverse event reporting systems at the sites, though inspections failed to identify the problems associated with LASIK device use at those facilities. Ambulatory surgical centers are among several other places required under 1990 legislation to report device-related patient death and serious injury to the FDA and device manufacturer, including a written protocol for the adverse event report.

FDA Warns Four Drugmakers to Halt Sales of Unapproved Codeine Sulfate Tablets  
The FDA issued warnings to four drugmakers to halt sales of unauthorized codeine sulfate tablets. The FDA said it never approved the opioid analgesic tabs - which are considered narcotics - and their efficacy is questionable. Companies and products issued warning letters include:

• Codeine Sulfate Tablets, 30 mg, 60 mg from Cerovene Inc.
• Codeine Sulfate Tablets, 30 mg, 60 mg from Lehigh Valley Technologies Inc.
• Codeine Sulfate Tablets, 30 mg, 60 mg from Dava International Inc.
• Codeine Sulfate Tablets, 30 mg, 60 mg from Glenmark Generics Inc.

The companies have 15 days to respond with a plan to cease marketing the drugs, 90 days to end manufacturing, and 180 days to cancel distribution of existing product.

Drunk Driving Continues To Be a Problem
Drunk driving continues to be a major problem across the US. Last year alone, 11,773 people were killed in crashes where one of the drivers was over the legal limit, a figure that represents nearly a third of all deaths caused by traffic accidents. Aside from the emotional and physical toll, the financial fallout is considerable, costing $51 billion annually in the US. Although such figures may already seem alarmingly high, they may be more significant when analyzed in the context of individual EDs, because the median ED costs of treating drunk drivers are about four times as much as those for sober drivers.

Seasonal Influenza Information Guide

Indications

Annual vaccination against seasonal influenza is recommended for

·         All persons who want to reduce their risk of becoming ill with influenza or of spreading it to others

·         All children and teens ages 6 months through 18 years

·         All persons age 50 years and older

·         All children and teens receiving long-term aspirin therapy

·         All women who will be pregnant during the influenza season

·         Adults and children with any of the following conditions:

o    a chronic disorder of the pulmonary (including asthma) or cardiovascular (except hypertension) system

o    a chronic disease of the blood. liver. or kidneys; immunosuppression (e.g., including that caused by medications. HIY); or metabolic disorder (e.g., diabetes)

o    a neurologic or n uromuscular disorder (e.g., cognitive dysfunction)

·         All residents of nursing homes or other chronic-care facilities

·         All healthcare personnel

·         All household contacts (including children) and caregivers of (1) children ages 0-59 months (especially younger than 6 months; (2) adults age 50 years and older; and (3) persons with high risk medial conditions

·         Persons planning to travel to an area of the world with influenza activity (e.g., to the tropics at any time of the year)

Contraindications and Precautions

·         Do not give influenza vaccine to a person who has had an anaphylactic reaction to a prior dose of the vaccine or any of its components (e.g., eggs). Minor illnesses with or without fever do not contraindicate use of influenza vaccine.

·         Do not give nasal spray LAIV to persons who are younger than age 2 years; age 2 through 4 years with possible reactive airways disease (e.g., history of recurrent wheezing or a recent wheezing episode*); age 50 years or older; pregnant; have a chronic disease that is an indication for routine influenza vaccination; or are a child or teen receiving long-term aspirin therapy. Injectable TIV is preferred for persons who have close contact with severely immunosuppressed persons during periods when the immunocompromised person requires protective isolation.

·         Guillain-Barré syndrome within 6 weeks following a previous dose of influenza vaccine is a precaution for vaccination with TIV or LAIV.

*Ask parents of children 2-4 years: “In the past 12 months, has a healthcare provider ever told you that your child had wheezing or asthma?” If yes, do not give LAIV; instead give TIV.

Vaccine Dosing and Administration

·         TIV: Give 0.25 mL if age 6-35 monyhs; give 0.5 mL if age 3 years or older. Give 1M with a 22-25g, 1-1½” needle. Choose vaccine according to patient’s age (i.e., FluZone: 6 months and older; Fluvirin: 4 years and older; Afluria, Fluarix, and FluLaval: 18 years and older).

·         LAIV (FluMist): Give 0.2 mL (0.1 mL sprayed into each nostril) to healthy non-pregnant persons ages 2 through 49 years.

·         Give 2 doses to all children younger than age 9 years who are receiving influenza vaccine for the first time or who failed to receive the 2^nd dose in the preceding year. Separate the 2 doses by at least 4 weeks.

Side Effects

·         The most common side effects from TIV are soreness and redness at the injection site, lasting 1-2 days

·         The most common side effect from LAIV are runny nose and nasal congestion.

Talking Points with Patients

·         Influenza is a serious respiratory disease caused by a virus. It is not the same as the common cold or an intestinal illness.

·         An average of 36,000 deaths and more than 200,000 hospitalizations related to seasonal influenza occur in the U.S. each year.

·         Vaccination is usually 70-90% effective in preventing influenza in healthy adults and children. Its effectiveness may be lower if the circulating influenza viruses are not matched by the vaccine strains, but vaccinated persons will likely have milder illness.

·         Unvaccinated healthy people who get influenza can spread their infection to others who are most vulnerable to its complications.

Timing: Vaccination should begin as soon as vaccine becomes available and should continue until supply is depleted.

Current information on H1NI influenza can be found at www.cdc.gov/h1n1flu

HIV-Infected Adults and Adolescents

Pregnant Women

Young Children

Hemodialysis Patients

Patients With Cardiovascular Disease

Past Situation Updates

Antiviral Recommendations

Emergency Use Authorization (EUA) of Medical Products

CDC Conference Calls for Clinicians
Hosted by CDC’s Clinician Outreach and Communication Activity (COCA)

CDC Clinical Reminders
Posted by CDC’s Clinician Outreach and Communication Activity (COCA)

Clinical Data Collection Forms and Templates

Previous Conference Calls

Caring for a Sick Person in Your Home

Interim Guidance for People With Heart Disease, Stroke, or Cardiovascular Disease

Home Care Guidance: Physician Directions to Patient/Parent

Resources for Laboratories

Centers for Public Health Preparedness (CPHP) H1N1 Online Training

Travelers' Health Resources

Travelers' Health Presentations

• Pain - People who have oral piercings cite pain as the first thing they notice after the procedure.
• Swelling - Piercing may cause swelling of the tongue. According to the American Dental Association, in extreme cases, a severely swollen tongue can actually close off the airway and restrict breathing.
• Prolonged bleeding - A blood vessel punctured during piercing may cause severe bleeding.
• Damage to the sublingual salivary glands - An improperly placed tongue piercing may damage the sublingual salivary glands (salivary glands under the tongue), which produce five percent of saliva entering the oral cavity.
• Aspiration (choking) - Jewelry may become loose in the mouth, creating a choking hazard.
• Plaque buildup - Plaque may build up on piercings, requiring more frequent cleanings.
• Damage to the teeth and gums - Jewelry may come in contact with both the teeth and gums, causing chipped or cracked teeth or gingival (gum) recession.
• Allergic reaction - Jewelry containing certain metals may cause an allergic reaction.Nerve damage - A piercing that penetrates a nerve may cause nerve damage, leading to numbness or loss of sensation at the piercing site.
• Infection - The wound from the piercing, coupled with bacteria in the mouth, creates an increased risk of infection.

• Alligator Blood
  Alligators heal quickly, rarely get infections, live in murky water and eat diseased food. Researchers at McNeese State University believe that proteins in an alligator's blood inhibit bacteria growth and, if that theory proves to be true, similar proteins may help humans.
• Bacterial DNA
  Reseachers at the University of Warwick used genome mining to isolate a previously unknown signaling chemical in Streptomyces bacteria that causes it to produce natural antibiotics. Reseachers at the University of Warwick used genome mining to isolate a previously unknown signaling chemical in bacteria that causes it to produce natural antibiotics.
• Chlorine
  A derivative of N-chlorotaurine made by NovaBay Pharmaceuticals mimics an immune system chemical similar to chlorine which damages bacterial proteins. The drug is in trials for treating UTIs. A derivative of N-chlorotaurine made by NovaBay Pharmaceuticals mimics an immune system chemical similar to chlorine which damages bacterial proteins. The drug is in trials for treating UTIs.
• Clay
  At least three different kinds of clay (two found in the U.S. and one found in France) seem to have anti-bacterial effects. Researchers at Arizona State University are looking into whether it can be used in medicine.
• Lasers and Dye
  Zap indocyanine green dye with a laser and it kills the bacterias that cause infections like staph and scarlet fever. Researchers in London the same technique may have applications in sterilizing wounds.
• Viruses
  Bacteriophages are viruses that attack and eat bacteria. Boston University researchers engineered some that penetrate and dissolve the protective walls or biofilsm around antibiotic-resistent 'superbug' colonies.

FDA Zicam Warning
Due to reports of post-viral anosmia associated with the use of three zinc-containing intranasal Bacteriophages are viruses that attack and eat bacteria. Boston University researchers engineered some that penetrate and dissolve the protective walls or biofilsm around antibiotic-resistent 'superbug' colonies.Due to reports of post-viral anosmia associated with the use of three zinc-containing intranasal

• Zicam products, the FDA has warned consumers to stop using the following products:
• Zicam Cold Remedy Nasal Gel
• Zicam Cold Remedy Swabs 
• Zicam Cold Remedy Swabs, Kids Size

• Zicam Cold Remedy RapidMelts with Vitamin C
• Zicam Cold Remedy RapidMelts
• Zicam Cold Remedy Oral Mist
• Zicam Cold Remedy Chewables
• Zicam Cold Remedy ChewCaps
• Zicam Cold Sore Gel Swabs
• Zicam Multisymptom Cold and Flu Liquid-Daytime
• Zicam Multisymptom Cold and Flu Liquid-Nighttime
• Zicam Multisymptom Cold and Flu To Go-Daytime
• Zicam Multisymptom Cold and Flu To Go-Nighttime
• Zicam Cough Max Cough Spray
• Zicam Cough Max Cough Melts
• Zicam Extreme Congestion Relief Nasal Gel
• Zicam Intense Sinus Relief Nasal Gel
• Zicam Healthy Z-ssentials
• Zicam Seasonal Allergy Relief Nasal Gel
• Zicam Seasonal Allergy Relief Gel Swabs  

What Does Your Doctor Look Like Naked?: Your Guide to Optimal Health