Link:  http://www.columbusdispatch.com/live/content/local_news/stories/2009/10/15/crowds.html?sid=101

Columbus Dispatch, 9/16/09

The doctors and nurses at Nationwide Children’s Hospital have never seen anything like it.

They used to think a busy day was 450 kids showing up in the emergency department and the on-campus urgent-care center.

These days, they’re seeing 600, more than half with flu symptoms. Those numbers, seen on many days since late September, are unprecedented, said Jack Clark, the senior vice president at Children’s who oversees the emergency department and urgent cares.

“I remember a week and a half ago saying we’d had our busiest day ever and then the next two days there were even more,” he said.

As for the off-site urgent-care centers the hospital operates, “All are cookin’. They’re all busier than ever.”

The hospital expedites care for the sickest kids, but those with mild illness might wait three hours or more at busy times. Patients and caregivers are wearing masks to reduce disease spread.

The hordes of sick children prompted the hospital to add emergency space in an unused area, Clark said. That added 15 exam rooms to the 45 normally available.

The hospital has asked for help from staff members who don’t normally work in the emergency department. Administrators are meeting regularly to prepare for other ways to boost capacity, including converting hallways into triage areas.

If matters get worse, the hospital can turn other patient-care areas into flu-treatment areas, Clark said.

All of the urgent cares operated by the hospital are seeing a lot more patients than normal.

Pediatric hospitals seem to be hardest hit so far by the flu pandemic, but many emergency departments at adult-care hospitals also are finding themselves unusually busy.

Not everyone needs to rush to the hospital with flu symptoms, experts have cautioned. Most people will recover fine at home with plenty of sleep and fluids or can be seen by their primary-care physician.

The Centers for Disease Control and Prevention says these signs should prompt a parent to take a child to the hospital: fast breathing or trouble breathing; bluish skin color; not drinking enough fluids; not waking up or interacting; a child so irritable that he or she does not want to be held; flulike symptoms improve then return with fever and a worse cough; fever with a rash.

Of the emergency patients seen lately, about 8 percent to 10 percent have been hospitalized. On a typical day, that percentage is closer to 12, Clark said.

Dr. Mark Moseley, an emergency-medicine physician at Ohio State University Medical Center, said they were seeing record numbers even before the flu hit, but the increase isn’t nearly what Children’s has experienced.

Several other hospitals in Columbus are seeing an increase in emergency-department visits, but none has reported having to pull in staff members from other areas or add additional emergency space.

Source:  Source reference:
Prymula R, et al “Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomized controlled trials” Lancet 2009; 374: 1339-50.

BackgroundAlthough fever is part of the normal inflammatory process after immunisation, prophylactic antipyretic drugs are sometimes recommended to allay concerns of high fever and febrile convulsion. We assessed the effect of prophylactic administration of paracetamol at vaccination on infant febrile reaction rates and vaccine responses.

MethodsIn two consecutive (primary and booster) randomised, controlled, open-label vaccination studies, 459 healthy infants were enrolled from ten centres in the Czech Republic. Infants were randomly assigned with a computer-generated randomisation list to receive three prophylactic paracetamol doses every 6—8 h in the first 24 h (n=226) or no prophylactic paracetamol (n=233) after each vaccination with a ten-valent pneumococcal non-typeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) co-administered with the hexavalent diphtheria-tetanus-3-component acellular pertussis-hepatitis B-inactivated poliovirus types 1, 2, and 3-H influenzae type b (DTPa-HBV-IPV/Hib) and oral human rotavirus vaccines. The primary objective in both studies was the reduction in febrile reactions of 38·0°C or greater in the total vaccinated cohort. The second objective was assessment of immunogenicity in the according-to-protocol cohort. These studies are registered with ClinicalTrials.gov, numbers NCT00370318 and NCT00496015.

FindingsFever greater than 39·5°C was uncommon in both groups (after primary: one of 226 participants [<1%] in prophylactic paracetamol group vs three of 233 [1%] in no prophylactic paracetamol group; after booster: three of 178 [2%] vs two of 172 [1%]). The percentage of children with temperature of 38°C or greater after at least one dose was significantly lower in the prophylactic paracetamol group (94/226 [42%] after primary vaccination and 64/178 [36%] after booster vaccination) than in the no prophylactic paracetamol group (154/233 [66%] after primary vaccination and 100/172 [58%] after booster vaccination). Antibody geometric mean concentrations (GMCs) were significantly lower in the prophylactic paracetamol group than in the no prophylactic paracetamol group after primary vaccination for all ten pneumococcal vaccine serotypes, protein D, antipolyribosyl-ribitol phosphate, antidiphtheria, antitetanus, and antipertactin. After boosting, lower antibody GMCs persisted in the prophylactic paracetamol group for antitetanus, protein D, and all pneumococcal serotypes apart from 19F.

InterpretationAlthough febrile reactions significantly decreased, prophylactic administration of antipyretic drugs at the time of vaccination should not be routinely recommended since antibody responses to several vaccine antigens were reduced.

Dexferrum (iron dextran injection) – Labeling change

Audience: Hematological healthcare professionals, hospital risk managers

American Regent and FDA notified healthcare professionals that anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. The Boxed Warning has been modified to recommend administering a test dose prior to the first therapeutic dose and observing for signs or symptoms of anaphylactic-type reactions during administration of Dexferrum. Fatal reactions have followed the test dose of iron dextran injection, even in situations where the test dose was tolerated. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions. It is recommended that resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions be readily available during Dexferrum administration.

Read the complete MedWatch 2009 Safety summary, including links to the Dear Healthcare professional letter and the revised prescribing information, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm186899.htm

Infection Control Measures for 2009 H1N1 Influenza

Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in
Healthcare Settings, Including Protection of Healthcare Personnel
http://www.cdc.gov/h1n1flu/guidance/ill-hcp.htm

Questions and Answers Regarding Respiratory Protection for Infection Control
Measures for 2009 H1N1 Influenza among Healthcare Personnel
http://www.cdc.gov/h1n1flu/guidance/ill-hcp_qa.htm

Questions and Answers about CDC’s Interim Guidance on Infection Control Measures
for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of
Healthcare Personnel
http://www.cdc.gov/H1N1flu/guidance/control_measures_qa.htm

2009 H1N1 Influenza Vaccine

2009 H1N1 Influenza Vaccine Supply Status
http://www.cdc.gov/h1n1flu/vaccination/vaccinesupply.htm

Question and Answers: Allocation and Distribution
http://www.cdc.gov/H1N1flu/vaccination/statelocal/centralized_distribution_qa.htm

Questions and Answers: 2009 H1N1 Influenza Vaccine
http://www.cdc.gov/h1n1flu/vaccination/public/vaccination_qa_pub.htm

Link:  http://cityroom.blogs.nytimes.com/2009/10/16/judge-halts-mandatory-flu-vaccines-for-health-care-workers/

NY Times, 10/16/09:  

A judge on Friday morning halted enforcement of a New York State directive requiring that all health care workers be vaccinated for the seasonal flu and swine flu.

The temporary restraining order by the judge, Thomas J. McNamara, an acting justice of the State Supreme Court in Albany, comes amid a growing debate about the flu vaccine. On Friday afternoon, the State Department of Health vowed to fight the restraining order, saying that the authorities “have clear legal authority” to require vaccinations, and noted that state courts had upheld mandatory vaccinations of health care workers against rubella and tuberculosis. Justice McNamara scheduled a hearing for Oct. 30 on the three cases before him, involving the flu vaccine.

The state health commissioner, Dr. Richard F. Daines, through the State Hospital Review and Planning Council, issued a regulation on Aug. 13 ordering health care workers to be vaccinated by Nov. 30 or face fines.

Dr. Daines later explained the reasoning behind the vaccine, saying in a statement on Sept. 24:

Questions about safety and claims of personal preference are understandable. Given the outstanding efficacy and safety record of approved influenza vaccines, our overriding concern then, as health care workers, should be the interests of our patients, not our own sensibilities about mandates. On this, the facts are very clear: the welfare of patients is, without any doubt, best served by the very high rates of staff immunity that can only be achieved with mandatory influenza vaccination – not the 40-50 percent rates of staff immunization historically achieved with even the most vigorous of voluntary programs. Under voluntary standards, institutional outbreaks occur every flu season. Medical literature convincingly demonstrates that high levels of staff immunity confer protection on those patients who cannot be or have not been effectively vaccinated themselves, while also allowing the institution to remain more fully staffed.

Terence L. Kindlon, a lawyer for three nurses who sued the state, asserting that the order violated their civil rights, said the judge’s ruling was a victory. New York was the only state in the country to mandate vaccinations for health care workers, he said.

The nurses — Lorna Patterson, Kathryn Dupuis and Stephanie Goertz — work in the emergency room at Albany Medical Center, a regional trauma unit.

“These are not libertarians, they are not lefties, they are not right-wing lunatics,” Mr. Kindlon said of his clients in a phone interview on Friday. “They are health care professionals, and they think the vaccination is not going to be good for them. They have no confidence that either the seasonal flu vaccine or H1N1 vaccine is going to do any good for them.”

Justice McNamara consolidated the nurses’ suit with two other lawsuits, brought by the New York State Public Employees Federation and the New York State United Teachers Union, which also challenged the regulation.

Mr. Kindlon said of his clients: “They basically were being administratively ambushed. This regulation came out of the Health Department during the dog days of August. People weren’t aware of it until September. Then they were suddenly advised that the drop-dead rate for receiving the vaccination from the state was Nov. 30.”

The hospital imposed its own deadline — mid-October — for vaccinations for its employees, Mr. Kindlon said.

The state is all but certain to fight the lawsuits and seek enforcement of the mandate. At a legislative hearing on Tuesday, Dr. Guthrie Birkhead, a state deputy health commissioner, defended the mandate, saying, “Health care settings are no different than any other setting where vaccination is the most effective method of preventing influenza.”

In a statement on Friday afternoon, the State Department of Health noted that Justice McNamara’s order was only temporary. Officials said in a statement:

In two weeks the Department is scheduled to be in court, where we will vigorously defend this lawsuit on its merits. We are confident that the regulation will be upheld. The Commissioner of Health and the State Hospital Review and Planning Council have clear legal authority to promulgate the mandatory regulation. As one court said in a 1990 ruling rejecting a challenge to regulations requiring mandatory rubella vaccinations and annual tuberculosis testing for health care workers: “Hospitals . . . exist for the benefit of their patients. They exist to cure the sick. The Legislature of this State has charged the Commissioner of Health with the responsibility of making hospitals safe places to get well. These regulations are tailored to accomplish that end.”

The issue of mandatory vaccinations has divided health care workers and even experts.

The Public Employees Federation, which has about 5,000 members covered by the regulations, said it encouraged its members to be vaccinated against the flu but opposed making the vaccine a condition of employment.

The New York State Nurses Association has taken a similar position. The association “supports immunization as an effective way to reduce the risk of contracting the flu, but upholds the right of registered professional nurses to choose whether or not they wish to be vaccinated,” officials said in a statement, adding, “The association believes effective patient protection is achieved through an aggressive voluntary vaccination program, coupled with a comprehensive infection prevention plan that includes education, proper hygiene practices, and the appropriate use of personal protective equipment.”

Patricia Finn, a lawyer for Suzanne Field, a nurse from Poughkeepsie, N.Y., who has filed a lawsuit in State Supreme Court in Manhattan challenging the mandatory vaccinations, said on Friday that her case would proceed despite the Albany restraining order, but added about the temporary restraining order:

We’re absolutely thrilled about it. I’m very pleased that the whole process has been slowed down. That’s what we’re so concerned about, the process of vaccinating. It’s not like getting your teeth cleaned; it’s pretty serious. It shouldn’t be taken lightly. So we were happy about this.

Link:  http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm187003.htm

FDA NEWS RELEASE

For Immediate Release: Oct. 16, 2009

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Approves New Indication for Gardasil to Prevent Genital Warts in Men and Boys

The U.S. Food and Drug Administration today approved use of the vaccine Gardasil for the prevention of genital warts (condyloma acuminata) due to human papillomavirus (HPV) types 6 and 11 in boys and men, ages 9 through 26.

Each year, about 2 out of every 1,000 men in the United States are newly diagnosed with genital warts.

Gardasil currently is approved for use in girls and women ages 9 through 26 for the prevention of cervical, vulvar and vaginal cancer caused by HPV types 16 and 18; precancerous lesions caused by types 6, 11, 16, and 18; and genital warts caused by types 6 and 11.

HPV is the most common sexually transmitted infection in the United States and most genital warts are caused by HPV infection.

“This vaccine is the first preventive therapy against genital warts in boys and men ages 9 through 26, and, as a result, fewer men will need to undergo treatment for genital warts,” said Karen Midthun, M.D., acting director of the FDA’s Center for Biologics Evaluation and Research.

Gardasil’s effectiveness was studied in a randomized trial of 4,055 males ages 16 through 26 years old. The results showed that in men who were not infected by HPV types 6 and 11 at the start of the study, Gardasil was nearly 90 percent effective in preventing genital warts caused by infection with HPV types 6 and 11.

Studies were conducted to measure the immune response to the vaccine in boys ages 9 through 15. The results showed that the immune response was as good as that found in the 16 through 26 years age group, indicating that the vaccine should have similar effectiveness.

The manufacturer will conduct postmarketing studies to obtain additional information on the safety and effectiveness of Gardasil in boys and men.

Gardasil is given as three injections over a 6-month period. Headache, fever and pain at the injection site, itching, redness, swelling and bruising, were the most common side effects observed.

Gardasil is manufactured by Merck and Company Inc. of Whitehouse Station, N.J.

Gardasil product information:
www.fda.gov/cber/products/gardasil.htm

Q: How many doctors does it take to change a light bulb?
A: Twenty: one primary care physican to change it and 19 specialists to take it apart and look at it under a microscope.

But I digress…….

There has been a slight bump in the number of flu cases across our colleges.  Check out this table to see what’s happening where your kids go.  In OH the attack rate is up 26% and 69% in MI.

http://omniphysicians.com/2009/10/16/flu-like-illnesses-on-campuses-last-week-19-2-per-10000-students/

See what happens when the drug company adds Vitamin C to  Nyquil without permission.

http://omniphysicians.com/2009/10/15/fda-what-the-heck-is-vitamin-c-doing-in-nyquil/

You don’t want to get sick in NJ.  According to a report, “Hospital physicians, nurses and other medical workers committed nearly 9,400 “serious medical errors” in 2007 that led to patients developing infections, blood clots and other conditions that threatened their health….”

http://omniphysicians.com/2009/10/15/nj-hospitals-oooops/

This news story indicates that thrombolysis for a CVA is rarer than a love letter to Hillary Clinton.  Although thrombolytic therapy with recombinant tissue plasminogen activator (r-tPA) is used more often at primary stroke centers, only about 3% of ischemic stroke patients were treated at these centers between 2004 and 2006. At hospitals not designated stroke centers, the number was even lower, at 1.3%.

http://omniphysicians.com/2009/10/15/stroke-thrombolysis/

Paul R

According to CIDRAP, 10/15/09:  “The American College Health Association (ACHA) reports that the incidence of flu-like illnesses on member campuses last week was 19.2 per 10,000 students, an increase of about 2% from the 18.9 per 10,000 the week before. The report listed 5,959 new cases at 238 schools. By region, the most new cases were reported in the middle Atlantic states and the Southeast.”