A guy runs into a bar and says, “Bartender, quick! Give me 20 shots of your best Scotch!”

So the bartender lines up 20 shots of his best Scotch and watches this guy down one after the other.

“Man,” the bartender says, “I’ve never seen anyone drink shots that fast!”
“You’d drink them that fast too if you have what I have,” the guy says.

“Oh my God,” says the bartender, “what do you have?”

“50 cents.”

But I digress……

2008-2009 Influenza Season Week 38 ending September 26, 2009

All data are preliminary and may change as more reports are received.

Flu Synopsis from CDC:

During week 38 (September 20-26, 2009), influenza activity remained elevated in the U.S

• 2,126 (22.8%) specimens tested by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.
• 99% of all subtyped influenza A viruses being reported to CDC were 2009 influenza A (H1N1) viruses.
• The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.
• Eleven influenza-associated pediatric deaths were reported and all eleven were associated with 2009 influenza A (H1N1) virus infection.
• The proportion of outpatient visits for influenza-like illness (ILI) was above the national baseline. Regions 2 through 10 reported ILI above region-specific baseline levels; only Region 1 was below its region-specific baseline.
• Twenty-seven states reported geographically widespread influenza activity, Guam and 18 states reported regional influenza activity, two states, the District of Columbia, and Puerto Rico reported local influenza activity, one state reported sporadic influenza activity, and the U.S. Virgin Islands and two states did not report.
• The 2009-10 influenza season officially begins October 4, 2009.

Beginning next week, heparin shipped to hospitals and pharmacies will be about 10% less potent than that currently available, a change that is likely to have clinical implications when the drug is administered as a bolus IV dose, the FDA said yesterday.

http://omniphysicians.com/2009/10/02/heparin-reduced-potency-by-10/

This will take you to the complete JAMA study which concludes that N95s don’t do a helluva lot more than surgical masks in preventing the flu.

http://omniphysicians.com/2009/10/02/surgical-mask-vs-n95/

Meanwhile, an NEJM article says N95 and only N95.

http://omniphysicians.com/2009/09/30/respiratory-protection-h1n1/

Here’s a chart showing the H1N1 hit rate in US colleges.  It’s down 19% nationwide but it’s up in OH (13%) and big time in MI(53%).

http://omniphysicians.com/2009/10/02/number-of-flu-like-illnesses-at-colleges-dropped-19-from-the-previous-week/

In the meantime, attached is a CDC report on the live H1N1 vacine which coming into your neighorhood next week.

Paul R.

Link:  http://www.medpagetoday.com/ProductAlert/Prescriptions/16253

MedPage, 10/1/09

Beginning next week, heparin shipped to hospitals and pharmacies will be about 10% less potent than that currently available, a change that is likely to have clinical implications when the drug is administered as a bolus IV dose, the FDA said today.

The loss in potency is the result of new manufacturing controls — including a new reference standard for the drug’s unit dose — adopted by United States Pharmacopeia (USP), a nonprofit standards-setting organization.

The FDA has known for months that the reference standards for heparin would change, but learned only three weeks ago that the change would reduce potency, said John K. Jenkins, MD, director of the office of new drugs, at the FDA’s Center for Drug Evaluation and Research.

The difference in potency, which is estimated at about 10% per labeled unit, is unlikely to affect subcutaneous administration because there is a wide range of bioavailability when heparin is administered by that route, he said.

Jenkins said the new standard has been in the works since 2007, when contamination of heparin resulted in hundreds of severe allergic reactions and deaths as well as widespread recalls and shortages.

When USP circulated the new drug monograph for comment during the spring and summer, “there was little concern about clinical significance,” but as manufacturers began making heparin using the new standard, one of the companies discovered the difference in potency and informed the FDA, Jenkins said.

The FDA then contacted other manufacturers and confirmed that the reduced potency was observed by all drugmakers using the new reference standard.

At that point, the FDA contacted USP to determine if the rollout of the new standard could be delayed until in vitro and in vivo testing could confirm the exact potency range.

But by then, it was too late. The four makers of heparin — APP, Hospira, Baxter, and B. Braun — had all retooled their manufacturing processes to make the drug based on the new standard, which takes effect today.

The best that the FDA could manage was an agreement to delay shipment of the new heparin until Oct. 8, Jenkins said.

To differentiate “new” from “old” heparin once supplies hit the shelves, the four manufacturers have agreed to special labeling on the new product.

Three companies — APP, the largest manufacturer, which markets heparin in vials; Baxter, which sells the drug in IV bags; and B. Braun, which also markets heparin in IV bags — have all agreed to add the letter “N” next to the lot number or expiration date on labels of “new” heparin.

The fourth manufacturer — Hospira which markets heparin in intravenous bags, vials, and syringes — said it will identify the new heparin with a unique numbering system.

Meanwhile, the FDA is cooperating with the companies to conduct both in vitro and in vivo testing to determine the exact extent of the potency difference. The in vitro tests should be completed in a few weeks, but “animal tests will take longer,” said Jenkins. He estimated the in vivo results would be available in less than two months.

But even with those test results, the FDA may not require changes in heparin labeling because dosing of the drug has always been a matter of “individual monitoring of patients” to determine the anticoagulant effect.

Regardless of potency, Jenkins said, heparin should continue to be dosed based on results of patient monitoring.

The Sacramento Bee (10/1, Hubert) reported that Sacramento EDs “have become overwhelmed with mentally ill patients…and the problem is about to get worse.” The “budget-strapped county plans to shutter the” 50 bed-crisis unit at Mental Health Treatment Center, which handles the “most severe psychiatric patients in the county,” the majority of whom are uninsured.

That means they will “likely…end up in hospital emergency departments, which are ill-equipped to properly treat them.” Already-long ED waiting times “are likely to increase, and overburdened staff members will be pushed to the limit,” according to Dr. Doug Kirk of UC Davis Medical Center. “Further cuts and closures by the treatment center, he predicted, will be catastrophic, with countless mentally ill people getting inadequate or no treatment and landing in jail or on the streets.”

The Dallas Morning News (10/1, Jacobson) reported, “Doctors’ offices and emergency [departments] across the Dallas area have been inundated this week with sick patients complaining of flu-like symptoms.” However, the H1N1 virus “has seemed to target the young and not the old.” This “lopsided outbreak is sending pediatricians scrambling, filling up the emergency [departments] at pediatric hospitals and draining many pharmacies of child-size doses of anti-viral medication.”

According to the Morning News, “more than 70 percent of the confirmed swine flu cases in Dallas County have been in people under 25 years old.”

Link to full text:  http://jama.ama-assn.org/cgi/content/full/2009.1466

Surgical Mask vs N95 Respirator for Preventing Influenza Among Health Care Workers

A Randomized Trial

Mark Loeb, MD, MSc; Nancy Dafoe, RN; James Mahony, PhD; Michael John, MD; Alicia Sarabia, MD; Verne Glavin, MD; Richard Webby, PhD; Marek Smieja, MD; David J. D. Earn, PhD; Sylvia Chong, BSc; Ashley Webb, BS; Stephen D. Walter, PhD

JAMA. 2009;302(17):(doi:10.1001/jama.2009.1466).

ABSTRACT

Context  Data about the effectiveness of the surgical mask compared with the N95 respirator for protecting health care workers against influenza are sparse. Given the likelihood that N95 respirators will be in short supply during a pandemic and not available in many countries, knowing the effectiveness of the surgical mask is of public health importance.

Objective  To compare the surgical mask with the N95 respirator in protecting health care workers against influenza.

Design, Setting, and Participants  Noninferiority randomized controlled trial of 446 nurses in emergency departments, medical units, and pediatric units in 8 tertiary care Ontario hospitals.

Intervention  Assignment to either a fit-tested N95 respirator or a surgical mask when providing care to patients with febrile respiratory illness during the 2008-2009 influenza season.

Main Outcome Measures  The primary outcome was laboratory-confirmed influenza measured by polymerase chain reaction or a 4-fold rise in hemagglutinin titers. Effectiveness of the surgical mask was assessed as noninferiority of the surgical mask compared with the N95 respirator. The criterion for noninferiority was met if the lower limit of the 95% confidence interval (CI) for the reduction in incidence (N95 respirator minus surgical group) was greater than –9%.

Results  Between September 23, 2008, and December 8, 2008, 478 nurses were assessed for eligibility and 446 nurses were enrolled and randomly assigned the intervention; 225 were allocated to receive surgical masks and 221 to N95 respirators. Influenza infection occurred in 50 nurses (23.6%) in the surgical mask group and in 48 (22.9%) in the N95 respirator group (absolute risk difference, –0.73%; 95% CI, –8.8% to 7.3%; P = .86), the lower confidence limit being inside the noninferiority limit of –9%.

Conclusion  Among nurses in Ontario tertiary care hospitals, use of a surgical mask compared with an N95 respirator resulted in noninferior rates of laboratory-confirmed influenza.

Trial Registration  clinicaltrials.gov Identifier: NCT00756574

Link:  http://www.reuters.com/article/topNews/idUSTRE59055420091001

Reuters, 10/1/09

Fifteen states could run out of hospital beds and 12 more could fill 75 percent of their beds with swine flu sufferers if 35 percent of Americans catch the virus in coming weeks, a report released Thursday said.

The study, based on estimates from a computer model developed by the U.S. Centers for Disease Control and Prevention, shows the strain hospitals and health departments could face as a second wave of swine flu surges.

“Our point in doing this is not to cry Chicken Little but really to point out the potential even a mild pandemic can have and how readily that can overwhelm the healthcare delivery system,” Jeffrey Levi, director of Trust for America’s Health, which sponsored the report, said in a telephone briefing.

According to the report, the number of people hospitalized could range from 168,025 in California to 2,485 in Wyoming, and many states may face shortages of beds.

Some may need to cut back on hospitalizations for elective procedures.

“States around the country will also have to figure out how to manage the influx of people in doctors’ offices and ambulatory care settings, in addition to the surge in hospitalizations,” Levi said.

He said state and local health departments are scrambling to set up distribution systems for the H1N1 vaccine as it becomes available this month, but challenges remained.

“These systems are untested, and glitches are sure to arise along the way,” Levi said.

Local health authorities are especially worried about reaching young people, who traditionally are not vaccinated for flu, and minorities, who were harder hit by the swine flu in the spring.

While the federal government will pay for the vaccine itself, Levi said, it was not yet clear how the actual cost of giving the shot will be financed.

Although many public and private insurance plans have said they will cover it, others have not yet agreed.

“This could become a huge burden for state and local health departments, or become a dangerous disincentive for people to get a vaccine,” he said.

The 35 percent attack rate used in the report is based on the 1968 flu pandemic, which was considered mild. It assumes an outbreak would last around eight weeks.

Levi said the number was consistent with World Health Organization statements predicting that up to a third of the world’s population will become sick with the new H1N1 virus that was declared a pandemic in June.

The President’s Council of Advisors on Science and Technology said in August that 1,8 million Americans may need to be hospitalized and around 30,000 could die, assuming a 30 percent infection rate.

LinK:  http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm184770.htm

Information for Healthcare Professionals – Authorization of Use of

Expired Tamiflu for Oral Suspension

[10-02-2009]
FDA is authorizing the use of certain lots of expired Tamiflu for Oral Suspension as part of the federal government’s response to the 2009 H1N1 Influenza public health emergency.

In July 2009, FDA authorized 4 lots of Tamiflu for Oral Suspension for use beyond their labeled expiration dates. FDA is now authorizing additional lots in an effort to ensure that Tamiflu for Oral Suspension is available for patients during this public health emergency. The lots of Tamiflu for Oral Suspension that are being authorized are part of the Strategic National Stockpile and have been tested through the federal government’s Shelf-Life Extension Program (SLEP).

Under SLEP, FDA conducts scientific testing and analysis to determine if certain drugs are acceptable for use beyond their expiration date. During testing, FDA comprehensively evaluates each lot to assure the quality and stability of the product. Through the SLEP testing process, FDA has determined that data support the use of these lots of Tamiflu for Oral Suspension beyond their expiration dates.

The lots of Tamiflu for Oral Suspension now authorized by FDA for use beyond their expiration dates are not required to be relabeled with information about the use of the products beyond their expiration dates. Therefore, healthcare professionals and patients might receive Tamiflu for Oral Suspension that is beyond its expiration date. In addition, fact sheets for both patients and healthcare professionals will be made available by public health officials. These fact sheets will contain information about the authorized use of these products beyond their expiration dates.

These decisions to authorize the use of certain lots of Tamiflu for Oral Suspension beyond their expiration dates are based on rigorous scientific testing and analysis. Healthcare professionals may wish to discuss this information with patients to inform them that the medication they have been given is authorized for use based on scientific testing and analysis.

Considerations for Healthcare Professionals:

• Be aware that specific lots of Tamiflu for Oral Suspension have been authorized for use beyond their expiration dates
• Understand that FDA has determined that data support the use of certain lots of Tamiflu for Oral Suspension beyond their expiration dates
• Consider discussing this information with patients to help them understand this information and address any concerns they may have about these products
• For any Tamiflu that is beyond its expiration date, you may verify if it has been authorized for use through the following website: http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm
• Consider discussing with patients, families, and caregivers the benefits of taking antiviral medications in relation to the potential risks of untreated illness

Information for Patients, Families, and Caregivers:

• FDA has determined that certain lots of Tamiflu for Oral Suspension are authorized for use beyond their expiration dates based on scientific testing and analysis
• Discuss any concerns you have about using Tamiflu for Oral Suspension with your healthcare professional
• Make sure to follow all directions given by your healthcare professional when using Tamiflu for Oral Suspension
• If you want to look up the lot number for your Tamiflu to see if it is authorized for use beyond its expiration date, go to http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm154962.htm and look for your lot number in the table under “Tamiflu Lots Whose Expiration Date Has Been Extended”

CIDRAP News, 10/2/09:  “The number of flu-like illnesses at colleges dropped 19% from the previous week, according to a report for the week ending Sep 25 from the American College Health Association (ACHA). The report showed 6,527 new cases at 248 schools. Though the report doesn’t include flu subtype, federal authorities have said about 99% of circulating strains are pandemic H1N1. Colleges in New England and some western states reported increases, but other parts of the country saw cases decline.”

Link:  http://www.acha.org/ILI_LatestWeek.cfm#chart_state

Source:   CDC (http://www.cdc.gov/flu/weekly/?date=100209)

“Nationwide during week 38, 4.2% of patient visits reported through the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) were due to influenza-like illness (ILI). This percentage is above the national baseline of 2.4%.”

CDC:   “Laboratory-confirmed influenza-associated hospitalizations are monitored through the Emerging Infections Program (EIP), a population-based surveillance network.

During April 15, 2009 – September 26, 2009, the following preliminary laboratory-confirmed overall influenza associated hospitalization rates were reported by the EIP (rates include influenza A, influenza B, and 2009 influenza A (H1N1)):

Rates for children aged 0-23 months, 2-4 years, and 5-17 years were 3.3, 1.4, and 1.1 per 10,000, respectively. Rates for adults aged 18-49 years, 50-64 years, and ≥ 65 years, the overall flu rates were 0.7, 0.8, and 0.7 per 10,000, respectively.”

Source:  CDC (http://www.cdc.gov/flu/weekly/?date=100209)

Source:  CDC (http://www.cdc.gov/flu/weekly/?date=100209)

2008-2009 Influenza Season Week 38 ending September 26, 2009

All data are preliminary and may change as more reports are received.

Synopsis:

During week 38 (September 20-26, 2009), influenza activity remained elevated in the U.S

• 2,126 (22.8%) specimens tested by U.S. World Health Organization (WHO) and National Respiratory and Enteric Virus Surveillance System (NREVSS) collaborating laboratories and reported to CDC/Influenza Division were positive for influenza.
• 99% of all subtyped influenza A viruses being reported to CDC were 2009 influenza A (H1N1) viruses.
• The proportion of deaths attributed to pneumonia and influenza (P&I) was below the epidemic threshold.
• Eleven influenza-associated pediatric deaths were reported and all eleven were associated with 2009 influenza A (H1N1) virus infection.
• The proportion of outpatient visits for influenza-like illness (ILI) was above the national baseline. Regions 2 through 10 reported ILI above region-specific baseline levels; only Region 1 was below its region-specific baseline.
• Twenty-seven states reported geographically widespread influenza activity, Guam and 18 states reported regional influenza activity, two states, the District of Columbia, and Puerto Rico reported local influenza activity, one state reported sporadic influenza activity, and the U.S. Virgin Islands and two states did not report.
• The 2009-10 influenza season officially begins October 4, 2009.