Archive for October 15th, 2009

FDA: What the heck is Vitamin C doing in Nyquil?

Link:  http://www.google.com/hostednews/ap/article/ALeqM5icl2hKXPBn_KQtcx1D9d_HjTTR5gD9BB21DO0

FDA warns P&G for adding vitamin C to Nyquil

(AP) –  WASHINGTON — Federal drug regulators are scolding Procter & Gamble for adding Vitamin C to its Vicks cold formulas, a combination not allowed by federal regulations.

The Food and Drug Administration issued a warning to the consumer products company, saying medications like Vicks Nyquil and Dayquil have not been approved to contain vitamin C.

According to the agency, a panel of experts found “no study which demonstrated that vitamin C is unequivocally effective for the prevention or treatment of the common cold.”

P&G advertising for Vicks says the vitamin “can help blunt” the effects of a cold.

The FDA is tasked with verifying marketing claims about drugs.

Calls placed to Cincinnati-based P&G were not immediately returned Wednesday

NJ Hospitals: Oooops!

Report finds 9,400 serious errors at N.J.

hospitals

 
Thursday, October 15, 2009

STATEHOUSE

BY SUSAN K. LIVIO

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, a report released yesterday concludes. …..Collectively, New Jersey’s 72 hospitals committed more mistakes than the national average in how frequently surgical patients developed an infection and how frequently their surgical wounds “split open,” according to the report…..

St. Barnabas Medical Center in Livingston is an example of how one facility could perform exceptionally in some areas and below par in others.

St. Barnabas made more mistakes than the national average in four of the 12 patient safety measures: accidentally puncturing an internal organ, causing injuries to mother and infant during a vaginal delivery, puncturing a lung and failing to prevent blood clots in the lung or large veins….”

Stroke thrombolysis

Link:   http://www.medscape.com/viewarticle/710509_print

October 14, 2009 (Baltimore, Maryland) — A new study using data from the National Inpatient Sample, a nationally representative database, shows that 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%.

“Thrombolysis is administered at profoundly low rates; overall, at the rate of 2% to 3% in the United States across the board,” said lead author Leslie K. Lee, a medical student at Columbia University Medical Center, New York City.

Leslie Lee explaining the poster to another neurologist.

Thrombolytic therapy is the only therapy approved by the US Food and Drug Administration for acute ischemic stroke. When the therapies were developed in the 1990s, the hope was that they would become widely used.

“We’ve clearly fallen short of that goal,” Mr. Lee said. He presented the new findings here at the American Neurological Association’s 134th Annual Meeting in Baltimore, Maryland.

Daunting Task

Providing thrombolytic therapy to patients with acute ischemic stroke is daunting. Clinton Wright, MD, MSc, from the University of Miami, who was not involved in the study noted, “This study underscores the importance of an organized stroke center network within an institution to maximize the use of thrombolytic therapy. [There's] need for further work in this field to identify the barriers to the use of thrombolytics.”

Many hospitals simply do not have the infrastructure and staff to provide thrombolysis as an option, Mr. Lee explained. The major problem probably is the limited time window for the therapy.

The recommendation has been that treatment must be administered within 3 hours of the onset of stroke symptoms, although a recent American Heart Association/American Stroke Association Science Advisory now states that tPA can be safely given out to 4.5 hours in selected patients, based on results of the third European Cooperative Acute Stroke Study.

Such prompt response, though, means the community must have an emergency network that can transport patients to a stroke center quickly. In addition, a hospital must have 24-hour physicians on call who are trained and licensed to provide thrombolytics, as well as 24-hour imaging to detect whether a patient is having a hemorrhagic or an ischemic stroke. The hospital also must have neuro-intensive care backup in case of hemorrhagic conversion of an ischemic stroke.

PSC Certification Is Valid

The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations) in 2004 began certifying hospitals as Primary Stroke Centers (PSCs). In general, slightly more than half of the PSCs were teaching hospitals, 58% were in the western United States, and almost all of them were urban.

The PSCs had to meet a number of criteria, one of which was delivering timely thrombolytic therapy to ischemic stroke patients. Although the Joint Commission has statistics on thrombolysis, no study had assessed the entire swath of both stroke centers and non–stroke centers across the nation.

The researchers used the National Inpatient Sample, the largest inpatient all-payer healthcare database, which comprises one fifth of all the hospitalizations in the United States. The researchers compared treatment rates for 2004 to 2006 at hospitals that were later designated PSCs in early 2009 and then extrapolated to look at ischemic stroke patients over the entire country.

Data showed that 3.0% of patients at stroke centers received thrombolysis, whereas only 1.3% of patients at non–stroke centers received it.

A multivariable logistic regression adjusted for differences in patients and hospitals, and the statistical significance of the difference between PSCs and non–stroke centers persisted. Admission to a present-day PSC almost doubled the odds of receiving thrombolysis (odds ratio, 1.96; 95% confidence interval, 1.61 – 2.38).

As would be expected, intracranial hemorrhage was also higher at PSCs, where 5.7% of patients had a diagnosis of intracranial hemorrhage in the same hospitalization vs 4.8% at non-PSC hospitals.

Mr. Lee added that the study shows that the Joint Commission PSC designation has validity. “It isn’t just a piece of paper. It means that these hospitals are truly able to deliver thrombolysis at significantly higher rates,” he said.

There is more work to be done. This study assessed hospitals, not patient outcome, and the National Inpatient Sample administrative data source provides no patient history, no information on whether thrombolysis was appropriate or timely, and no long term-outcomes.

Mr. Lee noted that in the current climate of healthcare cost concerns, it is important to establish whether this is an appropriate, cost-effective therapy for hospitals to provide, or whether it should be provided only at some hospitals and stroke patients should be routed there.

This work was supported by the Doris Duke Clinical Research Foundation. Mr. Lee and colleagues have disclosed no relevant financial relationships.

American Neurological Association 134th Annual Meeting: Abstract M27. Presented Monday, October 12, 2009.

Hospital sets up ILI triage tents

Link:  http://www.bakersfield.com/news/local/x1675932698/Swine-flu-claims-sixth-life-hospital-sets-up-triage-tents

Bakersfield, CA:  “Kern County has lost a sixth resident to the “swine flu.”

A local hospital has pitched tents to triage the growing number of patients showing up in its emergency department with coughs and fevers.

And local clinics and hospitals are struggling with shortages of vaccines for both the “swine flu” and the regular seasonal flu.

A 25-year-old woman died Tuesday from complications of the H1N1 flu virus, which has put 66 Kern County residents in the hospital this year, said Public Health Services Director Matt Constantine.

The woman’s story is likely to be repeated here as the fall flu season continues.

Over the last week, the emergency room at Memorial Hospital has seen record volumes of patients. Hospital Director of Emergency Services Jennifer Cook said the emergency department is handling between 210 and 230 patients.

That breaks records swine flu recorded in May when the hospital’s previous highest attendance of 180 was shattered by a 207-patient day.

Overwhelmed by the numbers, the hospital on Wednesday moved its triage and treatment functions for flu patients into tents in the doctor’s parking lot.

Patients with mild to moderate flu symptoms are evaluated immediately and treated in the tents, given prescriptions to handle their symptoms and discharged with instructions to go home, stay home, sleep a lot, drink a lot of fluids and stay away from healthy people, Cook said.

The tents, Cook said, keep sick people away from other emergency room patients and relieve the cramped conditions in the emergency room halls and waiting room.

“We needed to cohort the patients who have those flu-type symptoms,” Cook said. “They’re not getting any different care than they would get in the emergency department.”

Seriously ill patients with high fevers and other conditions like pneumonia, who cannot care for themselves, are being admitted to the hospital.

By Wednesday afternoon, Cook said, 30 people had been treated and released through the tents — a total slowed a bit by light rain.

Kern Medical Center has also changed procedures to handle rising worry about the “swine flu.”

Restricted visitation rules to fight the spread of the disease have actually been well-received by patients, said CEO Paul Hensler.

“Our visitors and patients have been surprisingly understanding. I really thought there would be more concern,” Hensler said. “I think they really understand it’s for their protection.”

Public Health has also been swamped with inquiries about the illness.

“We’re getting a number of calls — just a tremendous number – so much so that we’ve had to bring in people to answer phones,” Constantine said.

And the agency distributed all of the 2,000 doses of H1N1 nasal mist vaccine it received last week in a couple well-attended public clinics.

Patients waiting for the clinic on Saturday were lined up in a great loop around the parking lot of the Public Health building.

Hensler still has not received any of the H1N1 vaccine at KMC, but he stockpiled doses of the more traditional seasonal flu vaccine and has been able to weather a recent shortage on the non-H1N1 cure.

The California Department of Public Health said it will have an update Thursday on pandemic influenza and the vaccine delivery status for both seasonal flu and H1N1 flu.

Other health care organizations are dealing with different flu-related complications.

Steve Schilling, CEO of Clinica Sierra Vista, said he received 1,400 doses of the H1N1 nasal mist vaccine. What he’s running short of is the seasonal flu shot…..”

ILI on nation’s campuses up to 19.2 cases/10,000

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.”

Peramivir

Link: http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/oct1509peramivir.html

Oct 15, 2009 (CIDRAP News) – “In response to questions from citizens at a meeting yesterday, a Food and Drug Administration (FDA) official said the agency would make a decision “fairly soon” about permitting emergency use of the experimental antiviral drug peramivir to help patients severely ill with pandemic H1N1 influenza.

The FDA has been reviewing a possible emergency use authorization (EUA) for peramivir, which, like the licensed drugs oseltamivir (Tamiflu) and zanamivir (Relenza), is a neuraminidase inhibitor. Peramivir can be given intravenously (IV) or intramuscularly (IM), whereas oseltamivir is taken orally and zanamivir is inhaled as a powder……..”

Sep 21 BioCryst press release on HHS request for proposal to supply peramivir
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=410328

Sep 21 BioCryst press release on $77 million contract modification
http://investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=410327

OMNI Postings of 10/15/09

A CFO was crossing a road one day when a frog called out to him and said, “If you kiss me, I’ll turn into a beautiful princess.” He bent over, picked up the frog and put it in his pocket. The frog spoke up again and said, “If you kiss me and turn me back into a beautiful princess, I will stay with you for one week.”
The CFO took the frog out of his pocket, smiled at it and returned it to the pocket. The frog then cried out, “If you kiss me and turn me back into a princess, I’ll stay with you and do anything you want.” Again the CFO took the frog out, smiled at it and put it back into his pocket.
Finally, the frog asked, “What is the matter? I’ve told you I’m a beautiful princess that I’ll stay with you for a week and do anything you want. Why won’t you kiss me?” The CFO said, “Look, I’m a glorified bean counter. I don’t have time for a girlfriend — but a talking frog, now that’s cool.”

 

But I digress……

 

Attached is a press release announcing that younger kids will need 2 doses of the H1N1 vaccine.

 

You’re going to need to read this.  It came out just yesterday.  CDC is advising how hospitals should protect themselves.  This includes vaccinations, N95s, traffic flow, etc.   N95s are still advised.

http://omniphysicians.com/2009/10/15/cdc-h1n1-protection-in-hospitals/

 

 

This is a NEJM article telling us to be scared of dietay supplements. They’re about as scary as Nancy Pelosi without her Botox infusion or calling Sarah Palin, “Madame President.”  A wide range of dietary supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Of particular concern are the dozens of dietary supplements that are contaminated with prescription medications, controlled substances, experimental compounds, or drugs rejected by the FDA because of safety concerns. These potentially hazardous ingredients have been detected in products marketed for patients with diabetes, high cholesterol, or insomnia but are most frequently found in products that promise sexual enhancement, optimal athletic performance, and weight loss.

http://omniphysicians.com/2009/10/15/the-danger-of-dietary-supplements/

 

 

 

I’ve got my diseased eye on you!

http://omniphysicians.com/2009/10/15/7054/

 

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Paul R

Psoriasis & H1N1

LINK:  http://www.news-medical.net/news/20091013/Psoriasis-patients-taking-immunosuppressive-drugs-at-increased-risk-of-H1N1-flu-viruses.aspx

Psoriasis patients taking immunosuppressive

drugs at increased risk of H1N1 flu viruses

13. October 2009 05:43

People with psoriasis and/or psoriatic arthritis who are taking biologic or non-biologic immunosuppressive medications should receive the inactived forms of both seasonal influenza and H1N1 (swine flu) vaccines as soon as possible, according to a recommendation from the National Psoriasis Foundation.

The National Psoriasis Foundation’s medical experts recommend that patients taking immunosuppressive medication including biologic (Amevive, Enbrel, Humira, Remicade, Simponi or Stelara) or non-biologic (cyclosporine-Neoral or methotrexate) drugs take the following steps:

  • Get vaccinated early. The same medications that suppress psoriasis make patients more vulnerable to influenza viruses.
  • Receive both vaccines to be protected from seasonal and H1N1 flu viruses.
  • Receive only inactive vaccines. Both vaccines come in inactived and live forms. People taking immunosuppressive medication should only receive the inactivated vaccines.
  • Take more daily health precautions. The Centers for Disease Control (CDC) recommends avoiding close contact with people who are sick, washing hands frequently, and avoiding touching the eyes, nose and mouth.

According to the CDC, the seasonal flu vaccine is available beginning in September and through the winter. The inactivated form of the H1N1 vaccine will be available this fall, though exact dates are not known.

“For most people, flu is an annoying aspect of winter. For people with psoriasis and psoriatic arthritis who are taking immunosuppressive drugs, it can be a much more serious health threat,” said Mark Lebwohl, M.D., professor and chairman of dermatology at the Mount Sinai School of Medicine and chair of the National Psoriasis Foundation Medical Board. “With the addition of swine flu as a concern this year, we urge everyone on these drugs to take extra precaution.”

Lebwohl added that patients should discuss the risk and benefits of vaccination with their doctor.

In most other cases, the National Psoriasis Foundation recommends that patients with psoriasis and/or psoriatic arthritis follow the recommended schedule of immunization for the general population available on the CDC Web site.

SOURCE National Psoriasis Foundation

H1N1 & PE

Chest Radiographic and CT

Findings in Novel Swine-Origin

Influenza A (H1N1) Virus

(S-OIV) Infection

http://www.ajronline.org/aheadofprint/12_09_3599.pdf

 

Intro:  Patients with severe pandemic

H1N1 infections may be at greater risk for

developing pulmonary emboli, according to

an American Journal of Roentgenology

(AJR) study. Researchers compared

imaging studies performed on two groups,

those in the intensive care unit and those

who weren’t severely ill. Of 14 ICU patients

who underwent computed tomography

(CT), they saw pulmonary emboli in 5. The

authors said though most x-rays are

normal, CT can help identify complication

risks.

 

Abstract

 

 

 

 

Objective.

 

 

This article reviews the chest radiographic and CT findings in patients

with presumed/laboratory-confirmed novel swine-origin influenza A (H1N1) virus (S-OIV)

infection.

Materials and Methods.

 

 

Of 222 patients with novel S-OIV (H1N1) infection seen from May 2009 to July 2009, 66 patients (30%) who underwent chest radiographs formed the study population. Group 1 patients (n = 14) required ICU admission and advancedmechanical ventilation, and group 2 (n = 52) did not. The initial radiographs were evaluatedfor the pattern (consolidation, ground-glass, nodules, and reticulation), distribution, and extentof abnormality. Chest CT scans (n = 15) were reviewed for the same findings and for pulmonary embolism (PE) when performed using IV contrast medium.

Results .

 

 

Group 1 patients were predominantly male with a higher mean age (43.5 years versus 22.1 years in group 2; p < 0.001). The initial radiograph was abnormal in 28 of66 (42%) subjects. The predominant radiographic finding was patchy consolidation (14/28;50%) most commonly in the lower (20/28; 71%) and central lung zones (20/28; 71%). Allgroup 1 patients had abnormal initial radiographs; extensive disease involving 3 lung zone was seen in 93% (13/14) versus 9.6% (5/52) in group 2 (p < 0.001). No group 2 patients had > 20% overall lung involvement on initial radiographs compared with 93% of group 1 patients(13/14).

PEs were seen on CT in 5/14 (36%) of group 1 patients.

 

Conc lusion .

Chest radiographs are normal in more than half of patients with S-OIV

(H1N1) and progress to bilateral extensive air-space disease in severely ill patients, who are

at a high risk for PE.

 

 

 

 

 

 

 

Keratoconus & Acute Corneal Hydrops

Link:  http://content.nejm.org/cgi/content/full/361/16/e32?query=TOC

NEJM  Volume 361:e32

Keratoconus Complicated by Acute Corneal Hydrops
 
A 21-year-old woman with a history of myopia presented with the acute onset of foggy vision in her right eye and associated photophobia and mild sensation of the presence of a foreign body. Visual acuity was 20/20 in the unaffected eye and hand-motion vision only in the affected eye. She had a bulging, cloudy cornea (Panel A) and protrusion of the lower eyelid on downward gaze, known as the Munson sign (Panel B). Slit-lamp examination showed edema and opacification of the central cornea (corneal hydrops) (Panel C).Keratoconus is a disorder in which the cornea assumes an irregular conical shape. Acute hydrops is a well-known complication, occurring in approximately 3% of patients with keratoconus. Hydrops occurs after rupture of the posterior cornea leads to an influx of aqueous humor into the cornea, resulting in edema. Corneal edema typically resolves in 6 to 10 weeks; therefore, hydrops is usually not an indication for emergency corneal transplantation. Infectious causes of corneal opacification and visual loss, such as bacterial, viral, or fungal keratitis, must be ruled out as the cause of acute visual loss.

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Dementia Patients: Outcome

Link:  http://content.nejm.org/cgi/content/short/361/16/1529?query=TOC

NEJM  Volume 361:1529-1538

The Clinical Course of Advanced Dementia

Background Dementia is a leading cause of death in the United States but is underrecognized as a terminal illness. The clinical course of nursing home residents with advanced dementia has not been well described.

Methods We followed 323 nursing home residents with advanced dementia and their health care proxies for 18 months in 22 nursing homes. Data were collected to characterize the residents’ survival, clinical complications, symptoms, and treatments and to determine the proxies’ understanding of the residents’ prognosis and the clinical complications expected in patients with advanced dementia.

Results Over a period of 18 months, 54.8% of the residents died. The probability of pneumonia was 41.1%; a febrile episode, 52.6%; and an eating problem, 85.8%. After adjustment for age, sex, and disease duration, the 6-month mortality rate for residents who had pneumonia was 46.7%; a febrile episode, 44.5%; and an eating problem, 38.6%. Distressing symptoms, including dyspnea (46.0%) and pain (39.1%), were common. In the last 3 months of life, 40.7% of residents underwent at least one burdensome intervention (hospitalization, emergency room visit, parenteral therapy, or tube feeding). Residents whose proxies had an understanding of the poor prognosis and clinical complications expected in advanced dementia were much less likely to have burdensome interventions in the last 3 months of life than were residents whose proxies did not have this understanding (adjusted odds ratio, 0.12; 95% confidence interval, 0.04 to 0.37).

Conclusions Pneumonia, febrile episodes, and eating problems are frequent complications in patients with advanced dementia, and these complications are associated with high 6-month mortality rates. Distressing symptoms and burdensome interventions are also common among such patients. Patients with health care proxies who have an understanding of the prognosis and clinical course are likely to receive less aggressive care near the end of life.

 

 

The Danger of Dietary Supplements

Link:  http://healthcarereform.nejm.org/?p=2017&query=TOC

NEJM

American Roulette — Contaminated Dietary Supplements

Posted by NEJM • October 7th, 2009
Pieter A. Cohen, M.D.

In one of the most dangerous cities in the United States, one portly police sergeant has more to worry about than crime. His doctor had been encouraging him for years to lose weight, and like millions of other Americans, he decided to try a weight-loss supplement to help him shed his extra pounds. But instead of losing weight, he lost his job.  According to the label, his diet pills, which were imported from Brazil and sold in the United States, contained vitamin E, centella, senna, and cascara, among other “natural” ingredients. Not included on the label was the amphetamine detected in his urine drug screen. The now-unemployed sergeant is not alone. Such contaminated supplements represent an emerging risk to public health.

In August 2009, the U.S. Food and Drug Administration (FDA) discovered more products, most of them labeled as dietary supplements, that contain a wide variety of undeclared active pharmaceutical ingredients. Now, more than 140 contaminated products have been identified, but these represent only a fraction of the contaminated supplements on the market. Unfortunately, lenient regulatory oversight of dietary supplements, combined with the FDA’s lack of resources, has created a marketplace in which manufacturers can introduce hazardous new products with virtual impunity. Although manufacturers have since 2007 been required to report serious supplement-related adverse events to the FDA, the great majority of the estimated 50,000 adverse events that occur annually remain unreported.

This trend is particularly alarming given that, according to a recent National Health Interview Survey, about 114 million people — more than half the adult population of the United States — consume dietary supplements. These supplements, which include botanical products, vitamins and minerals, amino acids, and tissue extracts, are regulated by the FDA under the 1994 Dietary Supplement Health and Education Act (DSHEA). Before 1994, herbal products were considered food additives, and their manufacturers were required to show proof of safety before marketing them. Since the passage of the DSHEA, dietary supplements are presumed to be safe and can be marketed with very little oversight.

The regulatory environment for dietary supplements is poorly understood by both consumers and physicians. According to a 2002 Harris Poll, the majority of consumers believed that dietary supplements are approved by a government agency, and two thirds thought that the government requires that labels on supplements include warnings about their potential side effects and dangers. Physicians are also misinformed. A recent survey of more than 300 residents in internal medicine from 15 U.S. training programs showed that one third of the respondents believed that dietary supplements require FDA approval, and the majority did not know that adverse events suspected to have been caused by supplements should be reported to the FDA.1

The DSHEA presents serious obstacles to the FDA’s ability to detect and eliminate contaminated supplements. A wide range of dietary supplements have been found to be contaminated with toxic plant material, heavy metals, or bacteria. Of particular concern are the dozens of dietary supplements that are contaminated with prescription medications, controlled substances, experimental compounds, or drugs rejected by the FDA because of safety concerns. These potentially hazardous ingredients have been detected in products marketed for patients with diabetes, high cholesterol, or insomnia but are most frequently found in products that promise sexual enhancement, optimal athletic performance, and weight loss.

Recent events involving dietary supplements marketed for weight loss, which have been consumed by an estimated 15% of U.S. adults, illustrate this growing problem. In July 2009, the FDA expanded its alert to include 75 tainted weight-loss products that contain undeclared medications. Analyses by the FDA have found the stimulant sibutramine in weight-loss supplements at levels amounting to three times the maximum recommended daily dose. Several of the unapproved anorectic ingredients detected in dietary supplements have been linked to serious adverse events: rimonabant to suicide and fenproporex to both addiction and suicide. The inclusion of furosemide and other diuretics in some of these supplements may result in dehydration and hypokalemia; other contaminants, such as benzodiazepines and antidepressants, mask the side effects of stimulants while conferring an increased risk of dependence. Some weight-loss pills, including many from Brazil, combine multiple medications in a single formulation.2

Recently, unscrupulous manufacturers have made it more difficult for the FDA to detect undeclared ingredients by incorporating pharmaceutical analogues into their products. Analogues are created by modifying the original chemical structure of a compound — for example, by adding a hydroxyl group. It is suspected that these analogues are developed to evade detection by the FDA, making the products more difficult to regulate, and to reduce the risk of patent-infringement lawsuits. A recent analysis showed that more than half of 26 supplements marketed for the enhancement of sexual function contained analogues of phosphodiesterase type 5 inhibitors.3 Because these analogues have never been studied in humans, their risks are unknown, but unexpected adverse reactions to analogues have already been documented. Reports from Britain, China, and Japan, for instance, link an analogue of fenfluramine to liver damage, including fulminant hepatic failure necessitating transplantation.4,5

Many contaminated dietary supplements are sold over the Internet, but they have also been found in mainstream retail stores in the United States. Many of the tainted products are manufactured in China, but they have also been produced closer to home. In July 2009, federal agents executed search warrants to investigate allegations that a California-based company, American Cellular Labs, was manufacturing supplements contaminated with anabolic steroids.

Given the potential for dietary supplements to result in side effects and adverse interactions with drugs, physicians should explicitly ask all patients about the use of such supplements. Contaminated supplements expose consumers to additional health risks: common side effects may be misdiagnosed, and drug–drug interactions overlooked. Of even greater concern, it may be impossible to prove that the culpable contaminants are responsible for life-threatening sequelae, leaving future consumers at risk.

Physicians should maintain a high index of suspicion for supplement-induced adverse effects — even when the components on the label are not known to cause the observed effects. When appropriate, physicians should have supplements tested in clinical laboratories to detect unreported substances, and they should always report to the FDA both suspected adverse effects (through MedWatch, www.fda.gov/medwatch/report/hcp.htm) and suspected unlawful Internet sales of medical products (www.fda.gov/oc/buyonline/buyonlineform.htm).

The DSHEA has not ensured that hazardous dietary supplements will be identified or removed from the market in a timely fashion. I believe that Congress should give the FDA the requisite authority and resources to regulate dietary supplements so that the public can make well-informed decisions regarding the potential risks and benefits of consuming such supplements. Until that happens, millions of Americans will continue to be exposed to unacceptable risks in exchange for purported but unproven health benefits.

No potential conflict of interest relevant to this article was reported.

Source Information

From the Cambridge Health Alliance, Somerville, MA; and Harvard Medical School, Boston.

This article (10.1056/NEJMp0904768) was published on October 7, 2009, at NEJM.org.

References

     

  1. Ashar BH, Rice TN, Sisson SD. Physicians’ understanding of the regulation of dietary supplements. Arch Intern Med 2007;167:966-969. [Free Full Text]
  2. Cohen PA. Imported fenproporex-based diet pills from Brazil: a report of two cases. J Gen Intern Med 2009;24:430-433. [CrossRef][Web of Science][Medline]
  3. Poon WT, Lam YH, Lai CK, Chan AY, Mak TW. Analogues of erectile dysfunction drugs: an under-recognised threat. Hong Kong Med J 2007;13:359-363. [Medline]
  4. Adachi M, Saito H, Kobayashi H, et al. Hepatic injury in 12 patients taking the herbal weight loss aids Chaso or Onshido. Ann Intern Med 2003;139:488-492. [Free Full Text]
  5. Lai V, Smith A, Thornburn D, Raman VS. Severe hepatic injury and adulterated Chinese medicines. BMJ 2006;332:304-305. [Free Full Text]

CDC: H1N1 protection in hospitals

Link:  http://www.cdc.gov/h1n1flu/guidelines_infection_control.htm

Interim Guidance on Infection Control Measures for 2009 H1N1 Influenza in Healthcare Settings, Including Protection of Healthcare Personnel

October 14, 2009, 2:00 PM ET

CDC is releasing updated interim guidance on infection control measures to prevent transmission of 2009 H1N1 influenza in healthcare facilities. The updated guidance applies uniquely to the special circumstances of the current 2009 H1N1 pandemic and will be updated as necessary as new information becomes available throughout the course of this influenza season. It provides general guidance for all healthcare facilities. The updated guidance expands on earlier guidance by emphasizing that successfully preventing transmission requires a comprehensive approach, beginning with pandemic planning that includes developing written plans that are flexible and adaptable should changes occur in the severity of illness or other aspects of 2009 H1N1 and seasonal influenza. Revisions from earlier guidance include: criteria for identification of suspected influenza patients; recommended time away from work for healthcare personnel; changes to isolation precautions based on tasks and anticipated exposures; expansion of information on the hierarchy of controls which ranks preventive interventions in the following order of preference: elimination of exposures, engineering controls, administrative controls, and personal protective equipment; and changes to guidance on use of respiratory protection.

Definition of healthcare personnel

For the purposes of this guidance, healthcare personnel are defined as all persons whose occupational activities involve contact with patients or contaminated material in a healthcare, home healthcare, or clinical laboratory setting. Healthcare personnel are engaged in a range of occupations, many of which include patient contact even though they do not involve direct provision of patient care, such as dietary and housekeeping services. This guidance applies to healthcare personnel working in the following settings:  acute care hospitals, nursing homes, skilled nursing facilities, physician’s offices, urgent care centers, outpatient clinics, and home healthcare agencies.  It also includes those working in clinical settings within non-healthcare institutions, such as school nurses or personnel staffing clinics in correctional facilities. The term “healthcare personnel” includes not only employees of the organization or agency, but also contractors, clinicians, volunteers, students, trainees, clergy, and others who may come in contact with patients.

Background

More communities are being affected by 2009 H1N1 influenza in fall/winter 2009-2010 than were in spring/summer 2009. Seasonal influenza viruses may also cause illness this fall and winter, possibly at the same time that 2009 H1N1 virus outbreaks are occurring. Although the severity, amount and timing of illness that 2009 H1N1 influenza and seasonal influenza will cause is uncertain, as with any influenza season, some people will require medical care as a result of their influenza virus infections.  In view of these and other uncertainties, healthcare facilities will need to be ready to adjust their pandemic influenza plans as dictated by changing conditions. Staff in healthcare settings should monitor the CDC http://www.cdc.gov/h1n1flu and state and local health department websites for the latest information.

Symptoms of Influenza and Viral Shedding

The symptoms of influenza, including 2009 H1N1 influenza, can include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills, fatigue, nausea, diarrhea, and vomiting.  Depending on the case series, the proportion of persons who have laboratory confirmed 2009 H1N1 infection and do not have fever can range from about 10 to 50%. Because influenza symptoms are nonspecific, it can be difficult to determine if a person has influenza based on symptoms alone. Nonetheless, decisions for clinical management, particularly for outpatients, in most cases can be made on the basis of clinical and epidemiological information. Information on diagnostic testing for 2009 H1N1 viral infection can be found at http://www.cdc.gov/h1n1flu.

In general, the incubation period for influenza is estimated to range from 1 to 4 days with an average of 2 days.  Influenza virus shedding (the time during which a person might be infectious to another person) begins the day before illness onset and can persist for 5 to 7 days, although some persons may shed virus for longer periods, particularly young children and severely immunocompromised persons. The amount of virus shed is greatest in the first 2-3 days of illness and appears to correlate with fever, with higher amounts of virus shed when temperatures are highest.

Modes of 2009 H1N1 Influenza Transmission

2009 H1N1 influenza virus appears to be transmitted from person to person through close contact in ways similar to other influenza viruses. Although the relative contribution of each mode is uncertain, influenza virus can potentially be transmitted through:

  • Droplet exposure of mucosal surfaces (e.g., nose, mouth, and eyes) by respiratory secretions from coughing or sneezing;
  • Contact, usually of hands, with an infectious patient or fomite (a surface that is contaminated with secretions) followed by self-inoculation of virus onto mucosal surfaces such as those of the nose, mouth, and eyes; and
  • Small particle aerosols in the vicinity of the infectious individual.

Transmission of influenza through the air over longer distances, such as from one patient room to another, is thought not to occur. All respiratory secretions and bodily fluids, including diarrheal stools, of patients with 2009 H1N1 influenza are considered to be potentially infectious.

GENERAL RECOMMENDATIONS

Review Pandemic Plans for the 2009-2010 Fall/Winter Influenza Season

Facilities should review and, if not already in place, develop written pandemic influenza plans anticipating widespread transmission of 2009 H1N1 influenza in communities. CDC, with input from other federal partners, has developed checklists (http://pandemicflu.gov/professional/hospital/External Web Site Icon) to help healthcare facilities in their planning and preparedness for pandemic influenza. OSHA has also developed detailed guidance for healthcare settings (http://www.osha.gov/Publications/OSHA_pandemic_health.pdf Adobe PDF fileExternal Web Site Icon). Links to specific checklists and other planning resources are provided in the Appendix. Facilities should also check with state and local health departments for local guidance. During the planning process, facilities should review their work areas and job tasks to identify workers who will routinely be in close contact with influenza patients so that preventive strategies can be targeted and exposure that is not essential can be limited. Facilities also should consider their own unique circumstances and needs that may not be addressed in guidance documents. Planning committees can facilitate this process. Strong sustained management commitment and active worker participation in a comprehensive, coordinated prevention program are extremely important in promoting implementation of, and adherence to, prevention recommendations.

Use a Hierarchy of Controls to Prevent Influenza Transmission in Healthcare Settings

Facilities should use a hierarchy of controls approach to prevent exposure of healthcare personnel and patients and prevent influenza transmission within healthcare settings. The hierarchy of controls to protect workers from occupational injury or illness places preventive interventions in groups that are ranked according to their likely effectiveness in reducing or removing the source of exposure. To apply the hierarchy of controls to prevention of influenza transmission, facilities should take the following steps, in order of preference:

  1.  
    1. Elimination of potential exposures:  Eliminating the potential source of exposure ranks highest in the hierarchy of controls. Examples of interventions in this category include: taking steps to minimize outpatient visits for patients with mild influenza-like illness who do not have risk factors for complications, postponing elective visits by patients with suspected or confirmed influenza until they are no longer infectious, and denying entry to visitors who are sick.
    2. Engineering controls:  Engineering controls rank second in the hierarchy of controls. They are particularly effective because they reduce or eliminate exposures at the source and many can be implemented without placing primary responsibility of implementation on individual employees. In addition, these controls can protect patients as well as personnel. Examples of engineering controls include installing partitions in triage areas and other public spaces, to reduce exposures by shielding personnel and other patients; and using closed suctioning systems for airways suction in intubated patients.
    3. Administrative controls: Administrative controls are required work practices and policies that prevent exposures. As a group, they rank third in the hierarchy of controls because their effectiveness is dependent on consistent implementation by management and employees. Examples of administrative controls include promoting and providing vaccination; enforcing exclusion of ill healthcare personnel, implementing respiratory hygiene/cough etiquette strategies; and setting up triage stations and separate areas for patients who visit emergency departments with influenza-like illness, managing patient flow, and assigning dedicated staff to minimize the number of healthcare personnel exposed to those with suspected or confirmed influenza.
    4. Personal protective equipment (PPE): PPE ranks lowest in the hierarchy of controls. It is a last line of defense for individuals against hazards that cannot otherwise be eliminated or controlled. While providing personnel with appropriate PPE and education in its use is important, effectiveness of PPE is dependent on a number of factors. PPE is effective only if used throughout potential exposure periods. PPE will not be effective if adherence is incomplete or when exposures to infectious patients or ill co-workers are unrecognized. In addition, PPE must be used and maintained properly, and must function properly, to be effective. 
    • Establish non-punitive policies that encourage or require ill health care personnel workers to stay home. This should include contractors as well as staff.
    • Post signage at entry points instructing patients and visitors about hospital policies, including the need to notify staff immediately if they have signs and symptoms of influenza.
    • Establish mechanisms to identify patients with symptoms of respiratory illness at any point of entry to the facility. Provisions should be made for symptomatic patients to cover their nose and mouth with tissues when coughing or sneezing, or put on facemasks for source control, if tolerated, and for their prompt isolation and assessment. Information on diagnostic testing of patients for 2009 H1N1 influenza infection can be found at http://www.cdc.gov/h1n1flu
    • Establish triage procedures and engineering controls (e.g., partitions) that separate ill and well patients and limit the need for PPE use by staff. 
    • Consider limiting points of entry to the facility.
    • Limiting visitors for patients in isolation for influenza to persons who are necessary for the patient’s emotional well-being and care. Visitors who have been in contact with the patient before and during hospitalization are a possible source of influenza for other patients, visitors, and staff.
    • Scheduling and controlling visits to allow for:  
    •  
      • Screening for symptoms of acute respiratory illness before entering the hospital.
      • Instruction, before entering the patient’s room, on hand hygiene, limiting surfaces touched, and use of PPE according to current facility policy while in the patient’s room. 
      • Visitors should not be present during aerosol-generating procedures.
      • Visitors should be instructed to limit their movement within the facility.
      • When a single patient room is not available, consultation with infection control personnel is recommended to assess the risks associated with other patient placement options (e.g., cohorting, keeping the patient with an existing roommate). (See http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Isolation2007.pdf Adobe PDF file for additional information on cohorting, including other factors that may affect cohorting decisions.)
      • Communicating information about patients with suspected, probable or confirmed influenza to appropriate personnel before transferring them to other departments in the facility (e.g., radiology, laboratory) and to other facilities.
      • Limiting patient transport and movement of patients outside of the room to medically necessary purposes and minimizing waiting times and delays associated with transport and procedures conducted outside the patient’s room.
      • Providing influenza patients with facemasks to wear for source control, as tolerated, and tissues to contain secretions when outside of their room.
      • Encouraging patients who are able to perform hand hygiene to do so frequently and to follow respiratory hygiene and cough etiquette practices.
      • Providing portable x-ray equipment in cohort areas to reduce the need for patient transport.
      • Healthcare personnel entering the room of a patient in isolation should be limited to those truly necessary for performing patient care activities.
      • Standard Precautions – For all patient care, use nonsterile gloves for any contact with potentially infectious material, followed by hand hygiene immediately after glove removal; use gowns along with eye protection for any activity that might generate splashes of respiratory secretions or other infectious material. (See http://www.cdc.gov/ncidod/dhqp/gl_isolation_standard.html.)
      • Healthcare personnel should perform hand hygiene frequently, including before and after all patient contact, contact with respiratory secretions, and before putting on and upon removal of PPE. Soap and water or alcohol-based hand sanitizers should be used. (See http://www.cdc.gov/Handhygiene/.)
      • Bronchoscopy
      • Sputum induction
      • Endotracheal intubation and extubation
      • Open suctioning of airways
      • Cardiopulmonary resuscitation
      • Autopsies
      • Only perform these procedures on patients with suspected or confirmed influenza if they are medically necessary and cannot be postponed.
      • Limit the number of healthcare personnel present during the procedure to only those essential for patient care and support.
      • Conduct the procedures in an airborne infection isolation room (AIIR) when feasible.  Such rooms are designed to reduce the concentration of infectious aerosols and prevent their escape into adjacent areas using controlled air exchanges and directional airflow. They are single patient rooms at negative pressure relative to the surrounding areas, and with a minimum of 6 air changes per hour (12 air changes per hour are recommended for new construction or renovation). Air from these rooms should be exhausted directly to the outside or be filtered through a high efficiency particulate air (HEPA) filter before recirculation. Room doors should be kept closed except when entering or leaving the room, and entry and exit should be minimized during and shortly after the procedure. Facilities should monitor and document the proper negative-pressure function of these rooms. (See: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm.)
      • Portable HEPA filtration units may be used to further reduce the concentration of contaminants in the air. Some of these units can connect to local exhaust ventilation systems (e.g. hoods, booths, tents) or have inlet designs that allow close placement to the patient in order to assist with source control; however, these units do not eliminate the need for respiratory protection for individuals entering the room because they may not entrain all of the room air. Information on air flow/air entrainment performance should be evaluated for such devices.
      • Healthcare personnel should adhere to standard precautions http://www.cdc.gov/ncidod/dhqp/gl_isolation_standard.html, and wear respiratory protection equivalent to a fitted N95 filtering facepiece respirator or higher level of protection during aerosol-generating procedures.
      • Unprotected healthcare personnel should not be allowed in a room where an aerosol-generating procedure has been conducted until sufficient time has elapsed to remove potentially infectious particles. (For more information on clearance rates under differing ventilation conditions, please see http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5417a1.htm?s_cid=rr5417a1_e#tab1. This table assumes perfect mixing. For example, based on the table, an AIIR with 6 air changes per hour and perfect room mixing will require 46 minutes to reduce the concentration of airborne particles by 99%.  For a more realistic assumption of good mixing, the clearance times provided in this table should be multiplied by a mixing factor of 3. Thus, for an AIIR with 6 air changes per hour and normal room mixing, over two hours will be required to reduce the concentration of airborne particles by 99%). Environmental surface cleaning also is necessary to ensure that environmental contamination does not lead to infection transmission.
      • Difficulty breathing or shortness of breath
      • Pain or pressure in the chest or abdomen
      • Sudden dizziness
      • Confusion
      • Severe or persistent vomiting
      • Flu-like symptoms improve but then return with fever and worse cough
      • Instructed not to report to work, or if at work, to promptly notify their supervisor and infection control personnel/occupational health.
      • Excluded from work for at least 24 hours after they no longer have a fever, without the use of fever-reducing medicines.
      • If returning to work in areas where severely immunocompromised patients are provided care, considered for temporary reassignment or exclusion from work for 7 days from symptom onset or until the resolution of symptoms, whichever is longer. Clinical judgment should be used for personnel with only cough as a symptom, since cough after influenza infection may be prolonged and may not be an indicator of viral shedding. Healthcare personnel recovering from a respiratory illness may return to work with immunocompromised patients sooner if absence of 2009 H1N1 viral RNA in respiratory secretions is documented by real-time reverse transcriptase-polymerase chain reaction (rRT-PCR). Additional information on diagnostic testing for 2009 H1N1 influenza infection can be found at http://www.cdc.gov/h1n1flu
      • Reminded of the importance of practicing frequent hand hygiene (especially before and after each patient contact) and respiratory hygiene and cough etiquette after returning to work following an acute respiratory illness.
      • Allowed to continue or return to work unless assigned in areas where severely immunocompromised patients are provided care. In this case they should be considered for temporary reassignment or exclusion from work for 7 days from symptom onset or until the resolution of symptoms, whichever is longer. Clinical judgment should be used for personnel with only cough as a symptom, since cough after influenza infection may be prolonged and may not be an indicator of viral shedding. Healthcare personnel recovering from a respiratory illness may return to work with immunocompromised patients sooner if absence of 2009 H1N1 viral RNA in respiratory secretions is documented by rRT-PCR. Additional information on diagnostic testing for 2009 H1N1 influenza infection can be found at http://www.cdc.gov/h1n1flu
      • Reminded of the importance of practicing frequent hand hygiene (especially before and after each patient contact) and respiratory hygiene and cough etiquette after returning to work following an acute respiratory illness.
      • Ensure that sick leave policies for healthcare personnel (e.g., staff and contract personnel) are flexible and consistent with public health guidance and that employees are aware of the policies. (See http://www.cdc.gov/h1n1flu/business/guidance/.)
      • Ensure that sick employees are able to stay home without fear of losing their jobs.
      • Consider offering alternative work environments as an accommodation for employees at higher risk for complications of 2009 H1N1 influenza during periods of increased influenza activity or if influenza severity increases.
      • Not require a doctor’s note for workers with influenza to validate their illness or return to work.
    • Establish policies and procedures for patient placement and transport
      Any patient with respiratory illness consistent with influenza should promptly be asked to wear a facemask for source control, if tolerated, or cover their nose and mouth with tissues when coughing or sneezing, and placed directly in an individual room with the door kept closed, where medically appropriate. The precautions required for entry into patient rooms should be posted on the door. Once placed in rooms, patients with suspected or confirmed 2009 H1N1 influenza should be encouraged to practice respiratory hygiene and cough etiquette when they are coughing or sneezing throughout their duration of stay.

      Follow current facility procedures for transport and movement of patients under isolation precautions, including:

      Limit the number of healthcare personnel entering the isolation room

      Apply isolation precautions
      The following isolation precautions are recommended for healthcare personnel who are in close contact with patients with suspected or confirmed 2009 H1N1 influenza. For the purposes of this document, close contact is defined as working within 6 feet of the patient or entering into a small enclosed airspace shared with the patient (e.g., average patient room):

      Respiratory Protection
      Recommendation: CDC continues to recommend the use of respiratory protection that is at least as protective as a fit-tested disposable N95 respirator for healthcare personnel who are in close contact with patients with suspected or confirmed 2009 H1N1 influenza. This recommendation applies uniquely to the special circumstances of the current 2009 H1N1 pandemic during the fall and winter of 2009-2010 and CDC will continue to revisit its guidance as new information becomes available, within this season if necessary  

      Basis: The current recommendation is based on the unique conditions associated with the current pandemic, including low levels of population immunity to 2009 H1N1 influenza, availability of vaccination programs well after the start of the pandemic, susceptibility to infection of those in the age range of healthcare personnel, increased risk for complications of influenza in some healthcare personnel (e.g., pregnant women), and the potential for healthcare personnel to be exposed to 2009 H1N1 influenza patients because of their occupation.

      Supply considerations: CDC recognizes that some facilities are currently experiencing shortages of respiratory protection equipment and that further shortages are anticipated. Although the exact total supply in the public and private sectors is not known, a large gap between supply and demand is predicted. In the face of shortages, appropriate selection and use of respiratory protection is critical. A key strategy is to use source control, engineering, and administrative measures to reduce the numbers of workers who come in contact with patients who have influenza-like illness in order to reduce the consumption of respiratory protection equipment. For example, combining the use of triage procedures and use of partitions or other engineering controls might reduce exposures and the need for PPE.  Other strategies could include taking steps to either reduce consumption of disposable N95 filtering facepiece respirators or extend their use.  Some facilities that are experienced in their use may also be able to use alternative PPE for certain applications including more protective filtering facepiece respirators, reusable elastomeric tight-fitting respirators, and reusable powered air-purifying respirators (PAPRs).  For facilities that are able to use alternatives such as elastomeric respirators or PAPRs, processes must be in place to ensure that they are used properly and are reliably decontaminated. Additional information about these strategies, including frequently asked questions, are posted on the CDC 2009 H1N1 website (see http://www.cdc.gov/h1n1flu).

      Special care should be taken to ensure that respirators are available for situations where respiratory protection is most important, such as performance of aerosol-generating procedures on patients with suspected or confirmed 2009 H1N1 influenza or provision of care to patients with other infections for which respiratory protection is strongly indicated (e.g., tuberculosis).   

      Prioritized respirator use: Where a shortage of respirators exists despite reasonable efforts to obtain and maintain a sufficient supply for anticipated needs, in particular for very high exposure risk situations such as some aerosol-generating procedures (listed below), a facility should consider shifting to a prioritized respirator use mode. In this mode, respirator use is prioritized to ensure availability for healthcare personnel at most risk from 2009 H1N1 influenza exposure. Even under conditions of prioritized use, personnel attending aerosol-generating procedures on patients with suspected or confirmed 2009 H1N1 influenza should always use respiratory protection at least as protective as fitted N95 respirators. An example of prioritization for personnel not attending aerosol-generating procedures is shown in Table 2. Prioritization should be adapted to local conditions and should consider intensity and duration of exposure, personal health risk factors for complications of infection, and vaccination status. When in prioritized respirator use mode, respirator use may be temporarily discontinued for employees at lower risk of exposure to 2009 H1N1 influenza or lower risk of complicated infection. Gathering of personal information for the purposes of pandemic planning and response must be done in a fashion that is compliant with all applicable rules and regulations, including the Americans with Disabilities Act (ADA): http://www.eeoc.gov/facts/pandemic_flu.htmlExternal Web Site Icon. Contingency crisis planning is critical to efficient implementation of prioritized use during supply shortages. In making decisions about prioritization, facilities should consider needs for managing patients with diseases other than influenza that require respiratory protection (e.g. tuberculosis) and also considerations related to the timetable for obtaining more respirators. To assure that respirators are likely to be available for the most important uses, facilities should maintain a reserve sufficient to meet the estimated needs for performing aerosol-generating procedures and for managing patients with diseases other than influenza that require respiratory protection until supplies are expected to be replenished. 

      Facemasks for healthcare personnel who are not provided a respirator due to the implementation of prioritized respirator use: If a facility is in prioritized respirator use mode and unable to provide respirators to healthcare personnel who provide care to suspected and confirmed 2009 H1N1 influenza cases, the facility should provide those personnel with facemasks. Facemasks that have been cleared for marketing by the U.S. Food and Drug Administration have been tested for their ability to resist blood and body fluids, and generally provide a physical barrier to droplets that are expelled directly at the user. Although they do not filter small particles from the air and they allow leakage around the mask, they are a barrier to splashes, droplet sprays, and autoinoculation of influenza virus from the hands to the nose and mouth. Thus, they should be chosen over no protection. Routine chemoprophylaxis is not recommended for personnel wearing facemasks during the care of patients with suspected or confirmed 2009 H1N1 influenza.

      Hand Hygiene

      Aerosol-generating procedures
      Some procedures performed on patients are more likely to generate higher concentrations of respiratory aerosols than coughing, sneezing, talking, or breathing, presenting healthcare personnel with an increased risk of exposure to infectious agents present in the aerosol. Although there are limited objective data available on disease transmission related to such aerosols, many authorities view the following procedures as being very high exposure risk aerosol-generating procedures for which special precautions should be used:

      Although some have suggested that administration of nebulized medications (due to risk of inducing cough), acquisition of nasopharyngeal swabs/samples, and use of high-flow oxygen might create infectious aerosols of concern, less is known about the magnitude or potential for exposure.
      A combination of measures should be used to reduce exposures from high-risk aerosol-generating procedures, including:

      Duration of Isolation Precautions for Patients

      The recommended duration of isolation precautions for hospitalized patients is longer than that recommended for other populations because duration of virus shedding is likely to be longer than for outpatients with milder illness.  Isolation precautions for patients who have influenza symptoms should be continued for the 7 days after illness onset or until 24 hours after the resolution of fever and respiratory symptoms, whichever is longer, while a patient is in a healthcare facility. Shedding of influenza viruses generally diminishes over the course of 7 days, with transmission apparently correlating with fever. Given this, if isolation resources (e.g. private rooms) become limited, these resources should be prioritized for patients who are earlier in the course of illness. Clinical judgment may be used for patients with only cough as a symptom, since cough after influenza infection may be prolonged and may not be an indicator of viral shedding.  Because some patients with influenza may not have fever but may be shedding influenza virus, patients with any respiratory symptoms should follow hand and respiratory hygiene recommendations, and healthcare personnel working with such patients should continue to follow standard precautions. Patients should be discharged from medical care when clinically appropriate, not based on the period of isolation.

      In some cases, facilities may choose to continue isolation precautions for longer periods such as in the case of young children or severely immunocompromised patients, who may shed influenza virus for longer periods of time and who might be shedding antiviral resistant virus. Clinical judgment should be used to determine the need for continued isolation precautions for such patients. Communications regarding the patient’s diagnosis with post hospital care providers (e.g. Home-healthcare agencies, long-term care facilities) as well as transporting agencies is essential.

      Monitor and Manage Ill Healthcare Personnel

      Employee health services should establish procedures for tracking absences; reviewing job tasks and identifying personnel at higher risk for complications; assuring that employees have access via telephone to medical consultation and, if necessary, early treatment; and promptly identifying individuals with possible influenza. Healthcare personnel should self-assess for symptoms of febrile respiratory illness. An active approach in which personnel are asked daily about symptoms of febrile respiratory illness is also recommended. In most cases, decisions about work restrictions and assignments for personnel with respiratory illness should be guided by clinical signs and symptoms rather than by laboratory testing for influenza. Personnel should be provided with information about risk factors for complications of influenza, so those at higher risk know to promptly seek medical attention and be evaluated for early treatment if they develop symptoms of influenza. All personnel should be provided with specific instructions to follow in the event of respiratory illness with rapid progression, particularly when experiencing shortness of breath. (See: http://www.cdc.gov/h1n1flu/sick.htm.) Anyone with the following emergency warning signs needs urgent medical attention and should seek medical care promptly:

      Healthcare personnel who develop a fever and respiratory symptoms should be:

      Healthcare personnel who develop acute respiratory symptoms without fever should be:

      Facilities and organizations providing healthcare services should: 

      Antiviral Treatment and Chemoprophylaxis of Healthcare Personnel

      Please refer to the CDC web site for the most current recommendations on the use of antiviral agents for treatment and chemoprophylaxis: http://www.cdc.gov/h1n1flu/recommendations.htm. All healthcare personnel concerned about symptoms of influenza should seek advice from their medical provider promptly.

      Training and education of healthcare personnel

      All healthcare personnel should receive training on influenza prevention and risks for complications of influenza. The training should include information on risk assessment; isolation precautions; vaccination protocols; use of engineering and administrative controls and personal protective equipment; protection during high-risk aerosol-generating procedures; signs, symptoms, and complications of influenza; and to promptly seek medical attention for any concerns about symptoms of influenza.

      Healthcare Personnel at Higher Risk for Complications of Influenza

      Personnel at higher risk for complications from influenza infection include pregnant women, persons 65 years old and older, and persons with chronic diseases such as asthma, heart disease, diabetes, diseases that suppress the immune system, and certain other chronic medical conditions. (See http://www.cdc.gov/h1n1flu/recommendations.htm for a more comprehensive list.) Vaccination and early treatment with antiviral medications are very important for healthcare personnel at higher risk for influenza complications because they can prevent hospitalizations and deaths. Healthcare personnel at higher risk for complications should check with their healthcare provider if they become ill so that they can receive early treatment.

      Environmental Infection Control

      Routine cleaning and disinfection strategies used during influenza seasons can be applied to the environmental management of 2009 H1N1 influenza.  Management of laundry, utensils and medical waste should also be performed in accordance with procedures followed for seasonal influenza.   More information can be found at: http://www.cdc.gov/ncidod/dhqp/gl_environinfection.html.

      Table 1. Examples of Use of a
      Hierarchy of Controls to Prevent Influenza Transmission
      Elimination of sources of infection Postponing elective visits and procedures for patients with suspected or confirmed influenza until they are no longer infectious
      Denying healthcare facility entry to those wishing to visit patients if the visitors have suspected or confirmed influenza
      Minimizing outpatient and emergency department visits for patients with mild influenza-like illness who do not have risk factors for complications
      Keeping personnel at home while they are ill to reduce the risk of spreading influenza
         
      Engineering controls Installing partitions (e.g., transparent panels/windows/desk enclosures) in triage areas as physical barriers to shield staff from respiratory droplets
      Using local exhaust ventilation (e.g., hoods, tents, or booths) for aerosol-generating procedures
      Using hoods for the performance of laboratory manipulations that generate infectious aerosols
      Using ventilation controls in ambulances
      Installing hands-free soap and water dispensers, and receptacles for garbage and linens to minimize environmental contact
      Conducting aerosol-generating procedures in an airborne infection isolation room (AIIR) to prevent the spread of aerosols to other parts of the facility
      Using closed suctioning systems for airways suction in intubated patients
      Using high efficiency particulate filters on mechanical and bag ventilators
      Ensuring effective general ventilation and thorough environmental surface hygiene
         
      Administrative controls Vaccinating as much of the healthcare workforce as possible (once vaccine is available)
      Identifying and isolating patients with known or suspected influenza infections
      Implementing respiratory hygiene/cough etiquette programs
      Setting up triage stations, managing patient flow, and assigning dedicated staff to minimize the number of healthcare personnel exposed to those with suspected or confirmed influenza.
      Screening personnel and visitors for signs and symptoms of infection at clinic or hospital entrances or badging stations and responding appropriately if they are present
      Adhering to appropriate isolation precautions
      Limiting the number of persons present in patient rooms and during aerosol-generating procedures
      Arranging seating to allow 6 feet between chairs or between families when possible
      Ensuring compliance with hand hygiene, respiratory hygiene, and cough etiquette
      Making tissues, facemasks, and hand sanitizer available in waiting areas and other locations
      Establishing protocols for cleaning of frequently touched surfaces throughout the facility (elevator buttons, work surfaces, etc.)
      Locating signage in appropriate language and at the appropriate reading level in areas to alert staff and visitors of the need for specific precautions
      Placing facemasks on patients, when tolerated, at facility access points (e.g., emergency rooms) or when patients are outside their rooms (e.g. diagnostic testing).
      Placing facemasks on patients during transport; when tolerated; limiting transport to that which is medically necessary; and minimizing delays and waiting times during transport
         
      Personal protective equipment Wearing appropriate gloves, gowns, facemasks, respirators, eye protection, and other PPE

       

      Table 2. Prioritization of Respiratory Protection During Respirator Shortages for Healthcare Personnel Not Participating in Aerosol-Generating Proceduresa (Numbers 1 through 4 indicate relative priorities for respiratory protection, with 1 the highest priority and 4 the lowest priority)
      Exposure Scenario Not Vaccinatedb Vaccinatedc
      Personnel Without Risk Factors for Influenza-Related Complicationsd    
      Routine care – frequent close exposuree 2 4
      Routine care – infrequent close exposuref 3 4
           
      Personnel With Risk Factors for Influenza-Related Complicationsg    
      Routine care – frequent close exposure 1 3
      Routine care – infrequent close exposure 2 4
      a – This table is provided as an example of prioritization that considers intensity and duration of exposure, personal health risk factors for complications of infection, and vaccination status. Advance planning is critical to efficient implementation of prioritized use during supply shortages.
      b – Not vaccinated: not vaccinated or less than 14 days after vaccination. Consider including those with immunosuppressive conditions or treatment with immunosuppressive therapies anticipated to impair vaccine response in this group.
      c – Vaccinated: 14 or more days after vaccination.
      d – See section on “Healthcare Personnel at Higher Risk for Complications of Influenza” for list of personal risk factors for influenza-related complications; also see: http://www.cdc.gov/h1n1flu/recommendations.htm.
      e – Personnel frequently in close contact with patients with suspected or confirmed 2009 H1N1 influenza. For the purposes of this document, close contact is defined as working within 6 feet of the patient or entering into a small enclosed airspace shared with the patient (e.g., average patient room). This generally includes personnel working in settings where cases of suspected or confirmed 2009 H1N1 influenza are routinely seen (e.g. emergency departments and primary care in environments such as clinics in outpatient settings, employee healthcare facilities, and correctional facilities).
      f – Personnel infrequently in close contact with patients with suspected or confirmed 2009 H1N1 influenza. This generally includes personnel working in settings where cases of suspected or confirmed 2009 H1N1 influenza are not routinely seen and/or having job duties not involving close contact.

      g– Gathering of personal information for the purposes of pandemic planning and response must be done in a fashion that is compliant with all applicable rules and regulations, including the Americans with Disabilities Act (ADA).  A short technical assistance document is available at the following web address: http://www.eeoc.gov/facts/h1n1_flu.html. External Web Site IconConsider offering alternative work environments as an accommodation for employees at highest risk for complications of influenza during periods of increased influenza activity or if influenza severity increases.

       

      Appendix: Additional Information for Specific Healthcare Settings

      Additional information is available online to assist in customizing guidance to specific healthcare settings.  CDC, together with other agencies, is actively producing new and updated documents.  Many of these can readily be accessed via the following web pages:

      Information can also be obtained via the CDC-INFO National Contact Center, where representatives are available at all times to answer questions in English and Spanish:
      Call:               1-800-CDC-INFO         1-800-CDC-INFO (              1-800-232-4636         1-800-232-4636)
      TTY: (888) 232-6348,
      Email: cdcinfo@cdc.gov

      Hospitals

      Hospital Pandemic Influenza Planning Checklist: http://www.pandemicflu.gov/plan/healthcare/hospitalchecklist.htmlExternal Web Site Icon 

      Pandemic Influenza Preparedness and Response Guidance for Healthcare Workers and Healthcare EmployersExternal Web Site Icon. OSHA Publication 3328-05, (2007). Also available as a 405 KB PDF Adobe PDF fileExternal Web Site Icon, 104 pages.  https://www.osha.gov/Publications/3328-05-2007-English.htmlExternal Web Site Icon

      Frequently Asked Questions on Pandemic Influenza Preparedness and Response Guidance for Healthcare Workers and Healthcare Employers
      https://www.osha.gov/SLTC/pandemicinfluenza/pandemic_health.htmlExternal Web Site Icon

      Emergency Medical Services
      Emergency Medical Services and Non-Emergent (Medical) Transport Organizations Pandemic Influenza Planning Checklist: http://www.pandemicflu.gov/plan/healthcare/emgncymedical.htmlExternal Web Site Icon 

      Interim Guidance for Emergency Medical Services (EMS) Systems and 9-1-1 Public Safety Answering Points (PSAPs) for Management of Patients with Confirmed or Suspected Swine-Origin Influenza A (H1N1) Infection: http://www.cdc.gov/h1n1flu/guidance_ems.htm 

      Interim Guidance for Cleaning Emergency Medical Service (EMS) Transport Vehicles during an Influenza Pandemic: http://www.pandemicflu.gov/plan/healthcare/cleaning_ems.htmlExternal Web Site Icon 

      Managing Calls and Call Centers during a Large-Scale Influenza Outbreak: Implementation Tool: http://www.cdc.gov/h1n1flu/callcenters.htm 

      Medical Offices and Clinics
      Medical Offices and Clinics Pandemic Influenza Planning Checklist: http://www.pandemicflu.gov/plan/healthcare/medical.htmlExternal Web Site Icon 

      10 Steps You Can Take: Actions for Novel H1N1 Influenza Planning and Response for Medical Offices and Outpatient Facilities: http://www.cdc.gov/h1n1flu/10steps.htm 

      Obstetric Settings
      Considerations Regarding Novel H1N1 Flu Virus in Obstetric Settings: http://www.cdc.gov/h1n1flu/guidance/obstetric.htm 

      Outpatient Hemodialysis Settings
      Interim Additional Guidance for Infection Control for Care of Patients with Confirmed, Probable, or Suspected Novel Influenza A (H1N1) Virus Infection in Outpatient Hemodialysis Settings: http://www.cdc.gov/h1n1flu/guidance/hemodialysis_centers.htm

      Long-Term Care and Other Residential Services
      Long-Term Care and Other Residential Facilities Pandemic Influenza Planning Checklist: http://www.pandemicflu.gov/plan/healthcare/longtermcarechecklist.htmlExternal Web Site Icon 

      Home Health Care
      Home Health Care Services Checklist: http://www.pandemicflu.gov/plan/healthcare/healthcare.htmlExternal Web Site Icon 

      Home Care Guidance: Physician Directions to Patient/Parent: http://www.cdc.gov/h1n1flu/guidance_homecare_directions.htm 

      Home Health Care During an Influenza Pandemic: Issues and Resources: http://www.pandemicflu.gov/plan/healthcare/homehealth.htmlExternal Web Site Icon

      Pathology / Clinical Laboratory
      Post-mortem Care and Safe Autopsy Procedures for Novel H1N1 Influenza: http://www.cdc.gov/h1n1flu/post_mortem.htm

      Interim Biosafety Guidance for All Individuals handling Clinical Specimens or Isolates containing 2009-H1N1 Influenza A Virus (Novel H1N1), including Vaccine Strains: http://www.cdc.gov/h1n1flu/guidelines_labworkers.htm

      Educational Institutions
      School Planning web page (provides links to numerous resources): http://pandemicflu.gov/plan/school/index.htmlExternal Web Site Icon

      Correctional Institutions
      Correctional Facilities Pandemic Influenza Planning Checklist: http://www.pandemicflu.gov/plan/workplaceplanning/correctionchecklist.htmlExternal Web Site Icon

      Interim Guidance for Correctional and Detention Facilities on Novel Influenza A (H1N1) Virus: http://www.cdc.gov/h1n1flu/guidance/correctional_facilities.htm 

       

       

  2. Careful attention to elimination of potential exposures, engineering controls, and administrative controls will reduce the need to rely on PPE, including respirators. This is an especially important consideration during the current year, when shortages of respirators have already been reported by many healthcare facilities.

    It should be recognized that individual interventions may have a level of importance different from that suggested by their classification within the hierarchy of controls. For example, vaccination is an administrative control that depends upon the actions of both management and employees. However, vaccination is one of the most important interventions for preventing transmission of influenza to healthcare personnel. Its ability to prevent influenza transmission in both work and community settings is especially important, because influenza is a community-based infection that is transmitted in household and community settings. Other interventions that work in healthcare settings alone will not prevent such transmission.

    Examples of preventive interventions that can be used to prevent or reduce influenza infections, grouped according to the hierarchy of controls, are provided in Table 1.

    SPECIFIC RECOMMENDATIONS

    Promote and administer the 2009 H1N1 influenza and seasonal influenza vaccines

    Healthcare and emergency medical services personnel are among the priority groups recommended to receive the 2009 H1N1 influenza vaccine. (See http://www.cdc.gov/h1n1flu/vaccination/acip.htm.)  To improve adherence, vaccination should be offered to healthcare personnel free of charge and during working hours. Vaccination campaigns with incentives such as lotteries with prizes should be considered. Healthcare facilities should require personnel who refuse vaccination to complete a declination form. The Veterans Health Administration Influenza Manual is a useful source of information on best practices and strategies for increasing immunization rates. (See http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1978External Web Site Icon.)

    It is not anticipated that the seasonal influenza vaccine will provide protection against the 2009 H1N1 influenza virus. However, it is anticipated that seasonal influenza viruses will also be present in the U.S. during the 2009-2010 influenza season.  Influenza vaccination is effective against these seasonal viruses and should continue to be provided to healthcare personnel and given to unvaccinated patients. (See http://www.cdc.gov/flu/professionals/acip/.)

    Enforce respiratory hygiene and cough etiquette
    In addition to limiting numbers of ill people in the facility (e.g., by access control), respiratory hygiene and cough etiquette infection control measures (See http://www.cdc.gov/flu/professionals/infectioncontrol/resphygiene.htm) should be incorporated into infection control practices as part of Standard Precautions to prevent the transmission of all respiratory infections including 2009 H1N1 influenza.  This form of source control should be implemented by everyone in healthcare settings – patients, visitors, and staff alike. Respiratory hygiene and cough etiquette procedures should continue to be followed for the entire duration of stay.

    Establish facility access control measures and triage procedures

    Manage visitor access and movement within the facility
    Establish procedures for managing visitors to include: