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Nov. 4. 2009 – Many of the nation’s healthcare facilities have already taken practical steps to handle the escalating number of patients with H1N1 and seasonal flu. Others are considering innovative or more drastic approaches to reduce the potential strain on staff and resources.
How does your flu preparation compare with what other facilities are doing? Take a look at these ideas from around the country to assess your readiness, gain inspiration and shore up areas that could use additional help. (For a quick checklist, see 10 Ways to Prepare for Flu Season)
Start at the top of the list by implementing simple steps, such as creating and posting multilingual signs that inform visitors to notify staff if they have flu-like symptoms. The Centers for Disease Control and Prevention (CDC) has free, printable formats of Cover Your Cough posters in numerous languages for healthcare settings.
Stockpiling extra gloves and surgical masks is another straightforward step. The CDC’s updated H1N1 infection control guidance for healthcare settings recommends that all workers use N-95 respirators—a specific type of face mask that helps to prevent the spread of flu viruses—even though availability may be an issue. Some states, such as California, have made it mandatory.
Another idea comes from Sharp Mary Birch Hospital in San Diego, Calif., which is now using nurses as flu shot “roamers” to distribute vaccinations to employees. Roamers travel throughout the hospital with a vaccination cart; once an announcement has been made over a loudspeaker, employees wishing to receive the H1N1 shot come to the front desk and are quickly inoculated with little disruption to their work.
Roamers are just one way to make the vaccines more accessible to staff. The H1N1 vaccination programs for healthcare workers are generally voluntary and free, but some employers may make it mandatory for safety reasons. The American Nurses Association would only support a mandatory policy if employers followed specific guidelines to ensure that the policy is fair, equitable and not a condition of employment. The American Society of Health-System Pharmacists’ web site, www.YouCanStopTheFlu.com, uses pharmacist advocates to improve flu immunization rates among their fellow healthcare workers.
In addition to stocking up on supplies and immunizing staff, healthcare providers are finding a number of ways to manage capacity and care for patients who have the flu.
A small number of hospitals are experimenting with a drive-through triage area and overflow tents to relieve overcrowding in the emergency department (ED). In June, Stanford Hospital and Clinics in Palo Alto, Calif., conducted the first drive-through triage-and-care system, surge-capacity drill that allowed people with flu symptoms to remain in their cars while healthcare providers treated them through open windows. These patients were kept away from others and had their length of stay cut by 1.5 hours compared to a typical ED visit. This model is quickly gaining acceptance with other hospitals and can be implemented within a day.
The Trust for America’s Health report, H1N1 Challenges Ahead, determined that 15 states could run out of available hospital beds and 12 could exceed 75 percent of their bed capacity, if 35 percent of Americans contract the H1N1 flu virus. Consequently, healthcare facilities are considering ways to manage patient flow to free up hospital beds, possibly by reducing the number of non-flu related discretionary hospitalizations.
In Oklahoma, state health officials plan to cancel elective surgeries, release stable patients, or move patients to other hospitals in the state, if necessary, to free up bed space. They predict that as many as 17,000 Oklahomans with the H1N1 virus could end up in a hospital, filling 57 percent of the state’s hospital beds.
Florida and Utah are considering even more drastic measures to free up beds, such as barring patients with incurable cancer, end-stage multiple sclerosis, or a physician-signed “Do Not Resuscitate” order from being admitted to hospitals flooded with flu cases. Currently, guidelines are being drafted by Florida’s health department to determine who would receive treatment based on clinical scoring systems used to predict survival. In August, Utah conducted a surge-capacity drill to test this plan against realty, unveiling many difficulties that may arise.
“All hospitals have contingency plans for providing extra beds," stated Dale Carrison, DO, FACEP, chairman of the department of emergency medicine at the University of Nevada School of Medicine, in an article for the Las Vegas Review-Journal. "But where do we get the caregivers to care for people? That’s the limiting factor in this community."
One way that hospitals are looking to manage medical personnel shortages is by adding more temporary, part-time or on-call staff. Between hospital employees who get sick and are unable to work and the surge in patients with H1N1 and seasonal flu, healthcare facilities are facing a double whammy. Many are turning to staffing companies like AMN Healthcare to inquire about travel nurses and other temporary clinicians.
Some hospitals, like Sharp Chula Vista Medical Center in San Diego, have also used nursing students from local nursing schools to help with flu vaccinations, as “the number of people wanting the vaccine is growing larger than the number of nurse managers available to give it,” according to Sherri Fitzgerald RN, BSN, MSN, MBA, director of acute care and inservice/education.
Finally, some hospitals are taking advantage of the $90 million in Hospital Preparedness grants offered by the U.S. Department of Health and Human Services to enable their facilities to prepare for and respond to outbreaks of the H1N1 virus in local communities. Through it all, American Hospital Association President and CEO Rich Umbdenstock reports in an AHA press release that “hospitals are doing a thorough job of preparing for and handling H1N1 outbreaks in their communities.”
10 Ways to Prepare for Flu Season
1. Post multilingual signs about the flu
2. Stock up on protective devices and other supplies
3. Assign a flu shot nurse “roamer”
4. Offer free vaccines to staff
5. Restrict visitor access
6. Set up a drive-through triage area or tents for ED overflow
7. Practice surge-capacity drills
8. Manage patient flow to free up hospital beds
9. Add more temporary or on-call staff
10. Utilize hospital preparedness grant money
This week two influential healthcare institutions, the California Nurses Association/National Nurses Organizing Committee and Catholic Healthcare West in San Francisco, reached an agreement that averted a nursing strike scheduled for October 30 in the short term, and could set the pace for H1N1 protection throughout the nation in the long run, according to a press release.
Talk about throwing a monkey wrench into the swine-flu preparedness works.
The authors of a key study on N95 respirator use for H1N1 influenza protection have retracted their conclusion about favoring N95 masks over surgical or procedure masks, according to a October 31 MedPage Today article.
Originally the study from the University of New South Wales in Sydney, Australia, conducted on Chinese healthcare workers found that N95 respirators were effective and offered better protection than standard surgical masks. MedPage now reports: “After a reanalysis prompted by questions from peer reviewers, the findings no longer demonstrated a significant benefit for the N95 respirators,” reported Holly Seale, PhD, of the University of New South Wales in Sydney, Australia.
The news was presented at the annual meeting of the Infection Diseases Society of America (IDSA) and came as a shock to experts at the conference, according to MedPage.
Peer reviewers faulted the Australian study for not selecting the control group of nine hospitals on a random basis.
Since the recommendation by the IOM, a Canadian study, recently published in the Journal of the American Medical Association (JAMA), found that surgical masks compared with N95 respirators “resulted in noninferior rates of laboratory-confirmed influenza” among healthcare workers. This study, however, was not conducted on H1N1 virus transmission.
ABC News: In a surprise twist, authors…retracted findings of a study that found N95 respirators were better than surgical masks at preventing flu.
After a re-analysis prompted by questions from reviewers, the findings were no longer significant, said Holly Seale of the University of New South Wales in Sydney, Australia.
The original study, presented earlier this year, formed the basis of some recommendations on the use of masks in a health care setting.
The retraction — near the end of a presentation at the annual meeting of the Infectious Diseases Society of America — prompted a “rush to the microphones” by those involved in flu prevention, one expert said.
The findings appeared to differ — not only from previous reports, but also from the abstract submitted to this meeting, said Dr. Andrew Pavia of the University of Utah.
Seale acknowledged those differences and agreed that the original results no longer stand. She was not immediately available for additional comment.
The lead author of the study, Raina MacIntyre, also of the University of New South Wales, did not attend the meeting here.
The retraction took experts here by surprise, although many had been critical of some statistical aspects of the study, according to Dr. Neil Fishman of the University of Pennsylvania.
“I think there was little bit of shock that there was such a large change (in the results),” he told MedPage Today after the session.
The study was first presented in San Francisco earlier this year.
The N95 respirators are more costly than simple surgical masks and are in shorter supply. As well, there are costs involved if hospitals try to comply with guidance, he said.
The original Australian finding was a surprise to many experts, Fishman said, because it did not accord with other findings or with clinical experience.
A Canadian study in the Journal of the American Medical Association in October found no difference between fit-tested N95 masks and surgical masks.
The analysis, led by Mark Loeb of McMaster University in Hamilton, Ontario, was a true randomized trial among nurses in eight tertiary care hospitals in Canada.
In contrast, the Australian study, conducted in China, was a cluster randomized trial in which the unit of analysis was the hospital, Fishman said.
But the Australians were criticized because their control group of nine hospitals was not selected randomly, he said.
When the data were re-analyzed excluding those hospitals, the differences between N95 respirators and surgical masks were no longer significant, Seale reported.
“When the P-value was adjusted for clustering and multiple testing,” she reported, there was “no significant difference between N95 respirators and medical masks.”
Fishman said most clinical experience suggests that flu is spread by large droplets and should be blocked by even a simple barrier such as a surgical mask.
SYDNEY, Australia — “In a surprise twist, authors here retracted findings of a study that found N95 respirators were better than surgical masks at preventing flu.
After a re-analysis prompted by questions from reviewers, the findings were no longer significant, said Holly Seale of the University of New South Wales in Sydney, Australia.
The original study, presented earlier this year, formed the basis of some recommendations on the use of masks in a health care setting.”
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
BODYBUILDING.COM Is Conducting a Voluntary Nationwide and International Recall of 65 Dietary Supplements That May Contain Steroids
FOR IMMEDIATE RELEASE – Boise, ID – November 3, 2009 – As part of its ongoing cooperation with the Food and Drug Administration (”FDA”), Bodybuilding.com, LLC (the “Company”) announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products (the “Recalled Products”) described on the attached list, that were sold through the Company’s website, www.bodybuilding.com.
The FDA has informed the Company that it believes that the Recalled Products contain ingredients that are steroids. Specifically, the FDA has advised the Company of its concern that the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: “Superdrol,” “Madol,” “Tren,” “Androstenedione,” and/or “Turinabol.” While the Company has not had an opportunity to independently confirm the FDA’s concerns that the Recalled Products in fact contain these ingredients, the Company is undertaking this voluntary recall in an abundance of caution.
Acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death.
The Company has not received to date any reports of adverse events in connection with the Recalled Products. Because of the possible harmful effects of using products containing steroids, the Company is cooperating with the FDA to conduct a recall of the products the FDA has identified as containing steroids. Prior to agreeing to carry the Recalled Products, the Company received assurances from all of the manufacturers of the Recalled Products that these products were properly classified as dietary supplements in compliance with federal law, meaning that these products did not contain any unlawful ingredient. Customers who have any of the Recalled Products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above.
Any adverse events that may be related to the use of the Recalled Products should be reported to the FDA’s MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm], by phone [ 1-800-FDA-1088 1-800-FDA-1088], or by returning the postagepaid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA- 0178].
The Company is committed to providing accurate information about its products. The Company is working voluntarily with the FDA in this recall process.
Consumers should return any unused products purchased on the Company’s site to the Company. For instructions on how to return Recalled Products please call ( 1-866-236-8417 1-866-236-8417) or e-mail (service@bodybuilding.com) the Company.
RECALLED PRODUCT LIST
Brand Name
4Ever Fit D-Drol
Advanced Muscle Science Dienedrone
Advanced Muscle Science Liquidrone UTT
Anabolic Xtreme Hyperdrol X2
APS (aka Advanced Muscle Science) Mastavol
APS (aka Advanced Muscle Science) Revamp
APS (aka Advanced Muscle Science) Ultra Mass Stack
APS (aka Advanced Muscle Science) Ripped Stack
Better Body Sports Finadex
Black China Labs Straight Drol
Black China Labs Straight Phlexed
Body Conditioning Solutions TestraFLEX
Bjorklund Methyldrostanolone
BOSC Enterprises Epi-Tren
BOSC Enterprises Magna Drol
Chaparral Labs Epivol
Chaparral Labs Pheravol-V
Competitive Edge Labs M-Drol
Competitive Edge Labs P-Plex
Competitive Edge Labs X-tren
Diabolic Labs Epio-Plex
Diabolic Labs Finabolic 50
Diabolic Labs Revenge
Ergopharm 6-OXO
Ergopharm 6-OXO Extreme
EST (aka Engineered Sports Technology) MethAnstance
Daily Allocation Update
Posted November 3, 2009, 12:00 PM ET
Doses Allocated as of 11/02/09*
30,033,800
*Doses allocated to project areas for ordering are those that are at the distribution depots and ready for project areas to order.
Vaccine is allocated to each project area in proportion to its population (pro rata).
Aggregate Totals
Posted October 30, 2009, 12:00 PM ET
Doses Ordered as of 10/28/09
19,443,600
Doses Shipped as of 10/28/09**
16,870,000
**There is a lag time between allocation, ordering, and shipment of doses as project areas place orders and those orders are processed and shipped.
Vaccine Shipment Status
by Project Area
Posted October 30, 2009, 12:00 PM ET
Project Areas***
Total Doses Shipped
as of 10/28/09**
Alabama
212,700
Alaska
57,700
American Samoa
0
Arizona
332,800
Arkansas
201,100
California
2,025,700
Chicago
212,700
Colorado
255,300
Connecticut
187,000
Delaware
50,000
District of Columbia
49,000
Federal Worker Program*
82,300
Florida
750,300
Georgia
443,200
Guam
9,500
Hawaii
65,000
Idaho
113,300
Illinois
784,900
Indiana
460,800
Iowa
160,600
Kansas
117,100
Kentucky
178,900
Louisiana
253,800
Maine
84,100
Marshall Islands
0
Maryland
306,900
Massachusetts
404,500
Michigan
556,800
Micronesia
8,100
Minnesota
290,300
Mississippi
136,500
Missouri
250,000
Montana
49,000
Nebraska
111,200
Nevada
135,100
New Hampshire
58,600
New Jersey
597,200
New Mexico
116,100
New York
560,200
New York City
511,100
North Carolina
440,900
North Dakota
37,000
Northern Mariana Islands
2,400
Ohio
595,200
Oklahoma
168,200
Oregon
186,500
Pennsylvania
718,600
Philadelphia
93,500
Puerto Rico
42,900
Republic of Palau
1,300
Rhode Island
48,200
South Carolina
186,400
South Dakota
62,100
Tennessee
430,000
Texas
1,170,400
Utah
144,900
Vermont
52,100
Virgin Islands
5,400
Virginia
489,700
Washington
334,900
West Virginia
114,900
Wisconsin
333,000
Wyoming
32,100
*For more information, please visit: http://www.opm.gov/pandemic/memos/h1n1_20090930.asp**There is a lag time between allocation, ordering, and shipment of doses as project areas place orders and those orders are processed and shipped.***Project areas reflect CDC Public Health Emergency Response (PHER) Grantees
A. Tamiflu (oseltamivir phosphate) is an antiviral drug. It works by attacking the flu virus to keep it from multiplying in your body and by reducing the symptoms of the flu. Tamiflu can sometimes keep you from getting the flu if you take it before you get sick.
The term “flu” refers to illness caused by the influenza virus. The flu is a respiratory infection that can cause symptoms such as fever, chills, aches and pains, cough, and sore throat. The flu can range from mild common cold symptoms, to the typical “flu” symptoms described above, to life-threatening pneumonia and other complications, including secondary bacterial infections.
Tamiflu is used to treat people 1 year of age and older who have the flu (influenza A and B viruses). Tamiflu is also used for prevention (prophylaxis) of the flu in people 1 year of age and older. During the 2009 H1N1 influenza (“swine flu”) public health emergency, FDA authorized the use of Tamiflu in children less than 1 year of age.
Q. Is Tamiflu a substitute for the flu vaccine?
A. No. Getting the flu vaccine is the best way to protect against getting the flu and controlling the spread of the flu.
More information on the Seasonal and 2009 H1N1 flu vaccines is available on the flu vaccination page on the Flu.gov website.
Q. What do the terms treatment of the flu and prevention (prophylaxis) of the flu mean?
A. Treatment is used when a person is given Tamiflu because they have the signs and symptoms of the flu or have been diagnosed with the flu. Tamiflu has been shown to lessen the amount of time people are sick with the flu.
Prevention (prophylaxis) is when someone who does not have flu symptoms is given Tamiflu to help stop them from getting the flu because they are exposed to or come into close contact with someone (for example live with or take care of someone) who has the flu.
Q. Do I take Tamiflu the same way for treatment and prevention (prophylaxis) of the flu?
A. No. The number of times a day (frequency) and the number of days (duration) that you take Tamiflu are different for treatment and prevention of the flu. Your healthcare provider will tell you how to take Tamiflu. Take it exactly as your healthcare provider prescribes.
Q. What should people do if they continue to have or start to develop flu symptoms while taking Tamiflu?
A. If flu symptoms do not go away, or if new symptoms develop while taking Tamiflu, people should contact their healthcare provider. Other illnesses cause people to have symptoms similar to the flu, or may occur at the same time as the flu, and they might need other treatment.
Q. Does Tamiflu come in a liquid as well as capsules?
A. Yes, Tamiflu is available as a liquid (oral suspension) and as oral capsules of different sizes. Your healthcare provider will prescribe the strength that is right for you.
Q. Do I need to make the Tamiflu liquid (oral suspension)?
A. No, a pharmacist should mix Tamiflu liquid before giving it to you. If you get a bottle with only powder in it, you should return the medication to the pharmacy so it can be mixed correctly.
Q. Is there enough Tamiflu suspension?
A. For the 2009-2010 flu season there is not enough ofthe liquid Tamiflu made by the manufacturer. Some pharmacies may need to make a liquid for patients. The strength of the liquid made by the pharmacy may be different than the liquid from the manufacturer. You should always follow the directions on the medicine label for how much and how often to give the medication. You should speak with your healthcare provider if you have any questions.
Q. Does the liquid (oral suspension) need to be refrigerated?
A. Yes, liquid Tamiflu (oral suspension) should be stored in the refrigerator. Ask the pharmacist how long to keep the medicine, and then throw away the unused medicine after that time. You should only use the medication for as long as your healthcare provider has directed.
Q. Does liquid Tamiflu (oral suspensions) need to be shaken?
A. Yes, shake liquid Tamiflu well each time before you give it.
Q. What do I use to give liquid Tamiflu (oral suspension)?
A. The pharmacist should give you a syringe to measure the dose of liquid Tamiflu. Some syringes for oral use have markings in milligrams (mg) and some have markings in milliliters (mL). You and your pharmacist should look at the syringe and compare it to the directions on the medicine label. The unit of measure (mg or mL) on the medicine label should match the unit of measure (mg or mL) on the syringe. You should be able to use the syringe to measure the right amount (mg or mL) that is written on the medicine label. If you can not measure the right amount with the syringe you were given, then you should ask the pharmacist to give you a different syringe with different markings.
Q. What type of syringe should I use to give my child Tamiflu orally?
A. Parents or caregivers of children younger than one year of age will always need to use a syringe marked in milliliters (mL). If you have questions about how to give the medicine you should speak with your healthcare provider.
Q. What should I do if I am given Tamiflu capsules but can not swallow them?
A. If you have trouble swallowing Tamiflu capsules, you should tell your healthcare provider. If liquid Tamiflu is not available and you have capsules that give the right dose (30 mg, 45 mg or 75 mg), you may pull open the Tamiflu capsules and mix the powder with a small amount of sweetened liquid such as regular or sugar-free chocolate syrup. You don’t have to use chocolate syrup but thick, sweet liquids work best at covering up the taste of the medicine.
Q. Should women who are pregnant or nursing take Tamiflu?
A. Tamiflu may be of benefit for some pregnant and nursing women with 2009 H1N1 influenza. At this time, the U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women who are sick from 2009 H1N1 influenza may develop more serious illness and should be treated with a flu drug. Pregnant and nursing women are advised to talk with a healthcare professional before using Tamiflu.
Q. What are the most common side effects of Tamiflu?
A. The most common side effects of Tamiflu are nausea and vomiting. Usually, nausea and vomiting are not severe and happen in the first 2 days of treatment. Taking Tamiflu with food may lessen the chance of getting these side effects. Other side effects include stomach (abdominal) pain, nosebleeds, headache, and feeling tired (fatigue).
Q. What are the serious side effects of Tamiflu?
A. Children and teenagers with the flu may be at a higher risk for seizures, confusion, or abnormal behavior early during their illness. These serious side effects may happen shortly after beginning Tamiflu or may happen in people when the flu is not treated. These serious side effects are not common but may result in accidental injury to the patient. People who take Tamiflu should be watched for signs of unusual behavior and a healthcare provider should be contacted right away if the patient shows any unusual behavior while taking Tamiflu.
Rare cases of allergic reactions, including serious skin rashes, have happened in people who take Tamiflu. If a rash develops, stop taking Tamiflu and contact a healthcare provider right away.
FDA encourages consumers to report any side effects and medication errors from Tamiflu to FDA at 1-800-FDA-1088.� Q. Where can I get more information about Tamiflu and 2009 H1N1?
A. The following links provide additional information on Tamiflu:
A. Relenza (zanamivir) is an antiviral drug. It works by attacking the flu virus to keep it from multiplying in your body and reducing the symptoms of the flu. It can sometimes keep you from getting the flu if you take it before you get sick.
The term “flu” refers to illness caused by the influenza virus. The flu is a respiratory infection that can cause symptoms such as fever, chills, aches and pains, cough, and sore throat. The flu can range from mild common cold symptoms, to the typical “flu” symptoms described above, to life-threatening pneumonia and other complications, including secondary bacterial infections.
Relenza is used to treat people 7 years of age and older who have the flu (influenza A and B viruses). Relenza is also used for prevention (prophylaxis) of the flu in people age 5 years or older.
Q. Is Relenza a substitute for the flu vaccine?
A. No. Getting the flu vaccine is the best way to protect against getting the flu and controlling the spread of the flu.
Q. What do the terms treatment of the flu and prevention (prophylaxis) of the flu mean?
A. Treatment is used when a person is given Relenza because they have the signs and symptoms of the flu or have been diagnosed with the flu. Relenza has been shown to lessen the amount of time people are sick with the flu.
Prevention (prophylaxis) is when someone who does not have flu symptoms is given Relenza to help stop them from getting the flu because they are exposed to or come into close contact with someone (for example live with or take care of someone) who has the flu.
Q. Do I take Relenza the same way for treatment and prevention (prophylaxis) of the flu?
A. No. The number of times a day (frequency) and the number of days (duration) that you take Relenza are different for treatment and prevention (prophylaxis) of the flu. Your healthcare providers will tell you how to take Relenza. Take it exactly as your healthcare provider prescribes.
Q. What should I do if I continue to have or start to develop flu symptoms while taking Relenza?
A. If your flu symptoms do not go away, or if you get new symptoms while taking Relenza, contact your healthcare provider. Other illnesses cause people to have symptoms similar to the flu, or may occur at the same time as the flu, and they might need other treatment.
Q. How is Relenza supplied?
A. Relenza is a powder that you inhale into your mouth using a device called a Diskhaler. The powder is in a pouch called a blister. There are 4 blisters on each circular medication pack (Rotadisks). Each blister contains 5 mg of medicine. Each box of Relenza contains five Rotadisks.
Q. How many blisters are used for a dose?
A. Two (2) blisters are used for each dose. The 4 blisters on the Rotadisk are enough medicine for 2 doses. Your doctor will tell you how many times a day and for how many days you should take the medicine.
Q. Are there instructions for people who have never used an inhaler?
A. Yes, each box of Relenza has a Patient Instructions for Use leaflet that explains how to take Relenza using the Diskhaler device. These instructions are not a substitute for education and demonstration by your healthcare provider. Your healthcare provider will tell you how to use Relenza. Use it exactly as your healthcare provider prescribes. To help make sure Relenza is used the right way by children, it should be used only under adult supervision. The supervising adult must understand how to use the Diskhaler device.
To help you use Relenza the right way, the manufacturer, GlaxoSmithKline, also created a video on their website that demonstrates the proper use of the Relenza Diskhaler device, (see http://www.relenza.com/using-relenza-videos.html).
Q. Are there any other special instructions to remember?
A. Yes, it is important to remember to puncture both the top and bottom of the blister using the Diskhaler before inhaling the medication into your mouth. Relenza should never be used with any other device but the Diskhaler. The blisters of medicine should never be opened and mixed into a liquid.
Q. Are there people who should not take Relenza?
A. Yes. Relenza is not for people who have chronic lung diseases such as asthma or chronic obstructive pulmonary disease (COPD). Also, since the Relenza powder contains lactose, people who have an allergy to lactose should not use Relenza.
Talk with your healthcare provider if you have concerns about using Relenza.
Q. Should women who are pregnant or nursing take Relenza?
A. Relenza may be of benefit for some pregnant and nursing women with 2009 H1N1 influenza. At this time, the U.S. Centers for Disease Control and Prevention (CDC) recommends that pregnant women who are sick from 2009 H1N1 influenza may develop more serious illness and should get be treated with a flu drug. Pregnant and nursing women are advised to talk with a healthcare professional before using Relenza.
Q. What are the most common side effects of Relenza?
A. The most common side effects of Relenza are:
diarrhea
nausea
vomiting
headache
dizziness
nasal irritation
cough
ear, nose, and throat infections.
Q. What are the serious side effects of Relenza?
A. Some people have more trouble breathing while using Relenza, especially if you have chronic lung disease. If you have more trouble breathing after using Relenza, you should stop using Relenza and get medical help right away.
Children and teenagers with the flu may be at a higher risk for seizures, confusion, or abnormal behavior early during their illness. These serious side effects may happen shortly after beginning Relenza or may happen in people when the flu is not treated. These serious side effects are uncommon but may result in accidental injury to the patient. People who take Relenza should be watched for signs of unusual behavior and a healthcare provider should be contacted right away if a patient shows any unusual behavior while taking Relenza.
Rare cases of allergic reactions, including serious skin rashes, have happened in people who use Relenza. If a rash develops, stop Relenza and contact a healthcare provider right away.
Report any side effects and medication errors from Relenza to FDA at 1-800-FDA-1088.
Q. Where can I get more information about Relenza and 2009 H1N1?
Peramivir IV Questions and Answers for Health Care Providers
Q1. What action is FDA taking regarding Peramivir IV?
A. As part of the federal government’s response to the 2009 H1N1 public health emergency, the Commissioner of the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) authorizing the emergency use of the unapproved drug Peramivir IV, to treat certain hospitalized adult and pediatric patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology.
This set of Questions and Answers is not intended to be a substitute for the comprehensive information about Peramivir IV contained in the Peramivir IV Fact Sheet for Health Care Providers or for the terms and conditions as set forth in the EUA.
Q2. What is Peramivir IV?
A. Peramivir IV is an intravenous (IV) neuraminidase inhibitor that has a mechanism of action similar to the two approved neuraminidase inhibitors, Tamiflu (oseltamivir phosphate) capsules and for oral suspension and Relenza (zanamivir) Inhalation Powder, for oral inhalation. Neuraminidase inhibitors work by inhibiting the neuraminidase enzyme which affects the release of viral particles, thereby reducing the amount of virus in the body.
Q3. What uses of Peramivir IV are authorized under the EUA?
A. Under the EUA, Peramivir IV is authorized for emergency use in the treatment of certain hospitalized patients with suspected or laboratory confirmed 2009 H1N1 infection or infection due to nonsubtypable influenza A virus suspected to be 2009 H1N1 based on community epidemiology. Specifically, Peramivir IV is authorized only for the following patients who are admitted to a hospital and under the care or consultation of a licensed clinician (skilled in the diagnosis and management of patients with potentially life-threatening illness and the ability to recognize and manage medication-related adverse events):
Adult patients for whom therapy with an IV agent is clinically appropriate, based upon one or more of the following reasons:
patient not responding to either oral or inhaled antiviral therapy, or
drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible, or
the clinician judges IV therapy is appropriate due to other circumstances.
Pediatric patients for whom an IV agent is clinically appropriate because:
patient not responding to either oral or inhaled antiviral therapy, or
drug delivery by a route other than IV (e.g. enteral oseltamivir or inhaled zanamivir) is not expected to be dependable or is not feasible.
FDA has authorized the emergency use of Peramivir IV under EUA based upon its conclusion that the statutory criteria for issuance of an EUA, summarized below, have been met:
The 2009 H1N1 Influenza virus can cause influenza, a serious or life-threatening disease or condition;
based on the totality of scientific evidence available to FDA, it is reasonable to believe that Peramivir IV may be effective for the treatment of 2009 H1N1 influenza in certain adult and pediatric patients;
the known and potential benefits of Peramivir IV outweigh the known and potential risks of Peramivir IV for the treatment of 2009 H1N1 influenza in certain adult and pediatric patients; and
there is no adequate, approved, and available alternative to the emergency use of Peramivir IV for the treatment of 2009 H1N1 influenza in certain adult and pediatric patients.
Even though there are a number of limitations to the safety and efficacy data available at this stage of Peramivir IV’s development and the data reported are preliminary in nature, based upon the totality of scientific evidence available, it is reasonable to believe that Peramivir IV may be effective in certain patients as specified above.
Q4. Does the EUA authorize the use of Peramivir IV for the treatment of uncomplicated influenza or prevention of influenza?
A. No, the EUA states that Peramivir IV will only be authorized for the uses described in Q3. The Fact Sheet for Health Care Providers specifically states “Do not use Peramivir IV for the treatment of seasonal influenza A or B virus infections, for outpatients with acute uncomplicated 2009 H1N1 virus infection or for pre- or post-exposure chemoprophylaxis (prevention) of influenza.”
Q5: Under the EUA, who is authorized to hold and distribute Peramivir IV?
A. The EUA authorizes only the Centers for Disease Control and Prevention (CDC) to distribute Peramivir IV under its direction to a hospital at the request of the licensed treating clinician. Hospitals that receive Peramivir IV from CDC must, among other things, maintain adequate records showing receipt, use, and disposition of Peramivir IV.
Q6: Why is this EUA different than the EUAs for Tamiflu and Relenza?
A. FDA has approved new drug applications for Tamiflu and Relenza and they have been demonstrated to be safe and effective in adequate and well-controlled clinical studies. The EUAs for Tamiflu and Relenza authorize certain unapproved uses of Tamiflu and Relenza, subject to the terms and conditions of the EUAs. Unlike Tamiflu and Relenza, Peramivir IV is not approved by FDA for any use. FDA has concluded (among other things), based on the totality of scientific evidence available, that it is reasonable to believe that Peramivir IV may be effective in certain patients.
Q7: What are the specific conditions of authorization for health care providers in the EUA for Peramivir IV?
Health care providers must follow all the terms and conditions of the EUA for Peramivir IV. The EUA lists eight conditions of authorization that health care providers must follow when using Peramivir IV. The conditions of authorization are summarized below:
Health care providers will be aware of the EUA, including the terms and conditions as well as any authorized amendments. Health care providers will read the Fact Sheet for Health Care Providers, including the sections on Mandatory Requirements for Peramivir IV Administration Under Emergency Use Authorization and Considerations Prior to Peramivir IV Use Under EUA as well as any amendments.
Health care providers prescribing and/or administering Peramivir IV will ensure that the authorized Fact Sheet for Patients and Parents/Caregivers as well as any authorized amendments have been made available to patients and/or parents/caregivers through appropriate means. Health care providers (to the extent practicable given the circumstances of the emergency) will document in the patient’s medical record that: (a) patients/caregivers have been given the Fact Sheet for Patients and Parents/Caregivers, (b) patients/caregivers have been informed of the alternatives to receiving authorized Peramivir IV, and (c) patients/caregivers have been informed that Peramivir IV is an unapproved drug that is authorized for use under Emergency Use Authorization.
Prescribing health care providers (or their designees) will ensure that: (1) selected adverse events and all medication errors associated with the use of authorized Peramivir IV are reported to FDA’s MedWatch program; (2) that such reports include in the description section of the MedWatch Form 3500 the words “Peramivir EUA” and include the Peramivir Request number; and (3) that reports are made within seven calendar days from the onset of the event. Moreover, prescribing health care providers or their designees will conduct any follow-up requested by FDA and/or CDC. For detailed information on reporting requirements, see the Information for Healthcare Professionals sheet for mandatory adverse event reporting for emergency use of Peramivir IV under EUA.
Health care providers will prescribe and/or administer Peramivir IV only for the authorized uses covered in Question # 3.
Health care providers will ensure that patients with known or suspected renal insufficiency have creatinine clearance determined prior to Peramivir IV dose calculation and first administration.
Health care providers prescribing and/or administering authorized Peramivir IV will ensure that patients with history of severe allergic reaction to any other neuraminidase inhibitor (zanamivir or oseltamivir phosphate) or any ingredient of Peramivir IV will not receive authorized Peramivir IV.
Health care providers will only make available additional written information relating to the emergency use of Peramivir IV to the extent that it is consistent with and does not exceed the terms of the EUA (including the Facts Sheets for Patients and Parents/Caregivers).
Heath care providers will make available to FDA and/or CDC upon request any records maintained in connection with the EUA Letter of Authorization. Upon request, health care providers will report to FDA and/or CDC information with respect to the emergency use of Peramivir IV.
Q8: Are FDA’s Institutional Review Board (IRB)-review and IRB-notification requirements applicable to the emergency use of Peramivir IV (an unapproved, investigational drug) under the EUA?
A. No, FDA IRB-review and IRB notification requirements are not applicable to the emergency use of Peramivir IV (an unapproved, investigational drug) under the EUA. The terms and conditions for emergency use of Peramivir IV are set forth in the EUA and do not include IRB-review and notification requirements. Health care providers must follow the EUA’s terms and conditions of authorization when administering Peramivir IV in order to be within the scope of the EUA. For additional information on EUAs, please review FDA’s EUA guidance document .
Q9. How do health care providers request Peramivir IV under the EUA?
A. Requests for Peramivir IV are handled by the CDC through the Strategic National Stockpile. Only licensed clinicians with prescribing authority to treat certain hospitalized adult and pediatric patients, as outlined in the Fact Sheet for Health Care Providers, can request Peramivir IV. Hospitals and health care providers conducting activities related to authorized Peramivir IV, such as requesting, preparing, prescribing, and/or administering authorized Peramivir IV, must comply with the terms and conditions of the EUA. Health care providers conducting such activities related to authorized Peramivir IV will read the Fact Sheet for Health Care Providers and any amendments. Peramivir IV can be requested via CDC’s Peramivir IV Electronic Request System. Once the completed electronic request has been successfully submitted, acknowledgment will be sent to the email address(es) provided in the request. After the received request has been accepted and processed, a second e-mail notification will be sent. Please note that it may take up to 24 hours, once the decision to ship Peramivir IV is made, for the product to reach the indicated delivery location (i.e., hospital pharmacy).
Q10. Can health care providers request Peramivir IV for more than one patient?
A. Yes, Peramivir IV may be requested for more than one patient under the health care provider’s care, provided that each patient meets the criteria for treatment with Peramivir IV as described in the Fact Sheet for Health Care Providers. Each request for Peramivir IV to CDC via CDC’s Peramivir IV Electronic Request System is discrete for each patient for whom the request is being made. A unique Peramivir Request Number is assigned to each successful request submission. Health care providers should keep the Peramivir Request Number because it is required to be included in adverse event and medication error reports submitted to FDA.
Q11. Is there any other way health care providers can obtain Peramivir IV for patients other than through the CDCunder the Emergency Use Authorization?
A. Yes, clinical studies of Peramivir IV are currently being conducted. Health care providers considering whether a patient would be appropriate for inclusion in a clinical trial, should review the current Peramivir IV clinical trials athttp://www.clinicaltrials.gov.
In special circumstances, Peramivir IV may be obtained using FDA’s Emergency Investigational New Drug (E-IND) Application procedures. Special circumstances may include patients who do not meet criteria for Peramivir IV under the EUA or those not eligible to participate in a current Peramivir IV clinical trial.
Q12. Do the terms and conditions of this EUA apply to health care providers who already have Peramivir IV because they are a clinical site investigator for a Peramivir IV clinical trial or they obtain Peramivir IV under E-IND?
A. No, the terms and conditions of this EUA apply only to Peramivir IV made available through CDC. Health care providers who receive Peramivir IV because they are a clinical site investigator for a Peramivir IV clinical trial or they obtain the product under an E-IND, should follow the terms of the clinical trial protocol or E-IND protocol and requirements for investigational drugs. Please note that if you request Peramivir IV under this EUA through CDC’s Peramivir IV Electronic RequestSystem, you are required to agree that you are responsible for understanding and complying with the terms and conditions of the EUA.
Q13. There is no expiration date on the vial label of Peramivir IV. How long is this product (the unopened/unused intact vials) good?
A. Unlike FDA-approved drug products that require a labeled expiration date, an unapproved (investigational) product does not bear a labeled expiration date. However, stability and potency tests are performed by the product’s manufacturer at specified time intervals during the development phase of the drug to establish a shelf life. Based on available data reviewed by the FDA, the current lots (Lot #7438, 7439, 7440) of Peramivir IV distributed by CDC can be used up to June 2010, when stored as directed per the terms and conditions of the EUA as described in the Fact Sheet for Health Care Providers. The results of ongoing retesting by the manufacturer will be reviewed by FDA and the above date may be extended. Therefore, unopened/unused intact vials of Peramivir IV product with the above lot numbers should not be discarded in June 2010. Any updated information regarding shelf-life of this product will be provided as appropriate.
Q14. How is Peramivir IV supplied?
Peramivir IV is supplied in a 200 mg/20 mL single use vial.
Q15. How is Peramivir IV stored?
A. Vials of Peramivir IV should be stored at ambient temperature (15˚C-30˚C or 59˚F-86˚F). Once a diluted solution has been prepared, it should be administered immediately or stored under refrigerated conditions (2˚C-8˚C or 36˚F-46˚F), but should be allowed to reach room temperature prior to administration. The diluted solution should be administered within 24 hours following preparation. Any unused diluted solution must be discarded after 24 hours.
Hospitals must ensure that health care providers acting under the EUA abide by the institutional procedures regarding drug accountability.
Q16. How is Peramivir IV injection prepared?
A. Please refer to Section 3 Directions for Preparing Peramivir Injection in the Fact Sheet for Health Care Providers for detailed directions on preparing doses of Peramivir IV injection for both adult and pediatric patients. Because Peramivir IV is given intravenously, it is necessary to prepare under aseptic conditions and should be inspected visually for particulate matter and discoloration prior to administration.
The calculated amount of Peramivir IV must be diluted in 0.9% or 0.45% Sodium Chloride Injection, USP that does not contain dextrose or other electrolytes. There are no data to support dilution of Peramivir IV with dextrose containing solutions or solutions containing electrolytes other than sodium chloride. It is always recommended to administer intravenous medication immediately after preparation when possible.
Q17. Can the Fact Sheet for Patients and Parents/Caregivers be translated to a different language?
A.Under the EUA for Peramivir IV, CDC is authorized to make available additional written information relating to the emergency use of Peramivir IV to the extent that it is consistent with and does not exceed the terms of the EUA. CDC is currently working on translating the Fact Sheet for Patients and Parents/Caregivers into different languages and will make translated versions available on CDC’s website: http://www.cdc.gov/h1n1flu/eua/peramivir.htm.
Q18. Who can health care providers contact if they have more questions or have problems requesting Peramivir IV through CDC’s Peramivir IV Electronic Request System?
A.Health care providers who have further questions or need assistance using CDC’s Peramivir IV Electronic Request System or have any clinical questions can contact CDC by calling 1-800-CDC-INFO (1-800-232-4636).
Q19. What clinical trial information exists for Peramivir IV?
A. Peramivir IV is an investigational drug and is still being evaluated in phase 3 clinical trials. The available phase 2 and 3 safety and efficacy data for Peramivir IV have been reviewed by FDA. Results from the phase 2 and 3 trials with IV and intramuscular (IM) administration include a statistically significant effect of a single 300 mg or 600 mg IV dose of Peramivir IV compared to placebo in adult patients with acute uncomplicated influenza. Additionally, three phase 2 trials and one phase 3 trial, including one trial in hospitalized patients, did not show statistically significant treatment differences between Peramivir IV and placebo or Tamiflu (oseltamivir phosphate). Even though there are a number of limitations to the safety and efficacy data available at this stage of Peramivir IV’s development and the data reported are preliminary in nature, based upon the totality of scientific evidence available, it is reasonable to believe that Peramivir IV may be effective in certain patients.
Q20. How many patients have received Peramivir IV?
A. Approximately 1,891 clinical trial subjects have received Peramivir intravenously (IV) or intramuscularly (IM) at any dose for 1 to 10 days. A total of 478 subjects received a single 600 mg IV dose of Peramivir IV.
Overall, limited multiple dose safety data are available for the intravenous formulation. Only 33 adult clinical trial subjects have received approximately 600 mg (or higher) intravenously once daily for five or more days. No pediatric patients have received Peramivir IV in clinical trials. However, limited use of Peramivir IV in adults and children has been allowed for Peramivir IV 600 mg once daily for 5 to 10 days under emergency IND procedures.
Q21. Who should not receive Peramivir IV?
A. Peramivir IV should not be used in patients with a history of severe allergic reaction to any other neuraminidase inhibitors (Relenza or Tamiflu) or any ingredient of Peramivir IV.
Peramivir IV should not be used for treatment of 2009 H1N1 virus infection in patients with documented or highly suspected Tamiflu resistance. The influenza A H1N1 clinical isolates expressing the Tamiflu resistance-associated substitution H275Y appear to be resistant to Peramivir IV.�
In addition, as explained under Q4, the Fact Sheet for Health Care Providers specifically states “Do not use Peramivir IV for the treatment of seasonal influenza A or B virus infections, for outpatients with acute uncomplicated 2009 H1N1 virus infection or for pre- or post-exposure chemoprophylaxis (prevention) of influenza.”
Q22. What adverse events associated with Peramivir IV were reported in clinical trials?
diarrhea
nervousness
elevated blood pressure
nausea
insomnia
cystitis
vomiting
feeling agitated
anorexia
neutrophil count decreased
depression
proteinuria
dizziness
nightmares
hematuria
headache
hyperglycemia
ECG abnormalities (prolonged QTc interval observed in one patient in a phase 1 trial
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