KCER Summit

Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes

December 15, 2009, 9:00 AM ET

Why are some lots of pediatric H1N1 vaccine manufactured by Sanofi Pasteur in pre-filled syringes being recalled from the market?

As part of its quality assurance program, the manufacturer, Sanofi Pasteur, performs routine, ongoing stability testing of its influenza A (H1N1) vaccine after the vaccine has been shipped to providers. Stability testing means measuring the strength (also called potency) of a vaccine over time. It is performed because sometimes the strength of a vaccine can go down over time. On December 7, Sanofi Pasteur notified CDC and FDA that the potency in one batch (called a “lot”) of pediatric syringes that had been distributed was later found to have dropped below a pre-specified limit. As a result of this finding, Sanofi Pasteur tested additional lots and found that three other lots that had been distributed also had an antigen content that, while properly filled at the time of manufacturing, was later measured to be below pre-specified limits. This means that doses from these four vaccine lots no longer meet the manufacturer’s specifications for potency. Sanofi Pasteur will send providers directions for returning any unused vaccine from these lots.

What does potency mean for the H1N1 vaccine?

Potency (or strength) is determined by the measurement of the concentration of the active ingredient (also called antigen) in the H1N1 vaccine.

Are there any concerns about safety of vaccines from these lots?

No. There are no safety concerns with these lots of H1N1 vaccine. All lots successfully passed pre-release testing for purity, potency and safety.

Should infants and children who received vaccines from these lots be revaccinated?

No. The vaccine potency is only slightly below the “specified” range. The vaccine in these lots is still expected to be effective in stimulating a protective response despite this slight reduction in the concentration of antigen. There is no need to re-administer a dose to those who received vaccine from these lots. However, as is recommended for all 2009 H1N1 vaccines, all children less than 10 years old should get the recommended two doses of H1N1 vaccine approximately a month apart for the optimal immune response. Therefore, children less than 10 years old who have only received one dose of vaccine thus far should still receive a second dose of 2009 H1N1 vaccine.

What action(s) should parents of children who have received vaccine from the recalled lots take?

Parents of children who received vaccine from the recalled lots do not need to take any action, other than to complete the two-dose immunization series if not already completed.

What are the lot numbers affected by this recall?

Vaccine doses with the following lot numbers are included in the recall:

0.25 ml pre-filled syringes, 10-packs (NDC # 49281-650-25, sometimes coded as 49281-0650-25):
UT023DA
UT028DA
UT028CB

0.25 ml pre-filled syringes, 25-packs (NDC # 49281-650-70, sometimes coded as 49281-0650-70):
UT030CA

How many doses of the pediatric H1N1 vaccine are affected by this recall?

Approximately 800,000 doses of vaccine in these lots were distributed to providers.

Is the potency issue related to this recall isolated to just the pediatric H1N1 vaccine for 6-35 month olds?

The potency problem described here is specific to the four lots of Sanofi Pasteur’s pediatric H1N1 vaccine in 0.25 mL pre-filled syringes. Sanofi Pasteur is investigating what caused the problem. The same vaccine packaged in other dosing forms, such as pre-filled syringes for older children adults, and multi-dose vials, continues to meet specifications. This recall does not affect H1N1 vaccine produced by other manufacturers.

Were these lots of vaccine shipped after failing a required test?

No. The lots being recalled passed all quality controls and met all specifications before they were shipped.

All vaccines are routinely tested for purity, potency and safety prior to release. The four lots of vaccine met all required specifications at the time of release and shipment to distribution centers. The vaccine provided in multi-dose vials and the single-dose, 0.5 mL pre-filled syringes for persons 36 months and older continues to meet all specifications.

What is being done to notify providers who received vaccine from the affected lots?

Sanofi Pasteur will send a notification to providers who received doses from any of the four lots of vaccine so that they can return any unused vaccine.

Where were the affected lots of vaccine distributed?

Vaccine from these four lots was distributed throughout the United States.

For U.S. children 6-35 months old, what other options are available currently for vaccination against H1N1 influenza?

For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials has not experienced this drop in potency and meets all standards of safety, purity and potency. As with all multidose vials of vaccines, these multidose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation in the 6-35 month age group is the same as for the pre-filled syringes, 0.25 mL. For healthy children at least 2 years of age, the nasal spray (live, attenuated influenza vaccine) is also an option. This vaccine is produced in single-units that do not contain thimerosal.

Resolve to be ready!

This New Year’s Eve, nearly 50 percent of Americans will make at least one resolution as they look toward 2010. FKDC wants to encourage the renal community to make preparing for an emergency a resolution that is both important and easy to keep.

1. Create a family emergency plan. Your family may not be together when an emergency happens, so it is important to plan in advance: how you will contact one another; how you will get back together; and what you will do in different situations. You can download a family emergency plan template from by visiting http://www.ready.gov/america/makeaplan/index.html

2. Put together an emergency supply kit. You may need to survive on your own after an emergency. This means having your own food, water, and other supplies in sufficient quantity to last for at least three days. Local officials and relief workers will be on the scene after a disaster, but they cannot reach everyone immediately. You could get help in hours, or it might take days. In addition, basic services such as electricity, gas, water, sewage treatment, and telephones may be cut off for days, or even a week or longer. To find a complete checklist of the supplies your household may need in the event of an emergency, visit http://www.ready.gov/america/getakit/index.html

3. Be informed about the different types of emergencies that can happen in your area and their appropriate responses. Learn about the hazards that may strike your community, the risks you face from these hazards, and your community’s plans for warning and evacuation. You can obtain this information by visiting http://www.ready.gov/america/beinformed/index.html

4. Get involved in emergency preparedness. Visit www.CitizenCorps.gov to find local Citizen Corps Councils, USAonWatch (Neighborhood Watch) groups, Community Emergency Response Teams (CERT), Fire Corps programs, Volunteers in Police Service (VIPS) programs, and Medical Reserve Corps (MRC) units. Ask them what you can do to prepare and train yourself and your community for disasters and how to get involved locally.

Contact local chapters of the American Red Cross and National Voluntary Organizations Active in Disaster for local disaster preparedness and response service opportunities.

If you are interested in starting a local emergency preparedness initiative in your neighborhood or community, visit http://serve.gov/toolkits/disaster/index.asp to download a toolkit that will walk you through the steps to start a project.

FKDC encourages you to use these tools to make a New Year’s resolution that will bring you and your loved ones peace of mind.

Wishing you a happy and safe New Year, and remember, Resolve to Be Ready in 2010.

In Florida, we don't have to worry about cold weather very often. Just for that reason, it's important to be prepared for severe winter weather. You might not have the necessary supplies on hand in case of severe cold.

Heating Checklist

Have at least one of the following heat sources in case the power goes out:
*Fireplace with plenty of dry firewood or gas log fireplace
*Portable space heaters or kerosene heaters

Check with your local fire department to make sure that kerosene heaters are legal in your area.

Never place a space heater on top of furniture or near water.

Use electric space heaters with
*automatic shut-off switches and
*nonglowing elements.

Keep heat sources at least 3 feet away from furniture and drapes.

Never leave children unattended near a space heater.

Have the following safety equipment:
*Chemical fire extinguisher
*Smoke alarm in working order (Check once a month and change batteries once a year.)
*Carbon monoxide detector

Never use an electric generator indoors, inside the garage, or near the air intake of your home because of the risk of carbon monoxide poisoning:
*Do not use the generator or appliances if they are wet.
*Do not store gasoline indoors where the fumes could ignite.
*Use individual heavy-duty, outdoor-rated cords to plug in other appliances.

Cooking and Lighting Checklist

* Never use charcoal grills or portable gas camp stove indoors—the fumes are deadly.
* Use battery-powered flashlights or lanterns.
* Avoid using candles.
* Never leave lit candles alone.

Accusure Insulin Syringes Qualitest Pharmaceuticals - Recall

Qualitest Pharmaceuticals and FDA notified healthcare professionals of a nationwide recall of Accusure Insulin Syringes. All syringes, regardless of lot number, are subject to this recall. These syringes were distributed between January 2002 and October 2009 to wholesale and retail pharmacies nationwide (including Puerto Rico). The syringes in these lots may have needles which detach from the syringe. If the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into to the syringe, or remain in the skin after injection. Consumers who have any Accusure® Insulin Syringes should stop using them and contact Qualitest at 1-800-444-4011 for reimbursement. You can find the lot number on the white paper backing of each individual syringe. Click here for more information.

Dexferrum (iron dextran injection) - Labeling Change

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

Unomedical Issues Worldwide Recall of Certain Manual Pulmonary Resuscitators

Unomedical Inc., a manufacturer of medical devices, today announced that it is conducting a voluntary recall of certain units of the single-patient use Manual Pulmonary Resuscitator (MPR).

The recall only impacts MPRs manufactured from July 2002 – March 2008 and matching the lot numbers listed on the following Unomedical web page: http://www.unomedical.com/?pageid=H3160.

Unomedical is contacting customers to arrange for the return and credit of all MPR units subject to this recall by sending notification letters to distributors and customers. Customers with questions are urged to contact Unomedical at 1-800-634-6003.

Philips Issues Worldwide Recall of Select Heartstart Fr2+ Automated External Defibrillators

September 28, 2009 - Seattle - Philips announced today that it is voluntarily recalling approximately 5,400 HeartStart FR2+ automated external defibrillators (AEDs). This recall is being conducted due to the possibility of a memory chip failure that may render the device inoperable. Only certain HeartStart FR2+ AEDs (models M3860A and M3861A, distributed by Philips; and models M3840A and M3841A, distributed by Laerdal Medical) manufactured between May, 2007 and January, 2008 are included in the voluntary recall.

The HeartStart FR2+ defibrillators are used by trained responders and designated response teams to help treat sudden cardiac arrest. The device automatically analyzes the heart rhythm and determines whether a defibrillation shock is needed. If a shockable rhythm is detected, the FR2+ instructs the responder to deliver defibrillation therapy.

Philips has received reports of a memory chip failure in a small number of FR2+ units manufactured in 2007 and early 2008. These reported failures were detected during routine self tests, not during emergency use of the AED. Failure of this chip could render the AED inoperable and prevent it from delivering therapy when indicated, although Philips has received no reports of injury associated with this chip failure.

The AEDs affected by this recall have been distributed globally to fire departments, emergency medical services, hospitals, and other organizations. Philips is contacting customers to arrange for the return and replacement of all the recalled AEDs by sending notification letters to distributors and users. In addition, the company has set up a page on the Philips Web site with a serial number look-up tool to allow customers to find out if their FR2+ is part of this recall, as well as instructions on what to do if it is. The Web page is www.philips.com/FR2PlusAction.

Philips has notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact HeartStart Customer Service at 1-800-263-3342.

Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch Web site at www.fda.gov/medwatch.

New USP Standards for Heparin Products Will Result in Decreased Potency Adjustments may be needed to achieve desired anticoagulant effect in some patients.

The U.S. Food and Drug Administration today alerted health care professionals to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug.

To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose.

Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit.

FDA Alert to Health Care Professionals

USP Heparin Information

Information for Consumers: What You Should Know about Changes to Heparin

National Resource Center on Advancing Emergency Preparedness for Culturally Diverse Communities

http://www.diversitypreparedness.org/

The National Resource Center on Advancing Emergency Preparedness for Culturally Diverse Communities, developed by the Drexel University School of Public Health’s Center for Health Equality, with support from the HHS Office of Minority Health.

This website provides information on preparedness in a variety of languages, including: Albanian, Amharic, Arabic, Armenian, Bengali, Bosnian, Brazilian, Burmese, Chamorro, Chinese, Chinese Simplified, Chinese Traditional, Chuukese, Croatian, Dutch, English, Ethiopian, Farsi, French, German, Haitian Creole, Hindi, Hmong, Italian, Japanese, Khmer/Cambodian, Kirundi, Korean, Kurdish, Laotian, Marshallese, Mien, Oromo, Persian, Polish, Portuguese, Russian, Samoan, Serbian, Sinhalese, Somali, Spanish, Sri Lanka, Swahili, Tagalog, Thai, Tongan, Turkish, Ukrainian, Urdu, Vietnamese, and Yupik.

International Clean Hands Week is Sept. 20-26, 2009

The Clean Hands Coalition (CHC) reminds healthcare professionals that International Clean Hands Week is Sept. 20-26, 2009. The Clean Hands Coalition is a unified alliance of public and private partners working together to create and support coordinated, sustained initiatives to significantly improve health and save lives through hand hygiene. The CHC is facilitated by the Centers for Disease Control and Prevention (CDC) For more information and ideas on how to celebrate this week by raising hand hygiene awareness, go to http://www.cleanhandscoalition.org/nchw.htm

Recall: LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc)

Audience: Emergency medical personnel, consumers

[Posted 09/16/2009] FDA notified healthcare professionals of a Class I recall of certain LIFEPAK CR Plus Automated External Defibrillators (AED) manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the affected devices to improperly analyze the heart rhythm and may cause the device to delay or fail to deliver therapy.

The AEDs were manufactured and distributed from July 9, 2008 through August 19, 2008. An extremely humid environment may cause the LIFEPAK CR Plus AED to improperly analyze the rhythm correctly and may cause the device to delay or fail to delivery therapy.

Physio-Control called their customers from August 18-19, 2009 with a follow-up email message on August 20, 2009. The company sent replacements on August 19, 2009.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death.

Any adverse events or quality problems that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by phone [1-800-332-1088], or by returning the postage-paid FDA Form 3500 by mail or fax [1-800-FDA-0178].

[09/16/2009 - Recall Notice - FDA]

FDA ALERT: MYFORTIC

Myfortic (mycophenolic acid)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals

Novartis and FDA notified healthcare professionals that cases of Pure Red Cell Aplasia (PRCA) have been reported in patients treated with Myfortic. The WARNINGS and ADVERSE REACTIONS sections of the Myfortic Prescribing Information have been revised to reflect this new safety information.

PRCA is a type of anemia in which there is a selective reduction of red blood cell precursors on bone marrow examination. Patients with PRCA may present with fatigue, lethargy, and/or abnormal paleness of the skin (pallor). In some cases, PRCA was found to be reversible with dose reduction or cessation of Myfortic therapy. In transplant patients, however, reduced immunosuppression may place the graft at risk.

Read the complete MedWatch Safety summmary at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181306.htm

Levemir Insulin (Novo Nordisk):Stolen vials still may be on market

FDA is reminding the public that stolen vials of the long-acting insulin Levemir made by Novo Nordisk Inc. still may be on the market. Evidence gathered to date suggests that the stolen insulin was not stored and handled properly and may be dangerous for people to use. FDA has received multiple reports of patients who suffered an adverse event due to poor control of glucose levels after using a vial from one of the stolen lots.

Read the complete MedWatch 2009 Safety summary including a link to the FDA News release and the original June 13,2009 alerts at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm166359.htm

Join us for the next Coffee House Conversations™ telephone call!

To empower and educate individuals affected by chronic kidney disease (CKD), transplantation and donation, the National Kidney Foundation’s People Like Us hosts monthly Coffee House Conversations™ telephone calls. On these free, interactive telephone calls, you will hear from experts, and be given an opportunity to ask them questions.

Dial in to the toll free number and enter the password below for all Coffee House Conversations™ telephone series calls.

Call-In Number: 888-603-9220
Password: KIDNEY

The next call is:

• Get Ready for an Emergency
  Tuesday, September 15
  7:00 p.m. - 8:30 p.m. ET
  call in: 1.888.603.9220
  Pass code: KIDNEY
  

*Space is limited! You can register online now, call 1-888-JOIN-NKF (888-564-6653) or fill out this registration form (PDF* download).

Send an e-mail to coffeehouse@kidney.org for more information or to submit questions about upcoming calls.

August 24, 2009

Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals. Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico). This information is posted here.

August 13, 2009

GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology

Audience: Diabetes healthcare professionals, hospital risk managers, patients. FDA notified healthcare professionals of the possibility of falsely elevated blood glucose results when using GDH-PQQ glucose test strips on patients who are receiving therapeutic products containing certain non-glucose sugars. These sugars can falsely elevate glucose results, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.

GDH-PQQ glucose monitoring measures a patient’s blood glucose value using methodology that cannot distinguish between glucose and other sugars. Certain non-glucose sugars, including maltose, xylose, and galactose, are found in certain drug and biologic formulations, or can result from the metabolism of a drug or therapeutic product. The FDA Public Health Notification provides a list of GDH-PQQ Glucose Test Strips and recommends that healthcare practitioners avoid using GDH-PQQ glucose test strips in healthcare facilities or take steps to never use them on patients receiving interfering substances.

• [08/13/2009 - Public Health Notification - FDA]
• [08/13/2009 - Advice for Patients - FDA]

National Emergency Preparedness Education Week For Kidney Patients
September 13-19, 2009

The week of September 13-19, 2009 has been designated as the time for education and emergency preparedness for all patients requiring renal replacement therapy. All dialysis and transplant facilities across the United States will prepare each patient for the unexpected.

• Color poster
• Faxblast

KCER READY!

In honor of National Preparedness Month, we are very pleased to introduce KCER READY!

KCER READY! is a self assessment to help dialysis facilities and ESRD organizations promote a higher level of disaster preparedness for their staff and patients. We invite you to take a short quiz to evaluate your level of preparedness. Some of these questions are based on the national Readiness Quotient and others are based on the ESRD Conditions for Coverage regarding emergency preparedness. Are you KCER READY?

• KCER READY Memo
• Take the KCER READY! quiz

Swine flu now is so common, state labs limit testing

http://www.tampabay.com/news/health/article1022338.ece

By Richard Martin, Times Staff Writer
Posted: Jul 27, 2009 07:01 PM

Swine flu has become so widespread that public health officials in Florida and elsewhere have stopped mass testing for the virus.

Florida's state labs now test for the H1N1 virus only in patients with life-threatening illnesses or those who live near suspected outbreaks in settings such as summer camps, schools, nursing homes and jails. Florida's labs began the new practice on July 13; other states have made similar changes.

When the virus first emerged in April, the Centers for Disease Control and Prevention had recommended testing for all suspected cases of swine flu.

Now that the flu is established as a pandemic, the public health emphasis has changed from tracing the disease's progression to containing it.

Here's what the latest developments in the swine flu epidemic mean for you:

Why the change?

One of the main reasons for widespread testing when swine flu first emerged was to determine whether the virus could be stopped. Health officials now know it can't, said Dr. Patricia Ryder, director of the disease control division of the Pinellas County Health Department.

The virus has spread to every state and U.S. territory, and is spreading rapidly in nearly every country around the world.

So the role of the state labs has shifted to identifying the severity of the illness and preventing outbreaks in group settings.

But what if I have another kind of flu? Shouldn't I be tested?

Of patients who have tested positive for flu this summer, 98 percent have been found to have swine flu, said Dr. Richard S. Hopkins, acting state epidemiologist.

But if you really want a test, private doctors still can send samples to private labs.

Has this new testing policy changed how doctors treat patients with flu symptoms?

No. Doctors continue to prescribe antiviral drugs such as Tamiflu for patients with flu symptoms who also have underlying conditions such as asthma, obesity, heart and lung disease and pregnancy that put them in high-risk categories.

For most people with flu symptoms who are otherwise healthy, doctors do not prescribe antiviral drugs; rather, they tell those patients to stay home, rest, isolate themselves and drink fluids. This is to preserve the antivirals for those who need them most. The CDC also says that the drugs have little benefit for low-risk patients.

With less testing, how will we know how many people actually have swine flu?

Even with widespread testing, it has been impossible to know how many people have contracted the virus, because for most people, the symptoms are mild.

In the U.S., for example, the CDC has reported more than 40,000 swine flu cases, but officials estimate that more than 1 million people have or have had the virus.

Both the World Health Organization and CDC have announced that they would stop tracking and reporting the number of confirmed swine flu cases.

If there's no testing, how can I know to avoid places where people have the flu?

There never has been a requirement to publicly announce flu cases. Your best defense remains personal hygiene measures.

How do I protect myself and my family?

• Cover your nose and mouth with a tissue when you cough or sneeze. Throw the tissue in the trash after you use it.

• Wash your hands often with soap and water, or use alcohol-based hand cleaners, especially after you cough or sneeze.

• Avoid touching your eyes, nose or mouth.

• Avoid contact with those who have respiratory symptoms.

• Stay home if you are sick for seven days after your symptoms begin or until you have been symptom-free for 24 hours, whichever is longer.

What's the latest on the swine flu vaccine?

Vaccine development remains a top priority. The CDC has said that up to 40 percent of Americans could get swine flu this year and next, and several hundred-thousand could die unless a vaccine campaign is successful.

U.S. government and health officials are currently recruiting people for swine flu vaccine testing, with a goal of having one approved and ready for distribution in October.

Richard Martin can be reached at rmartin@sptimes.com or (727) 893-8330.

[Last modified: Jul 28, 2009 06:37 AM]

Win Big With Quality!

FMQAI: The Florida ESRD Network is pleased to announce its 2009 Annual Forum at the Renaissance Tampa Hotel International Plaza from November 15-17, 2009. The 2009 Annual Forum will provide you with excellent opportunities to share best practices and meet with the leaders in the renal community. Please join the Network, while we focus on the CMS goals of protecting patient safety, enhancing ongoing quality improvement, and improving patients’ experience of dialysis care.

SURVIVING THE STORM:
DISASTERS AND DIALYSIS
August 3, 2009 - Dallas, Texas

RESCHEDULED!

SURVIVING THE STORM: DISASTERS AND DIALYSIS is a forum to ensure effective preparedness and efficient response to disasters impacting kidney dialysis and transplant patients and facilities.

This conference will focus on special requirements of dialysis and transplant patients, inclusion of the ESRD population in emergency and disaster plans, applying national emergency management principles to dialysis/transplant, disaster education to advance the quality of care, and weather service resources available to the kidney community.

This meeting is free and open to the public but you must register to attend. Please complete and return the registration form.

Surviving the Storm: Disasters and Dialysis
Monday, August 3, 2009
8:00 a.m. - 4:00 p.m.
Adolphus Hotel
Dallas, Texas

This agenda is tentative as of June 22, 2009. A finalized agenda will be posted soon. Please contact Sherilyn Burris, sburris@nw7.esrd.net if you have questions about this meeting or would like to exhibit your company/organization.

Hotel Reservations

A limited number of rooms at the Adolphus Hotel have been set aside for all attendees at a government rate of $115.00. To make your reservations, please contact Kolina Ford at (813) 383-1530 xt3884 or kford@nw7.esrd.net. Room reservations must be made by Monday, July 20, 2009 to receive this discounted rate.

SPOTLIGHT: LIGHTNING SAFETY

There were 756 deaths from lightning from 1990-2003.

PLAN in advance your evacuation and safety measures. When you first see lightning or hear thunder, activate your emergency plan. Now is the time to go to a building or a vehicle. Lightning often precedes rain, so don't wait for the rain to begin before suspending activities.

IF OUTDOORS...Avoid water. Avoid the high ground. Avoid open spaces. Avoid all metal objects including electric wires, fences, machinery, motors, power tools, etc. Unsafe places include underneath canopies, small picnic or rain shelters, or near trees. Where possible, find shelter in a substantial building or in a fully enclosed metal vehicle such as a car, truck or a van with the windows completely shut. If lightning is striking nearby when you are outside, you should: Crouch down. Put feet together. Place hands over ears to minimize hearing damage from thunder. Avoid proximity (minimum of 15 ft.) to other people.

IF INDOORS... Avoid water. Stay away from doors and windows. Do not use the telephone. Take off head sets. Turn off, unplug, and stay away from appliances, computers, power tools, & TV sets. Lightning may strike exterior electric and phone lines, inducing shocks to inside equipment.

SUSPEND ACTIVITIES for 30 minutes after the last observed lightning or thunder.

INJURED PERSONS do not carry an electrical charge and can be handled safely. Apply First Aid procedures to a lightning victim if you are qualified to do so. Call 911 or send for help immediately.

Ready.gov: Hurricanes

Hurricanes are severe tropical storms that form in the southern Atlantic Ocean, Caribbean Sea, Gulf of Mexico and in the eastern Pacific Ocean. Scientists can now predict hurricanes, but people who live in coastal communities should plan what they will do if they are told to evacuate.

Step 1: Get A Kit / "To-Go Bag"

• Get an Emergency Supply Kit,which includes items like non-perishable food, water, a battery-powered or hand-crank radio, extra flashlights and batteries. You may want to prepare a portable kit and keep it in your car. This kit should include:
  • Copies of prescription medications and medical supplies;
  • Bedding and clothing, including sleeping bags and pillows;
  • Bottled water, a battery-operated radio and extra batteries, a first aid kit, a flashlight;
  • Copies of important documents: driver’s license, Social Security card, proof of residence, insurance policies, wills, deeds, birth and marriage certificates, tax records, etc.

• Make sure you have a “to-go bag” ready in case you need to evacuate, include:
  • Water and non-perishable food;
  • Battery operated radio and batteries so you can get important information from local officials;
  • First aid kit;
  • Flashlight;
  • Maps
  • Important documents such as proof residence, pictures of your family including pets, insurance policies, and tax records;
  • Comfortable clothing and blankets;
  • Unique family needs such as prescription medications, pet supplies, infant supplies or any other unique need your family may have;

Step 2: Make a Plan

Prepare your family

• Make a Family Emergency Plan. Your family may not be together when disaster strikes, so it is important to know how you will contact one another, how you will get back together and what you will do in case of an emergency
• Plan places where your family will meet, both within and outside of your immediate neighborhood.
• It may be easier to make a long-distance phone call than to call across town, so an out-of-town contact may be in a better position to communicate among separated family members.
• You may also want to inquire about emergency plans at places where your family spends time: work, daycare and school. If no plans exist, consider volunteering to help create one.
• Plan to Evacuate
  • Identify ahead of time where your family will meet, both within and outside of your immediate neighborhood.
  • Identify several places you could go in an emergency, a friend's home in another town, a motel or public shelter.
  • If you do not have a car, plan alternate means of evacuating.
  • If you have a car, keep a half tank of gas in it at all times in case you need to evacuate.
  • Take your Emergency Supply Kit.
  • Take your pets with you, but understand that only service animals may be permitted in public shelters. Plan how you will care for your pets in an emergency.
• Take a Community Emergency Response Team (CERT) class from your local Citizen Corps chapter. Keep your training current.

Step 3: Be Informed

Familiarize yourself with the terms that are used to identify a hurricane.

• A hurricane watch means a hurricane is possible in your area. Be prepared to evacuate. Monitor local radio and television news outlets or listen to NOAA Weather Radio for the latest developments.
• A hurricane warning is when a hurricane is expected in your area. If local authorities advise you to evacuate, leave immediately.
• Hurricanes are classified into five categories based on their wind speed, central pressure, and damage potential. Category Three and higher hurricanes are considered major hurricanes, though Categories One and Two are still extremely dangerous and warrant your full attention.

Saffir-Simpson Hurricane Scale

Scale Number (Category)	Sustained Winds (MPH)	Damage	Storm Surge
1	74-95	Minimal: Unanchored mobile homes, vegetation and signs.	4-5 feet
2	96-110	Moderate: All mobile homes, roofs, small crafts, flooding.	6-8 feet
3	111-130	Extensive: Small buildings, low-lying roads cut off.	9-12 feet
4	131-155	Extreme: Roofs destroyed, trees down, roads cut off, mobile homes destroyed. Beach homes flooded.	13-18 feet
5	More than 155	Catastrophic: Most buildings destroyed. Vegetation destroyed. Major roads cut off. Homes flooded.	Greater than 18 feet

• Hurricanes can produce widespread torrential rains. Floods are the deadly and destructive result. Slow moving storms and tropical storms moving into mountainous regions tend to produce especially heavy rain. Excessive rain can trigger landslides or mud slides, especially in mountainous regions. Flash flooding can occur due to intense rainfall. Flooding on rivers and streams may persist for several days or more after the storm. Learn more about preparing your home or business for a possible flood by reviewing the Floods page.

Prepare Your Home

• Cover all of your home's windows with pre-cut ply wood or hurricane shutters to protect your windows from high winds.
• Plan to bring in all outdoor furniture, decorations, garbage cans and anything else that is not tied down.
• Keep all trees and shrubs well trimmed so they are more wind resistant.
• Secure your home by closing shutters, and securing outdoor objects or bringing them inside.
• Turn off utilities as instructed. Otherwise, turn the refrigerator thermostat to its coldest setting and keep its doors closed.
• Turn off propane tanks.
• Ensure a supply of water for sanitary purposes such as cleaning and flushing toilets. Fill the bathtub and other large containers with water.

Prepare Your Business

Plan to stay in business, talk to your employees, and protect your investment.

• Carefully assess how your company functions, both internally and externally, to determine which staff, materials, procedures and equipment are absolutely necessary to keep the business operating.
• Identify operations critical to survival and recovery.
• Plan what you will do if your building, plant or store is not accessible.
  • Consider if you can run the business from a different location or from your home.
  • Develop relationships with other companies to use their facilities in case a disaster makes your location unusable.
• Learn about programs, services, and resources at U.S. Small Business Administration.

Listen to Local Officials
Learn about the emergency plans that have been established in your area by your state and local government. In any emergency, always listen to the instructions given by local emergency management officials.

Federal and National Resources

Find additional information on how to plan and prepare for a hurricane by visiting the following resources:

• Federal Emergency Management Agency
• NOAA Watch
• American Red Cross
• U.S. Environmental Protection Agency
• U.S. Department of Health and Human Services, Center for Disease Control

Pandemic Flu: Lessons From the Frontlines

http://healthyamericans.org/reports/?reportid=64

Trust for America's Health (TFAH), the Center for Biosecurity, and the Robert Wood Johnson Foundation (RWJF) analyze the initial response to the H1N1 outbreak, Pandemic Flu: Lessons From the Frontlines, which found that U.S. officials executed strong coordination and communication and an ability to adapt to changing circumstances, but it also how quickly the nation's core public health capacity would be overwhelmed if an outbreak were more severe or widespread.


The Pandemic Flu: Lessons From the Frontlines report reviews 10 early lessons learned from the response to the H1N1 (swine) flu outbreak, 10 ongoing core vulnerabilities in U.S. pandemic flu preparedness, and case studies of challenges communities around the country faced when responding to the outbreak. The 10 early lessons learned from the 2009 H1N1 outbreak in the report were that:

1. Investments in pandemic planning and stockpiling antiviral medications paid off;
2. Public health departments did not have enough resources to carry out plans;
3. Response plans must be adaptable and science-driven;
4. Providing clear, straightforward information to the public was essential for allaying fears and building trust;
5. School closings have major ramifications for students, parents and employers;
6. Sick leave and policies for limiting mass gatherings were also problematic;
7. Even with a mild outbreak, the health care delivery system was overwhelmed;
8. Communication between the public health system and health providers was not well coordinated;
9. WHO pandemic alert phases caused confusion; and
10. International coordination was more complicated than expected.

The report also identifies some surprises encountered during the H1N1 outbreak, including that much of the world's pandemic planning had revolved around the potential threat of the H5N1 (bird) flu virus, which had been circulating in Asia and elsewhere for nearly a decade. It also reveals that planners anticipated there would be six weeks of lead time between the time a novel flu virus was identified and its spread to the United States.

In addition, according to the analysis in Pandemic Flu: Lessons From the Frontlines, there are a number of systemic gaps in the nation's ability to respond to a pandemic flu outbreak. To further strengthen U.S. preparedness, the following 10 core areas must be addressed:

1. Maintaining the Strategic National Stockpile - making sure enough antiviral medications, vaccinations, and equipment are available to protect Americans, which includes replenishing the stockpile when medications and supplies are used;
2. Vaccine development and production - enhancing the biomedical research and development abilities of the United States to rapidly develop and produce a vaccine;
3. Vaccinating all Americans - ensuring that all Americans would be able to be inoculated in a short period of time;
4. Planning and Coordination - improving coordination among federal, state, and local governments and the private sector preparedness and planning activities on an ongoing basis, including taking into account how the nature of flu threats change over time;
5. School closings, sick leave, and community mitigation strategies - improving strategies to limit the spread of disease ensuring all working Americans have sick leave benefits and that communities are prepared to limit public gatherings and close schools as necessary;
6. Global coordination - building trust, technologies, and policies internationally to encourage science-based, consistent decision making across borders during an outbreak;
7. Resources - providing enough funding for the on-the-ground response, which is currently under funded and overextended;
8. Workforce - stopping layoffs at state and local health departments and recruiting the next generation of public health professionals;
9. Surge capacity - improving the ability for health providers to manage a massive influx of patients; and
10. Caring for the uninsured and underinsured - ensuring that all Americans will receive care during an emergency, which limits the spread of the contagious disease to others, and making sure hospitals and health care providers are compensated for providing care.

Free registration for First Aid and CPR with AED

In support of National Safety Month, the National Safety Council is offering free registration for "First Aid and CPR with AED."

Free Online Training (through June 7)

"First Aid and CPR with AED" can make the difference between life and death. Every year 1.1 million people in the U.S. have a heart attack and about half of them die. Many could have been saved if help came faster.

Registration is free through June 7 at www.nscfirstaid.com/nationalCPRweek.

Register as a "new student" and create your own login ID and password. Free registration is only until June 7. Once registered, you have 45 days to complete the course.

Hurricane Preparedness Week

Atlantic Hurricane Season begins June 1. Hurricane Preparedness Week is May 24-30. Each day of the week focuses on a different aspect of hurricane preparedness. Visit http://www.nhc.noaa.gov/HAW2/english/intro.shtm

ATLANTIC BASIN SEASONAL HURRICANE FORECAST FOR 2009
Forecast Parameter and 1950-2000 Climatology (in parentheses) Issue Date 9 April 2009

• Named Storms: 12
• Named Storm Days: 55
• Hurricanes: 6
• Hurricane Days: 25
• Intense Hurricanes: 2
• Intense Hurricane Days: 5

PROBABILITIES FOR AT LEAST ONE MAJOR (CATEGORY 3-4-5) HURRICANE LANDFALL ON EACH OF THE FOLLOWING COASTAL AREAS:

1. Entire U.S. coastline - 54% (average for last century is 52%)
2. U.S. East Coast Including Peninsula Florida - 32% (average for last century is 31%)
3. Gulf Coast from the Florida Panhandle westward to Brownsville - 31% (average for last century is 30%)
4. Average major hurricane landfall risk in the Caribbean

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

May 8, 2009 3:30 PM ET

These recommendations supplement the Centers for Disease Control and Prevention's Interim Guidance for Infection Control for Care of Patients with Confirmed or Suspected Swine Influenza A (H1N1) Virus Infection in a Healthcare Setting. This information is provided to clarify novel influenza A (H1N1) virus infection control recommendations that are specific to outpatient hemodialysis centers. This information complements, but does not replace the general infection control recommendations for novel influenza A (H1N1).

1. Hemodialysis patients meeting criteria for isolation precautions for novel H1N1 influenza (confirmed, probable, or suspected novel H1N1 infection – see guidance on case definition) may be dialyzed in outpatient dialysis centers if they would not normally be referred to a higher level of care based on their symptomatology. Patients should be triaged at or prior to arrival at the facility and symptomatic patients with febrile respiratory illness (defined as fever [greater than 37.8° Celsius] plus one or more of the following: rhinorrhea or nasal congestion; sore throat; cough) should be segregated from other patients as soon as possible.
2. Patients should wear a surgical mask and be placed in a separate room (if available) for dialysis with the door closed. Hepatitis B isolation rooms used to dialyze hepatitis B surface antigen positive patients should not be used for these patients unless: 1) the patient with suspected or confirmed novel H1N1 influenza virus is hepatitis B surface antigen positive or 2) the facility has no hepatitis B surface antigen positive patients who would require treatment in the isolation room.
3. If a separate room is not available, the patient should wear a surgical mask and should be treated at a corner or end-of-row station, away from the main flow of traffic if available. The patient should be separated by at least 6 feet from the nearest patient stations (in all directions). If a facility has more than one patient meeting criteria for novel H1N1 influenza isolation precautions, consideration should be given to cohorting these patients and the staff caring for them together in the unit and/or on the same shift.
4. Contact and Standard Precautions with eye protection (goggles or face shield) should be used by healthcare personnel when coming within 6 feet of patients meeting criteria for novel H1N1 influenza isolation precautions. This includes the use of a N95 respirator, nonsterile gloves and gown. Respirators, gowns and gloves should be removed and discarded and hand hygiene, with soap and water or alcohol based hand sanitizer, performed prior to leaving the dialysis station.
5. As with all hemodialysis patients, all supplies taken to the station should be reserved for that patient alone and either discarded after use or cleaned and disinfected prior to use by another patient (information available at the MMWR report: Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients).
6. Equipment such as chairside computers used for medical charting, should be utilized for that patient alone during the treatment of that patient and appropriately cleaned and disinfected before use for another patient
7. Environmental surfaces should also be cleaned and disinfected in accordance with standard facility protocols after the patient has vacated the station and before setting up the machine and arrival of a new patient into that station
8. Precautions should be kept in place for 7 days after the onset of the patient's symptoms or at least 24 hours after symptoms have resolved, whichever is longer.

CDC: Hepatitis B Vaccine Shortage

http://www.cdc.gov/vaccines/vac-gen/shortages/default.htm

In December 2008, Merck communicated with CDC that it expected to deplete available adult and dialysis formulations of their hepatitis B vaccine, Recombivax HB® in the first quarter of 2009. Once depleted, these formulations will be unavailable for the remainder of 2009. Supply of GSK's Adult hepatitis B vaccine (Adult Engerix-B®) and Adult hepatitis A/hepatitis B combination vaccine (Twinrix®) is sufficient to meet demand for routine adult usage of this vaccine as well as CDC's ongoing High Risk Adult Hepatitis B Initiative.

FDA: Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Audience: Diabetes healthcare professionals, patients

Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit

Pandemic Preparedness for Dialysis Patients and Providers

Over the past few years, the KCER Coalition's Pandemic Preparedness Response Team has worked diligently developing information and resources for pandemic planning for the kidney community. Their webpage (www.kcercoalition.com/pandemic.htm) is filled with free resources to help patients prepare themselves and to assist dialysis facilities in developing their pandemic plans.

Some documents of interest are:

PANDEMIC PREPAREDNESS: MOST IMPORTANT THINGS TO KNOW

PANDEMIC FLU PLANNING CHECKLIST FOR INDIVIDUALS WITH CHRONIC KIDNEY DISEASE AND THEIR FAMILIES

RECOMMENDATIONS FOR DEVELOPING A DIALYSIS FACILITY PANDEMIC PLANNING CHECKLIST

Patient Education!

Part of the CMS Conditions for Coverage require dialysis facilities to provide patient education on emergencies - including pandemic influenza. There are many resources available to promote patient education in your dialysis facility.

http://cdc.gov/h1n1flu/ The CDC is a clearinghouse for everything you need to know about swine flu (H1N1).

http://www.pandemicflu.gov/ One-stop access to U.S. Government swine, avian and pandemic flu information.

http://www.ready.gov/ "Ready's" pandemic influenza information

http://www.kcercoalition.com/ The KCER Coalition provides free educational resources, as well as useful links for swine flu.

H1N1 Flu (swine flu) - Florida

All Florida ESRD patients and providers should continue to monitor the CDC website for updated information regarding influenza and healthcare settings. All Florida residents should listen to their local media (television, radio, internet) for information specific to your area. Click here to find your local health department.

The Miami Herald reported three suspected cases in Florida. While there are still no confirmed cases, it is critical to remember the CMS Conditions for Coverage require all ESRD facilities have a plan for dealing with emergencies, including pandemic influenza.

Florida Wildfire Update

Florida - Deep Fire Update, - Broward & Collier Counties

Florida EOC is at activation Level III (monitoring). The Deep Fire has burned approximately 24,000 acres within Big Cypress National Preserve. The fire is 30% contained. No structures or facilities have been impacted, and there has been no request for Federal assistance. Crews continue burnout operations as a suppression strategy, while monitoring for and extinguishing spot fires. Because these operations are expected to impact visibility, Interstate 75 will remain closed until at least mid-day on Tuesday, and will reopen pending more favorable conditions. State Road 29 will remain closed until further notice. Big Cypress National Preserve has enacted some recreational access closures.

KCER Pandemic Team Monitors U.S. Swine Flu Outbreak

The Kidney Community Emergency Response (KCER) Coalition's Pandemic Preparedness Team is actively monitoring the U.S. swine flu outbreak. KCER has distributed information to the ESRD Networks and is avaliable for technical assistance. Please visit www.kcercoalition.com for pandemic preparedness information and resources for the kidney community.

FDA Recalls Zoll AED Plus Defibrillator, Digoxin

ZOLL AED Plus Defibrillator

Audience: Emergency medical personnel
[Posted 04/09/2009] ZOLL Medical Corporation and FDA notified healthcare professionals of a Class 1 recall of ZOLL AED Plus Defibrillators distributed from May, 2004 through February 9, 2009. The recall was initiated because the device may fail to deliver a defibrillation shock, which could result in failure to resuscitate a patient during treatment of sudden cardiac arrest. On February 12 and March 31, 2009, the company sent their distributors and customers recall letters with recommendations and instructions for customers on specific steps to mitigate the identified problems with this device. Please visit http://www.fda.gov/cdrh/recalls/recall-021209b.html and http://www.zollaedplusbatteryhelp.com/

Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)

Audience: Pharmacists, cardiology healthcare professionals, consumers
[Posted 04/01/2009] Caraco Pharmaceutical Laboratories and FDA notified healthcare professionals of a consumer-level recall of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin, a drug product used to treat heart failure and abnormal heart rhythms. The drug has a narrow therapeutic index and the existence of higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consumers with the recalled product should return these products to their pharmacy or place of purchase. Please visit http://www.fda.gov/oc/po/firmrecalls/caraco03_09.html

Florida flooding update, state emergency hotline activation

U.S. Highway 90 at the Suwannee River bridge (Madison and Suwannee County line) has closed to all traffic due to high water and flood conditions.

U.S. 90 Closed At The Suwannee River - Detour Route: http://www.floridadisaster.org/eoc/PressReleases2008/90%20Closure.pdf

The State Emergency Operations Center (SEOC) in Tallahassee has activated to a Level 1, or full activation, in response to the flooding conditions in the Panhandle and Big Bend regions of the state.

The Florida Emergency Information Line (FEIL) is now operational from 7 a.m. to 7 p.m. daily to provide residents information on current events and safety measures. The number for residents to call is:
800-342-3557

State of Florida - State Emergency Response Team
FOR IMMEDIATE RELEASE
CONTACT: ESF-14 Public Information

April 6, 2009
(850) 921-0217

STATE OF FLORIDA PREPARES FOR NORTH FLORIDA ROAD CLOSURES DUE TO FLOOD CONDITIONS ALONG THE SUWANNEE RIVER

TALLAHASSEE - State transportation, law enforcement and emergency management officials are preparing for the flooding of major roads in North Florida along the Suwannee River due to recent heavy rains in the region.

According to the Southeast River Forecast Center in Atlanta, the high levels of the Suwannee River could force the closure of U.S. 90 at the Suwannee River (Madison and Suwannee County line) as early as Wednesday.

If river water levels continue to rise, Interstate 10 (I-10) at the Suwannee River Bridge could also face closure as early as Thursday.

As a safety precaution, motorists are asked to delay or avoid travel through the impacted area until the conditions improve. Many smaller roads along the Suwannee River will be impacted as well over the
weekend.

To assist travelers, the state of Florida is coordinating response efforts with the state of Georgia to develop alternative routes through the region.

All motorists are advised to monitor their local media outlets for the latest information on weather conditions and possible road closures.

For real-time information on traffic conditions call 511 or visit www.FL511.com before getting on the road.

For additional information please visit www.FloridaDisaster.org

All students, teachers and parents can find educational information and free downloadable materials at: www.KidsGetAPlan.com

And for the latest daily situation and flash reports go to: www.YouTube.com/FloridaSERT

Flood alerts - Turn Around, Don't Drown

The southeast region of the United States is expecting moderate to major flooding. The National Weather Service is issuing watches and warning for flooding in the Gulf Region. Residents should monitor their local weather service office.

Resources are also available from:

• Southeast River Forecast Center http://www.srh.noaa.gov/alr/index.shtml
• Significant River Flood Outlook http://www.hpc.ncep.noaa.gov/nationalfloodoutlook/index.html
• Advanced Hydrologic Prediction Service http://www.weather.gov/ahps/

Flood alerts - Turn Around, Don't Drown

The southeast region of the United States is expecting moderate to major flooding. The National Weather Service is issuing watches and warning for flooding in the Gulf Region. Residents should monitor their local weather service office.

Resources are also available from:

• Southeast River Forecast Center (http://www.srh.noaa.gov/alr/index.shtml
• Significant River Flood Outlook (http://www.hpc.ncep.noaa.gov/nationalfloodoutlook/index.html
• Advanced Hydrologic Prediction Service (http://www.weather.gov/ahps/

Flood Safety Awareness Week! March 15-21.

http://www.floodsmart.gov/floodsmart/pages/landing_pages/landing_noaa.jsp?WT.mc_id=FEMA_NOAA

Floodwaters can be swift, powerful and, at times, deadly. However, advanced planning can help protect lives and minimize property losses due to flooding. With the spring thaw approaching, NOAA's National Weather Service and FEMA are partnering to observe the fifth annual Flood Safety Awareness Week, March 16-20, 2009.

The National Weather Service, along with FEMA's FloodSmart program, has launched a new Web page (www.floodsmart.gov/floodsmart/pages/landing_pages/landing_noaa.jsp?
WT.mc_id=FEMA_NOAA) that shows the effects and cost of flooding to millions of people in the United States. The site also provides essential information on what to know and do before, during and after a flood, and a variety of safety tips and online tools, including one that lets them see whether their homes and businesses are threatened at various flood stages.

"Floods claim nearly 100 lives and cost billions in property damage in the United States annually," said Jack Hayes, director of NOAA's National Weather Service. "Spring is peak flood season in many parts of the country, but floods can happen anywhere, at any time of the year. Many lives could be saved by following some simple and essential flood safety tips."

"Knowing what you can do to protect against the impact of flooding is critical in keeping your family, home and financial well-being secure," said Ed Connor, acting federal insurance administrator for FEMA's Mitigation Directorate. "Purchasing flood insurance is one important step you can take now. Many residents incorrectly believe that homeowners insurance covers the costs of flooding, but in fact, only a flood policy can." (Excerpt from www.noaanews.noaa.gov/stories2009/20090313_floodsafety.html)

FDA Notice: Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter recalled

FDA notified healthcare professionals of a Class 1 Recall of model numbers Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. These products were manufactured and distributed from February, 1997 through December, 2008. The company identified software and battery usage failures that result in a delay in or interruption of infusion that may cause serious injury and/or death. Baxter sent a letter to all of its customers, which included advice and instructions to institutions using the infusion pumps.

Read the MedWatch 2009 safety summary, including a link to the Recall Notice, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#Colleague

The importance of patient identification cards

In mid-November 2008, the Kidney Community Emergency Response (KCER) Coalition mailed out lavender-colored patient identification cards to all dialysis facilities. The purpose of these cards is to assist in identifying a dialysis patient to emergency management, special needs shelter staff, and law enforcement that the individual needs access to treatment. Additionally, these cards provide a space for the local ESRD Network patient hotline, and other spaces for critical emergency information.

For more about the lavender patient cards or to print more cards, please visit http://www.kcercoalition.com/lavender.htm

FDA Notice: CellCept

As directed, the Kidney Community Emergency Response (KCER) Coalition is providing this alert notice. Please share this information with your organization’s stakeholders, ESRD Network (facilities, patients), your State Agency contacts, and your staff. These notices will also be posted on the KCER website, http://www.kcercoalition.com/alerts.htm. Thank you!

CellCept (mycophenolate mofetil)

Audience: Renal, cardiac, and hepatic transplantation healthcare professionals
FDA and Roche Laboratories notified healthcare professionals of the introduction of a CellCept Medication Guide to provide important safety information in language that patients can easily comprehend. FDA regulations require a pharmacist to distribute a copy of the Medication Guide to every patient who fills a CellCept prescription from this point forward. FDA has also required the introduction of a Medication Guide for mycophenolic acid, marketed as Myfortic by Novartis.

Read the complete MedWatch 2009 Safety summary including links to the Dear Healthcare Professional and Dear Pharmacist letters, the new Medication Guide and the current Prescribing Information, at:

http://www.fda.gov/medwatch/safety/2009/safety09.htm#CellCept

CDC lanches SNAPS: Snap Shots of State Population Data

http://emergency.cdc.gov/snaps/

SNAPS provides local-level community profile information nationwide. It can be browsed by county and state and searched by zip code. SNAPS serves as a valuable tool when responding to public health emergency events at the state, Tribal, and local levels. It provides a "snap shot" of key variables for consideration in guiding and tailoring health education and communication efforts to ensure diverse audiences receive critical public health messages that are accessible, understandable, and timely.

SNAPS data is derived from the 2000 US Census and several 2003 CDC databases. For more information, see Credits.

FDA Alert: Innohep (12/31/08)

Celgene has issued a Dear Healthcare Professional letter describing a controlled clinical study suggesting that Innohep may increase the risk for death, compared to unfractionated heparin when used to treat elderly patients with renal insufficiency. It recommended consideration of alternatives to Innohep when treating these patients for deep vein thrombosis with or without pulmonary embolism.

Read the complete MedWatch 2008 Safety summary, including a link to the Dear Healthcare Professional letter and the December 2 FDA Ongoing Safety Review, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Innohep