| H1N1 Information |
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December 27, 2009
Dear DOH Partners:
This is the 18th edition of a weekly summary of critical updates and activities the Florida Department of Health will disseminate to assist with H1N1 activities.
NATIONAL
Updated Interim Recommendations: Special Considerations for Clinicians Regarding 2009 H1N1 Influenza in Severely Immunosuppressed Patients
These interim recommendations refer to patients who are severely immunosuppressed as a result of receiving treatment for malignancies; or as a result of receiving treatment related to solid organ or hematopoietic stem cell transplants; or as a result of autoimmune conditions and treatment.
Non-Safety-Related Voluntary Recall of Certain Lots of Sanofi Pasteur 2009 H1N1 Pediatric (0.25 mL, for 6-35 month olds) Vaccine in Pre-Filled Syringes
In recent testing of the amount of antigen in its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels. The manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine.
H1N1 Flu (Swine Flu): Resources for Pregnant Women
This is a quick overview of what pregnant women need to know about 2009 H1N1 flu.
It is in downloadable format for use in doctor's offices or by individuals.
H1N1 Flu (Swine Flu): Resources for Obstetric Health Care Providers
This is a quick overview of what pregnant women need to know about 2009 H1N1 flu.
It is in downloadable format for use in doctor's offices or by individuals.
Additional information released included CDC guidance updates, fact sheets, frequently asked questions & answers on H1N1 for African Americans, influenza hospitalizations and deaths, deaths relating to American Indians and Alaska Natives, in addition to an update in the international H1N1 situation. To view these and other updates, visit CDC's "What's New" section at: http://www.cdc.gov/h1n1flu/whatsnew.htm
STATE
Due to holiday scheduling, the next Partner Flu Guidance will be issued Friday, Jan. 8, 2010.
- People with the flu or flu-like illness should wait to travel until at least 24 hours after their fever has subsided without using fever-reducing medicines.
- If you or a loved one get sick while traveling, postpone traveling home until well.
- The symptoms of 2009 H1N1 flu virus in people are similar to the symptoms of seasonal flu and include fever, cough, sore throat, runny or stuffy nose, body aches, headache, chills and fatigue.
- We recommend anyone within the priority groups get vaccinated, even if they believe they have already contracted H1N1. Unless a person has had a state laboratory confirmed case of H1N1, it can not be certain they have contracted H1N1.
Continue to utilize the following resources to obtain the most current, accurate information regarding H1N1 flu:
The Florida Department of Health's flu information website: http://www.myflusafety.com and the Healthcare and Flu clinic locations pages: http://www.doh.state.fl.us/DEMO/php/Healthcare.htm and http://www.myflusafety.com/myfluclinic.htm.
Florida-specific disease data may be found on the Department of Health's, Bureau of Epidemiology Site: http://www.doh.state.fl.us/Disease_ctrl/epi/swineflu/Reports/reports.htm
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December 16, 2009
This is an official
CDC Health Update
Distributed via Health Alert Network
December 15, 2009, 10:04 EST (10:04 AM EST)
CDCHAN-00303-09-12-15-ADV-N
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
Summary
As part of its quality assurance program, Sanofi Pasteur, Inc., performs additional routine, ongoing testing of influenza vaccines after the vaccine has been distributed to health care providers to ensure that vaccines continue to meet required specifications. In recent testing of the amount of antigen in its influenza A (H1N1) monovalent vaccine, Sanofi Pasteur found four distributed lots of single-dose, pre-filled syringe pediatric (0.25 mL.) vaccine with antigen content lower than required potency levels. The manufacturer is conducting a non-safety related voluntary recall of these affected lots of vaccine.
Background
After performing these tests, Sanofi Pasteur notified the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) that the antigen content in one lot of pediatric syringes that had been distributed to providers 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 had fallen below pre-specified limits. This means that doses from these four vaccine lots no longer meet the specifications for antigen content.
Recommendations
While the antigen content of these lots is now below the specification limit for the product, CDC and FDA are in agreement that the small decrease in antigen content is unlikely to result in a clinically significant reduction in immune response among persons who have received the vaccine. For this reason, there is no need to revaccinate persons who have received vaccine from these lots.
Providers are being asked to return any vaccine to the manufacturer in the following lots that remains unused to the manufacturer:
- 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
These lots were shipped in November and are intended for children 6 months through 35 months of age. Sanofi Pasteur will send directions for returning unused vaccine from these lots to providers.
All vaccines are thoroughly tested prior to release and shipping to determine that they meet all manufacturer and FDA standards for purity, potency and safety. The affected vaccine met all specifications at the time of release. CDC and FDA have determined that there are no safety concerns for children who have received this vaccine. Sanofi Pasteur has discontinued distribution of the 0.25 mL syringes of H1N1 pediatric vaccines.
The drop in antigen content below the required specification that is described here is specific to Sanofi Pasteur's pediatric H1N1 monovalent vaccine in 0.25 mL pre-filled syringes. The same vaccine packaged in other forms, such as 0.5 mL pre-filled syringes for older children and adults and multi-dose vials, continue to meet specifications.
The antigen content in the affected lots of vaccine is only slightly below the specification limit. The slightly reduced concentration of vaccine antigen found in retesting these lots is still expected to be effective in stimulating a protective response. 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. So, 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.
For children 6 months of age and older, vaccine is available in multidose vials. The vaccine in multidose vials is safe and effective vaccine for children. One difference between vaccine in pre-filled syringes and the multidose vials is that the multidose vials contain a preservative (thimerosal) to prevent potential contamination after the vial is opened. The standard dose for this preparation for administration to infants 6-35 months old 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. The nasal spray vaccine is produced in single units that do not contain thimerosal.
For More Information:
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December 14, 2009
Dear DOH Partners:
This is the 17th edition of a weekly summary of critical updates and activities the Florida Department of Health will disseminate to assist with H1N1 activities. Please forward to appropriate parties.
NATIONAL
Updated Interim Recommendations for the Use of Antiviral Medications in the Treatment and Prevention of Influenza for the 2009-2010 Season
Information regarding use of intravenous peramivir under an emergency use authorization. Information on availability of renal dosing for peramivir. Updated oseltamivir dosing instructions for children younger than 1 year of age based on weight.
New: In The News Question & Answer on Antiviral Usage During the Pandemic
Significant increases in the proportion of hospitalized adults and children being treated with influenza antiviral drugs have been noted during the 2009 H1N1 pandemic compared to the proportion of adults and children that have been treated with flu antiviral drugs during past seasonal influenza epidemics.
New: Caring for Someone Sick at Home
Will you know what to do if someone in your home gets the flu? This new online guide from CDC provides step-by-step instructions on how to care for someone sick in your home. Learn what you can do to help your family this flu season.
Reporting H1N1-related Fraud and Abuse to CDC
Due to recent concerns regarding suspected cases of H1N1 influenza vaccine fraud and abuse, a separate 'fraud and abuse' e-mail box has been established by the Centers for Disease Control and Prevention (CDC). State/local health departments can report cases of suspected fraud and abuse via e-mail to: H1N1FraudAbuse@cdc.gov . Suspected cases of theft and/or counterfeit should be immediately reported to the 'CDC H1N1 Fraud and Abuse' e-mail box. Additional guidance regarding suspected fraud and abuse is pending review and will be posted on the CDC H1N1 Influenza Vaccination website at a later date.
2009 H1N1 Flu and Travel
To help holiday travelers stay healthy, the CDC launched a new information campaign about traveling during the 2009-2010 flu season. Visit this website for tips, posters and guidance.
Additional information released included CDC guidance updates, fact sheets, frequently asked questions & answers on H1N1, brochures and translations on several topics, in addition to: a Special Edition on FluAid, FluSurge, FluWorkLoss, and an update in the international H1N1 situation. To view these and other updates, visit CDC’s “What’s New� section at: http://www.cdc.gov/h1n1flu/whatsnew.htm
STATE
Florida-specific disease data may be found on the Department of Health’s, Bureau of Epidemiology Site: http://www.doh.state.fl.us/Disease_ctrl/epi/swineflu/Reports/reports.htm
The process used to produce the H1N1 flu vaccine is the same process used for seasonal flu vaccine, which has a strong and proven safety track record.
All H1N1 flu vaccines have undergone the same Food and Drug Administration (FDA) approval processes for manufacturing, testing and quality control as seasonal flu vaccines. Both seasonal and H1N1 flu vaccines are known to be safe when used as directed.
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Continue to utilize the following resources to obtain the most current, accurate information regarding H1N1 flu:
The Florida Department of Health's flu information website: http://www.myflusafety.com
The Healthcare Professionals page: http://www.doh.state.fl.us/DEMO/php/Healthcare.htm
The Vaccine Clinic Locations page: http://www.myflusafety.com/myfluclinic.htm.
Your local county health department: http://www.floridashealth.com
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December 4, 2009
Dear DOH Partners:
This is the 16th edition of a weekly summary of critical updates and activities the Florida Department of Health will disseminate to assist with H1N1 activities. Please forward to appropriate parties.
NATIONAL
This week the CDC released the following important information:
Some providers have reported receiving a potentially fraudulent e-mail similar to the attachment below. The e-mail appears to come from CDC but instead points users to a fake website that may be phishing for personal information. Immunization partners are advised to avoid clicking on embedded links to sites that are not familiar to them. Immunization partners should also consider advising providers of H1N1 vaccine that fraudulent e-mails may be circulating.
Again, if you receive such an e-mail or have questions about the authenticity of e-mails received from CDC, please avoid clicking on any embedded links. You may verify the authenticity of any suspect e-mails with an IT specialist in your agency or you may contact the CDC to verify the sender is a CDC employee.
Alert: Fraudulent emails referencing CDC-sponsored State Vaccination Program
CDC has received reports of fraudulent emails (phishing) referencing a CDC sponsored State Vaccination Program.
This recent e-mail from CDC discussed a fraudulent e-mail requesting information about persons receiving vaccination and has created questions from Florida H1N1 vaccination providers. This is entirely different from the following legitimate request to providers by the Florida DOH to participate in the survey described below:
The FL DOH H1N1 Incident Management Team is conducting an H1N1 Vaccine Target Group Surveillance Project to help estimate the uptake of vaccine by our priority target populations. H1N1 Vaccine Providers are being recruited for this specific study and are being requested to provide information on target groups for persons receiving H1N1 vaccinations. H1N1 Vaccine Providers that are registered in Florida SHOTS are being randomly selected to participate each week. We request that you record information about the H1N1 vaccinations that you are giving on one day during the week that your site was selected. We are not collecting any personal identifying information and we are not requesting you to go to any website to record information. After you collect information according to the instructions provided, you will be faxing the information to the Bureau of Epidemiology's confidential fax line. Again, this study is legitimate and is in no way connected to the fraudulent CDC email. We appreciate your participation as we evaluate the progress of our H1N1 vaccination campaign.
NEW: Caregiver Instruction Sheet: Opening and Mixing Tamiflu® Capsules
with Liquids if Child Cannot Swallow Capsules -
This document provides instructions for caregivers on how to open and mix Tamiflu® capsules with a thick sweetened liquid for children who cannot swallow capsules.
Update: Interim Guidance for Management of Influenza-Like Illness aboard
Commercial Aircraft during the 2009-10 Influenza Season -
This document provides updated guidance regarding management of influenza-like illness (ILI) before, during and after a flight, including personal protective measures for the crew, and reporting of ILI to CDC Quarantine Stations.
Additional information released included CDC guidance updates, fact sheets, questions & answers, brochures and translations on several topics, in addition to: parents who have children with high-risk medical conditions, a toolkit for K-12 schools, Q and As on H1N1 vaccine financing, and an update in the international H1N1 situation. To view these and other updates, visit CDC's "What's New" section at: http://www.cdc.gov/h1n1flu/whatsnew.htm
STATE
DOH has received multiple inquires about transferring H1N1 vaccines between various H1N1 registered providers. After reviewing this matter with Medical Quality Assurance (MQA), we are providing the following guidance. At this point, this guidance applies only to the distribution, redistribution, and transfer of H1N1 influenza vaccines.
County Health Departments (CHDs) are responsible for approving, documenting, and accounting for All H1N1 vaccine transfers between the following registered H1N1 registered providers.
1. Vaccine transfers from one CHD to another CHD.
2. Vaccine transfers between the CHD and a local H1N1 registered provider(s).
3. Vaccine transfers between a local H1N1 registered provider and another local H1N1 registered provider. These transfers must be approved and written documentation maintained (i.e., vaccine transfer log) by the CHD.
It is important to stress that proper storage and handling of the vaccine must be maintained during all vaccine transfers. It is also essential that CHDs ensure appropriate documentation of vaccine adjustments and transfers in Florida SHOTS for H1N1 inventory accountability. Please call the Florida SHOTS Help Desk at (888) 877-7468 if you have questions regarding inventory adjustments and Laura Rutledge at (850) 245-4342 for questions regarding the vaccine transfer process.
Continue to utilize the following resources to obtain the most current, accurate information regarding H1N1 flu:
The Florida Department of Health's flu information website: http://www.myflusafety.com and the Healthcare and Flu clinic locations pages: http://www.doh.state.fl.us/DEMO/php/Healthcare.htm and http://www.myflusafety.com/myfluclinic.htm
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November 16, 2009
A few additional comments have been received regarding PPE. The guidelines provided by DOH last week are posted at www.myflusafety.com and the link to the location is GuidelinesforLocalEMHealthCarePPE-SBreview.pdf.
You are encouraged to work with your local health department and/or emergency management office on PPE issues.
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November 9, 2009
Greetings H1N1 POCs,
In our efforts to expand our communication networks, we have been reaching out to additional associations and have some new people in our group that I would like to welcome. We appreciate you participating in our continued efforts to share H1N1 Information.
As a follow up to our conference call yesterday (11-5-09):
1. The Bureau of Immunizations, who operates the Florida SHOTS system, will send out a notice to all registered H1N1 vaccine providers of the need to re-order. This information will not be included in today's weekly update, instead this information will be sent directly to everyone registered in FL SHOTS. For those of you who were not able to be on the call, we discussed some of the mechanics of vaccine ordering and allocations. The FL SHOTS system does not have a mechanism for backfilling partial orders. So if a provider ordered 300 doses and only received 100, they would need to go back into the system and re-order 200 doses. Registered providers can go to www.flshots.com at anytime and check the status of their orders.
2. Your request for more information regarding the number of doses shipped to each county and potentially number of doses shipped to each county by facility (hospital, public, etc.) is under review. This requires further discussion within the Incident Management Team and I hope to be able to address this matter with you on next week's call.
3. Click here for the guidelines for ordering PPE. It does indicate that EM Constellation is being used.
4. Just in case you do not have the information regarding our conference calls, they are held on Thursday mornings from 10:30 - 11:00. The call in number is 888-808-6959 code 4886484.
Please let me know if you have additional questions or if I have missed anything.
Thank you and hope you have a great weekend.
AC
Anne-Carol (A.C.) Burke, M.A.
Florida Department of Health
H1N1 Information Management Branch
850-445-9265
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October 28, 2009
H1N1 SPECIAL NOTICE
At the CDC's request, the Food and Drug Administration (FDA) recently issued an emergency use authorization (EUA) for the antiviral drug Peramivir IV for use in treating critically ill patients with 2009 H1N1.
The use of Peramivir under EUA is targeted to physicians in hospital settings managing patients who are severely ill and have not responded to other antivirals. It is also for patients for whom oral or inhalational antivirals cannot be administered or won't be readily absorbed. Providers must submit a request to the CDC to use Peramivir. This can be done electronically at http://www.cdc.gov/h1n1flu/eua/peramivir.htm. As part of the conditions of the EUA, healthcare providers must report adverse events and all medication errors to FDA's MedWatch program within 7 calendar days.
For more information visit the CDC's site at http://www.cdc.gov/h1n1flu/eua/peramivir.htm , the FDA's site at Safety Alerts for HumanMedical Products or visit the Healthcare - Clinicians section of http://www.myflusafety.com/ . You can also call 1-800-CDC-INFO (1-800-232-4636) or send an email to: EUA.OCET@fda.hhs.gov.
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October 28, 2009
Of the 5 groups prioritized for H1N1 vaccination, two have more contact with pediatricians than any other health care providers - contacts of children < 6 months and people 6 months to 24 years of age. Of course, our practices also gives us ample opportunity to talk to pregnant women, and many of our patient's parents are 25-64 and with chronic health conditions. So it is important that we know what we need to get and give H1N1 vaccine.
The Florida Pediatric Society (FPS) has been in close communication with the Florida Department of Health since H1N1 came to our state. The information we share comes from the DOH and the CDC, but we will try to focus it on what you need when you need it, for there is so much out there. As the "rules and recommendations" are subject to change quickly and frequently, we will send out updates and alerts, but we also caution members to please continue to check the DOH and CDC websites directly as needed.
A simple, sample order set from the Immunization Action Coalition may be useful in many offices.
Download sample order set from the Immunization Action Coalition
At our request, the DOH compiled a more detailed Healthcare Provider Information FAQs.
Download Healthcare Provider Information FAQ
For the busy pediatrician, below we have what you need to know to get and give vaccine.
Ordering: Ordering vaccine is a two step process. You must first pre-register through Florida Shots (www.flshots.com) or directly with your County Public Health Department. After registering, you will need to go back online to actually place your order. The amount of your order does not have to correspond with the pre-registration quantity requested. After the County approves your order the vaccine will be shipped directly to your office, once available. You may not receive all that you ordered, depending on quantities available. Once you have received your shipment you can go back online and request more vaccine as needed. You will have the opportunity to specify which vaccine type (LAIV, preservative free pre-filled syringes, multi-dose vials) as long as it is available. There will be no tracking of backorders. If you received only 100 doses and ordered 300, you will need to go online and place a new order. LAIV (FluMist H1N1) and the multi-dose vials of inactivated vaccine are currently available and it is anticipated that the injectable preservative-free vaccine will be available next week.
Distribution: Distribution of H1N1 vaccine flows from the Feds (CDC) to the State DOH, which then distributes available vaccine to all counties in Florida based on county population. The local health department decides how to allocate supply within the county, and so determines how much a practice will receive. As more dosages are released nationally, more will trickle down to the individual offices. It is hoped that the bottleneck will be relieved by early to mid November as millions more dosages are put into the system. Each county can make their own "local" decisions; hence some confusion may arise when we compare one county plan to another.
Administration and Vaccine Codes: Florida Medicaid and Healthy Kids (S-CHIP) billing require the HCPCS code G9141 for Influenza A (H1N1) immunization administration and counseling, reimbursed at $10 ($8 for ARNPs). For all other patients (with or without insurance) you should use CPT code 90470 for administration of the vaccine and bill the maximum Medicare allowable for your region of the State. FPS has appealed ACHA's $10 allowable for administration as a hurdle to rapid and effective deployment of pediatric vaccination, but as of now no immediate changes are anticipated. We are scheduled to receive only half of what our colleagues practicing adult medicine will receive for immunizing their cooperative Medicare patients. The CPT code 90663 is for the vaccine itself, but patients may not be charged for the vaccine. Use V04.81 as ICD-9 diagnostic code. You may charge a patient without insurance an administration fee up to the Medicare allowable for your region of the State.
Administration and Recording of Vaccine Usage: Please remember to provide the patient (or parent) with the most current and updated VIS (attached, and available from CDC) prior to administering the vaccine. This is a federal law! Please review the VIS with the patient and make sure that all questions have been satisfactorily answered. Make sure that you record in the patient's chart the date of vaccine administration, date of VIS, route of administration, location, vaccine manufacturer, vaccine lot number, expiration date and signature of person administering the vaccine. It is recommended, but not required to record, all vaccines in Florida Shots. If the patient is not already registered in Florida Shots, please be aware that you can utilize the "rapid data screen" to enter the patient and vaccine.
Distribution by Risk Group: Identify children and adults in need of H1N1 vaccine by CDC priority guidelines, those considered to be in the high risk category include: all children between 6 months and 24 years of age; those adults age 25 through 64 years of age with chronic or serious illnesses, pregnant moms, all adults who are household contacts or caregivers for infants less than 6 months, all healthcare and emergency medical services personnel. These guidelines are subject to change based on local conditions and/or availability. Since there will be a limited supply of vaccine, at least initially, it will be up to the physician's discretion to decide whether to limit vaccination to the highest priority groups (e.g., children under 4 years, children with severe illness) or vaccinate anyone in the aforementioned categories in order not to miss any opportunity to vaccinate.
Please feel free to contact us at: 877-888-0800
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October 1, 2009
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October 23, 2009
Weekly Flu Guidance Update
NATIONAL
This week the CDC (and OSHA) released these key documents:
http://www.cdc.gov/H1N1flu/antivirals/safety_info.htm - This page will be updated periodically with new antiviral safety-related information as it becomes available. This page includes information on new warnings regarding administration of Relenza (zanamivir) Inhalation solution by nebulizer.
http://www.cdc.gov/h1n1flu/recommendations_pediatric_supplement.htm - Recommendations for Use of Antiviral Medications for the Management of Influenza in Children and Adolescent for the 2009-2010 Season -- Pediatric Supplement for Health Care Providers
http://www.cdc.gov/H1N1flu/antivirals/mixing_tamiflu_qa.htm - Opening and Mixing Tamiflu® Capsules with Liquids if Child Cannot Swallow Capsules
http://www.cdc.gov/h1n1flu/clinicians/pdf/childalgorithm2.pdf - 2009/2010 Influenza Season Triage Algorithm for Children. Guidance to assist healthcare providers, especially pediatric and family practice providers, in providing their clients H1N1 antiviral medication. The algorithm can be used regardless of whether or not the child has been vaccinated for influenza.
Additional information released included CDC guidance updates, fact sheets, questions & answers, brochures, and translations on several topics, including: treatment of HIV infected patients, the CDC Health Alert Network, H1N1 vaccine administration and billing questions and answers, antiviral safety information, information for first responders, vaccination procedures for babies, and information for pregnant women. To view these and other updates, visit CDC's "What's New" section at http://www.cdc.gov/h1n1flu/whatsnew.htm.
STATE
This week, the Florida Department of Health released information on how healthcare providers can report significant adverse events that occur after a H1N1 vaccination. Visit http://www.myflusafety.com/SwineFlu/documents/VAERSProviderLetter.pdf for more information.
Continue to utilize the following resources to obtain the most current, accurate information regarding H1N1 flu:
The toll free Florida Flu Information Line, 1-877-352-3581, is available 24/7 for recorded messages in English, Spanish and Haitian-Creole. Operators are available 8am to 8pm EST.
Florida-specific disease data may be found on the Department of Health's, Bureau of Epidemiology Site: http://www.doh.state.fl.us/Disease_ctrl/epi/swineflu/Reports/reports.htm
Healthcare providers who are interested in providing H1N1 Influenza vaccine can pre-register at http://www.flshots.com/.
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