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H1N1 Flu Situation Report
Crisis Criteria
Updated on: 3/31/2010 1:36:01 PM
CIDRAP reports that the World Health Organization's (WHO's) emergency committee of experts on February 23, 2010 recommended holding at the current pandemic alert level based on evidence of new community spread of the virus in West Africa and the possibility of a second wave of illnesses as the Southern Hemisphere enters its winter months. Members of the emergency committee were also concerned that transitioning to a post-peak pandemic phase could undermine control actions in some countries, he said, adding that the group said it would revisit the issue over the next several weeks when more epidemiological evidence is available.
On October 24, 2009, President Barack Obama declared a national emergency for 2009-H1N1. The declaration is reportedly not in response to any one incidental change, but instead is designed to quickly enable hospitals to implement disaster recovery procedural changes if necessary to respond to 2009-H1N1.
HHS Secretary Kathleen Sebelius renewed a public health emergency declaration for 2009-H1N1 in an online press release December 28, 2009.
On June 11th, the World Health Organization raised the pandemic alert to Phase 6, the highest level. It has remained at Phase 6 through the present day.
For more information on the virus' spread throughout the United States, please see FluView, the CDC's weekly influenza surveillance report.
Hospital Status
Updated on: 3/31/2010 10:40:01 AM
Distributor Status
Updated on: 3/31/2010 1:36:02 PM
The Healthcare Distribution Management Association (HDMA) has posted a website regarding distribution response to the flu situation. HDMA’s member pandemic contact list is also available on this site under “HDMA Member Contact Information for State Pandemic Influenza Planning”. States working to figure out how to distribute stockpile antivirals may wish to work with HDMA member distributors in their regions (contact HDMA for more information).
The CDC announced on February 22, 2010 that inventory capacity at CDC’s centralized distribution depots (McKesson) has been at 30 million doses of 2009 H1N1 vaccine (with comparable inventory capacity for ancillary supplies) since the program’s inception. Based on the current stage of the distribution program, CDC will maintain lower inventories of 2009 H1N1 vaccine and ancillary supplies at its centralized distribution depots as of April 1, 2010. This means that, over the next two months, CDC will gradually need to reduce inventory at the depots by approximately 50%. The goal of the reduction will be to maintain a reasonable inventory of 2009 H1N1 vaccine at the depots which will be available for order with additional vaccine in storage that could be shipped to the depots if needed. Clear here to read more.
H1N1 vaccine is being allocated to states in proportion to population. Under a centralized distribution system set up by the CDC, vaccination providers request doses from their state health department. States will screen the requests and then place orders with the CDC, which will transmit orders to McKesson Corp., the company handling the distribution.
Please click here for an update on the 2009 H1N1 Influenza Vaccine Supply Status.
Facts
Updated on: 3/31/2010 1:38:01 PM
The CDC reported on October 3rd that on the basis of samples tested, about 99% of circulating flu viruses are the novel flu strain.
Symptoms
According to the CDC, the clinical presentation of patients with uncomplicated 2009 H1N1 influenza virus infection is generally similar to seasonal influenza and includes abrupt onset of fever, cough, sore throat, myalgias, arthralgias, chills, headache and fatigue. Vomiting and diarrhea have been reported more often with 2009 H1N1 influenza than with seasonal influenza. As with seasonal influenza, some patients with 2009 H1N1 influenza will present without fever. Clinical judgment and local surveillance data for influenza and other respiratory pathogens are important in considering the differential diagnosis of patients presenting with influenza-like illness.
Transmission Characteristics
The CDC (via National Hand Hygiene Guidelines) states that H1N1 appears to transmit in the same way as the seasonal influenza. The CDC stated that the most common way influenza is transmitted from person-to-person is the so-called "droplet spread".
H1N1 influenza cannot be transmitted through consumption of pork products.
Objectives
Updated on: 3/31/2010 1:42:02 PM
These are the long-term planning issues Rx Response has identified as we proceed through a resurgence of the novel H1N1 influenza in the US this fall and winter:
*In the event that the marketplace cannot supply the demand for antivirals and H1N1 vaccine, how do private sector healthcare providers and critical infrastructure request access to state and local stockpiles? How and where should those seeking immunization receive the vaccine? For national or regional companies, standard emergency management protocols of requesting assistance from local resources have the potential to be overly burdensome, for all parties concerned. A streamlined approach is preferable. [Rx Response and the National Alliance of State Pharmacy Associations are involved in an initiative to track state-by-state registration procedures for both vaccines and antivirals. Rx Response partners can view this document by clicking here.]
*Identify the triggers for distribution of public stockpiles of antivirals. The lines of communication between the federal regulatory agencies that monitor manufacturing status of critical medicines and state public health and emergency management must remain open. This will allow for the states to better plan how and when to distribute stockpiled countermeasures. Polling pharmacies for inventory data is time consuming and the data collected is outdated by the time it is collated.
*Stockpiled antivirals at or nearing expiration. The FDA provided a release authorizing the emergency use of antivirals from the Strategic National Stockpile (SNS) at or beyond their expiration dates, and suggested that holders of stock consider keeping the product. An EUA last updated on October 31, 2009 extends authorized use to private-sector stockpiles of antivirals at or beyond their expiration date as well.
*Share information on issues inhibiting an efficient distribution of influenza-related medical supply. Rx Response seeks to be a critical partner to both its government and private-sector biopharmaceutical supply partner by positioning itself as an effective conduit of relevant and timely information.
To request access to Rx Response, please follow this link and fill out the Request Access form. For more information, contact Rx Response at contactus@rxresponse.org.
Human Health Impact
Updated on: 3/31/2010 1:40:01 PM
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced on November 2nd interim results that show that children nine years of age and younger have a significantly improved immune response when given a second 15-microgram dose of 2009 H1N1 influenza vaccine. To achieve an immune response likely to protect from illness, children nine years of age and younger should receive two 15-microgram doses of 2009 H1N1 vaccine.
NIAID also released a separate press release announcing that pregnant women - one of the most at-risk groups for H1N1 virus - mounted a robust immune response following just one dose of 2009 H1N1 influenza vaccine in an ongoing clinical trial.
As of February 13, 2010, three (3) state was reporting regional influenza activity. This count is down from forty-nine (49) states reporting widespread influenza activity as late as October 31, 2009.
Revised CDC surveillance efforts estimate that 47 million people were infected with and 9,820 people died from the novel 2009 H1N1 virus in the United States from April to November 14, while there were 213,000 H1N1-related hospitalizations during that time. This is up from 22 million people infected and 3,900 deaths estimated on October 17; 95% of the increases are thought to have occurred between October 17th and November 14th. Note that these are all mid-range estimates, so actual figures could be either higher or lower than those listed here.
Officially, there have been 40,302 laboratory-confirmed influenza-associated hospitalizations and 1,966 laboratory-confirmed influenza-associated deaths were reported to CDC from August 30, 2009 – February 13, 2010, according to the latest CDC FluView report.
The WHO reports that as of February 19, 2010, more than 212 countries and overseas territories/communities worldwide have reported laboratory confirmed cases of pandemic influenza H1N1 2009, including over 15,921 deaths. As many countries have stopped counting individual cases, particularly of milder illness, the case count is significantly lower than the actually number of cases that have occurred.
In addition, the WHO reports that intense and persistent influenza transmission continues to be reported in North America without evidence of a peak in activity. According to the CDC, more than 99.8% of circulating influenza viruses identified in the United States were 2009 H1N1 influenza as of November 14th, 2009.
The CDC stated that results from ongoing testing of novel influenza A (H1N1) viruses indicate that oseltamivir resistance remains rare. The CDC continues to recommend that the use of antiviral agents for treatment should be prioritized; zanamivir or oseltamivir are recommended for the treatment of persons with suspected novel H1N1influenza who are 1) hospitalized, or 2) at higher risk for complications due to influenza, even if hospitalization is not required. Furthermore, Dr. Tim Uyeki, a CDC flu expert, said that the spread of a Tamiflu-resistant strain may not be ongoing. Dr. Uyeki counseled that monitoring remains critical and the CDC has asked states to send more samples for resistance testing, and California said it has stepped up its testing. To read more, please click here.
Pharmaceutical Manufacturing Status
Updated on: 3/31/2010 1:42:02 PM
Vaccines:
Vaccine is allocated to each project area in proportion to its population (pro rata). Click here for updates on 2009 H1N1 Vaccine Supply Status.
The flow of vaccine to US providers has been far below earlier projections. Secretary Sebelius stated that low yields from the eggs used to grow the vaccine virus and difficulties in starting up new production lines were two main reasons for low early production numbers.
CIDRAP reports that CDC Director Thomas Frieden said they are pleased by other aspects of the vaccine. The vaccine closely matches the circulating H1N1 virus and is likely to be very effective, he said. He added that federal officials have high levels of confidence in the vaccine's safety because it is produced by the same manufacturers using the same methods as the seasonal flu vaccine, which has an excellent safety record. In a press release, MedImmune reaffirmed this, stating that the safety profile and immunogenicity of our nasal spray vaccine for the 2009 H1N1 virus is, as expected, similar to our seasonal influenza vaccine.
To read more about the vaccine production process, please see this Letter from the FDA Commissioner to Nation’s Doctors on H1N1 Vaccine.
To date, Sanofi Pasteur has committed to the U.S. government a total of 75.3 million doses of Influenza A (H1N1) 2009 Monovalent Vaccine. On September 21, MedImmune announced that the U.S. Department of Health and Human Services (HHS) has placed an order for an additional 29 million doses of its live attenuated influenza vaccine (LAIV) against the 2009 H1N1 influenza virus. This brings HHS orders to date to more than 40 million vaccine doses.
The U.S. Food and Drug Administration announced on September 15 that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and Sanofi Pasteur Inc. On November 10th, GlaxoSmithKline announced in a press release that the FDA approved its vaccine against the 2009 H1N1 virus as well.
Antivirals:
Roche announced in a December 2 press release that it has begun shipping additional quantities of Tamiflu® (oseltamivir phosphate) oral suspension (liquid). The added supplies of Tamiflu will begin arriving in pharmacies nationwide and will continue to roll out to wholesale and retail pharmacies during the next several weeks. CDC Director Thomas Frieden stated in a December 4th press release that the combination of renewed commercial supply and the release of SNS assets will mean that there should be comfortable levels of liquid Tamiflu going forward, even though there may be spot shortages.
On Nov. 17, federal officials confirmed the delivery of the U.S. government’s supply of 234,000 bottles of Tamiflu® oral suspension to all 62 project areas. The suspension was deployed after officials at the Centers for Disease Control and Prevention (CDC) identified a production gap based on information provided by Roche, the manufacturer of the suspension. This was the second phase of suspension deployment following the initial delivery of 300,000 bottles in October.
A Tamiflu Supply Letter put out by Roche on September 4, 2009 states that supplies of the Tamiflu (oseltamivir) for Oral Suspension as well as Tamiflu 30 mg and Tamiflu 45mg capsules are currently limited. David Reddy, Roche's pandemic taskforce leader, stated that because it takes 25 times more production capacity to make the pediatric liquid suspension, Roche foresaw the need for oseltamivir options for children and has focused more on developing and ramping up production of pediatric-dose capsules that were approved by the US Food and Drug Administration in 2007. Additional supplies for the oral suspension will be made available in November/December, and 30/45 mg capsules will be available in late September.
Furthermore, officials from Roche on September 11 said the company is producing Tamiflu at near-capacity levels and is collaborating on dozens of research studies, focusing on groups such as pregnant women who are at higher risk of complications from pandemic H1N1 flu. Reddy said that as of July, governments had about 270 million courses in their stockpiles and that Roche has 110 million more stockpiled.
For those who cannot swallow capsules, the 75mg capsules (which Roche has prioritized for production) can be opened and the contents mixed with food for immediate administration. If suspension is deemed the most appropriate dosage form, pharmacists may compound the suspension from 75 mg Tamiflu capsules using either of two vehicles: Cherry Syrup (Humco) or Ora-Sweet SF (sugar-free). Instructions for pharmacists can be found on the Roche Tamiflu website.
Government Status
Updated on: 3/31/2010 1:40:01 PM
On October 1, Health and Human Services Secretary Kathleen Sebelius released 300,000 pediatric doses of the antiviral drug Tamiflu (oseltamivir) from the national stockpile for distribution to states that may need it.
On September 2, the Obama administration announced that it will spend an additional $2.7 billion to buy H1N1 drugs and vaccines.
HHS wants to increase the proportion of zanamivir (Relenza) in the national stockpile relative to oseltamivir (Tamiflu), in light of a few recent instances of H1N1 resistance to the latter. The current split is 80% oseltamivir and 20% zanamivir; the agency would like to move to 50-50, but that will take time
Citing the questionable usefulness of reporting pandemic H1N1 case counts and the burden it puts on countries experiencing widespread transmission, the World Health Organization (WHO) announced on July 16 it will no longer issue regular reports of confirmed global case totals. However, it said it will provide regular updates on the spread of pandemic flu in newly affected countries. The CDC will likely make a similar move to downplay the number of confirmed cases, but it will maintain, if not expand, surveillance to gauge the health impact of the pandemic and the severity of the illness. Click here to read more.
The federal government centralized communications about H1N1 and seasonal flu on the federal government’s new Web site www.flu.gov. This one-stop comprehensive site brings together flu-related information from across HHS and other federal agencies. The expanded site builds on the pandemic planning information long presented on www.pandemicflu.gov, and incorporates information about the novel H1N1 flu as well as the seasonal flu.
On June 25, 2009, the US Centers for Disease Control and Prevention (CDC) at the Advisory Committee on Immunization Practices meeting in Atlanta issued updated guidelines for treatment of influenza, including novel H1N1, suggesting basing antiviral selection on laboratory test results when possible. The new guidance appears to be aimed at preventing the inadvertent prescription of oseltamivir (Tamiflu) for seasonal H1N1 infections, which have shown extensive resistance to oseltamivir in the United States and other parts of the world. Click here for more detail.
Department of Health and Human Services Secretary Sebelius on June 11, 2009 amended the Public Health and Emergency Preparedness (PREP) Act to include the Influenza Antivirals Oseltamivir Phosphate (Tamiflu®) and Zanamivir (Relenza®) as Covered Countermeasures, given these drug's effectiveness against the H1N1 virus and the virus' potential to evolve into an influenza strain capable of causing a pandemic of human influenza.
Pharmacy Status
Updated on: 3/31/2010 1:42:02 PM
Consistent with recently updated CDC recommendations, Roche released a letter on September 23 to raise awareness on dosing with Tamiflu for Oral Suspension. Healthcare providers and pharmacists should be aware that the oral dosing dispenser provided with Tamiflu for Oral Suspension is marked with 30mg, 45mg, and 60mg graduations, rather than graduations in milliliters (mL) or teaspoons (tsp).
To view the full letter, which includes dosing instructions in milligrams and milliliters for both treatment and prophylaxis, among other important information, please click this link.
Transportation
Updated on: 3/31/2010 10:42:02 AM
Payment Issues
Updated on: 3/31/2010 1:42:02 PM
The federal government will cover the costs of H1N1 vaccine throughout the United States. However, fees for administering the vaccine may still apply. Please see the CDC Questions and Answers on 2009 H1N1 Vaccine Financing for more information.
Federal health officials have allocated $1.5 billion to assist states with immunization planning and administration activities,Tom Frieden, MD, the CDC's director, told reporters at a press briefing on September 25.
H1N1 Guidance
Updated on: 3/31/2010 1:40:01 PM
A variety of CDC guidance to specific groups can be found at the CDC H1N1 Flu: Information for Specific Groups site. This includes guidance for parents, healthcare providers, businesses, and high-risk individuals, among other groups.
The CDC released Updated Interim Recommendations for clinicians regarding 2009 H1N1 influenza in severely immunosuppressed patients on December 16, 2009.
On November 25, 2009, the CDC updated its Resources for Pharmacists website to incorporate new lessons learned and relevant news related to 2009 H1N1.
OSHA, the Occupational Safety & Health Administration in the U.S. Department of Labor, has launched a website devoted to workplace safety and H1N1. Among the resources on this site are guidelines for both workers and employers; OSHA has divided both categories further into "Healthcare" and "All Other" groupings.
US House of Representatives' Education and Labor Committee Chairman Rep. George Miller, D-Calif., has introduced the Emergency Influenza Containment Act (HR 3991), which would guarantee any worker who is sick with flu up to 5 days paid leave. Some public health and business experts told Congress that making paid sick leave a national standard is crucial to controlling the H1N1 pandemic and future epidemics - although opinion on the perceived benefits is mixed. Click here to read more.
Updated CDC recommendations for the use of antivirals in the treatment and prevention of H1N1 of influenza is now available online.
On August 19, Department of Commerce (DOC) Secretary Gary Locke, Department of Health and Human Services (HHS) Secretary Kathleen Sebelius, and Homeland Security (DHS) Secretary Janet Napolitano announced in a press release new guidance for businesses to plan for and respond to pandemic flu. The guidance, released by the Centers for Disease Control and Prevention (CDC), is designed to help employers prepare for the impact of seasonal and 2009 H1N1 influenza. Employers’ plans should address such points as encouraging employees with flu-like symptoms or illness to stay home, operating with reduced staffing, and possibly having employees who are at higher risk of serious medical complications from infection work from home, according to the CDC guidance. Secretary Locke said the guidance suggests that companies adopt flexible, nonpunitive sick-leave policies that support one of the most important measures for preventing the spread of the virus: staying home when sick. The recommendations advise against requiring a doctor's note for returning to work, because such requests are likely to further stress an overburdened healthcare system. Please click here for a full printable version of the guidance document.
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