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Sunday, August 9, 2009

Influenza Update - novel H1N1 (2009)

Novel Influenza H1N1 (2009) Update 
MedPrep Consulting Group LLC
Dr. Stuart B. Weiss 
 INFLUENZA UPDATE
WHO PANDEMIC ALERT LEVEL 6
August 9, 2009
 
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CDC changes its guidance on how long to stay home, Federal officials issues new guidance on school closures and vaccine clinical studies begin.....boy its been a busy week.
Governments in North America have really turned up the heat on pandemic flu preparedness. President Obama is in Mexico for talks with the President of Mexico and the Prime Minister of Canada. A big topic on their agenda is mutual cooperation in responding to the resurgence of H1N1 expected in the next 6-8 weeks.
 
 Current Situation:
  • The CDC issued new guidance regarding how long sick individuals should stay home from work. The CDC issued new guidance based on the epidemiological data from the spring outbreak of novel H1N1 (2009). The new recommendations for non healthcare settings recommends that sick individuals stay home until they are free from fever (without fever reducing medicine) for 24 hours. This is a change from previous recommendations that they stay home for 7 days or fever-free for 24 hours, whichever was longer. Based on data from the spring, the average length of time people had fever was 2 -4 days so this new recommendation would result in 3-5 days of absenteeism in most cases. The new guidance can be found at: http://www.cdc.gov/h1n1flu/guidance/exclusion.htm
  • Federal officials issued new guidance for school closure. It can be found at: http://www.cdc.gov/h1n1flu/schools/schoolguidance.htm The new guidance discusses that if the H1N1 comes back with the same illness pattern and is not causing worse disease, the benefits of closing schools may not outweigh the negative aspects of children left home alone, parents missing work to watch the children, students missing meals and interruptions in education. If the flu comes back worse, there is a stronger case for closures. There is much more guidance in the document.
  • There was much discussion about vaccines and vaccine safety in the media this past week. The WHO held a press conference on this topic this past Thursday. The reported that there are 7 manufacturers with clinical trials in progress in 5 countries (China, Australia, UK, Germany and U.S.). They should have study results in September. That should lead to vaccine being licensed for use by late September / early October. WHO information on vaccines can be found at: http://www.who.int/csr/disease/swineflu/notes/h1n1_safety_vaccines_20090805/en/index.html
  • Health Experts are predicting that up to 1/3 of the world's population (2 billion people) may contract this new flu.
 
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ANALYSIS:
  
The updated guidance from the CDC on how long to stay home makes sense based on the data from the Spring outbreak. While this is based on the data showing that the maximal amount of viral shedding occurred when people had fever, there still was lower levels of viral shedding for up to ten days after people were symptom free. Therefore, workers who return to work must be counseled to practice good cough/sneeze etiquette, hand hygiene and to avoid close contact with people with known increased risk (pregnant workers, workers with underlying medical cardiac or respiratory conditions, workers living or caring for others at increased risk). We have sent updated policy recommendations to our clients to bring their policies into alignment with this new information. You should make certain that you have looked at your policies as well.
 
There continues to be concern over vaccine safety. We will know much more as clinical trials continue but I want to stress that there are many years worth of experience with influenza vaccines and much is known about their safety. Some of the vaccine being produced uses the same production methods as seasonal flu vaccine and should have the same excellent safety profile. There are some new techniques being used that includes adding a component to improve immune response with less vaccine (called adjuvanted vaccine). These are newer techniques that need more study. In general, these vaccines should be very safe. I want to caution however, in any large scale, mass vaccination program, even extremely rare side effects may be present due to the large number of people being vaccinated. When we look back at the swine flu vaccination program in 1976, there were 30 people that got a severe neurological complication called Guillain-Barre syndrome. While this was a tragedy for those people, it was only 30 out of 40 million. So while those cases received alot of press, they were extremely rare events. In addition, vaccine production has gotten much better in the past 30 years and you can be certain that there will be close surveillance of this new H1N1 vaccine when it is given to large numbers of people.
 
While we are talking about rare side effects, there will be another type of adverse event that will be reported and that is something that is temporally associated to the vaccine even though it doesn't actually have anything to do with the vaccine. This means that a person may develop a medical condition by chance close to the time when they received a vaccine. People may then make the assumption that the vaccine caused the problem when that was not the case.
 
Finally, take a look at the new school guidance. It encourages school officials to carefully weigh the benefits of closing schools before doing so. Since the virus is so wide spread, at this point, it may not be very useful to close schools unless the virus starts causing more severe disease.
 
 
ADVICE:

I have been advising you to take action in planning for quite some time now. Schools will reopen soon and we will see a resurgence of flu cases once that happens. By this time, you should have at least looked at your human resource policies and your supply chain. There are nine areas that we advise our clients to look at: HR, Corporate Governance, Incident Management, Security, Communications, Finance, Operations, Corporate Services and Information System. For each of these areas, take a look at your policies and procedures from the point of view of worker absenteeism. How will these areas function if large numbers of people are out for 3-5 days during October through February/March. Look upstream at your suppliers and downstream at your distributors to develop work-around solutions should they experience interruptions from absenteeism.

Now is the time to be preparing. Don't wait until September or October to review your plans.
 
If you need help, drop me a note. We have a policy matrix, policy toolkits, FAQ's, posters, employee educational materials, a trigger based action plan template and shortly, we will be releasing our new trigger decision model to replace the WHO Pandemic Phases. We can help you jumpstart your planning initiative or take a look at your plan with a fresh set of eyes.
 
 
Virtual Medical Director
If you don't have a corporate medical director, our Virtual Medical Director program may be a good solution for you. Our Virtual Medical Director service provides you with 24 hour access to physicians and experts trained in emergency medicine, disaster medicine, business continuity, occupational health and mental health crisis management to give you situation updates, analysis and advice. Contact us for further information.
 


 
Not preparing now would be a serious mistake.
 
 
 
If you have any questions or concerns that we can help you with, please feel free to reach out to me. My email is: sweiss@MedPrepGroup.com
 
 

 
MedPrep Consulting Group is internationally recognized as a leader in pandemic, disaster and business continuity planning, training and exercising. We have resources and expertise that you can count on. Ask us about our Virtual Medical Director Program.
 
Dr. Stuart Weiss is the CEO of MedPrep Consulting Group. For more information, visit www.MedPrepGroup.com
 

Stuart Weiss, MD, CBCP
MedPrep Consulting Group LLC
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Sunday, July 26, 2009

Influenza Update - novel H1N1 (2009)

Novel Influenza H1N1 (2009) Update
MedPrep Consulting Group LLC
Dr. Stuart B. Weiss
INFLUENZA UPDATE
WHO PANDEMIC ALERT LEVEL 6
July 26, 2009
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Uh-oh, are we seeing a drift in circulating flu virus, and what happened to the summer influenza hiatus?
This year, the flu season has continued in the Northern Hemisphere over the summer, a time when flu is typically non-existent. In the Southern Hemisphere, some concerning changes have occurred in the circulating H3N2 virus.
Current Situation:
  • Although cases continue to rise in the Southern Hemisphere, case counts will no longer be reported as they are not very meaningful.
  • In some countries in the Southern Hemisphere, the novel H1N1 virus is the dominant strain and in others, there is concomitant spread of both seasonal influenza and novel H1N1.
  • On Friday, a news story out of Canada reported that Canadian employers are seeing huge increases in H1N1 related employee absenteeism as well as confusion on sick time policies.
  • The CDC released a report about 4 children with novel H1N1 virus infections that developed neurological complications such as seizures or confusion/lethargy.
  • Reports from the Southern Hemisphere suggest the presence of a new H3N2 flu variant that has drifted. This could lead to a vaccine mismatch for the fall seasonal influenza vaccine in the Northern Hemisphere is this new H3N2 becomes dominant (see analysis below).
  • Samples of the novel H1N1 virus continue to show no genetic changes in the virus.
  • Several clinical trials are beginning to test new H1N1 vaccines. These trials are testing single and two dose regimens and different amounts of administered vaccine. These studies should take about 3 months to complete.
  • There was much news about "worst case scenarios" from the CDC this past week. Although the worst case scenario is scary, it is worst case, not most likely case. As planners, worst case scenarios are useful in planning but too much emphasis should not be given to the worst case.
  • MIT has a wonderful paper on novel H1N1 which summarizes what is currently occurring and reviews past pandemics. It is well worth the read. You can find it at: http://esd.mit.edu/WPS/2009/esd-wp-2009-07.pdf
  • The Advisory Committee on Immunization Practices (ACIP) will meet in Atlanta on July 29th and is expected to develop guidance for who should be prioritized for the new H1N1 vaccine when it is available.
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ANALYSIS:
In the United States over the summer, we really haven't had the usual flu hiatus. In both summer camps and military bases, there have been continued outbreaks of this new virus. Twenty states are still showing widespread influenza activity, all of it related to the new H1N1 virus. This is leading many to predict that once schools reopen in a little over a month, we may see a real spike in the number of novel H1N1 cases. This spike in new cases in young people is a real possibility and would occur in late August or September, a full month or two before we have vaccine available. This spike would lead to employee absenteeism as parents are forced to stay home with sick children.
The fact that the CDC reported finding neurological complications in children with the new H1N1 virus infection is concerning. Although all 4 children fully recovered, having large numbers of children develop seizures or confusion will stress our medical care system significantly.
In the United States, Federal officials are moving towards a voluntary mass flu vaccination program for the fall. That is a massive undertaking with many logistical nightmares, not the least of which is that the vaccine may come out two months after the number of flu cases begins to spike. The Federal government is ramping up for a bad flu season this year and so should you.
Lastly, the development of a new drifted H3N2 seasonal flu strain is concerning. As I have written about before, influenza viruses are very prone to genetic changes as they spread. Small genetic changes result from a drift while large genetic changes result from a shift. These small genetic drifts can sometimes make a virus different enough that the vaccine for it doesn't work. If this new drifted H3N2 becomes the dominant strain this coming fall/winter and we end up with an ineffective vaccine, then we will have a particularly bad seasonal flu season regardless of what the new H1N1 does. This will need to be watched as the Souther Hemisphere flu season continues.
ADVICE:
  • Plan for supply chain interruptions. It is very important for you to plan for supply chain interruptions this fall. With just-in-time delivery of much of the inventory in the U.S., there is no extra inventory to carry us through supply chain interruptions. Review how you will keep your company going if deliveries slow or stop for a period of time.
  • Look at your sick time policies. When reviewing these policies, look closely at your requirement for physician notes if your employees are out for a certain number of days. Many companies require such notes after 3 or 4 days of illness. You can expect that during a bad flu season, public health authorities will be recommending that people only seek medical care when they have severe illness so getting return to work notes will be problematic. At a recent exercise we ran in New York, we heard from many health care providers that they were inundated with people wanting a return to work notes.
  • Turn up the heat on your planning efforts. You only have a month or two before we will see the spike in cases from schools reopening. You must review your pandemic policies and trigger based action plan.
  • Develop a trusted source for important medical information and analysis. If you have a corporate medical director, include them in the planning process. If you do not have this resource in-house, hire us to serve as your Virtual Medical Director if you wish. See below for information.
Virtual Medical Director
If you don't have a corporate medical director, we'll be your medical director. Our Virtual Medical Director service provides you with 24 hour access to physicians and experts trained in emergency medicine, disaster medicine, business continuity, occupational health and mental health crisis management to give you situation updates, analysis and advice. Contact us for further information.

Pandemic Planning Services
If you need assistance with pandemic planning, we offer a full range of materials and services including policy templates, FAQ's, development of trigger based actin plans, refinement of plan triggers, plan audits, employee educational programs, exercises, etc. Give us a call or send me an email if you want more information.



Not preparing now would be a serious mistake.
If you have any questions or concerns that we can help you with, please feel free to reach out to me. My email is: sweiss@MedPrepGroup.com

MedPrep Consulting Group is internationally recognized as a leader in pandemic, disaster and business continuity planning, training and exercising. We have resources and expertise that you can count on. Ask us about our Virtual Medical Director Program.
Dr. Stuart Weiss is the CEO of MedPrep Consulting Group. For more information, visit www.MedPrepGroup.com

Stuart Weiss, MD, CBCP
MedPrep Consulting Group LLC
Join Our Mailing List