Tamiflu status downgraded!

Those of you who follow my blog or are my patients know that I've never been a fan of Tamiflu. I've written To Tamiflu or Not To Tamiflu and I've posted Tamiflu from guest blogger, Dr. Mark Helm. Despite the CDC's recommendation to use Tamiflu frequently, I rarely prescribe it. And when I do, I often find that the whole course isn't completed because the kids don't tolerate it well - usually vomiting, but occasionally they've had scary hallucinations. I haven't seen very much benefit, especially given the cost (and often the difficulty of finding it during peak flu season).

The World Health Organization (WHO) has recently downgraded the status of Tamiflu. The CDC and FDA will have to chime in for the US recommendations, but the WHO is a respected source of medical guidelines and I look forward to a response from the CDC.

As I've said before, Tamiflu doesn't seem to work as well as needed and it has significant side effects. Not all studies done on Tamiflu were published. Only studies showing a little benefit and minimal side effects were considered in making the recommendations to use it. If many studies show no benefit but aren't published, it makes it seem better than it is. Most studies are done in adults, but studies in children for prevention of flu and treatment of flu also fail to show much benefit.

A 2013 review of all the studies done in adults found only a 20.7 hour reduction in symptoms (yes, less than one day). In the elderly and those with chronic diseases (among the highest risk adults) no reduction was found. They also found no evidence of decreasing the risks of pneumonia, hospital admission, or complications requiring an antibiotic. This same review also showed more side effects than commonly reported. Nausea, vomiting, and psychiatric side effects are common.

I hope that the CDC reviews its recommendations for antiviral use before the influenza season hits this year. Until then, plan on getting your family protected with the flu vaccine. It isn't perfect, but it does help keep us from getting sick and it can help save lives!

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Flu Vaccine Recommendations for 2016-2017 Season

Flu vaccine recommendations change from year to year. Here's this year's summary:

• Everyone over 6 months should get a flu vaccine. This includes children, teens, adults, pregnant women, the elderly, and most people with chronic diseases.
• The vaccine can be used as soon as it is available. (Note: the elderly might benefit from waiting until October due to potentially shorter duration of protection.) Preferably vaccination will happen by November, but vaccination can be done any time the vaccine is available. Illness from influenza can occur at any time in the year, but is most common in the winter and early spring, so vaccinating throughout the season is appropriate if it has not already been done.
• The nasal spray is not recommended this year.
• People with egg allergies can get the flu vaccine and don't have to be monitored for 30 minutes afterwards unless they have a history of severe reactions to egg (not just hives). The amounts of egg protein in the flu vaccines are so low that an allergic reaction is not likely.
• Kids under 9 years of age who have previously received two or more total doses of any influenza vaccine only need one dose of flu vaccine this season. The big difference from previous recommendations is that the two doses don't need to have been given during the same season or even in consecutive seasons - any two flu vaccines count.
• Different brands of flu vaccine are approved for use in various age groups, but they all include the same strains of viruses. This year’s strains are:

o A/California/7/2009 (H1N1)pdm09-like virus
o A/Hong Kong/4801/2014 (H3N2)-like virus
o B/Brisbane/60/2008-like virus (B/Victoria lineage)
o B/Phuket/3073/2013-like virus (B/Yamagata lineage) (quadrivalent vaccines only)

The flu shot is not going to give you the flu. 

I got mine! 

It might cause a sore arm, low grade fever, and headache, but that is brief and doesn't limit activities. I have heard many times that people were sick after getting the shot, but most often they were sick with whatever virus was going around town, not the flu. If they did get the flu that season, they were generally not as sick as those who got the flu without previously being vaccinated. (People who had the FluMist at times did get very sick with the flu, which is one of the reasons it is not being used this year.)

Influenza disease causes significant illness that usually improves within 2 weeks, but can lead to severe complications (including death). The majority of people who get the flu do not develop the severe complications, but they do miss a significant amount of work or school. Save yourself (and your family) and get the shot!

Related blogs

Vaccines don't have to hurt as much as some fear

To Tamiflu or Not To Tamiflu...

Tamiflu: Guest blogger Dr. Mark Helm

How To Keep Your Family Healthy This Winter

Evolution of illness

Fever Is...

My Child's Cough and Breathing Sounds Like...

Cough Medicine: Which one's best?

"But the snot is green…" Or "How can we treat cough and colds?"

Prescriptions for Flu Shots

We have started to get requests for pharmacists again this year to give flu vaccines to our patients.

THIS MAKES ME FURIOUS! (Can I be any more clear with this? I am not usually alarmist, but it really is frustrating.) Let me try to explain. I apologize in advance for complaining, but...

Risk

The pharmacy is essentially wanting to put the onus on me to verify that the child is healthy enough for the vaccine and doesn't have any contraindications. Of course this is getting very difficult to do even in my office now that walk in clinics are conveniently located everywhere, so continuity of care is lost. If I haven't seen the child in many months, I might not realize that he had a wheezing episode last week but went to another urgent care center to manage. The pharmacy wants me to spend the time looking at the child's chart to verify the health of the child without seeing the child, write the prescription, and have unused flu vaccine sitting in my office (or waiting to be shipped to my office) that I must pay for but not use. Really???

Cost of care

And all of this for free, since the patient is not coming to my office for a visit, but spending his money at the pharmacy. My time needs to be valued somehow in this. A lawyer would charge for the time spent, but I cannot get reimbursed for this. Pediatricians are famous for being nice and giving free advice and care.

Now don't get me wrong. I didn't go into pediatrics to get rich. Medical students who want to get rich don't go into primary care. But I do need to cover my costs and support my practice by earning income with patients who come into the office. Primary care offices are struggling to survive. Many are selling out to hospitals, which increases healthcare costs. 

Continuity of care in the medical home: special dosing for kids, live viruses, and chronic illness

Flu vaccines in kids, especially under 9 years of age, have different rules than older kids and adults. They must have two vaccines of the same strain once before getting a simple yearly booster. If we don't have proper documentation of previous flu vaccines, they need two doses. Until we have a nationwide vaccine database, the pharmacy is unlikely to have the complete vaccine record for these kids and if they give some of the vaccine, the primary care office might not have records of the vaccines.

Parents often don't remember which of their children have been vaccinated -- let alone the specific dates and which particular vaccines were given. If kids get live virus vaccines, they must be given at least 28 days apart from one another or on the same day. This can cause issues if a child gets the kindergarten vaccines at their doctor's office and then a FluMist at the pharmacy or other walk in center (or vice versa). It is easy to see how mom and dad might each take the child to one of the places and not realize the contraindication. If all vaccines are given in one location (or if a person transfers records to another physician for continuing care at a new location) then this type of mistake can be more likely avoided. I try to remember to warn parents to wait at least 28 days before giving the FluMist to their child at the well visit if they get the MMR and/or chickenpox vaccines around flu vaccine time, but sometimes I forget and parents often forget when the time comes at the pharmacy. These kids don't suffer from harm, but the vaccine is not effective and must be given again. I've seen more than one frustrated family suffering from this scenario...

Another issue with getting vaccines outside the medical home is when there is a chronic issue, such as asthma, and parents don't accurately remember the severity. Even in my office when I've talked to parents and given a written Asthma Action Plan, they sometimes tell my nurse the child doesn't have a history of asthma. The nurse can question further because it's in the chart. The pharmacist won't know to question in a different way, especially if the family hasn't filled medications for that child at that pharmacy.

Inventory issues

We have been ordering and giving flu vaccines for longer than the 16 seasons I have been a part of Pediatric Partners. Each year there has been some frustration with the flu vaccine season.

See here and here and here for some of our headaches -- I wasn't blogging at the time of the novel H1N1 outbreak, but you all remember that, I'm sure.

Now that some kids get vaccinated at the parent's workplace, others at pharmacies, and others not at all it is getting more and more difficult to predict how much flu vaccine to order. If we over order, we are stuck with vaccine that can't be used (in other words, we stand to lose a lot of money). If we under order, parents are upset that we run out. Some years we can get more, others we can't.

We offer flu vaccines in our office, or at least we do when we have the vaccine in our office. For the second year in a row we are experiencing shipping delays. This is frustrating because we love to take advantage of the school aged kids (especially college aged "kids") being in the office in late summer and getting the flu vaccine out of the way. We can't give it at well visits if we don't have it, so we must pay nurses for more overtime having more flu vaccine clinics when we finally get the vaccines in stock. It's much easier for all to get it at an already established visit, but we do not have control of when the vaccine arrives at our office.

Pharmacies giving vaccines is a relatively new thing. I am frustrated that they are getting their supplies before us and offering them to our patients before we even have a chance. We have more and more difficulty ordering flu vaccines because we have no idea how many kids will get them elsewhere versus our office. We must pre-order during the winter before the next season, often when we are still offering vaccine for the current season, so we don't know if we will run out early or have leftovers. That makes it really hard to predict use for the next season.

Prescription requests 

Thankfully when I get a faxed request for such a prescription, I have an easy answer: No.

Our malpractice carrier has advised us to not write prescriptions for over the counter medications unless we are seeing the child in person. We have interpreted vaccine prescriptions to be in a similar category. If we cannot assess how sick or well a child is, we should not make the decision for any medicine (or vaccine) to be given. If the pharmacist wants to do an evaluation and order it, great. Otherwise, we are more than happy to vaccinate our patients.

Another reason to get the vaccine at your doctor's office

I just saw in a Slate article that vaccines might be better covered by insurance by an in network provider: "Pediatrician Walter Orenstein of Emory University, who chairs the National Vaccine Advisory Committee and formerly was the country’s assistant surgeon general, notes that the Affordable Care Act now requires that insurers cover vaccines against flu and several other diseases with “no co-payments or other cost-sharing requirements,” but, again, the catch is “when those services are delivered by an in-network provider.”"

Getting the vaccine

Please be patient with us. It wasn't that long ago that it was recommended to hold off on giving flu vaccines until October, thinking that the vaccine wouldn't last the season if given too early. Now that we know it is okay to give it earlier, that doesn't mean we must give it earlier. It isn't even October yet and people are panicking that they won't be able to get the vaccine. As far as I know, there's plenty of vaccine. It just hasn't all shipped yet. We are getting small allotments and giving it to kids whenever possible if they're in the office when we have stock. Unfortunately we can't schedule any vaccine appointments yet because our stock is too limited and we might run out before that appointment. We will be getting more soon. When we have enough in stock to schedule flu vaccine clinics we will let our patients know.

We're not alone in this. Most pediatricians I've asked are in the same boat. Please be patient with us all.

Dr Mellick got a FluMist in a previous season

Do Your Vaccines Contain Mercury?

We are often asked if our vaccines contain mercury. Some parents even want to see the package insert to check. Note: even if they do contain mercury, it usually doesn't say "mercury", so I suspect some of these parents wouldn't notice. Why wouldn't they notice? Because they learn one tag word that they should avoid, but they really don't understand what it is and why they need to avoid it. It's hard to talk to some parents who are adamant that they don't want vaccines for their children, but they don't know why... they just "heard they aren't safe." Really? You're not going to give your child something that has been shown time and time again to not only be safe, but that also saves lives? Just because you heard something you don't even remember details to you'll skip something that could save your child's life?

Short answer to the above question: No standard vaccine for children has had thimerosol since 2001. Some flu vaccine for older children and adults continues to have thimerosol, but most that we order for our office does not. If we offer a type with thimerosol, we will notify you before you choose to vaccinate. Not that we think it matters, but we know parents worry and want to know.

Most years I get the FluMist, but I think the year pictured it was in short supply.

Parents worry about thimerosol despite not really understanding when or why it's used. It's really sad when they ask if we have the "new" MMR without thimerosol. The MMR has never had thimerosol in it. Not ever. Yet many people share the mis-information online that it was/is the cause of autism. And people believe it. That's how much their online research has taught them.

If you hear that vaccines aren't safe from someone but don't ask for and understand the details, including looking at research papers and written articles that address the issue (along with evaluating the reliability of each research report and article) then you really shouldn't take the advice blindly. They might know as little as you on the subject and are just passing along bad information. Or the article you read might just be filling you with incorrect information. It's easy to do when a writer has a motivating factor, such as when the CDC Whistleblower "reanalyzed" data.

Mercury comes in many forms. Thimerosol (one form) is felt by scientists to be safe for use in vaccines at the very low levels required for its effect in vaccines. It has been removed from most vaccines given to children though due to a very vocal group of anti-vaxers getting some congressmen on their side. Not scientists or doctors, but law makers. This has increased the cost but not the safety, in my opinion. We use single dose vaccines except for staff flu shots, for whom we use the cheaper multi-dose vial. The multi dose must have preservatives, such as thimerosol, to keep it from getting contaminated with multiple uses. We usually have a few doses left out of that to give to patients so it's not wasted. When this type is given to patients, their parents are always told it is a multi dose type. There were only limited doses left over this season and they were gone long ago. Many parents were just happy to be able to get a flu shot for their child when they were in short supply early in the vaccine season and they trusted that it was safe.

So... would I give a vaccine with thimerosol to my kids? Yes. (And my oldest is a teen who did get the standard back when he was a baby, which was vaccines with thimerosol.)

Do we give them now? Not usually.

I think that many smart people still get blindsighted by well written but technically not correct information. They simply can't read all the studies, know how to understand the statistical significance of each study, and all the science behind everything. I have a degree in medicine and still rely on experts to do reviews and summarize the vast amount of information. I read some of the studies, but don't have enough information to make truly educated decisions based on what I have access to. Too many studies are behind pay walls and I don't want to pay to read them, nor do I have the time to read every study. 

But I trust expert panels that do.

Here are some links to pages that list the studies if you want to read them for yourself:

http://www.vaccinesafety.edu/cc-thim.htm
http://www.immunize.org/journalarticles/conc_thim.asp
http://www.immunizationinfo.org/science/mercury-vaccines

What if the flu vaccine doesn't cover the right strains?

Recent news reported that the FluMist nasal spray might not cover the Influenza A H1N1 strain as well as the injectable might. I know this may cause concern for parents whose children have already gotten the FluMist vaccine this season.

Don't panic! (Gee, I've said that a lot this year with the delayed shipments of flu vaccine...)

Why not panic? 

First, this is a theoretical concern. It is based on the findings that the FluMist didn't cover the H1N1 well last season and it is the same vaccine this year.

Second, the main strains of influenza that are starting to circulate this year are NOT that H1N1 strain anyway.

I thought FluMist was preferred this year...

The CDC continues to state that the preferred vaccine for 2-8 year olds is the FluMist because it seems to be more effective than the injectable form against the other strains contained in the vaccines. (This is of course only if the child doesn't have contraindications to the FluMist and the FluMist is available. No one should delay vaccination if one form is available to wait for another form.)

Should we wait to get the shot? I know there are shipping delays...

Both the CDC and the AAP state to give whatever vaccine is available as appropriate and to not delay giving the vaccine to wait for another type. This makes sense. If you can be vaccinated with only one type due to the shipping delays, why risk being completely unprotected when you can get a vaccine that will most likely protect. No vaccine is 100% effective. With influenza we have the additional difficulty that the flu virus changes each year, but there is some protection across types when the flu vaccine is given.

Why doesn't the strain match?

Flu strains change every year and scientists predict what strains will be circulating. The vaccine companies all make vaccine against the predicted strains. This year the main strains that have been identified in people sick with the flu are Influenza A H3N2 and Influenza B. It is still early in the season, so findings might change, but so far both the FluMist and injectable vaccines seem to be effective against those strains. The FluMist appears to offer better protection than the injectable if the strains are not quite matched.

In short: 

Any age-appropriate influenza vaccine should be used as soon as possible to protect as many people as possible against the flu.

Do kids who got the FluMist need to be given a shot this year?

No. It is not recommended to do a second vaccination unless it is the first flu vaccine and a child needs a booster dose this season. It is appropriate to use either form of the vaccine for eligible children over 2 years, and mixing and matching is okay, but there is no recommendation specifically to do that.

The good news: 

We are starting to see shipments of flu vaccine! Hopefully we'll soon be able to vaccinate your children!

Flu Vaccine 2014-15 Season

Every year it's something.

Flu vaccine causes distress every year for physician offices around the country.

I wrote about some of the issues last year here and here.

This year's flu vaccine is identical to the trivalent and quadrivalent vaccines of last season, so it should be easier.

But as always, there's a hitch.

This year there is a delay in shipping but no one really knows why. I've heard pharmacies are starting to advertise they have flu vaccine. From a business standpoint, we start to worry when we hear people say "I'll just do it at the pharmacy." We've already ordered more doses than last year and don't want to get stuck with supplies we can't use. Bad for business...

How flu vaccine makers choose their shipping times to various offices around the country is unknown to me. We order nearly a year in advance so they can make the requested number of doses. We must project how many infant vs child injectable doses of vaccine we will need and how many nasal spray doses we will need. Some years we can add to our order, but other years there are shortages. There are several makers of various brands, but in pediatrics we are limited to what types we order based on the ages for which it can be used.

As soon as we start getting the vaccine we will begin to offer them in the office. Typically we start getting a few doses at a time, so we can't advertise with those first small shipments. It will simply be patients who are in the office and eligible for the type we have will be offered flu vaccine. When we get enough to hold a flu vaccine clinic, we will send out e-newsletters to patients who are registered, as well as post on our website and Facebook page. Our flu clinics run smoothly because parents sign up on line. We will send paperwork ahead of time for you to fill out at home. Bringing that really helps. You will need to have signed our financial policy before the flu vaccine. To keep things running smoothly, we encourage you to do that ahead of time if you have not already done so. We also ask that your child is current on well visits in order to use our flu clinic. If your child needs a well visit, simply schedule one and he can get the vaccine at that visit. We will always give flu vaccine to patients and their siblings who are in the office for a visit (but without significant illness, such as fever) as long as supply lasts.

Who needs a flu vaccine and when should it be given?

It is recommended that everyone over 6 months of age get a flu vaccine each year. As soon as the vaccine is available, it can be given. Ideally the vaccine is given before the influenza season starts. Flu season usually peaks in January, but influenza can occur at any time of the year. I must put a plug in for getting the vaccine in your medical home if at all possible. This keeps vaccine records all in one place and helps support your doctor's office.

Which vaccine should my child get?

Children 6 months to 2 years should get the injectable vaccine. They are not eligible for the nasal spray (FluMist).

Starting in 2014-2015, the CDC recommends use of the nasal spray vaccine (FluMist) in healthy children 2 - 8 years of age, when it is immediately available and if the child has no contraindications or precautions to that vaccine.

Contraindications to the FluMist are:

• Children younger than 2 years
• Adults 50 years and older
• People with a history of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine
• Young children with asthma
• Children or adolescents on long-term aspirin treatment
• Children and adults who have chronic pulmonary, cardiovascular (except isolated hypertension), renal, hepatic, neurologic/neuromuscular, hematologic, or metabolic disorders
• Children and adults who have immunosuppression (including immunosuppression caused by medications or by HIV)
• Pregnant women
• Live virus vaccine (such as MMR or Varicella/chickenpox) within the past 4 weeks. The vaccines can be given together on the same day, but if not on the same day they must be given 28 days apart from one another.
• Most people with the above contraindications can still be vaccinated with the injectable vaccine - ask your doctor

Recent studies suggest that the nasal spray flu vaccine may work better than the flu shot in younger children. However, if the nasal spray vaccine is not immediately available and the flu shot is, children should get the flu shot. Don’t delay vaccination to find the nasal spray flu vaccine.

How many doses does my child need?

In young children who have never received a flu vaccine, two doses of the same strain should be given. If they've had two doses of the same strain previously, they only need one dose. In children over 9 years of age, regardless of previous vaccines, only one dose is needed. This is because it is presumed that by 9 years of age a child has been exposed to the influenza virus previously. Think of it as the first vaccine is the initial body's exposure to the virus in young children, then everyone needs a booster dose for the season, including the first season if a child has never had one before.

The CDC has put together a flow chart of how many doses are needed:

Can a person still get the flu even after getting the vaccine?

Each year experts pick the most likely strains of influenza virus that are expected. Some years they do a great job, other years it is not as accurate. There is some cross-reactivity among strains, so even in years that the wrong strains are in the vaccine, there is some protection against severe flu illness. So yes, it is possible to still get influenza, but usually the illness is mild.

Can a person get the flu from the vaccine?

No. I have heard many people say they get the flu from the vaccine, but this is not possible. People who get the nasal vaccine can get mild congestion (cold like symptoms), but they do not get the flu from the vaccine. It is possible that they were exposed to the actual flu virus and get sick before the vaccine has a chance to provide protection. Or they have a viral illness that isn't the flu. People with influenza often say they feel like they were run over by a train. They are sick. It is not just a cold.

Can I get the flu vaccine even though I have an egg allergy?

The following recommendations come from the Advisory Committee on Immunization Practices (ACIP):

People with a history of egg allergy who have experienced only hives after exposure to egg should receive the injectable influenza vaccine. Because there is limited data in the use of live attenuated influenza vaccine (FluMist) in egg allergic people, inactivated influenza vaccines (shots) either the IIV or trivalent recombinant influenza vaccine (RIV3) should be used.

Where can I get more information? 

Each year the CDC provides summary information about the current influenza vaccine season. You can read about the 2014-15 season, information on flu vaccine myths and misconceptions, and you can even see where the flu has hit.

 

Tamiflu: Guest blogger Dr. Mark Helm

Those of you who have spoken with me about Tamiflu or who have read my blog, To Tamiflu or Not To Tamiflu, know where I stand on Tamiflu. My online friend, Dr. Mark Helm, has written about Tamiflu in a very say-it-like-it-is way. Take the time to read and share!

photo source: PRWeb.com

Tamiflu is probably not going to help you.

Like all prescription medicines, Tamiflu (oseltamivir) can cause many complications. A large number of people who take oseltamivir have side effects which actually feel a lot like the flu (belly problems, headache, etc.). These side effects can be so bad that some people decide they want to stop taking the medicine and take their chances with the flu! Using oseltamivir in kids is very challenging. Children often can not understand or report that the medicine is making them feel bad or altering their thoughts or behaviors.

Almost all of what we know about the safety of this medicine comes from the company which makes and sells it. Doctors know only what that company has revealed. When objective researchers have tried to discover if it actually helps, they have generally found that oseltamivir does very little, if anything, to treat the flu. Even the company concedes that the drug MAY shorten symptoms of the flu by one to one and a half days. Oseltamivir has not been proven to change the outcomes (death, hospitalization, loss of time from work,) of having the flu. It also has not been well-studied in people with significant chronic diseases - who are exactly the people we most worry about when it comes to flu infections. If the medicine is started very early (less than 24-40 hours after symptoms begin), then it may shorten the length of time a person is sick by an average of about 31 hours. Again, this medicine does not seem to affect the need for hospitalization or risk of death that comes from being infected by the flu virus.

Oseltamivir is expensive. It may or may not be covered by your health plan's pharmacy benefit. If it is covered you may only have to pay a co-payment, but your employer or insurance company will have a much larger bill to pay. They will pass those costs on to you next year with premium increases (or cuts in benefits).

A helpful and well-reasoned pamphlet regarding the flu and Tamiflu (oseltamivir) is here. Here's more good stuff on Tamiflu (oseltamivir), including a helpful tab outlining side effects and their frequency.

The challenge for physicians and other prescribers on deciding when oseltamivir may be helpful is balancing the relatively low risk of any individual developing the flu (maybe 1 in 20) against the facts that more like 1 in 10 people taking the drug will have significant side effects, and that there is not likely to be any difference in outcomes for the patient.

So, if you can’t count on Tamiflu, what should you know and what can you do?

Flu will hit you like a ton of bricks, and make you feel horrible. It generally will flatten anyone for about 5-7 days. It is particularly dangerous for "high-risk" people - that is people who have other chronic illnesses, the very young or the very old. However, for health professionals, the more scary illness is the “second sickness” that may follow the flu. If a person with the flu starts to get a little better but then starts feeling worse, they should be seen by a doctor as soon as possible. Additionally if a person with the flu starts to gets worse after 2-3 days of the start of symptoms this is also very concerning.

Flu is a very serious disease every year. 2014 is no exception. The flu strain that is most common this year is the same variety that caused the global epidemic in 2009.

Fortunately, flu is largely preventable with immunization - this is why we try to immunize everyone we can. Despite what some say, the flu vaccine - particularly the injectable vaccine can not give you the flu. The flu shot contains no live virus - only proteins made by the virus. The small dose of these proteins in a flu shot are enough to train our immune system to recognize and fight off the flu. The nasal vaccine does contain a live virus, but it is altered so that it can only reproduce and spread at temperatures lower than in the human nose. Both vaccines teach the immune system to recognize and kill the flu virus.

The vaccine is adjusted each year to match the strains which are believed to be most likely to circulate in the coming season. The vaccine for the 2013-2014 season contains proteins which match the “H1N1” strain that is causing 90% of the disease. People who received the flu vaccine this season have a much lower risk of catching the flu than those who did not get vaccinated - but even for vaccinated people, the risk for flu is not zero. It generally takes at least two weeks after a flu vaccination for the body to develop a good, fighting response. So plan ahead for your vaccine next year… Anytime between Halloween and Thanksgiving is a good time to get vaccinated for the flu.

If you have not had your flu shot this season, and you are worried about the flu, ask to be vaccinated. Assuming that there is still some vaccine supply left, vaccination, avoiding prolonged close contact with people with the flu, and washing your hands are your best defenses against the flu. If you already had your flu shot this year, you should not be worried - you have already taken your best chance to avoid the flu.

About Dr. Helm:

Mark E. Helm, MD, MBA, FAAP is a general pediatrician in Oregon at Childhood Health Associates of Salem. He is active with the state and national American Academy of Pediatrics, involved with the Section on Clinical Pharmacy and Therapeutics, and the Section on Administration and Practice Management. He is currently a member of the Committee on Child Health Financing. Prior to becoming a pediatrician, Mark was a pharmaceutical industry “insider” working in market research. After training at Arkansas Children’s Hospital, Dr. Helm worked with the Arkansas Medicaid program to develop an evidence based “preferred drug list” and to establish policies which promoted safe and responsible use of medications, including psychotropic medication for children. Dr. Helm gets his flu shot every year.

Top 10 Posts of 2013

My last post of 2012 was my Top 10 Posts of 2012. I think I'll keep the tradition going with the Top 10 of 2013.

photo source: Shutterstock

This past year I have written about everything from insurance to illnesses to common parental concerns. My most influential blog has been about the generic formulations of Concerta, with 11,875 readers. It has been shared on ADHD blogs, various Facebook and Twitter feeds, and found on Google searches. I never thought over 1,000 people would read one of my posts, let alone over 10,000! Thank you to all who are reading and sharing!

If you don't want to miss a post, be sure to sign up for an e-mail subscription on the right!

From #10 to #1:

10. My Child's Cough and Breathing Sounds Like… is a collection of videos I compiled to help parents describe their child's cough.

9. Allergy Tips reviews ways to avoid allergens when possible and how to treat symptoms.

8. Flu Vaccine 2013: The Story Unfolds discusses how coding and billing issues impacted our office use of flu vaccines this season.

7. But the Snot Is Green… once again argues why the color of mucus does not make the diagnosis of bacterial sinusitis and gives information on treating colds and coughs.

6. To Tamiflu or Not to Tamiflu  might be a little intense for some readers because it reviews the research on Tamiflu risks and benefits. I am happy it is among the top 10 because I want people to see that Tamiflu isn't that miraculous of a drug for influenza. I get far too many requests for it this time of year. 

5. Flu Shot Information 2013-14 Season explains the different types of influenza vaccine available for the season. 

4. Help! My Child Has ______ Up His Nose! shares a "secret" tip I use to get some unwanted objects out of a child's nose. 

3. Screen Free Week is a challenge to readers to go Screen Free for a week. I have no idea why it is ranked so high. That is a surprise to me. 

2. Cough Medicine: Which One's Best reviews various cough medicines and other treatments of cough.

1. Generic Concerta Not Working Like the Brand Used To?  was read about 10 TIMES as much as any other post. It was found most often by a search engine, not direct shares, which tells me that many families are struggling with this issue. This is the post I am most passionate about. Any of my ADHD patients who are treated with Methylphenidate ER/Concerta know how angry I am that the FDA allows this substitution. I am thankful that the blog can help spread the word so that parents who are concerned about their child's sudden altered response to a medication can learn what might be the cause. I had so many updates to the original post, I wrote a follow up: Update on generic Methylphenidate HCl ER.

Blogs that missed the Top 10 that I wish more people would read include: 

Evolution of Illness - I wish people would read this because we often fall into the trap of wanting a quick fix. Too many parents bring kids into the doctor for a fast remedy only to find that there isn't one.  Resolution of illness takes time. Sometimes kids get worse, only to have the parent accuse a doctor of missing something. It happens to all good docs once in awhile…

First Period Q&A with a Tween - I wish people would find this one because it has questions every young lady thinks about but is often afraid to ask.

It's [Sports, School, Camp, Yearly] Physical Time - I wish people would read this so they understand the value of well exams and the scheduling constraints most pediatricians face. Don't call at the last minute!

Insurance Confusion - I wish people would read this because dealing with insurance is one of the most stressful parts of my job. I want people to learn about insurance to avoid financial surprises and to be responsible with insurance use.

Private Discussions with the Pediatrician - I wish people would read this because I am often uncomfortable (and sad for a child) when a parent wants them to leave the room for us to discuss something privately. Pre-planning with a quick phone call or secure message before the visit can save the child from excess worry.

What kids need to be able to do to leave the nest - This is one of my favorites because it was written at a very emotional point of my life. My kids are growing up and I reflected on what I really want them to know.

New Ideas

While most of my blogs were article-style writings, I introduced a few different types of blog this year. 

My first (and to date only) attempt at a video blog was Nutrition For the Picky Eater. It was born from a talk I gave at an ADHDKC.org parent meeting. 

I also did a picture blog with Lawn Mower Safety. 

I had one guest blogger. Sleep expert, Kerrin Edmonds, wrote Common Sleep Myths. 

Busy times…

April was my busiest month blogging. Seven posts that month. It tends to be a slow month in the office.  Ironically it was also Screen Free Week, a time I should have been off the computer!

• Allergy Tips

• Generic Concerta Not Working Like the Brand Used T...

• Screen Free Week April 29-May 5, 2013

• Help! My child has ___ up his nose!

• Group Teaching With Physicals

• Waiting times...

• Feeding Your Newborn

To Tamiflu or Not To Tamiflu...

photo source: Shutterstock

During flu season we have many requests for Tamiflu (oseltamivir) because of flu exposure or disease. I have rarely complied with these requests, though in recent years more often due to the powers that set the guidelines recommending it more. It is more common in my experience to hear negative feedback about side effects than it is to see patients get better faster. (Note: this is a very biased view, since those who are better would not call, but since so many call with side effects it seems fair to say I don't like the drug.)

I am not alone in my dislike of Tamiflu. I follow a listserv of pediatricians around the country and many share my views. A recent topic thread on treatment of flu has peaked my interest. One doctor suggested watching a TED Talk by Dr. Ben Goldacre: What doctor's don't know about the drugs they prescribe.  Dr. Goldacre starts talking about Tamiflu specifically about 10:10, but the entire lecture is done in an entertaining and informative manner if you have the time.

I feel deceived. When I practice medicine, I follow standard recommendations and guidelines that are based on peer reviewed articles and data. The question is, what important data is left out? There is a movement to solve this problem of unpublished studies. You can see updates at the Tamiflu Campaign of the British Medical Journal.

Back to influenza treatment...

First, current influenza treatment guidelines regarding the use of antivirals: 

The current guidelines basically say every child should be considered a candidate for an antiviral treatment. I understand the reasoning behind the first two conditions of antiviral use (except that studies don't really support even those indications), but I am very confused about the third highlighted below.

(from http://aapnews.aappublications.org/content/early/2013/09/02/aapnews.20130902-1)

ANTIVIRALS CONTINUE TO BE IMPORTANT IN THE CONTROL OF INFLUENZA.

Treatment should be offered for:

• any child hospitalized with presumed influenza or with severe, complicated or progressive illness attributable to influenza, regardless of influenza immunization status; and
• influenza infection of any severity in children at high risk of complications of influenza.

Treatment should be considered for:

• any otherwise healthy child with influenza infection for whom a decrease in duration of clinical symptoms is felt to be warranted by his or her pediatrician; the greatest impact on outcome will occur if treatment can be initiated within 48 hours of illness onset.

Then look at what a search for "unpublished tamiflu trials" shows.

For those of you unfamiliar with the Cochrane group, I need to take a quick sideline. They are a well respected group that reviews all the studies within certain parameters on one topic to evaluate the overall findings of several independent studies. 

From the Cochrane Group: A review of unpublished regulatory information from trials of neuraminidase inhibitors (Tamiflu - oseltamivir and Relenza - zanamivir) for influenza. These results are from a review of published and unpublished studies that they could find. From the abstract: "The authors have been unable to obtain the full set of clinical study reports or obtain verification of data from the manufacturer of oseltamivir (Roche) despite five requests between June 2010 and February 2011. No substantial comments were made by Roche on the protocol of our Cochrane Review which has been publicly available since December 2010. 

They found several problems with Tamiflu from the studies they were able to review:

• Drug manufacturers sponsored the trials, leading to publication and reporting biases. One of the authors reported that 60% of the data was never published. This is over half of the research, and I suspect it didn't support use of the medicine (remember the company that benefits from selling the medicine was doing the trials...)
• There was no decrease in hospitalization rate for influenza in people treated with Tamiflu.
• There was not enough evidence of prevention of complications from influenza. Design of the trials (again by the people who make the drug) did not report the prevention of complications from influenza, such as secondary infections.
• There is not evidence in the trials to support that Tamiflu reduces spread of the virus. One of the main reasons people request the medication is after exposure to prevent illness! (Note: this might have changed because the indications on the package insert now say it can be used to prevent illness in those over 1 year of age and they were previously not allowed to mention prophylaxis.) 
• Tamiflu reduced symptoms by 21 hours. Yep. Less than one day of fewer symptoms. For the cost of the drug and the potential side effects, is feeling sick for 1 day less really worth it? 
• There was a decreased rate of being diagnosed with influenza in those randomized to get Tamiflu, probably due to an altered antibody response. The authors suspect a body becomes less able to make its own antibodies against influenza when taking Tamiflu. 
• Side effects were not well documented.

A review study done in children exclusively Neuraminidase inhibitors for treatment and prophylaxis of influenza in children: systematic review and meta-analysis of randomised controlled trials focused on treatment of disease and prevention of illness after exposure. Findings included:

• Symptom duration decreased between 0.5 and 1.5 days, but only significantly reduced symptoms in 2 of 4 trials. That means in 2 of 4 trials there was no significant reduction in symptoms.
• Prophylaxis after exposure decreased incidence by 8% of symptomatic influenza. This means for every 13 people given Tamiflu to prevent disease, one case will be prevented. Not great odds.
• Treatment was not associated with an overall decrease in antibiotic use, suggesting it did not alter the complication of bacterial secondary infections.
• Tamiflu was associated with in increased risk of vomiting. About 1 in 20 children treated with Tamiflu had an increased risk of vomiting over the baseline vomiting due to influenza.
• There was little effect on the number of asthma exacerbations or ear infections by treating influenza with Tamiflu.

So what do I recommend during the cold and flu season?

1. Get vaccinated! The influenza vaccines have been shown to help prevent influenza and are very well tolerated with few side effects. If you or your children are due for other vaccines, be sure to get caught up.
2. If you get sick, stay home until you're fever free without the use of a fever reducer for at least 24 hours! Don't spread the illness to others by going to work or school. The influenza virus is spread for several days, starting the day before your symptoms start until 5-7 days after symptoms start-- kids may be contagious for even longer. You are most contagious the days you have a fever.
3. Wash hands well and frequently. If you can't use soap and water, use hand sanitizer.
4. Cover your cough and sneeze with your elbow or a tissue.
5. Avoid close contact with people who are sick. But remember that people spread the virus before they feel the first symptoms, so anyone is a potential culprit!
6. Don't share food, drinks, or towels (such as after brushing teeth to wipe your mouth) with others. 
7. Don't touch your eyes, nose, and mouth -- these are the portals for germs to get into your body. 
8. Keep infants away from large crowds during the sick season.
9. Frequently clean objects that get a lot of touches, such as keyboards, phones, doorknobs, refrigerator handle, etc.
10. Avoid smoke. It irritates the airway and makes it easier to get sick.
11. Remember that many germs make us sick during the flu season. Just because you've been sick once doesn't mean you won't catch the next bug that comes around. Use precautions all year long!

Because the guidelines recommend Tamiflu as above, I will probably be forced to prescribe it by worried parents who hope that their kids will feel better. (You've heard of defensive medicine, right?) 

Influenza is a miserable illness. The key is prevention. I've had my vaccine, how about you? 

Further Reading:

Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children: A link is available to the full text of the study by T Jefferson, MA Jones, P Doshi, CB Del Mar, CJ Heneghan, R Hama, and MJ Thompson.

Update 2016:

The CDC continues to recommend Tamiflu (oseltamivir) and other anti-viral medications. I continue to wonder why.

There continues to be a lot of confusion about unpublished studies. Investigators have documented their discussions with the maker of Tamiflu on Tamiflu correspondence with Roche.

Recent studies have tried to compile all that is known about how oseltamivir works:

• Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments. 

Results from this study include:

• In the treatment of adults, oseltamivir reduced the time to first alleviation of symptoms by 16.7 hours, 29 hours in children.
• There was no difference in rates of admission to hospital between treatment groups in both adults and children.
• Oseltamivir relieves symptoms in otherwise healthy children but has no effect on children with asthma who have influenza-like illness.
• Oseltamivir had no significant effect on admissions to the hospital.
• Oseltamivir causes gastrointestinal disturbances in both prophylaxis and treatment roles. In prophylaxis, it caused headaches, renal events (especially decreased creatinine clearance), and psychiatric effects. 

Update 2016/2017 Season:

The CDC recommendations for the use of antiviral medications remain essentially unchanged.

I have heard early reports that this year's flu vaccine is about 60% effective, but it is too early in the season to be sure. For up to date information on this season's flu, check out the CDC website.

Flu Vaccine 2013: The story unfolds

photo source: Shutterstock

I wrote about this year's flu vaccine new twist last month (Flu Shot Information 2013-14 Season).

Since that time I've learned some frustrating things.

Although it is not new news that companies are making two types of injectable flu vaccine this season (trivalent and quadrivalent), there are signs that we won't be able to start using it. The quadrivalent vaccine was not approved by the FDA until after the CPT coding book was published for this year, so no currently recognized code exists for the quadrivalent vaccine. Since every service and procedure a physician's office does is reported to the insurance company with a CPT code, the quadrivalent vaccine can't be given and appropriately documented with appropriate notification to the insurance company. The codes (90685 for 6-35 months and 90686 for 36+ months) are now assigned for the quadrivalent vaccine in CPT 2014, but insurance companies have until January to recognize them (with a retroactive time of 90 days possible- so possibly as early as October they can be used, but with a question of reimbursement for this very real cost, many businesses will be hesitant to use it).

There is only one type of FluMist, so there is only one code, allowing it to be used when in stock. (For more on CPT codes: What Are CPT Codes?)

You might wonder why this is important. First, CPT codes are used to document which vaccine is given and to send it to the insurance company. We must report the code accurately for inventory, billing, and proper documentation reasons. Insurance companies value each code differently, so the vaccine reimbursement will be different from code to code (and also varies among various insurance companies). The quadrivalent vaccine is of course more expensive than the trivalent vaccine, but it also covers another strain of virus, which makes it a better vaccine.

Our office received notice that our first shipment of quadrivalent injectable vaccine would soon be shipped. Since we won't be able to use it, we were forced to cancel that order. (It was only a small fraction of our overall order, so we hope to have more coming later when this mess is sorted out.)

My biggest frustration is that I want my most at risk patients vaccinated with the quadrivalent vaccine because it covers an additional strain of influenza. They can't wait until January. Many of these kids are not able to get the FluMist because they are under 2 years of age. I will be forced to give kids the less-preferred (though still good) vaccine, fully knowing that the only reason is tied to coding and billing. I've had parents mention that they would pay cash to avoid the delay, but that gets complicated with insurance contracts.

And what about the companies that have made all of their pre-ordered quadrivalent vaccines? If we all cancel our orders, they will have invested time, money, and resources into an entire line of product that will go unsold. Over the years many manufactures have gotten out of the vaccine market due to it being a money loser (despite what some anti-vaccine people state of us being in it only for the money). For a historical review of why companies stop making vaccines, leading to shortages over the years, please see this article: Why Are Pharmaceutical Companies Gradually Abandoning Vaccines? I worry that this type of craziness will lead to future flu vaccine shortages, resulting in more people getting sick and dying from influenza.

That all being said, the FluMist recommendations have become more relaxed as we gain experience in how it affects at risk groups of people. Because it is a live attenuated vaccine, initially higher risk people were not eligible to get the vaccine out of fear it would lead to wheezing. It is still not recommended for children under 2 years of age, but other groups for whom it used to be not recommended now may consider it. Children over 2 years who have a history of wheezing, a weakened immune system, diabetes, and other higher risk conditions MAY be eligible for this vaccine. Pregnant women also used to not be eligible, but many OB's are now recommending it because of its superior protection, which helps protect the newborn as well. You will need to talk with your provider if you feel your child should get the FluMist but has historically been unable due to higher risk status.

So, in a nutshell: this flu season follows suit with the fact that there is always something crazy that happens with flu vaccines. This is the most frustrated I've been though. In years past it usually has to do with shortages and trying to get mass numbers vaccinated within a relatively small window of time. Things that really are beyond what anyone can do. We can't anticipate the need, so ordering (and manufacturing) isn't always matched to demand. Proper codes for a new vaccine that had been announced is something that should have been anticipated. These coding problems are due to something people should have addressed, not unknown issues, which is why I am more frustrated than ever!

Stay tuned...

Flu Shot Information 2013-14 Season

Dr. Mellick getting FluMist

Dr. Stuppy getting a flu shot

Many parents are already asking about this year's flu vaccine, which means we've done a great job in the past making them aware that they need to think about getting the vaccine before they start seeing people get sick!

We feel so strongly that the vaccine is effective at protecting not only the person vaccinated but also the community around them that our office requires all staff to get a vaccine. We made the Honor Roll for Patient Safety from the Immunization Action Coalition for this requirement!

What's new this year?

Every year scientists predict which strains of Influenza A and Influenza B will likely be prevalent. The World Health Organization makes the recommendations for the vaccine based on these predictions. The strains chosen are the same for every company that makes the vaccine. The difference this year is that some will have three strains (trivalent) with two A and one B, others will have four strains (quadrivalent) with two A and two B.

Flu shot season causes headaches for doctor's offices. 

We must anticipate our need many months in advance and get our orders in. Each year the vaccine demand varies (a lot based on press reports on how badly people are getting sick, which we don't know when ordering). As more places offer vaccines (such as offices and pharmacies) the numbers of people getting vaccines at their doctor's office might go down. (I am biased, but of course believe getting them at your doctor's office is superior since we keep all your medical records in one place.)

From a business perspective, no one wants to be stuck with thousands of dollars of unused vaccine-- we can't stay in business if we lose money. We also don't want to have kids at risk of disease because they're unprotected and unable to find an appropriate vaccine when we run out. We certainly don't want parents yelling at our staff because we run out. Sometimes we've ordered enough overall, but our shipping allotments don't come fast enough for the demand. Shortages have happened over the years, something beyond anyone's control.

Scheduling mass flu vaccine clinics is often the best way to vaccinate large numbers of patients, but they are fraught with complications: how many people will show up, what flu vaccine (injectable vs nose spray) will they need? How many doses do we need on hand to hold a clinic? In times of shortages or low stock, how do you prioritize who gets the vaccine -- or do you want to just keep giving to anyone until it is gone so the office isn't stuck with unused vaccine at the end of the season? Do you give one dose to a 6 month old who you know won't be able to get the 2nd dose due to your supply running out?

This year there's a new spin to the variety of headaches: different vaccines will be available. Not just injectable vs nose spray. There will be some with 3 strains of virus, others with 4 strains. (For a review of how strains get into vaccine and how this year is different, see Quadrivalent Flu Vaccines: Four Means More Protection.)

So this year we have new questions: How are we supposed to order the different types, who gets which type, and are they interchangeable? How will the public perceive the difference and will they demand one or the other? Will insurance companies reimburse the cost appropriately, given that one is more expensive than the other? While in health care our goal is to keep everyone as healthy as can be, no office can afford to lose money on vaccines and stay in business.

What kinds of vaccine will be available this season?

There are many companies that make influenza vaccine, each with their own indications. For a complete list, see the chart on the CDC website. Our office has pre-ordered the FluMist and the Fluzone products (both forms) in part because we didn't know which would be available at the start of the season. We do not purchase the brands that are only available for older children or adults. Ask your doctor what they order.

All FluMist will be quadrivalent (4 strains) and is for children over 2 years without high risk conditions, such as asthma (presumed based on previous recommendations, this year's statement has not been released yet). It is expected to start shipping in July or August, though any individual office may not receive their order with the first shipping dates.

Fluzone Quadrivalent (4 strains) is an injectable vaccine for everyone over 6 months of age. It has already sold out  based on pre-season orders and will be available in limited quantities. Shipping dates will begin in August or September.

Fluzone Trivalent (3 strains) is an injectable vaccine for everyone over 6 months of age. It is expected to begin shipping in July and August. I have not heard of shortages.

Is adding a new strain dangerous?

Based on the chaos in the year of H1N1, I know that many parents fear "new" strains added to a flu shot. In actuality, every year the vaccine changes with very rare exception. That is because the flu strains predicted to cause disease change year to year. Adding a new strain does not make the vaccine less safe, just more effective.

Who needs the flu vaccines and how will they be given?

As of today, the finalized recommendations have not been approved. The preliminary recommendations  continue to recommend flu vaccine for all people over 6 months of age. (The link should update to the final recommendations as they become available.)

Last year it was recommended to start giving the vaccine as soon as it was received (previously it was suggested to wait until October so it remained effective throughout the season, but the vaccine is effective longer than previously thought so earlier vaccine is effective.) I presume this will remain the same.

If a child under 9 years of age has not had flu vaccine before, they need 2 doses in the same season to "prime" and "boost" immunity. If only one vaccine was given, the next season the child needs 2 doses unless they have gotten 2 of the same strain before. (This was easier last year because it was a rare year that the vaccine didn't change, so they could have gotten one the season prior, and the booster last year.) For children over 9 years, only one dose is needed, even if never received previously. After that first year of 2 doses, each year everyone just needs one dose unless it dramatically changes (as in the H1N1 year). I suspect since 3 of the 4 strains are the same this year, if a child needs 2 doses because they have not had 2 doses of the same strains, the vaccines are interchangeable. We will all find out when the final recommendation is given.

At this point I have not heard if high risk people should get preference for the quadrivalent vaccine. I don't think this will be possible in many cases, since many of the high risk are under 2 years old, and not eligible for FluMist. The injectable quadrivalent vaccine is in short supply, and many offices are likely to not get it at all. I personally feel it would be bad to wait for the quadrivalent vaccine if we have the trivalent vaccine in stock and an eligible patient is in the office. I'd rather vaccinate than potentially miss the opportunity all together. I'm sure others will differ in opinion since the quadrivalent vaccine is better protection. Talk to your pediatrician about their preference.

Although we cannot require all patients to get vaccinated, we certainly encourage it and try to make it as painless as possible (though the kids who get shots don't always agree). We will once again allow any patient in the office to get a flu vaccine (even if just there with a sibling for an appointment) and we will offer on line sign up for our clinics. On line sign up has proved very popular, both among our nurses and the families who come. It has really made the process run much more smoothly. There will not be a co pay collected at those clinics. (After we submit the claim to your insurance company if they tell us differently we will send a bill, but do not expect that in most cases.) Be sure you have registered for our e-Newsletter so you will be among the first to know when sign ups are ready for our patients. (No dates are set yet because we have not gotten verification on shipping dates. Please don't call the office to ask-- staff have no idea.) We will put information on our website as it becomes available in addition to posting on our Facebook page and sending the e-Newsletter.

We will all have to wait to see how this plays out! Every year something is new with the flu vaccine. What will be next?