A Tamiflu Rx question for my prescribing colleagues

[Skeptic Ginger]

No.

Just out of curiosity, do you have kids and what age group(s) are they in?


And have you made a determination as to how you would identify a serious case of flu vs a mild case? Are you using the requirement of hospitalization as the criteria? What does that say about the most benefit occurring if the drug is given in the first 48 hours? Have you looked at the data regarding the fatalities that have occurred in patients with no identified risk factors?

I ask this as a clinical consult, not as some rant that you should be making the same clinical decision as I am making.

 

[Skeptic Ginger]

....
ETA: I would've thought the medical community had a better grasp of actual risks than people in general. OTOH, that isn't setting the bar very high.

For influenza, the belief it is a benign disease in healthy people is widespread in the medical community.

You'd probably find just as many health care workers afraid of or at least resistant to flu shots as in the general population.

We tend to know our areas of practice well but other areas, not so much.

A medical researcher or provider involved in researching or treating influenza along with the public health officials are much more likely to fear the flu than other medical professionals.

 

[ExMinister]

It seems to me we should be erring on the side of prescribing more Tamiflu and not less. If there is any danger whatsoever that a patient could die if his/her symptoms are left untreated, then it is wrong to withhold medication that could prevent this. I would think we would be leaning toward over-prescribing, not under-prescribing, when cases like this child in Benbrook exist.

We already know that otherwise healthy children sometimes die from H1N1. So it's rare. So what? If it is your child who dies, will you care how rare it is? Knowing this, and assuming there is enough Tamiflu to go around, shouldn't the way Tamiflu is prescribed this flu season be adjusted accordingly?

If there isn't enough pediatric Tamiflu available, that needs to be remedied quickly, too.

That's my 2 cents.

 

[Audible Click]

I don't know if this is exactly on topic but today I took my 86 year old husband to his (not mine) doctor for a follow up on some neuro problems he has. I casually asked him if he knows how the H1NI vaccine will be distributed in our area. He replied that he didn't know but that he wasn't getting a shot and neither was his family. I asked if he was an anti-vaxxer and he said "no" and, of course, said that getting the shot was up to us but that we were not in the high risk group. My husband had a heart valve replacement a little over a year ago and while he's in fairly good shape for his age I thought that he was certainly a good candidate for the H1N1 shot. The doctor also said we may have some immunity from, possibly, being exposed to the swine flu in the 1970's. I'm 23 years younger then my husband and may not qualify for the flu shot but shouldn't he have it?

 

[Skeptic Ginger]

I don't know if this is exactly on topic but today I took my 86 year old husband to his (not mine) doctor for a follow up on some neuro problems he has. I casually asked him if he knows how the H1NI vaccine will be distributed in our area. He replied that he didn't know but that he wasn't getting a shot and neither was his family. I asked if he was an anti-vaxxer and he said "no" and, of course, said that getting the shot was up to us but that we were not in the high risk group. My husband had a heart valve replacement a little over a year ago and while he's in fairly good shape for his age I thought that he was certainly a good candidate for the H1N1 shot. The doctor also said we may have some immunity from, possibly, being exposed to the swine flu in the 1970's. I'm 23 years younger then my husband and may not qualify for the flu shot but shouldn't he have it?

People over 65 are less likely to get the new flu strain but if they do get it they are just as likely to have serious complications as with any other flu strain. People over 65 are second in line for the new vaccine. I recommend you both get the vaccine when it becomes available to you, probably within the next month. If you get influenza in the meantime, CDC does recommend Tamiflu for your age group. If Tamiflu is not available because of a shortage, ask for Relenza. And if seasonal flu begins circulating, then you get infected, you need Relenza, not Tamiflu since seasonal flu is resistant. Seasonal flu strains are not currently circulating.

I also just checked the CDC weekly report and the % of swine flu circulating that is resistant to Tamiflu remains at 0.6%.

 

[JoeTheJuggler]

For influenza, the belief it is a benign disease in healthy people is widespread in the medical community.

You'd probably find just as many health care workers afraid of or at least resistant to flu shots as in the general population.

My girlfriend is a nurse, and due to conversations with her I learned that only about 1/2 of health care professionals get the flu shot. At her hospital, anyone who refuses the shot has to fill out an affidavit saying that they refuse it against the urging of the hospital. She tells me that distressingly many still refuse it.

Just to avoid getting depressed over this. . . today I went to get my free seasonal flu shot from the large non-profit hospital here. Last year their free immunization program was very successful, so this year they greatly expanded it (many more locations and many more dates). I expected the turnout today to be relatively small.

I was sooo wrong! When I got there, the line was about 100 people long. They had around 15 stations where they actually gave the shot, so I moved through the line and was finished in just over 5 minutes. I asked one of the people if it was that way all day, and the answer was yes, it's been non-stop.

 

[Audible Click]

Thank you for the info, Skeptigirl.

ETA: We did get our seasonal flu shots in mid-September.

 

[JoeTheJuggler]

Apparently there is a shortage of the pediatric formulation (liquid). I have not looked into this at all. 14 yr olds can mostly swallow capsules just fine.

That's what I've been reading:

Associate Press
updated 3:12 p.m. CT, Wed., Sept . 23, 2009
ATLANTA - The maker of Tamiflu on Wednesday said there's a shortage of the children's version of the drug — the first-line treatment for swine flu and seasonal flu.

Switzerland-based Roche Holdings sent a notice to doctors and pharmacists about a shortage of the liquid version of Tamiflu for children and how to handle prescriptions in the meantime.

Linky.

 

[paximperium]

And if the 14 yr old in Texas who died was your patient, would you reassess that position?

No. No more than the half dozen healthy patients with H1N1 I intubated this season.

Just out of curiosity, do you have kids and what age group(s) are they in?

Not relevant.

And have you made a determination as to how you would identify a serious case of flu vs a mild case?

History, physical and vital signs.

Are you using the requirement of hospitalization as the criteria?

Mostly; but I would prescribe tamiflu to an influenza patient with abnormal vital signs even if they looked good. Tachycardia and hypoxia would be primary markers I would look for.

What does that say about the most benefit occurring if the drug is given in the first 48 hours?

"If you get any worse within 24hours please see your primary doctor or come back here for a recheck."

Have you looked at the data regarding the fatalities that have occurred in patients with no identified risk factors?

I've only read a few CDC and County bulletins. The Infectious Disease docs continue to harp on limiting tamiflu prescription unless they meet specific criteria.

 

[ExMinister]

ETA: In response to Joe, my local pharmacy verified that for me this morning too. They are running low on the pediatric Tamiflu for the youngest kids/infants.

 

[Skeptic Ginger]

...
Not relevant.

It is relevant. What I was thinking was, would I give or not give Tamiflu to my own child. I could not in good conscience, give it to my child and not someone else's. You know there is a different decision making process there. While we'd all like to think we are following standards because we believe they are correct. There are times when that is not such a clear decision.

History, physical and vital signs.
Mostly; but I would prescribe tamiflu to an influenza patient with abnormal vital signs even if they looked good. Tachycardia and hypoxia would be primary markers I would look for.

A fever of 101 or greater is usually accompanied by tachycardia. Can all parents safely assess hypoxia? I've seen nurses who couldn't.

"If you get any worse within 24hours please see your primary doctor or come back here for a recheck."

My problem with this is how often I've seen parents who after being sent home are reluctant to return, especially to an ED. There is a psychological barrier to returning to a medical provider after being sent away which has led to the death of more than one child. In addition, many of these kids are being told by their PMDs not to even bring the child in. The parent relates the symptoms over the phone and the provider says no treatment needed.

Is your ED phone triaging these kids? Are they being told to come in or not?

I've only read a few CDC and County bulletins. The Infectious Disease docs continue to harp on limiting tamiflu prescription unless they meet specific criteria.

With no discussion of using Relenza?

I'll post the data here in a bit. Quite a few of the fatalities have been in older children and adults with no identified risk factors. From my memory, it's been anywhere from 25 to 50% of the fatalities depending on the study.

 

[Dymanic]

And have you made a determination as to how you would identify a serious case of flu vs a mild case?

History, physical and vital signs.

The question as Skeptigirl asked it in the OP is the tricky one. A troubling number of the fatalities have been in patients with no previous history or any underlying conditions which would easily identify them as being at particularly high risk, and adopting a wait-and-see approach to sorting them out suffers from the drawback that serious illness typically does not emerge until well after the optimal time for initiating antiviral therapy has passed. Hand the stuff out to every previously healthy young person who presents, and you'll be throwing a lot of doses away on patients who didn't need them; but wait until they get really sick, and you'll be throwing them away anyway (at least, you'll be throwing away a lot of the potential effectiveness of those doses).

I sure don't see any easy solution to this puzzle. It's not even clear to me what would constitute "erring on the side of caution".

 

[paximperium]

It is relevant. What I was thinking was, would I give or not give Tamiflu to my own child. I could not in good conscience, give it to my child and not someone else's. You know there is a different decision making process there. While we'd all like to think we are following standards because we believe they are correct. There are times when that is not such a clear decision.

I agree, but the standards you set yourself as a professional is not absolute and I do not expect it to matter in the case of a loved one. Being a dad, mom or son overwhelms whatever professionalism you have. We are human after all.

A fever of 101 or greater is usually accompanied by tachycardia. Can all parents safely assess hypoxia? I've seen nurses who couldn't.

It is about presentation to the doctor, not home self diagnosis. If a young healthy kid's fever improves with tylenol in the ER and their heart rate and pulsox is normal, I consider it a mild flu or too early to consider treatment.

As an ER doc I get the luxury of making sure they see their pediatrian within 24hours after an ER visit by getting our Call-back nurse to help make sure it happens...unless they rapidly improve which is not likely with real influenza.
A pediatrician also gets a similar advantage in calling back or scheduling a recheck the next day if they are worried.

My problem with this is how often I've seen parents who after being sent home are reluctant to return, especially to an ED. There is a psychological barrier to returning to a medical provider after being sent away which has led to the death of more than one child. In addition, many of these kids are being told by their PMDs not to even bring the child in. The parent relates the symptoms over the phone and the provider says no treatment needed.

I'm not totally familiar with other systems. We have an Influenza Pandemic Clinic ready to go if or when it really strikes this winter. Until then, most just show up to their pediatrician's office.

Is your ED phone triaging these kids? Are they being told to come in or not?

Most are told to come in if they are worried(especially if their fevers do not improve with tylenol/motrin) or they will be scheduled for a pediatricians visit.

With no discussion of using Relenza?

Not to my knowledge. I know of it but I do not recall any specific bulletins about it.

 

[Skeptic Ginger]

From this WHO report on resistance to Tamiflu there is nothing there indicating widening our prescribing to those persons moderately ill is particularly risky. Especially given the fact the new vaccine is beginning to be distributed.

By moderately, I mean a person with a pretty significant case of flu but not a person with a mild case. I remain concerned that "severe" is really subjective at this point. I can't imagine there is any kind of consensus as to where the line on the continuum between moderate and severe actually lies.

Resistance is associated with immunocompromised patients and with prophylaxis.

Current conclusions [09-25-09]

These data support several conclusions. Cases of oseltamivir-resistant viruses continue to be sporadic and infrequent, with no evidence that oseltamivir-resistant pandemic H1N1 viruses are circulating within communities or worldwide.

To date, person-to-person transmission of these oseltamivir resistant viruses has not been conclusively demonstrated. In some situations, however, local transmission may have occurred, but without any further onward or ongoing transmission.

Except for immunocompromised patients, those infected with an oseltamivir-resistant pandemic H1N1 virus have experienced typical uncomplicated influenza symptoms. No evidence suggests that oseltamivir-resistant viruses are causing a different or more severe form of illness.

The occurrence of oseltamivir-resistant viruses is expected and is consistent with observations from early clinical trials. As use of antiviral drugs continues to grow, further reports of drug-resistance viruses are certain to occur. WHO and its network of collaborating laboratories are closely monitoring the situation and will issue information and advice on a regular basis as indicated.

 

[JoeTheJuggler]

I sure don't see any easy solution to this puzzle. It's not even clear to me what would constitute "erring on the side of caution".

Increase the supply of children's Tamiflu for future cases and use whatever is in the current supply right now. (And Roche says they're doing just that.)

ETA: I don't know if that's an "easy" solution, but it's certainly simple.

Also, as someone pointed out (and I've confirmed on the googlewebs), it's possible for pharmacists to grind up adult doses (or simply open capsules I guess) and make pediatric doses. Since there's an abundant supply of adult doses, there really is no shortage problem at all. (Also, as Skeptigirl points out, many of these "kids" are big enough to take adult doses--or at least can swallow capsules.)

It sounds like the resistance issue isn't one that these cases would worsen (unlike the prophylactic use of Tamiflu), so it sounds to me like the CDC really should change its recommendations.

 

[JoeTheJuggler]

Here's my Conspiracy Theory on the issue. (Gee, I've never started one before.)

The government is trying to protect the supply of Tamiflu because it either has knowledge of terrorist plans to use a biological weapon or because the Gummint itself is plotting to use biologicals.



ETA: I'd bet money that someone will point out to me that my CT has already been put forth seriously.

 

[Skeptic Ginger]

I asked a friend of mine what they were doing at her ED and she said the patients coming in with probable flu were mostly getting Tamiflu. So you go to an ED and it is assumed you are sicker than if you go to your PMD.

But if Dr I's ED is more conservative with the Tamiflu, we are back to individual provider judgment about what constitutes a severe case.

Leaving that up to provider judgment is fine in most cases. What I am thinking, however, is there is so much bias in the medical community about influenza that it is biasing that usually more neutral judgment.

This is speculation, of course, but think about the OP example. A 2 yr old with a temp of 104 is pretty common. And you wouldn't get that excited about it barring other factors. You would advise the family to take measures to lower the child's temp.

But a 14 yr old with a temp of 104 is seriously ill as is an adult with a temp of 104. Young kids' fever control mechanisms are not as well developed. So the fever is the result of the child's body's immaturity. The 14 yr old's fever is the result of the severity of the infection.

Why didn't the pediatrician's office recognize that when the family called them back? One possibility is the staff were in the mindset flu is mild. That creates a kind of tunnel vision and you don't see outside the tunnel.

 

[GreNME]

I'm not totally familiar with other systems. We have an Influenza Pandemic Clinic ready to go if or when it really strikes this winter. Until then, most just show up to their pediatrician's office.

They have these in TX already, and I believe some other places. Some hospitals have set up large tents outside the hospital on the grounds to take care of the people coming in (mostly kids). You know what? It's working.

That's what gets me most about all of this hype: here on this website we consistently point out the ratio of hits and misses to people regarding cold readers, and how those who fall for it are counting the hits and disregarding the misses. Yet with the H1N1, it seems the hype is more interested in highlighting the deaths and ignoring or glossing over the vast majority (not just 60-80%) who are dealing with being sick for a few days to a week, then none the worse for wear thanks to doctor recommendations of hydration, no activity, and plenty of rest. I've heard exactly one report (on NPR) from a reporter whose daughter caught it, was under bedrest for 3-4 days, and then recounted her time (mainly boredom) to her dad for the report itself. Everyone else is "OMG SOMEONE DIED!!!1!ELEVENTYONE!!"

One of the little-known pieces of information: the flu is affecting kids 25 and under due to a lack of resistance that people in their 30s and 40s have, and people older than that have already lived through from a strain in the middle of last century that bears a remarkable resemblance.

Consider me one of those who isn't questioning your professional integrity, paximperium.

 

[fls]

What I am thinking, however, is there is so much bias in the medical community about influenza that it is biasing that usually more neutral judgment.

Perhaps they are better inoculated against the availability bias?

Linda

 

[Skeptic Ginger]

Perhaps they are better inoculated against the availability bias?

Linda

I'm not quite clear which side you are referring to by "they".

Roche has been pumping out Tamiflu since 2005 and lots of people have taken the opportunity to stockpile it. In addition, expired stock is still good and in the US we can use it by order of the CDC.

Drugmaker considers Tamiflu supplies 'reasonable'; April 29, 2009

Global supplies of Tamiflu are "reasonable" because a generally mild flu season in the Northern Hemisphere left stockpiles largely untapped, said Terry Hurley, a spokesman for the drug's maker, Roche.

The company already was working to boost its global production capacity for Tamiflu, Hurley said. Within 12 months, he added, it will be able to make enough of the drug to treat 400 million people a year.

Drug combination 'could double Tamiflu supplies'; Source: Nature; 2 November 2005 Probenecid prevents urinary excretion of Tamiflu and can be used to extend supplies in an emergency.

‘No shortfall in Tamiflu supplies’ Aug 09

Capacity is not a constraint and we can supply 20 million doses in 10 days, and, if required, go up to 100 million capsules (needed to treat 10 million patients).”

Two months ago, the government asked companies making Oseltamivir to stockpile adequate raw material (mainly shikimic acid) in case of emergency.

Ample Tamiflu supply exists for 2008-2009 season.
APRIL 27, 2009; Cipla Can Supply Generic Tamiflu
Chugai/Roche to up Tamiflu supplies to Japan threefold; 8 Sept. 09

Chugai Pharmaceutical has revealed that it plans to increase the supply to March 2010 of the anti-influenza drug Tamiflu Capsule 75 and Tamiflu Dry Syrup 3% (oseltamivir phosphate) imported from its Swiss parent company Roche, for production and marketing in Japan.

The question I am bringing up here is not about giving Tamiflu to every kid with a runny nose. My issue is how we are defining a case severe enough to warrant Tamiflu.