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2013年9月28日星期六

Asthma inhalers



The New York Times has an excellent piece today on the phasing out of old asthma inhalers, which has already begun. However, the old asthma inhalers will completely unavailable by the end of the year. Many asthma inhalers are pressurized metered dose inhalers (pMDI’s) which means that when you push down on them, the medication sprays out like an aersol spray. Not all inhalers are pMDI’s. Some of the newer inhalers are dry powder inhalers (DPI’s) where the medicine is not sprayed out, but simply inhaled (Advair and Pulmicort are both DPI’s). However, all the rescue medication products available in the US (which is almost always albuterol) are only available in pMDI’s. The problem is that the propellant in these sprays was a CFC, which is bad for the enviornment. CFC’s have been banned by the government, and the asthma inhalers are the last remaining consumer products to have them. The new pMDI’s are made with another propellant, that is more environmentally friendly, HFA. However, there are several differences between the CFC pMDI’s and the HFA pMDI’s.


There is no generic albuterol HFA
The FDA considers the HFA inhalers new drugs, even though the active ingredient is off patent.
Issue #1- if the physician just writes albuterol, the pharmacist will likely dispense the CFC pMDI which will not be available in January 2009, and more importantly may not be available now because supplies are limited
Issue #2- if the physician writes albuterol HFA, since this product does not exist, the pharmacist will likely substitute one of the 3 branded products (ProAir, Ventolin HFA, and Proventil HFA). However, it may matter to you which one of these you get because………
Issue #3- each insurance company has a different policy regarding the CFC to HFA transition. The HFA inhalers are much more expensive. On the other hand, insurers worry that increasing the cost of the co-pay may decrease the use by patients and land them in the Emergency Room. Some insurers have picked one of the 3 products and assigned it a generic co-pay while others have no preference and assign all products the same higher co-pay.


There are some differences between the old CFC inhalers and the new HFA inhalers
The spray from the HFA inhalers is weaker. Inhalers require more priming (wasting the first few pumps) before the first use. Patients may feel a difference in the force and taste of the spray ( and confuse this for the medication not working). The HFA inhalers also require a slower and deeper inhalation.


There are some differences between the new inhalers
ProAir, Ventolin HFA, and Proventil HFA are all albuterol products. Ventolin HFA (made by GSK) has one advantage in that it has a dose counter. Research has shown that many asthmatic patients incorrectly estimate how much medication is left in their inhaler. Most inhalers will continue to spray propellant even when the active ingredient has been used up.
Finally, there is a 4th product called Xopenex, which is levalbuterol. The medication is very similar, but because of its structure may have fewer side effects such as shaking or rapid heart beat. Though the branded Xopenex HFA is currently more expensive than the generic albuterol CFC, when compared to the other three albuterol HFA’s, Xopenex may be the same or even less of a co-pay then the others, depending on your insurance.


What you should do
1. If you have asthma, disccus the CFC to HFA conversion with your doctor to make sure you are getting the right medication.


2. Know the co-pay level that your insurance will charge you for ProAir, Ventolin HFA, Proventil HFA and Xopenex HFA. If any of these are a generic co-pay, switch now. All things being equal, Ventolin (dose counter) and Xopenex (fewer side effects) may be preferred.


3. Use these medications for rescue only. The medications are really only for bad symptoms and emergencies. Current guidelines state that if you are using these medications more that two times a week, your asthma is not well controlled, and you need a better maintenance inhaler, which is an inhaler you take every day to control your asthma.


4. Recognize the differences between the HFA and CFC inhalers. As above, the spray will feel different, and will require some adjustments (priming, slower inhalations) than your previous albuterol pMDI.


5. Do not use Primatene Mist to save a few bucks. This is an over the counter asthma inhaler. It is dangerous and would never be approved by the FDA today. Older medications that are currently over the counter need to have been proven to kill or severely injure people before they will be pulled from the market. This is hard for Primatene Mist, because hard to say whether or not it was the inhaler or the asthma. The active ingredient is epinephrine which has a lot of side effects.


2013年9月27日星期五

Good news for asthmatics: Obama administration set to ban over-the-counter inhalers to save ozone layer

““Everybody knows that it makes no sense that you send a kid to the emergency room for a treatable illness like asthma, they end up taking up a hospital bed, it costs, when, if you, they just gave, you gave them treatment early and they got some treatment, and a breathalyzer, or inhalator, not a breathalyzer. I haven’t had much sleep in the last 48 hours.”” –Barack Obama, 9 October 2008



Wonderful news from the environmental do-gooders in Washington: the Obama administration is poised to ban over-the-counter breathalyzers, I mean inhalators, I mean inhalers in order to save the ozone layer



Remember how Obama recently waived new ozone regulations at the EPA because they were too costly? Well, it seems that the Obama administration would rather make people with Asthma cough up money than let them make a surely inconsequential contribution to depleting the ozone layer:

Asthma patients who rely on over-the-counter inhalers will need to switch to prescription-only alternatives as part of the federal government’s latest attempt to protect the Earth’s atmosphere.




The Food and Drug Administration said Thursday patients who use the epinephrine inhalers to treat mild asthma will need to switch by Dec. 31 to other types that do not contain chlorofluorocarbons, an aerosol substance once found in a variety of spray products.


The action is part of an agreement signed by the U.S. and other nations to stop using substances that deplete the ozone layer, a region in the atmosphere that helps block harmful ultraviolet rays from the Sun.


But the switch to a greener inhaler will cost consumers more. Epinephrine inhalers are available via online retailers for around $ 20, whereas the alternatives, which contain the drug albuterol, range from $ 30 to $ 60.





As Anthony Watts observes, “Let the hoarding begin“:



The eco-world has gone beserkers with this one, even CBS News is asking: Why? Me too especially since global ozone is predicted to recover [according to a 2004 EPA Report].

…What will really happen is that this will turn regular people and children into scofflaws, and they’ll buy over the counter inhalers in other countries like Mexico and have them shipped here. It will be another giant sucking sound.




So when some kid dies in 2012 because they couldn’t get access to an inexpensive, over-the-counter inhaler, let’s all give thanks to President Obama — because that’s one less ozone destroyer that we have to worry about.



2013年9月18日星期三

H.R.1220 - Asthma Inhalers Relief Act of 2013 Regarding EPA, CFC regulations



H.R.1220 – Asthma Inhalers Relief Act of 2013Directs the Administrator of the Environmental Protection Agency (EPA) to: (1) permit the distribution, sale, and consumption in the United States of remaining inventories of CFC epinephrine inhalers manufactured pursuant to the exception for medical devices under the Clean Air Act; (2) not take any enforcement action or otherwise seek to restrict the distribution, sale, or consumption of such inhalers on the basis of any federal law implementing the Montreal Protocol on Substances that Deplete the Ozone Layer; and (3) issue, in response to a request of any distributor or seller of such inhalers, a No Action Assurance Letter stating that the EPA will not initiate an enforcement action relating to the distribution or sale of any such inhaler occurring prior to August 1, 2013. Defines “CFC epinephrine inhaler” to mean any epinephrine inhaler containing chlorofluorocarbons that was manufactured and classified as over-the-counter before January 1, 2012. Terminates this Act on August 1, 2013.Please continue reading at: http://beta.congress.gov/bill/113th/house-bill/1220