FDA Announces End for CFC-Propelled Inhalers

As reported in Med Page Today, the FDA Announces End for CFC-Propelled Inhalers. Of the seven inhalers with deadlines for removal, only three are still being made:

Flunisolide (Aerobid Inhaler System) on June 30, 2011
Albuterol and ipratropium combination (Combivent Inhalation Aerosol) on Dec. 31, 2013
Pirbuterol (Maxair Autohaler) on Dec. 31, 2013

The reason for this is because CFC's are harmful for the environment, and the newer inahlers have to be replaced with a different, more environmentally friendly propellant called hydroflouroalkane or HFA. I have blogged about this previosuly (please see Asthma inhalers and More on Asthma Inhalers ).

According to the FDA, "patients using the inhalers scheduled to be phased out should talk to their health care professional about switching to one of several alternative treatments currently available. Until then, patients should continue using their current inhaler medication."

What you should do:
1. Albuterol If you are taking albuterol, please see my earlier posts. I still have patients that have their very old albuterol canisters, which are probably no longer effective. An important thing to know is that there is no longer any generic albuterol. More importanly, if your physician writes a prescription for albuterol, the pharmacist will likely give you ProAir, which may or may not be what your insurance prefers and/or what is least expensive for you. This is because many of the chain pharmacies are getting a kick back from the makers of ProAir. Make sure your provider writes for the correct inhaler. All things being equal (same co-pay for patients), I recommend Ventolin HFA (because it is the only one with a dose counter) or Xopenex HFA, because of diminished side effects. NEW INFORMATION: GSK, makers of Ventolin HFA sell a $9 inhaler, regardless of your insurance. Though the inhaler has fewer puffs in it, if you are using your inhaler that frequently, then your asthma is not under good control, and you should be on a different controller medication. Ask your doctor for Ventolin HFA 60 (they have to write the 60 part).

2. Maxair- Some patients love this drug, but it's going away. Before January 2014, get another albuterol. See above and previous posts for advice.

3. Aerobid- I didn't even realize they still made this medication. It is no more effective then other similar medications, probably less effective, possibly more side effects, and it tastes nasty. If you are on this medication, switch ASAP to another inhaled steroid. Good alternatives include Flovent, Pulmicort, Asmanex, and Alvesco.

4. Combivent- This will likely affect patients the most, since few patients are on Maxair or Aerobid, and there are far more COPD patients than asthmatics. It is very likely that before January, 2014, the makers of Combivent with come out with a Combivent HFA. However, there are reasons to consider switching now. Please see older posts Good News for COPD , Bad news for COPD: Why this meta-analysis should be believed (and the Avandia one should not) , and UPLIFTing News for COPD

Briefly, a few studies have come out which make me very concerned about using Combivent. One study published in the Annals of Internal Medicine studied a VA population and found that patients taking ipratropium had significantly higher death rate of about 11%. A second study was a meta-analysis published in JAMA that analysed date from 14,783 patients with COPD and found that patients taking either ipratropium or tiotropium (Spiriva) or both had a 58% increase in cardiovascular death, heart attack or stroke when compared to patients taking other meds (Advair, albuterol or placebo). Though combined, these studies might cause safety concerns with the entire class of anti-cholinergic inhalers, the UPLIFT trial, a long-term, large randomized controlled trial (4 years, almost 6000 patients) which unfortunately failed to show that Spiriva could decrease that rate of lung function decline, did show about 10% relatively fewer deaths. Thus, though anti-cholinergic medicines may cause some harm, it appears that this is likely mainly for the short acting ipratropium and not for the long acting tiotropium. I would therefore recommend that COPD patients talk to their doctors about stopping their Combivent now and switch to a different controller medication (Advair, Symbicort, Spiriva) and/or switch to albuterol alone as a rescure medication.

Generic and Therapeutic Substitutions

I was on the local DC news today regarding generic substitution.

Generic substitution is when your doctor writes for a prescription medication, but the pharmacists substitutes this with a generic medication. This is perfectly legal and, in general, a good thing for patients. For the most part, and for most drugs, the generic is just as good as the brand drug. However, as the news piece points out, there are some instances where the small difference between the generic and the brand name medication may make a difference. These are usually medicines where doses are very small such as hormones (thyroid medications, birth control pills) and medicines that have to be closely monitored. This does not necessarily mean that the generic is worse than the branded medication, but that switching from one to the other could have potential adverse effects.

One of the things that I spoke with the reporter about that is not in the above video (I have control over what I say, but not what they choose to sue), and only got a brief mention by the new anchor after the video was shown was about therapeutic substitution. This is a completely different ball game and a major concern of mine.

Therapeutic substitution is when your doctor writes a prescription for a branded drug and the pharmacist substitutes it not with the generic equivalent, but with a completely different generic drug in the same class. In this case, you are getting a totally different medication. For example, let's say your doctor writes a prescription for Crestor or Lipitor, both very potent cholesterol lowering drugs. You bring this prescription to the pharmacist, but instead of getting Crestor or Lipitor, you get simvastatin, a generic cholesterol medication. The difference here is that where the brand and generic equivalent will work about the same, this is not the case with a therapeutic substitution. Simvastatin will work in many patients but is not nearly as good as lowering cholesterol as Crestor or Lipitor. Thus, if the patient got switched and needed more cholesterol lowering than the simvastatin could provide (which is why I would write Crestor or Lipitor in the first place), that patient's cholesterol levels could be too high despite medication, potentially leading to heart attack and strokes. This is just one of many examples.

The practice of therapeutic substitution is currently illegal, but this could change. In Washington, DC where I practice, there is current legislation pending that would not only allow, but might compel a pharmacist to switch patients to cheaper medication, whether or not they were the same. In the case of DC, this is designed to save the government money from the millions of dollars its spends on prescription medications for our Medicaid patients.

With health care costs so high, physicians should do their best to try and write generic medications when possible. In additions, our pharmacist colleagues can be a tremendous help in figuring out ways to lower the costs of medications by using generics, whether it be a direct generic substitution or even therapeutic substitution. Pharmacist and blogger Mr.Medsaver has been doing this for quite some time, and I routinely read his helpful posts. However, pharmacists are not trained clinicians and do not know (and can not know) all the details of the patient's history or the rationale for the doctor choosing one drug over another. Though the pharmacist's suggestions are always welcome, I do not believe the should be allowed, and certainly not compelled or heaven forbid incentivized, to switch medications within the same therapeutic class. This could be very dangerous for patients.