Nasacort AQ Steroid Nasal Spray NOW Available OTC!

Sanofi announced in 2013 that the FDA had approved Nasacort steroid nasal spray to be made available over-the-counter (OTC) starting sometime spring 2014.

Well... It's now available for about $20. Here's where you can get it on Amazon.com.

Nasacort is a steroid nasal spray used to treat allergies in patients starting from the age of 2 years old. It is similar to prescription steroid nasal sprays like flonase, nasonex, etc. It is also the very first steroid nasal spray made OTC in the United States which can be both a blessing as well as a curse.

Why?

With Nasacort going OTC which will certainly make it more convenient for patients, I also anticipate that the other prescription steroid nasal sprays including flonase, nasonex, qnasl, zetonna, veramyst, etc will become much harder to prescribe due to insurance requiring patients to use OTC Nasacort first. Worst case, insurance may even simply stop paying for the prescription steroid nasal sprays.

After all, this is exactly what happened with prescription reflux and anti-histamine medications.

Source:
FDA Approves Sanofi's Nasacort(R) Allergy 24HR for Over-the-Counter Use. Wall Street Journal 10/11/13

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New Ragweed Under the Tongue Pill Instead of Allergy Shots Recommended by FDA Panel

Yesterday, the FDA Allergenic Products Advisory Committee supported approval for a new sublingual allergy tablets (Ragwitek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Given this is only a panel recommendation, final "official" FDA approval may not occur for another year or so for sale/distribution under prescription in the United States.

Ragwitek is made by ALK-Abello and Merck and treats patients aged 18-65 years who are allergic to only short ragweed pollen. The way Ragwitek is taken is placement of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the ragweed pollen season. The first dose is given in a medical office to ensure safety with all other doses taken at home. The tablet dissolves in less than 10 seconds.

Epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Ragwitek is similar to Oralair and Grastek which treat only grass allergy. Oralair and Grastek were both recommended by the FDA panel last year.

Source:
Sublingual Ragwitek Backed FDA Panel for Ragweed Allergy. Medscape 1/28/14

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Two New Sublingual Allergy Tablets Approved by FDA Advisory Committee

This week, the FDA Allergenic Products Advisory Committee unanimously supported approval for two new sublingual allergy tablets (Oralair and Grastek) that work the same way allergy shots do... but instead is dissolved under the tongue at home instead of a shot in the arm in a medical office. Although both tablets have been available in Europe for some time, final "official" FDA approval may not occur until end of 2014 (or later) for sale/distribution under prescription in the United States.

Oralair is made by a French pharmaceutical company Stallergenes and treats patients aged 10-65 years who are allergic to 5 different grasses: Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass. Treatment is composed of a buildup and maintenance phase. Starting 4 months prior to the grass pollen season, a 100 IR tablet is administered under the tongue in a medical office to ensure no significant side effects. At home on day 2, two 100 IR tablets are administered. On day three and daily thereafter, a 300 IR tablet is placed under the tongue until the end of the grass pollen season. The tablets take about 1 minute to dissolve.

Grastek (aka Grazax in Europe) is made by ALK-Abello and Merck and treats patients aged 5-65 years who are allergic to only Timothy Grass. Grastek has a simpler regimen of 1 sublingual tablet daily starting 12 weeks before and continued until the end of the grass pollen season. As with Oralair, the first dose is given in a medical office to ensure safety with all other doses are taken at home. The tablet dissolves in less than 10 seconds.

For both tablets, epipen needs to be available at home due to possible risk of anaphylaxis. As with allergy shots, patients on beta-blockers for high blood pressure are not eligible to undergo this treatment.

Sources:
Grastek Recommended by FDA Panel for Timothy Grass Allergy. Medscape 12/12/13

Sublingual Oralair Recommended for Grass Pollen Allergy. Medscape 12/11/13

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Nasacort Steroid Nasal Spray to be Available Over-The-Counter!

Sanofi announced today that the FDA has approved Nasacort steroid nasal spray to be made available over-the-counter (OTC) starting sometime spring 2014.

Nasacort is a steroid nasal spray used to treat allergies in patients start from the age of 2 years old. It will also be the very first steroid nasal spray made OTC in the United States which can be both a blessing as well as a curse.

Why?

With Nasacort going OTC which will certainly make it more convenient for patients, I also anticipate that the other prescription steroid nasal sprays including nasonex, qnasl, zetonna, veramyst, etc will become much harder to prescribe due to insurance requiring patients to use OTC Nasacort first. Worst case, insurance may even simply stop paying for the prescription steroid nasal sprays.

After all, this is exactly what happened with prescription reflux and anti-histamine medications.

Source:
FDA Approves Sanofi's Nasacort(R) Allergy 24HR for Over-the-Counter Use. Wall Street Journal 10/11/13

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Dante's Hell of Prescriptions: When Treatment Causes More Ills

Here is a scenario which I unfortunately see all too often... a scenario how prescriptions are provided to a patient to address their ills which due to associated side effects causes even more problems which in turn is treated with even more prescriptions.

Take for example a patient who presents with a chief complaint of cough for over 12 months.

Suspicion for bronchitis is made and prescription for levaquin (antibiotic) and tussionex (a narcotic cough suppressant) is given to the patient.

Unfortunately, the patient suffers side effects from both medications and is given additional prescriptions to address these side effects which in turn is treated with even more medications which have other side effects.

One can see how such a downward spiral of prescription hell can increasingly snowball to the patient's ultimate disease ridden state of numerous physical complaints ALL due to side effects of medications... especially when one considers that the initial complaint of cough was due to the side effect of lisinopril which was originally prescribed to treat hypertension (which in itself has no symptoms).

It is at times like these where some sanity to the medication madness needs to occur and I tell such patients to STOP all medications... including the true culprit lisinopril.

And that's why ENT physicians always ask what medications a patient is taking... even if at first blush, a blood pressure medication seems to have no relevance to an ENT doctor.

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New Oral Appliance for OSA (Only Needs Heat to Fit)

A new sleep apnea oral appliance can be fitted and used at home without going to a dentist called ApneaRx!

Oral appliances to treat obstructive sleep apnea (OSA) have an upper and lower component that fit into the upper and lower jaws. A mechanism within the device than allows for the lower jaw to be thrust forward to some degree which pulls the tongue and anterior airway forward thereby enlarging the airway and preventing obstructive apneas during sleep. It can also help with snoring.

Typically, such OSA oral appliances must be fit by a dentist and cost upwards of $300 or more.

Most patients or loathe to spend that kind of money if they are not sure if:

1) It will actually help
2) It will be something they can actually tolerate or use

That's where this new OSA oral appliance called ApneaRx comes in which is considered a "transition" device to try and see if oral appliances will work for a given patient before going with an expensive dentist-fit customized oral appliance.

In essence, the device is heated and bitten into for fitting. The device can than be adjusted in 1mm increments by squeezing from the sides.

If this device "works" for a patient, they can either continue to use this device, or now take the time and expense of getting a customized device from a dentist.

Best of all, you can get it on Amazon!

However, please be aware that there's only one size currently available which may be too large for 20% of patients, especially women. There will soon be a smaller version for those with a smaller mouth by the end of 2012.

Read brochure.

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Greater Patient Satisfaction At Expense of Better Care?

Much has been made about improving patient satisfaction in the healthcare industry in the belief that greater patient satisfaction equates with better health. To this end, patients are routinely asked to complete a survey based on their impressions on the care they received.

BUT... does greater patient satisfaction actually result in or is the result of better care???

According to a recent study... higher patient satisfaction actually resulted in:

• Greater inpatient hospitalization
• Higher overall healthcare utilization
• Higher prescription usage
• INCREASED RISK OF DEATH!

The one and only measured benefit of higher patient satisfaction scores was decreased ER use.

Why would there be an increased risk of death with higher patient satisfaction scores?

Well, if a doctor always does what the patient wants, that would tend to lead towards higher patient satisfaction... EVEN if it's the wrong thing to do.

For example... when a patient sees a doctor for a perceived sinus infection, it is not uncommon for a patient to expect to leave with an antibiotic.

Unfortunately, many sinus infections are actually viral URI for which antibiotics is the WRONG course of action.

Inappropriate antibiotics lead to drug-resistant infections which lead to deaths. They can also cause side effects that may require additional healthcare intervention.

However, if a doctor resists a patient's desire for an antibiotic, that would lead to a decrease in patient satisfaction.

Also, the more testing and treatment that is performed, the higher the risk of downstream adverse effects. For example, a patient may desire a CT scan of the chest to rule out lung cancer even though the chest x-ray is normal. Unfortunately, the CT scan picks up a small liver nodule. Needle biopsies are performed which unfortunately resulted in excessive bleeding requiring surgical correction and several days in the hospital. In the end, it was just a benign cyst that never required any treatment.

These examples may oversimplify a very complex issue, but it does suggest that one interpretation of higher patient satisfaction scores are that doctors and hospital systems may choose to do the wrong thing in order to get a better score.

Reference:
The Cost of Satisfaction: A National Study of Patient Satisfaction, Health Care Utilization, Expenditures, and Mortality. Arch Intern Med. Published online February 13, 2012. doi:10.1001/archinternmed.2011.1662

Media:
Why Rating Your Doctor Is Bad For Your Health. Forbes 1/2/13.

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