Patent Application
20070181119
1. Field of the Invention
The present invention relates to a device and method to reduce error in distinguishing topical inhaled agents used to treat respiratory tract disorders.
2. Description of the Prior Art
Individuals with obstructive pulmonary diseases are often required to utilize multiple medications, some of which are self-administered by inhalation. In the case of asthma, a disease characterized by shortness of breath, wheezing, cough, and excess sputum production, affected individuals often are required to use more than one inhaled medication. Asthmatic treatment typically requires the affected individual to use one inhaled medication regularly to control inflammation of the airway, and another inhaled medication to dilate the bronchial tree when symptoms occur that require immediate relief. This might be referred to as a regimen of “controller” and “rescue” medication. Medications for “controller” use act over many hours to days and include inhaled corticosteroids, examples being fluticasone, flunisolide, and triamcinolone, and long- acting bronchodilators, examples being salmeterol and formoterol. Short-acting beta-adrenergic agonists rapidly dilate the bronchial tree and their effects typically dissipate within a few hours. Examples of these inhaled medications that are used as “rescue” medication include albuterol, pirbuterol, and metaproterenol.
Rescue inhaler devices in current use have no structural characteristic to distinguish them from controller medication devices. The configurations of many of metered dose inhaler devices for rescue medication are the same or very similar to those of controller medication. For example, present brands of albuterol in metered dose inhalers include Proventil® and Proventil® HFA, manufactured by Schering, Ventolin® HFA manufactured by GlaxoSmithKline, and those manufactured by other pharmaceutical manufacturers that include Andryx, Armstrong, Ivax, and Warrick. None of these have any physical indication to convey to the user/patient that they are for immediate rescue use. Neither is any one of these products significantly distinguishable from controller medications on the market.
Examples of presently marketed metered dose controller inhalers that are similar in appearance to rescue medications are Aerobid® Inhaler containing flunisolide, manufactured by Forest, and Flovent® Inhalation Aerosol containing fluticasone proprionate, manufactured by GlaxoSmithKline. Were an individual to be prescribed GlaxoSmithKline's Flovent® as a ¢controller∞ and the same manufacturer's Ventolin® HFA for “rescue,” the two would be distinguishable only by name and color. Flovent® (a controller medication) is brick colored and Ventolin® HFA (a rescue medication) is blue. There is nothing about either the names or the colors that would suggest to a user which was for rescue, or which was for control. One might instinctively, and incorrectly, assume that the inhaler with the calming blue-gray color is the controller. Confusion such as this would be averted if rescue medications were clearly identified.
Therefore, what is needed is a rescue inhaler that has indicia to clearly distinguish it from controller medication and to convey to a user that it is to be used when required for immediate relief of symptoms.
Despite an increasing understanding of obstructive lung diseases such as asthma and the availability of better medications, asthma morbidity and mortality has not improved. Failure by the patient/user to comply with treatment is an important underlying cause, and successful treatment requires the patient/user to understand which of the medications are required and their proper usage. The likelihood of inappropriate treatment and error increase when treatments are confusing and self-administered by the patient/user.
Confusion with treatment may occur when individuals are required to use a multiplicity of agents for treatment. In the case of multiple inhalers, individuals are known to confuse one with another. The inventors are allergists that have recognized that, despite careful instruction, it is not uncommon for patients to make errors and confuse controller and rescue medications. When asked “which inhaler do you use when you get into trouble?,” some patients incorrectly point to the controller inhaler. In some instances, this may be attributable to forgetfulness, or mistaking one for another, or an interval in which the medication was not used for a period and then resumed. In some instances, the confusion is heightened when the patient was prescribed one brand of medication, and a substitution made at the pharmacy to fill an equivalent brand or brands that have different appearance.
An object of the present invention is to correct a source of error by providing a user with a rescue inhaler that is clearly distinguishable and conveys its role to a user. It is another object of the present invention to provide a rescue inhaler having indicia that clearly distinguishes the rescue medication-containing inhaler from the controller medication-containing inhaler.
It is an object of the present invention to provide these and other objectives in an inhaler device having an inhaler dispenser housing with an indicia that conveys use for emergency relief from a bronchial attack and an aerosol canister that contains an immediate acting bronchodilator medication, also known as a rescue medication. The indicia may be a word or words, a symbol, a shape, or any combination that signifies emergency use. The indicia may also be integrated into the shape of the dispenser housing where the structure of the dispenser housing conveys the notion that the contents are for emergency use.
In one embodiment of the present invention, words are used to convey such a notion. Examples of wording to convey such an impression include, but are not limited to, “rescue,” “emergency use,” “fast-acting,” “for worsening symptoms,” “for shortness of breath,” “relief medication,” and the like.
In another embodiment of the present invention, color may be used alone or in combination with words, symbols, and shapes. An example of color is “fire engine” red.
In another embodiment, symbols are used to convey the impression that the contents of the inhaler device are for emergency use. Examples of symbols that may be used to convey a similar impression are a fire hose, an open bronchial tree, a life (rescue) ring, and the like.
In another embodiment, a shape is used to provide the notice function. An example of a shape includes a fire hydrant shape. Other shapes that denote “emergency use” and that are easily recognized by a user may be used, etc.
It is important that the dispenser housing of the inhaler device is configured so that upon seeing the inhaler device, the inhaler device conveys to a user/patient and the user/patient easily recognizes that the inhaler device contains “rescue” medication for the immediate relief of obstructive lung disease symptoms. In this way, user compliance with the treatment prescribed by the user's caregiver for the user's obstructive lung disease is improved.
The preferred embodiment(s) of the present invention is illustrated in
Turning now to
Turning now to
The basic shape of inhaler device 10 in the Figures is meant to illustrate typical metered-dose inhalers that aerosolize medication in liquid form. It is within the scope of the present invention, however, to similarly provide indicia for other aerosolized rescue medications that might be employed by patients. Rescue medication in aerosolized powder form is one example. It is anticipated that manufacturers might manufacture separate indicia that can be applied to the inhaler device. It is considered most preferable, however, for the manufacturer to incorporate the indicia with the inhaler device prior to the user receiving it. Alternatively (though less preferred), an expert such as a pharmacist or other caregiver can apply the indicia to the dispenser housing 14 before the user receives it. However, it is not considered desirable to rely on the user to apply the indicia, due to the greater potential for error.
Although the preferred embodiments of the present invention have been described herein, the above description is merely illustrative. Further modification of the invention herein disclosed will occur to those skilled in the respective arts and all such modifications are deemed to be within the scope of the invention as defined by the appended claims.
