The container of the invention has a front and back panel and a pair of opposite side panels, the side panels being also attached to a top and bottom panel of a selected width disposed between each of the side panels and the front and back panel, thereby forming a box. Alternatively, the container of the invention may be a bag, pouch, or any combination of a box, bag, envelope, container or pouch. The container is divided into two compartments or a single compartment, and is particularly adapted to contain prescription drug samples in a first compartment and patient and disease state information, literature and other forms of media, and related products and services in the second compartment, thus forming a unitary container that may be distributed to a patient as a patient starter kit.
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Prescription drug as defined herein includes both branded and generic pharmaceuticals that are not sold over-the-counter (OTC). It is understood that OTC pharmaceuticals as defined under the Food Drug & Cosmetic Act and including but not limited to aspirin, laxatives, antacids, cough cold products may be contained within the second compartment. The second compartment may also include medical devices therein. Such devices include, but are not limited to, glucose test strips, lancets, band aids, glucometers, pedometers, pulsox readers, nebulizers, and the like.
The term “prescription drug sample” is as defined under The Prescription Drug Marketing Act (PDMA) (Public Law 100-293) enacted on Apr. 22, 1988, and modified by the PDA (Public Law 102-353, 106 Stat. 941) on Aug. 26, 1992.
As used herein the phrase “patient adherence” is synonymous with the phrase “patient concordance” which refers to the process whereby the patient and physician reach an agreement on how a drug will be used, if at all and the phrase “patient compliance” or “patient compliance and persistence”. Patient retention is defined as communication with the patient.
The phrase “prescription drug information” refers to information regarding the identification, uses, dosage, precautions, side effects, storage information, drug interaction information of the pharmaceutical sample provided. Such information may be provided in printed, electronic or other media format including, but not limited to, patient brochures, patient package inserts, web site information, CDs, DVDs, tapes, or memory sticks.
The phrase “disease state information” as used herein refers to an awareness of a particular condition and outcomes of treatment and their characteristics, including benefits and possible harms.
Suitable disease states include both acute, chronic conditions and lifestyle decisions (e.g. hair restoration, erectile dysfunction, dermatological, contraception) for which a prescription drug may be prescribed. Examples of suitable disease states for the patient starter kits of the present invention include, but are not limited to, arthritis (e.g. osteoarthritis, rheumatoid arthritis), hyperlipidemia, asthma, allergies, respiratory illnesses, osteoporosis, contraception, erectile dysfunction, hair restoration, overactive bladder, diabetes, obesity, hypertension, congestive heart failure, peripheral arterial disease, stroke, insomnia, migraine, infections, GI disorders, and acid reflux with all above conditions affecting adults and children.
The phrase “consumer package goods” as used herein refers to food, retail beverage and dairy products, condiments, smoking cessation products, ethnic products, health and beauty aids, OTC products, health, beauty and cosmetic products, weight control products, fitness shoes, exercise apparel, and the like.
The phrase “related consumer products” as used herein refers to, but is not limited to, coupons, product samples, medical devices, and medical services.
The phrase “consumer services” as used herein refers to, but is not limited to, clubs, retail associations, memberships (e.g. gym or spa), pharmacy services, pharmacies, financial security services, health insurance or HMO/PPO services.
The first component may be sized and configured to receive a variety of sizes of prescription drug sample packages or only patient education literature. The aperture or window of the first compartment can be sized and configured to permit viewing of the prescription drug sample (or voucher, debit card, discount card) therein as appropriate. Alternatively, when the container is a bag, the first component may be a single compartment, such as a zippered compartment or a pouch or pocket.
Alternatively, the first compartment may contain either in lieu of, or together with, the prescription drug sample, a means for obtaining the prescription drug. The means for obtaining a prescription drug include, but are not limited to, a prescription, a reimbursement for the cost of the first prescription such as a prescription voucher, a prescription discount card, enrollment information for a prescription discount program, a prescription co-pay waiver, a prescription co-pay discount, a coupon for a trial sample and combinations thereof. Prescription discount cards offer patient lower drug prices by reducing pharmacy dispensing fees, using less costly outlets such as the Internet and mail order, and negotiating discounts from pharmacies and drug manufacturers.
The contents of the second compartment are concealed from view. However, in an alternative embodiment, the container may be made from transparent material in which case the contents of the second compartment are immediately visible. Alternatively, when the container is a bag, the second component may be a compartment, such as a zippered compartment or a pouch or pocket.
The sample may be held in position via tabs. Alternatively, the sample may be adhesively secured in the recess via glue or thermoplastic material, or may be secured via any other means such as VELCRO®. Alternatively, the first compartment may contain samples of more than one prescription drug, such as from two classes of drugs employed in the therapeutic regimen of a particular disease state or lifestyle decision. For example, an oral anti-hypertensive sample and a diuretic sample, or a beta-blocker sample and an ACE inhibitor sample may be provided in the first component. Nothing herein is meant to limit the contents of first compartment to a single pharmaceutical drug sample.
In another embodiment, one or more patient starter kits are positioned in a tray-organizer that holds the individual patient kits for display or storage in the sample storage area. This tray may possess two or more tabs or short protruding leg extensions at the front bottom of the tray which hangs slightly over the edge of the storage shelf. The tabs cling or grip the shelf edge to prevent the tray from sliding or being pushed back on the shelf.
Nothing herein is meant to limit the size or shape of the container. Variations in the form, proportion, size and minor details of the structure of the container may be made without departing from the spirit or sacrificing any of the advantages of the invention. The container should be readily openable, economical to produce, and lend itself to pre-printing and mass production techniques. It is understood that the container itself can be printed with advertising, “brand” identification, descriptive or identifying data relating to the contents. Further, the container of the patient starter kit of the present invention may contain a plurality of compartments for holding the patient drug and disease state information, literature and other forms of media, and related products and services.
It has been well established that that the use of patient education can improve patient knowledge of disease processes, improve clinical outcomes, and enhance overall patient satisfaction. With an increasing number of patients and the economic reality of limited physician time per patient, the physician-patient encounter often leaves patients feeling uneducated about both their disease state and medication.
The present invention provides prescription samples and educational materials, and consumer goods, products and services at the point-of-care. The patient starter kits of the present invention enhance patient compliance, adherence to therapy, and patient retention. The kits may be received by the patients from the physician at the “moment of diagnosis”, thereby enhancing the patient's “point of care” experience in the physician office.
In one embodiment, the first compartment contains an oral anti-diabetic agent, and the second compartment contains patient and disease state information, literature and other forms of media, and related products and services pertaining to the regimen for type 2 diabetes mellitus. More specifically, the second compartment includes information, literature and other forms of media, and related products and services pertaining to diet such as meal planning and carbohydrate counting, increased exercise, smoking cessation, oral hypoglycemic drugs, and risk factor management, for example, footcare and wound care, in the forms of consumer coupons and product samples.
In a second embodiment, the first compartment contains an oral anti-lipidemic drug, and the second compartment contains information, literature and other forms of media, and related products and services pertaining to diet such as low cholesterol meals, and increased dietary fiber, and cholesterol checking devices, in the form of consumer coupons or product samples.
In yet another embodiment, the first compartment contains a cardiovascular drug, and the second compartment contains education programs, self management action plans, symptom monitoring device coupons and related OTC products, in the form of consumer coupons or product samples.
In yet another embodiment, the first compartment contains a means of obtaining a prescription drug such as a coupon for a trial sample, and the second compartment contains patient education literature and coupons.
In yet another embodiment, the patient starter kit contains more than two compartments where the first compartment contains the prescription drug sample or means to obtain the sample, the second or more compartments contains the patient and disease state information, literature and other forms of media, related consumer products, consumer package goods, devices, or services (samples, coupons, or literature).
A patient starter kit where the first compartment contains an oral hypoglycemic agent such as metformin, rosglitazone, piloglitazone, glipizide, and the second compartment contains diabetic footcare educational material such as a footcare guide, instructional CD or DVD, a tube of moisturizer, a coupon for odor control foot spray, together with a pair of insoles, a nail file, and a hand mirror.
A patient starter kit where the first compartment contains an oral anti-lipidemic drug such as simvastatin, lovastatin, fenofibrate, gemfibrozil, and the second compartment contains literature pertaining to the specific pharmaceutical in the first compartment, adjunctive disease state literature for maintaining a heart healthy low-cholesterol diet, coupons for egg or butter substitutes, high grain cereals, or gym memberships, and samples of salt substitutes, aspirin 81 mg enteric coated tablets, Vitamin E or Omega 3 fatty acid capsules, smoking cessation rebate and running shoe coupons.
A patient starter kit where the first compartment contains a prescription antibiotic such as azithromycin, ciprofloxacin, erythromycin, levofloxacin, amoxacillin, and the second compartment contains an OTC antipyretic such as acetaminophen, aspirin or ibuprofen, and coupons for cough/cold products, tissues, atomizers, and humidifiers.
While this invention has been described, it will be understood that it is capable of further modification, uses and/or adaptations of the invention following in general the principal of the invention and including such departures from the present disclosure as come within known or customary practice in the art to which the invention pertains, and as may be applied to the essential features hereinbefore set forth, as fall within the scope of the invention or the limits of the appended claims.
This Application claims priority to U.S. Provisional No. 60/809,767 filed on May 31, 2006.
Number | Date | Country | |
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60809767 | May 2006 | US |